WO2025072005A1 - Waste reducing applicator that applies an analyte sensor - Google Patents

Abstract

An applicator may include a housing made of a uniform synthetic material. The applicator may include a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material. The applicator may include a retraction spring that is also made of the uniform synthetic material. The applicator may include a sheath that is also made of the uniform synthetic material. The applicator may include a firing pin that is also made of the uniform synthetic material. The applicator may include a drive spring made that is also made of the uniform synthetic material. The applicator may include a puck carrier that is also made of the uniform synthetic material. The applicator may include the glucose sensor.

Description

WASTE REDUCING APPLICATOR THAT APPLIES AN ANALYTE SENSOR

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to United States Provisional Patent Application Serial No. 63/541,081 filed on September 28, 2023 and entitled "WASTE REDUCING APPLICATOR THAT APPLIES AN ANALYTE SENSOR,” which application is expressly incorporated herein by reference in its entirety.

BACKGROUND

[0002] A continuous glucose monitor (CGM) is a type of analyte sensing device that tracks a user’s blood glucose levels. As used herein, the term "analyte" refers to a substance that is the subject of an analysis. For instance, the CGM tracks glucose levels, and glucose is considered the analyte.

[0003] A “glucose level” is also commonly referred to as a “blood sugar” level. The CGM may include a very small sensor that enters or permeates at least partially through the user’s skin. Typically, the CGM will acquire a new reading on a periodic basis, such as once every select number of minutes. The CGM includes a wireless transmitter that then sends the reading to a receiving device, such as a smartphone.

[0004] The detection and/or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin A1C, or the like, can be vitally important to the health of an individual having diabetes. Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. Diabetics are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.

[0005] Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors, including convenience, testing discretion, pain associated with glucose testing, and cost.

[0006] To increase patient adherence to a plan of frequent glucose monitoring, in vivo analyte monitoring systems can be utilized (e.g., such as the above described CGM), in which a sensor control device may be worn on the body of an individual who requires analyte monitoring. To increase comfort and convenience for the individual, the sensor control device may have a small form-factor and can be assembled and applied by the individual with a sensor “applicator.”

[0007] The application process involves inserting at least a portion of a sensor, which senses a user’s analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes in to contact with the bodily fluid. The sensor control device may also be configured to transmit analyte data to another device, from which the individual or her health care provider (“HCP”) can review the data and make therapy decisions.

[0008] Current sensors are typically worn for 8-14 days. After that time period, the user will need to replace the sensor with a new one. While current sensors can be convenient for users, they create a significant amount of waste material, particularly over longer time periods. Thus, a need exists for an improved type of sensor insertion applicator that is easy to use and less prone to large amounts of waste.

[0009] The subj ect matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one exemplary technology⁷ area where some embodiments described herein may be practiced.

BRIEF SUMMARY

[0010] In some aspects, the techniques described herein relate to an applicator for inserting an glucose sensor into a subject, the applicator including: a housing made of a uniform synthetic material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; a retraction spring that is also made of the uniform synthetic material; a sheath that is also made of the uniform synthetic material; a firing pin that is also made of the uniform synthetic material; a drive spring made that is also made of the uniform synthetic material; a puck carrier that is also made of the uniform synthetic material; and the glucose sensor.

[0011] In some aspects, the techniques described herein relate to an applicator for inserting an glucose sensor into a subject, the applicator including: a housing made of a first material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the first material, the sharp being made of a second material; a retraction spring that is also made of the first material; a sheath that is also made of the first material; a firing pin that is also made of the first material; a drive spring made that is also made of the first material; a carriage that is also made of the first material; the glucose sensor; and a desiccant that is made of a third material.

[0012] In some aspects, the techniques described herein relate to an applicator for inserting an glucose sensor into a subject, the applicator including: a housing made of a material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the material; a retraction spring that is also made of the material; a sheath that is also made of the material; a firing pin that is also made of the material; a drive spring made that is also made of the material; a puck carrier that is also made of the material; and the glucose sensor; wherein the drive spring is configured to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface upon an application of a first force to the applicator, and wherein the sharp and a portion of the glucose sensor are positioned under the skin surface and in contact with a bodily fluid of the subject at the second position, and wherein the retraction spring is configured to displace the sharp carrier from the second position to a third position within the applicator and to withdraw the sharp from the skin surface upon an application of a second force to the applicator.

[0013] In some aspects, the techniques described herein can be implemented in a scenario involving other analyte sensing systems that use a sensor tail, with one end of that tail being inserted into a person’s body to be in contact with and to sense analyte levels in bodily fluid, such as blood or interstitial fluid.

[0014] In some aspects, the techniques described herein relate to a method of disposing of an applicator that includes: a housing made of a uniform synthetic material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; a retraction spring that is also made of the uniform synthetic material; a sheath that is also made of the uniform synthetic material; a firing pin that is also made of the uniform synthetic material; a drive spring made that is also made of the uniform synthetic material; a puck carrier that is also made of the uniform synthetic material; an glucose sensor; and a desiccant; wherein said method includes: causing the drive spnng to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface; causing the sharp and a portion of the glucose sensor to be positioned under the skin surface and in contact with a bodily fluid of the subject at the second position; causing the retraction spring to displace the sharp carrier from the second position to a third position within the applicator, resulting in withdrawal of the sharp from the skin surface; separating the desiccant from the applicator; separating the sharp from the applicator; and after the desiccant and the sharp are separated from the applicator, disposing the applicator in a recyclable waste container.

[0015] The aspects set out above, and the clauses and claims recited below are framed in terms of implementing the system using a glucose sensor. However, it is noted that the same systems, apparatus and techniques can be implemented using an analyte sensor, including analyte sensors for sensing other analytes, such as ketones, glutamate or lactate. [0016] In some implementations of the aspects, clauses and claims set out herein, the various elements of the applicator are each made of a uniform synthetic material, but different elements within the applicator may be made of different uniform synthetic materials.

[0017] Additional features and advantages will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the teachings herein. Features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. Features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to describe the manner in which the above-recited and other advantages and features can be obtained, a more particular description of the subj ect matter briefly described above will be rendered by reference to specific embodiments which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments and are not therefore to be considered to be limiting in scope, embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0019] Figure 1 illustrates an example architecture in which sensor data is being acquired and analyzed.

[0020] Figure 2 illustrates an example of an analyte sensor in the form of a continuous glucose monitor.

[0021] Figures 3A, 3B, and 3C illustrate various different views of an applicator.

[0022] Figure 4 illustrates different components of an applicator. [0023] Figure 5 illustrates a cross sectional view of an applicator.

[0024] Figure 6 illustrates further details of the applicator.

[0025] Figure 7 illustrates further details of the applicator.

