Subcutaneous analyte sensor applicator and continuous measurement system

Abstract

To provide an all-inclusive single-use continuous analyte measurement system.SOLUTION: An automatic insertion module includes: an applicator housing; a deployment button; and a preloaded insertion assembly that is fully disposed and secured within the button and partially disposed within the applicator housing when the button is in an initial mounted position in the applicator housing. A sensor module includes: a sensor lower housing releasably connected to the applicator housing; a sensor upper housing removably retained in an insertion assembly housing and spaced apart from the sensor lower housing, and an electrical sensor assembly disposed in the sensor upper housing. When an applicator system is in an initial, preloaded position, the sensor is temporarily disposed within a needle of a needle assembly.SELECTED DRAWING: Figure 1

Description

Detailed Description of the Invention

[0001] [background] 1. Field of the invention The present invention relates generally to continuous analyte measurements and, more particularly, to an analyte measurement system having a subcutaneously insertable analyte sensor, an automated insertion assembly, and a reader.

[0002] 2. Description of the Prior Art Continuous analyte measurement devices have been developed for implantation under a patient's skin. Continuous measurement systems typically use a miniature implantable sensor that is inserted subcutaneously or into the subcutaneous fat layer to test the analyte level in the interstitial fluid. A transmitter transmits information about the analyte level, for example, via wire to a monitor or wirelessly via radio waves from the sensor to a wireless monitor. These devices are typically implanted for a period of 3-7 days of use and measure the patient's glucose levels in real time.

[0003] One such device is disclosed in International Publication No. WO2018 / 118061 by Thomas H. Peterson et al. A continuous glucose measurement system and method is disclosed. The system and method includes an auto-insertion assembly for inserting a sensor through the skin and into subcutaneous tissue, where an auto-insertion housing with the sensor remains on the skin after insertion. The system and method also includes a sensor housing cover attachable to the sensor housing after insertion, where the sensor housing cover includes an electronic module and a battery. The system and method also includes an electronic device equipped with wireless communication for communicating with the electronic module of the sensor housing cover assembly, where the electronic device is configured to receive an input signal from the sensor, convert the input signal into analyte data, display the analyte data on a user interface of the electronic device, store the data for recall, and generate and / or transmit reports of the data.

[0004] In U.S. Patent Application Publication No. 2018 / 0235520 by Vivek Rao et al., systems, devices and methods are provided for inserting at least a portion of an in-vivo analyte sensor, such as a skin sensor, to sense an analyte level in a bodily fluid of a subject. The applicator is positioned against a skin surface and a force is applied to the applicator such that a portion of a sharp and the in-vivo analyte sensor are positioned within the subject. In particular, disclosed herein are applicator embodiments designed to prevent premature, jerky withdrawal and / or reduce the likelihood of improper sensor insertion. Also disclosed are applicator embodiments that include a sharp module having an angled sharp that may be configured to create an insertion path for the sensor.

[0005] U.S. Patent Application Publication No. 2016 / 0058344 by Vivek Rao et al. provides systems, devices, and methods for the assembly and subsequent delivery of an in vivo analyte sensor. An applicator with sensor electronics is inserted into a tray containing an assembly with a sharp and an analyte sensor. This insertion causes the assembly to mate with the sensor electronics and form a retractable sensor control device retained within the applicator. The applicator can then be placed at an appropriate location on a user's body to measure the user's analyte level.

[0006] The device of U.S. Patent Application Publication No. 2016 / 0058344 by Thomas H. Peterson et al. is a device for subcutaneous implantation of an in vivo sensor. An automatic insertion assembly for continuous glucose monitoring with needle delivery capability, the assembly having a deployment button including a needle deployment mechanism having a sharp that is retained in a pre-release position, and a housing body within whose top end the deployment button is movably received. The housing body has a sensor deployment assembly including a lumen and a sensor disposed within the lumen and extending from the lumen to a circuit board that is part of the sensor deployment assembly. The sensor deployment assembly matingly connects to the sharp, where the sharp extends beyond the sensor deployment assembly. The sensor deployment assembly includes a sensor that is not fixedly attached to the sharp and a sensor housing that is releasably received within a lower end of the housing body. The sharp extends within the sensor housing and into a sensor deployment assembly recess directly above a sensor opening at a bottom of the sensor housing.

[0007] U.S. Patent No. 10,213,139 to Vivek Rao et al. discloses a system, device, and method for the assembly and subsequent delivery of an in vivo analyte sensor. An applicator with sensor electronics is inserted into a tray containing an assembly with a sharp and an analyte sensor. This insertion mates the assembly with the sensor electronics to form a retractable sensor control device held within the applicator. The applicator can then be placed at an appropriate location on a user's body to measure the user's degradation levels.

[0008] U.S. Patent No. 10,010,280 to Manuel L. Donnay et al. discloses an apparatus for inserting a medical device into the skin of a subject and a method for inserting the medical device. An embodiment includes removing a generally cylindrical cap from an autoinsertion device to expose a generally cylindrical sleeve, removing a cover from a generally cylindrical container that holds a sensor component, and fitting the sensor component to the autoinsertion device.

[0009] U.S. Patent No. 9,788,771 to Gary A. Stafford discloses an automatic sensor inserter for placing a transcutaneous sensor within the skin of a living subject. In accordance with aspects of the invention, insertion characteristics such as the sensor insertion speed may be varied by a user. In some embodiments, the insertion speed is varied by changing the drive spring compression. The spring compression may be selected from a continuous range of settings and / or may be selected from a finite number of discrete settings. Methods relating to the use of this automatic inserter are also included.

[0010] U.S. Patent No. 9,750,444 to Gary A. Stafford discloses a system and method for providing a compressible interconnect to enable electrical communication between an electronics unit and an analyte sensor in an on-body analyte measurement device. In another embodiment, a system and method is provided for reducing the Z-height of an on-body analyte measurement device by utilizing a novel interconnect.

[0011] U.S. Patent No. 9,402,570 to Louis Pace et al. discloses on-body analyte sensor units and associated devices. These devices include any of the elements of packaging and / or loading systems, applicators, and the on-body sensor itself. Also disclosed are various methods of connecting electrochemical analyte sensors to and / or within the associated on-body analyte sensor units. This connector approach variously involves the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that remain separate until the end user brings them together.

[0012] No. 5,299,571 to John Mastrototaro discloses an apparatus for implanting an in vivo sensor. The apparatus includes a housing, a dual lumen tube extending from the housing, and an in vivo sensor housed within one lumen of the tube. A needle is housed within the other lumen of the tube and is inserted through the skin into the tube. After implantation, the needle is removed and the flexible tubing and sensor are left under the skin.

[0013] U.S. Patent Application Publication No. 2010 / 0022863 (2010, Mogensen et al.) discloses an automatic inserter for a transcutaneous sensor. The automatic inserter includes a needle unit and a sensor housing. The needle unit has a needle hub and a carrier body. The sensor housing and needle hub are releasably connected such that when they are connected, an insertion needle is attached along with the sensor (e.g., completely or partially surrounding the sensor). The carrier body guides movement relative to the housing between a retracted position and an advanced position. When released, the needle unit and sensor housing are pushed by a spring unit to an advanced position where the needle and sensor are placed subcutaneously. An upwardly curved portion of the housing leg sets an insertion angle of approximately 30 degrees into the patient's skin.

[0014] U.S. Patent Application Publication No. 2012 / 0226122 (2012, Meuniot et al.) discloses an automatic insertion device for an analyte sensor. The device has a housing, a blade shuttle, and a sensor shuttle that are positioned above the subcutaneous fat layer. A spring is compressed between the blade shuttle and the sensor shuttle. The blade shuttle and the sensor shuttle move towards the subcutaneous fat layer. When the spring force is released by the spring, the blade shuttle moves towards the subcutaneous fat layer and pierces the subcutaneous fat layer, creating a pathway to the subcutaneous fat layer. The analyte sensor is embedded by the sensor shuttle by following the blade shuttle into the pathway created by the blade shuttle. The blade shuttle then retracts from the subcutaneous fat layer, leaving the analyte sensor in the fat layer.

[0015] U.S. Patent Application Publication No. 2013 / 0256289 (2013, Hardvary et al.) discloses a diagnostic device having a partially retractable hollow guide needle for intradermal placement of a diagnostic element that is fixedly connected to a measurement means within the device, eliminating the need to remove the guide needle and connect the diagnostic element to the measurement means after placement within the skin.

[0016] [Summary of the Invention] In this disclosure, the term "substantially simultaneously" means that the individual actions occurring within the subcutaneous sensor insertion applicator of the present invention (i.e., assembling the sensor module as a single unit, inserting the sensor subcutaneously, retracting the needle assembly, switching on the power to the electronic sensor assembly, releasing the sensor module from the applicator module, and releasing the applicator module from the surface of the skin) as the insertion applicator is moved by the user / patient to insert the sensor subcutaneously within the patient's skin are not perceived by a human during the sensor insertion process.

[0017] It is an object of the present invention to provide an all-inclusive, single-use, continuous analyte measurement system. The present invention accomplishes these and other objects by providing a continuous analyte measurement system and method that includes an applicator module for inserting a sensor through the skin and into subcutaneous tissue, where the sensor module remains on the skin after insertion, and an electronic display device, such as a smartphone, with wireless communications for communication with the sensor module. The electronic display device is configured to receive input signals from the sensor, convert the input signals into analyte data, display the analyte data on a user interface of the electronic device, store the data for recall, and generate and / or transmit reports of the data. Various sensors, needles, and electronic displays are disclosed in International Patent Application Publication No. WO2018 / 118061 by Thomas H. Peterson et al., which is incorporated herein by reference in its entirety.

[0018] In one embodiment, a comprehensive single-use subcutaneous analyte sensor applicator and measurement system is disclosed. The system includes an automatic insertion module and a sensor module. The automatic insertion module includes an applicator housing, a deployment button with the applicator housing partially received within the button chamber, and a preloaded insertion assembly that is fully and securely disposed within the button chamber and partially disposed within the applicator housing chamber when the deployment button is in an initial loaded position. The preloaded insertion assembly includes an insertion assembly housing, a biasing element disposed within the assembly housing chamber, and a needle assembly disposed within the assembly housing chamber. The biasing element is in compression between the needle assembly and a bottom of the assembly housing. The sensor module includes a sensor under-housing removably connected to the applicator housing, a sensor over-housing removably retained relative to the insertion assembly housing and spaced from the sensor under-housing, and an electrical sensor assembly disposed within the sensor over-housing. Here, (a) the electrical sensor assembly has an electronic circuit with a power switch and a sensor electrically coupled to the electronic circuit, and (b) the sensor is temporarily disposed within the needle of the needle assembly when the applicator system is in an initial, preloaded position.

[0019] In another aspect of the invention, the applicator housing has an elongated applicator body defining an applicator housing chamber, a proximal inner body flange portion adjacent a proximal applicator housing end, and an applicator housing retaining arm.

[0020] In another embodiment, the deployment button has an elongated button body defining a button chamber and a closed button distal end, and the button retaining arm extends within the button chamber a predetermined distance from the closed button distal end toward the open button proximal end.

[0021] In one embodiment, the assembly housing has an assembly housing body with an assembly peripheral wall defining an assembly housing chamber, a closed housing proximal end, a housing bottom recessed into the closed housing proximal end, an open housing distal end, assembly housing retaining arms formed in the assembly peripheral wall and extending toward the closed housing proximal end, a plurality of housing retaining fingers formed in the assembly peripheral wall and extending beyond the closed housing proximal end and having inwardly facing housing finger hook surfaces, an assembly housing locking slot that interacts with the button retaining arm to secure the preloaded insertion assembly within the button chamber, and a needle assembly locking slot that interacts with the needle body retaining arm.

