Analyte sensor applicator

Abstract

An analyte sensor applicator for applying a wearable analyte monitoring device includes: a housing for holding an analyte sensor assembly; a cam assembly for delivering the analyte sensor; and a skin penetrator for inserting the sensor, wherein, after insertion, the skin penetrator is retracted within the top of the housing.

Description

[0001] Related applications

[0002] This application claims the benefit and priority of U.S. Provisional Application No. 62 / 895021, filed September 3, 2019, and U.S. Provisional Application No. 62 / 910701, filed October 4, 2019, the contents of which are incorporated herein by reference in their entirety for all purposes. Background Technology

[0003] Analyte tracking and monitoring enable improved monitoring, diagnosis, and treatment of diseases, including diabetes. Existing methods for measuring, monitoring, and tracking analyte levels may include sampling bodily fluids, preparing the sample for measurement, and assessing the analyte level in the sample. For example, a diabetic patient may prick their finger to obtain a blood sample for glucose measurement in a glucose monitoring unit. Such existing methods can be painful or inconvenient for patients, leading to lower compliance with physician instructions to read glucose readings, for example, at certain times of day or based on patient activity. Effective monitoring, diagnosis, and treatment may benefit from analyte sensors that eliminate the need for unpleasant blood draws and / or sample preparation, especially when samples are collected multiple times daily.

[0004] Transdermal-targeted sensing elements can be used to provide continuous monitoring without requiring multiple unpleasant blood draws per day. Insertors for the delivery of minimally invasive tissue implants, suitable for biosensors, microcatheters, and drug-eluting implants, are known. For example, an inserter for a transdermal-targeted sensing element of an analyte sensor is disclosed in patent application WO 2018 / 195286 entitled "Insertor for Analyte Sensor," which is incorporated herein by reference in its entirety for all purposes. Summary of the Invention

[0005] The embodiments relate to an applicator for a medical device. The applicator includes a housing containing a medical device such as a wearable analytical monitoring device. The housing also includes one or more components for securing the wearable device to a user's body, and optionally includes sterile sub-assemblies for insertable parts.

[0006] In one embodiment, the analyte sensor applicator includes a cam assembly comprising a cam, a piston, and a constrictor. The cam converts rotational motion into linear motion of the piston and constrictor along an insertion axis. The piston includes a piston base that secures the wearable analyte monitoring device to the user's skin while preventing rotation and / or slippage during retraction of the skin-penetrating element. A skin-penetrating element, such as a lancet, transdermally delivers the insertable portion of the sensor and engages with the constrictor. After transdermal sensor delivery, the lancet is withdrawn and automatically retracts through an opening in the piston base to an unexposed position between the piston base and the housing for safe disposal by the user.

[0007] Known analyte sensor applicator systems are typically provided as two-part systems, requiring the separate storage of a sterile insertable component and the assembly of the applicator. As described herein, an analyte sensor applicator that eliminates the need for user assembly is provided. A sterile sub-assembly is provided to maintain the insertable component in a sterile environment and incorporate it into the housing during manufacturing. The insertable component is contained within a sealed chamber that connects to a wearable device, and after sterilization, the sub-assembly and the remaining components are assembled within the applicator housing to form the final analyte sensor applicator assembly. The analyte sensor applicator may also include a detection mechanism to verify that a sterile environment has been established prior to final assembly. Furthermore, a non-invasive method is provided for inspecting the sterile sub-assembly contained within the sealed housing to confirm that the sterile environment has not been compromised during final assembly, packaging, transportation, etc.

[0008] Brief description of the attached figures

[0009] The above-described aspects, as well as other features, aspects, and advantages of the present technology, will now be described with reference to the accompanying drawings and various embodiments. However, the embodiments shown are merely examples and are not intended to be limiting. Throughout the drawings, similar symbols generally denote similar components unless the context requires otherwise. Note that the relative dimensions in the following drawings may not be drawn to scale.

[0010] Figure 1 This is a perspective view of an analytical material sensor applicator according to one embodiment.

[0011] Figure 2 This is a perspective view of the top and bottom components of the analyzer sensor applicator housing according to one embodiment.

[0012] Figure 3 An unfolded view depicting the components of one embodiment of the analyte sensor applicator and analyte sensor device.

[0013] Figure 4A This is an expanded diagram of another embodiment of the analyte sensor applicator and the analyte sensor.

[0014] Figure 4B This is a partially unfolded diagram of an implementation of the analyte sensor applicator and the analyte sensor.