[0026] Figures 8A, 8B, 8C, 8D, 8E, and 8F illustrate various details of a desiccant pouch.

[0027] Figure 9 illustrates an example applicator feature that removes the sharp.

[0028] Figure 10 illustrates a flowchart of an example method for using the applicator.

DETAILED DESCRIPTION

[0029] Generally, embodiments of the present disclosure relate to applicators and methods involving the use of those applicators. The embodiments also relate to the features and use of analyte sensor insertion applicators for use with in vivo analyte monitoring systems.

[0030] Accordingly, many embodiments include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including systems that are entirely non-invasive.

[0031] Beneficially, the disclosed applicators are structured in a manner so as to result in a reduced amount of waste being generated. In accordance with the disclosed principles, the applicator is generally made from three separate materials. For instance, the plastic components of the applicator are formed of a uniform synthetic material. These plastic components include the various springs, housing, carriers, and so on. The sharp is made of a second, different material. The desiccant is made of a third material. The applicator is now designed to streamline the removal of the sharp and the desiccant. With those two components removed, the remaining portion of the applicator can now be easily disposed of in a recycle bin because the remaining portions are formed of recycled and/or recyclable material. Because these components can be recycled, the embodiments beneficially generate a so-called '‘circular economy" with respect to the manufacture, use, and disposal of an applicator.

[0032] The disclosed embodiments also include various electronics, such as a “puck” (aka a “sensor control device”). As used herein, the term “puck” refers to a component that is typically disposed on a user’s skin via an applicator and that includes the analyte sensor. [0033] These devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g.. for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps. These sensor control device embodiments can be used and can be capable of use to implement those steps performed by a sensor control device from any and all of the methods described herein.

[0034] Advantageously, the disclosed embodiments provide for the improved assembly and use of an analyte sensor insertion device (aka an “applicator”) for use with in vivo analyte monitoring systems. That is, because the sharp is made of one material, the desiccant is made of another material, and all of the remaining components of the applicator are made of a uniform material, the embodiments help simplify the manufacture of the applicator and also help with its eventual disposal. Inasmuch as the non-sharp and non-desiccant components of the applicator are made of recycled and/or recyclable material, the embodiments beneficially create the circular economy so that applicators can be made easier, cheaper, and in a manner that is better for the environment. Accordingly, the embodiments are designed to improve the fabrication and disposal of the applicator so as to reduce an overall amount of waste that is generated.

[0035] Before describing these aspects of the embodiments in detail, it is first desirable to describe examples of applicators that can be present within, for example, an in vivo analyte monitoring system, as well as examples of their operation, all of which can be used with the embodiments described herein.

[0036] There are various types of in vivo analyte monitoring systems. “Continuous Analyte Monitoring” systems (or “Continuous Glucose Monitoring” systems), for example, can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule. “Flash Analyte Monitoring” systems (or “Flash Glucose Monitoring” systems or simply “Flash” systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. In vivo analyte monitoring systems can also operate without the need for finger stick calibration.

[0037] In vivo analyte monitoring systems can be differentiated from “in vitro” systems that contact a biological sample outside of the body (or “ex vivo”) and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user's blood sugar level. [0038] In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein. The sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing. The sensor control device, and variations thereof, can also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, to name a few.

[0039] In vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user. This device, and variations thereof, can be referred to as a “handheld reader device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a “receiver”), or a “remote” device or unit, to name a few. Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.

Example Architectures

[0040] Having just described various benefits and advantages provided by the disclosed embodiments, attention will now be directed to Figure 1. which illustrates an example architecture 100 that can be used to achieve the benefits mentioned above. Architecture 100 is shown as including a service 105. As used herein, the term “service” refers to an automated program that is tasked with performing different actions based on input. In some cases, service 105 can be a deterministic service that operates fully given a set of inputs and without a randomization factor. In other cases, service 105 can be or can include an artificial intelligence (Al) or machine learning (ML) engine, as shown by ML engine 110. With the ML engine 110, service 105 can operate even when faced with various different randomization factors.

[0041] As used herein, reference to any type of ML or Al may include any type of ML algorithm or device, convolutional neural network(s), multilayer neural network(s), recursive neural network(s), deep neural network(s), decision tree model(s) (e.g., decision trees, random forests, and gradient boosted trees) linear regression model(s), logistic regression model(s). support vector machine(s) (“SVM”), Al device(s), or any other type of intelligent computing system. Any amount of training data may be used (and perhaps later refined) to train the ML algorithm to dynamically perform the disclosed operations.

[0042] In some implementations, service 105 is a cloud service operating in a cloud environment, such as cloud 115. In some implementations, service 105 is a local service operating on a local device (e.g., sensor 130A, device 125, and/or any other device). In some implementations, service 105 is a hybrid service that includes a cloud component operating in the cloud 115 and a local component operating on a local client device. These two components can communicate with one another.

[0043] Service 105 is tasked with various operations that include collecting sensor data, analyzing that sensor data, and determining the impact of that sensor data with respect to a user associated with the sensor data. To do so, service 105 can include an analytics 120 component that is capable of performing data analysis on the collected sensor data. In some examples, analytics 120 and ML engine 110 can be the same component.

[0044] As shown in Figure 1, service 105 can communicate with a device 125. Device 125 can be any type of personal device, including any type of wearable device or mobile device. Examples of device 125 include, but certainly are not limited to, any type of device reader, smart phone, tablet, laptop, desktop, wearable device (e.g., a watch), and so on. Device 125 is shown as communicating with a sensor 130A and is further shown as receiving sensor data 135 from the sensor 130A (included as a part of a puck). Sensor BOA is the component that collects the sensor data 135. In some cases, device 125 and sensor BOA can be implemented on the same device. Sensor BOA is applied to a user’s body via an applicator BOB. That is, the applicator BOB applies the puck onto the user’s body, and the puck includes the sensor.

[0045] Sensor 130 A can be any type of sensor. One particular example of sensor BOA includes a CGM. A CGM operates by inserting a small sensing unit under a person’s skin. This sensing unit then measures that person’s interstitial glucose levels. Typically, this sensing unit acquires new' data at a periodic rate, such as once every' select number of minutes, although the data could also be collected continuously. That data is represented as sensor data 135 in Figure 1.

[0046] Device 125 communicates with sensor BOA using any type of near-field w ireless communication technology', such as BLUETOOTH. As a result, sensor data 135 is transmitted from sensor BOA to device 125 over that communication protocol. Service 105 can communicate with device 125 via any type of wireless communication protocol as well. In some implementations, the communication protocol is a BLUETOOTH protocol. In some implementations, the protocol is a wireless fidelity (Wi-Fi), near field communication (NFC), and/or Internet Protocol (IP). Often, device 125 transmits the sensor data 135 to the cloud 115, where that sensor data 135 is then stored in a repository that is accessible to service 105.

