Applicator for applying transcutaneous analyte sensors, and related manufacturing methods.

Abstract

Applicators for applying skin assemblies to the skin of a recipient, as well as methods for using and / or manufacturing them, are provided. [Solution] The applicator includes an insertion assembly configured to insert at least a portion of a skin assembly into the skin of a recipient; a housing configured to house the insertion assembly, the housing having an opening through which the skin assembly can pass; an actuation member configured, when actuated, to cause the insertion assembly to insert at least a portion of the skin assembly into the skin of a recipient; and a sealing element configured to provide a sterile barrier and a vapor barrier between the internal environment of the housing and the external environment of the housing.

Description

Technical Field

[0001] Incorporation by reference to related applications All priority claims identified in the application data sheet, or any amendments thereto, are incorporated herein by reference under 37 C.F.R. § 1.57. This application claims the benefit of U.S. Provisional Patent Application No. 62 / 521,969, filed Jun. 19, 2017. The foregoing application is incorporated herein by reference in its entirety and made a part hereof as if expressly set forth herein.

[0002] Applicators for applying an assembly onto a recipient's skin, and methods of using and / or manufacturing the same are provided. More specifically, devices for applying a transcutaneous analyte assembly onto a recipient's skin to accurately measure the recipient's blood glucose, and methods of using and / or manufacturing the same are provided.

Background Art

[0003] Diabetes mellitus is a disease in which the pancreas cannot produce sufficient insulin (type I or insulin-dependent), and / or insulin is ineffective (type II or non-insulin-dependent). In a diabetic state, the victim suffers from hyperglycemia, which can cause many physiological disorders associated with deterioration of small blood vessels, such as renal failure, skin ulcers, or bleeding into the vitreous humor of the eye. A hypoglycemic reaction (low blood sugar) can be induced by inadvertent overdose of insulin, or after normal administration of insulin or glucose-lowering drugs accompanied by abnormal exercise or insufficient food intake.

[0004] Traditionally, people with diabetes have carried self-monitoring blood glucose (SMBG) monitors, which typically require an uncomfortable finger-prick method. Due to the lack of comfort and convenience, people with diabetes usually only measure their glucose levels two to four times a day. Unfortunately, such time intervals are too far apart, which can lead to people with diabetes becoming aware of hyperglycemia or hypoglycemia too late, sometimes resulting in dangerous side effects. Glucose levels can, instead, be continuously monitored by a sensor system, which may include a skin sensor assembly. The sensor system may have a wireless transmitter that sends measurement data to a receiver, which can process and display information based on the measurements.

[0005] This background technology is provided to introduce a concise context for the following outline of the invention and for embodiments for carrying out the invention. This background technology is not intended to assist in determining the scope of the subject matter described in the claims, nor is it intended to limit the subject matter described in the claims to any implementation that solves any or all of the above disadvantages or difficulties. [Overview of the Initiative]

[0006] This apparatus and manufacturing method relates to a system and method for measuring analytes within a recipient, a system and method for manufacturing a transdermal analyte measurement system, and a system and method for applying a transdermal analyte measurement system to the skin of a recipient. Various embodiments of this system and method have several features, none of which alone contribute to their desired attributes. Without limiting the scope of this embodiment as expressed by the following claims, some of their more prominent features are briefly considered here. After considering this consideration, and especially after reading the section titled “Modes for Carrying Out the Invention,” you will understand how the features of this embodiment provide the advantages described herein.

[0007] According to a first embodiment, an applicator is provided for applying a skin assembly to the skin of a recipient. The applicator includes an insertion assembly configured to insert at least a portion of a sensor assembly into the skin of a recipient. The applicator includes a housing configured to house the insertion assembly. The housing includes an opening configured for the sensor assembly to pass through. The applicator includes an actuation member configured, when actuated, to cause the insertion assembly to insert at least a portion of the sensor assembly into the skin of a recipient. The applicator includes a sealing element configured to provide a sterile barrier and a vapor barrier between the internal environment of the housing and the external environment of the housing.

[0008] In some embodiments, the sealing element is releasable from the applicator. In some embodiments, the applicator further includes a skin assembly. In some embodiments, the skin assembly includes a sensor. In some embodiments, the skin assembly includes a transmitter. In some embodiments, the skin assembly includes an adhesive layer configured to adhere the skin assembly to the skin of the recipient. In some embodiments, the applicator further includes a support member configured to prevent at least lateral movement of the insertion assembly. In some embodiments, the support member includes an elastomer membrane. In some embodiments, the insertion assembly includes a needle. In some embodiments, the applicator further includes one or more ridges or recesses configured to provide the recipient with a tactile indication of gripping. In some embodiments, the applicator has a cross-sectional shape configured to provide the recipient with a tactile indication of gripping. In some embodiments, the applicator further includes at least one projection configured to prevent rotation of the applicator. In some embodiments, the housing includes a vent configured to be permeable to sterile gases. In some embodiments, the sealing element is configured to seal the vent. In some embodiments, the sealing element is configured to seal both the opening and the working member. In some embodiments, the working member includes a material that is permeable to sterilization gases. In some embodiments, the sealing element includes at least one of the following materials: metal foil (e.g., aluminum, titanium), metal substrate, aluminum oxide coated polymer, parylene, polymer coated with metal applied by vapor metallization, silicon dioxide coated polymer, or any material having a water vapor permeability of less than 10 g / 100 in², preferably less than 1 g / 100 in².

[0009] In some embodiments, the sealing element comprises a removable cap configured to bond with a portion of the housing. In some embodiments, the removable cap is configured to bond with the proximal portion of the housing. In some embodiments, the removable cap is configured to bond with the distal portion of the housing. In some embodiments, the removable cap is configured to bond with the housing in a uniaxial orientation. In some embodiments, the removable cap is configured to bond with a portion of the housing via threads. In some embodiments, the removable cap is configured to bond with a portion of the housing via an easily breakable member. In some embodiments, the easily breakable member is configured to provide a tamper indicator when broken. In some embodiments, the sealing element further comprises an O-ring configured to provide a seal between the removable cap and the housing. In some embodiments, the removable cap covers an actuarial member.

[0010] In some embodiments, the applicator further includes a tamper indicator. In some embodiments, the sealing element includes a first layer that is permeable to sterilization gas and a second layer that is substantially impermeable to water vapor. In some embodiments, the sealing element includes a first layer that is substantially impermeable to water vapor and seals an opening. In some embodiments, the sealing element further includes a second layer that is substantially impermeable to water vapor and seals an actuator. In some embodiments, the sealing element includes a peelable layer bonded to at least a portion of the housing. In some embodiments, the peelable layer is configured to provide a tamper indicator when removed. In some embodiments, the peelable layer is configured to seal a distal opening of the housing. In some embodiments, the peelable layer is configured to further seal an actuator. In some embodiments, the peelable layer is configured to seal a vent that is configured to be permeable to sterilization gas. In some embodiments, the vent is disposed on the side surface of the housing. In some embodiments, a porous polymer component is inserted into the vent.

[0011] In some embodiments, the sealing element comprises a flexible member disposed on at least a portion of the housing. In some embodiments, the flexible member comprises an elastomer. In some embodiments, the flexible member covers the actuarial member. In some embodiments, the flexible member is operably coupled to the actuarial member. In some embodiments, the flexible member has a bistable configuration to provide a visual indication of deployment after actuation. In some embodiments, the sealing element comprises an easily breakable member. In some embodiments, the easily breakable member covers the actuarial member, and removal of the easily breakable member exposes the actuarial member for actuation.

[0012] In some embodiments, the sealing element comprises a cup with a removable lid. In some embodiments, the cup is configured to be foldable after the lid is removed. In some embodiments, the cup is configured to seal the applicator from the environment outside the cup. In some embodiments, the cup comprises a skin-assembly alignment feature. In some embodiments, the cup comprises a needle protection feature. In some embodiments, the sealing element comprises a plug configured to bond to the housing via a friction fit.

[0013] In some embodiments, the actuarial member is disposed on the side surface of the housing. In some embodiments, the actuarial member is disposed on the proximal portion of the housing. In some embodiments, the actuarial member is embedded in the proximal portion of the housing. In some embodiments, the actuarial member comprises a cap coupled to the proximal portion of the housing. In some embodiments, the actuarial member is configured to actuate by moving the cap distally. In some embodiments, the sealing element further includes a sealing layer disposed between the cap and the housing. In some embodiments, the cap comprises a projection that penetrates the sealing layer and is configured to actuate the insertion assembly. In some embodiments, the insertion assembly is driven by a spring force. In some embodiments, after the insertion assembly has inserted the assembly onto the skin, the needle retracts from the insertion assembly. In some embodiments, the applicator further includes a safety member configured to prevent the actuarial member from acting. In some embodiments, the safety member comprises an easily breakable member, which is configured to prevent the actuarial member from acting until at least the easily breakable member is broken.

[0014] In some embodiments, the sealing element includes a first portion comprising a plurality of perforations and an adhesive layer disposed on the first side of the first portion. In some embodiments, the sealing element further includes a second portion disposed adjacent to the first side of the first portion, the second portion being configurable in a first configuration in which the first portion is spatially separated from the second portion, and a second configuration in which the second portion is bonded to the first portion via the adhesive layer, the sealing element being permeable to sterilization gas in the first configuration and impermeable to sterilization gas in the second configuration. In some embodiments, the second portion is configured to transition from the first configuration to the second configuration when the applicator is exposed to a partial vacuum exceeding a threshold. In some embodiments, the housing is disposable.

[0015] In a second embodiment, a method is provided for manufacturing an applicator configured to apply a sensor assembly to the skin of a recipient. The method includes providing an insertion assembly configured to insert at least a portion of a sensor assembly into the skin of a recipient. The method includes providing a housing configured to house the insertion assembly. The housing has an opening configured for the sensor assembly to pass through. The method includes providing an actuation member configured, when actuated, to cause the insertion assembly to insert at least a portion of the sensor assembly into the skin of a recipient. The method includes providing a releasable sealing element configured to provide a sterile barrier and a vapor barrier between the internal environment of the housing and the external environment of the housing.

[0016] A third aspect provides a method for manufacturing an applicator configured to apply a sensor assembly to the skin of a recipient. The method includes providing an insertion assembly configured to insert at least a portion of a sensor assembly into the skin of a recipient. The method includes providing a housing configured to house the insertion assembly. The housing has an opening configured for the sensor assembly to pass through. The method includes providing an actuation member configured, when actuated, to cause the insertion assembly to insert at least a portion of the sensor assembly into the skin of a recipient. The method includes exposing at least the internal environment of the housing to a sterile gas. The method includes enabling the discharge of the sterile gas from the internal environment of the housing. The method includes sealing the internal environment of the housing from the external environment of the housing.

[0017] In some embodiments, sealing at least the internal environment of the housing from the external environment of the housing is performed simultaneously for multiple applicators. In some embodiments, sealing the internal environment of the housing from the external environment of the housing includes exposing the multiple applicators to a partial vacuum above a threshold so that each sealing element of the multiple applicators transitions from being permeable to sterilization gas to being impermeable to sterilization gas. In some embodiments, sealing the internal environment of the housing from the external environment of the housing includes exposing the multiple applicators to a physical force sufficient to transition each sealing element of the multiple applicators from a first physical configuration permeable to sterilization gas to a second physical configuration impermeable to sterilization gas. In some embodiments, sealing the internal environment of the housing from the external environment of the housing includes exposing each of the multiple applicators' sealing elements, which include multiple perforations, to a temperature sufficient to at least partially melt each of the sealing elements, thereby sealing the multiple perforations in each of the sealing elements. In some embodiments, sealing the internal environment of the housing from the external environment of the housing involves exposing each of the multiple applicators, each containing a porous polymer component, to a temperature sufficient to form a sintered layer within the porous polymer component of each sealing element. In some embodiments, sealing the internal environment of the housing from the external environment of the housing involves depositing a layer impermeable to sterilization gases on at least a portion of each of the multiple applicators. In some embodiments, the layer includes at least one of aluminum oxide, parylene, vapor metallization, silicon dioxide, or a material applied via ion beam sputtering.

[0018] In some embodiments, an applicator is provided for applying a cutaneous assembly to the skin of a recipient. The applicator may include an insertion assembly configured to insert at least a portion of the cutaneous assembly into the skin of the recipient. A housing may be configured to receive the insertion assembly. The housing may have openings configured for the cutaneous assembly to pass through. The applicator may include an actuation member configured, upon activation, to actuate the insertion assembly to insert at least a portion of the cutaneous assembly into the skin of the recipient. The applicator may include a removable cap configured to couple with a portion of the housing. The applicator may include a layer containing a gas-permeable material, and the sealing element is configured to allow the entry and exit of sterile gases.

[0019] In some embodiments, the removable cap includes an opening located at the bottom edge of the removable cap. In some embodiments, a layer is bonded to the bottom of the removable cap and surrounds the opening. The removable cap may include a raised platform extending from the bottom edge of the removable cap. In some embodiments, the raised platform is spaced a predetermined distance from the skin assembly. The raised platform may include a plurality of channels. The plurality of channels may be equidistant along the perimeter of the raised platform. The plurality of channels may be configured to allow the entry of sterilization gas into the housing and the discharge of the sterilization gas from the housing.

[0020] In some embodiments, the applicator includes a safety feature that prevents the actuation of the actuation member. The safety feature can be unlocked by pushing the housing distally. Pushing the housing distally causes the housing to actuate along the inner housing of the applicator. The actuation member can be aligned with a trigger arm, and the actuation member is configured to actuate and deflect the trigger arm laterally. In some embodiments, a removable cap is configured to couple with the proximal portion of the housing. In some embodiments, the removable cap is configured to couple with the distal portion of the housing.

[0021] This summary of the invention is provided to introduce a selection of concepts in a simplified form. The concepts are further described in the forms for carrying out the invention. Other elements or steps not described in this summary of the invention are conceivable, and no elements or steps are necessarily required. This summary of the invention is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to an implementation that resolves any or all of the disadvantages described in any part of this disclosure. [Brief explanation of the drawing]

[0022] These and other features, embodiments, and advantages are described below with reference to the drawings, and are intended to be illustrative rather than limiting to the present invention. In the drawings, similar reference letters consistently indicate the corresponding features throughout similar embodiments.