[0015] Figure 5A and Figure 5B Cross-sectional views of one embodiment of the analyte sensor applicator are depicted before and after the insertion of the skin-penetrating component.

[0016] Figure 6A and Figure 6B A side view and a cross-sectional view of one embodiment of the applicator cam are depicted.

[0017] Figure 7A and Figure 7B A cross-sectional view depicting one embodiment of the applicator piston is shown.

[0018] Figure 8A and Figure 8B A cross-sectional view depicting one embodiment of the applicator components is shown.

[0019] Figure 9 A partial cross-sectional view depicting the position and movement of an embodiment of the cam assembly and wearable device prior to the insertion of the skin-penetrating component is depicted.

[0020] Figure 10 A partial cross-sectional view depicting the positions of the cam assembly and the wearable device after the skin-penetrating member has been inserted is shown.

[0021] Figure 11 An embodiment of a retractor located partially within a cam and in a distal position is shown.

[0022] Figure 12 A cross-sectional view of an analyte sensor applicator showing an exposed skin-penetrating component after insertion and retraction is depicted.

[0023] Figure 13 This is a cross-sectional view of a wearable analytical monitoring device and a sterile sub-component.

[0024] Figure 14 This is an unfolded diagram illustrating an implementation of a wearable analytical monitoring device and a sterile sub-component.

[0025] Figure 15 This is a bottom perspective view of the piston base for engagement with an embodiment of a wearable analytical monitoring device having an inspection port.

[0026] Figure 16A and Figure 16B This is a cross-sectional view of an implementation of the applicator and sterile components at two locations.

[0027] Figure 17A and Figure 17B These are cross-sectional views of a wearable analyte monitoring device with a sterile sub-component within the analyte sensor applicator, implemented from two different angles. Detailed Implementation

[0028] It should be understood that the embodiments of the invention described herein are not limited to the specific variations set forth herein, as various changes or modifications can be made to the invention. As will be apparent to those skilled in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any of the other embodiments without departing from the scope or spirit of the invention. Furthermore, various modifications can be made to adapt specific circumstances, materials, material composition, processes, process actions(s), or steps to the purpose, spirit, or scope of the embodiments of the invention. All such modifications are intended to fall within the scope of the claims set forth herein.

[0029] Furthermore, while methods may be depicted in the accompanying drawings or described in the specification in a specific order, these methods do not need to be performed in the specific order shown or in a sequential manner, nor do they need to be performed to obtain the desired result. Other methods not depicted or described may be incorporated into the example methods and procedures. For example, one or more additional methods may be performed before, after, simultaneously with, or between any of the stated methods. Moreover, these methods may be rearranged or reordered in other implementations. Furthermore, the separation of various system components in the implementations described above should not be construed as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged in multiple products. Additionally, other implementations are also within the scope of this disclosure.

[0030] Unless otherwise expressly stated or otherwise understood in the context of use, conditional language (such as “may,” “possibly,” “maybe,” or “can”) is generally intended to convey whether certain implementations include or exclude certain features, elements, and / or steps. Therefore, such conditional language is generally not intended to imply that one or more implementations require features, elements, and / or steps in any way.

[0031] Unless otherwise explicitly stated, connective language such as the phrase "at least one of X, Y, and Z" will be understood from the context as generally used to convey that an item, term, etc., may be X, Y, or Z. Therefore, such connective language is generally not intended to imply that some implementation requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0032] References to a singular number of articles include the possibility of the existence of multiple identical articles. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said,” and “the” include multiple referred objects unless the context explicitly requires otherwise. It will also be noted that claims may be drafted to exclude any optional elements. Thus, this statement is intended as a prior basis for the use of exclusive terms such as “unique,” ​​“only,” or the use of the negative restriction in references to elements of the claims.

[0033] It will be understood that when an element is referred to as "connected to" or "attached to" another element, it may be directly connected to or directly attached to that other element, or there may be an intermediate element. Conversely, if an element is referred to as "directly connected" or "directly attached to" another element, there is no intermediate element. It will also be understood that although the terms "first," "second," etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. Therefore, without departing from the teachings of the invention, a first element may be referred to as a second element.