[0047] In some implementations, the sensor data 135 is encrypted or otherwise integrity protected to ensure tampering does not occur. Also, in some implementations, any personally identifiable information (PII) is stripped from sensor data 135 prior to it being stored in the cloud 115.

[0048] Service 105 then uses its analytics 120 component and/or the ML engine 110 to analyze the sensor data 135. Service 105 generates output data 140 as a result of performing that analysis. In the scenario where sensor I 30A is a CGM and where the sensor data 135 reflects glucose levels for a user, the output data 140 can reflect glycemic insights such as a glycemic impact for the user. Glycemic impact generally refers to a patient’s bodily state with respect to blood sugar levels. Figure 2 provides another example.

[0049] Figure 2 shows a device 200, which is representative of device 125 from Figure 1. Device 200 (i.e. a puck) is in communication with a CGM 205, which is representative of sensor 130A. CGM 205 is currently affixed to the user’s arm and is tracking the user’s glucose levels. Device 200 is hosting an application (or simply “app"’) 210. App 210 provides a visualization of the tracked data (e.g., a graph or trace of glucose levels over a period of time).

Applicator Features

[0050] Figures 3A, 3B, and 3C illustrate various views of an applicator 300 coupled with a screw cap 305 and an end cap 310. Applicator 300 is representative of applicator 130B from Figure 1. Figures 3A, 3B, and 3C illustrate one example of how applicator 300 is shipped to and received by a user, prior to use by that user. In some embodiments, applicator 300 can be shipped to the user with the sensor and sharp contained therein.

[0051] Figure. 3B is a side perspective view depicting applicator 300 and cap 305 after being decoupled. Figure 3C is a perspective view depicting an example embodiment of a distal end of an applicator 300 with a puck 315 that includes the analyte sensor.

[0052] The applicator 300 can be used to insert an analyte sensor (included as a part of the puck) in a subject. Additional features of the applicator 300 are shown in Figure 4. [0053] As shown in Figure 4, the applicator includes a housing 400, a sharp carrier 405, a sharp 410, a sharp retraction spring 415, a sheath 420, a firing pin 425, a drive spring 430, and a puck carrier 435. The puck is not shown in Figure 4. The term “carriage” and the phrase “medical device carrier” are substitutable terms/phrases for “puck carrier.” [0054] Housing 400 operates as a trigger that releases under light pressure and activates the drive spring 430 to push the puck carrier 435 downward and to insert the sharp 410 and the analyte sensor into the subject. As the subject pulls the applicator away from the skin, the sharp retraction spring 415 is triggered, causing the sharp 410 to withdraw from the subject.

[0055] The applicator provides for a higher, more controlled insertion speed, relative to an applicator that relies on manual force for insertion. The applicator is further advantageous in that it can improve insertion success and can also reduce trauma at the insertion site, relative to an applicator that relies on manual force for insertion.

[0056] Housing 400 may be made of a uniform synthetic material 440. Notably, material 440 may be a recyclable 440A material and/or it may be a recycled 440B material. The sharp carrier 405 is coupled to the sharp 410, and the sharp carrier 405 is also made of the uniform synthetic material 440. The sharp retraction spring 415 is also made of the uniform synthetic material 440.

[0057] The sheath 420 is also made of the uniform synthetic material 440. The firing pin 425 is also made of the uniform synthetic material 440. The drive spring 430 may also be made of the uniform synthetic material 440. The puck carrier 435 may also be made of the uniform synthetic material 440. Thus, those components may be made of recyclable 440A material and/or recycled 440B material.

[0058] The sharp 410 is made of a second material 445 that is different from the material 440. Similarly, although not shown in Figure 4 (it is shown in later Figures), a desiccant may be included with the applicator, and the desiccant may be made of a third material 450 that is different from either one of the material 440 and the material 445. Thus, the non-desiccant and non-sharp components of the applicator may all be made of the same, uniform material. After use, a user can remove the sharp 410 and the desiccant. The sharp 410 can be properly disposed as a biohazard. The desiccant can be disposed of as well. The remaining portions of the applicator are all made of the same material, which is a recyclable material. As a result, the applicator (absent the desiccant and the sharp) can be disposed of in a recycle bin. Doing so results in less waste being contributed to a landfill and enables a circular economy. That is, recyclable material can be used to manufacture the applicator. After use, the applicator can then be recycled. A new applicator can thus be made from the recycled material. [0059] In some embodiments, the uniform synthetic material 440 is or includes a plastic material. In some embodiments, the uniform synthetic material 440 is or includes a high-density polyethylene (HDPE) material and/or polycyclohexylene dimethylene terephthalate (PCT). In some embodiments, the uniform synthetic material 440 is or includes a petroleum thermoplastic material. In some embodiments, the uniform synthetic material 440 is or includes a polyethylene material. In some embodiments, the uniform synthetic material 440 is or includes a plastic material.

[0060] As mentioned, the uniform synthetic material 440 is or may include a recyclable 440A material. In some cases, the uniform synthetic material 440 is or includes a recycled 440B material. Thus, the uniform synthetic material 440 is one of: a recyclable material or a recycled material.

Functionality Of The Applicator

[0061] The discussion will now turn to how the applicator functions. Initially, Figure 5 shows a side, cross-sectional view of an applicator. Applicator is show n as including a housing 500, a sharp carrier 505, a sharp retraction spring 510, a sheath 515, a firing pin 520, a drive spring 525, and a puck earner 530. Such components correspond with those components shown in Figure 4.

[0062] A user can push housing 500 in a distal direction (as shown by the downward arrow with the “F” label) to activate the applicator assembly process and to cause delivery of the analyte sensor. Afterwards, the canty of housing 500 can act as a receptacle for the sharp.

[0063] As housing 500 moves farther in a direction toward the user’s skin surface and as sheath 515 advances toward the distal end of housing 500 (i.e. the opposite end where the force F ' is being applied), some detent snaps (not labeled) will shift into various unlocked grooves, and the applicator is in an “armed” position, ready for use. When the user further applies force (e.g., force “F”) to the proximal end of housing 500 and while sheath 515 is pressed against the user's skin, the detent snaps pass over a firing detent (not labeled). This begins a firing sequence due to the release of stored energy in the deflected detent snaps, which travel in a proximal direction relative to the skin’s surface, toward a sheath stopping ramp, which is slightly flared outw ard with respect to the central axis and which slow s the sheath 515 movement during the firing sequence.

[0064] The next groove encountered by the detent snap after an unlocked groove is a final lockout groove, which the detent snap enters at the end of the stroke or pushing sequence performed by the user. A final lockout recess can be a proximally-facing surface that is perpendicular to the central axis and that, after the detent snap passes, engages a detent snap flat and prevents reuse of the device by securely holding sheath 515 in place with respect to housing 500. An insertion hard stop of a housing guide rib prevents sheath 515 from advancing proximally with respect to housing 500 by engaging a travel limiter face for the puck carrier 530.