[0023] [Figure 1A] This is an exploded cross-sectional view of an applicator for applying a skin assembly, including a sealing element, to the skin of a recipient, according to several embodiments. [Figure 1B] Figure 1A is an enlarged cross-section of the applicator, further illustrating the insertion assembly and the on-skin assembly according to several embodiments. [Figure 1C] A perspective view of an applicator for applying a skin assembly to a recipient's skin, including a sealing element having a frangible member, according to some embodiments, is shown. [Figure 2A] A perspective view of an applicator for applying a skin assembly to a recipient's skin, including a peelable tamper indication, according to some embodiments, is shown. [Figure 2B] It is a partially exploded perspective view of the applicator of FIG. 2A. [Figure 3A] A perspective view of an applicator for applying a skin assembly to a recipient's skin, including another tamper indication, according to some embodiments, is shown. [Figure 3B] It is an enlarged cross-sectional view of the applicator of FIG. 3A, and according to some embodiments, the sealing element includes an O-ring. [Figure 3C] It is an enlarged cross-sectional view of the applicators of FIGS. 3A and 3B, according to some embodiments. [Figure 4A] A perspective view of another applicator for applying a skin assembly to a recipient's skin, including a tamper indication, according to some embodiments, is shown. [Figure 4B] It is a partially exploded view of the applicator of FIG. 4A. [Figure 5A] A perspective view of an applicator for applying a skin assembly to a recipient's skin, including a tactile indication for the recipient's grip, according to some embodiments, is shown. [Figure 5B] It is a partially exploded view of the applicator of FIG. 5A. [Figure 6A] A perspective view of an applicator for applying a skin assembly to a recipient's skin, including a sealing element configured to couple with a housing in a uniaxial orientation, according to some embodiments, is shown. [Figure 6B] It is another perspective view of the applicator of FIG. 6A, with the sealing element shown separated from the housing. [Figure 7A] A perspective view of an applicator for applying a skin assembly to a recipient's skin, including a frangible member configured to prevent the actuation of an actuating member, according to some embodiments, is shown. [Figure 7B] This is a partially exploded view of the applicator shown in Figure 7A. [Figure 8A] The following is a perspective view of another applicator for applying a skin assembly to the skin of a recipient, which includes a fragile member configured to prevent the operation of an operating member, according to several embodiments. [Figure 8B] This is a cross-sectional view of the applicator shown in Figure 8A in its configuration before deployment. [Figure 8C] This is a cross-sectional view of the applicator in the deployed configuration shown in Figure 8A. [Figure 9A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, including an operating member configured as a cap disposed on top of the applicator housing, according to several embodiments. [Figure 9B] This is a cross-sectional view of the applicator shown in Figure 9A in its configuration before deployment. [Figure 9C] This is a cross-sectional view of the applicator in Figure 9A in its deployed configuration. [Figure 10A] The diagram shows perspective views of applicators for applying a skin assembly to the skin of a recipient, including a removable cap configured as a sealing element, according to several embodiments. [Figure 10B] Figure 10A is a partially exploded view of the applicator. [Figure 11] Figure 11A shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, according to several embodiments, which includes a flexible member disposed on at least a portion of the applicator housing. Figure 11B is a detail view of a portion of the flexible member of Figure 11A disposed on the actuating member. [Figure 12A] The images show cross-sectional views of applicators for applying a skin-on assembly to the skin of a recipient, including a flexible member having a bistable configuration that provides a visual representation of the unfolding, according to several embodiments. [Figure 12B] Figure 12A is a detailed cross-sectional view of a portion of the bistable configuration of the flexible member. [Figure 13A]This is an exploded view of an applicator for applying a skin assembly to the skin of a recipient, which includes a fragile member configured to cover an operating member, according to several embodiments. [Figure 13B] Figure 13A is an assembly diagram of the applicator. [Figure 13C] Figures 13A and 13B are perspective views of the applicator, with the easily breakable components removed, thereby exposing the operating components. [Figure 14] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, which includes a fragile portion having a flexible tab molded around an operating member, according to several embodiments. [Figure 15A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, which includes a peelable layer configured to seal the distal opening of the housing and further seal the working member, according to several embodiments. [Figure 15B] Figure 15A shows the applicator with the peelable layer removed. [Figure 16A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, which includes a peelable layer configured to seal the distal opening of the housing, further seal the working member, and further seal a vent that is permeable to sterile gases, according to several embodiments. [Figure 16B] Figure 16A is a partially exploded view of the applicator. [Figure 17A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, comprising a peelable layer configured to seal a distal opening within the housing and a plug configured to seal an operating member, according to several embodiments. [Figure 17B] Figure 17A shows the applicator with the plug removed. [Figure 17C] Figure 17A shows the applicator with the peelable layer at least partially removed. [Figure 18A]The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, comprising a removable cap configured to seal an operating member and a peelable layer configured to seal a distal opening within the housing, according to several embodiments. [Figure 18B] Figure 18A is a partially exploded view of the applicator. [Figure 19A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, comprising a fragile cap configured to seal an operating member and a peelable layer configured to seal a distal opening within the housing, according to several embodiments. [Figure 19B] Figure 19A is a partially exploded view of the applicator. [Figure 20A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, comprising a first peelable layer configured to seal a distal opening within the housing and a second peelable layer configured to seal an operating member disposed in a proximal opening within the housing, according to several embodiments. [Figure 20B] Figure 20A shows the operating member of the applicator. [Figure 21A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, comprising a plug configured to seal an operating member and a peelable layer configured to seal a distal opening within the housing, according to several embodiments. [Figure 21B] This is a detailed view of the applicator shown in Figure 21A, after the peelable layer has been removed. [Figure 21C] Figure 21A is a detailed view of the applicator with the plug-in cap removed. [Figure 22A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, comprising a first peelable layer configured to seal a distal opening in the housing and a vent permeable to sterile gases, and a second peelable layer configured to seal an operating member disposed in the proximal opening in the housing, according to several embodiments. [Figure 22B] This is a partially exploded view of the applicator shown in Figure 22A. [Figure 23] The image shows perspective views of applicators for applying a skin assembly to the skin of a recipient, configured to fit within a foldable cup having a removable lid, according to several embodiments. [Figure 24A] The diagram shows perspective views of a cup having a removable lid and configured to surround an applicator for applying a skin assembly to the skin of a recipient, according to several embodiments. [Figure 24B] Figure 24A is a cross-sectional view of the cup and applicator. [Figure 25A] This is a cross-sectional view of an applicator for applying a skin assembly to the skin of a recipient, which includes an operating member that is permeable to a sterile gas, according to several embodiments. [Figure 25B] Figure 25A is a detailed view of the operating member. [Figure 26A] Cross-sectional view of a soluble water barrier having multiple perforations for an applicator for applying a skin assembly to the skin of a recipient, according to several embodiments. [Figure 26B] Figure 26A is a cross-sectional view of the soluble moisture barrier after heating so that the moisture barrier melts and seals multiple perforations. [Figure 27A] This is a cross-sectional view of a moisture barrier according to several embodiments, which includes an elastomer layer having a portion permeable to a sterilization gas, and a permeable layer configured to allow the permeable gas to pass through when the elastomer layer and the permeable layer are in a first orientation relative to each other. [Figure 27B] Figure 27A is a cross-sectional view of a moisture barrier, showing an elastomer layer and a porous layer in a second orientation relative to each other, according to several embodiments, so that the moisture barrier is impermeable to sterilization gas and moisture. [Figure 28A] A perspective view of a tray configured to hold multiple applicators for bulk sterilization and moisture barrier sealing, according to several embodiments, is shown. [Figure 28B]Figure 28A is a detailed view of the tray, showing each applicator in a first configuration that is permeable to sterilization gas and a second configuration that is impermeable to both sterilization gas and moisture. [Figure 29] This is an exploded perspective view of a sealing element, according to several embodiments, which includes a first layer permeable to sterilization gas and a second layer impermeable to sterilization gas and moisture. [Figure 30A] This is an enlarged cross-sectional view of a sealing element, comprising a vent hole containing a material permeable to sterilization gas, according to several embodiments. [Figure 30B] Figure 30A is an enlarged cross-sectional view of the sealing element, in which at least a layer of ventilated material is sintered, thereby making it impermeable to sterilization gases. [Figure 31] Schematic diagrams of continuous analyte sensor systems according to several embodiments are shown. [Figure 32] This flowchart shows a method for manufacturing an applicator for applying a skin assembly to the skin of a recipient, according to several embodiments. [Figure 33] This flowchart shows another method for manufacturing an applicator for applying a skin assembly to the skin of a recipient, according to several embodiments. [Figure 34A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, including a removable cap configured to seal the applicator, according to several embodiments. [Figure 34B] Figure 34A is a cross-sectional view of the applicator. [Figure 34C] Figure 34A is a perspective view of the bottom of the applicator, which has a bottom layer. [Figure 34D] Figure 34A is a perspective view of the bottom of the applicator without a bottom layer. [Figure 35A] The image shows a perspective view of an applicator for applying a skin assembly to the skin of a recipient, including a removable cap configured to seal the applicator, according to several embodiments. [Figure 35B] Figure 35A shows a partially exploded view of the applicator. [Figure 36A] Perspective views of applicators for applying a skin assembly, including a sliding safety lock feature, to the skin of a recipient, according to several embodiments, are shown. [Figure 36B] Figure 36A is a perspective view of the applicator showing the operating member in the second state. [Figure 37A] The following are perspective views of applicators for applying a skin assembly to the skin of a recipient, having a two-state operating member, according to several embodiments. [Figure 37B] Figure 37A is a perspective view of the applicator showing the operating member in the second state. [Figure 38A] Perspective views of applicators for applying a skin assembly, including a rotating safety lock feature, to the skin of a recipient, according to several embodiments, are shown. [Figure 38B] This is a perspective view of the applicator in Figure 38A, showing the operating member in the second state. [Figure 39] Perspective views of applicators for applying a skin assembly to the skin of a recipient, including a removable cap release feature, according to several embodiments, are shown. [Figure 40] Perspective views of applicators for applying a skin assembly, including a push-button safety lock feature, to the skin of a recipient, according to several embodiments, are shown. [Modes for carrying out the invention]

[0024] The following description and examples illustrate in detail some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there are many variations and modifications of the invention that are encompassed by the scope of the invention. Therefore, the description of certain exemplary embodiments should not be considered to limit the scope of the invention.

[0025] This application relates to embodiments of applicators for applying a skin assemblies to the skin of a recipient, as well as methods for manufacturing and using them. Certain feature parts of the described applicators, as will be described in more detail with reference to the following figures, provide novel and inventive solutions to difficulties associated with previous applicator designs and / or methods for using or manufacturing them.

[0026] System Introduction U.S. Patent Publication US2013 / 0267811A1 (the entirety of which is incorporated herein by reference) describes a method in which Figure 31 is a schematic diagram of a continuous analyte sensor system 3100 attached to a recipient (e.g., a person). The analyte sensor system 3100 communicates with other devices 3108-3114 (which may be positioned remotely from the recipient). The transdermal analyte sensor system 3100, comprising a skin sensor assembly 3106, is fixed to the skin of the recipient via a base (not shown) which may be a disposable housing.

[0027] System 3100 includes a transdermal analyte sensor 3102 and an electronic unit (compatiblely referred to as “sensor electronics” or “transmitter”) 3104 for wirelessly transmitting analyte information to a receiver. The receiver may be located remotely from System 3100. In some embodiments, the receiver includes a display screen that can display information to a person, such as a recipient. Examples of receivers include dedicated display devices, mobile electronics, smartphones, smartwatches, tablet computers, laptop computers, and desktop computers. In some embodiments, the receiver may be an Apple Watch®, iPhone®, and iPad® manufactured by Apple Inc. The receiver may be running a customized system or a stock operating system, such as Linux®, iOS from Apple Inc., or Android® from Google Inc.

[0028] In some embodiments, the receiver is mechanically coupled to the electronic unit 3104, enabling it to receive data (e.g., analyte data) from the electronic unit 3104. For user convenience, in some embodiments, the receiver does not need to be mechanically coupled to the electronic unit 3104 and can even receive data from the electronic unit 3104 over long distances (e.g., when the receiver is several feet or even miles away from the electronic unit 3104).

[0029] During use, the sensing portion of the sensor 3102 may be located beneath the skin of the recipient, and the contact portion of the sensor 3102 may be electrically connected to the electronic unit 3104. The electronic unit 3104 may engage with a housing (e.g., a base) or be directly bonded to an adhesive patch fixed to the skin of the recipient.

[0030] The skin sensor assembly 3106 may be attached to a recipient using an applicator adapted to provide a convenient and secure application. Such an applicator may be used to mount the electronic unit 3104 to a base, insert the sensor 3102 into the recipient's skin, and / or connect the sensor 3102 to the electronic unit 3104. Once the electronic unit 3104 engages with the base and the sensor 3102 is inserted into the skin (and connected to the electronic unit 3104), the sensor assembly can be detached from the applicator.

[0031] The continuous analyte sensor system 3100 may include a sensor configuration that provides an output signal indicating the concentration of the analyte. The output signal, which includes sensor data (for example, raw data stream, filtered data, smoothed data, and / or otherwise transformed sensor data), is transmitted to a receiver.

[0032] In some embodiments, the analyte sensor system 3100 includes a transdermal glucose sensor, such as that described in U.S. Patent Publication US2011 / 0027127A1, the entire contents of which are incorporated herein by reference. In some embodiments, the sensor system 3100 includes a continuous glucose sensor and a transdermal sensor (for example, those described in U.S. Patent Nos. 6,565,509, 6,579,690, and 6,484,046). The contents of U.S. Patents 6,565,509, 6,579,690, and 6,484,046 are incorporated herein by reference in their entirety.

[0033] In some embodiments, the sensor system 3100 includes a continuous glucose sensor and a refillable subcutaneous sensor (for example, as described in U.S. Patent No. 6,512,939). In some embodiments, the sensor system 3100 includes a continuous glucose sensor and an intravascular sensor (for example, as described in U.S. Patent No. 6,477,395 and U.S. Patent No. 6,424,847). The contents of U.S. Patents No. 6,512,939, 6,477,395 and 6,424,847 are incorporated herein by reference in their entirety.

[0034] Various signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publications US2005 / 0203360A1 and U.S. Patent Publications US2009 / 0192745A1, the contents of which are incorporated herein by reference in their entirety. The sensor may extend through a housing that can maintain the sensor on the skin and can provide an electrical connection of the sensor to electronic equipment that can be provided to the electronic equipment unit 3104.

[0035] One or more relays, receivers, such as a key fob relay 3108 and a medical device receiver 3110 (e.g., an insulin delivery device and / or a dedicated glucose sensor receiver), as well as / or display devices, smartphones 3112, portable computers 3114, etc., may be communicatively coupled to the electronics unit 3104 (e.g., to receive data from the electronics unit 3104). The electronics unit 3104 may also be called a transmitter. In some embodiments, devices 3108-3114 transmit data to the electronics unit 3104. Sensor data can be transmitted from the sensor electronics unit 3104 to one or more of the key fob relay 3108, medical device receiver 3110, smartphones 3112, portable computers 3114, etc. In some embodiments, analyte values ​​are displayed on a display device.

[0036] Electronic unit 3104 can communicate with devices 3108-3114 and / or any number of additional devices via any suitable communication protocol. Examples of communication protocols include radio frequency, Bluetooth®, Universal Serial Bus, wireless local area network (WLAN) communication standards IEEE 802.11, 802.15, 802.20, 802.22, and other 802 communication protocols, ZigBee®, wireless (e.g., cellular) telecommunications, paging network communications, magnetic induction, satellite data communications, and / or proprietary communication protocols.

[0037] Additional sensor information is described in U.S. Patents No. 7,497,827 and 8,828,201. The entire contents of U.S. Patents No. 7,497,827 and 8,828,201 are incorporated herein by reference.

[0038] Any sensors shown or described herein may be analyte sensors, glucose sensors, and / or other suitable sensors. Sensors described in the context of any embodiment may be any sensors described or incorporated by reference herein, such as analyte sensors, glucose sensors, any sensors described herein, and any sensors incorporated by reference. Sensors shown or described herein may be configured to sense, measure, detect, and / or interact with any analyte.

[0039] As used herein, the term “analyte” is a broad term and should be given its usual and customary meaning to those skilled in the art (not limited to any special or customized meaning), referring to, but not limited to, substances or chemical components in a bodily fluid that can be analyzed (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, urine, sweat, saliva, etc.). Analytes may include naturally occurring substances, artificial substances, metabolites, or reaction products.

[0040] In some embodiments, the analyte for measurement by the detection area, device, system, and method is glucose. However, other analytes are also intended, including ketone bodies, acetyl-CoA, acarboxyprothrombin, acylcarnitine, adenine phosphoribosyltransferase, adenosine deaminase, albumin, α-fetoprotein, amino acid profiles (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan), andrenostenedione, antipyrine, arabinitol enantiomer, arginase, benzoylecgonine (cocaine), Biotinidase, biopterin, c-reactive protein, carnitine, carnosinase, CD4, ceruloplasmin, chenodeoxycholic acid, chloroquine, cholesterol, cholinesterase, conjugated 1-β-hydroxycholic acid, cortisol, creatine kinase, creatine kinase MM isozyme, cyclosporine A, d-penicillamine, de-ethylchloroquine, dehydroepiandrosterone sulfate, DNA (acetylated polymorphism), alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne type Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sex differentiation, 21-deoxycortisol), desbutylhalofantrin, dihydropteridine reductase, diphtheria / tetanus antitoxin, erythrocyte arginase, erythrocyte pro Toporphyrin, esterase D, fatty acid / acylglycine, free β-human chorionic gonadotropin, free erythrocyte porphyrin, free thyroxine (FT4), free triiodothyronine (FT3), fumarylacetase, galactose / gal-1-phosphate, galactose-1-phosphate uridyltransferase, gentamicin, glucose-6-phosphate dehydrogenase, glutathione, glutathione peroxidase, glycocholic acid, glycosylated hemoglobin, halofantrin, hemoglobin variant,Hexosaminidase A, human erythrocyte carbonic anhydrase I, 17-α-hydroxyprogesterone, hypoxanthine phosphoribosyltransferase, immunoreactive trypsin, lactate, lead, lipoprotein ((a), B / A-1, β), lysozyme, mefloquine, netylmycin, phenobarbiton, phenytoin, phytanic acid / pristanic acid, progesterone, prolactin, prolidase, purine nucleoside phosphorylase, kinin, inverted triiodothyronine (rT3), selenium, serum pancreatic lipase, shisomecin, somatomedin C, specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, guinea pig, tapeworm, amoeba histolytica, enterovirus, Giardia lamblia) Helicobacter pylori, Hepatitis B virus, Herpesvirus, HIV-1, IgE (atopic disease), Influenza virus, Donovan's leishmania, Leptospira, Measles / Mumps / Rubella, Mycoplasma leprae, Mycoplasma pneumoniae, Myoglobin, Irocystitis rotundifolia, Parainfluenza virus, Plasmodium falciparum, Poliovirus, Pseudomonas aeruginosa, Respiratory rash virus, Rickettsia (scrub typhus), Schistosomiasis mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma cruz / Langer's, Vesicular stomatis virus Examples of substances that may be present include, but are not limited to, viruses (such as Bancroftian filarial parasites, yellow fever virus), specific antigens (hepatitis B virus, HIV-1), succinylacetone, sulfadoxine, theophylline, thyrotropin (TSH), thyroxine (T4), thyroxine-binding globulin, trace elements, transferrin, UDP-galactose-4-epimerase, urea, uroporphyrinogen I synthase, vitamin A, leukocytes, and zinc protoporphyrin.