[0034] The terms “approximately,” “about,” “generally,” and “substantially” used herein refer to values, quantities, or characteristics that are close to a specified value, quantity, or characteristic that still performs the intended function or achieves the intended result. For example, the terms “approximately,” “about,” “generally,” and “substantially” can mean less than or equal to 10%, 5%, 1%, 0.1%, and 0.01% of the quantity. If the quantity is 0 (e.g., none, not having), the above ranges can be specific ranges and not within a specific percentage of that value. Furthermore, numerical ranges include numbers that define the range, and any single value provided herein can be used as an endpoint of a range that includes other single values ​​provided herein. For example, a set of values ​​(e.g., 1, 2, 3, 8, 9, and 10) is also a disclosure of numerical ranges such as 1-10, 1-8, 3-9, etc.

[0035] Some embodiments have been described with reference to the accompanying drawings. Distances, angles, etc., are merely illustrative and do not necessarily show precise relationships to the actual dimensions and layout of the illustrated apparatus. Components may be added, deleted, and / or rearranged. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc., disclosed herein in relation to various embodiments can be used in all other embodiments set forth herein. Moreover, it will be appreciated that any method described herein can be implemented using any apparatus suitable for performing the enumerated steps. Although numerous embodiments and variations thereof have been described in detail, other modifications and methods using them will be apparent to those skilled in the art. Therefore, it should be understood that various applications, modifications, elements, and substitutions may be made using equivalents without departing from the unique and inventive disclosure herein or the scope of the claims.

[0036] All existing subjects mentioned herein (e.g., works, patents, patent applications, and hardware) are incorporated herein by reference in their entirety, unless the subject matter may conflict with this disclosure (in which case the contents of this document shall prevail).

[0037] Embodiments of the disclosed and described technologies relate to applicators for components that can be used in transdermal delivery of medical devices. Example medical devices that can be used with the disclosed and described technologies include, but are not limited to, wearable body devices, such as analyte sensors, pumps for delivering therapeutic drugs (insulin, chemotherapy drugs, etc.), and any other devices as will be readily understood by those skilled in the art. Example medical device components that can be delivered transdermally through the embodiments disclosed and described herein include, but are not limited to, analyte sensing elements, drug delivery cannulas (microcatheters), or other delivery cavities of infusion pumps for delivering, for example, insulin and other therapeutic agents / treatments to a patient. Additional articles, including, but not limited to, drug-eluting implants, can be delivered through the embodiments disclosed herein. For analyte sensors, analytes that can be measured using the embodiments of the invention disclosed and described herein include, but are not limited to, glucose, galactose, fructose, lactate, peroxides, cholesterol, amino acids, ethanol, lactic acid, and mixtures of the foregoing.

[0038] Analytical sensors and components thereof that can be used with embodiments of the disclosed and described technologies include, but are not limited to, the analytical sensors and components thereof described in the following commonly assigned U.S. patents and patent applications: U.S. Patent Nos. 771467203, 9357952, and 8543182, filed December 16, 2004, September 23, 2013, and June 29, 2006, entitled "Implantable Biosensor and Method of Using Therewith"; and U.S. Patent No. 10695000, filed September 1, 2016, entitled "For..." U.S. Patent Application No. 15 / 754271, filed February 21, 2018, entitled "System and Method for Continuous Health Monitoring Using a Photoenzyme Analyte Sensor"; U.S. Patent Application No. 16 / 490118, filed February 28, 2018, entitled "Analyte Sensor and Method of Manufacturing an Analyte Sensor", and for all purposes, the contents of each of the foregoing confirmed patents and patent applications are incorporated herein by reference in their entirety.

[0039] Figure 1 and Figure 2 An embodiment of an analyte sensor applicator for transdermal insertion of an analyte sensor tip into a user's body and for external application of a wearable analyte monitoring device is described. The analyte sensor applicator 1 includes a housing top 2 and a housing bottom 3 that can be secured together, for example, by mating threads 4 and 4'. The wearable analyte monitoring device 10 can be stored within an airtight housing chamber to reduce contamination of the sensing components stored therein due to air exposure.

[0040] The analyte sensor applicator 1 may also include a skin-penetrating device 6 that engages with an insertable portion of the sensor. Figure 3 , Figure 4A and Figure 4B The unfolded diagram depicts the components and assemblies for delivery, fixation and inspection, as well as the wearable analytical monitoring device 10.