[0022] In one embodiment, the biasing element is located at one end against a recessed housing bottom of the assembly housing. In one embodiment, the needle assembly has a needle body with a needle body peripheral wall, a closed needle body distal end forming a needle body top, and an open needle body proximal end, where a needle body retaining arm is formed on the needle body peripheral wall whereby an outwardly facing needle retaining arm hook surface is disposed adjacent the closed needle body distal end, the needle assembly further has a needle receiving portion formed on the needle body top, a needle secured adjacent the needle distal end and extending parallel to the needle body peripheral wall a predetermined distance beyond the open needle body proximal end, and a biasing element is disposed through the open needle body proximal end against the closed needle body distal end, the outwardly facing needle being offset from a central axis of the automatic insertion applicator.

[0023] In one embodiment, the sensor lower housing has a plurality of lower housing locking elements that extend upwardly from the bottom of the lower housing a predetermined distance toward the applicator housing chamber.

[0024] In one embodiment, the sensor lower housing has a lower housing locking recess in the lower housing wall, and the applicator housing retention arm engages the lower housing locking recess when the deployment button is in the initial preloaded position.

[0025] In one embodiment, the sensor upper housing has an upper housing peripheral wall extending from the upper housing top forming a housing upper flange portion around a periphery of the upper housing top, the upper housing peripheral wall having a plurality of upper housing locking recesses adapted to matingly connect to a plurality of locking elements of the sensor lower housing.

[0026] In one embodiment, the electrical sensor assembly includes a power source coupled between the electronic circuitry and a power switch. In other embodiments of the automatic insertion assembly, the bottom surface of the sensor housing is configured to adhere to the patient during implantation of the sensor. In one embodiment, for example, the center deployment locking mechanism includes one or more holes with a resilient deployment catch extending upwardly from the inner bottom surface of the sensor housing, where the resilient deployment catch is biased to engage a deployment catch surface of the one or more holes in the sensor deployment assembly.

[0027] In another embodiment of the automatic insertion assembly, when subcutaneously implanted in a patient, the sensor has a working electrode of an electrode system on the sensor that extends into the patient about 4 mm to about 7 mm. In another embodiment, when subcutaneously implanted in a patient, the sensor has a working electrode of an electrode system on the sensor that extends into the patient about 2 mm to about 10 mm.

[0028] Another aspect of the invention is directed to a multi-layer thin film substrate assembly for use in forming a subcutaneous analyte sensor. In one embodiment, the substrate assembly includes a base layer made from an electrically insulating material. The base layer has a base layer substrate including a base layer proximal end, a base layer distal end, and a base layer intermediate portion extending longitudinally between the base layer proximal end and the base layer distal end.

[0029] The first metallization layer is disposed on the base substrate and defines at least one circuit extending longitudinally along the base substrate, each circuit having a conductive contact pad formed at each of the base substrate proximal end and the base substrate distal end, and a conductive trace electrically coupling the conductive contact pad at the base substrate proximal end to the conductive pad at the base substrate distal end.

[0030] The intermediate layer is disposed on the base layer. The intermediate layer has an intermediate layer substrate made from an electrically insulating material with a second proximal end, a second distal end, and a second intermediate portion. The intermediate layer has a plurality of intermediate layer through openings aligned with the base layer and with sidewalls. Each of the intermediate layer through openings communicates with a respective one of the conductive contact pads of the circuit of the base layer.

[0031] A second metallization layer is disposed on the intermediate layer and on the sidewalls of the through openings. The second metallization layer defines at least two circuits, each circuit of the second metallization layer having conductive contact pads formed at a second proximal end and a second distal end and a conductive trace electrically coupling the conductive contact pads at the intermediate layer second proximal end to the conductive pads at the intermediate layer distal end. One of the circuits is electrically coupled to a circuit of the base layer by a plurality of intermediate layer through openings.

[0032] A top layer made of an electrically insulating material is disposed on the middle layer. The top layer has a plurality of contact openings that mate with the respective conductive contact pads at the proximal end of the middle layer and a plurality of sensor openings that mate with the respective conductive contact pads at the distal end of the middle layer. This produces a substrate assembly comprising a substrate proximal end, a substrate distal end, and an assembly intermediate portion extending longitudinally between the substrate proximal end and the substrate distal end. Each of the conductive contact pads at the second distal end is adapted to receive an electrode agent to form a respective electrode, and each of the conductive contact pads at the second proximal end is produced to receive an electrical contact.

[0033] In another embodiment, the multi-layer thin film substrate assembly has multiple intermediate layers. In another embodiment, the base layer, the first metallization layer circuitry, the intermediate layer, the intermediate layer circuitry, and the top layer together provide an arcuate shape to the substrate assembly from the substrate proximal end to the substrate distal end.

[0034] In another embodiment of the substrate assembly, the electrically insulating material of each of the base, middle and top layers is a spun-on thermoset polyimide. In one embodiment, for example, the base layer and middle layer have a thickness of about 10 microns. In another embodiment of the substrate assembly, the top layer has a thickness that is about 5 times the thickness of the middle layer. In another embodiment of the substrate assembly, the top layer has a thickness of about 55 microns. In another embodiment of the substrate assembly, the sensor assembly has a thickness of about 75 microns. In yet another embodiment, the substrate distal end and the assembly middle portion each have a width of about 279 microns.

[0035] In another embodiment of the substrate assembly, the first metallization layer has a thickness in the range of about 900 angstroms to about 1500 angstroms. In another embodiment of the substrate assembly, the first metallization layer and the second metallization layer each comprise gold. In another embodiment, the first metallization layer and the second metallization layer each comprise a layer of chromium disposed on the base layer substrate and the interlayer substrate, with a layer of gold disposed on top of the chromium layer. In another embodiment, the second metallization layer comprises a layer of chromium disposed on the interlayer substrate, with a layer of gold disposed on top of the chromium layer, and a layer of platinum disposed on top of the gold layer.

[0036] In another embodiment of the substrate assembly, the base layer has at least two circuits including respective conductive pads for each circuit at the base layer proximal end and the base layer distal end. The middle layer has at least two second layer circuits with conductive pads for each second layer circuit at the middle layer proximal end and the middle layer distal end. In one embodiment, for example, the first metallization layer of the base layer has at least two other conductive contact pads at the base layer distal end that align with the conductive pads at the middle layer distal end.

[0037] Another aspect of the invention is directed to an electrochemical sensor assembly for use as a subcutaneous analyte sensor. In one embodiment, the electrode assembly has a base comprising a base substrate of electrically insulating material defining a base proximal end, a base distal end, and a base intermediate portion between the base proximal end and the base distal end. The base also has a first metallization layer disposed on the base substrate and defining at least one circuit extending longitudinally along the base substrate. Each circuit has a conductive contact pad formed on each of the base proximal end and the base distal end. A conductive trace electrically couples the conductive contact pad on the base proximal end to the conductive pad on the base distal end.

[0038] The intermediate layer is disposed on the base layer and has an intermediate layer substrate of electrically insulating material. The intermediate layer substrate has an intermediate layer proximal end, an intermediate layer distal end, and an intermediate layer intermediate portion. The intermediate layer has a plurality of second layer through openings aligned with the base layer and having a sidewall. Each of the plurality of second layer through openings communicates with a respective one of the conductive contact pads of the at least one circuit of the base layer. The second metallization layer is disposed on the intermediate layer substrate and the sidewalls of the second layer through openings. The second metallization layer defines at least two circuits, each of the second layer circuits having a conductive contact pad formed on the intermediate layer proximal end and the intermediate layer distal end, respectively, and a conductive trace electrically coupling the conductive contact pad of the intermediate layer proximal end to the conductive pad of the intermediate layer distal end. One of the at least two second layer circuits is electrically coupled to the at least one circuit of the base layer by the plurality of second layer through openings.

[0039] A top layer of electrically insulating material is disposed over the intermediate layer. The top layer is configured to electrically insulate the conductors from the proximal end of the intermediate layer. The intermediate layer has a plurality of contact openings that mate with the conductive contact pads on the intermediate layer distal end, and a plurality of sensor holes that mate with the respective conductive contact pads on the intermediate layer distal end, thereby producing a substrate assembly comprising a substrate proximal end, a substrate distal end, and an assembly intermediate portion extending longitudinally between the substrate proximal end and the substrate distal end.

[0040] The sensing layer is disposed on at least one conductive contact pad formed on the distal end of the intermediate layer to form at least one first detecting electrode. The reference layer is disposed on at least one conductive contact pad formed on the distal end of the intermediate layer to form a reference electrode. In other embodiments, a counter electrode and at least one second working electrode (also called a blank electrode because it is used not to measure a specific analyte but to measure background current caused by interferences in the sample) are further included. In yet other embodiments, there are one or more other working electrodes adapted to measure other specific analytes. In one embodiment, the at least first working electrode is a glucose measuring electrode.

[0041] In one embodiment, the sensing layer has three coating layers. A base coating layer is disposed directly on the metallized pad to form a working electrode that includes PHEMA, glucose oxidase, and / or glucose dehydrogenase. A second coating layer includes PHEMA and a plurality of microspheres made of a material that is substantially non-permeable or nearly non-permeable to glucose, but substantially highly permeable to oxygen. A third coating layer is disposed on top of the second coating layer, the third coating layer includes PHEMA and a material that prevents hydrogen peroxide from being released from the sensing layer. In one embodiment, the microspheres are made of polydimethylsiloxane. In one embodiment, the third coating layer includes catalase.

[0042] In another embodiment, the base coating layer comprises PHEMA, glucose oxidase, and / or glucose dehydrogenase, and an amount of microspheres that is less than the amount of microspheres in the second coating layer.

[0043] In another embodiment of the electrochemical sensor assembly, the base layer, the at least one circuit, the middle layer, the at least one second layer circuit, and the top layer together provide an arcuate shape to the substrate assembly from the substrate proximal end to the substrate distal end.

[0044] In one embodiment of the electrochemical sensor assembly, each of the base substrate, middle substrate, and top substrate are spin-formed and are thermoset polyimide.

[0045] In another embodiment of the electrochemical sensor assembly, the base layer substrate and the middle layer substrate each have a thickness of about 10 microns. In another embodiment, the top layer has a thickness about 5 times the thickness of the middle layer substrate. In another embodiment, the top layer has a thickness of about 55 microns. In another embodiment, the sensor assembly has a thickness of about 75 microns. In another embodiment, the substrate distal end and the assembly middle portion each have a width of about 279 microns.

[0046] In another embodiment of the electrochemical sensor assembly, the first metallization layer has a thickness in the range of about 900 Angstroms to about 1,500 Angstroms. In one embodiment, the first metallization layer and the second metallization layer each comprise gold. In another embodiment, the first metallization layer and the second metallization layer each include a chromium layer disposed on the base layer substrate and the middle layer substrate. A layer of gold is disposed on top of the chromium layer.

[0047] In another embodiment of the electrochemical sensor assembly, the second metallization layer includes a chromium layer disposed against the intermediate layer substrate, a gold layer disposed on the chromium layer, and a platinum layer disposed on the gold layer.

[0048] In another embodiment of the electrochemical sensor assembly, the base layer has at least two circuits, where one conductive pad with the sensing layer at the distal end of the intermediate layer forms a working electrode circuit and a second conductive pad at the distal end of the intermediate layer forms a blank electrode.

[0049] In another embodiment of the electrochemical sensor assembly, the base layer has at least two circuits and the middle layer has at least two circuits with respective conductive pads for each circuit at their respective distal and proximal ends. In another embodiment, the first metallization layer of the base layer includes at least two other conductive contact pads at the base layer distal end that align and mate with conductive pads at the middle layer distal end.