[0041] Salts, sugars, proteins, fats, vitamins, and hormones that occur naturally in blood or interstitial fluid can also constitute analytes in certain embodiments. Analytes, such as metabolites, hormones, antigens, antibodies, etc., may be naturally present in body fluids or endogenous. Alternatively, analytes, such as contrast agents for imaging, radioisotopes, chemical agents, carbon fluoride-based artificial blood, or drugs or pharmaceutical compositions, may be introduced into the body or be exogenous, including insulin, glucagon, ethanol, cannabis (marijuana, tetrahydrocannabinol, hashish), inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons), cocaine (crack cocaine), stimulants (amphetamine, methamphetamine, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine), and inhibitors (barbiturates, methacarone, Examples of analytes include, but are not limited to, tranquilizers (e.g., Valium, Librium, Miltown, Serax, Equanil, Tranxene), hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin), narcotics (heroin, codeine, morphine, opium, meperidin, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil), designer drugs (fentanyl, meperidin, amphetamine, methamphetamine, and analogs of phencyclidine, e.g., Ecstasy), anabolic steroids, and nicotine. Metabolites of drugs and pharmaceutical compositions may also be considered as analytes. For example, analytes such as neurochemicals and other chemicals produced in the body, including ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), 5-hydroxyindoleacetic acid (FHIAA), and intermediates of the citrate cycle, can be analyzed.

[0042] Many embodiments described herein utilize adhesives. One purpose of the adhesive may be to bond a base, a sensor module, and / or the sensor to a recipient (e.g., the recipient's skin). The adhesive may be configured to adhere to the skin. The adhesive may include a pad (e.g., located between the adhesive and the base). Additional adhesion information, including adhesive pad information, is described in U.S. Patent Application No. 14 / 835,603, filed on 25 August 2015. The entire contents of U.S. Patent Application No. 14 / 835,603 are incorporated herein by reference.

[0043] Sterilization and sealing of the applicator When foreign objects come into contact with the human body, there is a possibility of infection and can cause serious health damage. Therefore, sterilization of the applicator (and / or the part of the applicator that comes into contact with or is inserted into the body of the recipient) is not only desirable but required in many situations. In embodiments, a variety of sterilization methods can be used, including but not limited to heat sterilization, gamma ray sterilization, electron beam sterilization, and gas (e.g., ethylene oxide) sterilization. In embodiments adapted to gas sterilization, the applicator may be configured with one or more openings configured to allow the entry and exit of gas during one or more sterilization steps, at least one or more during the manufacturing process. In addition, in some embodiments, it may be desirable to seal the applicator from the entry of moisture (e.g., water vapor). Moisture, especially water vapor, can corrode (e.g., rust, discolor) metal parts within the applicator, such as needles, springs, or any other metal structures. Such corrosion in contact with the recipient, especially if the needle enters the recipient's skin, can cause serious health damage. Moisture can also promote the growth of infectious pathogens and provide a medium for their proliferation, which can cause serious health damage. This application provides various embodiments of an applicator that are gas-sterilizable and / or moisture (e.g., steam) sealed, for example by using one or more removable caps on the top end (e.g., proximal) or bottom end (e.g., distal), by one or more trigger mechanisms including an integrated cap, by one or more sealing layers covering one or more orifices, openings, or vents of the applicator, by a sterilizable gas-permeable polymer, by a sterilizable gas-permeable trigger mechanism, by a protective cup, or any combination thereof.

[0044] Applicator safety features Consumers may prefer to use applicators that provide specific safety features. For example, tamper-evident seals or other tamper-evidence features may be desirable because they allow consumers to identify when the applicator has been used previously or when the containment has been broken, thus avoiding the use of potentially defective or health-risk applicators. Examples of tamper-evidence features are described in more detail in relation to at least some of Figures 1A-40 below.

[0045] Furthermore, especially with disposable applicators, premature or unexpected deployment of the applicator can be frustrating or even dangerous. Therefore, consumers may find it desirable for applicators to include premature deployment prevention features to substantially reduce or prevent premature deployment. Examples of premature deployment prevention features are described in more detail in relation to at least some of Figures 1A-40 below.

[0046] In line with premature deployment prevention features, it may be desirable to provide features that minimize the risk of unintended activation when the applicator is dropped. For example, if the applicator is dropped onto an exposed trigger mechanism, the exposed trigger mechanism may be accidentally activated. However, in some cases, even if the trigger mechanism is not exposed, the impact of dropping the applicator itself may cause accidental activation of the applicator. Examples of drop prevention features and other premature deployment prevention features will be described in more detail in relation to at least some of Figures 1A to 140 below.

[0047] Mass production and / or sterilization The manufacturing cost of applicators is a concern not only for manufacturers but also for consumers. Generally, the lower the production cost of an applicator, the lower the cost for consumers. Therefore, it is desirable to provide mass production, sterilization, and / or sealing of applicators. Examples of applicator configuration and methods for bulk sterilization and / or sealing of applicators include, but are not limited to, melting, chemically altering, or physically altering vents, plugs, feature parts, or layers to change from a state that is permeable to sterilization gases and / or moisture (e.g., water vapor) to a state that is impermeable to sterilization gases and / or moisture, as will be described in more detail in relation to at least some of Figures 1A to 40 below.

[0048] Simple and reconfigurable deployment Consumers may also find it desirable to be able to easily position (and reposition as needed) an applicator on their body at a specific location using only one hand as needed, without necessarily needing a full view of the applicator when holding it in the desired position. Such easy one-handed deployment can be achieved by providing actuaries of various orientations and shapes, as well as by using one or more raised or recessed portions configured as tactile grips and / or orientation indicators, as will be described in detail in relation to at least some of Figures 1A-40 below. Consumers may also find it desirable to be able to reposition the applicator before activation, even after it has been initially placed on the body, without involving the integrity of the applicator and / or any adhesive provided thereon.

[0049] Embodiment including a removable cap Some embodiments may include a removable cap configured to function as a sterile seal and / or moisture barrier. For example, Figure 1A is an exploded section of an applicator 100 for applying a cutaneous assembly 102 to the skin of a recipient, including a sealing element 110, according to some embodiments. The applicator 100 comprises a housing 104 configured to house an insertion assembly 118 (see Figure 1B). The housing 104 comprises an opening 106 configured for the passage of the cutaneous assembly 102 (see Figure 1B) during deployment. The side of the housing 104 may further comprise an opening 120 configured to receive an actuator (not shown in Figures 1A-1C). Such an actuator, when actuated, may cause the insertion assembly 118 to insert at least a portion of the cutaneous assembly 102 into the skin of the recipient. The actuator is disposed on the side of the housing 104 in the area of ​​the opening 120. By providing the operating member on the side surface of the housing 104, the applicator 100 can provide the recipient with easy one-handed deployment of the skin assembly 102.

[0050] The housing 104 further comprises an optional flexible wall 128 configured to absorb at least a portion of the energy that would be transmitted to the applicator 100 if it were to fall. By absorbing the energy that would otherwise transmit a physical impact to the applicator 100, the flexible wall 128 may provide premature deployment prevention and fall protection features.

[0051] The applicator 100 further comprises a sealing element 110 configured to provide a sterile barrier and / or vapor barrier between the internal environment of the housing 104 and the external environment of the housing 104. As shown in Figure 1A, the sealing element 110 comprises a removable cap 112 configured to bond with a portion of the housing 104. Specifically, as an example, the removable cap 112 is configured to bond with the distal portion of the housing 104 via threads 114. For example, the threads 114 on the removable cap 112 may be configured to engage with threads 108 on the housing 104. The removable cap 112 can be separated from the housing 104 by twisting the removable cap 112 against the housing 104, or vice versa, until the threads 114 and 108 no longer engage with each other, and then pulling the housing 104 and the removable cap 112 apart. The sealing element 110 may further include a retaining element 138 between the removable cap 112 and the housing 104 before the removable cap 112 is removed. As shown, the removable cap 112 is covered by an actuation member disposed on the side of the housing 104. The sealing element 110 may further include a first layer 122 that is permeable to sterilization gases (e.g., ethylene oxide, or ETO). The first layer 122 may contain Tyvek® material, but any other material permeable to sterilization gases may be used. The application of the first layer 122 to the removable cap 112 may allow for the entry and exit of sterilization gases during manufacturing. The sealing element 110 may further include a second layer 124 that is substantially impermeable to moisture (e.g., water vapor). The second layer 124 may include metal foil, but any suitable material that is impermeable to moisture (e.g., water vapor), such as metal foil (e.g., aluminum or titanium), a metal substrate, an aluminum oxide coated polymer, parylene, a polymer coated with metal applied by vapor metallization, a polymer coated with silicon dioxide, or 10 g / 100 in 2 Less than or preferably 1 gram / 100 in 2Any material having a water vapor permeability of less than 1 / 2 may be used. The first layer 122 and the second layer 124 can seal the bottom opening 126 of the removable cap 112. Applying the second layer 124 on top of the first layer 122 after sterilization can further maintain sterility through the first layer and add a moisture barrier through the second layer. Together, the above features of the sealing element 110 can provide co-sterilization and moisture sealing of the applicator 100.

[0052] The applicator 100 further includes a support member 116 configured to prevent at least lateral movement of the insertion assembly 118. In some embodiments, the support member 116 may comprise an elastomer membrane, film, bulk elastomer, foam, or rigid structure. Furthermore, the support member 116 can hold the insertion assembly 118 in place during harmful movements such as drops or vibrations.

[0053] Figure 1B is an enlarged section of the applicator 100 of Figure 1A, further showing at least an insertion assembly 118 and a surface assembly 102 according to several embodiments. As shown in more detail in Figure 1B, the insertion assembly 118 may comprise a needle 140, for example, a C-needle configured to hold at least a portion of the sensor. In some embodiments, the insertion assembly 118 may be configured to drive the needle 140 using spring force. In some embodiments, the insertion assembly 118 may additionally or alternatively be configured to retract the needle 140 after the surface assembly 102 has been deployed onto the recipient's skin.

[0054] In some embodiments, the insert assembly 118 may include substantially similar components and / or mechanisms to the insert assembly 118 in Figures 8A–8C. In other embodiments, the insert assembly 118 may include substantially similar components from the insert assembly described in U.S. Patent Application No. 15 / 387088, which is incorporated herein in its entirety by reference. In non-limiting examples, the insert assembly 118 may include the nesting assembly 132 in Figures 7–11, the nesting assembly 132b in Figures 56–58, the nesting assemblies 132c and 132d in Figures 28–30, the nesting assembly 132e in Figure 31, the nesting assembly 132f in Figure 59, the nesting assembly 132g in Figures 44–45, the nesting assembly 132h in Figure 60, the nesting assembly 132i in Figures 48–50, the nesting assembly 132k in Figures 61–64, and Figures 71–7 This may include substantially similar components and / or mechanisms from the nesting assembly 132m of Figures 4, the nesting assembly 132n of Figures 76-79, the nesting assembly 132p of Figures 80-85, the nesting assembly 132q of Figures 86-88, the nesting assembly 132r of Figures 89-91, the nesting assembly 132s of Figures 92-100, or the nesting assembly 132w of Figures 110-119, each described in U.S. Patent Application No. 15 / 387088.

[0055] The applicator 100 further comprises a transcutaneous analyte sensor assembly (referred to as the “skin assembly”) 102 and an electronic unit (referred to as the “transmitter”) 134 for wirelessly transmitting analyte information to a receiver (not shown). Before deployment, the sensor 132 of the skin assembly 102 may be at least partially positioned on or inside the needle 140. During use, the sensor 132 is positioned beneath the skin of the recipient, and the contact portion of the skin assembly 102 is electrically connected to the transmitter 134. The skin assembly 102 is attached to an adhesive layer 136 for fixation to the skin of the recipient.

[0056] The cutaneous assembly 102 can be attached to a recipient by using an applicator 100 adapted to provide convenient and safe application. The applicator 100 may also be used to insert at least a portion of the cutaneous assembly 102 through the recipient's skin. Once a portion of the cutaneous assembly 102 is inserted, the applicator 100 is removed from the cutaneous assembly 102.

[0057] Generally, the skin assembly 102 includes an optional sensor configuration that provides an output signal indicating the concentration of an analyte, such as blood glucose. The output signal, which includes sensor data such as, for example, a raw data stream, filtered data, smoothed data, and / or otherwise transformed sensor data, is transmitted to a receiver, which may be, for example, a smartphone, a smartwatch, or a dedicated device. In some embodiments, the sensor 132 comprises a transdermal glucose sensor, such as the one described in U.S. Patent Publication US2011 / 0027127A1, the contents of which are incorporated herein by reference in their entirety. In some embodiments, the sensor 132 is a continuous glucose sensor, and comprises a transdermal sensor, such as the one described by reference to U.S. Patent No. 6,565,509 by Say et al. In another embodiment, the sensor 132 is a continuous glucose sensor, and comprises a subcutaneous sensor, such as the one described by reference to U.S. Patent No. 6,579,690 by Bonnecaze et al. or U.S. Patent No. 6,484,046 by Say et al. In some other embodiments, sensor 132 is a continuous glucose sensor and comprises a subcutaneous sensor, for example, as described with reference to U.S. Patent No. 6,512,939 by Colvin et al. In yet another embodiment, sensor 132 is a continuous glucose sensor and comprises an intravascular sensor, for example, as described with reference to U.S. Patent No. 6,477,395 by Schulman et al. In yet another embodiment, sensor 132 is a continuous glucose sensor and comprises an intravascular sensor, for example, as described with reference to U.S. Patent No. 6,424,847 by Mastrototaro et al. Other signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publication No. US2005 / 0203360A1 and U.S. Patent Publication No. US2009 / 0192745A1, the contents of which are incorporated herein by reference in their entirety.

[0058] In further embodiments, the applicator 100 may be configured for use in applying a drug delivery device, such as an infusion device, to the patient's skin. In such embodiments, the applicator 100 may include a catheter instead of, or in addition to, the sensor, which is connected to an infusion pump configured to deliver a liquid drug or other fluid into the patient's body. In embodiments, the catheter may be deployed in the skin in substantially the same manner as the sensor is deployed, as described herein, for example.

[0059] In some embodiments, the sensor 132 is formed from a wire or is in the form of a wire. For example, the sensor 132 may include an elongated conductive body, such as a bare elongated conductive core (e.g., a metal wire) or an elongated conductive core covered with one, two, three, four, five or more layers of material (each of which may or may not be conductive). The elongated sensor may be long and thin, but still flexible and strong. For example, in some embodiments, the minimum dimensions of the elongated conductive body are less than about 0.1 inches, less than about 0.075 inches, less than about 0.05 inches, less than about 0.025 inches, less than about 0.01 inches, less than about 0.004 inches, or less than about 0.002 inches. The sensor 132 may have a circular cross-section. In some embodiments, the cross-section of the elongated conductive body may be oval, rectangular, triangular, polyhedron, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, etc. In some embodiments, a conductive wire electrode is used as a core. One or two additional conductive layers may be added to such a clad electrode (for example, using an intervening insulating layer provided for electrical isolation). The conductive layers may consist of any suitable material. In certain embodiments, it may be desirable to use a conductive layer containing conductive particles (i.e., particles of conductive material) in a polymer or other binder.

[0060] In certain embodiments, the material used to form the elongated conductive body (e.g., stainless steel, titanium, tantalum, platinum, platinum-iridium, iridium, certain polymers, and / or similar) can be strong and rigid, and therefore resistant to breakage. For example, in some embodiments, the maximum tensile strength of the elongated conductive body is about 80 kPsi to about 500 kPsi. In another example, in some embodiments, the Young's modulus of the elongated conductive body is about 160 GPa to about 220 GPa. In yet another example, in some embodiments, the yield strength of the elongated conductive body is about 60 kPi to about 2200 kPsi. In some embodiments, the small diameter of the sensor 132 provides (e.g., imparts, enables) flexibility to these materials and therefore to the sensor as a whole. Thus, the sensor 132 can withstand repeated forces applied by the surrounding tissue.

[0061] In addition to providing structural support, resilience, and flexibility, in some embodiments the core (or its components) provides electrical conductivity for electrical signals from the working electrode to sensor electronic equipment (not shown). In some embodiments, the core comprises a conductive material such as stainless steel, titanium, tantalum, conductive polymers, and / or similar. However, in other embodiments, the core is formed from a non-conductive material such as a non-conductive polymer. In yet another embodiment, the core comprises multiple layers of material. For example, in some embodiments, the core comprises an inner core and an outer core. In a further embodiment, the inner core is formed from a first conductive material, and the outer core is formed from a second conductive material. For example, in some embodiments, the first conductive material is stainless steel, titanium, tantalum, conductive polymers, alloys, and / or similar, and the second conductive material is a conductive material selected to provide electrical conductivity between the core and the first layer and / or to attach the first layer to the core (for example, if the first layer is formed from a material that does not adhere well to the core material). In another embodiment, the core is formed from a non-conductive material (e.g., a non-conductive metal and / or a non-conductive polymer), and the first layer is a conductive material such as stainless steel, titanium, tantalum, a conductive polymer, and / or the like. The core and the first layer may be a single (or the same) material, such as platinum. Those skilled in the art will understand that additional configurations are possible.