[0041] An applicator frame 30, an applicator piston 15, an applicator cam 25, and an applicator retractor 20 are disposed within the top 2 of the applicator housing. A wearable analytical monitoring device 10 is connected to the retractor 20 via an applicator chuck 12 that engages with a receiving member on the bottom of the retractor 20. The applicator chuck 12 is connected to the top portion 11 of a skin-penetrating device (such as a lancet) via a snap-fit, welding, or adhesive connection. The applicator chuck 12 is connected to the retractor 20, which, upon insertion, retracts the lancet from the user's body and back into the housing. The connection between the chuck 12 and the retractor 20 can be achieved via a snap-fit, press-fit, or adhesive connection with a receiving member 57 within or at the bottom of the retractor 20.

[0042] exist Figure 5A and Figure 5B In one embodiment, a cam assembly is shown, comprising a cam 25, a retractor 20, and a piston 15. In this embodiment, the cam assembly includes a double-walled cylindrical cam 25 having an inner cam wall 25' and an outer cam wall 25", as well as an inner groove 36 and an outer groove 28 on a cylindrical cam surface. The cam 25 is configured to align within the applicator piston 15, and the piston 15 is slidably engaged with the outer groove 28 of the cam 25 via a piston pin 16. The retractor 20 is configured to align within the cam 25 and has an outer retractor pin 21 for slidably engaging with the inner cam groove.

[0043] In one embodiment, the components of the applicator are engaged in a snap-fit ​​arrangement. The applicator frame 30 includes an opening 32 configured to receive a piston arm 49, and an opening center frame portion 31 configured to receive a piston cylinder 17 to align the piston 15 within the applicator frame 30. The retractor 20 is aligned between an inner cam wall 25' and an outer cam wall 25", and the cam 25 is aligned with the retractor 20 within the piston cylinder 17. Figure 4A and Figure 4B In one embodiment, the piston 15 includes an internal piston pin 22 aligned with an opening in the bottom of the retractor 20 to prevent rotational movement of the retractor during insertion and retraction.

[0044] The top of the housing includes a mechanical connection such as a tab or bracket (e.g., 37) to engage the applicator frame 30, the cam 25, and optionally the piston 15. The cam includes a circumferential groove 27 adjacent to the top of the cam, which engages with one or more internal tabs 34 within the applicator frame 30.

[0045] In one embodiment, a spring, such as a torsion spring, tension spring, or compression spring, is located between the cam and the top of the housing, which bears the load released when pressed down onto the top of the housing. In one embodiment, the spring located in the spring cavity 29 surrounding the camshaft 26 includes a first end that engages with the cam 25 by winding around a hole 89 in the bottom of the cam. The second end of the spring engages with a slot 80 on the upper portion of the applicant frame 31. An uncompressed spring can be placed under a load by rotating the camshaft 26 to wind the spring. The applicant 1 can be activated by pressing the top of the housing 2, thereby disengaging the mechanical connection that locks the cam 25 to prevent rotation. The connection between the applicant frame and the top of the housing can be interrupted by a displaced cantilever pawl, pivot release, torsion release, or rotation release to unlock the cam and activate the movement of the component. For example, in the case where the top of the housing engages with a slot on the frame (e.g., via a cantilever pawl), the connection may be disengaged by pulling the pawl back under tension through a pushing, torsional, or rotational movement of the top of the housing, thereby releasing the cam.

[0046] In one implementation, such as in Figure 4A and Figure 4B as well as Figure 16A and Figure 16B As shown, a frame cover 40 is provided that engages with the top of a frame 30. The housing top 2 includes one or more locking features 88 (e.g., wedge-shaped features) that engage with a receiving member 33 in the frame cover 40, the receiving member 33 engaging with the frame 30 and engaging within one or more slots 65 in the wall of the cam 25 to prevent movement of the cam 25 under load. Downward pressure on the housing top 2 disengages the connection between the frame cover and the cam. The locking features 88 of the housing top 2 apply outward pressure to the frame 30 and the frame cover 40, thereby releasing the frame cover receiving member 65 from the slot in the wall of the cam.

[0047] In one embodiment, the spring 42 is pre-wound under load or otherwise stored in the applicator. In another embodiment, the spring may be wound externally by the user before use. A winding key or knob (e.g., located on the outer surface of the housing top 2 that is internally connected to the camshaft 26) can be twisted or rotated to rotate the cam and tension the spring. In other embodiments, an electric release device or compressed air may be used instead of the spring to apply pressure to the rotating component.