[0065] Figure 6 shows a state of the applicator prior to the analyte sensor being disposed onto the user’s skin. In particular, Figure 6 shows a cross-sectional view of an applicator in an initial state 600. As mentioned previously, applicator can include the following components: housing, sharp carrier, retraction spring, sheath, firing pin, drive spring, and puck carrier.

[0066] In the initial state 600. a distal end (e.g., the bottom end shown in Figure 6) of the applicator is ready to be positioned on a subject’s skin surface. In the initial state 600, the drive spring 605 and retraction spring 610 are each in a preloaded, compressed state, as shown by state 615 for the drive spring 605 and state 620 for the retraction spring 610. Stated differently, the drive spring 605 is in a compressed state when the device carrier, the sharp carrier, and the sharp are in a proximal position. Similarly, the retraction spring is in a compressed state when the device carrier, the sharp carrier, and the sharp are in the proximal position.

[0067] Recall, the drive spring 605 is made of the first material 440 from Figure 4. Similarly, the retraction spring 610 is also made of the first material 440. Thus, both the drive spring 605 and the retraction spring 610 are made of recyclable material, and those springs need not be removed from the applicator in order to recycle the applicator.

[0068] Drive spring 605 includes a first end coupled to the firing pin and a second end coupled to the puck carrier. Retraction spring 610 includes a first end coupled to the sharp carrier and a second end coupled to the puck carrier. In the initial state 600, puck carrier and sharp carrier are in a first position within applicator, in a spaced relation with the skin surface. Also, the drive spring 605 is in a compressed state between the firing pin and the puck carrier. Similarly, the retraction spring 610 is in a compressed state between the sharp carrier and the puck earner.

[0069] Accordingly, in some embodiments, an initial state of the drive spring is a compressed state, and an initial state of the retraction spring is a compressed state. In some cases, the initial state of the retraction spring is a compressed state between the sharp carrier and the puck carrier. According to one aspect, in the initial state, the puck carrier is coupled to the sheath by one or more latch-tab structures. According to another aspect, prior to disengagement of the sheath tabs, application of a force can increase the load on the drive spring by further compressing it.

[0070] According to another aspect, during the insertion process, as the puck carrier reaches a second position, the puck carrier and a distal portion of a sensor control unit (i.e. the puck) coupled with the puck carrier comes into resting contact with the skin surface. In some embodiments, the distal portion of the sensor control unit can be an adhesive surface. According to one aspect of the embodiments, after the insertion process is complete, the subject applies another force (e.g., shown as F2 in Figure 7) to the applicator, this time in a proximal direction. The force F2 can be the subject pulling or removing the applicator away from the skin's surface. Application of force F2 causes the retraction spring to displace the sharp carrier from the second position (e.g.. adjacent to the skin surface) to a third position within the applicator, which causes the sharp to withdraw from the skin surface.

[0071] More specifically, as F2 is applied, the drive spring displaces the puck carrier to a bottom portion of the applicator. A portion of the puck carrier protrudes beneath the bottom of the sheath. Similarly, during the sharp retraction state, the puck carrier tabs are flush with the bottom of the sheath’s slot.

[0072] According to another aspect, as force F2 continues to be applied, each of the puck carrier lock arms is positioned into a sheath notch. Consequently, puck carrier lock arms, which are biased in a radially outward direction, can expand in a radially outward direction through sheath notches. In turn, puck carrier lock arms disengage from and release sharp carrier, and retraction spring is free to expand in a proximal direction. As retraction spring expands in a proximal direction, sharp carrier is displaced to the third position within the applicator (e.g., top of sheath), which causes the sharp to withdraw from the skin surface.

[0073] Figure 7 shows a depiction of the applicator in a second state 700, which occurs after the puck has been disposed on the user’s skin. In state 700, the sharp is in a retracted state 705, as generally discussed above.

[0074] With respect to drive spring and sharp retraction spring, it should be noted that although compression springs are shown in the Figures, those of skill in the art will appreciate that other types of springs can be utilized in any of the embodiments described herein, including but not limited to torsion springs, disc springs, leaf springs and others. Furthermore, those of skill in the art will understand that the insertion and retraction speeds of the applicator embodiments described herein can be changed by changing the stiffness or length of the drive spring and the retraction spring, respectively. Similarly, those of skill in the art will understand that the timing of the sharp retraction can be modified by modifying the depth of the sheath channels (e.g., increasing depth of sheath channels can result in an earlier sharp retraction). As mentioned previously, regarding of what type of springs are used, the drive spring and sharp retraction spring are formed of the same material, which is a recyclable and/or recycled material. This material is the same material that forms the housing and the various other components (excluding the sharp and desiccant) of the applicator. Thus, other than the sharp and the desiccant, all components of the applicator are formed of recyclable and/or recycled material.

[0075] With respect to any of the applicator embodiments described herein, as well as any of the components thereof, including but not limited to the sharp, those of skill in the art will understand that said embodiments can be dimensioned and configured for use with sensors configured to sense an analyte level in a bodily fluid in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, sharps and distal portions of analyte sensors disclosed herein can both be dimensioned and configured to be positioned at a particular end-depth (i.e. the farthest point of penetration in a tissue or layer of the subject’s body, e.g., in the epidermis, dermis, or subcutaneous tissue). With respect to some applicator embodiments, those of skill in the art will appreciate that certain embodiments of sharps can be dimensioned and configured to be positioned at a different end-depth in the subject’s body relative to the final end-depth of the analyte sensor.

[0076] Tn some embodiments, for example, a sharp can be positioned at a first enddepth in the subject’s epidermis prior to retraction, while a distal portion of an analyte sensor can be positioned at a second end-depth in the subject’s dermis. In other embodiments, a sharp can be positioned at a first end-depth in the subject’s dermis prior to retraction, while a distal portion of an analyte sensor can be positioned at a second enddepth in the subject’s subcutaneous tissue. In still other embodiments, a sharp can be positioned at a first end-depth prior to retraction and the analyte sensor can be positioned at a second end-depth, wherein the first end-depth and second end-depths are both in the same layer or tissue of the subject’s body.

[0077] A number of deflectable structures are described herein, including but not limited to deflectable detent snaps, deflectable locking arms, sharp carrier lock arms, sharp retention arms, and module snaps. These deflectable structures are composed of a resilient material and are composed of recycled or recyclable plastic. Further, the material that forms these components is the same material that forms the other components of the applicator (excluding the sharp and desiccant) Each deflectable structure has a resting state or position that the resilient material is biased towards. If a force is applied that causes the structure to deflect or move from this resting state or position, then the bias of the resilient material will cause the structure to return to the resting state or position once the force is removed (or lessened). In many instances these structures are configured as arms with detents, or snaps, but other structures or configurations can be used that retain the same characteristics of deflectability and ability to return to a resting position, including but not limited to a leg, a clip, a catch, an abutment on a deflectable member, and the like.