[0062] In some embodiments, the transmitter 134 is integrated into the skin assembly 102, while in other embodiments, the transmitter 134 can be removably coupled to the sensor. The transmitter 134 includes electronic circuitry related to measuring and processing continuous analyte sensor data and is configured to implement algorithms related to processing and calibrating the sensor data. For example, the transmitter 134 can provide various aspects of the function of the sensor electronics module, as described in U.S. Patent Publication 2009 / 0240120A1 and U.S. Patent Publication 2012 / 0078071A1, the contents of which are incorporated herein by reference in their entirety. The transmitter 134 may include hardware, firmware, and / or software that enables the measurement of analyte levels via a glucose sensor such as the analyte skin assembly 102. For example, the transmitter 134 may include a potentiostat, a power supply for supplying power to the skin assembly 102, other components useful for signal processing and data storage, and preferably a telemetry module for one-way or two-way data communication between the transmitter 134 and one or more receivers, repeaters, and / or display devices. The electronic equipment may be fixed to a printed circuit board (PCB) or the like and can take various forms. For example, the electronic equipment may take the form of an integrated circuit (IC), such as an application-specific integrated circuit (ASIC), a microcontroller, and / or a processor. The transmitter 134 may also include sensor electronic equipment configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values ​​over time to corresponding measured analyte values, and analyzing fluctuations in estimated analyte values.Examples of systems and methods for processing sensor analyte data are described herein and in U.S. Patent Nos. 7,310,544, 6,931,327, U.S. Patent Publication No. 2005 / 0043598A1, U.S. Patent Publication No. 2007 / 0032706A1, U.S. Patent Publication No. 2007 / 0016381A1, U.S. Patent Publication No. 2008 / 0033254A1, and U.S. Patent Publication No. 2005 / 02 This is described in more detail in U.S. Patent Publication No. 03360A1, U.S. Patent Publication No. 2005 / 0154271A1, U.S. Patent Publication No. 2005 / 0192557A1, U.S. Patent Publication No. 2006 / 0222566A1, U.S. Patent Publication No. 2007 / 0203966A1, and U.S. Patent Publication No. 2007 / 0208245A1, the contents of which are incorporated herein by reference in their entirety.

[0063] One or more repeaters, receivers, and / or display devices, such as medical device receivers (e.g., insulin delivery devices and / or dedicated glucose sensor receivers), smartphones, portable computers, etc., are operably connected to the transmitter 134 and can receive data from the transmitter 134 and, in some embodiments, transmit data to the transmitter 134.

[0064] In some embodiments, the analyte value is displayed on a display device. In some embodiments, prompts or messages may be displayed on the display device to inform the user of information such as reference outliers, requests for reference analyte values, treatment recommendations, and deviations of measured analyte values ​​from estimated analyte values. In addition, prompts may be displayed to guide the user through calibration or calibration troubleshooting.

[0065] Although not necessarily shown in other figures, any applicator described herein may include the insertion assembly 118 and the skin assembly 102 described in relation to Figures 1A and 1B.

[0066] The applicator 100 may further include a tamper indicator 130, specifically a tamper evident ring configured to detach from the removable cap 112 when the removable cap 112 is screwed against the housing 104. In this way, the tamper indicator 130 can provide a safety feature to the user using the applicator 100 so that a tamper becomes visually apparent to the user if the tamper evident ring is damaged.

[0067] Figure 1C shows another applicator 150 for applying the cutaneous assembly 102 to the skin of a recipient, which includes a sealing element 160 having an easily breakable member 164, according to several other embodiments. Applicator 150 may have all the features described above in relation to applicator 100 in Figures 1A and 1B, except that the sealing element 160 includes a removable cap 162 configured to bond to the distal portion of the housing 104 via the easily breakable member 164, instead of utilizing the threads 114 and 108. In some embodiments, the easily breakable member 164 includes a loop and a circumferentially easily breakable portion configured to be removed by pulling the loop. In this way, the sealing element 160 including the removable cap 162 and the easily breakable member 164 can maintain sterility and, at the same time, provide moisture sealing to the element in the housing 104. The easily breakable member 164 can prevent the sealing cap 162 from being removed without also removing the easily breakable member 164. The easily breakable member 164 further provides a tamper indicator and safety features to the user using the applicator 150, so that if the easily breakable member 164 is damaged, the tamper becomes visually apparent to the user.

[0068] Figure 2A shows a perspective view of an applicator 200 for applying a skin assembly 102 to the skin of a recipient, including a peelable tamper indicator 230, according to several embodiments. The applicator 200 may have all the features described above in relation to the applicator 100 in Figures 1A and 1B, except for features specifically indicated below as not being present. For example, although not shown, the applicator 200 may further include at least an insertion assembly 118 and a skin assembly 102, as described in relation to Figures 1A to 1C.

[0069] The applicator 200 comprises a housing 204, a sealing element 210 including a removable cap 212, and a peelable tamper indicator 230. The housing 204 does not necessarily include the flexible wall 128 or threads 108 as described above in relation to Figures 1A and 1B. Similarly, the removable cap 212 does not necessarily include the threads 114. However, the removable cap 212 may include at least one projection 220 or flat (e.g., substantially planar) section configured to prevent rotation of the applicator 200 and provide an orientation indicator to the user. The removable cap 212 can be separated from the housing 204 by peeling off the peelable tamper indicator 230 and pulling the removable cap 212 away from the housing 204. Thus, if the peelable tamper indicator 230 is disturbed, the tamper will be visually apparent to the user.

[0070] Figure 2B is a partially exploded view of the applicator 200 of Figure 2A. As clearly shown in Figure 2B, the applicator 200 may further include an actuator 250 (e.g., a push button) configured to insert at least a portion of the skin assembly 102 (see Figure 1B) into the recipient's skin through an opening 106 into the insertion assembly 118 (see Figure 1B) when activated. Similar to Figures 1A-1C, a removable cap 212 covers the actuator 250 thanks to the actuator 250 being disposed on the side of the housing 204, and the removable cap 212 covers the distal portion of the housing 204 that encloses the actuator 250. Enclosing the actuator 250 in this manner can prevent accidental activation. The sealing element 210 may further include a first layer 122 and a second layer 124, as previously described in relation to Figure 1B. The first layer 222 and the second layer 224 may be disposed on one or more openings 226 at the bottom of the removable cap 212. In some embodiments, the one or more openings 226 facilitate sterilization and / or ventilation of the applicator 200. The above-described features of the sealing element 210 may provide co-sterilization and moisture sealing of the applicator 200.

[0071] Figure 3A shows a perspective view of an applicator 300 for applying a cutaneous assembly 102, including a perforated tamper indicator 330, to the skin of a recipient, according to several embodiments. The applicator 300 may have all the features described above in relation to the applicator 100 in Figures 1A and 1B, except for features specifically indicated below as not being present. For example, although not shown, the applicator 300 may further include at least an insertion assembly 118 and a cutaneous assembly 102, as described in relation to Figures 1A to 1C.

[0072] The applicator 300 comprises a housing 304, a sealing element 310 having at least a removable cap 312, and a tamper indicator tab 330 with adhesive attached. The tamper indicator tab 330 may be paper, polymer, or other suitable film material backed with adhesive. The tamper indicator tab 330 may further include perforated, cut, or deformed sections to guide the removal of the tamper indicator tab 330. The housing 304 is further shown to include an optional flexible wall 128, but may not include the threads 108 as previously described in relation to Figures 1A and 1B. Similarly, the removable cap 312 may not include the threads 114. The removable cap 312 can be separated from the housing 304 by twisting the removable cap 312 away from the housing 304. Any tampering by the applicator 300 may result in the destruction of the tamper indicator tab 330, providing the user with visual evidence of tampering.

[0073] Figure 3B is an enlarged section view of the applicator 300 of Figure 3A, according to several embodiments. As shown, the removable cap 312 and / or housing 304 may include a retaining element 138, as previously described in relation to Figures 1A and 1B. The sealing element 310 may further include an O-ring 340 configured to provide a seal between the removable cap 312 and the housing 304. In some embodiments, the O-ring 340 may be integrally molded with either the cap 312 or the housing 304.

[0074] Figure 3C is another enlarged section of the applicator 300 of Figures 3A and 3B, according to several embodiments. As shown, the side of the housing 304 may further include an opening 120 configured to receive an actuator (not shown in Figures 3A-3C), as previously described in relation to Figures 1A and 1B. By providing the actuator on the side of the housing 304, the applicator 300 can provide the recipient with easy one-handed deployment of the skin assembly 102 (not shown in Figure 3C).

[0075] Figure 3C further shows the opening 126 at the bottom of the removable cap 312, as previously described in relation to Figures 1A and 1B. Although not shown, the sealing element 310 may further comprise a first layer 122 and a second layer 124 covering the opening 126, as previously described in relation to Figures 1A and 1B. Together, the above features of the sealing element 310 can provide co-sterilization and moisture sealing of the applicator 100.

[0076] Figure 4A shows another applicator 400 for applying a skin assembly 102, including a tamper indicator tab 330, to the skin of a recipient, according to several embodiments. Figure 4B is a partially exploded view of the applicator 400 of Figure 4A. The applicator 400 has substantially similar features to the applicator 200 of Figures 2A and 2B, except that the peelable tamper indicator 230 is replaced with the tamper indicator tab 330 of Figures 3A-3C. As shown in Figure 4B, the applicator 400 may have one or more openings 226 at the bottom of a removable cap 212, as described above at least in relation to Figure 2B. The first layer 122 and the second layer 124 may cover one or more openings 226.

[0077] Figure 5A shows another applicator 500 for applying the skin assembly 102 to the skin of a recipient, including a tactile indication of grip for the recipient, according to several embodiments. Figure 5B is a partially exploded view of the applicator 500 of Figure 5A. The applicator 500 has substantially all the features of the applicator 200 of Figures 2A and 2B, but further includes a tamper-evident twist-off collar 530 replacing the peelable tamper indicator 230, and at least one set of one or more ridges or recesses 542, 544 configured to provide a tactile indication of grip for the recipient. For example, Figures 5A and 5B show a housing 504 which may be substantially the same as the housing 204 of Figures 2A and 2B, but further includes a first set of one or more ridges or recesses 542 configured to provide a tactile indication of grip for the recipient. Figures 5A and 5B further show a removable cap 512 which may be substantially the same as the removable cap 212, but further includes a second set of one or more ridges or recesses 544 configured to provide the receiver with a tactile indication of gripping. As shown in Figure 5BB, the applicator 500 may have one or more openings 226 at the bottom of the removable cap 212, at least as described above in relation to Figure 2B. The first layer 122 and the second layer 124 may cover one or more openings 226.

[0078] Furthermore, the tamper-evident twist-off collar 530 is positioned in a mating position between the housing 504 and the removable cap 512. In some embodiments, a first portion 530a of the tamper-evident twist-off collar 530 may be coupled to the removable cap 512, and a second portion 530b of the tamper-evident twist-off collar 530 may be coupled to the housing 504. The removable cap 512 can be separated from the housing 504 by twisting the removable cap 512 against the housing 504 or vice versa until the first portion 530a shakes off the second portion 530b, and then pulling the removable cap 512 away from the housing 504. In its integrated state, the tamper-evident twist-off collar 530 may provide a seal (e.g., a sterile barrier and a moisture or water vapor barrier) between the housing 504 and the removable cap 512. In its separated state, the tamper-evident twist-off color 530 can provide the user with a tamper indicator.

[0079] Figure 6A shows another applicator 600 for applying the skin assembly 102 to the skin of a recipient, which includes a removable cap 612 configured to bond with the housing 604 in a single-axis orientation, according to several embodiments. Figure 6B is a partially exploded view of the applicator 600 of Figure 6A. The applicator 600 has substantially all the features of the applicator 200 of Figures 2A and 2B, but does not include the removable cap 612 and the peelable tamper indicator 230 including the housing 604, and further includes at least one set of at least one ridge or recess 642, 644, both bonded in a single-axis orientation and configured to restrict rotation about this axis when assembled and to provide the recipient with a tactile indication of gripping.

[0080] For example, Figures 6A and 6B show a housing 604 which may be substantially the same as the housing 204 in Figures 2A and 2B, but further includes a first set of one or more ridges or recesses 642 configured to provide the recipient with a tactile indication of gripping. The housing 604 may also include a visual indicator 608 located on the surface of the housing 604 (shown as located on the top surface). The visual indicator 608 may be a slight protrusion or slight recess from the surface of the housing 604. Furthermore, the visual indicator 608 may have a shape similar to the shape of the skin assembly 102. The orientation of the visual indicator 608 may coincide with the orientation of the skin assembly 102 in the applicator 600. Thus, the visual indicator 608 may help orient the user to the orientation of the skin assembly 102 in the applicator 600 before deployment.

[0081] The housing 604 further has a non-planar, irregularly shaped mating edge 652 so that the housing 604 fits properly with the removable cap 612 in a uniaxial orientation. Similarly, Figures 6A and 6B further show a removable cap 612 which is substantially the same as the removable cap 212, but further includes a second set of one or more ridges or recesses 644 configured to provide the recipient with a tactile indication of gripping. The removable cap 612 further has an irregularly shaped mating edge 654 which is complementary in shape to the mating edge of the housing 604 so that the removable cap 612 fits properly with the housing 604 in a uniaxial orientation. The removable cap 612 can be removed from the housing 604 by twisting the removable cap 612 against the housing 604 or vice versa, and then pulling the removable cap 612 away from the housing 604. In some embodiments, the irregularly shaped mating edges 652, 654 of the housing 604 and the removable cap 612 also function as tamper indicators, as any tamper that causes relative displacement in any direction between the removable cap 612 and the housing 604 will cause them to separate, thereby providing a visual indication of tampering.

[0082] Embodiment including top cap operating member Some embodiments may include an actuation member that is coupled to or integrally formed with a removable cap. For example, Figure 7A shows a perspective view of an applicator 700 for applying a cutaneous assembly 102 to the skin of a recipient, according to some embodiments, which includes a fragile member as a safety configured to prevent the actuation member from operating. Figure 7B is a partially exploded view of the applicator 700 of Figure 7A. Although not shown, the applicator 700 may further include an insertion assembly 118 and a cutaneous assembly 102, as described in relation to Figures 1A-1C and further described in relation to Figures 8B and 8C below.

[0083] The applicator 700 comprises a housing 704 configured to accommodate an insertion assembly 118 (not shown), and includes an opening 106 through which a surface assembly 102 can pass. The housing 704 further comprises a vent 762 configured to be permeable to sterilization gases and to maintain a sterilization barrier. In some embodiments, the vent 762 may be located on the top (i.e., proximal) side of the housing 704. In some embodiments, a porous polymer component is inserted into the vent 762, for example, a Porex® plug. In some embodiments, as described above in relation to Figures 1A and 1B, a second layer 124 can be located directly on the opening 106 after sterilization, thereby providing a moisture barrier to the distal portion of the housing 704.

[0084] In some embodiments, the insertion assembly 118 and the skin assembly 102 (not shown in detail in Figure 7B) may be placed inside the housing 704, and then the second layer 124 may be placed over the opening 106 to seal the distal portion of the housing 704. Then, entry and exit of sterile gas may be achieved through the vent 762, and then the sealing layer 764 may be placed over the vent 764 and the proximal portion of the housing 704 to completely seal the inside of the housing 704 from the external environment. Thus, in some embodiments, the combination of at least the housing 704, the second layer 124 and the sealing layer 764 may form a sealing element configured to provide a sterile barrier and a vapor barrier between the internal environment of the housing 704 and the external environment.

[0085] The applicator 700 further comprises an actuator 750 having a nesting cap coupled to the proximal portion of the housing 704. Thus, the sealing layer 764 is disposed between the actuator 750 (i.e., the cap) and the housing 704. The actuator 750 is configured to be actuated by moving the cap distally. Thus, the actuator 750 may further comprise a projection 752 configured to penetrate the sealing layer 764 as the cap moves distally, thereby actinguating an insertion assembly 118 (not shown) within the housing 704. In some embodiments, the actuator 750 may be spring-loaded such that a pressure exceeding a threshold is required to move the cap sufficiently distally to actuate the actuator 750.

[0086] The applicator 700 may further include a fragile safety member 766 configured to prevent the operation of the actuator 750. In some embodiments, the fragile safety member 766 is positioned between the actuator 750 and the distal portion of the housing 704 such that the fragile safety member 766 physically prevents the actuator 750 from moving until at least the fragile safety member 766 is removed or sufficiently displaced. In this way, the fragile safety member 766 simultaneously provides a premature deployment feature, a drop protection feature, and a tamper indicator.

[0087] Figure 8A shows another applicator 800 for applying the skin assembly 102 to the recipient's skin, which, according to several embodiments, includes another easily breakable safety member 866 configured to prevent the operation of the actuating member 850. Applicator 800 is substantially the same as application 700 described above in relation to Figures 7A and 7B, but includes several similar feature parts having slightly different shapes except for the ventilation holes 764, and further shows several additional feature parts described below.

[0088] For example, the applicator 800 is shown to include a housing 704 and a second layer 124, as previously described in relation to Figures 7A and 7B. The applicator 800 further comprises an easily breakable safety member 866 having substantially the same features and positions as the easily breakable safety member 766 in Figures 7A and 7B, but having substantially a horizontal orientation rather than substantially a vertical orientation. The applicator 800 further comprises an actuation member 850 coupled to the proximal portion of the housing 704 and having substantially the same function as the actuation member 750, but with a slightly different shape, comprising a nesting cap.