[0050] In another embodiment of the present invention, a continuous glucose measurement system is disclosed. The system includes an auto-insertion assembly, a sensor housing cover assembly, and electronics. The auto-insertion assembly includes an auto-insertion housing, a deployment button disposed within the auto-insertion housing such that the deployment button is slidable from a first position to a second position to deploy a subcutaneous sensor through the skin into subcutaneous tissue, and a sensor housing that receives and captures the sensor deployment assembly from the deployment button. The sensor deployment assembly includes a subcutaneous sensor. The sensor housing cover assembly is configured for attachment to the sensor housing after insertion of the subcutaneous sensor, the cover assembly including an electronic module positioned for electronic coupling to the subcutaneous sensor and capable of storing and transmitting computed data based on input signals from the sensor. The electronics includes wireless communication for communication with the electronic module of the sensor housing cover assembly. The electronics includes electronic circuitry and software for receiving input signals from the sensor, converting the input signals into analyte data, displaying the analyte data on a user interface of the electronics, storing the data for recall, and generating and / or transmitting reports of the data.

[0051] In another embodiment, a sensor of a continuous glucose measurement system includes a base layer including a base electrical circuit and a middle layer including an intermediate electrical circuit, the middle layer having an opening to the base layer that electrically connects a portion of the intermediate electrical circuit with a portion of the base electrical circuit.

[0052] In another embodiment, a method of inserting a sensor subcutaneously is disclosed. The method includes providing a comprehensive single-use subcutaneous analyte sensor applicator and measurement system including an automatic insertion module coupled to a sensor module, where the system is pre-assembled, pre-loaded, and ready to use without the user having to assemble any part of the system prior to placing the system on a patient's skin, and without the user having to manipulate the system to power electronic circuitry within the sensor module either before or after activation of the system or inserting the sensor subcutaneously. The method further includes placing the system against the patient's skin and activating the automatic insertion assembly. The activation step causes the applicator system to automatically assemble the sensor module as a unit, implant the sensor subcutaneously, retract the needle assembly, switch on the power to the electrical sensor assembly, release the sensor module from the applicator module, and automatically release the applicator module from the surface of the skin substantially simultaneously. Automatically assembling the sensor module as a unit to the patient's skin, subcutaneously implanting the sensor, automatically powering the electronic circuitry, and automatically separating the auto-insertion module from the assembled sensor module and the patient's skin.

[0053] In one embodiment, the providing step includes removing an adhesive tape cover from a bottom of the applicator housing prior to the placing step. In one embodiment, the actuation step includes: positioning the deployment button in the second position on the applicator housing; the deployment button is pressed against the animal's skin from an initial preloaded position on said applicator housing such that while the needle is fully retracted into an assembly housing located within the deployment button, the needle containing the sensor penetrates the skin and inserts the sensor while keeping the sensor deployed.

[0054] In another embodiment, the providing step includes attaching a double-sided adhesive pad having a pad opening to the open proximal body end of the applicator housing of the automatic insertion module prior to the placing step, such that the pad opening of the adhesive pad is aligned with the needle axis of the needle.

[0055] In another embodiment, a method of making a comprehensive single-use subcutaneous analyte sensor applicator and measurement system is disclosed that includes forming each of: (a) an applicator housing defining an applicator housing chamber and an applicator housing retaining arm, (b) a deployment button defining a button chamber and a button retaining arm, (c) an assembly housing defining an assembly housing chamber and an assembly housing retaining arm with an outwardly facing housing arm hook surface formed in the assembly housing, (d) a biasing element, (e) a needle assembly having a needle body and a needle fixedly attached to the needle body, the needle extending a predetermined distance beyond the needle body defining a needle axis, (f) a sensor lower housing having a power actuator and a lower housing opening adapted to receive the needle, (g) a sensor upper housing having an upper housing top with a housing top opening, and (h) an electrical sensor assembly comprising an electronic circuit having a power switch and a sensor electrically coupled to the electronic circuit. Subsequent to this forming, the method includes disposing a biasing element within an assembly housing chamber of the assembly housing; inserting the needle assembly into the assembly housing chamber such that the needle body contacts the biasing element, and then pushing the needle body into the assembly housing chamber to compress the biasing element until the needle body retaining arms lock into the needle assembly locking slots of the assembly housing such that the needle extends beyond the closed housing proximal end and through the housing proximal end opening; inserting the combined needle assembly, biasing element and assembly housing into the button chamber of the deployment button until the button retaining arms of the deployment button lock into the assembly housing locking slots of the assembly housing; attaching the sensor-on housing to the assembly housing including the needle assembly and biasing element such that the needle of the needle assembly extends through the upper housing top opening of the sensor-on housing; and inserting an electrical sensor assembly into the sensor-on housing such that the sensor is located within the needle.The assembly housing, biasing element, needle assembly, the above-sensor housing, and the electrical sensor assembly form a preloaded insertion assembly. The method further includes attaching the below-sensor housing to the open proximal body end of the applicator housing, and inserting a portion of the applicator housing a predetermined distance into the button chamber such that the applicator body peripheral wall at the open distal body end of the applicator housing slides between the assembly housing and a deployment button until an assembly housing retention arm hooks into a distal applicator housing notch in the applicator body peripheral wall.

[0056] In one embodiment, the method further includes attaching a single-sided adhesive tape having a pad opening to the open proximal body end of the applicator housing such that a pad opening in the single-sided adhesive tape is aligned with the needle shaft. [Brief description of the drawings]

[0057] [Figure 1] FIG. 1 is a front perspective view of one embodiment of the present invention showing a subcutaneous sensor applicator ready for use. [Figure 1B] FIG. 2 is a bottom perspective view of the applicator of FIG. 1, showing the adhesive pad. [Diagram 2] FIG. 2 is a front plan view of the applicator of FIG. 1. [Diagram 3] FIG. 2 is a left side plan view of the applicator of FIG. 1. [Figure 4] FIG. 2 is an exploded view of the applicator of FIG. 1. [Diagram 5] FIG. 13 is a front perspective view of one embodiment of a deployment button of the applicator. [Figure 6] FIG. 6 is a front plan view of the deployment button of FIG. 5. [Figure 7] 7 is a cross-sectional view of the deployment button of FIG. 5 taken along line F7-F7. [Figure 8] 6 is a cross-sectional view of the deployment button of FIG. 5 taken along line F8-F8. [Figure 9] FIG. 6 is a top view of the deployment button of FIG. 5. [Figure 10] FIG. 6 is a bottom view of the deployment button of FIG. 5 . [Figure 11] 5 is a front perspective view of one embodiment of an applicator housing of the applicator of FIG. 4. [Figure 12] FIG. 12 is a front plan view of the applicator housing of FIG. 11. [Figure 13] 13 is a cross-sectional view of the applicator housing of FIG. 11 taken along line F13-F13. [Figure 13A] FIG. 14 is a close-up view of one embodiment of the cam wall of FIG. [Figure 13B] FIG. 14 is an enlarged view of the needle assembly housing stop 38 of FIG. 13. [Figure 14] 14 is a cross-sectional view of the applicator housing of FIG. 11 taken along line F14-F14. [Figure 15] FIG. 12 is a top view of the applicator housing of FIG. 11. [Figure 16] FIG. 12 is a bottom view of the applicator housing of FIG. 11. [Figure 17] FIG. 5 is a front perspective view of one embodiment of a sub-sensor housing of the applicator of FIG. [Figure 18] FIG. 18 is a front plan view of the sensor lower housing of FIG. 17. [Figure 19] FIG. 19 is a cross-sectional view of the sensor lower housing of FIG. 17 taken along line F19-F19. [Figure 20] FIG. 18 is a cross-sectional view of the sensor lower housing of FIG. 17 taken along line F20-F20. [Figure 20A] FIG. 21 is an angled perspective view of the inner bottom of the sensor under-housing illustrating one embodiment of the power activator shown in FIG. [Figure 21] FIG. 18 is a top view of the sensor lower housing of FIG. 17. [Figure 22] FIG. 18 is a bottom view of the sensor lower housing of FIG. 17. [Figure 23] FIG. 5 is a front perspective view of one embodiment of an insertion assembly housing of the applicator of FIG. [Figure 24] FIG. 24 is a front plan view of the insert assembly housing of FIG. 23. [Diagram 25] 25 is a cross-sectional view of the insert assembly housing of FIG. 23 taken along line 25-25. [Figure 26] 26 is a cross-sectional view of the insert assembly housing of FIG. 23 taken along line 26-26. [Figure 27] FIG. 24 is a top view of the insert assembly housing of FIG. 23. [Figure 28] FIG. 24 is a bottom view of the insert assembly housing of FIG. 23. [Figure 29] FIG. 24 is a bottom perspective view of the insertion assembly housing of FIG. 23. [Diagram 30] FIG. 13 is a front perspective view of one embodiment of a needle assembly of the applicator. [Diagram 31] FIG. 31 is a front plan view of the needle assembly of FIG. [Diagram 32] FIG. 32 is a cross-sectional view of the needle assembly of FIG. 30 taken along line F32-F32. [Diagram 33] FIG. 33 is a cross-sectional view of the needle assembly of FIG. 30 taken along line F33-F33. [Diagram 34] FIG. 31 is a top view of the needle assembly of FIG. [Diagram 35] FIG. 31 is a bottom view of the needle assembly of FIG. [Diagram 36] FIG. 2 is a front, top, perspective view of an embodiment of a sensor housing containing an embodiment of an electrical sensor assembly. [Figure 36A] FIG. 37 is an exploded view of the auto-insertion assembly of FIG. 36. [Figure 37] FIG. 37 is a rear, lower perspective view of the sensor upper housing and electrical sensor assembly of FIG. 36. [Figure 38] FIG. 37 is a front, top, perspective view of the sensor upper housing of FIG. 36. [Figure 38A] FIG. 4 is an enlarged view of an upper housing holding recess; [Figure 39] FIG. 39 is a front plan view of the sensor upper housing of FIG. 38. [Diagram 40] FIG. 40 is a cross-sectional view of the sensor-top housing of FIG. 38 taken along line F40-F40. [Diagram 41]39 is a cross-sectional view of the sensor-top housing of FIG. 38 taken along line F41-F41. [Diagram 42] FIG. 38 is a rear, perspective, bottom view of one embodiment of the electronic circuitry of the electrical sensor assembly shown in FIG. [Diagram 43] FIG. 43 is a front, perspective, top view of the electronic circuit shown in FIG. [Diagram 44] FIG. 43 is an enlarged, perspective, bottom view of the electronic circuit of FIG. 42 in the area designated F44 showing the power switch. [Diagram 45] FIG. 2 is a rear, perspective view of one embodiment of a sensor of the electrical sensor assembly. [Figure 46] FIG. 46 is a front perspective view of the sensor of FIG. 45. [Figure 47] FIG. 47 is an enlarged front view of the sensor of FIG. 46. [Figure 48] FIG. 2 is a left-side cross-sectional view of the applicator system of FIG. 1 taken along line F48-F48 in FIG. 1, illustrating the applicator system ready for use. [Figure 49] 2 is a front cross-sectional view of the applicator system of FIG. 1 taken along line F49-F49 of FIG. 1. [Figure 50A] FIG. 50A is an enlarged view of the applicator system of FIG. 49 at the area defined as 50A, showing the outwardly facing button retaining arms engaged with the insertion assembly housing locking slots. [Figure 50B] FIG. 50 is an enlarged view of the applicator system of FIG. 49 in the area defined as F50B. [Figure 51] FIG. 49 is a left-side cross-sectional view of the applicator system of FIG. 48, illustrating the applicator system partially deployed just prior to releasing contact of the various retaining arms. [Figure 52] FIG. 52 is an enlarged cross-sectional view of the applicator system of FIG. 51 within the area defined as F52, illustrating the needle retaining arm hook surface facing outward, immediately prior to full deployment and release of the needle body. [Figure 53] FIG. 52 is a front cross-sectional view of the application system of FIG. 51. [Figure 54]FIG. 54 is an enlarged cross-sectional view of the applicator system of FIG. 53 within the area defined as F54, illustrating the applicator housing retention arms facing inward, just prior to full deployment and release of the sensor module. [Figure 55] FIG. 49 is a left side cross-sectional view of the applicator system of FIG. 48 illustrating the applicator system fully deployed with the needle assembly retracted within the insertion assembly housing. [Figure 56] FIG. 56 is an enlarged cross-sectional view of the applicator system of FIG. 55 within the area defined as F56, illustrating the needle body against the closed button distal end. [Figure 57] FIG. 56 is a front cross-sectional view of the applicator system of FIG. 55 fully deployed. [Figure 58] FIG. 58 is an enlarged cross-sectional view of the applicator system of FIG. 57 within the area defined as F58, illustrating the applicator housing retaining arms fully released from the under-sensor housing locking recesses and facing inward. [Figure 59] FIG. 13 is an enlarged cross-sectional view of the assembly housing retaining arm and the elongated camming wall of the applicator housing in a ready-to-use orientation. [Figure 60] FIG. 13 is an enlarged cross-sectional view of the assembly housing retaining arm and the elongated cam wall of the applicator housing in a fully deployed orientation; [Figure 61] FIG. 2 is a right side plan view of a fully deployed sensor applicator system illustrating the sensor module deployed and separated from the applicator module. [Figure 62] FIG. 62 is a front plan view of the fully deployed sensor applicator of FIG. 61. [Figure 63] FIG. 1 is a perspective view of one embodiment of a sharp of the present invention illustrating the sharp tip, the sharp open area, and a portion of the sharp body. [Figure 64] FIG. 65 is an end perspective view of the sharp portion of FIG. 64 illustrating the recessed hole defined by the sharp open area. [Figure 65] FIG. 1 is a perspective view of one embodiment of a continuous measurement system of the present invention, illustrating a sensor applicator and a display module. [Figure 66] FIG. 1 is a schematic diagram of the continuous measurement system of the present invention in use. [Figure 67] FIG. 1 is a perspective view of one embodiment of a multi-layer sensor. [Figure 68] FIG. 68 is an enlarged perspective view of the multi-layer sensor of FIG. 67, illustrating the base layer, middle layer, and top layer. [Figure 69] FIG. 68 is a top view of the sensor of FIG. 67 showing the base layer with the electrical contacts and sensor ends circled. [Figure 70] FIG. 70 is an enlarged view of the electrical contact portion of FIG. 69. [Figure 71] FIG. 70 is an enlarged view of the sensor end of FIG. 69. [Figure 72] FIG. 68 is a plan view of the sensor of FIG. 67, showing only the middle layer containing the electrical contacts and the sensor end circuitry. [Figure 73] FIG. 73 is an enlarged view of the electrical contact portion of FIG. 72. [Figure 74] FIG. 73 is an enlarged view of the end of the sensor in FIG. 72. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] [Detailed Description of the Invention] The present disclosure is not limited to the specific embodiments described herein, as these may vary, and the terminology used to describe these specific embodiments is not intended to be limiting.

