Subcutaneous sample 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 generally relates to the measurement of continuous specimens. More particularly, the present invention relates to a specimen measurement system having a subcutaneous insertable specimen sensor, an automatic insertion assembly, and a reading device.

[0002] 2. Description of the Related Art Continuous specimen measurement devices have been developed for embedding in a patient's skin. Continuous measurement systems typically use a miniature implantable sensor that is inserted into the subcutaneous or subcutaneous fat layer to examine the specimen level in the tissue fluid. A transmitter transmits information about the specimen level, for example, wired to a monitor or wirelessly by radio waves from the sensor to a wireless monitor. These devices are typically implanted for a usage period of 3 to 7 days and measure the patient's glucose value 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 are disclosed. This system and method have an automatic insertion assembly for inserting a sensor into the subcutaneous tissue through the skin, and an automatic insertion housing with the sensor remains on the skin after insertion. Also, this system and method have a sensor housing cover that can be attached to the sensor housing after insertion, and this sensor housing cover includes an electronic module and a battery. This system and method also have an electronic device equipped with wireless communication for communicating with the electronic module of the sensor housing cover assembly, and this electronic device receives an input signal from the sensor, converts the input signal into specimen data, displays the specimen data on the user interface of the electronic device, stores the data for retrieval, and is configured to create and / or transmit a report of the data.

[0004] In U.S. Patent Application Publication No. 2018 / 0235520 by Vivek Rao et al., a system, apparatus, and method are provided for inserting at least a portion of an in vivo sample sensor, such as a skin sensor, to sense the level of a sample in a subject's bodily fluids. The applicator is positioned relative to the skin surface, and force is applied to the applicator so that a portion of the sharp object and the in vivo sample sensor are positioned within the subject's body. In particular, embodiments of the applicator are disclosed herein that are designed to prevent premature abrupt withdrawal and / or reduce the possibility of improper sensor insertion. Embodiments of the applicator are also disclosed that include a sharp module having an angled sharp object which may be configured to create an insertion path for the sensor.

[0005] In U.S. Patent Application Publication No. 2016 / 0058344 by Vivek Rao et al., a system, apparatus, and method relating to the assembly and subsequent dispensing of an in vivo sample sensor. An applicator having sensor electronics is inserted into a tray containing a sharp object and an assembly having a sample sensor. This insertion causes the assembly to couple with the sensor electronics, forming a retractable sensor control unit held within the applicator. The applicator can then be positioned appropriately on the user's body to measure the user's sample level.

[0006] The device described in 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. This device is used for drug delivery. An automated insertion assembly for continuous glucose monitoring with output capability, comprising a deployment button including a needle deployment mechanism having a sharp portion held in a pre-release position, and a housing body in which the deployment button is movably received within its upper end. The housing body comprises a sensor deployment assembly comprising a lumen and a sensor disposed within the lumen and extending from the lumen to a circuit board which is part of the sensor deployment assembly. The sensor deployment assembly is mated to the sharp portion, where the sharp portion extends beyond the sensor deployment assembly. The sensor deployment assembly comprises a sensor not fixedly mounted to the sharp portion and a sensor housing which is detachably received within the lower end of the housing body. The sharp portion extends within the sensor housing and directly above the sensor opening at the bottom of the sensor housing into a recess of the sensor deployment assembly.

[0007] U.S. Patent No. 10,213,139 by Vivek Rao et al. discloses a system, apparatus, and method for assembling and subsequent dispensing of an in vivo sample sensor. An applicator having sensor electronics is inserted into a tray containing an assembly having a sharp portion and a sample sensor. This insertion combines the assembly with the sensor electronics, forming a retractable sensor control unit held within the applicator. The applicator can then be placed in an appropriate location on the user's body to measure the user's degradation levels.

[0008] Manuel L. Donnay et al., U.S. Patent No. 10,010,280, discloses a device for inserting a medical device into the skin of a subject, and a method for inserting a medical device. Embodiments include removing a substantially cylindrical cap from an auto-insertion to expose a substantially cylindrical sleeve, removing a cover from a substantially cylindrical container holding a sensor component, and fitting the sensor component into the auto-insertion.

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

[0010] U.S. Patent No. 9,750,444 by Gary A. Stafford discloses a system and method for providing a compressible interconnect for enabling electrical communication between an electronic unit and a sample sensor in an on-body sample analyzer. In other embodiments, a system and method are provided for reducing the Z height of an on-body sample analyzer by utilizing a novel interconnect.