[0048] like Figure 6A , Figure 6B , Figure 7A , Figure 8B as well as Figures 9 to 11As shown, the rotational motion of cam 25 is converted into linear motion of piston 15. As piston pin 38 follows the outer cam groove 28 (described by arrow 60), and piston 15 moves distally parallel to the insertion axis (line A-A') to allow the skin-penetrating device and sensor to enter the skin. In one embodiment, piston 15 is held in the distal position because during the retraction of the lancet by the constrictor, piston pin 38 engages with groove 61 at the bottom of cam 25 in the locked position. Optionally, a latch or stop may be present on the piston edge to hold the piston on the frame and lock it in place in the distal position.

[0049] like Figure 6A , Figure 6B , Figure 7A , Figure 8B as well as Figures 9 to 11 As depicted, the rotational motion of cam 25 is also converted into linear motion of constrictor 20. In one embodiment, constrictor pin 21 engages a groove 70 on the inner cam surface. Constrictor 20 moves in a distal direction during insertion, and subsequent proximal movement of constrictor 20 retracts the skin-penetrating device 6 after insertion.

[0050] The slope and shape or pattern of the external and / or internal grooves on the cam can be changed to increase or decrease the speed or force at which the piston or retractor moves upward or downward, or to select the number of times either component moves upward or downward, or whether either component moves upward or downward at all. In one embodiment, the piston and retractor can be designed to move independently of each other.

[0051] like Figure 7A and Figure 7B As shown, the piston 15 includes a concave base 50 that conforms to the geometry of the outward-facing surface of the wearable device. Figure 4A and Figure 4B As shown, prior to activation, the wearable device 10 is contained within a concave portion of a piston base 50 within the top 2 of the housing. During insertion, the piston 15 moves along the insertion axis to allow the insertable portion 5 of the analyte sensor to enter the user's skin. After insertion, the piston 15 locks to a distal position to secure the wearable analyte monitoring device 10 to the user's skin, preventing slippage or twisting if the skin-penetrating device 6 is independently retracted by the retractor. After insertion, the skin-penetrating device 6 retracts through a hole 66 in the piston base 50 and is secured within the top 2 of the housing behind the piston base 50 to prevent injury to the user.

[0052] By comparison, in Figure 12In the insertion device shown, both the piston 15 and the lancet 6 are retracted into the housing 69. Without a base for the piston, the lancet 6 is not secured behind the piston base and remains exposed, making the user vulnerable to injury.

[0053] Before device activation and insertion, the wearable analyzer monitoring device can be mechanically held within the piston base 50 by means such as a low-tack adhesive located between the wearable device and the piston base. In an alternative embodiment, the wearable device can be held within the housing by a key 35 located in the bottom of the housing 3. The key 35 aligns with one or more components on the bottom of the wearable device until the bottom of the housing 3 is removed. In an alternative embodiment, one or more springs are disposed within the housing, each spring having an arm that engages with the wearable device and a spring portion that is held in place under load by a retractor; upon retraction via the retractor, the spring arm releases the wearable device from the piston base. In another embodiment, a magnet can be placed within a retractor that magnetically engages with a magnetic component such as a battery within the wearable device. The magnetic connection that properly secures the wearable device within the housing may disengage upon retraction of the retractor, thereby releasing the wearable device from the top of the housing 2.

[0054] In another embodiment, such as Figure 14 and Figure 15 As shown, the outer surface of the housing of the wearable analytical monitoring device 10 includes means to prevent the device from rotating within the housing. In one embodiment, a recess or protrusion 161 may be provided to the surface of the wearable device, and a mating structure 162 (e.g., in the form of a protrusion or recess) may be provided to the piston base 50 to hold the wearable device in place. By holding the wearable device in place, the adhesive patch 44 will also be held in place. In another embodiment, the piston base includes a vent 163 that provides an overflow path to eliminate air displaced away from the piston base during insertion, thereby preventing the adhesive 44 from slipping or the user's skin from concave for better placement.

[0055] exist Figure 7A In another embodiment shown, the piston 15 includes a piston base 50 surrounded by a piston flange 82. The piston flange extends in a proximal direction at an angle away from the piston base 50 and away from the user's skin. The piston flange 82 also includes a vent 83 for air displacement during insertion.

[0056] exist Figure 4A and Figure 4B An alternative embodiment of the analyte sensor applicator is shown. A housing top 2 and a housing bottom 3 are provided, and the applicator frame 30 includes a frame cover 40 that engages with the frame 30. In this embodiment, as... Figure 4BAs shown, the cam assembly is aligned within the applicator frame 30 and below the applicator cover 40, and the spring 42, which engages with the cam 25 to activate the device, is constrained below the frame cover 40. A cam assembly comprising the cam 25, piston 15, and retractor 20 is provided. In this embodiment, the retractor 20 includes an edge 46 extending at a gentle slope between its top and bottom for sliding engagement with a pin within the cam. During the rotational movement of the cam, the cam pin 63 follows the edge 46 of the retractor, causing the retractor to move in a linear direction.