Desiccant Features

[0078] Attention will now be directed to Figures 8A, 8B, 8C, 8D, 8E, and 8F, which provide various illustrations with respect to a desiccant. Recall, the desiccant is made of a different material than the sharp and the other components of the applicator. Often, the desiccant can be discarded in a traditional waste bin. The other components of the applicator (excluding the sharp and the desiccant) can be discarded in a recycle bin because those components are made of recyclable material.

[0079] Figure 8A shows a container 800A, which may include any of the applicators mentioned herein. A lid or covering is included as a part of the container 800 A, and the lid includes a desiccant pouch 805 A. In some cases, the lid is formed of foil w hile in other cases the lid is formed of a thermoplastic material. In the case where the lid is formed of a plastic, then that plastic may be the same type of plastic as the plastic of the applicator. Thus, if the desiccant and foil portions are removed, the lid can also be recycled.

[0080] In Figure 8A, the desiccant pouch 805 A is enveloped or included in a foil pouch comprising the formed foil 810, which is sealed (e.g., seal 815) to additional foil, which includes a hole 820 to enable the desiccant pouch 805A to absorb moisture from within the container 800A when the lid is sealed to the container 800A. In this example scenario, the foil can be tom or otherwise removed to enable the desiccant to be extracted from the lid. The foil may then optionally be disposed of, and the desiccant can be disposed of as well in a waste receptacle.

[0081] Figure 8B shows a different scenario involving the container 800B. Here, the desiccant pouch 805B is adhered to the formed foil 825 via an adhesive 830. During disposal, the desiccant pouch 805B can be peeled away from the formed foil 825 and the various components can be disposed of properly.

[0082] Figure 8C shows a container 800C and a desiccant pouch 805C. Desiccant pouch 805C is adhered to the formed foil 835 via a w eld 840. [0083] Figure 8D shows a container 800D and a desiccant pouch 805D. Desiccant pouch 805D is held in place by foil 845 to a thermoplastic cup 850. In Figure 8D, the foil 845 includes a hole 855 to allow the desiccant pouch 805D to absorb moisture from the container 800D.

[0084] Figure 8E shows a container 800E and a loose desiccant pouch 805E. In this example scenario, the loose desiccant pouch 805E is not adhered to the flat foil 860; instead, the loose desiccant pouch 805E is a free body included within the container 800E. [0085] Figure 8F shows a container 800F and a desiccant pouch 805F. In this example, foil 865 is provided, and a vacuum formed cup 870 is sealed to the foil 865. A hole 875 is included as a part of the vacuum formed cup 870 to allow the desiccant pouch 805F to absorb moisture.

[0086] Accordingly, in some embodiments, the applicator further includes a desiccant, and the desiccant may be separable from the applicator. The process of separating the desiccant from the applicator may involve peeling the desiccant away from the applicator. [0087] In some implementations, the desiccant is included in a foil pouch that also includes the applicator. The process of separating the desiccant from the applicator may involve either removing the applicator from the foil pouch or removing the desiccant from the foil pouch.

Ejection Of The Sharp

[0088] The disclosed applicator may also include a mechanism to facilitate the ej ection of the sharp after the puck has been applied to the user’s skin. Figure 9 shows an example of the applicator with an eject button 900A disposed on a top portion of the applicator. Figure 9 shows a cut away view of the eject button 900B and 900C as well as the sharp 905A initially coupled to the applicator and the sharp 905B subsequently being removed as a result of the eject button 900C being pressed.

[0089] While Figure 9 particularly shows an embodiment in which the eject button is in the form of a button, various alternatives are available as well. For instance, the applicator may include a twist cap member that, when twisted, also causes the sharp to be released. Thus, the embodiments enable the removal of the sharp, which is typically formed of a non-recyclable material. The non-sharp components and the non-desiccant components are made of recyclable material. By removing the sharp and the desiccant from the applicator, the remaining portions of the applicator can all be recycled in an easy manner, thereby promoting a circular economy in which the recyclable material can be recycled, and the applicator can optionally be made of recycled material. Other Features

[0090] Accordingly, some embodiments are generally directed to a type of applicator for inserting an analyte (e.g., glucose) sensor into a subject. In some cases, the applicator includes a housing made of a first material. The applicator further includes a sharp carrier coupled to a sharp. The sharp carrier is also made of the first material, but the sharp is made of a second material. The applicator includes a retraction spring that is also made of the first material. The applicator includes a sheath that is also made of the first material. The applicator further includes a firing pin that is also made of the first material and a drive spring made that is also made of the first material. The applicator includes a puck carrier that is also made of the first material and an analyte sensor. The applicator may further include a desiccant that is made of a third material.

[0091] In some implementations, the first material is a recyclable material and/or is made of a recycled material. The first material, the second material, and the third material may be different.

[0092] In some implementations, the desiccant is coupled to the applicator via an adhesive. In some implementations, the desiccant is peelable away from the applicator in a non-destructive manner, with respect to the desiccant. Optionally, the desiccant may be peelable away from the applicator and, when the desiccant is peeled away, no portion of the desiccant remains on the applicator. Optionally, the desiccant and the applicator may be stored in a container.

[0093] In some embodiments, the retraction spring is a limited use spring. In some embodiments, the retraction spring is a single use spring.

[0094] In some embodiments, the drive spring is a limited use spring. Similarly, the drive spring may be a single use spring.

[0095] In some embodiments, the sharp is removable from the applicator. For instance, the applicator may further include a button that, when pressed, triggers removal of the sharp. As another example, the applicator may further include a twist cap member that, when twisted, triggers removal of the sharp. The sharp is removable after the analyte sensor is disposed on a skin of a subject. Relatedly. the sharp is removable from the sharp carrier. The sharp is removable from the sharp carrier after the firing pin is triggered. Also, the sharp is removable from the sharp carrier after the drive spring transitions from a first state to a second state. The sharp is removable from the sharp carrier after the retraction spring transitions from a first state to a second state. [0096] The drive spring is initially in a compressed state. The sharp is removable from the sharp earner after a further compression of the drive spring, where this further compression occurs while the applicator is being fired.

[0097] In some implementations, the applicator includes (i) a housing made of a material; (ii) a sharp carrier coupled to a sharp, the sharp carrier also being made of the material; (iii) a retraction spring that is also made of the material; (iv) a sheath that is also made of the material; (v) a firing pin that is also made of the material; (vi) a drive spring made that is also made of the material; (vii) a puck carrier that is also made of the material; and (viii) the analyte sensor.

