Caps for use with various injection pens and related devices and methods
The universal pen cap addresses the challenge of varying medication injection pen geometries by providing adaptable elements and electromechanical actuators, enhancing usability and reducing cognitive burden for users with diabetic fatigue syndrome.
Patent Information
- Application Number
- JP2025537883
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-27
- Filing Date
- 2023-12-27
- Publication Date
- 2026-01-16
AI Technical Summary
Existing medication injection pens have varying geometries that impose a significant cognitive burden on users, particularly those with diabetic fatigue syndrome, leading to increased learning barriers and risks of dosing errors due to the need for multiple specific caps and complex management.
A universal pen cap designed to accommodate various geometries of medication injection pens, featuring adaptable elements and electromechanical actuators for secure fitting, sensors for event detection, and a display for dosage data collection, reducing the cognitive burden and improving usability.
The universal pen cap enables consistent and predictable use across multiple pen types, reducing stress and the likelihood of dosing errors, and enhances usability for users with physical disabilities by facilitating easy attachment and detachment.
Smart Images

Figure 2026501557000001_ABST
Abstract
Description
[Technical Field]
[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medication injection pens and caps for medication therapy administration. [Background technology]
[0002] Drug injection pens (also called "drug administration pens," "administration pens," "drug injection pens," or "medication injection pens") are used to deliver a variety of drugs and are also used for drug-based therapies. For example, some therapies may include, but are not limited to, growth hormone, insulin, fertility drugs, and homozygous familial hypercholesterolemia (HoFH) treatment. Summary of the Invention
[0003] Various embodiments described below provide benefits and / or solve one or more of the foregoing or other problems in the art with devices and methods for a universal pen cap for medical injection pens. Various embodiments include a pen cap for use with an injection pen, the pen cap comprising one or more adaptable elements. The adaptable elements are configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens.
[0004] Some embodiments include a pen cap for interfacing with an injection pen, the pen cap including means for removably connecting the pen cap to a plurality of different injection pen geometries.
[0005] An additional embodiment includes a pen cap for interfacing with an injection pen, the pen cap including one or more adaptable elements configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens. Additionally, the pen cap further includes an electromechanical actuator coupled to the one or more adaptable elements and configured to actuate the one or more adaptable elements to adapt the one or more adaptable elements to a given geometry of a given injection pen.
[0006] Another embodiment includes a pen cap for interfacing with an injection pen, the pen cap comprising means for removably coupling the pen cap to a plurality of different geometries of a plurality of different injection pens, the pen cap including an electromechanical actuator operably coupled to the means and configured to at least partially effectuate the operation of the means.
[0007] Other embodiments include a method of actuating an electromechanical pen cap that includes detecting a pen cap event using one or more sensors and actuating a clasping mechanism in response to the event.
[0008] Another embodiment includes a pen cap for interfacing with a medical injection pen, the pen cap including one or more adjustable floor elements configured to adjust the distance the injection pen inserts into the pen cap, the one or more adjustable floor elements including floor block elements defining a cavity configured to accommodate the geometry of the injection pen.
[0009] Various embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]
[0010] [Figure 1A] FIG. 1 is a side view of an injection pen inserted into a conventional pen cap. [Figure 1B] FIG. 1 is a side view of an injection pen separated from a conventional pen cap. [Figure 2] FIG. 1 shows multiple injection pens with interrelated conventional pen caps. [Figure 3A] FIG. 1 is a side view of a universal pen cap in a disengaged configuration according to one or more embodiments of the present disclosure. [Figure 3B] FIG. 3B is a side view of the universal pen cap shown in FIG. 3A in an engaged configuration. [Figure 4A] FIG. 10 is a side view of a universal pen cap according to one or more additional embodiments of the present disclosure. [Figure 4B] FIG. 4B is a perspective view of the universal pen cap of FIG. 4A with a housing thereon. [Figure 5A] FIG. 5 is an enlarged perspective view of a cam element of the universal pen cap of FIG. 4. [Figure 5B] FIG. 5 is an enlarged perspective view of the cam assembly of the universal pen cap of FIG. 4 in a first orientation. [Figure 5C] FIG. 4B is an enlarged perspective view of the cam assembly of the universal pen cap of FIG. 4A in a second orientation. [Figure 6A] FIG. 1 is a side view of a universal pen cap in a disengaged position according to one or more embodiments of the present disclosure. [Figure 6B] FIG. 6B is a cross-sectional view of the universal pen cap of FIG. 6A in a disengaged position. [Figure 6C] FIG. 6C is a cross-sectional view of the universal pen cap of FIGS. 6A and 6B in an engaged position. [Figure 7A] FIG. 1 is a side view of a universal pen cap according to one or more embodiments of the present disclosure disengaged from an injection pen. [Figure 7B] FIG. 7B is a cross-sectional side view of the universal pen cap of FIG. 7A. [Figure 7C] 7B is a front view of the universal pen cap of FIG. 7A taken along the central longitudinal axis of the universal pen cap. [Figure 8]FIG. 7B is a box diagram illustrating an operable connection between the universal pen cap of FIG. 7A and an electromechanical actuator in accordance with one or more embodiments of the present disclosure. [Figure 9A] FIG. 1 is a perspective view of a universal pen cap according to one or more embodiments of the present disclosure. [Figure 9B] FIG. 9B is a cross-sectional side view of the universal pen cap of FIG. 9A extended over an injection pen. [Figure 10A] FIG. 1 is a side view of a universal pen cap according to one or more embodiments of the present disclosure. [Figure 10B] FIG. 10B is a cross-sectional side view of the universal pen cap of FIG. 10A according to one or more embodiments. [Figure 11A] FIG. 1 is a perspective view of a universal pen cap and multiple injection pens according to one or more embodiments of the present disclosure. [Figure 11B] FIG. 11B is a cross-sectional side view of the universal pen cap and multiple injection pens of FIG. 11A. [Figure 11C] FIG. 11B is a cross-sectional side view of the universal pen cap of FIG. 11A with an injection pen inserted therein. [Figure 12] FIG. 1 is a perspective view of a universal pen cap according to one or more embodiments of the present disclosure. [Figure 13A] FIG. 1 is a perspective view of a universal pen cap according to one or more embodiments. [Figure 13B] FIG. 13B is a front view of the universal pen cap of FIG. 13A in a disengaged configuration. [Figure 13C] FIG. 13B is a front view of the universal pen cap of FIG. 13A in an engaged configuration. [Figure 14] FIG. 13B is a box diagram illustrating the operable connection between the universal pen cap of FIG. 13A and an electromechanical actuator. [Figure 15A] FIG. 1 is a perspective view of a universal pen cap in a disengaged configuration according to one or more embodiments of the present disclosure. [Figure 15B]FIG. 15B is a perspective view of the universal pen cap of FIG. 15A in an engaged configuration according to one or more embodiments. [Figure 15C] 15B is a cross-sectional side view of the universal pen cap of FIG. 15A engaging an injection pen, according to one or more embodiments. [Figure 16] FIG. 15B is a box diagram illustrating the operable connection between the universal pen cap of FIG. 15A and an electromechanical actuator. [Figure 17] FIG. 1 is a cross-sectional side view of a universal pen cap according to one or more embodiments of the present disclosure. [Figure 18A] FIG. 1 is a perspective view of a universal pen cap according to one or more embodiments of the present disclosure. [Figure 18B] 18B is a front view of the universal pen cap of FIG. 18A looking down the longitudinal axis of the universal pen cap. FIG. [Figure 19A] FIG. 1 is a perspective view of a universal pen cap in an engaged configuration according to one or more embodiments. [Figure 19B] FIG. 19B is a perspective view of the universal pen cap of FIG. 19A in a disengaged configuration. [Figure 20A] FIG. 1 is a perspective view of a universal pen cap in an engaged configuration according to one or more embodiments of the present disclosure. [Figure 20B] FIG. 20B is a perspective view of the universal pen cap of FIG. 20A in a disengaged configuration. [Figure 21A] FIG. 1 is a perspective view of a universal pen cap according to one or more embodiments of the present disclosure. [Figure 21B] FIG. 21B is a side view of the universal pen cap of FIG. 21A with an injection pen inserted therein. [Figure 21C] FIG. 22C is a side view of the universal pen cap of FIGS. 21A and 22B in a disengaged state. [Figure 21D] FIG. 21D is a side view of the universal pen cap of FIGS. 21A-21C in an engaged state. [Figure 21E] FIG. 21B is a perspective view of the universal pen cap of FIGS. 21A-21D in an engaged state. [Figure 22A] FIG. 21C is a side view of a pen click mechanism that can be used with the universal pen cap of FIGS. 21A and 21B. [Figure 22B] FIG. 22B is a perspective view of the pen click mechanism of FIG. 22A in a disengaged position. [Figure 22C] FIG. 22B is a perspective view of the pen click mechanism of FIG. 22A in an engaged position. [Figure 23A] FIG. 1 is a perspective view of a universal pen cap having an electromechanical actuator according to one or more embodiments of the present disclosure. [Figure 23B] FIG. 23B is a cross-sectional perspective view of the universal pen cap of FIG. 23A. [Figure 24] FIG. 1 illustrates a semi-transparent side view of a floor block element according to one or more embodiments of the present disclosure. [Figure 25A] FIG. 1 is a semi-transparent side view of a universal pen cap with an adjustable floor element according to one or more embodiments of the present disclosure. [Figure 25B] FIG. 25B is an exploded side view of the universal pen cap with adjustable floor element of FIG. 25A. [Figure 26A] 10A-10C illustrate a floor block element partially inserted into a universal pen cap, according to one or more embodiments. [Figure 26B] FIG. 26B shows the floor block element of FIG. 26A with an injection pen inserted therein. [Figure 27A] FIG. 1 is a cross-sectional side view of a universal pen cap including an adjustable floor system in a first position according to one or more embodiments of the present disclosure. [Figure 27B] FIG. 27B is a cross-sectional side view of the universal pen cap of FIG. 27A including the adjustable floor system in a second position. [Figure 28A] FIG. 1 is a cross-sectional side view of a universal pen cap including an adjustable floor system in a first position according to one or more embodiments of the present disclosure. [Figure 28B] FIG. 28B is a cross-sectional side view of the universal pen cap of FIG. 28A including the adjustable floor system in a second position. [Figure 29] FIG. 1 is a cross-sectional side view of a universal pen cap including an adjustable floor system according to one or more embodiments of the present disclosure. [Figure 30] FIG. 1 is a flow diagram of a method of operation of the universal pen cap in accordance with one or more embodiments of the present disclosure. [Figure 31] FIG. 1 is a block diagram of an exemplary system including a universal pen cap, one or more sensors, and an electromechanical actuator, according to one or more examples. [Figure 32] FIG. 1 is a flow diagram of a method for actuating one or more adaptable elements of a universal pen cap. [Figure 33] FIG. 1 is a flow diagram of a method for actuating one or more adaptable elements of a universal pen cap. [Figure 34] FIG. 1 is a flow diagram of an exemplary computing device in accordance with one or more embodiments. [Figure 35] FIG. 1 is a schematic diagram of an exemplary computing device in accordance with one or more embodiments. [Figure 36A] FIG. 10 is a side exploded view of a portion of a universal pen cap according to another embodiment. [Figure 36B] FIG. 36B is a side exploded view of the clamping mechanism of the universal pen cap shown in FIG. 36A. [Figure 36C] FIG. 36B is a side exploded view of the clicker mechanism of the universal pen cap shown in FIG. 36A. [Figure 37A] FIG. 1 is a front perspective view of a pen clamp according to one embodiment. [Figure 37B] FIG. 12 is a front perspective view of two pen clamps that clamp a dispensing pen, according to one embodiment. [Figure 38] FIG. 1 is a side perspective view of a portion of a universal pen cap, according to one embodiment. [Figure 39A-1] FIG. 10 is a side view of a clicker mechanism in state O, according to one embodiment. [Figure 39A-2] FIG. 10 is a schematic diagram of a clicker mechanism in state O, according to one embodiment. [Figure 39B-1] FIG. 1 is a side view of a clicker mechanism in state 1, according to one embodiment. [Figure 39B-2] FIG. 1 is a schematic diagram of a clicker mechanism in state 1, according to one embodiment. [Figure 39C-1] FIG. 10 is a side view of a clicker mechanism in state 2, according to one embodiment. [Figure 39C-2] FIG. 10 is a schematic diagram of a clicker mechanism in state 2, according to one embodiment. [Figure 39D-1] FIG. 10 is a side view of the clicker mechanism in state 2.5, according to one embodiment. [Figure 39D-2] FIG. 10 is a schematic diagram of the clicker mechanism in state 2.5, according to one embodiment. [Figure 39E-1] FIG. 10 is a side view of a clicker mechanism in state 3, according to one embodiment. [Figure 39E-2] FIG. 10 is a schematic diagram of a clicker mechanism in state 3, according to one embodiment. [Figure 39F-1] FIG. 10 is a side view of a clicker mechanism in state 4, according to one embodiment. [Figure 39F-2] FIG. 10 is a schematic diagram of a clicker mechanism in state 4, according to one embodiment. [Figure 40A] FIG. 10 is a front view of a second clicker body of the clicker mechanism as viewed from the central longitudinal axis of the universal pen cap, according to one embodiment. [Figure 40B] 40B is a front view of a first clicker body of a clicker mechanism interacting with a second clicker body shown in FIG. 40A viewed from the central longitudinal axis of the universal pen cap, according to one embodiment. FIG. [Figure 41] FIG. 10 is an interior side view of a portion of a universal pen cap having an access wall, according to one embodiment. [Figure 42] FIG. 1 is a top perspective view of a portion of a universal pen cap, according to one embodiment. [Figure 43] FIG. 10 is a side view of a friction clamp used to clamp a dispensing pen, according to one embodiment. [Figure 44A]44 is a front view of the friction fastener shown in FIG. 43 clamping the dispensing pen in a first orientation, viewed from the central longitudinal axis of the universal pen cap, according to one embodiment. [Figure 44B] 44 is a front view of the friction fastener shown in FIG. 43 clamping the dispensing pen in a second orientation, viewed from the central longitudinal axis of the universal pen cap, according to one embodiment. [Figure 44C] FIG. 44 is a front view of the friction fastener shown in FIG. 43 clamping the dispensing pen in a third orientation, viewed from the central longitudinal axis of the universal pen cap, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION
[0011] The diagrams presented herein are not actual diagrams of any infusion delivery and data collection system or any components of this system, but rather are merely idealized representations used to explain the present invention.
[0012] Diabetes mellitus is a chronic metabolic disorder caused by the inability of the pancreas to produce sufficient amounts of the hormone insulin, resulting in the inability of the body's metabolism to adequately absorb sugars and starches. This inability to absorb these carbohydrates can lead to hyperglycemia, i.e., excessive glucose in the blood plasma. Hyperglycemia is associated with a variety of serious and life-threatening long-term complications, including dehydration, ketoacidosis, diabetic coma, cardiovascular disease, chronic renal failure, retinal damage, and nerve damage, which can lead to limb amputation.
[0013] Permanent treatment is often required to maintain appropriate blood glucose levels (the amount of glucose in a person's bloodstream or a glucose value representing this (also referred to herein as an "estimated glucose value"), e.g., blood glucose levels measured by a blood glucose meter or glucose levels generated by a glucose monitor) within a normal range. Maintaining appropriate glucose levels is traditionally achieved by regularly providing insulin to the person with diabetes (PWD). Maintaining appropriate glucose levels can pose a significant cognitive burden for the PWD (or caregiver) and affect many aspects of the PWD's life. For example, the cognitive burden on the PWD can result from, among other things, tracking meals and constant check-ins, and micro-correction of glucose levels. Regulating glucose levels by the PWD can include taking insulin, tracking insulin doses and glucose, determining how much insulin to take, how often to take insulin, where to inject insulin, and how to time insulin doses relative to meals and / or glucose excursions.
[0014] The following example of a typical daily routine for a PWD further illustrates the significant cognitive burden on the PWD: In the morning, the first thought / action by the PWD is often related to the PWD's glucose, such as, "What is the PWD's glucose level?" What were the PWD's glucose levels overnight? And how is the PWD feeling now? After checking the PWD's glucose level (e.g., using a blood glucose meter or monitor), the PWD can then consider what action to take, such as adjusting their morning activities, changing when or what they eat for breakfast, or deciding to take rapid-acting (RA) insulin and where to inject it. Before the PWD eats breakfast (or any meal), the PWD considers the amount and type of food they intend to eat and perhaps modifies the PWD's RA insulin dose based on the carbohydrate content of the foods they choose to eat. Before the PWD administers RA insulin, the PWD tries to remember when the PWD took their last dose of insulin, what happened the last time the PWD ate a particular meal, and how the PWD felt.
[0015] Before leaving the home, PWDs consider, among other things, whether they have sufficient supplies for glucose monitoring or insulin administration. This can include batteries, charging devices, backup supplies, glucose testing supplies, and insulin supplies to treat high glucose levels. Additionally, PWDs should consider any physical activity that affects their glucose (e.g., walking children to school, going to the gym, riding a bicycle) because exercise can cause their blood glucose to drop lower than expected. Even before driving a vehicle, PWDs should check their glucose to determine if it is at a safe level for driving.
[0016] As lunchtime approaches, the PWD considers their glucose before eating lunch, for example, what time they might expect to eat, what they expect to eat throughout the day, etc. Thus, the PWD tallies carbohydrates and adjusts their insulin dose in their head. The PWD also considers which insulin doses have been taken recently and whether those doses may still be working to lower blood glucose. Because this is all happening in tandem with whatever the PWD is doing during their busy day, the PWD often forgets or fails to fully consider all of the above factors.
[0017] Throughout the day, PWDs often check their glucose levels, especially on days when their activities differ from a typical day. This constant thinking, checking, and planning can be extremely exhausting, especially when each check requires decisions, math, and possible behavioral changes. Additionally, during the day, PWDs may check their supply inventory, speak with their healthcare providers (HCPs), refill prescription medications, and contact their health plan to discuss their treatment and / or supplies.
[0018] In the evening, the PWD may have to take their daily insulin dose of long-acting (LA) insulin. Additionally, the PWD may determine if their glucose is stable before falling asleep. If they use an infusion pump, the PWD must check if their insulin pump is low on insulin and if they need to top up before sleep. If the PWD has a continuous glucose monitor, the PWD must ensure that the monitor is functioning. Even then, based on what the PWD eats for dinner, the nighttime insulin may not be able to keep the PWD's glucose stable. Nighttime glucose levels can disrupt sleep and add anxiety that can disrupt sleep.
[0019] Therefore, managing diabetes requires considerable attention to detail throughout the day. Even with careful planning and self-monitoring, PWDs may skip doses, double doses, or administer the wrong amount and / or type of insulin. Insufficient insulin can lead to hyperglycemia, and too much insulin can lead to hypoglycemia, which can result in clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or death.
[0020] One of the most common methods of administering insulin doses involves using a drug delivery pen (a drug delivery pen utilized to administer insulin may be referred to herein as an "insulin pen"). Because PWDs may need to take insulin immediately, they are often forced to carry one or more drug delivery pens (see, e.g., FIGS. 1A and 1B). Delivery pens often include a cap to improve portability, prevent loss of the medication contained therein, and protect against accidental puncture or injection. In addition to the various types of drugs / medications (e.g., various types of insulin) that can be contained in delivery pens, the geometries of different delivery pens can vary greatly. As shown in FIGS. 1A and 1B, a delivery pen 100 is provided. The delivery pen 100 includes a pen cap 102 having a cap clip 104 and a delivery pen body 110. The delivery pen body 110 includes a cartridge holder 112 for receiving a removable pen cartridge 115 and plunger 113, a dose knob 114, and a dose window 116 having a dose indicator 118. The delivery pen body 110 also includes a rubber seal 120 located at the opposite end of the dose knob 114 adjacent where the removable pen cartridge 115 is located. For example, delivery pens may differ in pen barrel diameter, pen barrel length, label placement, nib geometry, nib placement, and other features. Furthermore, different brands of insulin pens may have significantly different insulin pen shape characteristics, even for insulin pens with the same insulin dose type (see, e.g., FIG. 2). In particular, FIG. 2 shows a Toujeo® Max SoloStar® insulin pen 200, a Tresiba® FlexTouch® U-200 insulin pen 205, a Toujeo® SoloStar® insulin pen 210, a Lantus® SoloStar® U-100 insulin pen 215, and a Tresiba® FlexTouch® U-100 insulin pen 220.Additionally, over the course of treatment, users may switch between multiple insulin brands based on, but not limited to, insurance, treatment, and preference. Typically, each dispensing pen has its own unique pen cap that is specifically designed to work with the geometry of the dispensing pen. Thus, a PWD may have multiple dispensing pens, and the caps for each dispensing pen may vary widely in shape and size.
[0021] A challenge for many PWD is diabetic fatigue syndrome (DFS). DFS is a multifactorial syndrome commonly associated with increased fatigue or fatigability in people with diabetes. The plethora of different insulin pens (including potentially widely varying geometries between pens) can increase the learning barrier for users as well as the cognitive burden of managing their diabetes on top of an already overwhelming list of tasks PWDs must worry about on a daily basis. These issues are exacerbated for users with DFS or other cognitive impairment conditions. Due to the highly specific dosing requirements for treating diabetes with insulin, these learning and cognitive burdens imposed by the various physical characteristics of insulin pens can create a greater risk of dosing errors or lead to an inability to apply the dose, which, as discussed above, can result in clumsiness, difficulty speaking, confusion, loss of consciousness, seizures, or even death.
[0022] Embodiments of the present disclosure include a universal pen cap adapted to accept a plurality of medication injection pens (e.g., insulin injection pens) having various geometries, particularly at their tips. For example, a universal pen cap for use with injection pens includes one or more adaptable elements arranged to removably couple the universal pen cap to a plurality of different geometries of a plurality of different injection pens. In various embodiments, the universal pen cap includes a mechanical actuator configured to modify the one or more adaptable elements. In various embodiments, the universal pen cap includes an electromechanical actuator coupled to the one or more adaptable elements for modifying the elements. The electromechanical actuator is adapted to actuate the one or more adaptable elements to adjust the one or more adaptable elements to a selected geometry that matches, e.g., substantially matches, a given geometry of a given injection pen, particularly a given geometry of its tip. In various embodiments, the universal pen cap includes one or more sensors for detecting various pen cap events, such as disengagement of the universal pen cap from the pen or engagement of the universal pen cap to the pen. The one or more sensors are configured to enable the universal pen cap to automatically configure the universal pen cap in response to a sensing action by a user. In various embodiments, the universal pen cap includes an adjustable floor element that adjusts the distance an injection pen is inserted into the universal pen cap. The adjustable floor element is configured to be mechanically adjusted by a user or electromechanically adjusted by an electromechanical actuator operably coupled to the adjustable floor element. In various embodiments, the universal pen cap includes one or more batteries for powering various elements (e.g., without limitation, the electromechanical actuators) included within the universal pen cap.
[0023] Additionally, in various embodiments, a universal pen cap for an injection pen (e.g., an insulin pen) is configured for dosage data collection. In various embodiments, the universal pen cap includes a display screen for displaying one or more of estimated glucose values (EGV), units of EGV, a trend indicator for EGV, a recommended dose, an identification of insulin type, a recommended injection site, the time and amount of previous doses, and / or an on-board insulin value to remind the user of their most recent dose. In various embodiments, the universal pen cap includes buttons for receiving meal information, insulin dosage information, a response to a recommendation, etc. from the user. In various embodiments, the buttons are selected from physical buttons, capacitive or resistive touch buttons, buttons on a display, or a combination / subcombination thereof. In various embodiments, the display screen includes a touch screen configured to include one or more capacitive touch buttons in its user interface. In various embodiments, the universal pen cap for dose collection includes one or more indicator lights configured to illuminate to indicate that the pen cap is transferring data, illuminate to indicate that user attention is required, and / or illuminate to indicate whether the dose collection function is active.