[0059] The present invention is illustrated in Figures 1-74. Figure 1 is a front perspective view of one embodiment of a subcutaneous sensor applicator 10 ready for use. Figure 1B is a bottom perspective view of the applicator 10, showing a single-sided adhesive pad 14 with an adhesive pad cover 12. As shown, the adhesive pad cover 12 is transparent for the sole purpose of showing the location of the adhesive layer 13, although the adhesive pad cover 12 may be opaque. As shown, the adhesive layer 13 of the adhesive pad 14 is aligned with the outer housing flange portion 27 of the applicator housing 21 and the adhesive pad opening 14a, which is aligned with the needle shaft L2 (shown in Figures 32-33). The non-adhesive side of the single-sided adhesive pad 14 is joined by welding to the lower housing bottom 172 of the sensor lower housing 170 (shown in Figure 22). Figures 2 and 3 are front and left plan views, respectively, of the applicator 10, showing a longitudinal axis L1 extending through the center of the sensor applicator 10. The ready-to-use subcutaneous sensor applicator 10 includes an applicator housing assembly 20 and a deployment button assembly 40. What distinguishes the present invention over other similar devices is that the ready-to-use subcutaneous sensor applicator 10 is fully assembled and does not require any structural components to be joined by a user prior to use. The user simply removes the ready-to-use subcutaneous sensor applicator 10 from its packaging, removes the adhesive tape cover 12 from the adhesive tape 14 on the bottom of the applicator housing 20 to expose the adhesive that aligns with the proximal outer body flange portion 27, places the subcutaneous sensor applicator at a predetermined location on the user's skin or the patient's skin, and presses the deployment button assembly 40. Pressing the deployment button assembly 40 once deploys the sensor module 160 (not shown, see FIGS. 3 and 61-62) on the skin, deploys the analyte sensors subcutaneously within the skin, and automatically turns on power to the electronic circuitry. The user does not need to assemble the sensor module onto the applicator, nor does he or she need to manipulate structures on the applicator to remove the deployment button assembly from the sensor module or do anything else to power the electronic circuitry within the sensor module after the sensor is subcutaneously inserted.

[0060] 4, an enlarged front perspective view of applicator 10 is illustrated. Applicator 10 includes applicator module 15 and an unassembled sensor module 160. Applicator module 15 includes button deployment assembly 40, which includes a preloaded insertion assembly 100, and applicator housing assembly 20.

[0061] The preloaded insert assembly 100 includes an insert assembly housing 110, a needle assembly 140, a biasing element 149, and an electrical sensor assembly 220. When the needle assembly 140 is in the armed or cocked position, the needle assembly 140 and biasing element 149 are disposed within the insert assembly housing 110 with the biasing element 149 compressed in tension, and the insert assembly housing 110 is locked within the deployment button 50. The electrical sensor assembly 220 is captured by the insert assembly housing 110 at a lower or proximal end thereof such that a portion of the sensor 250 is removably disposed within the needle 155 of the needle assembly 140 when the needle assembly 140 is in the armed or cocked position.

[0062] The applicator housing assembly 20 includes an applicator housing 21 and a sensor sub-housing 170 that is captured by the applicator housing 21 and that is released from the applicator housing 21 when the sensor applicator system is deployed. As shown in Figures 1-3, the deployment button assembly 40 is coupled to the applicator housing assembly 20 such that a portion of the insert assembly housing 110 is within the applicator housing 21 and a portion of the applicator housing 21 is within the deployment button 50. These various assembled structural components will now be described individually.

[0063] Turning now to Figures 5-10, various views of the deployment button 50 are illustrated. Figure 5 is a front, left, perspective view of the deployment button 50. The deployment button 50 has an elongated button body 52, a closed button distal end 53, and an optional button body flange 56 disposed at an open button proximal end 54. The elongated button body 52 has a peripheral wall 57 that defines a button chamber 58. Figure 6 is a front plan view of the deployment button of Figure 5. As can be seen from Figures 5-10, the elongated button body 52 has a length BL that is greater than a width BW. The length BL is approximately 1.5 inches (3.8 cm), but is not limited to this dimension. The width BW is approximately 1.25 inches (3.2 cm), but is not limited to this dimension. The button chamber has a depth BD of approximately 1.4 inches (3.5 cm), but is not limited to this dimension. As shown in Figures 5-6 and 8, the sides of the elongated button body 52 may have ridges or grooves 59 to facilitate gripping the deployment button 50 with the user's fingers and thumbs when placing it on the user's / patient's skin.

[0064] 7 is a cross-sectional view of the deployment button of FIG. 5 taken along line F7-F7. Within the button chamber 58, a plurality of optional elongated spacers 70 extend a predetermined distance from the closed button distal end 53 toward the open button proximal end 54. Also within the button chamber 58 is an optional spacer wall 72 that extends a predetermined distance along the inside of the perimeter wall 57 from the closed button distal end 53 toward the open button proximal end 54. The spacer wall 72 is located within the button chamber 58 such that a space is created between the plurality of elongated spacers 70 and the spacer wall 72. This space is merely provided to facilitate assembly during manufacturing.

[0065] FIG. 8 is a cross-sectional view of the deployment button of FIG. 5 taken along line F8-F8. In addition to the plurality of optional elongated spacers 70 and optional spacer wall 72, there is at least a pair of outwardly facing button retaining arms 60. The button retaining arms 60 are connected to the closed button distal end 53 and extend within the button chamber 58 a predetermined distance within the space created between the plurality of elongated spacers 70 and the spacer wall 72. The button retaining arms 60 are resilient so that they can flex toward the center of the button chamber 58 and return to their original position. At the end of the retaining arms is a button retaining arm hook structure 61. As shown in FIGS. 7 and 8, the closed button distal end 53 has an optional recess 53a on its outer surface for placement of an index finger when actuating the subcutaneous analyte sensor applicator system 10, if so desired.

[0066] 9 is a top view of the deployment button 50. In this view, a pair of optional closed end ports 53b are illustrated, through which one can look down to see the hook structures 61 of the button retaining arms 60. The openings 53b are the result of the mold used when injection molding the part.

[0067] 10 is a bottom view of the deployment button 50. In this view, the relationship of the plurality of elongated spacers 70 and spacer walls 72, including the button retaining arms 60 and optional button flanges 56, is more clearly illustrated.

[0068] Turning now to Figures 11-16, the structure of the applicator housing 21 will be described. Figure 11 is a front, left, perspective view of the applicator housing 21, and Figure 12 is a front plan view of the applicator housing 21. The applicator housing 21 has an elongated applicator body 22 formed by an applicator peripheral wall 25 that defines an applicator housing chamber 28, an open distal body end 23, an open proximal body end 24, a proximal inner body flange portion 26 (shown in Figure 15), and a proximal outer body flange portion 27. The proximal outer body flange portion 27 is a key feature of the applicator 10. The purpose of the flange is to passively apply a solid uniform pressure to the adhesive tape using the deployment force of the mechanism. The resultant force of 3-5 lbs of deployment force is purposefully used to securely fix the pressure sensitive adhesive (PSA) of the adhesive tape to the skin of the user / patient. This is a key aspect of the present invention that achieves the overall integrated passivity of the mechanism for the user. After the sensor and applicator are simultaneously inserted and released, respectively, the user does not need to apply pressure to the adhesive tape to secure it to the user / patient's skin. The applicator housing 21 also includes an inwardly facing applicator housing retaining arm 30 formed in the applicator peripheral wall 25. The applicator housing retaining arm 30 extends at a predetermined angle from the applicator peripheral wall 25 into the applicator housing chamber 28 and terminates near the open proximal body end 24. The applicator housing retaining arm 30 is flexible enough to allow the arm 30 to be pushed back toward the peripheral wall 25. A plurality of spacer slots 39 extend from the open distal body end 23 of the applicator elongated body 22 a predetermined distance sufficient to accommodate a plurality of elongated spacers 70 of the deployment button 50.

[0069] FIG. 13 is a cross-sectional view of the applicator housing of FIG. 11 taken along line F13-F13. In addition to the inwardly facing applicator housing retaining arms 30, there are two other features along the inner surface of the applicator peripheral wall 25. These features include an elongated cam wall surface 32 and an applicator assembly housing stop 38. FIG. 13A is an enlarged view of the cam wall surface 32 defined by the area F13A. As can be seen, the upper surface portion 32a has a first surface portion recess 33, a first angled surface 34a that extends along the cam wall surface 32 away from the first surface portion recess 33 and is angled toward the applicator housing chamber 28, and a second angled surface 34b that extends along the cam wall surface 32 away from the first angled surface 34 and is angled away from the applicator housing chamber 28. The cam surface 36 extends away from the second angled surface 34a along the central surface portion 32b and is angled further away from the applicator housing chamber 28. The cam surface 36 terminates at the lower surface 32c having a second surface recess 35. FIG. 13B is an enlarged view of the insert assembly housing stop 38 defined by the area F13B. The insert assembly housing stop 38 is located to create an end point for the movement of the deployment housing assembly 40 when the deployment button 50 is actuated. FIG. 14 is a cross-sectional view of the applicator housing of FIG. 11 taken along line F14-F14. This view illustrates the applicator housing retention arm 30 facing inward with the retention arm hook end 30a and showing the retention arm 30 extending at an angle toward the open proximal body end 24.