[0057] In another embodiment, a plurality of wedges (not shown) disposed on the inner surface of the top 2 of the housing can engage with slots 33 on the frame cover 40 to lock the component parts and prevent the cam from moving before activation. Before activation, the wearable analyte monitoring device 11 is secured between the piston 15 and the bottom 3 of the housing by a clamp 12 engaging with the retractor 20 and a key 35 in the bottom 3 of the housing.

[0058] In an optional embodiment (not shown), a cam assembly including a cam and a piston is provided, and the retractor is eliminated. In this embodiment, the piston includes a piston base for holding the wearable device in place against the user's skin, and a cylindrical portion that moves independently of the bottom portion. The cylindrical portion of the piston engages with the cam. In one embodiment, the piston is aligned within the cam and includes a pin on an outer surface to engage with a groove on an inner cam surface; alternatively, the cam is aligned within the piston, and a piston pin on the inner cylindrical piston surface engages with an outer cam groove. The cylindrical piston portion may also include a member that engages with a clamp and a skin-penetrating device for insertion and retraction of the skin-penetrating device. In this embodiment, when the cam is activated, the bottom portion of the piston is pushed to a distal position by the cylindrical piston portion and locked in place, thereby holding the wearable device against the user's skin; the cylindrical portion returns to a proximal position without the base by slidably engaging with a cam groove that holds the skin-penetrating device behind the bottom portion of the piston. The cylindrical portion may include a "stop" to engage in the locked proximal position.

[0059] exist Figure 13 , Figure 14 and Figure 15This document describes an embodiment of a wearable analyte monitoring device 10. The wearable analyte monitoring device 10 may include a wearable housing, an analyte sensor assembly including an analyte sensor, an electronic component assembly 81, a transducer, and / or a battery 79. An adhesive pad 44, optionally attached to the wearable device, may also include, for example, attachment to the bottom 3 of the housing to adhere the wearable analyte monitoring device 10 to the user's skin. A plurality of attachment elements 14 may be included within the wearable analyte monitoring system to secure components within the housing of the wearable analyte monitoring device 10.

[0060] Effective methods for sterilizing insertable components (such as electron beam (E-BEAM) sterilization or other radiation-based sterilization techniques) may be harmful to the electronic components of the analyte sensor assembly. Therefore, the wearable analyte monitoring device 10 may also include a sterilization sub-assembly 56 that is sterilized (e.g., by electron beam) prior to further manufacturing of the wearable analyte monitoring component 10. Figure 13 As shown in the cross-sectional view, the wearable analyte monitoring device 10 includes a sterile sub-assembly 55 coupled to the wearable device 10. Insertable portions of the sensor 5 and the lancet 6 are sealed in a small chamber 85, such as a cap 56, and sterilized during manufacturing before being integrated with other components of the wearable device. The lancet can mate with a coil at one end of the sensor 5 to be inserted into the cap, and the other end of the sensor 5 is integrated into the electronics.

[0061] The cap 56 has an opening at its first end to receive an insertable portion into a chamber; the cap opening is sealed and coupled to the wearable device in a manner that achieves and maintains a sterile barrier. An inert fluid 77 (e.g., argon) may be filled into the cap, thereby displacing oxygen from the environment. A sealant is provided to seal the opening of the sterile cap 56, thereby retaining the inert fluid within the chamber 85. The sterility of the insertable member is maintained within the chamber of the cap 56 until insertion into the user's body.

[0062] A method is provided for confirming a) the establishment of a sterile barrier and b) the maintenance of the sterile barrier after further assembly. An oxygen sensing component 78 may be applied to or added to the chamber 85 of the cap before sealing. After assembly, the presence of oxygen in the cap can be queried by a light source such as a UV light source, indicating whether oxygen is leaking into a sterile sub-assembly within the chamber. The oxygen sensing component 78 may comprise an oxygen-sensing polymer, a polymer laminate, or a polymer matrix doped with a luminescent compound, such as an oxygen-detecting dye. In some embodiments, the dye is a luminescent dye. In some embodiments, the dye is a porphyrin dye such as tetratetrafluorophenylporphyrin platinum (pT-TFPP). Depending on the amount of oxygen present, the luminescent dye (e.g., a metal derivative) may emit a measurable signal. In some embodiments, the porphyrin dye is configured to reversibly bind oxygen and emit light upon binding oxygen. A compatible or specified frequency light source can be used to query the presence or absence of fluorescence behavior indicating the presence of oxygen in the sterile cap. When querying a signal indicating a rupture of the sterile barrier, it can be assumed that an insertable component within the chamber may be exposed to a non-sterile environment.