[0089] Figure 8B is a cross-section of the applicator 800 of Figure 8A in its pre-deployment configuration. Figure 8B further shows the insertion assembly 118 disposed within the housing 704 and sealing layer 764. However, the applicator 800 omits the vent 764, and instead the sealing layer 764 is disposed over the opening in the proximal portion of the housing 704. Thus, in some embodiments, the insertion assembly 118 and the supraskin assembly 102 may be disposed within the housing 704, and then the two layers 124 may be disposed over the opening 106, thereby sealing the distal portion of the housing 704. Then, entry and exit of sterile gas may be achieved through the opening in the proximal portion of the housing 704, after which the sealing layer 764 may be disposed over the opening and proximal portion of the housing 704, thereby completely sealing the inside of the housing 704 from the outside environment. Therefore, in some embodiments, the combination of at least the housing 704, the second layer 124, and the sealing layer 764 can form a sealing element configured to provide a sterilization barrier and a vapor barrier between the internal environment of the housing 704 and the external environment.

[0090] Figure 8B further shows a projection 752 of the actuator 850 (e.g., a nesting cap) in a position ready to pierce the sealing layer 764 as the actuator 850 moves distally. The applicator 800 is further shown as including a spring feature 854 (e.g., a molded or integrated spring feature) configured to provide a biased configuration of the actuator 850, as previously described in relation to Figures 7A and 7B.

[0091] Figure 8C is a cross-section of the applicator 800 of Figure 8A in its deployed configuration. As shown, the second layer 124 has been removed before deployment, and the actuator 850 is shown moved distally, with the projection 752 piercing the sealing layer 764 and activating the insertion assembly 118.

[0092] Figure 9A shows another applicator 900 for applying a skin assembly 102 to the skin of a recipient, according to several embodiments, which includes an actuator 950 configured as a cap disposed on top of the housing 704 of the applicator 900. Applicator 900 is substantially similar to applicator 800 described above in relation to Figures 8A-8C, except as described below. As shown in Figure 9A, applicator 900 includes a housing 704, a second layer 124 sealing an opening 106 (not shown) in the housing 704, and a sealing layer 764 disposed on the proximal portion of the housing 704. Applicator 900 further includes an actuator 950 having a cap coupled to the proximal portion of the housing 704. The actuator 950 includes a projection 752 configured to penetrate the sealing layer 764 during operation of the actuator 950. The cap forming the actuator 950 may further include a side bend 956 configured to unlock the actuator 950. Specifically, moving the lateral bend 956 allows the actuator 950 to move the arm distally. The actuator 950 penetrates the sealing layer 764 and further moves the protrusion 752 to actuate the insertion assembly 118 (see Figures 8B and 8C, not shown). Furthermore, the applicator 900 does not have to include the spring feature 854, and instead has a spring feature 954 disposed on the side of the housing 704 between the housing 704 and the cup of the actuator 950, which may provide substantially the same effect as the spring feature 854. In some embodiments, the spring feature 954 may be coupled at one end to the housing 704 and at the other end to the actuator 950 forming the cup. The actuator 950 may provide additional premature deployment prevention and drop protection features.

[0093] Figure 9B further shows a projection 752 of the actuator 950 (e.g., a nesting cap) in a position ready to pierce the sealing layer 764 as the actuator 950 moves distally. The applicator 900 is further shown as including a spring feature 954 configured to provide a biased mode of the actuator 950, as described above.

[0094] Figure 9C is a cross-section of the applicator 900 of Figure 9A in its deployed configuration. As shown, the second layer 124 has been removed before deployment, the actuator 950 has moved distally, the side bend 956 is shown as recessed, the sealing layer 764 pierces the protrusion 752 and acts on the insertion assembly 118.

[0095] Figure 10A shows another applicator 1000 for applying a skin assembly 102 to the skin of a recipient, including a removable cap 1012 configured as a sealing element, according to several embodiments. Figure 10B is a partially exploded view of the applicator 1000 of Figure 10A. Hereinafter, the applicator 1000 will be discussed with reference to both Figures 10A and 10B. The applicator 1000 is substantially the same as the applicator 700 of Figures 7A and 7B, except as described below. The applicator 1000 comprises a housing 1004 which may function substantially the same as the housing 704. The applicator 1000 further comprises a nested cap 1050 which functions as an actuation member. The applicator 1000 may not include the second layer 124 or the easily breakable safety member 766 of Figures 7A and 7B. Alternatively, the applicator 1000 may include a removable cap 1012 configured to engage with the distal portion of the nesting cap 1050 actuator via threads 1014. In some embodiments, a permeable layer 1052 to sterilization gases, such as Tyvek®, may be contained beneath the removable cap 1012 or attached to the removable cap 1012 so that the layer 1052 can be removed by the removable cap 1012. Threads 1014 disposed on the removable cap 1012 may be configured to engage with threads (not shown) disposed on the inner surface of the cap forming the actuator 1050. The removable cap 1012 can be separated from the actuator 1050 by twisting the removable cap 1012 against the nesting cap 1050 or vice versa. Therefore, since the nesting cap actuation member 1050 is coupled to the removable cap 1012, the applicator 1000 cannot be actuated while the removable cap 1012 is fixed to the applicator 1000. Thus, the removable cap 1012 provides not only a sealing element configured to provide a sterilization barrier and a vapor barrier between the internal and external environments of the housing 1004, but also features to prevent premature deployment and drop protection.

[0096] Embodiments including a flexible shell Some embodiments may include a flexible member configured as a shell or cover, which is disposed on top of the housing and operably coupled to an actuator. For example, Figure 11A shows another applicator 1100 for applying a supraskin assembly 102 to the skin of a recipient, which, according to some embodiments, includes a flexible member 1160 disposed on top of at least a portion of the housing 1104. Although not shown, the applicator 1100 may further include an insertion assembly 118 and a supraskin assembly 102, as described at least in relation to Figures 1A to 1C. The applicator 1100 comprises a housing 1104 capable of enclosing the insertion assembly 118 and the supraskin assembly 102. The applicator 1100 may further include an actuator 1150 disposed on the side of the housing 1104 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the supraskin assembly into the skin of the recipient. The applicator 1100 may further comprise a flexible member 1160 disposed on top of the housing 1104. The applicator 1100 may further comprise a second layer 124 capable of sealing the distal portion of the flexible member 1160. Thus, the second layer 124, together with the flexible member 1160, provides a sealing element configured to provide a sterilization barrier and a vapor barrier between the internal and external environments of the housing 1104. As shown in Figure 11A, the flexible member 1160 may comprise a flexible member 1162 configured to be disposed on top of the actuator 1150 such that the actuator 1150 is actuated when the flexible section 1162 is pressed. In some embodiments, the flexible section 1162 may be bistable in that it has two states: a first loaded state and a second deployed state. In such embodiments, the flexible section 1162 may provide a positive visual tamper indicator when in the second deployed state. Furthermore, the flexible nature of the flexible member 1160 can further provide features to prevent premature deployment and protect against drops by absorbing energy that could otherwise cause physical impact to the applicator 1100.

[0097] Figure 11B is an enlarged view of a portion of the flexible member 1160 of Figure 11A, which is positioned on the operating member 1150. Figure 11B only shows the flexible section 1162 of the flexible member 1160 in more detail.

[0098] Figure 12A shows another applicator 1200 for applying a skin assembly 102 to the skin of a recipient, which includes a flexible member 1260 having a bistable configuration that provides a visual representation of the unfolding, according to several embodiments. Figure 12B is an enlarged view of a portion of the bistable configuration of the flexible member 1200 in Figure 12A. The applicator 1200 is substantially the same as the applicator 1100 of Figures 11A and 11B, except that an actuator (not shown) is disposed on the proximal portion of a housing (not shown), and the flexible member 1260 includes a molded accordion-like section 1262 disposed on the proximal portion of the flexible member 1260, configured such that when the molded accordion-like section 1262 is pressed, the actuator mounted at the top is actuated, and is disposed on the actuator. Figure 12A shows the molded accordion-shaped section 1262 in the first loaded state, and Figure 12B shows the molded accordion-shaped section 1262 in the second unfolded state.

[0099] Figure 13A is an exploded view of another applicator 1300 for applying a skin assembly 102 to the skin of a recipient, which includes a flexible member 1360 containing a fragile member 1364 configured to cover an actuator 1350, according to several embodiments. Applicator 1300 is substantially the same as applicator 1100 of Figures 11A and 11B, except as described below. Applicator 1300 comprises a housing 1104 of Figures 11A and 11B, the housing 1104 comprising an actuator 1150 disposed on the side of the housing 1104. Applicator 1300 further comprises a flexible member 1360, the flexible member 1360 itself comprising a fragile member 1364 and a fragile tab 1366. Applicator 1300 further comprises a second layer 124 disposed above the distal opening of the flexible member 1360, and in some embodiments, a first layer 122. In this way, the flexible member 1360, the second layer 124, and, in embodiments including it, the first layer 122, can form a sealing element configured to provide a sterilization barrier and a vapor barrier between the internal and external environments of the housing 1304. By pulling down the easily breakable tab 1366 and then pulling it around the applicator 1300, the easily breakable tab 1366 and the easily breakable member 1360 can be removed in preparation for using the applicator 1300. Thus, at least the easily breakable member 1360 and the easily breakable tab 1366 can simultaneously provide sterilization and moisture sealing of the joint, tamper indicator, and features to prevent premature deployment and drop protection.

[0100] Figure 13B is a summary diagram of the applicator 1300 from Figure 13A before the removal of the easily breakable member 1360 and the easily breakable tab 1366. Figure 13C shows the applicator 1300 from Figures 13A and 13B after the easily breakable member 1364 has been removed, thereby exposing the operating member 1350.

[0101] Figure 14 shows another applicator 1400 for applying a skin assembly 102 to the skin of a recipient, according to several embodiments, comprising a main portion 1460 comprising a flexible material, disposed on at least a portion of the applicator 1400. The applicator 1400 comprises a housing 1404 configured to house an insertion assembly 118 (not shown) and comprising an opening 106 (not shown) through which the skin assembly 102 (not shown) can pass. The applicator 1400 further comprises an actuator 1470 configured, when activated, to cause the insertion assembly to insert at least a portion of the skin assembly 102 into the skin of the recipient. The main portion 1460 may include, for example, rubber, silicone, or any other flexible and soft material that provides impact protection and grip to the user. The main portion 1460 may be overmolded together with the housing 1404. The main portion 1460 can further cover the actuation member 1470, thereby providing some means of protection against accidental activation and additional sealing to the applicator 1400. The main portion 1460 extends over at least the proximal portion of the housing 1404, thereby providing both grip and drop protection to the receiver. The main portion 1460 may include an elastomer material configured to absorb at least a portion of the energy imparted to the applicator 1400 in the event of a drop. Furthermore, in other embodiments, the main portion 1464 may be removed by pulling away the flexible tab 1466 from the applicator 1400 to reveal a hidden button. In such embodiments, the main portion 1464 can provide an additional tamper indicator or button activation prevention feature.

[0102] Additional Embodiments Alternatively, or in addition to a removable cap, various embodiments may include one or more other feature components configured to provide sterile sealing and / or a moisture barrier. A subset of such embodiments may comprise a single housing without a top or bottom cap. For example, Figure 15A shows a perspective view of an applicator 1500 for applying a supcutaneous assembly 102 to the skin of a recipient, according to several embodiments, which includes a peelable layer 1524 configured to seal a distal opening 106 of a housing 1504 and further seal an actuator 1550. The applicator 1500 comprises a housing 1504 configured to house an insertion assembly 118 and having an opening 106 through which the supcutaneous assembly 102 can pass. The applicator 1500 further comprises an actuator 1550 disposed on the side of the housing 1504 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the supcutaneous assembly into the skin of the recipient. In some embodiments, the peelable layer 1524 is bonded to at least a portion of the housing 1524. For example, as shown at least in Figure 15A, the peelable layer 1524 is configured to seal the opening 106 and the actuator 1550. Thus, the peelable layer 1524 forms a sealing element configured to provide a sterilization barrier and / or vapor barrier between the internal and external environments of the housing 1504. In some embodiments, the peelable layer 1524 is a single piece forming the sealing element. The applicator 1500 can be prepared for use by removing the peelable layer 1524, thereby exposing both the opening 106 and the actuator 1550. In this way, the peelable layer 1524 may also simultaneously provide tamper indicator, premature deployment prevention, and drop protection features. Figure 15B shows the applicator 1500 of Figure 15A with the peelable layer 1524 removed.

[0103] Figure 16A shows another applicator 1600 for applying a supraskin assembly 102 to the skin of a recipient, which, according to several embodiments, includes a peelable layer 1624 configured to seal a distal opening 106 of the housing 1604, further seal an actuator 1650, and further seal a vent 1662 that is permeable to sterile gases. Figure 16B is a partially exploded view of the applicator 1600 of Figure 16A. The applicator 1600 comprises a housing 1604 configured to house an insertion assembly, such as the insertion assembly 118 shown in Figure 8B, and includes an opening 106 through which a supraskin assembly, such as the supraskin assembly 102 shown in Figure 1B, can pass. The applicator 1600 further comprises an actuator 1650 disposed on the side of the housing 1604 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the supraskin assembly into the skin of the recipient. The applicator 1600 further comprises a vent 1662 configured to be permeable to sterile gases. In some embodiments, a porous polymer component (e.g., a Porex® plug) may be inserted into the vent 1662. In some embodiments, the vent 1662 may be located on a side of the housing 1604 that is substantially radially outward and substantially perpendicular to the opening 106, for example, in some embodiments. In some embodiments, the peelable layer 1624 is bonded to at least a portion of the housing 1624. For example, as shown at least in Figure 16A, the peelable layer 1624 is configured to seal only two sides of the opening 106, the operating member 1650, and the vent 1662, for example, the applicator, one of which is provided with the vent 1662. Thus, the peelable layer 1624 forms a sealing element configured to provide a sterile barrier and / or vapor barrier between the internal and external environments of the housing 1604. For example, the peelable layer 1624 is bonded to the housing 1604, thereby sealing the opening 106 on the distal surface of the housing 1604, but not yet sealing the vent 1662. The applicator 1600 can then be exposed to a sterilizing gas that can penetrate the still-exposed vent 1662, thereby sterilizing the inside of the housing 1604.Next, the peelable layer 1624 is positioned over the vent 1662 on the second surface of the housing 1604, thereby sealing the vent 1662 and providing a moisture barrier. The applicator 1600 is ready for use by removing the peelable layer 1624, thereby exposing both the opening 106 and the operating member 1650. In this way, the peelable layer 1624 may also simultaneously provide tamper indicator, premature deployment prevention, and drop protection features.

[0104] Figure 17A shows a perspective view of an applicator 1700 for applying a subcutaneous assembly 102 to the skin of a recipient, according to several embodiments, which includes a peelable layer 1724 configured to seal a distal opening 106 of a housing 1704 and a plug or cap 1770 configured to seal an actuator 1750. The applicator 1700 comprises a housing 1704 configured to house an insertion assembly 118 and an opening 106 through which the subcutaneous assembly 102 can pass. The applicator 1700 further comprises an actuator 1750 (see Figures 17B and 17C) disposed on the side of the housing 1704 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the subcutaneous assembly into the skin of the recipient. The applicator 1700 further includes a peelable layer 1724 bonded to at least a portion of the housing 1724. For example, as shown at least in Figure 17A, the peelable layer 1724 is configured to seal the opening 106. The applicator 1700 further comprises a plug 1770 configured to seal around the actuator 1750. Thus, the peelable layer 1724 and the plug 1770 form a sealing element configured to provide a sterilization barrier and / or vapor barrier between the internal and external environments of the housing 1704. As will be described in more detail with reference to Figures 17B and 17C, the applicator 1700 is ready for use by removing the peelable layer 1724 and the plug 1770, thereby exposing the opening 106 and the actuator 1750, respectively. In this way, the peelable layer 1724 and / or the plug 1770 can simultaneously provide at least tamper-indicating and premature deployment prevention features.

[0105] Figure 17B shows the applicator 1700 from Figure 17A with the plug 1770 removed. As shown, when the plug 1770 is removed, the actuarial member 1750 is exposed and ready for operation.

[0106] Figure 17C shows the applicator of Figure 17B with the peelable layer 1724 further removed, at least partially. As shown, once the peelable layer 1724 is removed, the opening 106 is exposed and the applicator 1700 is ready for use by the recipient.

[0107] Figure 36A shows a perspective view of an applicator 3600, including a housing 3604, a sliding safety lock feature 3640, and an actuator 3650, according to several embodiments. The safety lock feature 3640 may include at least one button located near the top of the housing 3604. In some embodiments, the safety lock feature 3640 includes two buttons located on either side of the top of the housing 3604. As shown in Figure 36A, the actuator 3650 is in a locked position, where the outer surface of the actuator 3650 is coplanar with the outer surface 3606 of the housing 3604. In this locked position, the user cannot press the actuator 3650 to trigger the internal insertion assembly. As shown in Figure 36B, the safety lock feature 3640 is pressed. By actinguating the safety lock feature 3640, the internal latch component releases the actuator 3650 from the locked position to the unlocked position. The outer surface of the actuator 3650 protrudes radially outward from the outer surface 3606 of the housing 3604. In this unlocked position, the user can press the actuator 3650 to trigger the internal insertion assembly.