[0070] FIG 15 is a top view of applicator housing 21. This view shows proximal inner body flange portion 26 as well as retention arm hook end 30a. In FIG 16, proximal inner body flange The flange portion 26 includes a flange recess 26a designed to receive the sensor sub-housing 200 to provide a coplanar surface between the open proximal body end 24 and the sensor sub-housing 200, and the inwardly facing applicator housing retention arms 30 hold the sensor sub-housing 200 until the subcutaneous analyte sensor applicator system is deployed.

[0071] 17-22, various views of one embodiment of the sensor lower housing 170 are illustrated. Figures 17 and 18 are front, left perspective and front plan views, respectively, of the sensor lower housing 170. The sensor lower housing 170 has a lower housing bottom 172, a lower housing wall 173 extending upwardly from the lower housing bottom 172 and defining a lower housing chamber 184, and a peripheral bottom flange 171 extending orthogonally away from the lower housing wall 173. At least two opposing locations on the lower housing wall 173 are lower housing locking elements 174 that face inwardly and are used to retain the sensor upper housing 200 and electrical sensor assembly 220 after deployment of the applicator system 10. Also shown in at least two opposing locations on the lower housing wall 173 are lower housing retaining recesses 178 for receiving applicator housing retaining arms 30 that retain the sensor lower housing 170 at the open proximal body end 24 of the applicator housing 21 prior to deployment of the applicator system 10. Also shown are a number of optional flange notches 182 in the peripheral bottom flange 171. These notches are not necessary and are merely used to facilitate assembly of the sensor lower housing 170 to the applicator housing 21 and are not an essential aspect of the invention. A power actuator 175 extends from the lower housing bottom 172 into the lower housing chamber 182 such that a power switch contacts the electrical sensor assembly 220 when the sensor upper and lower housings 170, 200 are mated as the sensor applicator system 10 is deployed. In this embodiment, the power actuator 175 is resilient to have a cross-sectional shape that slopes from the lower housing bottom 172 into the lower housing chamber 184. This is illustrated in FIG. 20A. When the sensor applicator system is deployed such that the coupling of the sensor upper and lower housings 170, 200 causes the power switch 240 (shown in FIG. 44 ) on the electronic circuit 230 to exert a biasing tension on the power actuator 175, which in turn maintains the biasing tension on the power switch 240.

[0072] 19 and 20 are cross-sectional views of the sensor lower housing 170 of FIG 17 taken along lines F19-F19 and F20-F20, respectively, which more clearly show the inwardly facing lower housing locking element 174, the lower housing retention recess 178, and the power actuator 175.

[0073] 21 and 22 are top and bottom plan views, respectively, of the lower sensor housing 170. In this embodiment, there are three openings 176: air vents 176a, 176b, and a sensor opening 176c. The sensor opening 176c is for accommodating the subcutaneous sensor 250 when the sensor applicator is deployed. Openings 176a and 176b are optional and allow air to be blown across the patient's skin to remove trapped moisture from the sensor housing 170.

[0074] 23-29, various views of one embodiment of the insert assembly housing 110 are illustrated. Figures 23 and 24 are front perspective and front plan views of the insert assembly housing 110. The insert assembly housing 110 has an assembly housing body 112, an open housing distal end 113, a closed housing proximal end 114, an assembly housing bottom 115, and a peripheral assembly wall 111 that defines an assembly housing chamber 118. The peripheral assembly wall 111 houses the button retaining arms 60 that face outward when the insert assembly housing 110 is assembled to the deployment button 50, and the open housing distal end 113 and closed housing proximal end 114 define an assembly housing chamber 118. 2 and 3. The insert assembly housing 110 has an assembly housing locking slot 130 spaced from the distal end 113. When the insert assembly housing 110 is inserted and retained within the deployment button 50, it remains locked within the deployment button 50 and moves with the deployment button 50 at all times.

[0075] The peripheral assembly wall 111 also has a number of assembly housing retention arms 120. Each of the retention arms 120 includes an outwardly facing housing arm hook surface 121. The retention arms 120 latch into the first face recess 33 of the elongated camming wall to lock the insert assembly housing 110 within the applicator housing 21. This effectively locks the deployment button 50 to the applicator housing 21 with the button retention arm 60 of the deployment button 50 locking into the assembly housing locking slot 130 of the peripheral assembly wall 111 of the insert assembly housing 110. During deployment of the sensor applicator system, each of the assembly housing retention arms 120 slides along the elongated camming wall from the first face recess 33 when ready for use to the second face recess 35 when in the deployed orientation.

[0076] Another aspect of the assembly peripheral wall 111 is that it has a plurality of housing retention fingers 124. Each of the retention fingers 124 has an inwardly facing finger hook surface 125. Each of the retention fingers 124 extends below the assembly housing bottom 115 to retain the sensor-on-housing 200 when the sensor applicator system 10 is in a ready-to-use orientation. The peripheral wall 111 also has a needle assembly locking slot 132 that extends a predetermined distance from the closed housing proximal end 114 toward the open housing distal end 113. The needle assembly locking slot 132 is for receiving the applicator assembly housing stop 38 of the applicator housing 21 and will interact with a needle assembly 140 (described below) when the sensor applicator system 10 is deployed to insert a subcutaneous sensor 250.

[0077] 25 and 26, cross-sectional views of the insert assembly housing 110 are shown taken along lines F25-F25 and F26-F26, respectively. As shown in these figures, the assembly housing bottom 115 is recessed to accommodate the sensor-on-housing 200. A plurality of housing retention fingers 124 retain the sensor-on-housing 200 within the recessed housing bottom 115 until released by actuation of the sensor applicator system 10.

[0078] 27 and 28 are top and bottom views of the insertion assembly housing 110. In these figures, it is clearly shown that the outwardly facing housing arm hook surface 121 of the assembly housing retaining arm 120 extends beyond the circumference of the assembly peripheral wall 111 to engage the elongated cam wall surface 32 of the applicator housing 21. These figures also illustrate the presence of a housing proximal end opening 116 for receiving the needle 155 of the needle assembly 140. Also shown is at least one optional assembly housing rail 117, which also extends along the main portion of the assembly peripheral wall 111 between the open housing distal end 113 and the closed housing proximal end 114 and beyond the circumference of the assembly peripheral wall 111. If included, this optional rail 117 is disposed within a corresponding applicator housing groove 29 to facilitate alignment of the insertion assembly housing 110 within the applicator housing 21. FIG. 29 is a bottom perspective view of insertion assembly housing 110 to visualize the structural relationship of assembly housing bottom 115, assembly housing retaining arms 120, housing retaining fingers 124, and needle assembly locking slots 132.

[0079] 30-35, various views of one embodiment of needle assembly 140 are illustrated. Figures 30 and 31 are front perspective and front plan views of needle assembly 140. 40 includes a needle body 142 and a tubular needle 155 with a needle wall 155a (not shown) fixedly attached to the needle body 142. Here, the tubular needle 155 defines a needle axis L2 (shown in FIGS. 32 and 32).

[0080] 32 and 33 are cross-sectional views of the needle assembly of FIG. 30 taken along lines 32-32 and 33-33, respectively. A needle 155 is positioned in alignment with the housing proximal end opening 116 of the insertion assembly housing 110. The needle body 142 has a closed needle body distal end 143, an open needle body proximal end 144, a needle body top 145, a needle body retaining arm 150, and a needle housing 154. The needle 155 has a needle wall 155a forming a needle body 156 with a needle distal end 157 and a needle proximal end 158. The needle distal end 157 is secured to the needle housing 154 of the needle body 142. More specifically, the needle is secured to the needle housing 154, which is firm and durable. A possible fastening material is UV epoxy. This fixation is important because the portion of the needle wall that is removed must be precisely aligned with the sensor 250. The needle proximal end 158 has a needle sharp 159.

[0081] The needle 155 has a needle release area 156a where a portion of the needle wall 155a is removed. The needle release area 156a extends a predetermined distance from the needle proximal end 158. The needle release area 156a is necessary to accommodate the sensor 150 and retract the needle 155 after the sensor 150 is deployed subcutaneously. FIG. 32 shows the structure of the needle body holding arm 150, where the holding arm 150 has an outwardly facing needle holding arm hook surface 151 that extends beyond the needle body peripheral wall 141 when the needle body holding arm 150 is in a relaxed state. The needle body holding arm 150 is flexible and configured to be compressed toward and into the needle body peripheral wall 141. FIG. 33 shows one embodiment of the needle housing portion 154 of the needle body 142. The needle receiving portion 154 is configured to define a range within which the biasing element 149 resides between the closed needle body distal end 143 and the closed housing proximal end 114 of the insertion assembly housing 110. When the needle assembly 140 is assembled inside the assembly housing chamber 118 of the insertion assembly housing 110, the biasing element 149 is in a compressed state and the needle body retaining arm 150 is positioned and retained thereby in the needle assembly locking slot 132 of the insertion assembly housing 110 until released by interference with the applicator assembly housing stop 38 of the applicator housing 21 when the deployment button assembly 40 is deployed to insert the sensor 250 subcutaneously. When the applicator assembly housing stop 38 presses the needle body retaining arm 150 into the needle body 142, the biasing element 149 transitions to a less compressed state which causes the needle assembly 140 to slide toward the open housing distal end 113, thereby retracting the needle 155 away from the over-sensor housing 200.

[0082] 34 and 35 are top and bottom views of the needle assembly 140. These views illustrate the position of the needle body retaining arm 150 relative to the needle body 142. The needle body groove 146 is also shown and is included for two reasons: (a) to prevent inadvertent disengagement of the button retaining arm 60, which faces outwardly of the deployment button 50, from the assembly housing locking slot 130, and (b) to prevent possible interference with the needle body 142 as it slides up toward the deployment button top 55 after the sensor 250 is implanted in the subcutaneous tissue. In the bottom view, the profile 149a of the biasing element 149 is shown to show the relative position of the biasing element 149 relative to the inner top surface of the needle body top 145.

[0083] 36 and 37, there are illustrated a front, top, perspective view and a rear, bottom perspective view of one embodiment of the sensor-on-housing 200 including the electrical sensor assembly 220. The electrical sensor assembly 220 includes an electronic circuit 230 and a sensor 250. FIG. 36 shows the subcutaneous sensor 250 extending a predetermined distance below the sensor-on-housing 200. FIG. 37 shows the electrical sensor assembly 220 remaining within the sensor-on-housing 200. After the electrical sensor assembly 220 is assembled within the sensor-on-housing 200, a potting compound 215 is applied to the sensor 250. The potting compound 215 is applied to the upper housing 200 by an automated dispenser (not shown). The potting compound 215 is poured until it seeps under the electronic circuitry 230 and the potting compound 215 is even at the base of the actuation switch 240 (shown in FIG. 44) and spreads around the inside of the sensor-over-housing 200 and electronic circuit-holding portion 209. The potting compound is typically a waterproof material and is preferably a two-part fast-curing material. FIG. 36A is an exploded view of FIG. 36 showing the electrical sensor assembly 220 and the sensor-over-housing 200.

[0084] 38, 38A, and 39 are respectively a front perspective view, a close-up view of the upper housing retention recess, and a front plan view of the sensor upper housing 200. The sensor upper housing 200 has an upper housing top 205, an upper housing top opening 206, a circumferential upper housing wall 207 extending perpendicularly away from the upper housing top 205 and defining an upper housing chamber 212 (shown in FIGS. 40 and 41), and a housing top flange portion 208 extending perpendicularly from the upper housing top 205 beyond the circumferential upper housing wall 207. The circumferential upper housing wall 207 also includes an upper housing locking recess 210 adjacent the housing top flange portion 208. The upper housing locking recess 210 is positioned to lock into engagement with a corresponding lower housing locking element 174 when combined and deployed on a user's skin to form the sensor module 160. On the inside of the circumferential upper housing wall 207 is at least one electronics retaining portion 209 which retains the electronics 230 within the upper housing chamber 212 .