[0098] The drive spring may be configured to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface upon an application of a first force to the applicator. The sharp and a portion of the analyte sensor are positioned under the skin surface and in contact with a bodily fluid of the subject at the second position. The retraction spring is configured to displace the sharp carrier from the second position to a third position within the applicator and to withdraw the sharp from the skin surface upon an application of a second force to the applicator.

[0099] In some cases, the material is a uniform material. The material may be one of a recyclable material or a recycled material. The material may include one of: (i) a uniform synthetic material; (ii) a recyclable polymer; (iii) a high-density polyethylene (HDPE) material; (iv) polycyclohexylene dimethylene terephthalate (PCT) material; (v) a petroleum thermoplastic material; (vi) a polyethylene material; or (vii) a plastic material. [00100] In some cases, the applicator further includes a desiccant. The desiccant may be removable from the applicator. Similarly, the sharp may be removable from the applicator. During firing of the applicator, the retraction spring transitions from a first state to a second state. Also, during firing of the applicator, the drive spring transitions from a first state to a second state. After firing of the applicator, the sharp is removable, and the applicator is disposable as recyclable waste.

Example Methods

[00101] The following discussion now refers to a number of methods and method acts that may be performed. Although the method acts may be discussed in a certain order or illustrated in a flow chart as occurring in a particular order, no particular ordering is required unless specifically stated, or required because an act is dependent on another act being completed prior to the act being performed. [00102] Atention will now be directed to Figure 10, which illustrates a flowchart of an example method 1000 involving the use of an applicator. This applicator includes: (i) a housing made of a uniform synthetic material; (ii) a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; (iii) a retraction spring that is also made of the uniform synthetic material; (iv) a sheath that is also made of the uniform synthetic material; (v) a firing pin that is also made of the uniform synthetic material; (vi) a drive spring made that is also made of the uniform synthetic material; (vii) a puck carrier that is also made of the uniform synthetic material; (viii) an analyte sensor; and (ix) a desiccant.

[00103] Method 1000 includes causing (act 1005) the drive spring to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface.

[00104] Method 1000 includes causing (act 1010) the sharp and a portion of the analyte sensor to be positioned under the skin surface and in contact with a bodily fluid of the subject at the second position. The sharp and a portion of the analyte sensor may be moved from the first position within the applicator to a second position in which they extend, optionally perpendicularly, from the plain formed by the lower surface of the applicator or applicator housing.

[00105] Method 1000 includes causing (act 1015) the retraction spring to displace the sharp carrier from the second position to a third position within the applicator, resulting in withdrawal of the sharp from the skin surface.

[00106] Acts 1020 and 1025 may be performed in parallel or in serial with one another. Act 1020 includes separating the desiccant from the applicator. Act 1025 includes separating the sharp from the applicator.

[00107] After the desiccant and the sharp are separated from the applicator, act 1030 includes disposing the applicator in a recyclable waste container.

[00108] In some aspects, the techniques described herein can be implemented in a scenario involving other analyte sensing systems that use a sensor tail, with one end of that tail being inserted into a person’s body to be in contact with and to sense analyte levels in bodily fluid, such as blood or interstitial fluid.

Numbered Clauses

[00109] In summary, an applicator may include a housing made of a uniform synthetic material. The applicator may include a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material. The applicator may include a retraction spring that is also made of the uniform synthetic material. The applicator may include a sheath that is also made of the uniform synthetic material. The applicator may include a firing pin that is also made of the uniform synthetic material. The applicator may include a drive spring made that is also made of the uniform synthetic material. The applicator may include a puck carrier that is also made of the uniform synthetic material. The applicator may include the glucose sensor.

[00110] The present invention can also be described in accordance with the following numbered clauses.

[00111] Clause 1. An applicator for inserting an glucose sensor into a subject, the applicator comprising: a housing made of a uniform synthetic material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; a retraction spring that is also made of the uniform synthetic material; a sheath that is also made of the uniform synthetic material; a firing pin that is also made of the uniform synthetic material; a drive spring made that is also made of the uniform synthetic material; a puck carrier that is also made of the uniform synthetic material; and the glucose sensor. [00112] Clause 2. The applicator of clause 1, wherein the uniform synthetic material includes a plastic material.

[00113] Clause 3. The applicator of clause 1 or 2, wherein the uniform synthetic material includes a high-density polyethylene (HDPE) material.

[00114] Clause 4. The applicator of any of clauses 1 to 3. wherein the uniform synthetic material includes poly cyclohexylene dimethylene terephthalate (PCT).

[00115] Clause 5. The applicator of any of clauses 1 to 4, wherein the uniform synthetic material includes a petroleum thermoplastic material.

[00116] Clause 6. The applicator of any of clauses 1 to 5. wherein the uniform synthetic material includes a polyethylene material.

[00117] Clause 7. The applicator of any of clauses 1 to 6, wherein the uniform synthetic material is a plastic material.

[00118] Clause 8. The applicator of any of clauses 1 to 7. wherein the uniform synthetic material is a high-density polyethylene (HDPE) material.

[00119] Clause 9. The applicator of any of clauses 1 to 8, wherein the uniform synthetic material is poly cyclohexylene dimethylene terephthalate (PCT).

[00120] Clause 10. The applicator of any of clauses 1 to 9. wherein the uniform synthetic material is a petroleum thermoplastic material. [00121] Clause 11. The applicator of any of clauses 1 to 10, wherein the uniform synthetic material is a polyethylene material. [00122] Clause 12. The applicator of any of clauses 1 to 11, wherein the uniform synthetic material is a recyclable material.

[00123] Clause 13. The applicator of any of clauses 1 to 12, wherein the uniform synthetic material is a recycled material.

[00124] Clause 14. The applicator of any of clauses 1 to 13, wherein the uniform synthetic material is one of: a recyclable material or a recycled material.

[00125] Clause 15. The applicator of any of clauses 1 to 14, wherein the applicator further includes a desiccant, and wherein the desiccant is separable from the applicator.

[00126] Clause 16. The applicator of clause 15, wherein separating the desiccant from the applicator involves peeling the desiccant away from the applicator.

[00127] Clause 17. The applicator of clause 15 or 16, wherein the desiccant is included in a foil pouch that also includes the applicator, and wherein separating the desiccant from the applicator involves either removing the applicator from the foil pouch or removing the desiccant from the foil pouch.

[00128] Clause 18. The applicator of any of clauses 1 to 17, wherein an initial state of the drive spring is a compressed state.

[00129] Clause 19. The applicator of any of clauses 1 to 18, wherein an initial state of the retraction spring is a compressed state.