[0108] Figure 37A shows a perspective view of an applicator 3700, including a housing 3704 and a toggleable actuator 3750, according to several embodiments. The toggleable actuator 3750 may feature two states: a locked state and an unlocked state. As shown in the figure, the toggleable actuator 3750 is in the locked state. In this state, the outer surface 3752 of the toggleable actuator 3750 protrudes at a certain angle from the outer surface 3706 of the housing 3704. The angle of the toggleable actuator 3750 can indicate to the user that the applicator is locked and cannot be triggered for sensor insertion. Furthermore, the toggleable actuator 3750 cannot be pushed radially inward to trigger the internal insertion assembly. As shown in Figure 37B, the toggleable actuator 3750 is in the unlocked state. The user can press the top of the toggleable actuator 3750 to deflect it so that its outer surface 3752 is coplanar with the outer surface 3706 of the housing 3704. In this state, the toggleable actuator 3750 can be pushed radially inward to trigger the internal insertion assembly.

[0109] Figure 38A shows a perspective view of an applicator 3800, including a housing 3804 having an outer surface 3806, an actuator 3850, and a rotary safety lock feature 3810, according to several embodiments. As shown in the figure, the housing 3804 may include an opening 3808. The opening 3808 may be configured to extend through which the actuator 3850 passes. In the locked state, as shown in the figure, the actuator 3850 is a spring button contained inside the housing 3804. In this state, the applicator 3800 cannot be triggered to insert the sensor through the actuator 3850. As shown in Figure 38B, the rotary safety lock feature 3810 can be rotated in a clockwise or counterclockwise direction. When the user rotates the safety lock feature 3810, the actuator 3850 rotates in the corresponding direction within the housing 3804. The user can rotate the safety lock feature 3810 until the actuarial member 3850 reaches the unlocked state. In the unlocked state, due to a spring-like mechanism, such as the nature of the actuarial member 3850, the actuarial member 3850 extends beyond the outer surface 3806 and out of the opening 3808. In this state, the user can push the actuarial member 3850 radially inward to trigger the internal insertion assembly.

[0110] Figure 39 shows a perspective view of an applicator 3900, including a housing 3904, an actuation member 3950, a removable cap 3910, and a release button 3920, according to several embodiments. The removable cap 3910 can be released by pressing the release button 3920. In such embodiments, the release button 3920 may feature a latch release assembly for removing the removable cap 3910 from the housing 3904. The release button 3920 can be incorporated into other embodiments of removable cap applicators, such as, but not limited to, Figures 2A-2B, 4A-4B, 5A-5B, 6A-6B, 10A-10B, 18A-18B, 34A-34D, and 35A-35B.

[0111] Figure 40 shows a perspective view of an applicator 4000 including a housing 4004, a safety button 4040, and an actuation member 4050, according to several embodiments. As shown in the figure, the safety button 4040 may be located on the top of the housing 4004. In such embodiments, pushing the safety button 4040 distally can change the actuation member 4050 from a locked state to an unlocked state. The operation of the safety button 4040 releases an internal trigger lock feature and prevents the actuation member 4050 from operating.

[0112] Embodiment of an additional removable cap Figure 18A shows a perspective view of an applicator 1800 for applying a supraskin assembly 102 to the skin of a recipient, according to several embodiments, including a removable cap 1812 configured to seal an actuator and a peelable layer configured to seal a distal opening within the housing. Figure 18B is a partially exploded view of the applicator 1800 of Figure 18A. The applicator 1800 comprises a housing 1804 configured to house an insertion assembly 118 (not shown) and includes an opening 106 through which the supraskin assembly 102 can pass. The applicator 1800 further comprises an actuator 1850 disposed on the proximal (i.e., apex) of the housing 1804 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the supraskin assembly into the skin of the recipient. In some embodiments, the actuator 1850 protrudes from the proximal portion of the housing 1804. The applicator 1800 may further comprise a vent 1862 configured to allow sterile gas to pass through. In some embodiments, a porous polymer component (e.g., a Porex® plug) may be inserted into the vent 1862. In some embodiments, the vent 1862 may be located, for example, adjacent to the opening 106, on the distal portion of the housing 1804, and may face substantially the same distal direction as the opening 106. The applicator 1800 further includes a peelable layer 1824 bonded to at least a portion of the housing 1804. For example, as shown at least in Figure 18A, the peelable layer 1824 is configured to seal the opening 106 and the vent 1862 along a single planar surface (i.e., the distal surface of the housing 1804). Thus, the peelable layer 1824 forms a sealing element configured to provide a sterile barrier and / or vapor barrier between the internal and external environments of the housing 1804.

[0113] The applicator 1800 further comprises a removable cap 1812 configured to engage with the proximal (i.e., apical) portion of the housing 1804. In some embodiments, the removable cap 1812 further comprises one or more ridges or recesses 1842 configured to provide the receiver with a tactile indication of gripping. In some embodiments, the removable cap 1812 is configured to engage with the housing 1804 via threads. For example, threads 1814 disposed on the removable cap 1812 may be configured to engage with threads 1808 disposed on the housing 1804. In some embodiments, the applicator 1804 further comprises a tamper-evident twist-off collar 1830 disposed at the engagement position between the housing 1804 and the removable cap 1812. As previously described in relation to Figures 5A and 5B, the first portion 1830a of the tamper-evident twist-off collar 1830 may be coupled to a removable cap 1812, and the second portion 1830b of the tamper-evident twist-off collar 1830 may be coupled to a housing 1804. The removable cap 1812 can be separated from the housing 1804 by shaking the first portion 1830a away from the second portion 1830b and twisting the removable cap 1812 against the housing 1804 until the threads 1808 and 1814 are no longer engaged, or vice versa, and then pulling the removable cap 1812 away from the housing 1804. In its integrated state, the removable cap 1812 may provide a seal with the housing 1804 (e.g., a sterile barrier and a moisture or water vapor barrier). In its separated state, the tamper-evident twist-off collar 1830 may provide a tamper indicator to the user. Therefore, the peelable layer 1824, the tamper-evident twist-off collar 1830, and the removable cap 1812 can form a sealing element.

[0114] Figure 19A shows a perspective view of an applicator 1900 for applying a skin assembly 102 to the skin of a recipient, according to several embodiments, which includes an easily breakable cap 1912 configured to seal the actuarial member 1950 and a peelable layer 1924 configured to seal the distal opening 106 in the housing 1904. Figure 19B is a partially exploded view of the applicator 1900 of Figure 19A. The applicator 1900 may have substantially the same components as the applicator 1800 of Figures 18A and 18B, but omits the tamper-evident twist-off collar 1830, threads 1808 and 1814, and replaces the removable cap 1812 with an easily breakable cap 1912 and a pull tab 1966. For example, the housing 1904, opening 106, vent 1962, operating member 1950, and peelable layer 1924 correspond to the housing 1804, opening 106, vent 1862, operating member 1850, and peelable layer 1824, respectively. Furthermore, the applicator 1900 may further include a projection 1920 configured to prevent the applicator 1900 from rotating, as previously described in relation to Figure 2.

[0115] The easily breakable cap 1912 is configured to bond to the proximal portion of the housing 1904. In some embodiments, the easily breakable cap 1912 includes a pull tab 1966. The easily breakable cap 1912 is configured to be removed by pulling the pull tab 1966, thereby releasing the easily breakable cap 1912. In this way, the easily breakable cap 1912 and the peelable layer 1924 can form a sealing element configured to provide a sterile barrier and / or vapor barrier between the internal and external environments of the housing 1904. The easily breakable cap 1912 further provides a tamper indicator to the recipient using the applicator 1900 so that if the easily breakable cap 1912 breaks, the tamper is visually apparent to the user. The easily breakable cap 1912 further provides premature deployment prevention and drop protection features in that it prevents access to the actuator 1950 until it is removed.

[0116] Figure 34A shows a perspective view of an applicator 3400 for applying a skin assembly 102 to the skin of a recipient, including a removable cap 3410 configured to seal the applicator 3400, according to several embodiments. The applicator 3400 may include a housing 3404 having a main portion 3408. The main portion 3408 may be overmolded in the housing 3404. In some embodiments, the main portion 3408 is overmolded in an actuation member 3450. Furthermore, the main portion 3408 may be composed of, for example, rubber, silicone, or any other flexible and soft material. The main portion 3408 may provide impact protection and grip to the user. Additionally, the main portion 3408 may include an elastomer material configured to absorb at least a portion of the energy imparted to the applicator 3400 in the event of a fall.

[0117] The applicator 3400 may include an actuation member 3450 (e.g., a push button) formed integrally with the housing 3404. The actuation member 3450 may be configured to be pressed by the user to actuate the internal insertion assembly 3470 (see Figure 34B). In some embodiments, after the removable cap 3410 is removed, the housing 3404 is configured to be pressed against a surface (e.g., the user's skin) to unlock the actuation member 3450. The housing 3404 is actuated along the inner housing 3406 to align the actuation member 3450 with the trigger arm of the insertion assembly 3470. The actuation member 3450 can then be pushed laterally to actuate the trigger arm and actuate the insertion assembly 3470.

[0118] As shown in Figure 34B, the applicator, the removable cap 3410, can be secured to the housing 3404 by connecting the threads 3414 of the cap with the corresponding threads 3416. Furthermore, the seal 3420 may be configured to compress between the removable cap 3410 and the distal portion 3418 of the housing 3404. The seal 3420 may be made of an elastomer and / or other compressible material. The seal 3420 may be configured to provide a gas barrier and / or vapor barrier between the applicator 3400 and the surrounding environment. Although not shown, the removable cap 3410 can be removed from the housing 3404 by twisting the removable cap 3410 against the housing 3404, or vice versa, until the threads 3414 of the cap and the corresponding threads 3416 of the housing 3404 no longer engage with each other. The removable cap 3410 may include a groove 3412 to improve user grip during attachment or removal of the cap 3410 from the housing 3404.

[0119] As shown in Figure 34C, the bottom layer 3460 is coupled to the distal end of the removable cap 3410 and can seal the opening 3422 of the removable cap 3410. The bottom layer 3460 may be similar to the first layer 122 in Figure 1A. The bottom layer 3460 may be permeable to sterilization gases (e.g., ethylene oxide, or ETO). Furthermore, the bottom layer 3460 may contain Tyvek® material, but any other material permeable to sterilization gases may be used. The bottom layer 3460 may allow sterilization gases to enter and exit through the removable cap 3410 during manufacturing. As shown in Figure 34D, without the bottom layer 3460, the removable cap 3410 may include the opening 3422. Furthermore, the removable cap 3410 may include at least one opening channel 3424. In some embodiments, the removable cap 3410 includes at least two opening channels 3424. In some embodiments, the removable cap 3410 includes at least three open channels 3424. In some embodiments, the removable cap 3410 includes at least four open channels 3424. In some embodiments, the removable cap 3410 includes at least six open channels 3424. Each open channel 3424 may be configured to allow sterile gas to enter the housing 3404. In some embodiments, the open channels 3424 are formed within a platform 3402. The platform 3402 may be a raised platform from the distal end of the removable cap 3410. The platform 3402 may be configured to be spaced a certain distance away from the surface sensor assembly 102. The open channels 3424 may be open slots spaced equidistantly along the perimeter of the platform 3402.

[0120] As such, sterilization gas from the surrounding environment of the applicator 3400 may pass through the bottom layer 3460, through the open channel 3424, and then enter the internal components of the applicator 3400. The reverse process may occur to discharge sterilization gas from within the applicator 3400, through the open channel 3424, through the bottom layer 3460, and back into the surrounding environment of the applicator 3400.

[0121] Figure 35A shows a perspective view of the applicator 3500, including a removable cap 3510. The applicator 3500 may also include a housing 3504 and an actuation member 3550. The removable cap 3510 can be removablely mounted to the housing 3504. As shown in Figure 35B, the housing 3504 includes a female thread 3514, and the removable cap 3510 includes a male thread 3516. In such embodiments, the female thread 3514 may be located inside the housing 3504 and thus hidden or partially hidden from the user after the user removes the removable cap 3510 from the housing 3504. In other embodiments, the housing 3504 may not be housed inside the housing 3504 and instead include a male thread protruding from the exposed lower body of the housing 3504. In such embodiments, the removable cap 3510 may include a corresponding female thread that is hidden or partially hidden from the user. In some embodiments, the removable cap 3510 may include at least one groove 3512 to improve user grip during attachment or removal of the cap 3510 from the housing 3504.

[0122] Embodiments including multiple peelable layers Some embodiments may include one or more peelable layers (e.g., sheets of material bonded to a portion of the applicator (e.g., by adhesive, heat scribing) and easily removable from the housing by a peeling action), which may be bonded to a removable cap or formed integrally with the removable cap. Figure 20A shows a perspective view of an applicator 2000 for applying a supracutaneous assembly 102 to the skin of a recipient, according to some embodiments, which includes a first peelable layer 2024 configured to seal a distal opening 106 of the housing 2004 and a second peelable layer 2064 configured to seal an actuator 2050 disposed at the proximal opening of the housing. Figure 20B shows the actuator of the applicator of Figure 20A in the pre-actuated and actuated positions, respectively. The applicator 2000 comprises a housing 2004 configured to house an insertion assembly 118 (not shown) and an opening 106 (not shown) through which the supracutaneous assembly 102 can pass. The applicator 2000 further comprises an actuator 2050 disposed on the proximal (i.e., apex) portion of the housing 2004 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the skin assembly into the recipient's skin. In some embodiments, the actuator 2050 is embedded in the proximal portion of the housing 2004. The applicator 200 further comprises a first peelable layer 2024 configured to seal the opening 106 of the housing 2004 and a second peelable layer 2064 configured to seal the actuator 2050. Thus, the first peelable layer 2024 and the second peelable layer 2064 may form a sealing element configured to provide a sterile barrier and / or vapor barrier between the internal and external environments of the housing 2004. The applicator 2000 can be prepared for use by removing the first peelable layer 2024 and the second peelable layer 2064. Therefore, the first peelable layer 2024 and the second peelable layer 2064 can simultaneously provide tamper-proof and premature delamination prevention features.

[0123] Figure 21A shows a perspective view of an applicator 2100 for applying a supraskin assembly 102 to the skin of a recipient, which includes, in some embodiments, a plug 2170 configured to seal an actuator 2150 and a peelable layer 2124 configured to seal a distal opening 106 in a housing 2104. The applicator 2100 comprises a housing 2104 configured to house an insertion assembly 118 and an opening 106 through which the supraskin assembly 102 can pass. The applicator 2100 further comprises an actuator 2150 disposed on the proximal (i.e., apical) portion of the housing 2104 and configured, when activated, to cause the insertion assembly 118 to insert at least a portion of the supraskin assembly into the skin of the recipient (see Figure 21C). In some embodiments, the actuator 2150 is embedded in the proximal portion of the housing 2104. The applicator 2100 further includes a peelable layer 2124 coupled to at least a portion of the housing 2104. For example, the peelable layer 2124 is configured to seal the opening 106 (see Figure 21B). The applicator 2100 further comprises a plug 2170 configured to seal the actuator 2150. Thus, the peelable layer 2124 and the plug 2170 form a sealing element configured to provide a sterile barrier and / or vapor barrier between the internal and external environments of the housing 2104. The applicator 2100 may further comprise one or more ridges or recesses 2144 configured to provide a tactile indication of gripping to the recipient. In some embodiments, the applicator 2100 may further comprise at least one projection 2120 configured to prevent rotation of the applicator 2100. The projection 2120 may also function as an orientation indicator for the user.

[0124] In an alternative embodiment, the housing 2104 may be a deformable container that can be bent inward and outward. In such an embodiment, compression of the housing 2104 may actuate an insertion assembly within the housing 2104, such as the insertion assembly 118 (shown in Figure 8B). The deformation caused by compressing the housing 2104 may detach a trigger arm or latch (not shown) that can release the insertion assembly. Furthermore, in such an embodiment, a ridge or recess 2144 may be an actuating indicator to inform the user where to compress in order to actuate and fire the insertion assembly.

[0125] As shown in detail in Figures 21B and 21C, the applicator 2100 is ready for use by removing the peelable layer 2124 and the insertion cap 2170, thereby exposing the opening 106 and the operating member 2150, respectively. In this way, the peelable layer 2124 and / or the insertion plug 2170 can simultaneously provide at least tamper indicator and premature deployment prevention features.

[0126] Figure 21B shows the applicator 2100 of Figure 21A with the peelable layer 2124 removed. As shown, when the peelable layer 2124 is removed, the opening 106 is exposed.

[0127] Figure 21C shows the applicator 2100 of Figure 21A with the insertion cap 2170 removed. As shown, once the insertion cap 2170 is removed, the operating member 2150 is exposed and ready for operation.