[0085] 40 and 41 are cross-sectional views of the sensor-on-housing of FIG. 38 taken along line F40-F40 and line F41-F41, respectively. A tubular upper housing needle guide 211 descends from the upper housing top opening 206. The upper housing needle guide 211 has a guide distal end 211a and a guide proximal end 211b. Additionally, the needle guide 211 extends a predetermined distance such that when the sensor-on-housing 200 is mated with the sensor-on-housing 170, the guide proximal end 211b of the upper housing needle guide 211 does not extend further than the lower housing bottom 172. The guide proximal end 211b has a portion 211c removed to accommodate the sensor 250. The sensor 250 has a bend located within this portion 211c such that a portion of the sensor 250 is located within the needle release area of ​​the needle 155. 41 is a cross-sectional view of the sensor upper housing of FIG. 38 taken along line F41-F41, showing the upper housing locking recess 210. FIG.

[0086] Proceeding to Figures 42 and 43, the electronic circuit 230 is illustrated without the sensor 250. Figure 42 is a bottom perspective view and Figure 43 is a top perspective view. Figure 43 clearly shows the battery 235 which delivers power to the electronic circuit 230. Figure 42 shows the circuit power switch 240 in a normal off position. Figure 44 is an enlarged view of the area F44 defined in Figure 42. The circuit power switch 240 is frusto-conical in shape near the top of the electronic components of the electronic circuit 230. The circuit power switch 240 is disposed on the electronic circuit 230 and engages with the power actuator 175 of the sensor lower housing 170 when the sensor upper housing 200 and the sensor lower housing 170 are engaged during operation and deployment of the sensor applicator system. When engaged, the power actuator 175 presses against the circuit power switch 240, which then couples power from the battery 232 to the electronic circuit 230 and the sensor 250. When this movement occurs, the sensor module 160 automatically powers on. That is, this action occurs automatically when the sensor applicator system 10 is deployed, the sensor module 160 is deployed on the user's skin, and the sensor is implanted subcutaneously. The electronic circuitry 230 also includes electronic components, such as a transmitter (not shown) for wireless communication of the sensor and other data with the electronic device 902, such as devices described below.

[0087] 45 and 46 are front and rear views, respectively, of one embodiment of a sensor 250. Sensor 250 includes a sensor distal end 260, a sensor intermediate section 270, and a sensor proximal section 280. The sensor distal end 260 has a plurality of contact pads 262 that are electrically coupled to the electronic circuitry 230. The sensor proximal portion 280 along with a portion of the sensor intermediate portion 270 are implanted subcutaneously within the skin of a user / patient. A plurality of electrodes 282 are exposed at the sensor proximal portion 280, at least one of the plurality of electrodes 282 configured to measure an analyte, such as glucose. When others of the plurality of electrodes 282 are so configured, one or more analytes may be measured. In this embodiment, the sensor 250 has a bend such that the sensor proximal portion 280 is transverse, preferably perpendicular, to the sensor distal end 260.

[0088] 47 is a close-up, rear view of the sensor 250 showing the sensor proximal portion 280 and multiple electrodes 282 with the sensor distal end 260 extending away from the viewer and into the plane of the figure. As can be seen, this embodiment of the sensor 250 has one or more frictional surfaces 284 that appear like bumps along the side of the sensor proximal portion 280. These "bumps" contact the inner surface of the needle wall 155a in the needle release area 156a. The frictional contact between the sensor proximal portion 280 and the needle wall 155a and the size of the sensor 250 allow the needle 155 to penetrate the user's skin and implant the sensor proximal portion 280 subcutaneously without damaging the sensor proximal portion 280 or any part of the sensor 250, and then the needle 155 can be retracted with the sensor proximal portion 280 still implanted.

[0089] Proceeding to Figures 48-62, the operation of the sensor applicator system 10 in a fully-contained and ready-to-use state is described. Figures 48 and 49 are cross-sectional views of the applicator system 10 in a fully-contained state. Figure 48 is a left-side cross-sectional view of the applicator system 10 of Figure 1 taken along line F48-F48 in Figure 1, showing the applicator system 10 in a fully-contained state. As shown, the sensor applicator system 10 is packaged and fully-contained, ready to use. Thus, the user does not need to assemble the "sensor module" to the automatic inserter, nor does the user need to physically connect a power source to the sensor module to operate it (i.e., to power the electronics and sensors). In this fully-contained and ready-to-use position, the needle assembly 140 is coupled within the insertion assembly housing 110 with the biasing element 149 in a compressed state that stores potential energy that is used to retract the needle 155 once deployed. The sensor-top housing 200 is held at the closed proximal end 114 of the insertion assembly housing 110. The needle 155 extends through the upper housing needle guide 211 towards the sensor-bottom housing 170, where the needle proximal end 158 is directly aligned with and located near the sensor opening 176c of the sensor-bottom housing 170. FIG. 49 is a front cross-sectional view of the applicator system of FIG. 1 taken along line F49-F49 of FIG. 1. This view shows the outwardly facing button retaining arms of the deployment button 50 engaged with the assembly housing locking slots 130 of the insertion assembly housing 110. This is more clearly illustrated in FIG. 50A, which is an enlarged view within the area defined by F50A of FIG. 49. This view also illustrates the inwardly facing applicator housing retaining arms 30 coupled to the housing locking recesses 178 to retain the sensor-bottom housing 170 in the applicator housing 21. This is more clearly illustrated in FIG. 50B, which is an enlarged view within the area defined by F50b in FIG.

[0090] 51 and 53 are cross-sectional views of the applicator system 10 in a deployed orientation just prior to complete implantation of the sensor 250, before the needle 155 is retracted and before the upper and lower housings, 200, are mated together. The purpose is to show the spatial relationship of the associated retention arms and corresponding locking recesses of the various components. At substantially the same time, the sensor module 160 is complete, the needle 155 and the sensor 250 are in the subcutaneous tissue of the user, the needle assembly 140 is automatically retracted, and the sensor module 160 is released from the applicator housing 21. FIG. 51 is a left cross-sectional view of the applicator system of FIG. 48, showing the applicator system partially deployed, just short of full deployment. FIG. 52 is an enlarged view within the area defined by F52 in FIG. 51, showing the needle head 155 and the sensor 250 in the subcutaneous tissue of the user. FIG 53 is a front cross-sectional view of the applicator system of FIG 51 showing the closed housing proximal end 114 of the insertion assembly housing 110 contacting the inwardly facing applicator housing retaining arm 30. FIG 54 is an enlarged view within the area defined by F54 in FIG 53.

[0091] 55 and 57 are cross-sectional views of the applicator system 10 in a deployed orientation upon completion of implantation of the sensor 250. FIG. 55 is a left cross-sectional view of the applicator system of FIG. 48, showing the applicator system 10 fully deployed with the needle assembly 140 retracted into the insertion assembly housing 110. As shown, the sensor-upper housing 170 is mated with the sensor-lower housing 200, and the needle assembly 140 has been moved by the kinetic energy of the released biasing element 149. The needle body upper portion 145 now contacts the deployment button upper portion 55. FIG. 56 is an enlarged view within the area defined by F56 of FIG. 55. FIG. 55 more clearly illustrates the contact between the needle body upper portion 145 and the deployment button upper portion 55. FIG. 57 is a front cross-sectional view of the applicator system 10 of FIG. 55 fully deployed. In this view, the closed housing proximal end 114 contacts the inward facing applicator housing retaining arm 30 and, at its most advanced point, pushes the retaining arm 30 completely away from the sensor sub-housing 170, releasing the now-formed sensor module 160 from the applicator module 15. FIG. 58 is an enlarged view within the area defined by F58 in FIG. 57, more clearly showing how the retaining arm 30 is released from the sensor sub-housing 170.

[0092] 59 and 60 are cross-sectional views of the assembly housing retention arm 120 and the elongated camming wall 32 of the applicator housing 21 in the ready-to-use and fully deployed orientations. In the ready-to-use orientation, sufficient force is required on the deployment button 50 to overcome the resistance force created by the first ramped surface 34a of the camming wall 32. The first ramped surface 34a urges the assembly housing retention arm 120 towards the assembly housing chamber 118 (i.e., sliding on / along the first ramped surface 34a) until the assembly housing retention arm 120 reaches the second ramped surface 34b of the camming wall 32. The initial force applied to the deployment button 50 combined with the force of the biased arm 120 causes the deployment button to continue to move to its fully deployed position without the need for any further force as the assembly housing retention arm 120 follows along the second angled surface 34b and the camming surface 36 which continues to slope away (i.e., outwardly) from the applicator housing chamber 28 until the assembly housing retention arm 120 reaches the second surface recess 35 of the elongated camming wall 32. At this point, downward movement of the deployment button assembly 50 stops as the sensor module 160 is fully deployed.

[0093] 61 and 62 are right side and front plan views of a fully deployed sensor applicator system 10, illustrating the sensor module 160 deployed and separated from the applicator module 15 with the sensor 250 deployed subcutaneously within the skin of a user / patient.

[0094] Needle / Sharp Part 63 and 64 are perspective views of one embodiment of a needle / sharp 300 of the present invention. Needle / sharp 300 has a sharp body 302, a sharp open area 304, and a sharp tip 306. Sharp body 302 is a circular portion of sharp 300 that extends longitudinally and defines an enclosed tube 301 therethrough.

[0095] A wire EDM machining operation or a laser operation is used to remove a portion of the tubular wall 303 along the sharp 300 a predetermined distance to define a sharp open area 304. This reduces the overall height 310 of the sharp 300. Both the wire EDM machining operation and the laser operation remove a portion of the tubular wall 303 along the sharp 300 a predetermined distance to define a sharp open area 304. This reduces the overall height 310 of the sharp 300. The sharp open area 304 is part of a longitudinally extending annulus with the tubular wall 303 along the length of the sharp open area 304 and defines a recessed hole 314 from the sharp tip 306 that is not covered by the sharp body 302. The recessed hole 314 is sized to accommodate the continuous measurement sensor 250.

[0096] CGM system 65 and 66, one embodiment of a CGM system 1000 of the present invention is illustrated. The CGM system 100 includes a subcutaneous analyte sensor applicator 10 and electronics 900, 902 equipped for wireless communication. The adhesive pad 14, which is welded only to the bottom of the under-sensor housing 170, also has an adhesive layer on the opposite side of the adhesive pad 14 that overlaps with the bottom of the proximal outer body flange portion 27 of the applicator housing 21 for adhesive attachment of the applicator module 15 to the patient's skin. This is illustrated in FIG. 1B.

[0097] FIG 66 illustrates one embodiment of the system 1000 in use after insertion of the sensor 250 into the subcutaneous tissue. As shown, FIG 66 illustrates one example of the electronics 902, 902', and transmitter 1004 (which is a sensor module 160 including the sub-sensor housing 170, the supra-sensor housing 200, and the electrical sensor assembly 220) on a patient's arm. The transmitter 1004 communicates analyte measurement data from the continuous measurement sensor 250 (deployed subcutaneously within the patient) to the electronics 902. This data is displayed to the user at the user interface 918.

[0098] The system 1000 also includes system software installed on the electronic device 902 that is equipped for wireless communication with the transmitter 1004. Optionally, the system 1000 utilizes a calibration sample strip reader 906 (not shown) that can wirelessly communicate with the electronic device 902. Although a smartphone with software is shown, it is understood that these electronic devices may be dedicated smartphone-sized readers / meters or integrated meters that include dedicated continuous glucose measurement meters integrated with blood glucose meters for calibration. Examples of the electronic device 902 include computers, tablet computers, smartphones, data loggers, watches, automobile information / entertainment systems, or other electronic devices. Wireless communication may be via radio frequency (RF) communication, Wi-Fi, Bluetooth, Near Field Communication (NFC), sensor radio, Mobile Body Area Network (MBAN), or other wireless communication protocols. In this embodiment employing a strip reader 906, the strip reader 906 has integrated BLE (BlueTooth Low energy) and wirelessly sends calibration data to the electronic device 902 and queries the patient as to their willingness to use the new calibration data points.