[0024] Embodiments of the disclosed universal pen cap may be advantageous over conventional injection pen caps typically used with medication / drug injection pens. For example, conventional approaches, such as having a pen cap designed to fit only one specific pen shape, can impose cognitive burden on PWDs, particularly those with DFS, who attempt to manage multiple different injection pens, in addition to the already cognitively demanding task inherent in managing diabetes. In contrast, the disclosed universal pen cap is adapted for use with many types of injection pens having various geometries, thus enabling PWDs to use the disclosed universal pen cap with one or more of numerous types of pens, resulting in consistency, predictability, and reusability for PWDs, thereby reducing the cognitive burden placed on PWDs, particularly in their daily insulin management. This reduction in cognitive burden can result in reduced stress, allow for faster and easier application of medication doses, and reduce the likelihood of failing to apply the required medication dose. Furthermore, the inclusion of sensors and electromechanical actuators in various embodiments allows for automated insertion and removal of the injection pen, and thus can provide additional benefits, including greater usability, particularly for PWDs who may have mild to severe physical disabilities that can make it difficult to remove conventional pen caps that are typically pressure-fit onto injection pens. For example, a PWD with a DFS may struggle to remove a conventional pen cap because their physical condition may prevent them from generating sufficient gripping force to grasp and pull the pen cap from the injection pen. In contrast, various embodiments herein can enable removal of a universal pen cap, requiring relatively little physical effort by the user.
[0025] 3A is a side view of a universal pen cap 300 in a disengaged configuration according to one or more embodiments of the present disclosure. FIG. 3B is a side view of the universal pen cap 300 of FIG. 3A in an engaged configuration. Referring to both FIGS. 3A and 3B, in various embodiments, the universal pen cap 300 includes at least one compression actuator 302, an actuation arm 304, and an engagement member 306 operably coupled to the compression actuator 302. In various embodiments, the at least one compression actuator 302 is adapted to swing the engagement member 306 radially inward toward a central longitudinal axis of the universal pen cap 300 and engage (e.g., contact) the pen 308 in response to displacement of one or more portions of the at least one compression actuator 302, such as when an injection pen 308 is inserted into the universal pen cap 300 and pressed against the at least one compression actuator 302.
[0026] In various embodiments, the actuation arms 304 are rotatably coupled to the engagement members 306 at respective longitudinal ends of the actuation arms 304. For example, in various embodiments, the actuation arms 304 are coupled to the engagement members 306 via a hinge connection. Each actuation arm 304 includes an arm 314 and a biasing element 310 (e.g., without limitation, a spring). In various embodiments, the biasing element 310 is oriented along the longitudinal axis of the arm 314 and configured to compress in response to actuation of the compression actuator 302, thereby causing the actuation arm 304 to bias the engagement members 306 radially inward and at least partially engage the engagement members 306 with the injection pen 308. Thus, when the universal pen cap 300 is in the disengaged position (e.g., as shown in FIG. 3A ), an injection pen (e.g., injection pen 308) can be inserted into the universal pen cap 300, which, when substantially inserted, displaces at least a portion of the compression actuator 302, thereby compressing the biasing element 310 of the actuation arm 304 and causing the engagement member 306 to pivot and rotate radially inward toward the central longitudinal axis of the universal pen cap 300 and engage the injection pen.
[0027] In various embodiments, the compression actuator 302 includes an end portion, a contact portion, a biasing element, and one or more connecting arms. The end portion is configured to receive the engagement portion. The contact portion is configured for the injection pen 308 to contact, such as at its end tip, and move axially relative to the end portion. The one or more connecting arms extend from the contact portion in an axial direction opposite the end portion. The biasing element is axially disposed between the end portion and the contact portion and is configured to bias the contact portion axially away from the end portion. In these embodiments, the engagement member 306 includes a connecting portion and an engaging portion. The connecting portion rotatably connects to one or more connecting arms, such as at the distal ends of the one or more connecting arms via a joint. In these embodiments, the connecting portion includes an annular shape, e.g., approximately semi-annular, with connections at its ends to the one or more connecting arms. In the illustrated embodiment, each end of the connecting portion is rotatably coupled to the distal ends of the connecting arms, and each connecting arm is on either side of the universal pen cap 300, circumferentially offset by, e.g., 180 degrees or approximately 180 degrees. The engagement portion extends axially from the connecting portion in a direction opposite the end portion. In the illustrated embodiment, the engagement portion is circumferentially offset by 90 degrees or approximately 90 degrees from the end and from the joint formed with each connecting arm. When the engagement portion is offset by 90 degrees or approximately 90 degrees from the joint the connecting portion forms with the distal end of the connecting arm, rotation of the engagement member 306 about the joint causes radial movement of the distal end of the engagement portion (distal to the connecting portion) to enable the engagement member 306 to securely clamp an injector pen 308 inserted within the universal pen cap 300. In various embodiments, the engagement member 306 further includes a clamping portion that projects radially inward from the distal end of the engagement portion. In various embodiments, the clamping portion is adapted to directly contact the injector pen 308 and clamp the injector pen 308 with sufficient force to secure the injector pen within the universal pen cap 300. In various embodiments, the universal pen cap 300 includes a plurality of actuation arms 304, each actuation arm circumferentially aligned with an engagement portion.In the illustrated embodiment, the corresponding actuation arm 304 of the rotatable connection between the actuation arm 304 and the engagement portion is formed at a joint located between the distal and proximal ends of the engagement portion. In various embodiments, engagement between the injector pen 308 and the contact portion causes the contact portion to compress a biasing element and move axially toward the end portion, causing the connecting arm to also move axially toward the end portion. Due to the connection portion to the connecting arm and the connection portion to the actuation arm 304, the axial movement of the connecting arm rotates the distal end of the engagement portion radially inward and contacts the injector pen 308, securing the injector pen within the universal pen cap 300.
[0028] In various embodiments, when the universal pen cap 300 is in the engaged position (e.g., as shown in FIG. 3B ), subsequent actuation of the actuated compression actuator 302 pivots and rotates the biasing element 310 radially outward, thereby reducing the inward radial force exerted by the actuation arm 304 on the engagement member 306 and releasing the injection pen 308, allowing removal of the injection pen 308.
[0029] FIG. 4A is a side view of a universal pen cap 400 according to one or more embodiments. FIG. 4B shows a perspective view of the universal pen cap of FIG. 4A with a housing thereon. With reference to FIGS. 4A and 4B, in various embodiments, the universal pen cap 400 includes an engagement member 406, an actuation arm 404, a cam element 402, a guide element 412, an interface element 414, and a body frame 416. In various embodiments, the engagement member 406 is rotatably coupled to the actuation arm 404, which is attached to the body frame 416. The engagement member 406 is configured to pivot relative to the actuation arm 404. The interface element 414 is sized and shaped to abut a longitudinal end of the injector pen 410 when the injector pen 410 is inserted into the universal pen cap 400. The interface element 414 is coupled to the engagement member 406 and the guide element 412. Additionally, the interface element 414 is coupled to the body frame 416 via one or more biasing elements 408, which bias the interface element 414 axially relative to the body frame 416 (e.g., in a direction opposite to the direction in which the injection pen 410 is inserted into the universal pen cap 400). The engagement member 406 is configured to pivot relative to the interface element 414. The guide element 412 is rotatably coupled to the interface element 414 and engages a cam element 402, which will be described in more detail below. While a particular cam element 402 is shown in Figures 4A-5C, one skilled in the art will appreciate that other types of cam elements may be used in actuating the universal pen cap 400.
[0030] In various embodiments, the engagement member 406 is sized and shaped to engage the injector pen 410. For example, the engagement member 406 is sized and shaped to define an opening sized to receive the injector pen 410 therebetween. In various embodiments, the engagement member 406 has a general jaw shape and is configured to clamp onto the injector pen 410 during operation. In the illustrated embodiment, engagement between the injector pen 410 and the interface element 414 causes the interface element to translate axially toward the body frame 416. Translation of the interface element 414 also causes the joint between the interface element 414 and the engagement member 406 to move axially toward the body frame 416. The axial movement of these joints rotates the engagement member 406 relative to the actuation arm 404 at the joint therebetween and also moves the joint between the engagement member 406 and the actuation arm 404 radially inward. This radially inward movement rotates the actuation arm 404 relative to the body frame 416. Relative movement of the components causes engagement members 406 to move radially inward and contact injector pen 410 to secure injector pen 410 within universal pen cap 400, such as by clamping.
[0031] In various embodiments, the actuation arm 404 includes one or more biasing members that bias the engagement member 406 to which the actuation arm 404 is coupled in one or more directions away from the body frame 416. The actuation arm 404 is coupled to the engagement member 406 at a radially outermost portion of the engagement member 406 such that when the engagement member 406 pivots relative to the actuation arm 404, the engagement member 406 rotates radially inward or outward.
[0032] 4B, in various embodiments, the universal pen cap 400 includes a housing 418 configured to house various elements of the universal pen cap 400 (e.g., without limitation, the engagement member 406, the actuation arm 404, the cam element 402, the guide element 412, the interface element 414, and the body frame 416). Although the housing 418 is shown with respect to one or more embodiments in FIGS. 4A and 4B, the housing 418 or a similar housing can be utilized in various embodiments disclosed herein.
[0033] Figure 5A is a close-up perspective view of cam element 402 according to one or more embodiments. Figure 5B is a close-up view of cam element 402 and guide element 412 when universal pen cap 400 is in a disengaged configuration according to one or more embodiments. Figure 5C is a close-up view of cam element 402 and guide element 412 when universal pen cap 400 is in an engaged configuration according to one or more embodiments.
[0034] 4-5C , in various embodiments, the cam element 402 includes a groove passage 502 having a first passage 504 and a second passage 506 formed therein. The first passage 504 generally includes a general hook shape that starts in a first direction and curves back in a second direction opposite the first direction, and the second passage 506 includes a general hook shape or an inverted hook shape. The first passage 504 and the second passage 506 are connected to each other at opposite longitudinal ends of the first passage 504 and the second passage 506 such that the first passage 504 and the second passage 506 together form a generally heart-shaped groove, and the second passage 506 generally mirrors the first passage 504. The cam element 402 is adapted to guide movement of the pin of the guide element 412 along the first path 504 from the first rest area 508 to the second rest area 510 and along the second path 506 from the second rest area 510 to the first rest area 508. In various embodiments, the groove passage 502 is formed to prevent the pin from entering the second path 506 from the first rest area 508 and from entering the first path 504 from the second rest area 510.
[0035] The first path 504 includes a first stationary region 508, a first sloped region 524, a first ridge 522, a first recess 512, and a second ridge 526. The second path 506 includes a second stationary region 510 connected to the second ridge 526 of the first path 504, a second sloped region 528, a second recess 514, and a third sloped region 530 connected to the first stationary region 508 of the first path.
[0036] The first sloped region 524 of the first path 504 extends from the first resting region 508 to the first ridge 522. The depth of the first sloped region 524 relative to the top surface of the cam element 402 decreases from the first resting region 508 to the first ridge 522. In various embodiments, the slope of the first sloped region 524 is such that the pin of the guide element 412 does not get stuck or stall on the first sloped region 524 due to friction between the pin and the surface of the first sloped region 524. In various embodiments, the slope of the first sloped region 524 is variable. The first recess 512 is adjacent to the first ridge 522 and is formed at a lower depth relative to the top surface than the first ridge 522. The depth difference formed between the first ridge 522 and the first recess 512 is configured to prevent the pin of the guide element 412 from traveling from the first recess 512 to the first ridge 522. The first ridge 522 terminates at an abrupt edge where the first path 504 transitions from the first ridge 522 to the first recess 512. For example, the first recess 512 includes a greater depth relative to the first ridge 522 such that as the pin of the guide element 412 travels along the first path 504, the pin rises along the first sloped region 524 from the first rest region 508 up to the first ridge 522 and then drops into the first recess 512. The second ridge 526 slopes upward from the first recess 512 toward the second path 506. The second ridge 526 is formed with a variable slope. The second ridge 526 abruptly terminates at an edge (e.g., a cliff edge) at the second rest region 510 of the second path 506, the edge being formed at a depth greater than the depth of the end of the second ridge 526 adjacent to the first ridge 522. The second rest region 510 is formed at a depth less than the edge of the second ridge 526. The depth difference formed between the second rest region 510 and the second ridge 526 is such that the pin of the guide element 412 is prevented from traveling from the second rest region 510 to the second ridge 526.
[0037] The second sloped region 528 of the second path 506 slopes upward from the second rest region 510 and terminates abruptly at the edge (e.g., cliff edge) of the second recess 514 of the second path 506, the edge being formed at a depth greater than the end adjacent the second rest region 510 and greater than the second recess 514. The depth difference formed between the second recess 514 and the edge of the second sloped region 528 is configured to prevent the pin of the guide element 412 from traveling from the second recess 514 to the second sloped region 528. In various embodiments, the end adjacent the second rest region 510 includes an edge having a shallower depth than the second rest region 510. This edge is configured to prevent the pin of the guide element 412 from exiting the second rest region 510 without a force being applied to the pin. The third sloped region 530 of the second path 506 extends from the second recess 514 toward the first rest region 508 and abruptly terminates at an edge (e.g., a cliff edge) at the first rest region 508 of the first path 504. The depth of the third sloped region 530 relative to the top surface of the cam element 402 decreases from the second recess to the edge of the third sloped region 530. In various embodiments, the slope of the third sloped region 530 is such that the pin of the guide element 412 does not get stuck or stall on the third sloped region 530 due to friction between the pin and the surface of the third sloped region 530. In various embodiments, the slope of the third sloped region 530 is variable. The depth difference between the first rest region 508 and the edge of the third sloped region 530 is such that the pin of the guide element 412 cannot travel from the first rest region 508 to the third sloped region 530.
[0038] 4-5C together, in operation, when the engagement member 406 is in the disengaged configuration, the injector pen 410 is inserted into the universal pen cap 400 in a first axial direction (e.g., a direction extending into the universal pen cap 400). In various embodiments, during insertion of the injector pen 410 into the universal pen cap 400, the injector pen 410 abuts the interface element 414, causing the interface element 414 to translate in the first axial direction along the central longitudinal axis of the universal pen cap 400. Translating the interface element 414 in the first axial direction along the central longitudinal axis of the universal pen cap 400 causes the interface element 414 to pull the engagement member 406 and push the guide element 412 in the first axial direction. Pulling the engagement member 406 causes the engagement member 406 to pivot about its connection with the actuation arm 404 and rotate radially inward toward the injector pen 410.
[0039] Further, in various embodiments, pushing the guide element 412 in the first axial direction causes the pin of the guide element 412 to travel along the first path 504 from the first rest region 508, along the first sloped region 524 to the first ridge 522, and into the first recess 512. The first recess 512 is configured to provide a mechanical stop for the pin of the guide element 412 and to prevent further movement of the guide element 412 in the first axial direction. As a result, stopping the pin of the guide element 412 in the first recess 512 is configured to provide feedback to the user that the injection pen 410 is fully inserted into the universal pen cap 400.
[0040] Furthermore, when the user releases the injection pen 410, the biasing element 408 is configured to translate the interface element 414 at least some distance in a second axial direction opposite the first axial direction along the central longitudinal axis of the universal pen cap 400. Translating the interface element 414 in the second axial direction along the central longitudinal axis of the universal pen cap 400 causes the interface element 414 to pull the guide element 412 in the second axial direction. Pulling the guide element 412 in the second axial direction causes the pin of the guide element 412 to travel from the first recess 512, along the second ridge 526, and into the second rest area 510, and further, the bias provided by the biasing element 408 is configured to at least substantially prevent the pin from moving away from the second rest area 510 without intentional interaction by the user. The edge formed between the second rest area 510 and the second sloped area 528 is configured to further substantially prevent the pin from exiting the second rest area 510 without intentional interaction by a user. Furthermore, one skilled in the art will recognize that the edge at the interface of the first ridge 522 and the first recess 512 are configured to prevent the pin of the guide element from traveling backward along the first path 504. Similarly, the biasing member 704 and the first sloped area 524 provide resistance to the pin of the guide element 412 traveling along the first path 504 such that the pin of the guide element 412 typically does not travel along the first path 504 unintentionally. Furthermore, the edge at the interface of the first ridge 522 and the first recess 512 are configured to provide an audible and tactile feedback click to the user when the injection pen 410 is fully inserted into the universal pen cap 400. Additionally, the edge at the interface of the second ridge 526 and the second rest area 510 is configured to provide an audible and tactile feedback click to the user indicating that the engagement member 406 is fully engaged with the injector pen 410. For example, when the pin of the guide element 412 is within the second rest area 510, the universal pen cap 400 is in the engaged configuration and is configured to secure the injector pen 410 with the engagement member 406.
[0041] Furthermore, when the pin of the guide element 412 is within the second rest region 510, the user can subsequently press the injector pen 410 in the first axial direction, causing the guide element 412 to translate in the first axial direction, thereby causing the pin of the guide element 412 to travel along the second path 506 from the second rest region 510 along the second sloped region 528 and into the second recess 514. The second recess 514 is configured to provide a mechanical stop for the pin of the guide element 412 and to further impede movement of the guide element 412 in the first axial direction. As a result, stopping the pin of the guide element 412 in the second recess 514 is configured to provide feedback to the user that the injector pen 410 has been pressed sufficiently to allow the universal pen cap 400 to move into the disengaged configuration.
[0042] Thus, when the user releases the injector pen 410, the biasing element 408 is configured to translate the interface element 414 in a second axial direction along the central longitudinal axis of the universal pen cap 400. Translating the interface element 414 in the second axial direction along the central longitudinal axis of the universal pen cap 400 causes the interface element 414 to push against the engagement member 406. Pushing the engagement member 406 is configured to pivot the engagement member 406 about its connection with the actuation arm 404 and rotate radially outward, away from the injector pen 410. Furthermore, translating the interface element 414 in the second axial direction along the central longitudinal axis of the universal pen cap 400 causes the interface element 414 to pull the guide element 412 in the second axial direction. Pulling guide element 412 in the second axial direction causes the pin of guide element 412 to travel along second path 506 from second recess 514, along third sloped region 530 to third ridge 532, and into first rest region 508. When the pin of guide element 412 is within first rest region 508, universal pen cap 400 is in a disengaged configuration, allowing removal of injector pen 410 or subsequent insertion or re-engagement of injector pen 410. Furthermore, the stopping of the pin of guide element 412 within first rest region 508 is configured to provide feedback to the user that the injector pen has been disengaged by engagement member 406, indicating that the user can remove injector pen 410.
[0043] FIG. 6A is a side view of a universal pen cap 600 in a disengaged position in accordance with one or more embodiments of the present disclosure. FIG. 6B is a cross-sectional view of the universal pen cap 600 of FIG. 6A in a disengaged position. FIG. 6C is a cross-sectional view of the universal pen cap 600 of FIGS. 6A and 6B in an engaged position. Referring to FIGS. 6A-6C, in various embodiments, in the engaged position, the universal pen cap 600 engages the injector pen 610. In the disengaged position, the universal pen cap 600 disengages from the injector pen 610. In various embodiments, the universal pen cap 600 includes a clamping assembly 612 and a body 604. In various embodiments, the clamping assembly 612 includes a clasping element 602 and hinge arms 606 / 608. In various embodiments, the clasping element 602 is positioned to apply a clamping force to the injector pen 610 and is configured to hold the injector pen 610 in place while in the engaged position. 6A-6C, the clasping elements 602 are positioned on opposite sides of the body 604 with the contact surfaces of the clasping elements 602 substantially facing each other, such as being positioned approximately 180 degrees circumferentially from each other relative to the axis of the universal pen cap 600. In various embodiments, the clasping elements 602 are adapted to move axially relative to the body 604. In various embodiments, the clamping assembly 612 includes three or more clasping elements 602, including but not limited to three or more clasping elements 602.
[0044] The upper end (i.e., the end closest to the closed end of the universal pen cap 600) is disposed radially inward relative to the lower end (i.e., the end closest to the open end of the universal pen cap 600) of the clasping element 602. In various embodiments, the lower end of the clasping element 602 is rotatably connected to one or more hinge arms 606 at a first longitudinal end of each of the one or more hinge arms 606. The hinge arms 606 are then rotatably connected to the body 604 at a second longitudinal end of each hinge arm 606 / 608, i.e., at a second longitudinal end opposite the first longitudinal end of each hinge arm 606 / 608. In various embodiments, the two hinge arms 606 connected to each clasping element 602 connect to the body 604 at the same fixed position and connect to each other at their respective longitudinal ends to form a clasping linkage. In various embodiments, the universal pen cap 600 includes a clasping linkage that joins the clasping element 602 and the body 604 on each side of the clasping element 602 .
[0045] In operation, upon insertion of the injector pen 610, the injector pen 610 engages the respective contact surfaces of the clasping element 602 at or near the top end of the injector pen 610, as can be seen in Figures 6A and 6B. As the injector pen 610 is further inserted into the universal pen cap 600, the engagement with the injector pen 610 causes the clasping element 602 to move axially toward the top end of the universal pen cap 600. This axial movement causes the clasping element 602 to rotate about its fixed position on the body 604, reducing the angle of the tightening linkage, thereby bringing the lower ends of the clasping elements closer together, thereby bringing more of the respective contact surfaces of the clasping elements 602 into contact with the injector pen 610, as seen in Figure 6C. In various embodiments, bringing the lower ends closer together also results in a clamping force being applied to the injector pen 610 while the clasping elements 602 are in the engaged position shown in Figure 6C. Upon removal of the injection pen 610, the clasping elements 602 are pulled away from the upper end of the universal pen cap 600 toward the locked position, which moves the lower ends of the clasping elements 602 radially outward, reducing the amount of contact between the respective contact surfaces of the clasping elements 602 and the injection pen 610 and reducing the clamping force. In various embodiments, each clamping linkage includes a mechanical stop that prevents the hinge arms 606 from over-rotating and preventing the first longitudinal ends from moving axially toward the lower ends beyond the locked position, thereby preventing the application of a clamping force during removal of the injection pen 610. In other embodiments, the universal pen cap 600 includes a mechanical stop that prevents the clasping elements 602 from moving axially beyond a specific position relative to the bottom of the body 604 to prevent the application of a clamping force during removal of the injection pen 610.
[0046] FIG. 7A is a side view of an example universal pen cap 700 adapted to receive an injection pen 710, in accordance with one or more embodiments of the present disclosure. FIG. 7B is a cross-sectional side view of the universal pen cap 700 of FIG. 7A, in accordance with one or more embodiments of the present disclosure. Referring together to FIGS. 7A and 7B, in various embodiments, the universal pen cap 700 includes an outer frame element 702 defining one or more first openings 706 and second openings 708. For example, the outer frame element 702 includes an outer wall 714 having the one or more first openings 706 formed therein, and the second openings 708 are defined by the outer frame element 702 at its longitudinal ends. The outer wall 714 may include an annular or hollow cylindrical shape. In various embodiments, the universal pen cap 700 includes one or more catch members 712 coupled to the outer frame. In various embodiments, the universal pen cap 700 includes one or more biasing members 704 operably coupled to the one or more catch members 712.
[0047] In operation, the one or more catch members 712 extend through the one or more first openings 706 and are configured to engage an injector pen (e.g., injector pen 710) when the injector pen is inserted into the second opening 708 of the outer frame element 702. Additionally, the one or more biasing members 704 are configured to exert a pushing force on the one or more catch members 712, the pushing force urging the one or more catch members 712 radially inward toward the central longitudinal axis of the universal pen cap. For example, prior to inserting the injector pen 710, the one or more catch members 712 extend through the outer frame element 702 and into a cavity defined by the outer frame element 702 as a result of being biased by the one or more biasing members 704, the cavity being configured to receive the injector pen. Upon inserting the injector pen 710, the one or more catch members 712 are configured to apply an inward radial force to the injector pen 710 while allowing a user's pushing force to continue inserting the injector pen 710. When fully inserted, the injector pen 710 abuts the inner surface of the outer frame element 702 while the one or more catch members 712 exert an inward radial force on the injector pen 710 in response to the biasing member 704 resiliently biasing the one or more catch members 712 radially inward. Furthermore, the inward radial force exerted by the one or more catch members 712 via the one or more biasing members 704 keeps the injector pen 710 held within the outer frame element 702 and allows a pulling force from the one or more catch members to remove the injector pen 710 despite being engaged.