[00130] Clause 20. The applicator of any of clauses 1 to 19, wherein an initial state of the retraction spring is a compressed state between the sharp carrier and the puck carrier.

[00131] Clause 21. An applicator for inserting an glucose sensor into a subject, the applicator comprising: a housing made of a first material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the first material, the sharp being made of a second material; a retraction spring that is also made of the first material; a sheath that is also made of the first material; a firing pin that is also made of the first material; a drive spring made that is also made of the first material; a puck carrier that is also made of the first material; the glucose sensor; and a desiccant that is made of a third material.

[00132] Clause 22. The applicator of clause 21 , wherein the first material is a recyclable material.

[00133] Clause 23. The applicator of clause 21 or 22, wherein the first material is made of a recycled material. [00134] Clause 24. The applicator of any of clauses 21 to 23, wherein the first material, the second material, and the third material are different.

[00135] Clause 25. The applicator of any of clauses 21 to 24, wherein the desiccant is coupled to the applicator via an adhesive.

[00136] Clause 26. The applicator of any of clauses 21 to 25, wherein the desiccant is peelable away from the applicator in a non-destructive manner.

[00137] Clause 27. The applicator of any of clauses 21 to 26. wherein the desiccant is peelable away from the applicator and, when the desiccant is peeled away, no portion of the desiccant remains on the applicator.

[00138] Clause 28. The applicator of any of clauses 21 to 27, wherein the desiccant and the applicator are stored in a container.

[00139] Clause 29. The applicator of any of clauses 21 to 28, wherein the retraction spring is a limited use spring.

[00140] Clause 30. The applicator of any of clauses 21 to 29, wherein the retraction spring is a single use spring.

[00141] Clause 31. The applicator of any of clauses 21 to 30, wherein the drive spring is a limited use spring.

[00142] Clause 32. The applicator of any of clauses 21 to 31, wherein the drive spring is a single use spring.

[00143] Clause 33. The applicator of any of clauses 21 to 32, wherein the sharp is removable from the applicator.

[00144] Clause 34. The applicator of any of clauses 21 to 33, wherein the applicator further includes a button that, when pressed, triggers removal of the sharp.

[00145] Clause 35. The applicator of any of clauses 21 to 34, wherein the applicator further includes a twist cap member that, when twisted, triggers removal of the sharp.

[00146] Clause 36. The applicator of any of clauses 21 to 35, wherein the sharp is removable after the glucose sensor is disposed on a skin of a subject.

[00147] Clause 37. The applicator of any of clauses 21 to 36, wherein the sharp is removable from the sharp carrier.

[00148] Clause 38. The applicator of any of clauses 21 to 37, wherein the sharp is removable from the sharp carrier after the firing pin is triggered.

[00149] Clause 39. The applicator of any of clauses 21 to 38, wherein the sharp is removable from the sharp carrier after the drive spring transitions from a first state to a second state. [00150] Clause 40. The applicator of any of clauses 21 to 39, wherein the sharp is removable from the sharp carrier after the retraction spring transitions from a first state to a second state.

[00151] Clause 41. The applicator of any of clauses 21 to 40, wherein the drive spring is initially in a compressed state, and wherein the sharp is removable from the sharp carrier after a further compression of the drive spring, said further compression occurring while the applicator is being fired.

[00152] Clause 42. An applicator for inserting an glucose sensor into a subject, the applicator comprising: a housing made of a material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the material; a retraction spring that is also made of the material; a sheath that is also made of the material; a firing pin that is also made of the material; a drive spring made that is also made of the material; a puck carrier that is also made of the material; and the glucose sensor; wherein the drive spring is configured to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface upon an application of a first force to the applicator, and wherein the sharp and a portion of the glucose sensor are positioned under the skin surface and in contact with a bodily fluid of the subject at the second position, and wherein the retraction spring is configured to displace the sharp carrier from the second position to a third position within the applicator and to withdraw the sharp from the skin surface upon an application of a second force to the applicator.

[00153] Clause 43. The applicator of clause 42, wherein the material is a uniform material.

[00154] Clause 44. The applicator of clause 42 or 43, wherein the material is one of a recyclable material or a recycled material.

[00155] Clause 45. The applicator of any of clauses 42 to 44, wherein the material includes one of: a uniform synthetic material; a recyclable polymer; a high-density polyethylene (HDPE) material; polycyclohexylene dimethylene terephthalate (PCT) material; a petroleum thermoplastic material; a polyethylene material; or a plastic material. [00156] Clause 46. The applicator of any of clauses 42 to 45, wherein the applicator further includes a desiccant, wherein the desiccant is removable from the applicator, and wherein the sharp is removable from the applicator.

[00157] Clause 47. The applicator of any of clauses 42 to 46, wherein, during firing of the applicator, the retraction spring transitions from a first state to a second state. [00158] Clause 48. The applicator of any of clauses 42 to 47, wherein, during firing of the applicator, the drive spring transitions from a first state to a second state.

[00159] Clause 49. The applicator of any of clauses 42 to 48, wherein, after firing of the applicator, the sharp is removable, and wherein the applicator is disposable as recyclable waste.

[00160] Clause 50. A method of disposing an applicator that includes: a housing made of a uniform synthetic material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; a retraction spring that is also made of the uniform synthetic material; a sheath that is also made of the uniform synthetic material; a firing pin that is also made of the uniform synthetic material; a drive spring made that is also made of the uniform synthetic material; a puck carrier that is also made of the uniform synthetic material; an glucose sensor; and a desiccant; wherein said method includes: causing the drive spring to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface; causing the sharp and a portion of the glucose sensor to be positioned under the skin surface and in contact with a bodily fluid of the subject at the second position; causing the retraction spring to displace the sharp carrier from the second position to a third position within the applicator, resulting in withdrawal of the sharp from the skin surface; separating the desiccant from the applicator; separating the sharp from the applicator; and after the desiccant and the sharp are separated from the applicator, disposing the applicator in a recyclable waste container.

[00161] The present invention may be embodied in other specific forms without departing from its characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMS What is claimed is:

1. An applicator for inserting a glucose sensor into a subject the applicator comprising: a housing made of a uniform synthetic material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; a retraction spring that is also made of the uniform synthetic material; a sheath that is also made of the uniform synthetic material; a firing pin that is also made of the uniform synthetic material; a drive spring made that is also made of the uniform synthetic material; and a puck earner that is also made of the uniform synthetic material.

2. The applicator of claim 1, wherein the uniform synthetic material comprises a plastic material.

3. The applicator of claim 1, wherein the uniform synthetic material includes a high-density polyethylene (HDPE) material.

4. The applicator of claim 1 , wherein the uniform synthetic material includes polycyclohexylene dimethylene terephthalate (PCT).