[0063] Examples of applicable analyte sensors and oxygen sensing components include, but are not limited to, the materials disclosed in the commonly owned U.S. Patent Application No. 16 / 490118, filed February 28, 2019, entitled “Analyte Sensor and Method of Manufacturing Analyte Sensor”, and U.S. Patent Application No. 16 / 193305, filed November 16, 2018, entitled “System and Method for Continuous Health Monitoring Using a Photoenzyme Analyte Sensor,” the contents of which are incorporated herein by reference in their entirety for all purposes.

[0064] For ease of inquiry and visualization, the sterile chamber of the cover 56, or at least a portion thereof, may comprise a material, such as transparent polycarbonate, that is optically transparent to sterilization (e.g., UV sterilization) and / or inquiry techniques. In one embodiment, the sterile chamber comprises an integral cover (e.g., by welding or other sealing methods) attached to the wearable base 10 to form a sealing joint 84. To further suppress air permeability, at least a portion of the cover 56 may be coated with a non-air-permeable material. Optionally, the cover may be covered by a second cover comprising a non-air-permeable material, which may be attached to the wearable base 10 or directly attached to the first sterile cover.

[0065] In other embodiments, the cover may include two parts, wherein the first part is molded together with, integrated into, or attached to the wearable base. When the second cover is molded into the wearable base, a staggered joint may be provided to facilitate separation of the cover from the wearable base before it is applied to the user. The second part of the two-part sterile chamber may be attached to the first part by known methods such as welding, bonding, press-fitting, or screwing.

[0066] like Figure 17A and Figure 17B As shown, the bottom 3 of the analyte sensor applicator housing also includes an inspection port 54 to check for the presence of a sterile environment on the sterile cap 56. The inspection port 54 in the applicator housing is aligned with the optically transparent portion of the assembled sterile cap. The inspection port 54 can be attached as a hole or other optically transparent component to any location on the housing aligned with the optically transparent portion of the sterile sub-assembly 55. The sterile barrier can also be queried via the final packaging material. Figure 17A and Figure 17B In this embodiment, the inspection port is located within the applicator key 35 that secures the sterile sub-assembly 55 to the bottom 3 of the housing. Figure 17A and Figure 17B In this embodiment, the inspection port 54 is visible through a transparent portion or hole in the applicator key 35 located in the bottom 3 of the housing.

[0067] The applicator key 35 also provides a connection between the sterile sub-assembly 55 and the bottom 3 of the applicator housing. In this embodiment, when the bottom 3 of the applicator housing is removed, the user simultaneously removes the sterile cap 56 of the sterile sub-assembly 55, exposing the insertable portions of the lancet 6 and the sensor 5 for immediate application and insertion of the wearable device. This configuration reduces the number of steps required for the user to prepare the system for insertion. Figure 17A and Figure 17B As depicted, the geometry of the sterile cap can be conical, and the portion of the key for receiving the sterile cap can be a matching geometry.

[0068] In one embodiment, a loose-fit connection is provided between the housing bottom 3 and the key 35; in another embodiment, the connection between the housing bottom 3 and the key 35 is a pivot. In cases where misalignment between the housing bottom 3 and the wearable base 10 may cause stress on the joint 84 between the sterile cap 56 and the wearable base 10, the loose-fit connection facilitates realignment and eliminates stress that could lead to leakage or rupture of the sterile barrier.

[0069] exist Figure 16AIn one embodiment, the portion of the applicator key 35 contained within the applicator housing bottom 3 that connects to the sterile sub-assembly 55 has a cubic shape. In one embodiment, the end of the cap remote from the wearable device may have a snap-fit ​​connection 86 that engages with the key 35. When the housing bottom 3 is twisted or rotated to separate it from the housing top 2, the sterile sub-assembly 55 contained in the key disengages from the wearable device and is removed. The sterile sub-assembly may have one or more flat protrusions 87 or extensions that engage with the key 35 to facilitate removal when the housing bottom 3 is rotated or twisted.