[0048] In various embodiments, the one or more biasing members 704 include a biasing element (for example, but not limited to, a spring) configured to apply a spring force to the one or more catch members 712, causing the catch members to extend through the one or more first openings 706 and protrude into the cavity of the universal pen cap 700 toward the central longitudinal axis of the universal pen cap 700. In other embodiments, the one or more biasing members 704 include an elastomeric material disposed against the one or more catch members 712, such that the elastomeric material urges the one or more catch members 712 radially inward to extend through the first openings 706 and protrude into the cavity of the universal pen cap 700 toward the central longitudinal axis of the universal pen cap 700. In other embodiments, the one or more catch members 712 comprise an elastomeric material, and thus the one or more catch members 712 protrude through the one or more first openings 706 and resistively engage with an injection pen (e.g., injection pen 710) inserted within the universal pen cap 700 without the need for one or more biasing members 704.
[0049] In one or more embodiments, the one or more catch members 712 include an engagement surface that engages with the surface of the injector pen. The engagement surface includes a substantially concave profile when viewed from the longitudinal axis of the universal pen cap 700 so as to substantially complement the curvature of an injector pen inserted within the universal pen cap 700. The one or more catch members 712 include a material having varying roughness and friction. For example, the one or more catch members 712 include rubber, plastic, steel, iron, or an elastomeric material. In various embodiments, the catch members 712 include an additional material disposed on the engagement surface of the catch members 712 (e.g., without limitation, an abrasive disposed on the engagement surface of the catch members 712). In various embodiments, the engagement surface includes an irregular pattern, thus allowing the engagement surface to exert greater friction when engaging another surface (e.g., the surface of an injector pen).
[0050] 7C is a front view of the universal pen cap 700 taken from the central longitudinal axis of the universal pen cap 700 through the second opening 708, illustrating an example of one or more catch members 712 at different levels of extension through one or more first openings 706, in accordance with one or more embodiments of the present disclosure. Referring now to FIGS. 7A-7C together, in various embodiments, the first openings 706 are configured to allow radial translation of the one or more catch members 712 when an outward radial pressure is applied to the catch members 712 and the biasing member 704, for example, when an injection pen is inserted into the second opening 708.
[0051] 7C , when an injector pen (e.g., injector pen 710) is substantially inserted into second opening 708, the injector pen resistively retracts catch member 712 and biasing member 704, as indicated by retracted catch member 716. In this position, catch member 712 engages the surface of the injector pen. Furthermore, when an injector pen is not inserted into second opening 708, biasing member 704 causes catch member 712 to protrude into the cavity of universal pen cap 700.
[0052] In various embodiments, the universal pen cap 700 is operably coupled to an electromechanical actuator 802 (e.g., as shown in FIG. 8 ). The electromechanical actuator 802 is configured to actuate the one or more catch members 712 such that actuation of the electromechanical actuator 802 causes the one or more catch members 712 to extend through the at least one first opening 706. In various embodiments, the electromechanical actuator 802 includes a solenoid. In this embodiment, the one or more catch members 712 include a magnetic material and are disposed within the solenoid such that actuation of the solenoid causes the one or more catch members 712 to translate along a central longitudinal axis of the solenoid. In various other embodiments, the electromechanical actuator 802 includes a servo configured to translate the one or more catch members through the at least one first opening 706 upon actuation of the servo.
[0053] FIG. 9A is a perspective view of a universal pen cap 900 according to one or more embodiments of the present disclosure. FIG. 9B is a cross-sectional side view of the universal pen cap 900 extended over an injection pen according to one or more embodiments. Referring to both FIG. 9A and FIG. 9B, in various embodiments, the universal pen cap 900 includes a tube having a plurality of continuous segments 904. In various embodiments, the inner diameter of the tube gradually decreases along a central longitudinal axis of the universal pen cap 900, with each segment of the plurality of continuous segments 904 having the inner diameter. In various embodiments, each of the inner diameters is substantially constant throughout the continuous segment 904. In some embodiments, the outer diameter of the tube is substantially constant, but the tube is formed of a plurality of continuous inner right cylinders of gradually decreasing diameter.
[0054] 9B , in various embodiments, the plurality of continuous segments 904 are configured to telescopically extend in a first longitudinal direction of the universal pen cap 900 and contract in a second longitudinal direction opposite the first longitudinal direction. In operation, the universal pen cap 900 is configured to telescopically extend over an injector pen (e.g., injector pen 902) such that one segment of the plurality of continuous segments 904 having an appropriate diameter to engage the surface of the injector pen engages the surface of the injector pen in an interference fit.
[0055] FIG. 10A is a side view of a universal pen cap 1000 according to one or more embodiments of the present disclosure. FIG. 10B is a cross-sectional side view of the universal pen cap 1000 of FIG. 10A. Referring to both FIGS. 10A and 10B, in various embodiments, the universal pen cap 1000 includes an outer wall 1006 including an inner frustoconical cavity 1008 including a frustoconical shape formed therein. The inner frustoconical cavity 1008 includes an inner diameter that narrows along a central longitudinal axis of the universal pen cap 1000 with a larger diameter end of the frustoconical shape at an open end of the outer wall 1006. In various embodiments, the outer surface 1002 of the universal pen cap 1000 includes a substantially equal diameter along the central longitudinal axis of the universal pen cap. In other embodiments, the outer surface 1002 includes a narrowed diameter that is complementary to the size and shape of the frustoconical cavity 1008.
[0056] In operation, the universal pen cap 1000 is configured to receive the injection pen 1004 within the frusto-conical cavity 1008 such that when the injection pen 1004 is inserted into the universal pen cap 1000, the surface of the injection pen 1004 mates with the surface of the frusto-conical cavity 1008 in an interference fit.
[0057] Figure 11A is a perspective view of a universal pen cap 1100 for receiving multiple injector pens 1104a-c, according to one or more embodiments of the present disclosure. Figure 11B is a cross-sectional side view of the universal pen cap 1100 of Figure 11A for receiving multiple injector pens 1104a-c. Referring to both Figures 11A and 11B, the universal pen cap 1100 includes a shell 1112, a slot 1106, and a sleeve element 1102. The sleeve element 1102 includes a radially extending member 1108.
[0058] In various embodiments, the outer shell 1112 includes an outer wall 1114 shaped to at least partially surround a longitudinal end of the injector pen (e.g., any one of the injector pens 1104a-c). The outer wall 1114 includes an open end formed therein. The slot 1106 is formed in the outer wall 1114 and extends radially through the outer wall 1114 and also extends axially along a portion of the outer wall 1114. For example, the slot 1106 defines a cutout portion from the outer wall 1114 beginning at a longitudinal end of the shell 1112 that extends at least some distance along the longitudinal axis of the shell 1112. In various embodiments, slot 1106 is formed in a hook shape including a first axial section extending axially in a first direction along outer wall 1114 from an open end of outer wall 1114, a circumferential portion extending circumferentially from the end of the first axial section, and a second axial section extending axially in a second direction opposite the first direction partially toward the open end of outer wall 1114. Additionally, sleeve element 1102 is adapted to removably couple to a longitudinal end of an injection pen (e.g., injector pens 1104a-c). In various embodiments, sleeve element 1102 includes a body and a radially extending member 1108. In various embodiments, the body includes an annular shape formed with an internal cavity adapted to receive an injection pen. A radially extending member 1108 extends radially outward from the body and is sized and shaped to slide along slot 1106 when the injection pen is inserted into the universal pen cap, interfacing with the slot to removably secure the injection pen to shell 1112.
[0059] In various embodiments, sleeve element 1102 is configured to fit over and encompass at least a portion of a plurality of different injector pen geometries. For example, in various embodiments, sleeve element 1102 comprises a deformable material, such as an elastomeric material, that is adapted to deform / stretch to conform to the shapes of different injector pen geometries, and sleeve element 1102 stretches and fits around at least the longitudinal ends of the injector pen.
[0060] 11C is a cross-sectional side view of a sleeve element 1102 that fits over an injector pen and removably secures the injector pen to the shell 1112, according to various embodiments of the present disclosure. In various embodiments, the sleeve element 1102 is at least partially made of an elastomeric material, such that when an injector pen (e.g., injector pen 1104b) is encompassed by the sleeve element 1102, the elastomeric material forms at least one elastomeric seal 1110 with the shell 1112 when the sleeve element 1102 and the injector pen are removably secured to the shell 1112 by the slot 1106 and at least one radially extending member 1108.
[0061] 11A-11C , in various embodiments, the interior cavity of the outer shell 1112 is formed with a tip receiving portion and a body receiving portion. The tip receiving portion is adapted to receive the top of an injector pen and is formed with an inner diameter smaller than the inner diameter of the body receiving portion, forming a lip therebetween. The body receiving portion is adapted to receive the sleeve element 1102 and a portion of the injector pen covered by the sleeve element 1102. In various embodiments, a portion of the sleeve element 1102 at or adjacent to the leading edge of the sleeve element 1102 includes a larger diameter than the tip receiving portion. In various embodiments, the interference between the portion of the sleeve element 1102 and the lip acts as a seal. In various embodiments, the interference between the portion of the sleeve element 1102 and the lip acts as a stop that prevents further insertion of the injector pen into the universal pen cap 1100, and the stop controls the insertion depth of the injector pen. In various embodiments, the portion of the sleeve element 1102 includes a flange that protrudes radially outward from the body of the sleeve element 1102.
[0062] 11A-11C together, in operation, a user can removably couple sleeve element 1102 around an injector pen such that sleeve element 1102 at least partially surrounds a side of the injector pen. Furthermore, when sleeve element 1102 is fitted over an injector pen (e.g., injector pen 1104b), one or more radially extending members 1108 are configured to slide in a first axial direction along slot 1106 when the injector pen is inserted into shell 1112. When injector pen 1104b is fully inserted, the injector pen, and thereby sleeve element 1102, is rotated toward slot 1106, and a pulling force then draws one or more radially extending members 1108 into the substantially hook-shaped groove defined by slot 1106. In various embodiments, a biasing member presses on the inserted injector pen 1104b when injector pen 1104b is fully inserted into shell 1112. For example, upon insertion of injector pen 1104b into shell 1112, the biasing member generates a force in a second axial direction, the second axial direction being opposite to the first axial direction. Thus, when the injector pen is inserted and the one or more radially extending members 1108 reach the longitudinal ends of slot 1106, injector pen 1104b is rotated toward the hook-shaped groove defined by slot 1106; thus, when the pushing pressure of insertion is released, the biasing member urges injector pen 1104b, and thereby sleeve element 1102 and one or more radially extending members 1108, to translate at least some distance in the second axial direction until the one or more radially extending members abut the sides of the hook-shaped groove defined by slot 1106. In this position, the sleeve element 1102 engages the shell 1112 via one or more radially extending members 1108 to secure the injector pen 1104 b within the shell 1112 .
[0063] 12 is a perspective view of a universal pen cap 1200 according to one or more embodiments of the present disclosure. In various embodiments, the universal pen cap 1200 includes a shell 1204 and a ring element 1202.
[0064] In various embodiments, the ring element 1202 is adapted to removably couple to the injector pen 1206 such that the ring element circumferentially surrounds the injector pen 1206. In various embodiments in which the ring element 1202 is fabricated from an elastomeric material, the ring element 1202 forms an elastomeric seal with the outer shell 1204 while the ring element 1202 is coupled to the injector pen and while the injector pen 1206, and therefore the ring element 1202, is inserted within the outer shell 1204. The ring element 1202 may be any material sufficient to form an interference fit with the outer shell 1204. For example, in various embodiments, the ring element 1202 comprises an elastomeric material. However, one skilled in the art will understand that the ring element 1202 may be formed from any material sufficient to form an interference fit with the outer shell 1204.
[0065] FIG. 13A is a perspective view of a universal pen cap 1300 according to one or more embodiments of the present disclosure. FIG. 13B is a front view of the universal pen cap 1300 in a disengaged configuration. FIG. 13C is a front view of the universal pen cap 1300 in an engaged configuration. Referring together to FIGS. 13A-13C, in various embodiments, the universal pen cap 1300 includes a collar 1302, a plurality of angled protrusions 1304 defining cavities, and a plurality of roller elements 1306 disposed within the respective cavities formed by the angled protrusions 1304. In various embodiments, the angled protrusions 1304 extend radially inward from the collar 1302, and the thickness of each of the angled protrusions 1304 increases circumferentially. In various embodiments, the angled protrusions 1304 are evenly spaced circumferentially around the collar 1302. In various embodiments, the angled protrusions 1304 define a plurality of angled surfaces 1308 adapted to contact the roller elements 1306. In various embodiments, the angled protrusion 1304 defines an angled recess adapted to receive a portion of the roller element 1306 .
[0066] In various embodiments, the universal pen cap 1300 includes at least one roller element retainer selected from an internal track, a cage, and a flexible collar configured to secure the roller elements 1306 therein. In various embodiments, each roller element 1306 is attached to a protrusion configured to run within the track. In various embodiments, a stopper is configured to limit the movement of the roller elements 1306.
[0067] In various embodiments, each of the roller elements 1306 is positioned adjacent to a corresponding ramped protrusion that is adapted to contact the outer radial surface of the injector pen 1310 and the respective ramped surface 1308 while the injector pen 1310 is inserted into the universal pen cap 1300. In various embodiments, the roller elements 1306 and the ramped protrusions 1304 are adapted for relative circumferential motion (hereinafter "relative rotation") therebetween. For example, in operation, the injector pen 1310 is inserted into the universal pen cap 1300 in a first axial direction (e.g., a direction extending into the universal pen cap 1300). Once the injector pen 1310 is inserted into the universal pen cap 1300, relative rotation between the collar 1302 and the roller elements 1306 is caused by a user rotating the collar 1302 in a first rotational direction, for example, about a central longitudinal axis of the universal pen cap 1300. Relative rotation between the collar 1302 and the roller elements 1306 causes the roller elements 1306 to slide or roll upward along the relative inclined surfaces 1308, thereby translating the roller elements 1306 radially inward toward the central longitudinal axis of the universal pen cap 1300 and into interference engagement with the injector pen 1310. Similarly, causing relative rotation between the collar 1302 and the roller elements 1306, such as by rotating the collar 1302 in a second rotational direction opposite the first rotational direction about the central longitudinal axis of the universal pen cap 1300, causes each of the roller elements 1306 to slide or roll downward along the respective inclined surfaces 1308, thereby translating the roller elements 1306 radially outward away from the central longitudinal axis of the universal pen cap 1300, thereby reducing the radial interference between the roller elements 1306 and disengaging the injector pen 1310. Disengaging the roller element 1306 from the injector pen 1310 allows the user to remove the injector pen 1310 and then insert the injector pen 1310 or another injector pen into the universal pen cap 1300.
[0068] In various embodiments, the roller elements 1306 comprise substantially cylindrical rods elongated along the longitudinal axis of the universal pen cap 1300. In various embodiments, each cylindrical rod comprises a retention feature configured to hook into a retention feature (e.g., without limitation, a track, a cage, etc. between the collar 1302 and the flexible collar). In various other embodiments, the roller elements 1306 comprise substantially spherical bearings. The roller elements 1306 comprise a durable material, such as plastic, iron, steel, rubber, etc.
[0069] In various embodiments, the universal pen cap 1300 is operably coupled to an electromechanical actuator 1402 (e.g., as shown in FIG. 14 ). The electromechanical actuator 1402 is configured to cause relative rotation between the collar 1302 and the roller element 1306, such as causing rotation of the collar 1302 about a central longitudinal axis of the universal pen cap 1300 to both a disengaged configuration and an engaged configuration. For example, in various embodiments, the electromechanical actuator 1402 includes a solenoid configured to rotate the collar 1302 relative to the roller element 1306. In another example, the electromechanical actuator 1402 includes a servo operably connected to the universal pen cap 1300, such that actuation of the servo causes the collar 1302 to rotate about the central longitudinal axis of the universal pen cap 1300.
[0070] FIG. 15A is a perspective view of a universal pen cap 1500 in a disengaged configuration in accordance with one or more embodiments of the present disclosure. FIG. 15B is a perspective view of the universal pen cap 1500 in an engaged configuration. FIG. 15C is a cross-sectional side view of the universal pen cap 1500 engaged with an injection pen 1506. Referring together to FIGS. 15A-15C, in various embodiments, the universal pen cap 1300 includes a tapered collet 1504, an annular collar 1502, and an outer frame member 1510. In various embodiments, the collet 1504 defines a plurality of recesses 1508 formed in a radially outer surface of the tapered collet 1504, as well as a slot extending axially from the end of the tapered collet 1504 having a larger diameter toward the end of the tapered collet 1504 having a smaller diameter. In various embodiments, the recesses are oriented relative to one another in a spiral pattern. In various embodiments, the tapered collet 1504 defines a frusto-conical opening configured to receive at least a portion of the injector pen 1506 .
[0071] In various embodiments, the annular collar 1502 includes a radially inner surface 1514 that defines a central axial opening configured to receive the tapered collet 1504. In various embodiments, the diameter of the radially inner surface 1514 is greater than the minimum diameter of the tapered collet 1504 and less than the maximum diameter of the tapered collet 1504. In various embodiments, the collar 1502 includes one or more protrusions 1512 extending radially inward from the radially inner surface of the annular collar 1502. Further, the one or more protrusions 1512 are sized, shaped, and positioned to be received within one of the plurality of recesses 1508 and to slide along the recess 1508 during operation of the universal pen cap 1500. In various embodiments, translation of the annular collar 1502 in a first axial direction along the tapered collet 1504 causes at least a portion of the tapered collet 1504 to bend radially inward toward the longitudinal axis of the universal pen cap 1500. In various embodiments, the slots facilitate radially inward bending of at least a portion of the tapered collet 1504 to be bent. In operation, when the universal pen cap 1500 is in the disengaged configuration (e.g., shown in FIG. 15A ), the universal pen cap 1500 receives an insulin pen (e.g., an injection pen 1506) through a central axial opening in the tapered collet 1504. A user can then physically rotate the annular collar 1502 (and thus the outer frame member 1510) so that one or more protrusions 1512 slide along the plurality of recesses 1508, thereby translating the annular collar 1502 along the longitudinal axis of the universal pen cap 1500. Translating the annular collar 1502 toward the engaged configuration (e.g., shown in FIG. 15B ) is configured to flex the tapered collet 1504 radially inward, the diameter of the tapered collet 1504 being greater than the diameter of the radially inner surface 1514 of the annular collar. The tapered collet 1504 is configured to engage an injector pen at least partially received therein in response to the tapered collet 1504 flexing radially inward.
[0072] In various embodiments, the tapered collet 1504 includes one or more elongated members extending longitudinally parallel to and circumferentially oriented around the central longitudinal axis of the universal pen cap 1500, the one or more elongated members being configured to flex radially inward in response to translation of the annular collar 1502.
[0073] In various embodiments, the universal pen cap 1500 includes an outer frame member 1510. The outer frame member 1510 includes a tapered collet 1504 and one or more elongated guide members 1516 extending longitudinally parallel to a central longitudinal axis of the universal pen cap 1500. The one or more elongated guide members 1516 include one or more elongated recesses formed therein that extend along the length of the elongated guide members 1516. The one or more elongated guide members 1516 are configured to receive at least a portion of the annular collar 1502 within the elongated recesses of the elongated guide members 1516, such that when the annular collar 1502 is translated along the recess 1508 into an engagement configuration of the universal pen cap 1500, the received portion of the annular collar 1502 slides along the one or more elongated recesses, thereby rotating the outer frame member 1510 with the annular collar 1502. In this manner, by rotating the outer frame member 1510, a user can slide the annular collar 1502 along the one or more elongated recesses as well as the plurality of recesses 1508, and translate it along the longitudinal axis of the universal pen cap 1500. Thus, by rotating the outer frame member 1510, a user can advance the universal pen cap 1500 from a disengaged configuration (e.g., as shown in FIG. 15A ) to an engaged configuration (e.g., as shown in FIG. 15B ), and vice versa.
[0074] In various embodiments, the universal pen cap 1500 includes an electromechanical actuator 1602 operably coupled to its actuation components (e.g., shown in FIG. 16 ). In particular, in various embodiments, the electromechanical actuator 1602 is configured to actuate one or both of the outer frame member 1510 or the annular collar 1502. In various embodiments, actuation of the electromechanical actuator 1602 rotates the outer frame member 1510 and / or the annular collar 1502 such that the annular collar 1502 translates along a longitudinal axis of the universal pen cap 1500 between an open configuration and a closed configuration of the universal pen cap 1500. In various embodiments, the electromechanical actuator 1602 includes a servo operably coupled to the outer frame member 1510 and / or the annular collar 1502, such that actuation of the servo causes the annular collar 1502 to translate along a longitudinal axis of the universal pen cap 1500. Although described with respect to a specific example, one skilled in the art will understand that any conventional electromechanical actuator may be used, so long as the electromechanical actuator is configured to translate the annular collar 1502 along the longitudinal axis of the universal pen cap 1500.
[0075] 17 is a cross-sectional side view of a universal pen cap 1700 according to one or more embodiments of the present disclosure. In various embodiments, the universal pen cap 1700 includes an outer frame element 1706 that defines a side cavity 1710, a body cavity 1714, and an opening 1712. The universal pen cap 1700 includes an electromechanical actuator 1704 and an engagement element 1702, both disposed within the side cavity 1710.
[0076] In various embodiments, while in the disengaged position, engaging element 1702 is disposed within side cavity 1710 at a position selected from a position proximate to body cavity 1714, a position adjacent to body cavity 1714, and a position partially within body cavity 1714. Electromechanical actuator 1704 is adapted to be actuated to cause engaging element 1702 to protrude into body cavity 1714 and engage with an injector pen (e.g., injector pen 1708) when the injector pen is inserted into opening 1712. Engaging element 1702 is adapted to contact the injector pen and secure at least a portion of the injector pen disposed within opening 1712 within opening 1712.
[0077] In operation, when the engaging element 1702 is in the disengaged configuration (e.g., before the electromechanical actuator 802 is actuated), the injector pen 1708 is inserted into the universal pen cap 1700 in a first axial direction (e.g., a direction extending into the universal pen cap 1700). After the injector pen is substantially inserted into the universal pen cap 1700, actuation of the electromechanical actuator 1704 translates the engaging element 1702 radially inward toward a central longitudinal axis of the universal pen cap 1700 and toward the injector pen 1708. The engaging element 1702 then engages with the injector pen 1708 such that the position of the injector pen 1708 is maintained within the universal pen cap 1700. The electromechanical actuator 802 is then configured to disengage the engaging element 1702 from the injector pen 1708, allowing removal of the injector pen 1708.
[0078] In various embodiments, the electromechanical actuator 1704 includes a solenoid actuator and the engaging element 1702 includes a magnet. In at least some of these various embodiments, a compression element is disposed at least partially within the solenoid electromechanical actuator 1704 and is adapted to translate the engaging element 1702 along a longitudinal axis of the solenoid into the body cavity 1714. In various other embodiments, the electromechanical actuator 1704 includes a servo actuator configured to protrude the engaging element 1702 into the body cavity 1714 in response to the servo electromechanical actuator 1704 being actuated.
[0079] In one or more embodiments, the engaging element 1702 includes an engagement surface that engages with the surface of the injector pen. In various embodiments, the engagement surface includes a substantially concave profile when viewed from the longitudinal axis of the universal pen cap 1700 so as to substantially complement the curvature of an injector pen inserted within the universal pen cap 1700. In various embodiments, the engaging element 1702 includes a material having varying roughness and friction. In some of these various embodiments, the engaging element 1702 includes at least one of rubber, plastic, steel, iron, or an elastomeric material. In various embodiments, the engaging element 1702 includes different materials disposed on the engagement surface of the engaging element 1702. In some of these various embodiments, an abrasive material is disposed only on the engagement surface of the engaging element 1702. In various embodiments, the engagement surface includes an irregular pattern, thus allowing the engagement surface to exert greater friction when engaging another surface (e.g., the surface of an injector pen).
[0080] Figure 18A is a perspective view (frame elements not shown for clarity) of a universal pen cap 1800 according to one or more embodiments of the present disclosure. Figure 18B is a front view (frame elements not shown for clarity) of the universal pen cap 1800 looking down the longitudinal axis of the universal pen cap 1800. Referring to both Figures 18A and 18B together, in various embodiments, the universal pen cap 1800 includes an annular drive gear 1802, an annular receiver gear 1806 operably engaged with the annular drive gear, and an engagement member 1804 disposed within a central opening of the annular receiver gear 1806.