[0128] Figure 22A shows a perspective view of an applicator 2200 for applying a subcutaneous assembly 102 to the skin of a recipient, which includes, in some embodiments, a first peelable layer 2224 configured to seal a distal opening 106 of the housing 2204 and a vent 2262 (optional) permeable to sterile gases, and a second peelable layer 2264 configured to seal an operating member (not shown) disposed at the proximal opening of the housing 2204. Figure 22B is a partially exploded view of the applicator 2200 of Figure 22A. The applicator 2200 may be substantially the same as the applicator 2000 of Figures 20A and 20B, except as described below. Applicator 2200 comprises a housing 2204, a first peelable layer 2224, an actuator (not shown), and a second peelable layer 2264 corresponding to housing 2004, a first peelable layer 2024, an actuator (not shown), and a second peelable layer 2064 of applicator 2000. Applicator 2200 further comprises a vent 2262 which may substantially correspond to vent 1962, as previously described in relation to Figures 19A and 19B. Thus, the first peelable layer 1924 is configured to seal both the opening 106 and the vent 2262 of housing 2204. Notably, the vent 2262 located on the distal portion of housing 2204 adjacent to the opening 106 may further provide at least one projection 2220 configured to prevent rotation of applicator 2200. The protruding portion 2220 can also function as a user orientation indicator.

[0129] Embodiment using a protective cup Figure 23 shows a collapsible cup 2390 configured to surround an applicator 2300 for application to the skin of a recipient, having a removable lid 2392 and configured to accommodate a skin assembly 102 inside. The collapsible cup 2390 has a removable and / or peelable lid 2392. The collapsible cup 2390 is configured to act as a sealing element that seals the applicator 2300 from the environment outside the collapsible cup 2390. In some embodiments, the collapsible cup 2390 includes an elastomer. In some embodiments, the collapsible cup 2390 is configured to fold after the removal of the removable and / or peelable lid 2392. The applicator 2300 may be compatible with any applicator, including those described in this detailed description.

[0130] Figure 24A shows a cup 2490 having a removable lid 2492 and configured to surround an applicator 2400 for applying the skin assembly 102 to the recipient's skin, according to several embodiments. In some embodiments, the cup 2390 is contained within an injection-molded cup. The cup 2490 is configured to act as a sealing element that seals the applicator 2400 from the environment outside the cup 2490. The applicator 2400 (see Figure 24B) can be prepared for use by peeling the removable lid 2492 from the cup 2390 and removing the applicator 2400 therefrom. The applicator 2400 may be substituted with any of the aforementioned applicators.

[0131] Figure 24B is a cross-sectional view of the cup 2490 and applicator 2400 of Figure 24A. As shown, the applicator 2400 is disposed within the cup 2490. In some embodiments, the cup 2490 may further comprise a surface assembly alignment feature 2494. In some embodiments, the surface alignment feature 2494 may further comprise a needle protection feature, which protects the needle from damage or external contact, as well as keeping the surface assembly 102 in proper position, by restricting at least lateral movement of the needle of the insertion assembly 118.

[0132] Examples of alternatives for operating components This application describes several different applicator embodiments. However, this application is not limited to the isolated embodiments described. For example, any actuator in any described embodiment can be replaced with any other actuator described above as needed. Any actuator can be used to actuate an insertion assembly, such as insertion assembly 118 (not shown). For example, any applicator may instead have actuators disposed on the side of the housing (see Figures 1A-6B, 11A, 11B, 13A-17C, and 25), actuators disposed on the proximal (i.e., top) portion of the housing (see Figures 12A, 12B, and 18A-22B), actuators that are internal or are themselves caps (see Figures 7A-10B), actuators that are engaged by pressing down and actuated by pressing a bend (see Figure 9), a general push button, a bistable button (see Figures 11A-12B), or any of the above examples, but which are further permeable to sterile gases (see Figures 25A-25B). In some embodiments, any applicator may include multiple actuating members, and pressing down one or more of these actuating members can actuate the insertion assembly. In some embodiments, it may be necessary to press at least two actuating members simultaneously or sequentially to actuate the insertion assembly.

[0133] Figure 25A is a cross-sectional view of an applicator 2500 for applying a skin assembly 102 to the skin of a recipient, including an actuator 2550 that is permeable to sterilization gases, according to several embodiments. Figure 25B is an enlarged view of the actuator of Figure 25A. The applicator 2500 comprises the actuator 2550, which itself comprises a material that is permeable to sterilization gases, e.g., Porex®. The structure of the applicator 2500 is not important here, and therefore the applicator 2500 can correspond to any applicator, including those described herein. Accordingly, any applicator described herein may replace its actuator with the actuator 2550, for example, with an actuator that is permeable to sterilization gases. In such embodiments, any vents may be omitted, as the actuator may also function as a vent.

[0134] Mass production, sterilization, and / or packaging of applicators. As mentioned above, it is sometimes desirable to be able to mass-produce, sterilize, and / or seal applicators. This not only reduces the manufacturing cost per unit but also potentially lowers the cost to the consumer of the applicator. Therefore, the following describes several embodiments that enable the mass production, sterilization, and / or sealing of multiple applicators simultaneously.

[0135] Figure 26A is a cross-section of a soluble moisture barrier 2624 having multiple perforations 2628 for an applicator 2600 for applying a skin assembly 102 to the skin of a recipient, according to several embodiments. For example, a soluble moisture barrier 2624 having one or more perforations 2628 may be used as a sealing element and may be disposed, for example, over an opening 2626 of a removable cap 2612, as described above in relation to at least Figures 1A-1C and 3A-3C. The applicator 2600 may be exposed to a sterilization gas which can enter through one or more perforations 2628 and then discharge, thereby sterilizing the components within the applicator 2600. Once sterilization is complete, the soluble moisture barrier 2624 may be exposed to a temperature sufficient to at least partially dissolve or reflow the moisture barrier material 2624, which can seal the perforations 2628, as shown in Figure 26B. Therefore, in one state, the soluble moisture barrier 2624 acts as a vent that allows sterilization of the applicator 2600, and in another state, the soluble moisture barrier 2624 acts as a seal for the applicator 2600.

[0136] Figure 26B is a cross-section of the soluble moisture barrier 2624 from Figure 26A after heating to allow it to cool and solidify. The soluble moisture barrier 2624 is configured to redistribute itself in a form in which multiple perforations 2628 are closed and sealed. Since the operational conversion method is the application of enough heat to melt the soluble moisture barrier material 2624, bulk sterilization and moisture sealing of multiple applicators can be achieved without direct contact with the components.

[0137] Figure 27A is a cross-section of a moisture barrier 2724 including an elastomer layer 2724b and a perforated layer 2724a according to several embodiments. The moisture barrier 2724 can be used as a sealing element and can be integrated with a removable cap 2712, for example, as described above in relation to any previous figure showing a removable cap. The perforated layer 2724a may be considered a first part of the sealing element and may comprise a plurality of perforations 2728 and an adhesive layer 2746 disposed on the first side of the perforated layer 2724a. The elastomer layer 2724b may be considered a second part of the sealing element and may include a portion permeable to sterilization gases. The elastomer layer 2724b is disposed adjacent to the first side of the perforated layer 2724a. The elastomer layer 2724b can be configured in a first configuration in which the elastomer layer 2724b is spatially separated from the perforation layer 2724a, providing a path for a sterilization path through multiple perforations 2729 and a portion of the elastomer layer 2724a that is permeable to sterilization gases. The elastomer layer 2724b can transition to a second configuration in which the elastomer layer 2724b is bonded to the perforation layer 2724a via an adhesive layer 2746, thereby eliminating the path for sterilization gases and making the moisture barrier 2724 impermeable to sterilization gases. In some other embodiments, the adhesive layer 2746 may be omitted, and the elastomer layer 2724b may be attracted to the perforation layer 2724a without requiring adhesion, thereby sealing the applicator. Figure 27A shows the first configuration.

[0138] As shown in Figure 27A, the applicator 2700 may be exposed to sterilization gas, which can enter and exit through multiple perforations 2728 in the perforated layer 2724a and through a permeable layer 2730 (e.g., Tyvek®) that is permeable to sterilization gas, thereby sterilizing the components within the applicator 2700. Once sterilization is complete, the applicator 2700 is exposed to partial vacuum, thereby creating a pressure gradient sufficient to move the elastomer layer 2724b from the first configuration to the second configuration. As shown in Figure 27B, the pressure gradient pulls the elastomer layer 2724b toward the perforated layer 2427a, which seals the moisture barrier 2724 from sterilization gas and moisture. Generally, this concept applies to any design that utilizes a pressure gradient to actuate a valve that can be closed after gas sterilization (e.g., ethylene oxide sterilization). For example, another embodiment may include an elastomer stopper configured to move and close an air / vapor passage when a sufficient flow rate of vacuum is applied.

[0139] Figure 27B is a cross-section of the moisture barrier 2724 of Figure 27A, showing the elastomer layer 2724b and perforated layer 2724a in a second orientation such that the moisture barrier is impermeable to sterilization gas and moisture, according to several embodiments. Since the operable conversion method is the application of a partial vacuum sufficient to actuate the elastomer layer 2724b from the first configuration to the second configuration, batch sterilization and / or vapor (e.g., water vapor) sealing of multiple applicators can be achieved simultaneously by exposing multiple applicators to a partial vacuum at the same time. This can support highly efficient sterilization of multiple applicators.

[0140] Figure 28A shows a tray 2802 configured to hold a plurality of applicators 2800 for bulk sterilization and moisture barrier sealing, according to several embodiments. Each of the plurality of applicators 2800 may have a structure similar to those described in relation to Figures 27A and 27B, except, for example, that the elastomer layer 2724b is disposed on the outside of the perforation layer 2724a. In such embodiments, the elastomer layer 2724b would be in the first configuration as described above. The plurality of applicators 2800 may be disposed on the tray 2802.

[0141] As shown in Figure 28A, the applicator 2800 can be exposed to sterilization gas that can enter and then discharge through multiple perforations 2728 in the perforated layer 2724a and through the permeable layer 2730 (e.g., Tyvek®, see Figures 27A-B) of the elastomer layer 2724b which is permeable to sterilization gas, thereby sterilizing the components within each of the multiple applicators 2800. Once sterilization is complete, force applicator 2804 can be applied to the multiple applicators 2800 to apply sufficient force to transition the elastomer layer 2824b of each of the multiple applicators 2800 from the first configuration to the second configuration, thereby providing a moisture barrier 2824 that is impermeable to sterilization gas and moisture. Such a transition is shown in Figure 28B.

[0142] Figure 28B is a magnified view of tray 2802 of Figure 28A, showing each of the multiple applicators 2800 in a first configuration permeable to sterilization gas and a second configuration impermeable to sterilization gas and moisture. The operable conversion method is the application of sufficient force to actuate the elastomer layer 2724b of each applicator from the first configuration to the second configuration, so batch sterilization and / or vapor sealing of multiple applicators can be achieved simultaneously by simultaneously exposing the multiple applicators to physical force through the force applicator 2804.

[0143] Figure 29 is an exploded view of a sealing element according to several embodiments, which includes a first layer 2922 permeable to sterilization gas and a second layer 2924 impermeable to sterilization gas and moisture. The sealing element may be integrated with a removable cap 2912, for example, as described above in relation to any previous figure showing a removable cap.

[0144] The first layer 2922 may include Tyvek®, but any other material permeable to sterilization gases may be used. Application of the first layer 2922 to the removable cap 2912 may allow for subsequent entry and exit of sterilization gases during manufacturing. The second layer 2924 may include metal foil, but any other material impermeable to moisture (e.g., water vapor), such as metal foil (e.g., aluminum, titanium), metal substrate, aluminum oxide coated polymer, parylene, metal coated polymer applied by vapor metallization, silicon dioxide coated polymer, or 10 g / 100 in 2 Less than or preferably 1 gram / 100 in 2 Any substance having a water vapor transmission rate of less than 1 / 2 may be applied. The first layer 2922 and the second layer 2924 can seal the opening (not shown) of the removable cap 2912. Applying the second layer 2924 on top of the first layer 2922 after sterilization may provide an additional moisture barrier to the applicator 2900. Since the second layer 2924 can be applied to multiple applicators simultaneously, batch sterilization and / or steam sealing can be achieved.

[0145] Figure 30A is an enlarged view of a sealing element having a vent 3062 made of a material permeable to sterilization gases, according to several embodiments. In some embodiments, the material may include a porous polymer component such as Porex®, but any material permeable to sterilization gases may be used. The sealing element may be integrated with a removable cap 3012, for example, as described above in relation to any previous figure showing a removable cap. One or more applicators utilizing the sealing element with the vent 3062 may be exposed to sterilization gases that can enter and exit the applicators through the vent 3062. Once sterilization is complete, the sealing element with the vent 3062 may be exposed to a temperature sufficient to form a sintered layer 3063 (see Figure 30B) in the porous polymer component of the vent 3062.

[0146] Figure 30B is a magnified view of the sealing element in Figure 30A, showing the sintered layer 3063 of the vent 3062, which is impermeable to sterilization gases. An effective conversion method is the application of sufficient heat to sinter the porous polymer component of the vent 3062, so that batch sterilization and / or vapor sealing of multiple applicators can be achieved simultaneously.

[0147] In another embodiment, the applicator may be sealed in a container after sterilization is complete. The container can surround the applicator and act as a moisture barrier. This can be useful for batch sterilization and / or steam sealing of multiple applicators. In some embodiments, the container may be a bag, wrap, thermoformed product, or some form of equipped device.

[0148] Manufacturing method Figure 32 is a flowchart 3200 illustrating a method for manufacturing an applicator for applying a skin assembly 102 to the skin of a recipient, according to several embodiments. The steps in flowchart 3200 may be performed to manufacture any applicator, as previously described in relation to one of the figures above. Certain steps are described below, but a method for manufacturing such an applicator may include more, fewer, or different steps, in the same or different order as those described below. Furthermore, in some embodiments, this method can be used to manufacture multiple applicators in batches.

[0149] Flowchart 3200 includes block 3202, which includes providing an insertion assembly configured to insert at least a portion of a cutaneous assembly into the skin of a recipient. For example, a cutaneous assembly 102 can be provided, as described above at least in relation to Figure 1B.

[0150] Flowchart 3200 further includes block 3204, which includes providing a housing configured to receive an insertion assembly, the housing having an opening through which the over-skin assembly can pass. Such a housing may be as described above in relation to any of Figures 1A-30.

[0151] Flowchart 3200 further comprises block 3206, which includes providing an actuator configured to actuate an insertion assembly upon activation, thereby inserting at least a portion of the on-skin assembly into the skin of the recipient. For example, any actuator described above in relation to any of Figures 1A to 30 can be provided.

[0152] Flowchart 3200 further includes block 3208, which includes providing a sealing element configured to provide a sterilization barrier and / or vapor barrier between the internal environment of the housing and the external environment of the housing. For example, a sealing element such as those described above in relation to any of Figures 1A to 30 may be provided. For example, such a sealing element does not necessarily have to include a single element, but instead may include any combination of threads, a first or second layer, a sealing layer, a peelable sealing layer, an easily breakable member or cap, a flexible member, an O-ring, a bag, or a removable cap with or without other sealing, as described above in relation to any combination from Figures 1A to 30.

[0153] Figure 33 is a flowchart illustrating another method for manufacturing an applicator for applying a skin assembly 102 to the skin of a recipient, according to several embodiments. The steps in flowchart 3300 may be performed to manufacture any applicator, as previously described in relation to one of the previous figures. Certain steps are described below, but a method for manufacturing such an applicator may include more, fewer, or different steps, in the same or different order as those described below. Furthermore, in some embodiments, this method can be used to manufacture multiple applicators in batches.

[0154] Flowchart 3300 includes block 3302, which includes providing an insertion assembly configured to insert at least a portion of a cutaneous assembly into the skin of a recipient. For example, a cutaneous assembly 102 can be provided, as described above at least in relation to Figure 1B.

[0155] Flowchart 3300 further includes block 3304, which includes providing a housing configured to receive an insertion assembly, the housing having an opening through which the over-skin assembly can pass. Such a housing may be as described above in relation to any of Figures 1A-30.

[0156] Flowchart 3300 further comprises block 3306, which includes providing an actuator configured to actuate an insertion assembly upon activation, thereby inserting at least a portion of the on-skin assembly into the skin of the recipient. For example, any actuator described above in relation to any of Figures 1A to 30 can be provided.

[0157] Flowchart 3300 further includes block 3308, which includes exposing at least the internal environment of the housing to a sterilizing gas. For example, the internal environment of any housing described above in relation to Figures 1A-30 can be exposed to a sterilizing gas such as ethylene oxide (ETO) as described above, or by exposing the applicator to the sterilizing gas before forming, providing, manufacturing, or applying a sealing element that converts the housing from permeable to at least impermeable to the sterilizing gas.

[0158] Flowchart 3300 further includes block 3310, which includes enabling the discharge of sterilization gas from the internal environment of the housing. For example, when exposing the applicator to sterilization gas, the sterilization gas may be removed, allowing sufficient time to pass for the manufacturing process to continue, thereby enabling substantially all of the sterilization gas to be discharged from the internal environment of the housing.