[0070] Once activated and attached to the patient's skin via the adhesive pad 44, the analyte sensor assembly can be used for a period of time, after which the patient can remove the analyte sensor from the skin by peeling the adhesive pad 44 off. Removing the analyte sensor assembly also removes the sensing element from the patient's skin.

[0071] The analyte sensor applicators disclosed and described herein can be disposable applicators or reusable applicators that can be used more than once to deliver related device components transdermally and attach the device to the skin of a user or patient. In some embodiments, after the wearable analyte monitoring device has been safely removed and disposed of by the user, an unused wearable analyte monitoring device can be inserted into the analyte sensor applicator. The user can rewind and activate the applicator to attach a new wearable analyte monitoring device. Therefore, the cost of wearable medical devices (e.g., analyte sensors) is reduced when the applicator is reusable. For subsequent use of the applicator, the user can purchase new sterile components that include a pre-loaded medical device (emitter, analyte sensor, and skin penetration device).

[0072] As will be readily understood by those skilled in the art, embodiments of the disclosed and described applicator, wearable monitoring device, and sterile components can be designed as components of other skin-penetrating elements for transdermal delivery of medical devices, such as drug delivery cannulas (microcatheters) or other delivery cavities of infusion pumps for delivering, for example, insulin and other therapeutic agents / treatments to a patient. Furthermore, lancets and other skin-penetrating elements can be used in conjunction with the disclosed and described applicator and sterile components to implant drug-eluting implants.

Claims

1. An analyte sensor applicator for inserting a sensor with a skin-penetrating device and retracting the skin-penetrating device to a covered position, the analyte sensor applicator comprising: The applicator housing has an opening at its distal end; Insertable parts of skin-penetrating devices and sensors; A cam assembly, located within the housing, comprises: Cylindrical cam, including a rotating shaft; A piston, which engages with an external cam surface, the piston comprising: i, piston base, and ii. the port passing through the piston base; and A contractor, engaged within the cam and connected to the skin-penetrating device, build; The distal portion of the skin-penetrating device and sensor is inserted into the cap and kept within the cap in a first sterile environment; Components for visually detecting the sterile environment within the lid; and An inspection port, located within the applicator housing, is used to detect the sterile environment; The piston moves linearly between a proximal and distal position for inserting the sensor with the skin-penetrating device. The retractor moves linearly between a distal position and a proximal position to retract the inserted skin-penetrating device and return it to an unexposed position via the piston port. The cover is filled with an inert fluid, and the component used for visually detecting the sterile environment is a fluorescent material for detecting oxygen.

2. The analyte sensor applicator according to claim 1, wherein, The cam includes an external groove, and the piston includes a pin that floats in the external groove.

3. The analyte sensor applicator according to claim 1 or claim 2, wherein, The cam includes an internal groove, and the retractor includes a pin floating in the internal groove.

4. The analyte sensor applicator according to claim 1, wherein, The constrictor includes a groove or edge on its outer surface, and the cam includes a pin that follows the groove or edge of the constrictor.

5. The analyte sensor applicator according to claim 4, wherein, The piston includes one or more internal pins that engage with one or more holes within the constrictor to suppress rotational movement.

6. The analyte sensor applicator according to claim 1, further comprising: Wearable analyte monitoring devices include: a. Electronic components and sensor components, connected to the proximal side of the wearable analytical monitoring device, and b. An adhesive component located on the distal side to adhere the wearable analytical monitoring device to the user. The insertable portion of the skin-penetrating device and the sensor protrudes from the distal side.

7. The analyte sensor applicator according to claim 1, wherein, The skin-penetrating device is a bloodletting needle.

8. The analyte sensor applicator according to claim 6, wherein, The piston includes a disc-shaped piston base that engages with the wearable analytical monitoring device.

9. The analyte sensor applicator according to claim 1, wherein, The insertable portion of the skin-penetrating device retracts through the piston port.

10. The analyte sensor applicator according to claim 1, wherein, The constrictor is configured to move independently of the piston.

11. The analyte sensor applicator according to claim 1, wherein, The retractor moves to the proximal position, and after insertion, the piston base remains in a fixed distal position.

12. The analyte sensor applicator according to claim 11, wherein, The retractor engages with the second cam groove for linear movement along the insertion axis as the cam rotates.

13. The analyte sensor applicator according to claim 1, wherein, The cam engages with the edge of the retractor and is used to cause the retractor to move linearly along the insertion axis as the cam rotates.

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