[0081] In various embodiments, the annular drive gear 1802 defines a central opening configured to receive at least a portion of an injection pen, and at least a portion of the annular drive gear is configured to rotate circumferentially about the longitudinal axis of the universal pen cap 1800. In various embodiments, 1806 is configured to rotate about an axis of the annular receiver gear, such as an axis perpendicular to the longitudinal axis of the universal pen cap. The annular receiver gear 1806 is adapted to rotate and translate the engagement member 1804 along the axis of the annular receiver gear 1806, which in various embodiments is an axis perpendicular to the longitudinal axis of the universal pen cap 1800. Thus, as the annular drive gear 1802 rotates, it engages the operably coupled annular receiver gear 1806, thereby rotating the annular receiver gear 1806 and translating the engagement member toward the central longitudinal axis of the universal pen cap 1800.
[0082] In various embodiments, the annular drive gear 1802 is configured to receive a portion of the injector pen (e.g., the injector pen 1808) such that the annular drive gear 1802 circumferentially surrounds the injector pen. When the annular drive gear 1802 receives at least a portion of the injector pen, the annular drive gear 1802 rotates in a first rotational direction about a central longitudinal axis of the universal pen cap 1800. The annular drive gear 1802 is adapted to rotate to translate the engagement member 1804 in an axial direction of the engagement member, such as an axis perpendicular to the longitudinal axis of the universal pen cap, thereby engaging the engagement member 1804 with the injector pen.
[0083] In various embodiments, the universal pen cap 1800 includes a frame element. In various embodiments, the frame element is a substantially cylindrical frame member received within and rotatably coupled to a central opening of the annular drive gear 1802. The annular receiver gear 1806 is rotatably coupled to the frame element. In this example, the frame element includes a first opening in its sidewall and a second opening defined at its longitudinal end, the second opening configured to at least partially receive an injection pen (e.g., injector pen 1808). In various embodiments, the engagement member 1804 is configured to translate through the first opening and engage with the injection pen when the injection pen is at least partially received within the second opening. In various embodiments, either or both of the annular drive gear 1802 and the annular receiver gear 1806 are coupled to the frame element and adapted to rotate independently of the frame element.
[0084] In various embodiments, the frame element is adapted to at least partially receive the annular receiving gear 1806 therein and to receive a first portion of the annular drive gear 1802 therein, which portion is adapted to engage with the annular receiving gear 1806. A second portion of the annular drive gear 1802 is external to the frame element and is adapted to be accessible to a user and rotatable relative to the frame element.
[0085] In various embodiments, the universal pen cap 1800 includes only one gear (e.g., only the annular receiver gear 1806) that includes an engagement member 1804 configured to be translated by a user by turning the annular receiver gear 1806. In various of these embodiments, the universal pen cap 1800 includes a gripping member (e.g., a thumbscrew head, an abrasive grip, etc.) coupled to the annular receiver gear 1806 to allow ergonomic rotation of the annular receiver gear 1806 by a user. In various embodiments, the annular receiver gear 1806 is rotatably coupled to a frame element, and at least a portion of the annular receiver gear is disposed outside the frame element for a user to access the annular receiver gear.
[0086] 19A is a perspective view of a universal pen cap 1900 in an engaged configuration according to one or more embodiments of the present disclosure. FIG. 19B is a perspective view of the universal pen cap 1900 in a disengaged configuration. Referring to both FIG. 19A and FIG. 19B together, in various embodiments, the universal pen cap 1900 includes a clamping device including a first arm 1902 and a second arm 1904, where the second arm is rotatably coupled to the first arm 1902. In various embodiments, the first arm 1902 includes a first body portion and a first connecting portion. The first body portion is adapted to extend generally in the axial direction of the universal pen cap 1900. The first connecting portion extends from the first body portion at an obtuse angle. In the illustrated embodiment, the first connecting portion includes two arms extending from an end of the first body portion. In various embodiments, the first arm 1902 also includes a first engagement portion that extends from the first body portion laterally relative to the first body portion and radially inward relative to the axis of the universal pen cap 1800. The first engagement portion is adapted to contact the injection pen while the universal pen cap 1900 is in the engaged configuration. In some of these various embodiments, the first body portion, the first coupling portion, and the first engagement portion are formed as a unitary structure.
[0087] In various embodiments, the second arm 1904 includes a second body portion and a second connecting portion. The second body portion is adapted to extend generally axially of the universal pen cap 1900. The second connecting portion extends at an obtuse angle from the second body portion. In the illustrated embodiment, the second connecting portion includes two arms extending from an end of the second body portion. The first connecting portion and the second connecting portion are adapted to be rotatably connected. In various embodiments, the second arm 1904 also includes a second engaging portion extending laterally from the second body portion and radially inward relative to the axis of the universal pen cap 1800. The second engaging portion is adapted to contact the injector pen while the universal pen cap 1900 is in the engaged configuration. In some of these various embodiments, the second body portion, the second connecting portion, and the second engaging portion are formed as a unitary structure.
[0088] In various embodiments, the universal pen cap 1900 includes a threaded element 1908 configured to move the first arm 1902 and the second arm 1904 between a disengaged configuration and an engaged configuration. In the illustrated embodiment, the distal end of the first engagement portion rotatably couples the ends of the second engagement portion with the obtuse angles of the first arm 1902 and the second arm 1904 facing one another. In the illustrated embodiment, the first arm 1902 includes a mounting bracket. In this embodiment, the universal pen cap further includes a mounting pin having a threaded hole formed therein adapted to receive the threaded element 1908. The first mounting pin is connected to the mounting bracket of the first arm, and the second mounting pin is connected to the second coupling portion, such as at the distal end of the second coupling portion relative to the connection between the second coupling portion and the second body portion. In other embodiments, the first and second mounting pins are formed as a unitary structure with the first and second arms 1902, 1904, respectively. In various embodiments, one of the mounting elements defines a through hole, and the other of the mounting elements defines a threaded through hole. In various embodiments, the screw element 1908 includes a threaded portion that engages the threaded hole and a locking groove configured to maintain the position of the screw element 1908 relative to the through hole along the longitudinal axis of the screw element 1908 while allowing the screw element 1908 to rotate. For example, in the illustrated embodiment, the second mounting pin defines a threaded through hole, and the first mounting pin defines a through hole. In this configuration, the screw element 1908 is configured to translate along its axis relative to the second mounting element and the second arm 1904 and to rotate the first arm 1902 relative to the second arm 1904, the rotation being about the connection point between the first and second connecting portions.
[0089] In operation, when the first arm 1902 and the second arm 1904 are in the disengaged position, the injector pen 1906 can be inserted between the first arm 1902 and the second arm 1904. While the injector pen 1906 is between the first arm 1902 and the second arm 1904, the screw element 1908 is configured to rotate, causing the first arm 1902 to rotate relative to the second arm about the connection point and swing radially inward toward the second arm 1904. This rotation causes the first arm 1902 and the second arm to engage with the injector pen 1906. As a result, when the first arm 1902 and the second arm engage with the injector pen 1906, the universal pen cap 1900 is in the engaged position and configured to secure the injector pen 1906 with the first arm 1902 and the second arm 1904.
[0090] In various other embodiments, the universal pen cap 1900 includes a torsion spring disposed about the connection point between the first arm 1902 and the second arm 1904. In some of these various other embodiments, the torsion spring engages the first arm 1902 and the second arm 1904 such that the torsion spring resistively biases the first arm 1902 and the second arm 1904 inwardly about the connection point between the first arm 1902 and the second arm 1904 into the engaged configuration of the universal pen cap 1900. In various these embodiments, the first arm 1902 and the second arm 1904 each include a first lever portion and a second lever portion that respectively extend past the connection point between the first arm 1902 and the second arm 1904. The first arm 1902 and the second arm 1904 are configured to rotate about the connection point into a disengaged configuration in response to a user exerting an inward force on the first and second lever portions against the bias of a torsion spring. While the inward force is maintained on the first and second lever portions against the bias of the torsion spring, the universal pen cap 1900 is configured to receive an injection pen (e.g., injection pen 1906) between the first arm 1902 and the second arm 1904. Additionally, the universal pen cap 1900 is configured such that, in response to a user releasing the inward force on the first and second lever portions, the torsion spring causes the first arm 1902 to swing radially inward relative to the second arm 1904 and rotatably about the connection point between the first arm 1902 and the second arm 1904, causing the universal pen cap 1900 to engage with the injector pen 1906. The radially inward swing of the first arm causes the first arm 1902, and thereby the second arm 1904, to engage with the injector pen 1906 disposed therebetween.
[0091] In various embodiments, the electromechanical actuator is coupled to at least one arm selected from the first arm 1902 and the second arm 1904, such as via a screw element 1908. The electromechanical actuator is configured to rotate the at least one arm selected from the second arm 1904 relative to the first arm 1902 and the first arm 1902 relative to the second arm 1904.
[0092] 20A is a perspective view of a universal pen cap 2000 in an engaged configuration according to one or more embodiments of the present disclosure. FIG. 20B is a perspective view of the universal pen cap 2000 in a disengaged configuration. Referring to both FIG. 20A and FIG. 20B together, in various embodiments, the universal pen cap 2000 includes a first arm 2002 and a second arm 2004 rotatably coupled to the first arm 2002. In various embodiments, the universal pen cap 2000 includes an electromechanical actuator 2008 coupled to each of the first arm 2002 and the second arm 2004. In various embodiments, the electromechanical actuator 2008 is configured to rotate the second arm 2004 relative to the first arm 2002. The universal pen cap 2000 may be substantially similar to the universal pen cap 1900, except for including the electromechanical actuator 2008 and the operation provided by the actuator. In particular, in various embodiments, the first arm 2002 and the second arm 2004 include various features and connections as the first arm 1902 and the second arm 1904 described above.
[0093] In various embodiments, the first arm 2002 and the second arm 2004 are configured to receive an injection pen (e.g., injection pen 2006). In some of these various embodiments, the universal pen cap 2000 is configured to receive the injection pen 2006 between the first arm 2002 and the second arm 2004 while in a disengaged configuration (e.g., shown in FIG. 20B). Upon actuation, the electromechanical actuator 2008 is configured to rotate the first arm 2002 radially inward relative to the second arm 2004 about a connection point between the first arm 2002 and the second arm 2004 to an engaged position (e.g., shown in FIG. 20A). Thus, upon actuation of the electromechanical actuator 2008, the first arm 2002 and the second arm 2004 are configured to engage with the injection pen 2006 inserted between the first arm 2002 and the second arm 2004.
[0094] In various embodiments, the electromechanical actuator 2008 may be a solenoid actuator. In various other embodiments, the electromechanical actuator 2008 may be a servo actuator. In various embodiments, the electromechanical actuator 2008 may be configured to draw power only during a configuration change to cause the universal pen cap to transition or adjust between configuration states (e.g., between the open position shown in FIG. 17B and the closed position shown in FIG. 17A), such as transitioning from a first configuration of the universal pen cap that is not intended to engage with an injector pen to a second configuration that is intended to engage with an injector pen.
[0095] Figure 21A is a perspective view of a universal pen cap 2100 according to one or more embodiments of the present disclosure. Figure 21B is a side view of the universal pen cap 2100. Figure 21C is a side view of the universal pen cap 2100 of Figures 21A and 22B in a disengaged state. Figure 21D is a side view of the universal pen cap 2100 of Figures 21A-21C in an engaged state. Figure 21E is a perspective view of the universal pen cap 2100 of Figures 21A-21D in an engaged state.
[0096] 21A-21E, in various embodiments, a universal pen cap 2100 includes a collet 2102 and an outer sleeve 2104. In various embodiments, the collet 2102 includes an end portion and a plurality of elongated members 2110 oriented circumferentially about a central longitudinal axis of the universal pen cap and extending from the end portion in an axial direction relative to, e.g., parallel to, the central longitudinal axis of the universal pen cap 2100. In various embodiments, each of the elongated members 2110 of the collet 2102 includes a tapered portion having a tapered width along its longitudinal length. The tapered width is radial and increases from the end of the tapered portion near the end portion of the collet 2102 to the end of the tapered portion near the open end of the collet 2102 (distal to the end portion).
[0097] The outer sleeve 2104 is disposed around the plurality of elongate members 2110. In various embodiments, the outer sleeve 2104 comprises an annular shape, such as a hollow right cylinder. The outer sleeve 2104 and the elongate members 2110 are configured for relative movement between the outer sleeve 2104 and the elongate members 2110, such that the outer sleeve 2104 slides against the radially outermost surface of the elongate members 2110. In various embodiments, the outer sleeve 2104 is configured to engage the elongate members 2110 at a point along a side of the elongate members 2110. For example, in various embodiments, the elongate members 2110 include a tapered width with a diameter of the inner radial surface of the outer sleeve 2104 that engages the elongate members where the circumference of the collet is greater than the circumference of the inner radial surface of the outer sleeve 2104, thus bending the plurality of elongate members 2110 radially inward toward the central longitudinal axis of the universal pen cap 2100. Thus, when an injection pen (e.g., the injection pen 2106) is inserted into the universal pen cap 2100, the elongate members 2110 engage with the injection pen in response to the outer sleeve 2104 translating along the longitudinal axis of the universal pen cap 2100 relative to the elongate members 2110, thereby bending the elongate members 2110 radially inward toward the central longitudinal axis of the universal pen cap 2100 into an engaged state, as shown in FIGS.
[0098] In various embodiments, the inner radial surface of the outer sleeve 2104 is a right cylinder including a diameter greater than the outer diameter of the tapered portion of the end proximal to the end portion and less than the outer diameter of the tapered portion of the end distal to the end portion. In various embodiments, the inner radial surface of the outer sleeve 2104 is tapered complementarily to the tapered elongate members 2110, such that as the relative axial position of the outer sleeve 2104 and the universal pen cap 2100 changes the position of the outer sleeve 2104 further away from the end portion along the longitudinal axis of the universal pen cap 2100, the inner radial surface of the outer sleeve 2104 substantially complementarily engages with one or more tapered outer surfaces of the elongate members 2110, thereby bending the plurality of elongate members 2110 radially inward toward the central longitudinal axis of the universal pen cap 2100 into engagement. In various embodiments, the taper of the inner radial surface is substantially complementary to the taper of the tapered portion at a first axial location along the collet 2102, and the inner diameter of the outer sleeve 2104 is substantially the same as the outer diameter of the tapered portion. Repositioning the outer sleeve 2104 to a second position axially away from the end portion relative to the first position, where the outer diameter of the tapered portion is larger than the inner diameter of the outer sleeve 2104 at the corresponding location, results in radial interference between the outer sleeve 2104 and the elongated member 2110, causing bending of the elongated member radially inward.
[0099] In various embodiments, the universal pen cap 2100 includes a clicker mechanism 2112 configured to move the collet 2102 relative to the outer sleeve 2104, which is secured to the outer cover of the universal pen cap 2100. In some of these various embodiments, the outer sleeve 2104 is formed with the outer cover as a unitary structure.
[0100] Examples of clicker mechanisms are shown in FIGS. 22A-22C. Referring now to FIGS. 22A-22C, FIG. 22A is a side view of an example clicker mechanism. FIG. 22B is a perspective view of the clicker mechanism in a closed position. FIG. 22C is a perspective view of the clicker mechanism in an open position. In various embodiments, the clicker mechanism includes a button 2204, a guide element 2210, a biasing member, and a cam element 2202. The button 2204 is disposed at a closed end of the universal pen cap 2100 opposite an open end of the universal pen cap 2100 adapted to receive an injection pen 2106. The guide element 2210 extends axially from the button 2204 and is adapted to engage the cam element 2202. In some of these various embodiments, the guide element 2210 is formed as a unitary structure with the button 2204. The biasing member is disposed between the button 2204 and the collet 2102, such as an end portion of the collet 2102. The biasing member is adapted to bias the collet 2102 away from the cap 2100. In various embodiments, the biasing member is a spring, such as a coil spring. The cam element 2202 is adapted to interact with the guide element 2210 to guide the position of the cam element 2202 relative to the button 2204. In various embodiments, the collet 2102 includes the cam element 2202 formed therein, such as in one of the elongate members 2110. In various other embodiments, the cam element 2202 is fixed to the collet 2102. The cam element 2202 includes a channel 2208 that is adapted to guide the guide element 2210 between two positions formed therein. In some of these various embodiments, the channel 2208 is substantially similar to the channel 502, including the first passage 504, the second passage 506, and their various components, described above with respect to FIGS. 4-5C . The guide element 2210 includes a pin 2206 (see FIGS. 22B and 22C) that is adapted to be received within and move along the channel 2208 .
[0101] In various embodiments, in operation, when an injection pen is inserted into the universal pen cap 2100, the universal pen cap 2100 is configured such that when a user applies a pushing force to the clicker mechanism, particularly the button 2204, until a click is heard or felt, the applied force releases the pin 2206 from a first position within the groove passage 2208, and the biasing member moves the pin 2206 to a second position within the groove passage 2208, causing the elongated member 2110 to translate along its longitudinal axis into interference with the outer sleeve 2104, thereby deflecting the elongated member 2110 radially inward toward the central longitudinal axis of the universal pen cap 2100 and allowing it to engage with the injection pen 2106 inserted therein. The universal pen cap 2100 is configured so that when the user applies a subsequent pushing force to the clicker mechanism until a click is heard or felt, this force releases the pin 2206 from the second position, pushing the pin back to the first position and retracting the elongated member 2110 along its longitudinal axis from interference with the outer sleeve 2104, thus reducing or eliminating the inward radial force of the elongated member 2110 and reducing the engagement between the elongated member 2110 and the injector pen 2106, thereby allowing the user to remove the injector pen 2106 from the universal pen cap 2100.
[0102] In various embodiments, when the pen clicker is in the disengaged configuration (e.g., as shown in FIG. 22C ), the universal pen cap 2100 is configured to receive the injection pen 2106 therein and to receive a pushing force applied by a user to the button 2204, thereby releasing the pin from a first position in the channel 2208 and allowing the biasing member to push the collet 2102 and the pin 2206 to travel along the channel 2208 to a second position and the universal pen cap 2100 to be in the engaged configuration (e.g., as shown in FIG. 22B ). In various embodiments, the pin 2206 is biased inwardly toward a surface of the channel 2208, such as by a second biasing element, so that when the pin 2206 is moved into the recess of the channel 2208, the user will feel and / or hear a click caused by the pin 2206 hitting the surface as it enters the recess of the channel 2208. When the clicker mechanism is in the engaged configuration, the universal pen cap 2100 is configured to receive a pushing force applied by a user to the button 2204 until a click is heard or felt, and in response to releasing the button 2204, the pin 2206 travels along the groove channel 2208 to the open position. In various embodiments, moving the universal pen cap 2100 from the open position to the closed position, or vice versa, does not move the elongate member 2110 relative to the outer sleeve 2104, but rather translates the outer sleeve 2104 along the longitudinal axis of the universal pen cap 2100 relative to the elongate member 2110.
[0103] In various embodiments, the universal pen cap 2100 includes an electromechanical actuator 2310, as illustrated by the universal pen cap 2300 in FIGS. 23A and 23B. FIG. 23A is a perspective view of the universal pen cap 2300 having the electromechanical actuator 2310, according to one or more embodiments of the present disclosure. FIG. 23B is a cross-sectional perspective view of the universal pen cap 2300 of FIG. 23A. Referring to both FIGS. 23A and 23B together, the universal pen cap 2300 may be similar to the universal pen cap 2100, except for including the electromechanical actuator 2310. In particular, in various embodiments, the universal pen cap 2300 includes a collet 2304 that is the same as or substantially similar to the collet 2102, and an outer sleeve 2306 that is the same as or substantially similar to the outer sleeve 2104. In various embodiments, the electromechanical actuator 2310 is configured to slide the outer sleeve 2104 along the radially outermost surfaces of the plurality of elongated members 2314 of the collet 2304. Optionally, electromechanical actuator 2310 is configured to slide outer sleeve 2104 along the radially innermost surface of another sleeve 2308 .
[0104] In various embodiments, the electromechanical actuator 2310 comprises a servo actuator. In some of these various embodiments, the electromechanical actuator 2310 includes a gear 2322 that rotates about a longitudinal axis of the electromechanical actuator 2310. Additionally, the outer sleeve 2306 includes a ridged receiver 2320 at least partially disposed on an outer radial surface of the outer sleeve 2306 along the longitudinal axis of the universal pen cap 2300, and includes a series of ridges that are substantially complementary to the gear 2322 such that rotation of the gear 2322 is configured to translate the outer sleeve 2306 relative to the elongate member 2314 along the longitudinal axis of the universal pen cap 2300. The injection pen 2302 is also shown.
[0105] In various other embodiments, the electromechanical actuator 2310 includes a solenoid actuator. In some of these various embodiments, the electromechanical actuator 2310 at least partially surrounds the outer sleeve 2306. Furthermore, the outer sleeve 2306 includes a magnetic material such that actuation of the solenoid electromechanical actuator 2310 surrounding the outer sleeve 2104 translates the outer sleeve 2306 along the longitudinal axis of the universal pen cap 2300. In various embodiments, the electromechanical actuator 2310 is configured to be actuated by an actuation device. In various embodiments, the actuation device includes an input selected from a button and a switch.
[0106] In some cases, the pen cap (including at least one of the various universal pen cap embodiments disclosed herein) may obscure or encompass various amounts of the injection pen depending on the length of the injection pen or the length of the pen cap. This can lead to potential problems because the injection pen often contains important information contained on a label, often located on the side of the injection pen, that may be covered or obscured by the universal pen cap. Accordingly, in one or more embodiments of the present disclosure, the universal pen cap includes one or more adjustable floor elements configured to adjust the distance the injection pen can be inserted into the universal pen cap. In various embodiments, the one or more adjustable floor elements include a floor block element defining a cavity configured to accommodate the geometry of the injection pen. For example, in various embodiments, the universal pen cap includes a floor block element and a drive mechanism configured to adjust the positioning of the floor block element within the universal pen cap along a longitudinal axis, thereby adjusting the distance the injection pen can be inserted into the universal pen cap. In various embodiments, the drive mechanism includes an electromechanical actuator. In various other embodiments, the drive mechanism includes a mechanical actuator configured to be actuated by a user.
[0107] 24, which is a semi-transparent side view of an example floor block element 2400 in accordance with one or more embodiments of the present disclosure. In various embodiments, floor block element 2400 defines a cavity 2402 and an opening 2404. In various embodiments, cavity 2402 is configured to accommodate at least a portion of the tip of an injector pen when the injector pen is inserted into opening 2404. In some of these various embodiments, as shown in FIG. 24, cavity 2402 includes a space defined to occupy the needle and / or needle cover of the tip of the injector pen.
[0108] Figure 25A is a semi-transparent side view of a universal pen cap including an adjustable floor element 2500 in accordance with one or more embodiments of the present disclosure. Figure 25B is a side exploded view of the universal pen cap with the adjustable floor element 2500. Referring to both Figures 25A and 25B together, in various embodiments, the adjustable floor element 2500 includes a floor block element 2400 and an electromechanical actuator 2508. The electromechanical actuator 2508 is operably coupled to a lead screw element 2510, and the floor block element 2400 includes a receiving threaded portion 2512 configured to receive the lead screw element 2510.
[0109] In various embodiments, the electromechanical actuator 1704 is configured to rotate the lead screw element 2510 about a central longitudinal axis of the lead screw element 2510. Further, the lead screw element 2510 is configured to mate with the receiving threaded portion 2512 such that a first circumferential rotation of the lead screw element 2510 causes a first axial translation of the floor block 2506 in the direction of the longitudinal axis of the floor block element 2400, and a second circumferential rotation of the lead screw element 2510 opposite the first circumferential direction causes a second axial translation of the floor block 2506 opposite the first axial direction in the direction of the longitudinal axis of the floor block element 2400. In various embodiments, the floor block 2506 is disposed within the outer tube element (e.g., pen cap barrel 2516) such that an injection pen (e.g., injection pen 2514) is received within the floor block 2506 when inserted into the universal pen cap barrel.
[0110] Thus, a user can adjust the depth to which an injection pen (e.g., injection pen 2514) can be inserted into an outer tube element (e.g., pen cap barrel 2516) by translating floor block 2506 within the pen cap barrel by actuating electromechanical actuator 2508.