[0159] Flowchart 3300 further includes block 3312, which includes sealing the internal environment of the housing from the external environment of the housing. For example, sealing elements such as those described above in relation to any of Figures 1A to 30 may be provided. For example, such sealing elements do not necessarily have to consist of a single element, but instead may include any combination of threads, a first or second layer, a sealing layer, a peelable sealing layer, an easily breakable member or cap, a flexible member, an O-ring, a bag, or a removable cap, with or without other sealing, as described above in relation to any combination from Figures 1A to 30.

[0160] In some embodiments, sealing at least the internal environment of the housing from the external environment of the housing is performed simultaneously for multiple applicators. In some embodiments, sealing the internal environment of the housing from the external environment of the housing includes exposing multiple applicators to a partial vacuum above a threshold such that each sealing element of the multiple applicators transitions from being permeable to the sterilization gas to being impermeable to the sterilization gas, as described above at least in relation to Figures 27A and 27B.

[0161] In some embodiments, sealing the internal environment of the housing from the external environment of the housing involves exposing a plurality of applicators to a physical force sufficient to transition each sealing element of the plurality of applicators from a first physical configuration permeable to the sterilization gas to a second physical configuration impermeable to the sterilization gas, as described above in relation to Figures 28A and 28B.

[0162] In yet another embodiment, sealing the internal environment of the housing from the external environment of the housing includes, as previously described in relation to Figures 26A and 26B, exposing each of the sealing elements of the plurality of applicators, which include a plurality of perforations, to a temperature sufficient to at least partially melt each of the sealing elements, thereby sealing the plurality of perforations in each of the sealing elements.

[0163] In yet another embodiment, sealing the internal environment of the housing from the external environment of the housing includes, as previously described in relation to Figures 30A and 30B, exposing each of the sealing elements of the plurality of applicators, which includes a porous polymer component, to a temperature sufficient to form a sintered layer in the porous polymer component of each sealing element.

[0164] In yet another embodiment, sealing the internal environment of the housing from the external environment of the housing includes depositing a layer impermeable to sterilization gases on at least a portion of each of the multiple applicators, as previously described in relation to Figure 29. In some such embodiments, the layer is made of metal foil (e.g., aluminum, titanium), a metal substrate, an aluminum oxide coated polymer, parylene, a polymer coated with metal applied by vapor metallization, a silicon dioxide coated polymer, or 10 g / 100 in 2 Less than or preferably 1 gram / 100 in 2 It includes at least one of any materials having a water vapor transmission rate of less than 1.

[0165] The specification and figures of U.S. Patent Application No. 15 / 387,088, filed on 21 December 2016 and published as U.S. Patent Publication No. 2017 / 0188910A1, are incorporated herein by reference in their entirety and form part of this application.

[0166] It should be understood that all methods and processes disclosed herein may be used in any continuous or intermittent glucose monitoring system. It should also be understood that the implementation and / or execution of all methods and processes may be carried out by any suitable local or remote device or system. Furthermore, any combination of devices or systems may be used to implement these methods and processes.

[0167] The above description, in complete, clear, concise, and precise terms, indicates the best possible mode of manner and process for carrying out and using the invention, so as to enable those skilled in the art to construct and use the invention. However, the invention is susceptible to modifications and alternative configurations from those discussed above, which are entirely equivalent. As a result, the invention is not limited to the specific embodiments disclosed. In contrast, the invention encompasses all modifications and alternative structures that fall within the spirit and scope of the invention, as generally represented by the following claims which specifically refer to and individually claim the subject matter of the invention. Although this disclosure has been illustrated and described in detail in the drawings and the above description, such illustrations and descriptions are to be considered descriptive or illustrative, not restrictive.

[0168] All references listed herein are incorporated herein in their entirety by reference. This Specification is intended to supersede and / or take precedence over any publications and patents or patent applications incorporated by reference to the extent that they conflict with the disclosures contained herein.

[0169] Unless otherwise explicitly defined, all terms (including technical and scientific terms) have their ordinary and customary meanings as indicated to those skilled in the art, and are not limited to any special or customized meanings unless expressly defined herein. It should be noted that the use of a particular term when describing a particular feature or aspect of the Disclosure should not be construed as implying that the term is being redefined herein if it is limited to including any particular characteristic of the feature or aspect of the Disclosure to which it relates. In particular in the appended claims, terms and phrases used in this application, and their variations thereof, should be construed as non-restrictive, as opposed to restrictive, unless otherwise explicitly stated. In the examples above, the term “including” should be interpreted as meaning “including without limitation,” “listed but not limited to,” etc., and the term “equipped with,” when used herein, is synonymous with “including,” “containing,” or “characterizing,” and is comprehensive or non-restrictive, without excluding additional unlisted elements or method steps, the term “having” should be interpreted as “having at least,” the term “including” should be interpreted as “listed but not limited to,” and the term “examples” is used to provide illustrative examples of matters in consideration, rather than a comprehensive or restrictive list of such matters, “known,” “common,” Adjectives such as “standard” and similar terms should not be interpreted as limiting the matters described to those available during a given period or at a given point in time, but rather as encompassing known, ordinary, or standard techniques that may be available or known now or at any time in the future; and the use of terms such as “preferred,” “desired,” “desired,” or “coveted” and similar terms should not be understood as implying that certain features are critical, essential, or even important to the structure or function of the invention, but rather should simply be intended to highlight alternative or additional features that may or may not be utilized in particular embodiments of the invention.Similarly, a group of items connected by the conjunction "and" should not be interpreted as requiring each item to exist within the group; rather, unless otherwise specified, it should be interpreted as "and / or." Likewise, a group of items connected by the conjunction "or" should not be interpreted as requiring mutual exclusivity between the items; rather, unless otherwise specified, it should be interpreted as "and / or."

[0170] If a range of values ​​is provided, it is understood that the upper and lower limits, as well as the intermediate values ​​between the upper and lower limits of that range, are included within the embodiment.

[0171] With respect to substantially any plural and / or singular terms herein, a person skilled in the art can convert from plural to singular and / or singular to plural as appropriate to the context and / or use. Various singular / plural substitutions may be explicitly stated herein for clarity. The indefinite articles “a” or “an” do not exclude the plural. A single processor or other unit may accomplish the functions of several matters described in the claims. The mere fact that certain criteria are described in separate claims that differ from each other does not imply that combinations of these criteria cannot be used for benefit. Reference numerals in the claims should not be construed as limiting the scope.

[0172] If a particular number is intended in the description of an introduced claim, such intention is clearly stated in the claim, and if no such statement is present, such intention is not present, as will be further understood by those skilled in the art. For example, to aid understanding, the following appended claims may include the use of the introductory phrases “at least one” and “one or more” to introduce the description of a claim. However, the use of such phrases should not be interpreted as implying that the introduction of the description of a claim by the indefinite article “a” or “an” implies that any particular claim containing such introduced description is limited to embodiments containing only one such description (for example, “a” and / or “an” should typically be interpreted as meaning “at least one” or “one or more”), and the same applies to the use of definite articles used to introduce the description of a claim. In addition, even when a specific number of descriptions in an introduced patent claim is explicitly stated, a person skilled in the art will recognize that such a statement should typically be interpreted as meaning at least that number (for example, the mere statement “two descriptions” without other modifiers typically means at least two descriptions, or two or more descriptions). Furthermore, when a conventional expression similar to “at least one of A, B, and C, etc.” is used, such a structure is generally intended to mean that a person skilled in the art will understand the conventional expression (for example, “a system having at least one of A, B, and C” includes, but is not limited to, A alone, B alone, C alone, A and B, A and C, B and C, and / or a system having A, B, and C, etc.).Where a conventional expression similar to “at least one of A, B, or C, etc.” is used, such a structure is generally intended to mean that a person skilled in the art will understand the conventional expression (for example, “a system having at least one of A, B, or C” includes, but is not limited to, A alone, B alone, C alone, A and B, A and C, B and C, and / or a system having A, B, and C, etc.). A person skilled in the art will further understand that substantially any disjunct word and / or phrase indicating two or more alternative terms should be understood as construing the possibility of including one of the terms, either of the terms, or both of the terms, whether in a description, claim, or drawing. For example, the phrase “A or B” is understood to include the possibilities of “A” or “B” or “A and B”.

[0173] All figures used herein to describe quantities of components, reaction conditions, etc., should be understood to be modified in all cases by the term “approximately.” Therefore, unless otherwise indicated, numerical parameters described herein are approximations that may vary depending on the desired properties to be obtained. At a minimum, and not as an attempt to limit the application of the equivalence principle to any claim scope in any application claiming priority to this application, each numerical parameter should be interpreted with regard to a significant number of digits and ordinary rounding methods.

[0174] Furthermore, although the above has been described in some detail as examples and embodiments for the purpose of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be made. Therefore, the description and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather as encompassing all modifications and substitutes that fall within the true scope and spirit of the invention.

Claims

1. An apparatus for inserting a transdermal glucose sensor, wherein the transdermal glucose sensor comprises an internal portion and an external portion, and the apparatus is A housing having an opening, wherein the housing is configured to be temporarily positioned against the skin of the recipient with the opening facing the skin of the recipient, A transcutaneous glucose sensor assembly housed within the housing, comprising the transcutaneous glucose sensor and sensor electronic equipment, wherein the external portion of the transcutaneous glucose sensor is coupled to the sensor electronic equipment, and the transcutaneous glucose sensor assembly is configured to pass through the opening of the housing during deployment. An insertion assembly comprising a needle having a C-shaped cross-section housed within the housing, wherein the internal portion of the transdermal glucose sensor is positioned inside the needle, the insertion assembly is configured to insert the internal portion of the transdermal glucose sensor into the skin of the recipient using the needle, and the needle and housing are configured to be removed from the recipient after insertion with the internal portion of the transdermal glucose sensor transdermally implanted in the recipient; A cap configured to be screwed into the housing, and configured to be removed by rotating the cap relative to the housing, An elastomer support member that contacts the inner surface of the cap, A device equipped with the following features.

2. The apparatus according to claim 1, wherein the elastomer support member is configured to maintain the insertion assembly in a predetermined position during harmful movements, including drops and vibrations.

3. The apparatus according to claim 1, wherein a tamper indicator is positioned on the screw-in joint between the cap and the housing.

4. The apparatus according to claim 3, wherein the tamper indicator comprises a perforated, cut, or deformed section.

5. The apparatus according to claim 1, wherein the housing comprises at least one ridge.

6. The apparatus according to claim 1, further comprising an actuator configured to push the insertion assembly so that the transcutaneous glucose sensor assembly passes through the opening, thereby inserting the internal portion of the transcutaneous glucose sensor into the skin of the recipient.

7. The apparatus according to claim 1, wherein the needle is exposed when the cap is removed.

8. The apparatus according to claim 1, wherein the elastomer support member is configured to absorb shock during harmful movements, including drops or vibrations.

9. An apparatus for inserting a transdermal glucose sensor, wherein the transdermal glucose sensor comprises an internal portion and an external portion, and the apparatus is A housing having an opening, wherein the housing is configured to be temporarily positioned against the skin of the recipient with the opening facing the skin of the recipient, A transcutaneous glucose sensor assembly housed within the housing, comprising the transcutaneous glucose sensor and sensor electronic equipment, wherein the external portion of the transcutaneous glucose sensor is coupled to the sensor electronic equipment, and the transcutaneous glucose sensor assembly is configured to pass through the opening of the housing during insertion, An insertion assembly comprising a needle having a C-shaped cross-section housed within the housing, wherein the internal portion of the transdermal glucose sensor is positioned inside the needle, the insertion assembly is configured to insert the internal portion of the transdermal glucose sensor into the skin of the recipient using the needle, and the needle and housing are configured to be removed from the recipient after insertion with the internal portion of the transdermal glucose sensor transdermally implanted in the recipient; A sealing element screw-connected to the housing, wherein the sealing element is configured to be removed from the housing by screwing it away from the housing, Equipped with, The sealing element comprises an inner chamber, an outer chamber, and an elastomer support member. The in-vivo portion of the transdermal glucose sensor is located within the inner chamber. The inner chamber has an end opening with an outer boundary edge, The device wherein the annular portion of the surface of the elastomer support member engages with the outer boundary edge of the end opening of the inner chamber of the sealing element.

10. The apparatus according to claim 9, wherein the sealing element is configured such that the inner chamber, the outer chamber, and the elastomer support member are separated from the housing and the needle is exposed by screwing the sealing element to the housing.

11. The apparatus according to claim 9, wherein at least a portion of the sealing element is provided with a threaded cap.

12. The apparatus according to claim 9, wherein the elastomer support member is not in contact with the insertion end of the needle.

13. The apparatus according to claim 9, further comprising an actuator configured to push the insertion assembly through the opening, thereby inserting the internal portion of the transcutaneous glucose sensor into the skin of the recipient.

14. The apparatus according to claim 9, wherein a tamper indicator is positioned on the screw-in joint between the sealing element and the housing.

15. The apparatus according to claim 14, wherein the tamper indicator comprises a perforated, cut, or deformed section.

16. The apparatus according to claim 9, wherein at least a portion of the outer chamber is formed by a threaded cap.

17. The apparatus according to claim 9, wherein the outer chamber at least partially surrounds the inner chamber.

18. The apparatus according to claim 17, wherein the elastomer support member forms a boundary between the inner chamber and the outer chamber.

19. The apparatus according to claim 9, wherein the elastomer support member forms a boundary between the inner chamber and the outer chamber.

20. An apparatus for inserting a transdermal glucose sensor, wherein the transdermal glucose sensor comprises an internal portion and an external portion, and the apparatus is A housing having an opening, wherein the housing is configured to be temporarily positioned against the skin of the recipient with the opening facing the skin of the recipient, A transcutaneous glucose sensor assembly housed within the housing, comprising the transcutaneous glucose sensor and sensor electronic equipment, wherein the external portion of the transcutaneous glucose sensor is coupled to the sensor electronic equipment, and the transcutaneous glucose sensor assembly is configured to pass through the opening of the housing during insertion, An insertion assembly comprising a needle having a C-shaped cross-section housed within the housing, wherein the internal portion of the transdermal glucose sensor is positioned inside the needle, the insertion assembly is configured to insert the internal portion of the transdermal glucose sensor into the skin of the recipient using the needle, and the needle and housing are configured to be removed from the recipient after insertion with the internal portion of the transdermal glucose sensor transdermally implanted in the recipient; A cap screwed onto the housing, configured to be removed by rotating the cap relative to the housing, An elastomer support member that contacts the inner surface of the cap, wherein the elastomer support member and the screw connection between the cap and the housing form at least part of the seal of the device, and the elastomer support member helps to maintain the insertion assembly in place during harmful movements, including drops and vibrations, A device equipped with the following features.

21. The apparatus according to claim 20, wherein the needle is exposed when the cap is removed.

22. The apparatus according to claim 20, wherein a tamper indicator is positioned on the screw-in joint between the cap and the housing.

23. The apparatus according to claim 22, wherein the tamper indicator comprises a perforated, cut, or deformed section.

24. The apparatus according to claim 20, wherein the housing comprises at least one ridge.

25. The apparatus according to claim 20, further comprising an actuator configured to push the insertion assembly so that the transcutaneous glucose sensor assembly passes through the opening, thereby inserting the internal portion of the transcutaneous glucose sensor into the skin of the recipient.

26. An apparatus for inserting a transdermal glucose sensor, wherein the transdermal glucose sensor comprises an internal portion and an external portion, and the apparatus is A housing having an opening, wherein the housing is configured to be temporarily positioned against the skin of the recipient with the opening facing the skin of the recipient, A transcutaneous glucose sensor assembly housed within the housing, comprising the transcutaneous glucose sensor and sensor electronic equipment, wherein the external portion of the transcutaneous glucose sensor is coupled to the sensor electronic equipment, and the transcutaneous glucose sensor assembly is configured to pass through the opening of the housing during insertion, An insertion assembly comprising a needle having a C-shaped cross-section housed within the housing, wherein the internal portion of the transdermal glucose sensor is positioned inside the needle, the insertion assembly is configured to insert the internal portion of the transdermal glucose sensor into the skin of the recipient using the needle, and the needle and housing are configured to be removed from the recipient after insertion with the internal portion of the transdermal glucose sensor transdermally implanted in the recipient; A sealing element screw-connected to the housing, wherein the sealing element is configured to be removed from the housing by screwing it off, the sealing element comprising a cap screw-connected to the housing, the cap comprising a bottom surface having an opening, the opening of the bottom surface of the cap being covered with a layer of material permeable to sterilization gas, A platform rising from the bottom surface of the cap, the platform comprising at least one opening, the at least one opening configured to allow sterilization gas to enter the internal environment of the housing, A device equipped with the following features.

27. The apparatus according to claim 26, further comprising an elastomer support member that contacts the inner surface of the cap.

28. The apparatus according to claim 26, wherein the cap forms an inner chamber and an outer chamber.

29. The apparatus according to claim 26, wherein the needle is exposed when the sealing element is removed.

30. The apparatus according to claim 26, wherein a tamper indicator is positioned on the screw-in joint between the cap and the housing.

31. The apparatus according to claim 26, wherein the housing comprises at least one ridge.

32. The apparatus according to claim 26, wherein the layer of the material includes Tyvek.

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