[0099] In one embodiment, the transmitter 1004 communicates with the electronic device 902 using a wireless PAN (WPAN) such as Bluetooth Low Energy (BLE). In other embodiments, the communications may use other wireless communication protocols that are generally effective within ranges of a few centimeters to a few meters. In some embodiments, for example, the system software is configured to communicate using the Android and / or Apple software platform installed on a mobile phone or the like, and has a range of up to 30 feet.

[0100] In one embodiment, the transmitter 1004 is designed to conserve power and operate via a standard Bluetooth BLE protocol. For example, sensor readings from the continuous measurement sensor 250 are transmitted from the transmitter 1004 every five minutes, and the sensor readings are displayed to the user promptly after being received by the user's electronic device 902. Typically, the transmitter 1004 will successfully connect with the electronic device 902 after one or two attempts. .

[0101] In one embodiment, the system 100 uses a universally unique identifier (UUID) filter to avoid unwanted communications from other devices. It is expected that multiple devices may be present and detected near the electronic device 902, especially if the user is in a dense area, such as a subway, concert, or other public place.

[0102] In one embodiment, the system 1000 utilizes calibration data obtained wirelessly from another strip reader. For example, a finger reading for glucose is taken and then manually or automatically entered into the system 1000 for calibration. In one embodiment, the software app of the system 1000 has a means for the user to manually enter a one-point calibration value obtained from any meter. For example, the user uses the interface of the electronics 902 to enter a calibration reading of 100 mg / dl obtained using another strip reader. After entering the calibration data, the user can accept, reject, or manually re-enter the calibration data. In another embodiment, the system software receives BLE calibration information from an external meter. After the system 1000 receives the calibration data, the user can accept, reject, or manually re-enter the calibration data into the user interface.

[0103] The system software provides a user interface 918, an example of which is a touch-sensitive display screen. In one embodiment, the user interface 918 has a main screen 909 with indicators 910a for radio strength and battery strength. Other indicators 910b display the analyte concentration (e.g., glucose concentration) in units such as mg / dL (milligrams per deciliter) or mmol / L (millimoles per liter). Indicator 910c displays a glucose trend arrow to communicate to the user whether the analyte concentration (e.g., glucose) is increasing, decreasing, or unchanged. In one embodiment, the trend arrow indicator 901c also indicates the relative rate of change.

[0104] In one embodiment, for example, a rate of change having an absolute value equal to or greater than a predetermined value (e.g., 3 mg / dL / min or greater) is displayed as two vertically oriented arrows (up or down), a rate of change in a second predetermined region having an absolute value less than the predetermined value (e.g., 2-3 mg / dL / min) is displayed as one vertically oriented arrow (up or down), a rate of change in a third predetermined region having an absolute value less than the second predetermined region (e.g., 1-2 mg / dL / min) is displayed as a horizontally tilted 45 degree arrow (up or down), and a rate of change in a fourth predetermined region having an absolute value less than the absolute value of the third predetermined region (e.g., 1 mg / dL / min or less) is displayed as a horizontal arrow to indicate steady state. In one embodiment, the rate of change is calculated based on five consecutive data points using the following formula:

[0105]

number

[0106] In one embodiment, the analyte (e.g., glucose) concentration is updated every minute with data from the transmitter 1004 and displayed on the main screen 909. Optionally, the transmitted data is updated every minute if the electronic device 902 is out of range or otherwise unavailable for reception. If so, the data is updated and stored within the transmitter 1004. In one embodiment, each transmission by the transmitter 1004 includes a predetermined number of previous data points (e.g., 5) to fill in the missing data if the electronic device 902 is unable to receive in the meantime.

[0107] The main screen 909 also displays a plot of analyte concentration versus time 911. In one embodiment, the Y-axis (analyte concentration) is configured to automatically scale with a minimum Y-axis value 10% below the minimum value of the plotted data and a maximum Y-axis value 10% above the maximum value of the plotted data. The X-axis may be configured to display a user selected time frame.

[0108] The main screen 909 also displays a macro timescale 912 of data that includes the data displayed in plot 911. A portion of the data displayed in the macro timescale 912 is highlighted and corresponds to the data displayed in the plot 911. For example, the macro timescale 912 may be configured to display analyte concentration data over a 3 hour, 6 hour, 12 hour, 24 hour, 3 day, or 1 week period. Thus, the data displayed in the plot 911 is a subset of the data displayed in the macro timescale 912. In one embodiment, the highlight region 913 of the macro timescale 912 is an active element of the user interface 918. For example, touching the highlight region 913 in the middle and dragging left and right selects and moves the data in the plot 911. Similarly, touching the highlight region 913 at the left edge 913a or right edge 913b and dragging left and right expands or contracts the highlight region 913 along the time axis. When the size or position of the highlighted region 913 is adjusted, the plot 911 automatically updates to display data between the same minimum and maximum times of the highlighted region 913. The main screen 909 also displays an active service icon 915. Selecting the active service icon 915 displays a service screen with indicators 910 for calibration and customization. For example, the service screen includes indicators 910 for setting upper and lower bounds, alarm limits, display units, device pairing settings, time frame, x-axis time range, etc. For example, a user accesses the service screen to set the macro timescale 912 and the time range of data displayed in the plot 911. Selecting the calibration icon opens a calibration screen that is used to calibrate the analyte data. In some embodiments, the service screen includes instructions for use and a link to access the instructions.

[0109] For example, user set or default values ​​for maximum and minimum concentration / control limits are displayed on plot 911 as dashed lines 916a, 916b, respectively, running horizontally. In one embodiment, user set control limits are not alerted. Default control limits provide upper and lower alarm limits and upper and lower reportable range limits. As a result, readings greater than maximum value 916a or less than minimum value 916b are alerted, such as by vibration or an audible alert to the user. In one embodiment, maximum concentration limit 916a has a default value of 510 mg / dL and minimum concentration limit 916b has a default value of 90 mg / dL.

[0110] In some embodiments, the system software may be configured to generate reports for a healthcare professional. For example, touching an icon opens a report or configuration that can be forwarded to a healthcare professional via the cloud, such as time above and below target ranges, alert reports, CGM values, predicted A1C and eAG values, sample measurements per hour, etc.

[0111] In one embodiment, the system 1000 allows a user to manually enter a one-point calibration value from another glucose strip reader. For example, a user may enter 100 mg / dl as obtained from a test strip measurement. After entering the calibration value, the patient may accept, reject, or manually delete the calibration data. Re-enter the user interface.

[0112] In other embodiments, the system 1000 is configured to receive the calibration information from the strip reader via BLE or other wireless communication protocols.

[0113] In some embodiments, the settings and preferences may be locked and only accessible by entering a password, biometric information, or other information that acts as a key to unlock the settings and preferences menu.

[0114] In one embodiment, the system 1000 performs general data operations using the following general variable labels: A0=(M*X+B)-(N*Y+C) A1=A0+calibration adjustment A2=A1 / 18.018018 X=((Channel 0>*0.000494)-1)*1000 Y=((channel1>*0.000494)-1)*1000 The general variables are defined as follows:

[0115] A0 is the uncalibrated CGM value in mg / dL. A1 is the calibrated displayed CGM value in mg / dL. A2 is the calibrated displayed CGM value in mmol / L (alternative part).

[0116] X is the mV reading output on channel 0 (sensor signal channel). M is the slope correction factor for channel 0. B is the offset correction factor for channel 0.

[0117] Y is the mv read output of channel 1 (blank signal channel). N is the slope correction factor for channel 1. C is the offset correction factor for channel 1.

[0118] In one embodiment, the values ​​of the M, B, N, and C variables are stored in the electronic device 902. In one embodiment, the values ​​A0, A1, X, and Y are stored in a Sqlite database along with data timestamps, such as date, channel-0-value, channel-1-value, calculated-glucose-value, calculated-glucose-value-calibration, and device-id. Optionally, a separate database contains patient entered calibration data with timestamps such as date, entered-calibration-value, and device-id.

[0119] In one embodiment, values ​​of A1 or A2 (displayed to the patient in plot 911) that are greater than a predetermined maximum limit (e.g., 500 mg / dL or 27.7 mmol / L) will result in an error message displayed to the user interface 918, such as "Above Reporting Range." Similarly, values ​​of A1 or A2 that are less than a predetermined minimum limit (e.g., 40 gm / dL or 2.2 mmol / L) will result in an error message displayed to the user, such as "Below Reporting Range."

[0120] Communications between the transmitter 1004 and the electronic device 902 are secure. For example, the BLE supported security management protocol is used between the transmitter 1004 and the electronic device 902. SMP defines procedures and behaviors for managing pairing, authentication, and encryption between devices, including encryption and authentication, pairing and bonding, key generation for device ID verification, data signing, encryption, and pairing methods based on the input / output capabilities of the transmitter 1004 and the electronic device 902. To define.

[0121] In one embodiment, the electronic device 902 is a watch configured to wirelessly communicate with the transmitter 1004. In such an embodiment, the system software includes three screens on the user interface 918 of the electronic device 902' configured as a watch. The first screen displays the current analyte concentration and units of measurement. For example, the glucose concentration is displayed by indicator 910b in mg / dL or mmol / L and is updated every five minutes. The trend arrow indicator 910c shows the relative rate of change as described above.

[0122] The second screen displays the most recent glucose concentration and units of measurement. The second screen displays a plot 911 using the previous hour of analyte concentration data, with the Y-axis being glucose concentration and the X-axis being time. Upper and lower limits 916a, 916b are displayed as dashed lines. The third screen displays a macro timescale 912 using 24 hours of acquired data.

[0123] Sensor structure 67 is a perspective view of one embodiment of a multi-layered sensor assembly 500 ready for reagent deposition to produce a continuous measurement sensor 250. In this embodiment, the multi-layered sensor assembly 500 includes a reference electrode 534, a blank or second working electrode 533, a counter electrode 532, and a first working electrode 530. The electrodes 530, 532, 533, 534 are formed at the substrate distal end 502 and are in electrical communication through conductive contact pads 503 at the substrate proximal end 501 and the assembly middle portion 530. The multi-layered sensor substrate 500 is useful for forming subcutaneous analyte sensors, such as glucose measurement sensors.

[0124] A sensing layer (not shown) is formed on each of the first and second working electrodes 530, 533. The sensing layer can be made of three coating layers: a base coating layer, a second coating layer, and a third or top coating layer. The base coating layer is a coating comprising poly-2-hydroxyethyl methacrylate (PHEMA) that is disposed directly on the exposed metal at the bottom of each hole in the substrate distal end 502. Specific to the first working electrode measuring glucose, glucose oxidase and / or glucose dehydrogenase are also included. The second working electrode or blank electrode does not contain enzymes and is used only to measure background noise and / or interference in the sample. This is because the first working electrode has a total current, including a portion driven by the amount of glucose in the subcutaneous tissue, as well as a background noise and / or interference derived current. An algorithm can be used to subtract the current derived from the second working electrode or blank electrode from the first working electrode to provide a more accurate glucose measurement. The second coating layer is disposed directly on the base coating layer and includes a plurality of microspheres made of PHEMA and polydimethylsiloxane (PDMS). PDMS is a material that is substantially non-permeable to glucose, but substantially highly permeable to oxygen. The third or top coating layer is disposed directly on the second coating layer and includes PHEMA and catalase. The catalase is a material that prevents hydrogen peroxide from the detection layer from being released into the surrounding environment, in this case the surrounding subcutaneous tissue. For the reference electrode 534, a silver-silver chloride (AgCl) layer is formed on the metal at the bottom of the hole, and then the AgCl layer is covered by a hydrogel film. The counter electrode 532 has a metal at the bottom of the hole covered only by a hydrogel film.