[0111] FIG. 26A is a cross-sectional side view of an annular floor block 2606 coupled to a pen cap 2602, according to one or more embodiments of the present disclosure. FIG. 26B is a half-cross-sectional side view of an injection pen partially inserted into the annular floor block 2606 shown in FIG. 26A. Referring to both FIGS. 26A and 26B together, in various embodiments, the annular floor block 2606 includes a body, an external flange 2618, and an internal flange. The body includes an annular shape and a ridge 2604 circumferentially disposed around at least a portion of the outer cylindrical surface of the annular shape. In various embodiments, the ridge 2604 extends cylindrically in a ring or ring sector. In other various embodiments, the ridge 2604 defines external threads. The external flange 2618 extends radially outward from a first end of the body and defines a lip adapted to abut the end of the pen cap 2602. The internal flange extends radially inward from the inner surface of the body at a second end opposite the first end of the body, the inner surface defining a cavity. The second end is adapted to be received within the end of the pen cap 2602. In various embodiments, the annular floor block 2606 is disposed within the cavity formed in the body of the annular floor block 2606 and includes one or more flexible arms 2608 adjacent to the inner circumferential surface and extending axially away from the second end toward the first end, which is opposite the pen cap 2602. In various embodiments, the one or more flexible arms 2608 are cantilevered across at least a portion of the inner circumferential surface. For example, in the illustrated embodiment, the one or more flexible arms 2608 extend axially adjacent at least a portion of the inner surface in a cantilevered configuration from the annular surface defined by the internal flange into the cavity.
[0112] In various embodiments, the one or more flexible arms 2608 are sized, shaped, and angled such that they allow at least partial insertion of an injector pen (e.g., injector pen 2610), as shown in FIG. 26B. In some of these various embodiments, the one or more flexible arms 2608 extend primarily axially and also partially radially inward toward the central longitudinal axis of the annular floor block 2606, such that when the injector pen is inserted, the one or more flexible arms 2608 flex outward toward the inner side of the annular floor block 2606 to accommodate the periphery of the injector pen. In various embodiments, the one or more flexible arms are configured to engage with a feature of the injector pen. As shown in FIG. 26B, the injector pen generally features a circumferentially disposed ridge or lip (e.g., injector pen lip 2612) where the pen cartridge contacts the pen handle. Thus, in various embodiments, one or more flexible arms 2608 include a floor block lip 2614 configured to engage with the injection pen lip to prevent the one or more flexible arms 2608 from sliding over the surface of the injection pen. In various embodiments, the floor block lip 2614 protrudes inward. In some of these various embodiments, the lip 2614 includes a bulbous cross-section that protrudes radially inward at the end of the one or more flexible arms 2608.
[0113] In various embodiments, the plurality of ridges 2604 are configured to complementarily mate with the pen cap ridges 2616, such that the pen cap ridge 2616 fits between two of the plurality of ridges 2604, as shown in Figures 26A and 26B. In various embodiments, in response to a continued pushing force applied by a user, when the one or more flexible arms 2608 engage the injection pen lip 2612, the annular floor block 2606 translates along the longitudinal axis of the pen cap 2602 until the pen cap 2602 engages the floor block lip 2618. In some of these various embodiments, when a user inserts an injection pen (e.g., injector pen 2610) into the annular floor block 2606 to the point where the one or more flexible arms 2608 engage the injection pen lip 2612, in response to continued pushing force applied by the user, the plurality of ridges 2604 translate over the pen cap ridges 2616 until the floor block lip 2618 engages the pen cap 2602. Thus, if a user switches from a shorter to a longer pen cartridge, the user pushes the injection pen into the pen cap 2602, and the injection pen and one or more flexible arms 2608 engage sooner, and continued pushing force automatically translates the annular floor block 2606, until the tip of the injection pen engages the pen cap 2602 or the pen cap 2602 engages the floor block lip 2618. Additionally, if a user changes to a longer injection pen, the user can manually pull the annular floor block to the desired length, and in various embodiments in which the ridges 2604 define external threads, the user can manually turn the annular floor block to change the length of the combination of the pen cap 2602 and the annular floor block 2606. In various embodiments, the annular floor block 2606 includes a button operably connected to one or more springs configured to release the annular floor block 2606.The one or more springs are adapted and arranged to translate the annular floor block 2606 between its longest and shortest positions relative to the pen cap 2602 in response to actuation of the button.
[0114] As mentioned above, in various other embodiments, the plurality of ridges 2604 define external threads and are in the form of helical ridges that extend circumferentially at least once around the outer surface of the annular floor block 2606. The helical ridges are configured to operably mate with the pen cap ridges 2616 such that rotation of the pen cap 2602 or the annular floor block 2606 causes the pen cap ridges 2616 to thread between adjacent helical ridges / threads, allowing the annular floor block 2606 to translate along its longitudinal axis within the pen cap 2602.
[0115] FIG. 27A is a cross-sectional side view of a universal pen cap 2700 including an adjustable floor system 2704 in a first position, in accordance with one or more embodiments of the present disclosure. FIG. 27B shows a cross-sectional side view of the universal pen cap of FIG. 27A including the adjustable floor system 2704 in a second position. In various embodiments, the universal pen cap 2700 includes a housing 2702 configured to receive an injection pen 2714. In various embodiments, the adjustable floor system 2704 includes female threads 2706 formed within the housing 2702 and an externally threaded shaft 2708 configured to threadably engage the female threads 2706. The externally threaded shaft 2708 includes an end 2710 configured to define an adjustable floor that is movable by threading the male-threaded shaft 2708 into and out of the female threads 2706. In various embodiments, in response to the injector pen 2714 being inserted into the housing 2702, the externally threaded shaft 2708 moves within the pen barrel 2702 to adjust its internal length from the opening 2716 in the housing 2702 to the end 2710 of the externally threaded shaft 2708, thereby accommodating the length of the injector pen 2714 or the length of the portion of the injector pen 2714 configured to be received within the pen cap. In various embodiments, the externally threaded shaft 2708 is configured to lock into place within the housing 2702 using indentations (e.g., but not limited to, teeth or hooks on the inside of the barrel). In various embodiments, the universal pen cap 2700 includes an electromechanical drive mechanism 2712 (e.g., but not limited to, a motor, servo, or solenoid mechanism). Electromechanical drive mechanism 2712 is configured to rotate externally threaded shaft 2708 and move end 2710 axially relative to the axis of the shaft to change the position of end 2710 relative to opening 2716 .
[0116] FIG. 28A is a cross-sectional side view of a universal pen cap 2800 including an adjustable floor system 2802, according to one or more embodiments of the present disclosure. FIG. 28B shows a cross-sectional side view of the universal pen cap 2800 of FIG. 28A including the adjustable floor system 2802 in a second position. In various embodiments, the adjustable floor system includes an inner tube 2804, a rotating nut 2806, and a threaded stamp 2812. The inner tube 2804 is configured to receive the rotating nut 2806 therein. The rotating nut 2806 includes internal threads 2808 formed at one end and a cavity 2810 formed at the opposite end. The cavity 2810 is configured to receive a portion of the injection pen, including its tip. The threaded stamp 2812 includes external threads configured to mate with the internal threads 2808 of the rotating nut 2806. The rotating nut 2806 is configured to rotate on the threaded stamp 2812, causing the rotating nut 2806 to translate axially within the inner tube 2804 along its longitudinal axis. Movement of the rotating nut 2806 within the inner tube 2804 allows the position of the cavity 2810 to be moved to a known position to occupy the correct length for receiving a particular injection pen within the universal pen cap 2800. The rotating nut 2806 can translate along the threaded stamp 2812 by various mechanisms. In various embodiments, the cavity 2810 includes a notch 2814 configured to receive the needle and needle cover of the injection pen. In various embodiments, the adjustable floor system 2802 includes a magnet 2816 disposed within the rotating nut 2806 (e.g., positioned radially outward from the cavity 2810 and evenly spaced circumferentially around the rotating nut 2806). In various embodiments, the magnet 2816 is a permanent magnet. In various embodiments, the adjustable floor system 2802 includes offset stamps 2818 extending radially outward from the inner tube 2804 and a coil 2820 wrapped around the offset stamps 2818. In various embodiments, the offset stamps 2818 are evenly spaced circumferentially around the inner tube 2804 (e.g., without limitation, at the top and bottom of the inner tube 2804).In various embodiments, the adjustable floor system 2802 includes an electromechanical driver 2822 configured to rotate the threaded stamp 2812. In various embodiments, the combination of the magnet 2816, coil 2820, and electromechanical driver 2822 is configured to translate the rotating nut 2806 along the threaded stamp 2812, thereby axially translating the rotating nut 2806 within the inner tube 2804. While a single female thread 2808 and threaded stamp 2812 combination is shown in FIGS. 28A and 28B , in various embodiments, the adjustable floor system 2802 includes multiple female threads 2808 formed in the rotating nut 2806, each female thread aligned with a corresponding threaded stamp 2812.
[0117] In various embodiments, the calibration of any of the adjustable floor systems disclosed herein (for example, but not limited to, adjustable floor system 2704 and adjustable floor system 2802) is configured for self-calibration or pre-programmed calibration.
[0118] 29 is a cross-sectional side view of a universal pen cap 2900 including an adjustable floor system 2912 in accordance with one or more embodiments of the present disclosure. In various embodiments, the universal pen cap 2900 includes an inner tube 2902, a clasping mechanism 2904, a clasping mechanism motor 2906, a release sensor 2908, an entry sensor 2910, an insertion sensor 2920, the adjustable floor system 2912, and a controller 2922. The clasping mechanism 2904 is configured to actuate from a disengaged state to an engaged state to secure the tip of the injector pen within the inner tube 2902 by applying a compressive force to the tip of the injector pen while in the engaged state. The clasping mechanism motor 2906 is configured to actuate the clasping mechanism 2904 between the disengaged and engaged states in response to a signal received from the controller 2922.
[0119] In various embodiments, the release sensor 2908 is configured to detect a pull by a user attempting to cause an opposing relative axial movement between the injection pen and the universal pen cap 2900 (i.e., by sending a signal to the controller 2922). In various embodiments, the release sensor 2908 includes a force sensor (such as, but not limited to, a load cell, strain gauge, or pressure sensor for detecting a force indicative of a user attempting to pull the injection pen out of the universal pen cap 2900). For example, in various embodiments, the release sensor 2908 is operably coupled to one or more adaptable elements of the universal pen cap 2900 (such as, but not limited to, the clasping mechanism 2904 and the clasping mechanism motor 2906), and in response to detecting a force on the adaptable elements that engage the injector pen caused by a user attempting to remove the universal pen cap 2900 from the injector pen, data indicative of an attempted removal of the injector pen from the universal pen cap 2900 causes the clasping mechanism motor 2906 to actuate the clasping mechanism 2904 from an engaged state to a disengaged state, releasing the injector pen. In various embodiments, the clasping mechanism motor 2906 and the release sensor 2908 are operably coupled to a controller 2922, and the controller is configured to cause the clasping mechanism motor 2906 to release the injector pen in response to receiving data indicative of an attempted removal of the injector pen from the release sensor 2908. In various embodiments, the controller is configured to cause the clasping mechanism motor 2906 to actuate the clasping mechanism 2904 into the disengaged state in response to the detected force being greater than a predetermined threshold.
[0120] In various embodiments, release sensor 2908 is configured to detect a force exerted on the injector pen by one or more adaptive elements (such as, but not limited to, a clamping force applied by clasping mechanism 2904). For example, in various embodiments, release sensor 2908 is configured to detect the force with which clasping mechanism 2904 engages the injector pen and, in response to detecting the force, communicate data corresponding to the force to controller 2922.
[0121] In various embodiments, the entry sensor 2910 is configured to detect the insertion of an injection pen into the universal pen cap 2900 (for example, but not limited to, insertion into the inner tube 2902). In various embodiments, the entry sensor 2910 is positioned adjacent to an opening in the inner tube 2902 and is configured to detect the presence of an object, such as an injection pen, at the opening in the inner tube 2902. Although described with respect to a specific location on the universal pen cap, one skilled in the art will understand that in various embodiments, the entry sensor 2910 is positioned anywhere on the universal pen cap 2900 within the opening of the universal pen cap 2900 to detect the presence (e.g., during insertion or removal) of an injection pen at or adjacent to the mouth / opening of the universal pen cap 2900.
[0122] In various embodiments, the entry sensor 2910 includes a proximity sensor configured to detect an object coming within a detectable proximal distance to the entry sensor. In various embodiments, the proximity detector includes at least one sensor selected from an optical sensor configured to detect shape, light, or motion within an operable distance of the optical sensor, and an infrared sensor configured to detect a transmissive or reflective infrared indicator within an operable distance of the infrared sensor. In various embodiments, the entry sensor 2910 is configured to transmit data to the controller 2922, the data indicating the detection of a detected pen entry event.
[0123] In various embodiments, the adjustable floor system 2912 includes an adjustable floor 2914, an adjustable floor actuator 2916 configured to axially move the adjustable floor 2914 within the inner tube 2902, and an adjustable floor motor 2918 configured to cause actuation of the adjustable floor actuator 2916. In various embodiments, the adjustable floor system 2912 includes any combination of one or more aspects of the adjustable floor systems disclosed herein.
[0124] In various embodiments, the insertion sensor 2920 is configured to detect when the injector pen is fully inserted into the universal pen cap 2900. In various embodiments, the insertion sensor 2920 is configured to detect the position of the injector pen within the universal pen cap 2900 such that actuation of one or more adaptable elements of the universal pen cap secures the injector pen within the universal pen cap 2900.
[0125] In various embodiments, the insertion sensor 2920 is located on the bottom of the universal pen cap 2900 opposite its opening (e.g., at the inner closed distal end). In various embodiments, the insertion sensor 2920 is located on or adjacent to the adjustable floor system 2912 and configured to detect proximity of the end of the injection pen to the adjustable floor system 2912 (e.g., without limitation, proximity to the adjustable floor 2914 of the adjustable floor system 2912, e.g., contact with the adjustable floor 2914). One skilled in the art will understand the location and configuration of the insertion sensor 2920 for detecting an injection pen indicating that the injection is substantially inserted into the universal pen cap 2900 (e.g., without limitation, within a predetermined amount of full insertion of the tip of the injection pen into the universal pen cap 2900). In various embodiments, the insertion sensor 2920 includes at least one sensor selected from a proximity sensor and a force sensor. In various embodiments, the proximity sensor is configured to detect the position of an object within a detectable distance of the proximity sensor. In various embodiments, the proximity sensor includes at least one of optical, audio, and infrared detection capabilities to detect the presence and / or position of the tip of an injection pen disposed within the inner tube 2902. In various embodiments, the force sensor is configured to detect a force applied to the force sensor by the tip of the injection pen, indicating that a user has pushed the injection pen to a fully inserted position within the universal pen cap 2900. In various embodiments, the force sensor includes at least one sensor selected from a load cell, a strain gauge, or a pressure sensor to detect the force with which the injection pen is inserted into the universal pen cap 2900.
[0126] In various embodiments, the clasping mechanism 2904 is configured to actuate into engagement in response to detection of the injection pen by the insertion sensor 2920 (for example, but not limited to, detection of the injection pen indicating substantial insertion of the injection pen into the universal pen cap 2900). In various embodiments, the insertion sensor is operably coupled to the controller 2922 and configured to send data to the controller, the data indicating at least substantial insertion of the injection pen into the universal pen cap 2900. In various embodiments, the controller is configured to send a command to the clasping mechanism motor 2906 to cause the clasping mechanism motor 2906 to actuate the clasping mechanism 2904 into engagement with the injection pen.
[0127] In various embodiments, the controller 2922 includes a processor 2924 and a memory 2926. The memory stores computer-executable instructions that, when executed, cause the processor 2924 to control the universal pen cap 2900 and, in various embodiments, to retrieve data related to the insertion and removal of an injector pen and other data related to the insertion and removal of an injector pen, such as the operation of the clasping mechanism 2904 between engaged and disengaged states.
[0128] In various embodiments, the processor 2924 is configured to compare the data received from the insertion sensor 2920 to at least one threshold selected from a force threshold detected by the force sensor and a proximity threshold detected by the proximity sensor, in various embodiments, the at least one threshold is indicative of the injection pen being substantially inserted into the universal pen cap 2900.
[0129] In various embodiments, any of the entry sensor 2910, the release sensor 2908, and the insertion sensor 2920 further includes a sensor configured to detect at least one condition selected from contamination, wear, and damage to the universal pen cap 2900 and / or the injection pen. In various embodiments, the processor 2924 is configured to determine the level of contamination, wear, and damage to the universal pen cap 2900 in response to data received from the sensors. In various embodiments, the processor 2924 is configured to determine the amount of force exerted by the clasping mechanism 2904 necessary to sufficiently engage the injection pen to secure the injection pen within the universal pen cap 2900. For example, different surface frictions of materials used on the exterior of the injection pen may require different forces to be applied by the clasping mechanism 2904 to sufficiently engage the injection pen.
[0130] In various embodiments, the processor 2924 is configured to detect an operational error (e.g., without limitation, an inability to engage or disengage with an injection pen) of the universal pen cap 2900. In various embodiments, the processor 2924 is configured to cause one or more user interface elements (e.g., a display screen) included in the universal pen cap to display a message or error report, or to transmit a message or error report to a separate user device.
[0131] 30 shows a flow diagram of a method 3000 of operation of a universal pen cap according to one or more embodiments of the present disclosure. In various embodiments, the method includes ensuring the clasping mechanism is open at operation 3002 in response to detecting the insertion of an injection pen into the universal pen cap. In various embodiments, detecting the insertion of the injection pen is performed by the controller 2922 based on a signal received from the entry sensor 2910 and comparing the data to a predetermined value for the data. In various embodiments, the injection pen is inserted into the universal pen cap by a user of the injection pen.
[0132] In various embodiments, method 3000 includes, in response to the injector pen being substantially inserted into the universal pen cap, securing the injector pen with a clasping mechanism at operation 3004. In various embodiments, operation 3004 includes controller 2922 actuating the clasping mechanism into an engaged configuration. In various embodiments, determining that the injector pen is substantially inserted into the universal pen cap includes comparing data received from insertion sensor 2920 to one or more predetermined values indicative of the position of the injector pen.
[0133] In various embodiments, method 3000 further includes, in response to detecting the relative force between the injector pen and the universal pen cap, releasing the injector pen from the clasping mechanism at operation 3006. In various embodiments, detecting the relative force between the injector pen and the universal pen cap includes controller 2922 receiving data from release sensor 2908 indicative of the axial force applied between the universal pen cap 2900 and the injector pen and comparing the data to a threshold indicative of a user attempting to remove the injector pen from universal pen cap 2900.
[0134] 29 , in various embodiments, the controller 2922 is configured to calibrate the adjustable floor system 2912 (i.e., self-calibrate the universal pen cap 2900). In various embodiments, the controller 2922 utilizes data obtained from the entry sensor 2910, the release sensor 2908, and the insertion sensor 2920 to determine relative information about the injector pen and the universal pen cap 2900 (such as, but not limited to, the position of the tip of the injector pen relative to the adjustable floor 2914 when the injector pen is fully inserted, and the force applied to the injector pen while the clasping mechanism 2904 is engaged). In various embodiments, the controller 2922 is configured to adjust various components of the universal pen cap 2900 in response to the obtained data (e.g., adjust the position of the adjustable floor 2914 to position the tip of the injector pen within a predetermined threshold of the adjustable floor 2914, and adjust the force applied to the injector pen by the clasping mechanism 2904, for example, but not limited to, above a first threshold to ensure the injector pen is properly secured and below a second threshold to prevent damage to the injector pen).
[0135] In various embodiments, the controller 2922 is configured to insert the injector pen and move the adjustable floor 2914 until a pre-designated feature is detected. For example, the entry sensor 2910 detects the injector pen and its movement, and in response, the controller 2922 causes the adjustable floor motor 2918 to move the adjustable floor 2914 with the injector pen until the pre-designated feature reaches a predetermined position. In various embodiments, the pre-designated feature is a label on the injector pen, and the adjustable floor is moved until, for example, the leading edge of the label is detected, so that the label is visible with the injector pen substantially inserted into the universal pen cap. In various embodiments, the pre-designated feature includes at least one of an indentation, a protrusion, and a marking located on the injector pen at a predetermined location on the exterior of the injector pen relative to the placement of the label to ensure the label is not obstructed when the injector pen is inserted into the universal pen cap. In various embodiments, the pre-designated feature includes a step-down from the pen handle to the pen cartridge.
[0136] In various embodiments, the controller includes pre-programmed calibrations that include predetermined relative positioning of various components based on the pen geometry (e.g., without limitation, adjustable floor and clasping mechanism positions in engaged and disengaged states). In various embodiments, when a user begins using a medication, the user selects the medication through a feature on the mobile device within the app or a feature on the universal pen cap display. This then prompts the adjustable floor to move to the correct position within the universal pen cap based on the length of the pen so as not to obstruct the label. In various embodiments, the controller 2922 obtains data regarding the pen geometry from an associated user device application (e.g., the user scans a barcode, such as, without limitation, a linear or matrix (2D) barcode, that identifies the injection pen geometry, which is provided to the controller 2922 by the user device).
[0137] As discussed herein, PWDs with DFS sometimes exhibit symptoms that make it difficult to remove or safely shield a medical injection pen. Due to the inherent risk of a PWD being unable to apply the required dose or safely shield the needle, it may be advantageous to enable automatic engagement or disengagement of a universal pen cap from the injection pen to facilitate easier removal or shielding of the injection pen, which may further reduce the cognitive strain that PWDs must endure on a daily basis and may help ensure that the PWD is able to administer the required dose of medication / medication.
[0138] In various embodiments, the controller 2922 is configured for data collection events related to the removal of the universal pen cap 2900 from the injection pen and the replacement of the universal pen cap 2900 with the injection pen. The data collection events may indicate, but are not limited to, a dispensing event. In various embodiments, the data collection events include receiving measurements from one or more sensors (e.g., but not limited to, the entry sensor 2910, the release sensor 2908, and the insertion sensor 2920) at the controller 2922, comparing the measurements to predetermined thresholds, identifying that an event has occurred, and / or providing data or a derivative of the data related to the event to a user, such as via a display screen, and / or to an external device associated with the universal pen cap, such as a user device. For example, universal pen cap events may include, but are not limited to, detecting entry of an injection pen into the universal pen cap, detecting insertion of a pen into the universal pen cap, detecting a force indicative of an attempt to remove the universal pen cap from the injection pen, detecting a force of one or more adaptable elements used to engage the injection pen, detecting movement or orientation of the universal pen cap, and detecting the temperature of a drug / medication in the universal pen cap or an injection pen inserted into the universal pen cap.
[0139] In various embodiments, one or more sensors (e.g., without limitation, entry sensor 2910, release sensor 2908, and insertion sensor 2920) include an accelerometer. In various embodiments, the universal pen cap is configured to automatically wake up (e.g., begin drawing power) in response to a detected shake or orientation change of the accelerometer. In some of these various embodiments, one or more adaptable elements included on the universal pen cap are configured to operate in response to received data (e.g., a detected shake or orientation change) of the accelerometer. In various embodiments, the universal pen cap is configured to automatically enter a sleep mode (e.g., enter a low or no power consumption state) in response to not receiving data from the accelerometer and other sensors for a predetermined period of time.
[0140] Additionally, in various embodiments, the universal pen cap is also configured for greater injection pen retention by preventing one or more adaptable elements included in the universal pen cap from being unintentionally activated, such as by unintentional movements like shaking or dropping the universal pen cap. For example, in various embodiments, the accelerometer is configured to detect movements, such as dropping or incidental or accidental movements of the injection pen, resulting from the normal, everyday movements of a user holding or supporting the universal pen cap, as opposed to intentional forces applied to the injection pen and universal pen cap to remove the injection pen. In these embodiments, the accelerometer is configured to ignore the detected movements. Additionally, in various embodiments, the accelerometer is configured to collect information or data related to a drop of the injection pen and universal pen cap, which may be used to evaluate safety, warranty, and device failure information. In various embodiments, the universal pen cap is configured to display information about the drop on a user interface device (e.g., a display) included on the universal pen cap and / or transmit data related to the drop to a user device associated with the universal pen cap.