5. The applicator of claim 1, wherein the uniform synthetic material includes a petroleum thermoplastic material.

6. The applicator of claim 1 , wherein the uniform synthetic material includes a polyethylene material.

7. The applicator of claim 1, wherein the uniform synthetic material is a plastic material.

8. The applicator of claim 1, wherein the uniform synthetic material is a high- density polyethylene (HDPE) material.

9. The applicator of claim 1, wherein the uniform synthetic material is polycyclohexylene dimethylene terephthalate (PCT).

10. The applicator of claim 1, wherein the uniform synthetic material is a petroleum thermoplastic material.

11. The applicator of claim 1, wherein the uniform synthetic material is a polyethylene material.

12. The applicator of claim 1, wherein the uniform synthetic material is a recyclable material.

13. The applicator of claim 1, wherein the uniform synthetic material is a recycled material.

14. The applicator of claim 1, wherein the uniform synthetic material is one of: a recyclable material or a recycled material.

15. The applicator of claim 1, wherein the applicator further includes a desiccant, and wherein the desiccant is separable from the applicator.

16. The applicator of claim 15, wherein separating the desiccant from the applicator involves peeling the desiccant away from the applicator.

17. The applicator of claim 15, wherein the desiccant is included in a foil pouch that also includes the applicator, and wherein separating the desiccant from the applicator involves either removing the applicator from the foil pouch or removing the desiccant from the foil pouch.

18. The applicator of claim 1, wherein the drive spring is in a compressed state when the device carrier, the sharp carrier, and the sharp are in a proximal position.

19. The applicator of claim 1, wherein the retraction spring is in a compressed state when the device carrier, the sharp carrier, and the sharp are in a proximal position.

20. The applicator of claim 1, wherein the retraction spring is in a compressed state between the sharp carrier and the puck carrier.

21. An applicator for inserting a glucose sensor into a subject, the applicator comprising: a housing made of a first material: a sharp carrier coupled to a sharp, the sharp carrier also being made of the first material, the sharp being made of a second material; a retraction spring that is also made of the first material; a sheath that is also made of the first material; a firing pin that is also made of the first material; a drive spring made that is also made of the first material; a carriage that is also made of the first material; and a desiccant that is made of a third material.

22. The applicator of claim 21, wherein the first material is a recyclable material.

23. The applicator of claim 21, wherein the first material is made of a recycled material.

24. The applicator of claim 21, wherein the first material, the second material, and the third material are different.

25. The applicator of claim 21, wherein the desiccant is coupled to the applicator via an adhesive.

26. The applicator of claim 21 , wherein the desiccant is peelable away from the applicator in a non-destructive manner.

27. The applicator of claim 21. wherein the desiccant is peelable away from the applicator and, when the desiccant is peeled away, no portion of the desiccant remains on the applicator.

28. The applicator of claim 21, wherein the desiccant and the applicator are stored in a container.

29. The applicator of claim 21, wherein the retraction spring is a limited use spring.

30. The applicator of claim 21, wherein the retraction spring is a single use spring.

31. The applicator of claim 21 , wherein the drive spring is a limited use spring.

32. The applicator of claim 21, wherein the drive spring is a single use spring.

33. The applicator of claim 21, wherein the sharp is removable from the applicator.

34. The applicator of claim 21 , wherein the applicator further includes a button that, when pressed, triggers removal of the sharp.

35. The applicator of claim 21, wherein the applicator further includes a twist cap member that, when twisted, triggers removal of the sharp.

36. The applicator of claim 21. wherein the sharp is removable after the glucose sensor is disposed on a skin of a subject.

37. The applicator of claim 21, wherein the sharp is removable from the sharp carrier.

38. The applicator of claim 21, wherein the sharp is removable from the sharp carrier after the firing pin is triggered.

39. The applicator of claim 21, wherein the sharp is removable from the sharp carrier after the drive spring transitions from a first state to a second state.

40. The applicator of claim 21, wherein the sharp is removable from the sharp carrier after the retraction spring transitions from a first state to a second state.

41. The applicator of claim 21, wherein the drive spring is initially in a compressed state, and wherein the sharp is removable from the sharp carrier after a further compression of the drive spring, said further compression occurring while the applicator is being fired.

42. An applicator for inserting a glucose sensor into a subject, the applicator comprising: a housing made of a material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the material; a retraction spring that is also made of the material; a sheath that is also made of the material; a firing pin that is also made of the material; a drive spring made that is also made of the material; and a puck carrier that is also made of the material; wherein the drive spring is configured to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface upon an application of a first force to the applicator, and wherein the sharp and a portion of the glucose sensor are positioned under the skin surface and in contact with a bodily fluid of the subject at the second position, and wherein the retraction spring is configured to displace the sharp carrier from the second position to a third position within the applicator and to withdraw the sharp from the skin surface upon an application of a second force to the applicator.

43. The applicator of claim 42, wherein the material is a uniform material.

44. The applicator of claim 42, wherein the material is one of a recyclable material or a recycled material.

45. The applicator of claim 42, wherein the material includes one of: a uniform synthetic material; a recyclable polymer; a high-density polyethylene (HDPE) material; poly cyclohexylene dimethylene terephthalate (PCT) material; a petroleum thermoplastic material; a polyethylene material; or a plastic material.

46. The applicator of claim 42, wherein the applicator further includes a desiccant, wherein the desiccant is removable from the applicator, and wherein the sharp is removable from the applicator.

47. The applicator of claim 42, wherein, during firing of the applicator, the retraction spring transitions from a first state to a second state.

48. The applicator of claim 42, wherein, during firing of the applicator, the drive spring transitions from a first state to a second state.

49. The applicator of claim 42, wherein, after firing of the applicator, the sharp is removable, and wherein the applicator is disposable as recyclable waste.

50. A method of disposing of an applicator that includes: a housing made of a uniform synthetic material; a sharp carrier coupled to a sharp, the sharp carrier also being made of the uniform synthetic material; a retraction spring that is also made of the uniform synthetic material; a sheath that is also made of the uniform synthetic material; a firing pin that is also made of the uniform synthetic material; a drive spring made that is also made of the uniform synthetic material; a puck carrier that is also made of the uniform synthetic material; and a desiccant; wherein said method includes: causing the drive spring to displace the puck carrier and the sharp carrier from a first position within the applicator in spaced relation with a skin surface to a second position adjacent to the skin surface; causing the sharp and a portion of the glucose sensor to be positioned under the skin surface and in contact with a bodily fluid of a subject at the second position; causing the retraction spring to displace the sharp carrier from the second position to a third position within the applicator, resulting in withdrawal of the sharp from the skin surface; separating the desiccant from the applicator; separating the sharp from the applicator; and after the desiccant and the sharp are separated from the applicator, disposing of the applicator in a recyclable waste container.