[0125] 68, a perspective close-up view shows base layer 510, middle layer 550, and top layer 580, which make up multi-layer sensor substrate 500. By "middle layer" herein is meant a layer adjacent to top layer 580 without an intervening electrically insulating layer, if there is another layer between base layer 510 and middle layer 550. Base layer 510 is electrically insulating and has a substrate proximal end 514 and a substrate distal end 516, and a substrate proximal end 514 and a substrate distal end 516. and a substrate intermediate portion 518 between the substrate proximal end 514 and the substrate distal end 516. The substrate metallization layer 520 is disposed on the base layer 510 and defines at least one circuit 552 extending longitudinally along the base layer 510. Each circuit 552 has a conductive contact pad 524 formed on the substrate proximal end 514, a conductive contact pad 526 formed on the substrate distal end 516, and a conductive trace 528 electrically coupling the conductive contact pad 524 of the substrate proximal end 514 to the conductive pad 526 of the substrate distal end 516.

[0126] Intermediate layer 550, also electrically insulating, is disposed on base layer 510 and has an intermediate layer proximal end 554, an intermediate layer distal end 556, and an intermediate layer intermediate portion 558. Intermediate layer 550 has a size and shape corresponding to base layer 520 and aligns with base layer 510. Intermediate layer 550 has conductive contact pads 560 at intermediate layer distal end 556 adapted to receive electrode material or reagents to form respective electrodes. Each of the conductive contact pads 562 at intermediate layer proximal end 554 is adapted to receive an electrical contact.

[0127] Top layer 580 is also electrically insulating and disposed on middle layer 550. Top layer 580 has a size and shape corresponding to middle layer 550 and base layer 510. Top layer 580 has top layer proximal end 582, top layer distal end 584, and top layer middle portion 586, where top layer 580 aligns with base layer 510 and middle layer 550. Top layer 580 has a number of openings, including contact opening 590 on substrate proximal end 501 and sensor hole 592 on substrate distal end 502. Contact opening 590 and sensor hole 592 align with conductive contact pads 560 and 562, respectively, of middle layer 550. The base layer 510, middle layer 550, and top layer 580 are fabricated with circuitry 552 on base layer 510 and circuitry 572 on middle layer 550 to produce a multi-layer sensor substrate 500 having a substrate proximal end 501, a substrate distal end 502, and an assembly intermediate portion 503 extending longitudinally between substrate proximal end 501 and substrate distal end 502, as shown, for example, in Figure 42. Substrate distal end 502 and assembly intermediate portion 503 each have a width of approximately 279 microns.

[0128] 69-71, the base layer 510 is illustrated in plan view in FIG. 44, the substrate proximal end 514 is shown enlarged in FIG. 70, and the substrate distal end 516 is shown enlarged in FIG. 71. The base layer 510 is electrically insulating and comprises a base substrate 512 having a substrate proximal end 514, a substrate distal end 516, and a substrate intermediate portion 518 extending between and connecting the substrate proximal end 514 and the substrate distal end 516. In one embodiment, the base substrate 512 is made of polyimide and has a thickness of 7.5 μm to 12.5 μm. For example, the base substrate 512 has a thickness of about 10 μm. In one embodiment, described in more detail below, the base substrate 512 is formed by spin-coating polyimide on a glass plate, followed by lithography processing.

[0129] The substrate metallization layer 520 is disposed directly on the base substrate 512 and defines at least one circuit extending longitudinally along the base substrate 512 from the base substrate proximal end 514 to the base substrate distal end 516. In the illustrated embodiment, the substrate metallization layer 520 defines two circuits 522. The circuits 522a, 522b each have a conductive contact pad 524a, 524b formed at the substrate proximal end 514. The circuit 522a has conductive contact pads 526a1-526a2 formed at the substrate distal end 516. The circuit 522b has a conductive contact pad 526b at the distal end 516. Each of the circuits 522a, 522b includes conductive traces 528 (528a and 528b) that electrically couple the conductive contact pads 524a1-524a2, 524b at the substrate proximal end 514 to the conductive pads 526a, 526b, respectively, at the substrate distal end 516. For example, the circuit 522a is configured for a working electrode 530 of the sensor assembly 500, and the circuit 522b is configured for a blank electrode 533 of the sensor assembly 500 (shown in FIG. 67).

[0130] Each of the contact pads 526a1-526a2 is sized and shaped to correspond to one or more of the contact pads 562 of the intermediate metallization layer 550, rather than being sized solely for a through hole 564 of the intermediate layer substrate 552. An advantage of this configuration is that the contact pads 526a1-526a2 reduce stresses induced in the contact pads 562 caused by the spin coating process described below, which stresses can lead to cracking of the contact pads 562 of the intermediate metallization layer 570. In one embodiment, for example, the contact pad 526a1 is sized and shaped to substantially underlie the contact pad 562a of the intermediate metallization layer 570, but not the through hole 564c. The contact pad 526a2 is sized and shaped to substantially underlie the contact pads 562b, 562c and the through hole 564d of the intermediate metallization layer 570.

[0131] In one embodiment, the substrate metallization 520 has a total thickness of 1200±300 Å (on For example, the substrate metallization layer 520 may be formed by depositing a first portion of chromium (200±150 Å) directly on and facing the base substrate 512 and a second portion of gold (1000 A first portion of chromium (200±150 Å) is deposited directly on the chrome and a third portion of chrome (200±150 Å) is deposited directly on the gold. Thus, substrate metallization layer 520 has a thickness ranging from about 900 Å to about 1500 Å. Other conductive materials and thicknesses are acceptable for substrate metallization layer 520 depending on the intended use of sensor assembly 500.

[0132] 72-74, the intermediate layer 550 is illustrated in plan view in FIG. 72. The second proximal end 554 is shown enlarged in FIG. 73, and the second distal end 556 is shown enlarged in FIG. 74. The intermediate layer 550 has an intermediate layer substrate 552 that is electrically insulating and defines a plurality of intermediate layer through openings 564 with sidewalls extending to the base layer 510, where each of the intermediate layer through openings 564 is in electrical communication with a conductive contact pad 524, 526 of the circuit 552 of the base layer 510. In one embodiment, the intermediate layer substrate 552 is made of polyimide that is spin coated onto the base layer 510 and the substrate metallization layer 520, for example, by a method 600 for making a multi-layer sensor substrate 500, as described below. In one embodiment, the intermediate layer substrate 552 has a thickness of 7.5 μm to 12.5 μm, such as about 10 μm.

[0133] The intermediate metallization layer 570 is disposed directly on the intermediate layer substrate 552 and on the sidewalls of the through openings 564 to define at least two intermediate layer circuits 572. Each intermediate layer circuit 572 has a conductive contact pad 560 formed at the intermediate layer proximal end 554, a conductive contact pad 562 formed at the intermediate layer distal end 556, and a conductive trace 574 electrically coupling the contact pad 560 at the intermediate layer proximal end 554 to the conductive contact pad 562 at the intermediate layer proximal end 556, and at least one other conductive pad 560, 562 in electrical contact with the through opening 564. The at least one additional conductive pad 560, 562 is electrically coupled to the base layer circuit 552 by or through the through opening 564. For example, an intermediate metallization layer 570 is deposited on the top surface 550 a , the sidewalls of the through openings 564 , and a portion of the substrate metallization layer 520 to create electrical continuity between the substrate metallization layer 520 and each of the contact pads 560 , 562 .

[0134] In one embodiment of the intermediate layer proximal end 554 shown in Figure 73, for example, intermediate layer circuit 572a includes contact pad 560b and intermediate layer circuit 572b includes contact pad 560c. Contact pads 560a, 560d are isolated from intermediate layer circuit 572a, 572b. Contact pad 560a (e.g., for working electrode 130) defines two through openings 564a and contact pad 560b (e.g., for blank electrode 133) defines two through openings 564b, each having electrical communication with substrate metallization layer 520 at contact pads 524a and 524b (see Figure 70).

[0135] In one embodiment of the intermediate layer distal end 556 shown in FIG. 74, for example, intermediate layer circuit 572a includes contact pad 562a and intermediate layer circuit 572b includes contact pad 562c. Contact pads 562b, 562d are isolated from intermediate layer circuits 572a, 572b. Intermediate layer substrate 552 has through opening 564c at contact pad 562b (e.g., for blank electrode 133) that has electrical continuity to substrate metallization layer 520 at contact pad 526b (shown in FIG. 71). Intermediate layer substrate 552 defines opening 564d with contact pad 562d that has electrical continuity with contact pad 526a2 (shown in FIG. 71). Contact pads 562d, 562b are isolated from intermediate layer circuits 572a, 572b. Contact pad 562a (i.e., reference electrode 134) is segmented into three contact pad portions 562a1, 562a2, and 562a3. Reference electrode 534 is segmented to prevent the Ag / AgCl from cracking and peeling off from contact pad 562a, which is a distinct advantage in this patent when sensor 500 is implanted subcutaneously.

[0136] An advantage of the multi-layer sensor assembly 500 is the ability to construct a small width sensor that penetrates subcutaneous tissue, which can be achieved by placing all the conductive traces side-by-side on a single substrate. Because the multi-layer sensor assembly 500 utilizes multiple layers for traces, this allows for a small width by limiting each layer to one or two circuit traces.

[0137] Although preferred embodiments of the present invention are described herein, the above description is merely illustrative. Further modifications of the invention disclosed herein will occur to those skilled in the art. All such modifications are deemed to be within the scope of the present invention as defined by the appended claims.

Claims

1. A method of using a measurement system (10) comprising a sensor (250), comprising: The method comprises: A measurement system (10) comprising an applicator module (15) and a sensor module (160), comprising: a deployment button (50) for deploying the sensor module (160) is operated once by a user, and as the deployment button (50) moves from a ready position to a deployed position, an electrical sensor assembly (220) is powered within the sensor module (160) and the measurement system (10) is ready for use; placing the measurement system (10) at the target site; and operating the measurement system (10), the operating step resulting in substantially simultaneously assembling and deploying the undeployed sensor module (160) as a single unit to the target site, positioning the sensor (250), powering the electrical sensor assembly (220), and separating the applicator module (15) from the sensor module (160) and the target site; The sensor module (160) a sensor lower housing (170) having a lower housing opening (176) adapted to receive a needle (155) via actuation of said deployment button (50) and a powered actuator (175), said sensor lower housing (170) being releasably connected to the applicator housing (21) by an applicator housing retention arm (30); a sensor upper housing (200) having an upper housing upper portion (205) with a housing upper opening (206) through which the needle (155) extends, the sensor upper housing (200) being removably retained relative to the insertion assembly housing (110) and spaced from the sensor lower housing (170); an electrical sensor assembly (220) disposed within the sensor housing (200) and including an electronic circuit (230) having a circuit power switch (240) configured to provide a biasing tension by the powered actuator (175) and a sensor (250) electrically coupled to the electronic circuit (230), the sensor (250) being temporarily disposed within the needle (155) when the deployment button (50) is in the ready position; method.

2. The applicator module (15) has an applicator housing (21), The providing step includes removing an adhesive tape cover (12) from the applicator housing (21) prior to the placing step. The method of claim 1.

3. the actuating step includes depressing the deployment button (50) from the ready position on the applicator housing (21) toward the target site such that the needle (155) containing the sensor (250) penetrates the target site and inserts the sensor (250) while keeping the sensor (250) deployed, between the time when the deployment button (50) deploys to the deployed position on the applicator housing (21) and the time when the needle (155) is fully retracted into the insertion assembly housing (110) located within the deployment button (50). The method of claim 1.

4. The applicator module (15) further comprises an insertion assembly (100), the insertion assembly (100) having a needle assembly (140), the needle assembly (140) including the needle (155); the providing step includes providing a single-sided adhesive pad (14) having an adhesive pad opening (14a) and a non-adhesive side, a portion of the non-adhesive side being welded to a lower housing bottom (172) of the sensor lower housing (170) of the sensor module (160) prior to the placing step such that the adhesive pad opening (14a) of the single-sided adhesive pad (14) is aligned with a needle axis (L2) of the needle (155); The method according to claim 3.

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