[0141] In various embodiments, the universal pen cap includes a temperature sensor configured to sense the temperature of the universal pen cap, the temperature of the injection pen, and / or the temperature of the medication / medication in the injection pen inserted within the universal pen cap. In various embodiments, the controller is configured to issue an alert to the user in response to the temperature sensor detecting a temperature above or below one or more predetermined thresholds. In various embodiments, the alert includes information regarding the temperature of the medication in the injection pen inserted within the universal pen cap. In various embodiments, the universal pen cap includes a display on the exterior of the universal pen cap configured to display a usage pattern, such as, for example, the temperature of the universal pen cap or the temperature of the medication / medication in the injection pen inserted within the universal pen cap, over a period of time.
[0142] 31 shows a block diagram of a system 3100. The system 3100 includes a universal pen cap, one or more sensors, and an electromechanical actuator.
[0143] 32 shows a flow diagram of a method 3200 of operation of a universal pen cap (e.g., any of the universal pen caps of the present disclosure) in accordance with one or more embodiments of the present disclosure. At operation 3202 of method 3100, the universal pen cap is configured to detect a universal pen cap event using one or more sensors. At operation 3204 of method 3200, the universal pen cap actuates one or more adaptable elements in response to detecting the universal pen cap event.
[0144] 33 shows a flow diagram of a method 3300 for actuating one or more adaptable elements of a universal pen cap in response to detecting insertion of an injection pen into the universal pen cap. At operation 3302, the universal pen cap detects attempted insertion of the injection pen using one or more sensors. At operation 3304, the universal pen cap verifies that the one or more adaptable elements are in a disengaged configuration. In various embodiments, in response to the one or more sensors detecting that the one or more adaptable elements are in an engaged configuration and not engaged with the injection pen, the universal pen cap moves the one or more adaptable elements to a disengaged configuration to allow subsequent insertion of the injection pen. At operation 3306, the universal pen cap detects complete insertion of the injection pen into the universal pen cap. In various embodiments, complete insertion includes insertion of the injection pen such that the tip of the injection pen is within a predetermined distance from the closed longitudinal end of the universal pen cap. In some of these various embodiments, completing the insertion includes inserting the injector pen such that the tip of the injector pen is within the floor block element (e.g., without limitation, any of the floor block elements of the present disclosure). Further, completing the insertion includes placing the injector pen within the universal pen cap to substantially match a predetermined positioning. In operation 3308, the universal pen cap actuates one or more adaptable elements into an engaged configuration. In various embodiments, upon inserting the injector pen into the universal pen cap (e.g., without limitation, any of the universal pen caps discussed herein), the universal pen cap actuates one or more adaptable elements to releasably engage the elements with the injector pen.
[0145] FIG. 34 shows a flow diagram of a method 3400 for actuating one or more adaptable elements of a universal pen cap in response to a detected force. In various embodiments, method 3400 is performed by a device or system, such as a universal pen cap for a medical injection pen disclosed herein. At operation 3402, the universal pen cap uses a sensor to detect a force indicative of an attempted removal of the injection pen from the universal pen cap. In various embodiments, the sensor detects a force generated by a user attempting to pull the universal pen cap from the injection pen where the universal pen cap engages the injection pen. At operation 3404, the universal pen cap verifies that one or more adaptable elements are in an engaged configuration. For example, a sensor detects that one or more adaptable elements are engaged with an injection pen inserted within the universal pen cap. In various other embodiments, a sensor detects that one or more adaptable elements are in an engaged configuration but not engaged with the injection pen. At operation 3406, in response to detecting a force greater than a predetermined threshold, the universal pen cap actuates one or more adaptable elements to a disengaged configuration. In various embodiments, upon moving to the disengaged configuration, the one or more adaptable elements are no longer engaged with the injector pen. In various embodiments, the disengaged configuration causes the one or more adaptable elements to reduce engagement with the injector pen by reducing the force exerted on the injector pen so that the user can remove the injector pen. In various embodiments, the universal pen cap performs an additional operation to determine if the one or more adaptable elements have moved to the disengaged configuration. In various embodiments, the universal pen cap detects removal of the injector pen after the one or more adaptable elements have moved to the disengaged configuration.
[0146] FIG. 35 is a block diagram of an example computing device 3514 configured to be utilized within and / or as part of a universal pen cap disclosed herein. In various embodiments, the computing device 3514 is configured (e.g., without limitation, programmed) to perform one or more of the processes described above. It will be understood that one or more computing devices can implement the computing device 3514. The computing device 3514 includes a processor 3502, a memory 3502, a storage device 3506, an I / O interface 3508, and a communication interface 3510, communicatively coupled by a communication infrastructure 3512. While an example computing device is illustrated in FIG. 35, the components illustrated in FIG. 35 are not intended to be limiting. Additional or alternative components may be used in various other embodiments. Furthermore, in various embodiments, the computing device 3514 includes fewer components than those illustrated in FIG. 35. The components of the computing device 3514 illustrated in FIG. 35 will now be described in further detail.
[0147] In one or more embodiments, processor 3502 includes hardware for executing instructions, such as those that make up a computer program. By way of example and not limitation, to execute instructions, processor 3502 retrieves (or fetches) instructions from an internal register, an internal cache, memory 3504, or storage device 3506, decodes them, and executes them. In one or more embodiments, processor 3502 includes one or more internal caches for data, instructions, or addresses. By way of example and not limitation, processor 3502 includes one or more instruction caches, one or more data caches, and one or more translation lookaside buffers (TLBs). Instructions in an instruction cache may be copies of instructions in memory 3504 or storage device 3406. In various embodiments, memory 3504 is used to store data, metadata, and programs executed by the processor. The memory 3504 includes one or more of volatile and non-volatile memory, such as random access memory ("RAM"), read only memory ("ROM"), solid state disk ("SSD"), flash memory, phase change memory ("PCM"), or other types of data storage devices. In various embodiments, the memory 3504 is internal or distributed memory.
[0148] The storage device 3506 includes a storage device for storing data or instructions. By way of example, and not limitation, the storage device 3506 includes the non-transitory storage media described above. In various embodiments, the storage device 3506 includes at least one storage device selected from a hard disk drive (HDD), a floppy disk drive, flash memory, an optical disk, a magneto-optical disk, a magnetic tape, or a universal serial bus (USB) drive, or a combination of two or more thereof. In various embodiments, the storage device 3506 includes removable or non-removable (or fixed) media, as appropriate. The storage device 3506 may be internal or external to the computing device 3514. In one or more embodiments, the storage device 3506 is a non-volatile solid-state memory. In various other embodiments, the storage device 3506 includes a read-only memory (ROM). Where appropriate, the ROM may be mask-programmed ROM, programmable ROM (PROM), erasable PROM (EPROM), electrically erasable PROM (EEPROM), electrically erasable and programmable ROM (EAROM), or flash memory, or a combination of two or more of these.
[0149] The I / O interface 3508 enables a user to provide input to, receive output from, and otherwise transfer data to and receive data from the computing device 3514. In various embodiments, the I / O interface 3508 includes a mouse, a keypad or keyboard, a touch screen, a camera, an optical scanner, a network interface, a modem, other known I / O devices, or a combination of such I / O interfaces. The I / O interface 3508 may include one or more devices for presenting output to a user, including, but not limited to, a graphics engine, a display (e.g., a display screen), one or more output drivers (e.g., a display driver), one or more audio speakers, and one or more audio drivers. In particular embodiments, the I / O interface 3508 is configured to provide graphical data to a display for presentation to a user. The graphical data may represent one or more graphical user interfaces and / or other graphical content that may be useful in a particular implementation.
[0150] The communications interface 3510 includes hardware, software, or both. In any event, the communications interface 3510 provides one or more interfaces for communications (e.g., packet-based communications, etc.) between the computing device 3514 and one or more other computing devices or networks. By way of example and not limitation, the communications interface 3510 may include a network interface controller (NIC) or network adapter for communicating with an Ethernet or other wired-based network, or a wireless NIC (WNIC) or wireless adapter for communicating with a wireless network such as WI-FI.
[0151] Additionally or alternatively, in various embodiments, communication interface 3510 is configured to facilitate communication with one or more portions of an ad-hoc network, a personal area network (PAN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), or the Internet, or a combination of two or more of these. One or more portions of one or more of these networks may be wired or wireless. By way of example, communication interface 3510 may facilitate communication with a wireless PAN (WPAN) (e.g., a BLUETOOTH® WPAN, etc.), a Wi-Fi network, a Wi-MAX network, a cellular network (e.g., a Global System for Mobile Communications (GSM) network), or other suitable wireless network, or a combination thereof.
[0152] Additionally, communication interface 3510 is configured to facilitate communication of various communication protocols. Examples of communication protocols that may be used include, but are not limited to, data transmission media, communication devices, Transmission Control Protocol ("TCP"), Internet Protocol ("IP"), File Transfer Protocol ("FTP"), Telnet, Hypertext Transfer Protocol ("HTTP"), Hypertext Transfer Protocol Secure ("HTTPS"), Session Initiation Protocol ("SIP"), Simple Object Access Protocol ("SOAP"), Extensible Markup Language ("XML") and variations thereof, Simple Mail Transfer Protocol ("SMTP"). "), Real-Time Transport Protocol ("RTP"), User Datagram Protocol ("UDP"), Global System for Mobile Communications ("GSM") technology, Code Division Multiple Access ("CDMA") technology, Time Division Multiple Access ("TDMA") technology, Short Message Service ("SMS"), Multimedia Message Service ("MMS"), Radio Frequency ("RF") signaling technology, Long Term Evolution ("LTE") technology, wireless communication technology, in-band and out-of-band signaling technology, and other suitable communications networks and technologies.
[0153] Communications infrastructure 3512 includes hardware, software, or both that couple together components of computing device 3514. By way of example, and not limitation, communications infrastructure 3512 may include an Accelerated Graphics Port (AGP) or other graphics bus, an Enhanced Industry Standard Architecture (EISA) bus, a Front Side Bus (FSB), a HyperTransport (HT) interconnect, an Industry Standard Architecture (ISA) bus, an InfiniBand interconnect, a Low Pin Count (LPC) bus, a memory bus, a Micro Channel Architecture (MCA) bus, a Peripheral Component Interconnect (PCI) bus, a PCI-Express (PCIe) bus, a Serial Advanced Technology Attachment (SATA) bus, a Video Electronics Standards Association Local (VLB) bus, or another suitable bus, or any combination thereof.
[0154] 36A-36C show side exploded views of portions of a universal pen cap 3600 ready to receive a variety of different dispensing pens having various sizes (e.g., the different dispensing pens shown in FIG. 2), including a dispensing pen 3601 according to another embodiment of the present disclosure. As shown in FIG. 36A, the universal pen cap 3600 includes an adjustable collar 3602, a clamping mechanism 3604, a clicker mechanism 3606, and an optional inner tube 3608. The optional inner tube 3608 can be configured to house at least the clamping mechanism 3604 and the clicker mechanism 3606.
[0155] The adjustable collar 3602 is configured to accept a variety of different dispens, including the dispensing pen 3601. The dispensing pen 3601 includes a needle and / or needle cover 3603. In some embodiments, the adjustable collar 3602 can be similar to the collar 1502 shown in FIG.
[0156] 36B, the clamping mechanism 3604 includes two pen clamps 3612a,b, two clamping links 3614a,b, a spring well 3616, a pen datum 3615, and a clamp spring 3618 having one end attached to the spring well 3616. The clamping links 3614a,b, along with the clamp spring 3618, can operate similarly to the actuation arms 304 shown in FIGS. 3A and 3B to surround, engage, and disengage from the administration or injection pen 3601. In some embodiments, the overall form factor and size of the clamping mechanism 3604 can be reduced by using a single clamp spring 3618 rather than a biasing element 310 on each of the actuation arms 304.
[0157] In various embodiments, the pen clamps 3612a,b are attached to the spring well 3616 via a hinge connection. Thus, the pen clamps 3612a,b are configured to swing radially inward toward a central longitudinal axis of the universal pen cap 3600 and engage (e.g., contact) the dosing pen 3601 when the dosing pen 3601 is inserted into the universal pen cap 3600. In response to the pen clamps 3612a,b swinging radially inward, the tightening links 3614a,b press against the spring well 3616 along the longitudinal axis, compressing the clamp spring 3618. As shown in FIG. 37 , the pen clamps 3612a,b have a rigid body 3701 and a resilient member 3704 attached to a bottom surface 3702 of the rigid body 3701. The rigid body 3701 can be formed of, for example, a hard plastic. The resilient member 3704 can be formed of an elastomeric material. The resilient member 3704 is configured to allow a variety of dosing pens (including the dosing pen 3601) of varying diameters to fit securely within the pen clamps 3612a,b. In some embodiments, the pen clamps 3612a,b can be formed using a two-shot injection molding process. The two-shot injection molding process can create undercuts 3705 that allow for an increased contact surface area between the rigid body 3701 and the resilient member 3704, thereby increasing the mechanical bond strength between the rigid body 3701 and the resilient member 3704. Each end of the pen clamps 3612a,b includes an opening 3710 to accommodate a pin (not shown) that can be used to attach the pen clamps 3612a,b to the spring well 3616. In another embodiment, shown in FIG. 38, each end of the pen clamps 3612a,b can include a ball 3805 configured to attach to a socket (not shown) formed in the spring well 3616 using a ball-and-socket method. By using a ball and socket method to attach the pen clamps 3612a,b to the spring wells 3616 (via ball protrusions 3805) rather than a pin via openings 3710 as shown in Figures 37A and 37B, the reliability of the pen clamps 3612a,b can be improved during their life cycle of inserting and removing a dosing pen.
[0158] 36B, in various embodiments, the clamping links 3614a,b are coupled to the pen clamps 3612a,b at their respective longitudinal ends. For example, the clamping links 3614a,b in various embodiments can be coupled to the pen clamps 3612a,b via hinge connections. In various embodiments, the clamp spring 3618 is oriented along the longitudinal axis of the universal pen cap 3600 and is configured to compress in response to radial movement of the pen clamps 3612a,b.
[0159] In some embodiments, at least a portion of the pen datum 3615 is contained within a clamp spring 3618. The pen datum 3615 is configured to move along the longitudinal axis of the universal pen cap 3600 within the clamp spring 3618, which engages the clicker mechanism 3606. Longitudinal movement of the pen datum 3615 occurs when the dosing pen 3601 is inserted through the adjustable collar 3602 and spring well 3616 into the pen datum 3615. In some embodiments, the pen datum 3615 is shaped to allow at least a portion of the needle and / or needle cover 3603 to pass therethrough. In some embodiments, the pen datum 3615 can include a dead stop mechanism (not shown) configured to limit the amount of dosing pen 3601 that can enter the pen datum 3615. The pen datum 3615 includes two longitudinally extending arms 3665 that form an opening that allows components of the clicker mechanism 3606 to pass therethrough. The pen datum 3615 includes pen datum protrusions 3670 disposed along the longitudinal length of the pen datum 3615 that protrude radially inward of the pen datum 3615 and are configured to travel along the guide passage 3905 of the clicker mechanism 3606. In some embodiments, each of the longitudinally extending arms 3665 of the pen datum 3615 includes a pen datum protrusion 3670 that protrudes radially inward of the pen datum 3615. Each of the pen datum protrusions 3670 is configured to travel along the guide passage 3905.
[0160] 36C , the clicker mechanism 3606 includes a biasing member 3620 (for example, but not limited to, a spring), a clicker retainer 3622, and a clicker portion consisting of a first clicker body 3624 and a second clicker body 3626. In some embodiments, at least a portion of the needle and / or needle cover 3603 of the dispensing pen 3601 is configured to pass through the pen datum 3615 and into the clicker retainer 3622. The pen datum 3615 has an opening along its longitudinal axis configured to allow the biasing member 3620, the clicker retainer 3622, and at least the first clicker body 3624 to pass therethrough. The clicker retainer 3622 is configured to support the first clicker body 3624 and the second clicker body 3626. The first clicker body 3624 and the second clicker body 3626 are configured to form a guide passage 3905 that wraps around the clicker bodies 3624, 3626. In some embodiments, the guide passage 3905 is shaped as a cardioid, having a zigzag or angled surface that wraps around the clicker bodies 3624, 3626. The use of a cardioid-shaped guide passage 3905 in conjunction with the clicker mechanism 3606 can reduce the form factor and size of the clicker mechanism 3606, for example, as compared to the cam element 402 and guide element 412 shown in FIGS. 5A-5C . It will be appreciated that the first clicker body 3624 and the second clicker body 3626 are configured to rotate in the same direction during operation of the clicker mechanism 3606. The pen datum 3615 is configured to move back and forth over the biasing member 3620, clicker retainer 3622, and first clicker body 3624 along the longitudinal axis of the universal pen cap 3600. Linear travel of the pen datum 3615 along the longitudinal axis of the universal pen cap 3600 causes the inwardly projecting pen datum protrusion(s) 3670 to run along the guide passage 3905 formed by the first clicker body 3624 and the second clicker body 3626, pushing against the first clicker body 3624 and the second clicker body 3626 to rotate them and compress the biasing member 3620.36A, the guide passage 3905 can include a zigzag or angled surface, with the pen datum protrusion(s) 3670 configured to run along the zigzag or angled surface. Operation of the clicker mechanism 3606 is discussed in more detail below with respect to FIGS. 39A-39E.
[0161] Figures 39A-39F show the operation of the clicker mechanism 3606 in various operating states when a dispensing pen 3601 is inserted into the universal pen cap 3600. Figure 39A-1 shows a portion of the universal pen cap 3600 when the dispensing pen 3601 is not in contact with the pen datum 3615 or another part of the clamping mechanism 3604 or the clicker mechanism 3606 (State 0). The pen datum protrusion(s) 3670 are at the start position 3908 of the guide passage 3905. As shown in Figure 39A-2, both the clamp spring 3618 and the biasing member 3620 are in their normal positions.
[0162] Figure 39B-1 shows a portion of the universal pen cap 3600 when the dosing pen 3601 begins to contact the pen datum 3615, but insertion of the dosing pen 3601 has not yet begun to compress both the clamp spring 3618 and the biasing member 3620 (State 1). The pen datum protrusion(s) 3670 remain stationary at the start position 3908 of the guide passage 3905. As shown in Figure 39B-2, both the clamp spring 3618 and the biasing member 3620 remain in their normal positions.
[0163] FIG. 39C-1 shows a portion of the universal pen cap 3600 when insertion of the dosing pen 3601 advances the pen datum 3615 relative to the spring well 3616 (State 2). The clamping links 3614a,b are configured to rotate around the pen datum 3615 and begin to contact the outer periphery of the dosing pen 3601. As shown in FIG. 39C-2, the clamp spring and optionally the biasing member 3620 are configured to compress an amount dependent on the diameter of the dosing pen 3601 inserted within the universal pen cap 3600. Advancement of the pen datum 3615 causes the biasing member 3620 to begin to compress. Additionally, the pen datum protrusion(s) 3670 advance along the sloped surface 3675 of the guide passage 3905 as the first clicker body 3624 and the second clicker body 3626 rotate based on the compression of the biasing member 3620.
[0164] FIG. 39D-1 shows a portion of the universal pen cap 3600 when the dosing pen 3601 is fully inserted and further travel is limited by the clicker mechanism 3606 (state 2.5). This position defines the maximum user pushing force required to lock the dosing pen 3601 into the universal pen cap 3600. As shown in FIG. 39D-2, the pen datum protrusion(s) 3670 have advanced further along the guide channel 3905, causing compression of both the biasing member 3620 and the clamp spring 3618 (along with the dosing pen 3601). The advancement of the pen datum 3615, and therefore the pen datum protrusion(s) 3670, also rotates the first clicker body 3624 and the second clicker body 3626. In some embodiments, the radial flexure 4005 of the second clicker body 3626 can be configured to be urged radially inward by the teeth 4010 on the first clicker body 3624, and then click radially outward when State 2.5 is reached, thereby providing tactile and auditory feedback to the user. In some embodiments, at State 2.5, the biasing member 3620 is at or near its maximum compression.
[0165] FIG. 39E-1 shows a portion of the universal pen cap 3600 when a user releases the dispenser pen 3601 and allows the biasing member 3620 to move the pen datum 3615 forward (State 3). State 3 defines the clamping force (and therefore the retention force) applied to the dispenser pen 3601 by the clamping mechanism 3604 and clicker mechanism 3606. It will be appreciated that the retention force may also depend on the coefficient of friction between the dispenser pen 3601 and the pen clamps 3612a, b. The coefficient of friction between the dispenser pen 3601 and the pen clamps 3612a, b may vary based on the geometry of the dispenser pen 3601. As shown in FIG. 39E-2, the pen datum protrusion(s) 3670 are locked in their final state within the clicker mechanism 3606 at the locking position 3910 of the guide passage 3905. In the locked position 3910, both the biasing member 3620 and the clamp spring 3618 are compressed, but the biasing member 3620 is not as compressed as it was in state 2.5. Once in state 3 (one or more pen datum protrusion(s) 3670 are locked in their final state), the user can remove the dosing pen 3601 from the universal pen cap 3600 by pushing the dosing pen 3601 into the universal pen cap 3600. Pushing the dosing pen 3601 into the universal pen cap 3600 releases the pen datum protrusion(s) 3670 from the locked position 3910 and releases the clamp spring 3618 and biasing member 3620, returning the pen datum protrusion 3670 to the start position 3908 of the guide channel 3905.
[0166] FIG. 39F-1 shows a portion of the universal pen cap 3600 when the dosing pen 3601 has been safely removed from the universal pen cap 3600 (State 4). State 4 is defined as the pen datum protrusion(s) 3670 being locked in their final state within the clicker mechanism 3906, but the dosing pen 3601 is no longer within the universal pen cap 3600. This can occur when the user removes the dosing pen 3601 from the universal pen cap 3600 by pulling out the dosing pen 3601 rather than pushing it into the universal pen cap 3600 after the pen datum protrusion(s) 3670 have been locked in their final state. As shown in FIG. 39F-2 , the pen datum protrusion(s) 3670 remain locked in their final state within the clicker mechanism 3606 at the locked position 3910 in the guide passage 3905, and the clamp spring 3618 and biasing member 3620 remain compressed despite the removal of the dosing pen 3601. In some embodiments, the user can reset the click mechanism 3606 back to state 0 by pushing the dosing pen into the universal pen cap 3600 where it contacts the now-closed pen clamps 3612 a,b. The user continues to insert the dosing pen until the pen datum protrusion(s) 3670 reach the position in the guide passage 3905 associated with state 2.5. The user can then release the dosing pen, and the click mechanism will reset back to state 0.
[0167] 40A and 40B, the second clicker body 3626 can include a radial tactile feedback flexure 4005 (see FIG. 40A ) and the first clicker body 3624 can include teeth 4010 to provide tactile and auditory feedback to the user while inserting the dispensing pen 3601 into the universal pen cap 3600. For example, movement of the pen datum 3615 can cause the radial tactile feedback flexure 4005 to be urged radially inward by the teeth 4010 and then click radially outward when the clicker mechanism 3606 reaches a specified state. In some embodiments, the pen datum 3615 can cause the radial tactile feedback flexure 4005 to be urged radially inward by the teeth 4010 and then click radially outward when the clicker mechanism 3606 reaches state 2.5, as shown in FIGS. 39D-1 and 39D-2.
[0168] In some embodiments, the overall size (e.g., radial size) of the universal pen cap 3600 can be reduced by reducing the wall thickness of the housing of the universal pen cap 3600 that houses the clamping mechanism 3604 and the click mechanism 3606 and / or by removing the optional inner tube 3608 (used to provide ingress protection).
[0169] 41 , the universal pen cap 3600 can include an access wall 3640 that protects the electrical components of the universal pen cap 3600 (e.g., battery 3645, printed circuit board 3647, charging port 3649, display 3650, etc.) from the entry of foreign objects at or near the open end or mouth 3655 of the universal pen cap 3600, particularly at a location 3660 between the printed circuit board 3647 and the open end 3655. The access wall 3640 can run along the longitudinal length of the universal pen cap 3600 and can, for example, surround a portion of the battery 3645 used to power the universal pen cap 3600. In some embodiments, the access wall 3650 can be attached to the top housing of the universal pen cap 3600.
[0170] In some embodiments, as shown in Figure 42, the universal pen cap 3600 can include a charging port 4205 located adjacent to the pen cap display 4210. By locating the charging port 4205 adjacent to the pen cap display 4210, the charging port 4205 can be protected by an access wall 3650 (see Figure 41).
[0171] FIG. 43 illustrates a friction clamp 4305 that can be used in place of the pen clamps 3612a,b shown in FIGS. 36 and 37. The friction clamp 4305 is configured to radially clamp a dosing pen (e.g., dosing pen 3601) by means of two friction shoes 4310a,b. In some embodiments, the friction shoes 4301a,b can be spring-loaded contacts. In this configuration, the user directly opposes the friction force provided by the friction shoes 4310a,b upon both insertion and removal of the dosing pen 3601. Thus, the friction shoes 4310a,b are configured to apply a radial force to retain the dosing pen 3601 within the universal pen cap (e.g., universal pen cap 3600). The friction shoes 4310a,b can be configured to contact various points on the dosing pen depending on the geometry of the dosing pen. The friction shoes 4310a,b are tapered at an angle such that the friction catch 4305 can always be tangent to the delivery pen, regardless of the delivery pen's rotational orientation. As shown in FIGS. 44a-44c, the friction force of the friction catch 4305 on the delivery pen 3601 can vary based on the delivery pen's orientation. For example, the delivery pen 3601 has a rigid body 4403 and indicia or cutouts 4401 that can provide, for example, a diagram of the delivery substance (e.g., insulin) contained within the delivery pen 3601. However, these indicia or cutouts 4401 can reduce frictional contact with the friction shoes 4301a,b. For example, FIG. 44a shows that each of the friction shoes 4310a,b forms two contact points on the rigid body 4403 of the delivery pen 3601 without the friction shoes 4310a,b straddling the indicia or cutouts 4401. The indicia or cutout 4401 does not straddle the friction shoes 4310a,b. Fig. 44B shows that each of the friction shoes 4310a,b forms one contact point on the rigid body 4403 with the other contact point on the indicia or cutout 4401. Fig. 44C shows that the indicia or cutout 4401 straddles each of the friction shoes 4310a,b while still allowing the friction shoes 4310a,b to form two contact points on the rigid body 4403.
[0172] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.
[0173] As used herein, the term "may" in reference to a material, structure, feature, function, or method act indicates that the term is contemplated for use in the practice of one embodiment of the present disclosure, and such term is used in preference to the more restrictive term "is" to avoid the implication that other compatible materials, structures, features, functions, and methods that can be used in combination therewith are or must be excluded.
[0174] As used herein, the use of any relative terminology such as "first," "second," etc. is used for clarity and convenience in understanding this disclosure and the accompanying drawings, and no particular preference or order is to be implied or relied upon unless the context clearly dictates otherwise.
[0175] As used herein, the term "substantially" with respect to a given parameter, characteristic, operation, or condition means and includes, to some extent, that one of ordinary skill in the art would understand that the given parameter, characteristic, or condition is met with a small degree of variance, such as within acceptable manufacturing tolerances. By way of example, depending on the particular parameter, characteristic, or condition that is substantially met, the parameter, characteristic, or condition may be at least 90.0% met, at least 95.0% met, at least 99.0% met, or in some cases at least 99.9% met.
[0176] As used herein, the term "about" when used in reference to a given parameter is inclusive of the stated value and has a meaning that varies with context (e.g., the term includes the degree of error associated with the measurement of the given parameter, as well as variations resulting from manufacturing tolerances, etc.).
[0177] The embodiments of the present disclosure described above and illustrated in the accompanying drawings do not limit the scope of the present invention, as these embodiments are merely examples of embodiments of the present invention as defined by the appended claims and their legal equivalents. Any equivalent embodiments are intended to be within the scope of the present invention. Indeed, various modifications of the present disclosure, in addition to those shown and described herein, may become apparent to those skilled in the art from this specification, including alternative useful combinations of the described content features. Such modifications and embodiments are also intended to be included within the scope of the appended claims and their legal equivalents.
[0178] Additional non-limiting embodiments of the present disclosure include the following.
[0179] Embodiment 1: A pen cap for use with an injection pen, the pen cap comprising one or more adaptable elements configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens.
[0180] Embodiment 2: The pen cap of embodiment 1, wherein the plurality of different injection pens comprises at least two different injection pens having different geometries.
[0181] Embodiment 3: A pen cap as described in embodiments 1 and 2, wherein the one or more adaptable elements comprise at least one actuator and a plurality of arms operably coupled to the at least one actuator, and the plurality of arms are configured to rotate at least a portion of the plurality of arms radially inward toward a central longitudinal axis of the pen cap in response to actuation of the at least one actuator.
[0182] Embodiment 4: A pen cap as described in embodiments 1 to 3, wherein the one or more adaptable elements comprise a tube having a plurality of successive segments, the inner diameter of the tube gradually decreasing along a central longitudinal axis of the pen cap, and each segment of the plurality of successive segments comprising the inner diameter.
[0183] Embodiment 5: The pen cap of any one of embodiments 1 to 4, further comprising an outer frame element including an outer wall, wherein the one or more adaptable elements comprise: a first opening formed in the outer wall; at least one catch member coupled to the outer frame element and configured to extend through the first opening and engage with the injection pen when the injection pen is inserted into the second opening of the outer frame element; and a biasing member configured to urge the at least one catch member radially inward toward a central longitudinal axis of the pen cap.
[0184] Embodiment 6: A pen cap as described in embodiments 1 to 5, wherein the one or more adaptable elements comprise an outer wall including a frustoconical cavity having a frustoconical shape formed therein, the frustoconical cavity including an inner diameter that narrows along a central longitudinal axis of the pen cap with a larger diameter end of the frustoconical shape at the open end of the outer wall.
[0185] Embodiment 7: A pen cap according to any one of embodiments 1 to 6, further comprising: an outer shell including an outer wall shaped to at least partially surround a longitudinal end of an injection pen, the outer shell including an open end formed therein; and a slot formed in the outer wall extending radially through the outer wall and axially along a portion of the outer wall, wherein one or more adaptable elements comprise a sleeve element configured to be removably coupled to the longitudinal end of one of the injection pens, the sleeve element being sized and shaped to slide along the slot when the injection pen is inserted into the pen cap, and comprising a radially extending member adapted to interface with the slot to removably secure the injection pen to the outer shell.
[0186] Embodiment 8: A pen cap as described in embodiments 1 to 7, wherein one or more adaptable elements comprise a collet having a plurality of elongated members oriented circumferentially around a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; and an outer sleeve disposed around the plurality of elongated members, the outer sleeve and the plurality of elongated members being configured for relative movement between the outer sleeve and the plurality of elongated members, and the outer sleeve sliding against the radially outermost surfaces of the plurality of elongated members based on the relative movement between the outer sleeve and the plurality of elongated members.
[0187] Embodiment 9: A pen cap as described in embodiments 1 to 8, wherein the one or more adaptable elements comprise: a collar including a radially inner surface; a plurality of inclined protrusions extending radially inward from the radially inner surface, wherein the thickness of each of the inclined protrusions increases circumferentially and the inclined protrusions are evenly spaced circumferentially around the radially inner surface of the collar; and a plurality of roller elements, each roller element positioned adjacent to a corresponding inclined protrusion of the plurality of inclined protrusions, and configured to contact an outer radial surface of the injection pen, wherein the plurality of roller elements and the plurality of inclined protrusions are adapted to provide relative circumferential movement between the plurality of roller elements and the plurality of inclined protrusions.
[0188] 10. The pen cap of claim 1, wherein the one or more adaptable elements comprise: a tapered collet having a plurality of recesses formed in a radially outer surface thereof, the plurality of recesses being oriented relative to one another in a spiral pattern, the tapered collet defining a frusto-conical opening configured to receive at least a portion of one of a plurality of different injection pens; an annular collar having a radially inner surface defining a central axial opening, the annular collar configured to receive the tapered collet through the central axial opening and having one or more protrusions extending radially inward from the radially inner surface, the one or more protrusions being sized, shaped, and positioned to be received in each of the plurality of recesses and to slide along the respective recesses during operation, wherein translation of the annular collar in a first axial direction along the tapered collet causes at least a portion of the tapered collet to bend radially inward toward a longitudinal axis of the pen cap; and an outer frame member attached to the radially outer surface of the annular collar.
[0189] 11. A pen cap as described in embodiments 1 to 10, wherein the one or more adaptable elements comprise: an annular drive gear, the annular drive gear defining a central opening for receiving at least a portion of one of a plurality of different injection pens, and at least a portion of the annular drive gear configured to rotate circumferentially about a longitudinal axis of the pen cap; an annular receiver gear operably engaged with the annular drive gear and configured to rotate about an axis of the annular drive gear, the annular receiver gear including a central opening formed therein; and an engagement member disposed within the central opening, the annular receiver gear adapted to rotate in a manner that translates the engagement member along its axis.
[0190] Embodiment 12: A pen cap for interfacing with an injection pen, the pen cap comprising means for removably connecting the pen cap to a plurality of different geometries of a plurality of different injection pens.
[0191] Embodiment 13: The pen cap of embodiment 12, wherein the plurality of different injection pens comprises at least two different injection pens having different geometries.
[0192] Embodiment 14: A pen cap as described in embodiments 12 and 13, wherein the means comprises at least one actuator and a plurality of arms operably connected to the at least one actuator, and the plurality of arms are configured to rotate at least a portion of the plurality of arms radially inward toward a central longitudinal axis of the pen cap in response to actuation of the at least one actuator.
[0193] Embodiment 15: A pen cap according to embodiments 12-14, wherein the means comprises a tube having a plurality of successive segments, the inner diameter of the tube gradually decreasing along a central longitudinal axis of the pen cap, and each segment of the plurality of successive segments comprising the inner diameter.
[0194] Embodiment 16: A pen cap according to any of embodiments 12 to 15, further comprising an outer frame element including an outer wall, wherein the means comprises an opening formed in the outer wall, at least one catch member coupled to the outer frame element and configured to extend through the opening and engage with the injection pen when the injection pen is inserted into the opening of the outer frame element, and a biasing member configured to urge the at least one catch member radially inward toward the central longitudinal axis of the pen cap.
[0195] Embodiment 17: A pen cap according to embodiments 12-16, wherein the means comprises an outer wall including a frustoconical cavity having a frustoconical shape formed therein, the frustoconical cavity including an inner diameter that narrows along a central longitudinal axis of the pen cap with a larger diameter end of the frustoconical shape at an open end of the outer wall.
[0196] Embodiment 18: A pen cap according to any of embodiments 12 to 17, further comprising: an outer shell including an outer wall shaped to at least partially surround a longitudinal end of an injection pen, the outer wall including an open end formed therein; and a slot formed in the outer wall extending radially through the outer wall and axially along a portion of the outer wall; wherein the means comprises a sleeve element configured to be removably coupled to the longitudinal end of one of the injection pens, the sleeve element being sized and shaped to slide along the slot when the injection pen is inserted into the pen cap, and comprising a radially extending member adapted to interface with the slot to removably secure the injection pen to the shell.
[0197] Embodiment 19: A pen cap as described in embodiments 12 to 18, wherein the means comprises: a collet having a plurality of elongated members oriented circumferentially around a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; and an outer sleeve disposed around the plurality of elongated members, the outer sleeve and the plurality of elongated members being configured for relative movement between the outer sleeve and the plurality of elongated members, and wherein the outer sleeve slides against the radially outermost surfaces of the plurality of elongated members based on the relative movement between the outer sleeve and the plurality of elongated members.
[0198] Embodiment 20: A pen cap as described in embodiments 12 to 19, wherein the means comprises a locking ring comprising: a collar including a radially inner surface; a plurality of angled protrusions extending radially inward from the radially inner surface, wherein the thickness of each of the angled protrusions increases circumferentially and the angled protrusions are evenly spaced circumferentially around the radially inner surface of the collar; and a plurality of roller elements, each roller element positioned adjacent to a respective one of the angled protrusions, and configured to contact an outer radial surface of the injection pen, wherein the plurality of roller elements and the plurality of angled protrusions are adapted to allow relative circumferential movement between the plurality of roller elements and the plurality of angled protrusions.
[0199] Embodiment 21: A pen cap as described in embodiments 12 to 20, wherein the means comprises: a tapered collet, the tapered collet having a plurality of recesses formed in a radially outer surface thereof, the plurality of recesses being oriented relative to one another in a spiral pattern, the tapered collet defining a frusto-conical opening configured to receive at least a portion of one of a plurality of different injection pens; an annular collar having a radially inner surface defining a central axial opening, the annular collar configured to receive the tapered collet through the central axial opening and having one or more protrusions extending radially inward from the radially inner surface, the one or more protrusions being sized, shaped, and positioned to be received in each of the plurality of recesses and to slide along the respective recess during operation, wherein translation of the annular collar in a first axial direction along the tapered collet causes at least a portion of the tapered collet to bend radially inward toward a longitudinal axis of the pen cap; and an outer frame member attached to the radially outer surface of the annular collar.
[0200] Embodiment 22: A pen cap as described in embodiments 12 to 21, wherein the means comprises: an annular drive gear, the annular drive gear defining a central opening for receiving at least a portion of one of a plurality of different injection pens, at least a portion of the annular drive gear configured to rotate circumferentially about a longitudinal axis of the pen cap; an annular receiver gear operably engaged with the annular drive gear and configured to rotate about an axis of the annular drive gear, the annular receiver gear including a central opening formed therein; and an engagement member disposed within the central opening, the annular receiver gear being adapted to rotate in a manner that translates the engagement member along its axis.
[0201] Embodiment 23: A pen cap for use with an injection pen, comprising: one or more adaptable elements configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens; and an electromechanical actuator coupled to at least one of the one or more adaptable elements and configured to actuate the one or more adaptable elements to adapt the one or more adaptable elements to a given geometry of a given injection pen.
[0202] Embodiment 24: The pen cap of embodiment 23, wherein the plurality of different injection pens are at least two different injection pens having different geometries.
[0203] Embodiment 25: The pen cap according to embodiments 23 and 24, wherein the electromechanical actuator comprises at least one actuator selected from a servo actuator and a solenoid actuator.
[0204] Embodiment 26: A pen cap as described in embodiments 23 to 25, further comprising an outer frame element including an outer wall, wherein one or more adaptable elements comprise an opening formed in the outer wall and at least one catch member coupled to the outer frame element, extending through the opening, and configured to translate radially inward and outward through the opening, and wherein an electromechanical actuator is configured to translate the at least one catch member radially inward to engage with the injection pen in response to the injection pen being inserted into the opening in the outer frame element.
[0205] Embodiment 27: A pen cap as described in embodiments 23 to 26, wherein the one or more adaptable elements comprise an outer frame element defining an opening sized and shaped to receive the longitudinal ends of multiple injection pens, and the electromechanical actuator comprises a solenoid actuator, and the one or more adaptable elements comprise one or more engagement elements and a compression element disposed at least partially within the solenoid actuator and adapted to translate the one or more engagement elements along a longitudinal axis of the solenoid actuator, the solenoid actuator being positioned such that the longitudinal axis of the solenoid actuator is substantially perpendicular to the longitudinal axis of the pen cap, and the compression element is configured to apply an inward radial force to the one or more engagement elements relative to the longitudinal axis of the pen cap in response to actuation of the solenoid actuator.
[0206] Embodiment 28: A pen cap as described in embodiments 23 to 27, wherein the one or more adaptable elements comprise a clamping device, the clamping device comprising a first arm and a second arm rotatably connected to the first arm, and an electromechanical actuator is connected to at least one arm selected from the first arm and the second arm and configured to rotate the at least one arm selected from the second arm relative to the first arm and the first arm relative to the second arm.
[0207] Embodiment 29: The pen cap of embodiment 28, further comprising a torsion spring configured to hold the clamping device in a disengaged configuration until the electromechanical actuator is actuated.
[0208] Embodiment 30: A pen cap as described in embodiments 23 to 29, wherein one or more adaptable elements comprise a collet having a plurality of elongated members oriented circumferentially around a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; and an outer sleeve arranged around the plurality of elongated members, wherein the outer sleeve and the plurality of elongated members are configured for relative movement between the outer sleeve and the plurality of elongated members, and wherein the outer sleeve slides against the radially outermost surfaces of the plurality of elongated members based on the relative movement between the outer sleeve and the plurality of elongated members, and an electromechanical actuator is configured to cause relative movement between the outer sleeve and the plurality of elongated members.
[0209] Embodiment 31: A pen cap according to embodiments 23-30, wherein the electromechanical actuator is configured to draw power only during a configuration change event of the pen cap.
[0210] Embodiment 32: The pen cap of embodiment 31, wherein the configuration change event includes a transition from a first configuration of the pen cap that is not intended to engage with one of the multiple injection pens to a second configuration that is intended to engage with the injection pen.
[0211] Embodiment 33: A pen cap as described in embodiments 23 to 32, further comprising a sensor coupled to the electromechanical actuator and configured to provide data to the electromechanical actuator, wherein the electromechanical actuator is configured to adjust the pen cap from the first configuration to the second configuration in response to the data received from the sensor.
[0212] Embodiment 34: The pen cap of embodiment 33, wherein the data indicates the sensed insertion of one injection pen of the plurality of injection pens into the pen cap.
[0213] Embodiment 35: The pen cap of embodiments 33 and 34, wherein the data indicates a detected attempt to remove the pen cap from one of the injection pens.
[0214] Embodiment 36: A pen cap according to embodiments 33 to 35, wherein the sensor comprises at least one type of sensor selected from a motion sensor, a proximity sensor, a pressure sensor, and an optical sensor.
[0215] Embodiment 37: A pen cap as described in embodiments 23 to 36, further comprising an actuation device coupled to the electromechanical actuator and configured to adjust the pen cap from the first configuration to the second configuration in response to actuation of the actuation device.
[0216] Embodiment 38: A pen cap as described in embodiment 37, wherein the actuation device comprises an input selected from a button and a switch.
[0217] Embodiment 39: A pen cap for interfacing with an injection pen, comprising: means for removably coupling the pen cap to a plurality of different geometries of a plurality of different injection pens; and an electromechanical actuator operably coupled to at least one element of the means and configured to at least partially effectuate the operation of the means.
[0218] Embodiment 40: A pen cap according to embodiment 39, wherein the plurality of different injection pens comprises at least two different injection pens having different geometries.
[0219] Embodiment 41: A pen cap according to embodiments 39 and 40, wherein the electromechanical actuator comprises at least one actuator selected from a servo actuator and a solenoid actuator.
[0220] Embodiment 42: A pen cap as described in embodiments 39 to 41, further comprising an outer frame element including an outer wall, wherein the means comprises an opening formed in the outer wall and at least one catch member coupled to the outer frame element, extending through the opening, and configured to translate radially inward and outward through the opening, and wherein the electromechanical actuator is configured to translate the at least one catch member radially inward to engage with the injection pen in response to the injection pen being inserted into the opening in the outer frame element.
[0221] Embodiment 43: A pen cap as described in embodiments 39 to 42, wherein the means comprises an outer frame element defining an opening sized and shaped to receive the longitudinal ends of a plurality of injection pens, the electromechanical actuator includes a solenoid actuator, the means comprises one or more engagement elements and a compression element disposed at least partially within the solenoid actuator and adapted to translate the one or more engagement elements along a longitudinal axis of the solenoid actuator, the solenoid actuator being positioned such that the longitudinal axis of the solenoid actuator is substantially perpendicular to a central longitudinal axis of the pen cap, and the compression element is configured to apply an inward radial force to the one or more engagement elements relative to the central longitudinal axis of the pen cap in response to actuation of the solenoid actuator.
[0222] Embodiment 44: A pen cap as described in embodiments 39 to 43, wherein the means comprises a clamping device, the clamping device comprising a first arm and a second arm rotatably connected to the first arm, and the electromechanical actuator is connected to at least one arm selected from the first arm and the second arm and configured to rotate the at least one arm selected from the second arm relative to the first arm and the first arm relative to the second arm.
[0223] Embodiment 45: A clamping device as described in embodiment 44, further comprising a torsion spring configured to hold the clamping device in a disengaged configuration until the electromechanical actuator is actuated.
[0224] Embodiment 46: A pen cap as described in embodiments 39 to 45, wherein the means comprises: a collet having a plurality of elongated members oriented circumferentially around a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; and an outer sleeve arranged around the plurality of elongated members, the outer sleeve and the plurality of elongated members being configured for relative movement between the outer sleeve and the plurality of elongated members, and the outer sleeve sliding against the radially outermost surfaces of the plurality of elongated members based on the relative movement between the outer sleeve and the plurality of elongated members, and an electromechanical actuator configured to cause relative movement between the outer sleeve and the plurality of elongated members.
[0225] Embodiment 47: A pen cap according to embodiments 39 to 46, wherein the electromechanical actuator is configured to draw power only during a configuration change event of the pen cap.
[0226] Embodiment 48: A pen cap as described in embodiments 39 to 47, further comprising a sensor coupled to the electromechanical actuator and configured to provide data to the electromechanical actuator, wherein the electromechanical actuator is configured to adjust the pen cap from the first configuration to the second configuration in response to the data received from the sensor.
[0227] Embodiment 49: The pen cap of embodiment 48, wherein the data indicates the sensed insertion of one injection pen of the plurality of injection pens into the pen cap.
[0228] Embodiment 50: The pen cap of embodiments 48 and 49, wherein the data indicates a detected removal attempt of the pen cap from one injection pen of the plurality of injection pens.
[0229] Embodiment 51: A pen cap according to embodiments 48 to 50, wherein the sensor comprises at least one type of sensor selected from a motion sensor, a proximity sensor, a pressure sensor, and an optical sensor.
[0230] Embodiment 52: A pen cap as described in embodiments 39 to 51, further comprising an actuation device coupled to the electromechanical actuator and configured to adjust the pen cap from the first configuration to the second configuration in response to actuation of the actuation device.
[0231] Embodiment 53: A pen cap as described in embodiment 52, wherein the actuation device comprises an input selected from a button and a switch.
[0232] Embodiment 54: A method of actuating an electromechanical pen cap, comprising: detecting a pen cap event using one or more sensors; and actuating a clasping mechanism in response to the event.
[0233] Embodiment 55: The method of embodiment 54, comprising the steps of detecting an attempted insertion of the injection pen using one or more sensors, detecting that the clasping mechanism is open, detecting complete insertion of the injection pen into the pen cap, and actuating the clasping mechanism to a closed position.
[0234] Embodiment 56: The method of embodiments 54 and 55, further comprising the steps of detecting a force indicative of an attempted removal of the injection pen from the pen cap, detecting that the clasping mechanism is closed, activating the clasping mechanism to an open position in response to detecting that the force is greater than a predetermined threshold, and confirming that the clasping mechanism is in the open position.
[0235] Embodiment 57: A pen cap for interfacing with a medical injection pen, the pen cap comprising one or more adjustable floor elements configured to adjust the distance an injection pen can be inserted into the pen cap, the one or more adjustable floor elements comprising floor block elements defining a cavity configured to accommodate the geometry of the medical injection pen.
[0236] Embodiment 58: A pen cap as described in embodiment 57, wherein the one or more adjustable floor elements further comprise an electromechanical actuator, a threaded screw element operably connected to the electromechanical actuator, and an outer tube element configured to accommodate the floor block element, and the floor block element comprises a receiving threaded portion configured to receive the threaded screw element.
[0237] Embodiment 59: A pen cap as described in embodiments 57 and 58, wherein the one or more adjustable floor elements further comprise a body including an annular shape having an outer peripheral surface and an inner peripheral surface that define a cavity, a plurality of ridges arranged circumferentially around at least a portion of the outer peripheral surface, and one or more flexible arms arranged within the cavity, extending axially adjacent to the inner peripheral surface, and cantilevered across at least a portion of the inner peripheral surface.
[0238] Embodiment 60: A pen cap for use with an injection pen, comprising one or more adaptable elements configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens.
[0239] Embodiment 61: A pen cap according to embodiment 60, wherein the plurality of different injection pens comprises at least two different injection pens having different geometries.
[0240] Embodiment 62: A pen cap as described in embodiment 60, wherein the one or more adaptable elements include a clamping mechanism and a clicker mechanism, and the clicker mechanism is configured to detachably connect any of a plurality of injection pens by mechanically adapting the clamping mechanism and the clicker mechanism to a given injection pen having a given geometric shape.
[0241] Embodiment 63: A pen cap as described in embodiment 60, wherein the clamping mechanism includes a clamp spring, a spring well that accommodates the clamp spring oriented along the longitudinal axis of the pen cap, a pen datum configured to move along the longitudinal axis of the pen cap within a portion of the spring well and the clamp spring, a pen clamp movably attached to the spring well via a hinge connection so as to swing radially inward toward the longitudinal axis of the pen cap, and a tightening link that attaches the clamp link to the spring well, wherein the pen clamp is configured to compress the clamp spring via the tightening link and the spring well when an injection pen is inserted into the pen cap.
[0242] Embodiment 64: A pen cap as described in embodiment 63, wherein the clicker mechanism includes a biasing member oriented along the longitudinal axis of the pen cap, a clicker portion, and a clicker retainer supporting the clicker portion, the clicker portion forming a guide passage that wraps around the clicker portion, and the clicker portion is configured to rotate as the pen datum moves along the longitudinal axis of the pen cap.
[0243] Embodiment 65: A pen cap as described in embodiment 64, wherein the guide passage is shaped as a cardioid that wraps around the clicker portion.
[0244] Embodiment 66: A pen cap as described in embodiment 64, wherein the clicker portion includes a first clicker body and a second clicker body configured to rotate in the same direction as the pen datum moves along the longitudinal axis of the pen cap.
[0245] Embodiment 67: A pen cap as described in embodiment 66, wherein the first clicker body includes one or more teeth and the second clicker body includes one or more radial flexures, which are configured to provide tactile and / or auditory feedback to the user by being pushed radially inward by the one or more teeth during rotation of the clicker portion and then clicking radially outward when the clicker mechanism reaches a desired operating state.
[0246] Embodiment 68: A pen cap as described in embodiment 63, wherein the pen clamp includes a ball protrusion configured to be movably attached to the spring well via a ball-and-socket method.
[0247] Embodiment 69: A pen cap as described in embodiment 63, wherein the pen clamp includes a rigid body and an elastic member attached to a bottom surface of the rigid body, and the rigid body includes an undercut into which the elastic member fits to increase the contact surface area between the rigid body and the elastic member.
[0248] Embodiment 70: A pen cap as described in embodiment 63, wherein the pen clamp includes two friction shoes configured to apply a radial force to a given injection pen inserted into the pen cap.
[0249] Embodiment 71. A pen cap according to embodiment 60, further comprising an ingress wall that protects the electronic components of the pen cap from foreign matter.
[0250] Embodiment 72: A pen cap as described in embodiment 64, wherein the clicker mechanism is configured to operate in multiple operating states when a given injection pen is inserted into the pen cap.
[0251] Embodiment 73: A pen cap as described in embodiment 72, wherein the plurality of operating states includes a locked state in which the pen datum is locked with a clicker mechanism and a given injection pen is inserted into the pen cap.
[0252] Embodiment 74: The pen cap of claim 72, wherein the plurality of operating states includes a safety-removal operating state in which the pen datum remains locked with the clicker mechanism when a given injection pen is forcibly withdrawn from the pen cap.
Claims
1. 1. A pen cap for use with an injection pen, comprising: One or more adaptable elements configured to removably couple the pen cap to a plurality of different injection pen geometries. Equipped with Pen cap.
2. the plurality of different injection pens comprises at least two different injection pens having different geometries; The pen cap according to claim 1 .
3. the one or more adaptable elements include a clamping mechanism and a clicker mechanism; the clicker mechanism is configured to releasably couple any of the plurality of injection pens by mechanically adapting the clamping mechanism and the clicker mechanism to a given injection pen having a given geometry; The pen cap according to claim 1 .
4. the clamping mechanism includes a clamp spring, a spring well that houses the clamp spring oriented along a longitudinal axis of the pen cap, a pen datum configured to move along the longitudinal axis of the pen cap within a portion of the spring well and the clamp spring, a pen clamp movably attached to the spring well via a hinge connection to swing radially inward toward the longitudinal axis of the pen cap, and a fastening link that attaches a clamp link to the spring well; the pen clamp is configured to compress the clamp spring via the clamping link and the spring well when the injection pen is inserted into the pen cap; The pen cap according to claim 3.
5. the clicker mechanism includes a biasing member oriented along a longitudinal axis of the pen cap, a clicker portion, and a clicker retainer supporting the clicker portion, the clicker portion forming a guide passage that wraps around the clicker portion, and the clicker portion configured to rotate as the pen datum moves along the longitudinal axis of the pen cap.
5. The pen cap according to claim 4.
6. the guide passage is shaped as a cardioid that wraps around the clicker portion; 6. The pen cap according to claim 5.
7. the clicker portion includes a first clicker body and a second clicker body configured to rotate in the same direction as the pen datum moves along the longitudinal axis of the pen cap; 6. The pen cap according to claim 5.
8. the first clicker body includes one or more teeth and the second clicker body includes one or more radial flexures configured to be urged radially inward by the one or more teeth during rotation of the clicker portion and then click radially outward when the clicker mechanism reaches a desired operating state, thereby providing tactile and / or auditory feedback to a user.
8. The pen cap according to claim 7.
9. the pen clamp includes a ball protrusion configured to be movably mounted to the spring well via a ball-and-socket arrangement; 5. The pen cap according to claim 4.
10. the pen clamp includes a rigid body and an elastic member attached to a bottom surface of the rigid body, the rigid body including an undercut into which the elastic member fits to increase the contact surface area between the rigid body and the elastic member; 5. The pen cap according to claim 4.
11. the pen clamp includes two friction shoes configured to apply a radial force to the given injection pen inserted into the pen cap; 5. The pen cap according to claim 4.
12. Further, an entrance wall is provided to protect the electronic components of the pen cap from foreign matter. The pen cap according to claim 1 .
13. the clicker mechanism is configured to operate in a plurality of operating states when the given injection pen is inserted into the pen cap; 6. The pen cap according to claim 5.
14. the plurality of operating states includes a locked state in which the pen datum is locked with the clicker mechanism and the given injection pen is inserted into the pen cap; 14. The pen cap of claim 13.
15. the plurality of operational states includes a safety-removal operational state in which the pen datum remains locked with the clicker mechanism when the given injection pen is forcibly withdrawn from the pen cap; 14. The pen cap of claim 13.
16. the one or more adaptable elements: at least one actuator; and a plurality of arms operably connected to the at least one actuator; the plurality of arms configured to rotate at least a portion of the plurality of arms radially inward toward a central longitudinal axis of the pen cap in response to actuation of the at least one actuator. The pen cap according to claim 1 .
17. the one or more adaptable elements comprise a tube having a plurality of successive segments, the inner diameter of the tube gradually decreasing along a central longitudinal axis of the pen cap, each segment of the plurality of successive segments including the inner diameter; The pen cap according to claim 1 .
18. further comprising an exterior frame element including an exterior wall, said one or more adaptable elements comprising: a first opening formed in the outer wall; at least one catch member coupled to the outer frame element and configured to extend through the first opening and engage an injection pen when the injection pen is inserted into the second opening of the outer frame element; a biasing member configured to urge the at least one catch member radially inward toward a central longitudinal axis of the pen cap; Equipped with The pen cap according to claim 1 .
19. the one or more adaptable elements comprise an outer wall including a frusto-conical cavity having a frusto-conical shape formed therein, the frusto-conical cavity including an inner diameter that narrows along a central longitudinal axis of the pen cap with a larger diameter end of the frusto-conical shape at an open end of the outer wall; The pen cap according to claim 1 .
20. a shell including an outer wall shaped to at least partially surround a longitudinal end of the injection pen, the outer wall including an open end formed therein; a slot formed in the outer wall extending radially through the outer wall and axially along a portion of the outer wall; Furthermore, the one or more adaptable elements comprising a sleeve element configured to be removably coupled to the longitudinal end of an injector pen of a plurality of injector pens, the sleeve element being sized and shaped to slide along the slot when the injector pen is inserted into the pen cap, the sleeve element comprising a radially extending member adapted to interface with the slot to removably secure the injector pen to the shell; The pen cap according to claim 1 .
21. the one or more adaptable elements: a collet comprising a plurality of elongated members oriented circumferentially about a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; an outer sleeve disposed around the plurality of elongated members, the outer sleeve and the plurality of elongated members configured for relative movement between the outer sleeve and the plurality of elongated members, the outer sleeve sliding against the radially outermost surfaces of the plurality of elongated members based on the relative movement between the outer sleeve and the plurality of elongated members; Equipped with The pen cap according to claim 1 .
22. the one or more adaptable elements: a collar including a radially inner surface; a plurality of angled protrusions extending radially inward from the radially inner surface, the thickness of each of the plurality of angled protrusions increasing circumferentially, the plurality of angled protrusions being evenly spaced circumferentially around the radially inner surface of the collar; a plurality of roller elements, each roller element positioned adjacent to a respective one of the plurality of angled protrusions, the plurality of roller elements configured to contact an outer radial surface of the injection pen; Equipped with The plurality of roller elements and the plurality of inclined protrusions are adapted for relative circumferential movement between the plurality of roller elements and the plurality of inclined protrusions. The pen cap according to claim 1 .
23. the one or more adaptable elements: a tapered collet comprising a plurality of recesses formed in a radially outer surface thereof, the plurality of recesses being oriented relative to one another in a spiral pattern, the tapered collet defining a frusto-conical opening configured to receive at least a portion of one of the plurality of different injection pens; an annular collar having a radially inner surface defining a central axial opening, the annular collar configured to receive the tapered collet through the central axial opening, the annular collar having one or more protrusions extending radially inward from the radially inner surface, the one or more protrusions sized, shaped, and positioned to be received within a respective one of the plurality of recesses and adapted to slide along the respective recess during operation, wherein translation of the annular collar in a first axial direction along the tapered collet causes at least a portion of the tapered collet to bend radially inward toward a longitudinal axis of the pen cap; an outer frame member attached to a radially outer surface of the annular collar; Equipped with The pen cap according to claim 1 .
24. the one or more adaptable elements: an annular drive gear defining a central opening for receiving at least a portion of one of the plurality of different injection pens, at least a portion of the annular drive gear configured to rotate circumferentially about a longitudinal axis of the pen cap; an annular receiver gear operatively engaged with the annular drive gear and configured to rotate about an axis of the annular drive gear, the annular receiver gear including a central opening formed therein; an engagement member disposed within the central opening, the annular receiver gear adapted to rotate to translate the engagement member along the axis; Equipped with The pen cap according to claim 1 .
25. 1. A pen cap for interfacing with an injection pen, comprising: means for removably connecting said pen cap to a plurality of different injection pen geometries; Pen cap.
26. the plurality of different injection pens comprises at least two different injection pens having different geometries; 26. The pen cap of claim 25.
27. The means comprises: at least one actuator; a plurality of arms operatively connected to the at least one actuator; the plurality of arms configured to rotate at least a portion of the plurality of arms radially inward toward a central longitudinal axis of the pen cap in response to actuation of the at least one actuator.
26. The pen cap of claim 25.
28. the means comprises a tube having a plurality of successive segments, the inner diameter of the tube gradually decreasing along a central longitudinal axis of the pen cap, each segment of the plurality of successive segments including the inner diameter; 26. The pen cap of claim 25.
29. further comprising an outer frame element including an outer wall, said means comprising: an opening formed in the outer wall; at least one catch member coupled to the outer frame element and configured to extend through the opening in the outer frame element and engage an injection pen when the injection pen is inserted into the opening; a biasing member configured to urge the at least one catch member radially inward toward a central longitudinal axis of the pen cap; Equipped with 26. The pen cap of claim 25.
30. the means comprises an outer wall including a frusto-conical cavity having a frusto-conical shape formed therein, the frusto-conical cavity including an inner diameter that narrows along a central longitudinal axis of the pen cap with a larger diameter end of the frusto-conical shape at an open end of the outer wall; 26. The pen cap of claim 25.
31. a shell including an outer wall shaped to at least partially surround a longitudinal end of the injection pen, the outer wall including an open end formed therein; a slot formed in the outer wall extending radially through the outer wall and axially along a portion of the outer wall; Equipped with the means comprising a sleeve element configured to be removably coupled to the longitudinal end of the injector pen of the plurality of injector pens, the sleeve element being sized and shaped to slide along the slot when the injector pen is inserted into the pen cap, and comprising a radially extending member adapted to interface with the slot to removably secure the injector pen to the shell; 26. The pen cap of claim 25.
32. The means comprises: a collet comprising a plurality of elongated members oriented circumferentially about a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; an outer sleeve disposed about the plurality of elongated members, the outer sleeve and the plurality of elongated members configured for relative movement between the outer sleeve and the plurality of elongated members, the outer sleeve sliding against the radially outermost surfaces of the plurality of elongated members based on the relative movement between the outer sleeve and the plurality of elongated members; Equipped with 26. The pen cap of claim 25.
33. The means comprises: a collar including a radially inner surface; a plurality of angled protrusions extending radially inward from the radially inner surface, the thickness of each of the plurality of angled protrusions increasing circumferentially, the plurality of angled protrusions being evenly spaced circumferentially around the radially inner surface of the collar; a plurality of roller elements, each roller element positioned adjacent to a respective one of the plurality of angled protrusions, the plurality of roller elements configured to contact an outer radial surface of the injection pen; a lock ring having a the plurality of roller elements and the plurality of inclined protrusions are adapted to cause relative movement in the circumferential direction between the plurality of roller elements and the plurality of inclined protrusions; 26. The pen cap of claim 25.
34. The means comprises: a tapered collet comprising a plurality of recesses formed in a radially outer surface thereof, the plurality of recesses being oriented relative to one another in a spiral pattern, the tapered collet defining a frusto-conical opening configured to receive at least a portion of one of the plurality of different injection pens; an annular collar having a radially inner surface defining a central axial opening, the annular collar configured to receive the tapered collet through the central axial opening, the annular collar having one or more protrusions extending radially inward from the radially inner surface, the one or more protrusions sized, shaped, and positioned to be received within a respective one of the plurality of recesses and adapted to slide along the respective recess during operation, wherein translation of the annular collar in a first axial direction along the tapered collet causes at least a portion of the tapered collet to bend radially inward toward a longitudinal axis of the pen cap; an outer frame member attached to a radially outer surface of the annular collar; Equipped with 26. The pen cap of claim 25.
35. The means comprises: an annular drive gear defining a central opening for receiving at least a portion of one of the plurality of different injection pens, at least a portion of the annular drive gear configured to rotate circumferentially about a longitudinal axis of the pen cap; an annular receiver gear operatively engaged with the annular drive gear and configured to rotate about an axis of the annular drive gear, the annular receiver gear including a central opening formed therein; an engagement member disposed within the central opening, the annular receiver gear adapted to rotate to translate the engagement member along its axis; and Equipped with 26. The pen cap of claim 25.
36. 1. A pen cap for use with an injection pen, comprising: one or more adaptable elements configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens; an electromechanical actuator coupled to at least one of the one or more adaptable elements and configured to actuate the one or more adaptable elements to adapt the one or more adaptable elements to a given geometry of a given injection pen; Equipped with Pen cap.
37. the plurality of different injection pens being at least two different injection pens having different geometries; 37. The pen cap of claim 36.
38. the electromechanical actuator comprises at least one actuator selected from a servo actuator and a solenoid actuator; 37. The pen cap of claim 36.
39. further comprising an exterior frame element including an exterior wall, said one or more adaptable elements comprising: an opening formed in the outer wall; at least one catch member coupled to the outer frame element, extending through the opening, and configured to translate radially inward and outward through the opening; Equipped with the electromechanical actuator is configured to translate the at least one catch member radially inward to engage the injector pen in response to insertion of the injector pen into the opening in the outer frame element; 37. The pen cap of claim 36.
40. the one or more adaptable elements: an outer frame element defining openings sized and shaped to receive the longitudinal ends of said plurality of injection pens; Equipped with the electromechanical actuator comprises a solenoid actuator, and the one or more adaptable elements are: one or more engagement elements; a compression element disposed at least partially within the solenoid actuator and adapted to translate the one or more engagement elements along a longitudinal axis of the solenoid actuator, the solenoid actuator being oriented such that the longitudinal axis of the solenoid actuator is substantially perpendicular to the longitudinal axis of the pen cap; Equipped with the compression element is configured to exert an inward radial force on the one or more engagement elements relative to the longitudinal axis of the pen cap in response to actuation of the solenoid actuator.
37. The pen cap of claim 36.
41. The one or more adaptable elements comprise a clamping device, the clamping device comprising: a first arm, and a second arm rotatably connected to the first arm; Equipped with 37. The pen cap of claim 36, wherein the electromechanical actuator is coupled to at least one arm selected from the first arm and the second arm and configured to rotate the at least one arm selected from the second arm relative to the first arm and the first arm relative to the second arm.
42. a torsion spring configured to hold the clamping device in a disengaged configuration until the electromechanical actuator is actuated.
42. The pen cap of claim 41.
43. the one or more adaptable elements: a collet comprising a plurality of elongated members oriented circumferentially about a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; an outer sleeve disposed about the plurality of elongated members, the outer sleeve and the plurality of elongated members configured for relative movement between the outer sleeve and the plurality of elongated members, wherein the outer sleeve slides against the radially outermost surfaces of the plurality of elongated members upon relative movement between the outer sleeve and the plurality of elongated members; Equipped with the electromechanical actuator is configured to cause the relative movement between the outer sleeve and the plurality of elongated members.
37. The pen cap of claim 36.
44. the electromechanical actuator is configured to draw power only during a configuration change event of the pen cap; 37. The pen cap of claim 36.
45. a configuration change event comprising a transition of the pen cap from a first configuration not intended to engage with one of the plurality of injector pens to a second configuration intended to engage with the injector pen; 45. The pen cap of claim 44.
46. a sensor coupled to the electromechanical actuator and configured to provide data to the electromechanical actuator, the electromechanical actuator configured to adjust the pen cap from a first configuration to a second configuration in response to the data received from the sensor.
37. The pen cap of claim 36.
47. the data indicating the sensed insertion of an injection pen of the plurality of injection pens into the pen cap; 47. The pen cap of claim 46.
48. the data indicating a sensed attempt to remove the pen cap from one of the plurality of injection pens; 47. The pen cap of claim 46.
49. 47. The pen cap of claim 46, wherein the sensor comprises at least one type of sensor selected from a motion sensor, a proximity sensor, a pressure sensor, and an optical sensor.
50. further comprising an actuation device coupled to the electromechanical actuator and configured to adjust the pen cap from a first configuration to a second configuration in response to actuation of the actuation device.
37. The pen cap of claim 36.
51. the actuation device comprises an input selected from a button and a switch; 51. The pen cap of claim 50.
52. 1. A pen cap for interfacing with an injection pen, comprising: means for removably connecting said pen cap to a plurality of different injection pen geometries; an electromechanical actuator operatively coupled to at least one element of said means and configured to at least partially effect movement of said means; Equipped with Pen cap.
53. the plurality of different injection pens comprises at least two different injection pens having different geometries; 53. The pen cap of claim 52.
54. the electromechanical actuator comprises at least one actuator selected from a servo actuator and a solenoid actuator; 53. The pen cap of claim 52.
55. further comprising an outer frame element including an outer wall, said means comprising: an opening formed in the outer wall; at least one catch member coupled to the outer frame element, extending through the opening, and configured to translate radially inward and outward through the opening; Equipped with the electromechanical actuator is configured to translate the at least one catch member radially inward to engage the injector pen in response to insertion of the injector pen into the opening in the outer frame element; 53. The pen cap of claim 52.
56. The means comprises: an outer frame element defining openings sized and shaped to receive the longitudinal ends of said plurality of injection pens; Equipped with the electromechanical actuator comprises a solenoid actuator, and the means one or more engagement elements; a compression element disposed at least partially within the solenoid actuator and adapted to translate the one or more engagement elements along a longitudinal axis of the solenoid actuator, the solenoid actuator being oriented such that the longitudinal axis of the solenoid actuator is substantially perpendicular to a central longitudinal axis of the pen cap; Equipped with the compression element is configured to exert an inward radial force on the one or more engagement elements relative to the central longitudinal axis of the pen cap in response to actuation of the solenoid actuator.
53. The pen cap of claim 52.
57. The means comprises a clamping device, the clamping device comprising: a first arm, and a second arm rotatably connected to the first arm; Equipped with the electromechanical actuator is coupled to at least one arm selected from the first arm and the second arm and configured to rotate the at least one arm selected from the second arm relative to the first arm and the first arm relative to the second arm.
53. The pen cap of claim 52.
58. a torsion spring configured to hold the clamping device in a disengaged configuration until the electromechanical actuator is actuated.
58. The clamping apparatus of claim 57.
59. The means comprises: a collet comprising a plurality of elongated members oriented circumferentially about a central longitudinal axis of the pen cap and extending axially relative to the central longitudinal axis of the pen cap, each of the elongated members including a tapered width along its longitudinal length; an outer sleeve disposed around the plurality of elongated members, the outer sleeve and the plurality of elongated members configured for relative movement between the outer sleeve and the plurality of elongated members, wherein the outer sleeve slides against the radially outermost surfaces of the plurality of elongated members upon relative movement between the outer sleeve and the plurality of elongated members; Equipped with the electromechanical actuator is configured to cause the relative movement between the outer sleeve and the plurality of elongated members.
53. The pen cap of claim 52.
60. the electromechanical actuator is configured to draw power only during a configuration change event of the pen cap; 53. The pen cap of claim 52.
61. a sensor coupled to the electromechanical actuator and configured to provide data to the electromechanical actuator, the electromechanical actuator configured to adjust the pen cap from a first configuration to a second configuration in response to the data received from the sensor.
53. The pen cap of claim 52.
62. the data indicating the sensed insertion of an injection pen of the plurality of injection pens into the pen cap; 62. The pen cap of claim 61.
63. the data indicating a sensed attempt to remove the pen cap from an injection pen of the plurality of injection pens; 62. The pen cap of claim 61.
64. the sensor comprises at least one type of sensor selected from a motion sensor, a proximity sensor, a pressure sensor, and an optical sensor; 62. The pen cap of claim 61.
65. further comprising an actuation device coupled to the electromechanical actuator and configured to adjust the pen cap from a first configuration to a second configuration in response to actuation of the actuation device.
53. The pen cap of claim 52.
66. the actuation device comprises an input selected from a button and a switch; 66. The pen cap of claim 65.
67. 1. A method of actuating an electromechanical pen cap, comprising: Detecting a pen cap event using one or more sensors; actuating a clasping mechanism in response to said event; Including, method.
68. detecting an attempted insertion of an injection pen using the one or more sensors; detecting that the clasping mechanism is open; detecting complete insertion of the injection pen into the pen cap; actuating the clasping mechanism to a closed position; Including, 68. The method of claim 67.
69. detecting a force indicative of an attempted removal of the injection pen from the pen cap; detecting that the clasping mechanism is closed; in response to detecting the force being greater than a predetermined threshold, actuating the clasping mechanism to an open position; verifying that the clasping mechanism is in an open position; further comprising:
69. The method of claim 68.
70. 1. A pen cap for interfacing with a medical injection pen, said pen cap comprising: one or more adjustable floor elements configured to adjust the distance an injection pen can be inserted into the pen cap; Equipped with the one or more adjustable floor elements comprising a floor block element defining a cavity configured to accommodate the geometry of the medical injection pen; Pen cap.
71. said one or more adjustable floor elements: an electromechanical actuator; a threaded screw element operably coupled to the electromechanical actuator; an outer tube element configured to receive the floor block element; Furthermore, the floor block element comprises a receiving threaded portion configured to receive the threaded screw element; 71. The pen cap of claim 70.
72. said one or more adjustable floor elements: a body including an annular shape having an outer circumferential surface and an inner circumferential surface that define a cavity; a plurality of ridges circumferentially disposed about at least a portion of the outer circumferential surface; one or more flexible arms disposed within the cavity, extending axially adjacent the inner circumferential surface and cantilevered across at least a portion of the inner circumferential surface; Further provided with 71. The pen cap of claim 70.