[0011] U.S. Patent No. 9,402,570 by Louis Pace et al. discloses on-body sample sensor units and associated apparatus. These apparatus include any of the following elements: a packaging and / or loading system, an applicator, and the on-body sensor itself. Also disclosed are various methods for connecting an electrochemical sample sensor to and / or within the associated on-body sample sensor unit. This connector approach involves various arrangements of proprietary sensors and auxiliary elements to facilitate the assembly of separate electronic assemblies and sensor elements, which remain separate until the end user puts them together.

[0012] U.S. Patent No. 5,299,571 by John Mastrototaro discloses an apparatus for implanting a biosensor. The apparatus includes a housing, a dual-lumen tube extending from the housing, and a biosensor housed in one lumen of the tube. A needle is housed in the other lumen of the tube and is transmitted through the skin. It is used to insert a tubing. After implantation, the needle is removed, and the flexible tube and sensor are left under the skin.

[0013] U.S. Patent Application Publication No. 2010 / 0022863 (2010, Mogensen et al.) discloses an automated inserter for a transcutaneous sensor. The automated 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, and when they are connected, the inserting needle is mounted along 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 the advanced position where the needle and sensor are positioned subcutaneously. The upwardly curved portion of the housing's legs 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 automated insertion device for a sample sensor. The device comprises a housing positioned above the subcutaneous fat layer, a blade shuttle, and a sensor shuttle. A spring is compressed between the blade shuttle and the sensor shuttle. The blade shuttle and sensor shuttle move toward the subcutaneous fat layer. When the spring force is released by the spring, the blade shuttle moves toward the subcutaneous fat layer, piercing it and creating a path into the subcutaneous fat layer. The sample sensor is embedded by the sensor shuttle by following the blade shuttle into the path created by the blade shuttle. The blade shuttle then retracts from the subcutaneous fat layer, leaving the sample sensor in the fat layer.

[0015] U.S. Patent Application Publication No. 2013 / 0256289 (Hardvary et al., 2013) discloses a diagnostic device. This diagnostic device has a partially retractable hollow guide needle for intradermal placement of a diagnostic element fixed and connected to a measuring means within the device. This eliminates the need to remove the guide needle and connect the diagnostic element to the measuring means after intradermal placement.

[0016] [Overview of the prefecture] 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 switch to the electronic sensor assembly, releasing the sensor module from the applicator module, and releasing the applicator module from the surface of the skin) when the insertion applicator is moved by the user / patient to insert the sensor subcutaneously within the patient’s skin are not perceived by the human during the sensor insertion process.

[0017] The objective of the present invention is to provide a single-use, continuous sample measurement system that includes all necessary components. The present invention achieves these and other objectives by providing a continuous sample measurement system and method comprising an applicator module for inserting a sensor into subcutaneous tissue via the skin, the sensor module being left on the skin after insertion, and an electronic display device, such as a smartphone, equipped with wireless communication for communication with the sensor module. The electronic display device is configured to receive an input signal from the sensor, convert the input signal into analyte data, display the analyte data on the user interface of the electronic device, store the data for recall, and create and / or transmit a data report. Various sensors, needles, and electronic display devices 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 specimen sensor applicator and measurement system is disclosed. The system includes an auto-insertion module and a sensor module. The auto-insertion module includes an applicator housing, a deployment button in which the applicator housing is partially housed within a button chamber, and a preloaded insertion assembly which is fully fixedly disposed within the button chamber and partially disposed within the applicator housing chamber when the deployment button is in its initial mounting 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 compressed between the needle assembly and the bottom of the assembly housing. The sensor module includes a lower sensor housing detachably connected to the applicator housing, an upper sensor housing detachably held relative to the insertion assembly housing and spaced apart from the lower sensor housing, and an electrical sensor assembly disposed within the upper sensor housing. Herein, (a) the electrical sensor assembly comprises an electronic circuit with a power switch and a sensor electrically coupled to the electronic circuit, and (b) the sensor is temporarily positioned within the needle of the needle assembly when the applicator system is in its initial preload position.

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

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

[0021] In one embodiment, the assembly housing includes an assembly housing body having an assembly periphery wall defining an assembly housing chamber; a closed proximal housing end; a housing bottom recessed to the closed proximal housing end; an open distal housing end; an assembly housing retaining arm formed on the assembly periphery wall and extending toward the closed proximal housing end; a plurality of housing retaining fingers formed on the assembly periphery wall and extending beyond the closed proximal housing end, each having an inwardly facing housing finger hook surface; an assembly housing locking slot that interacts with the button retaining arm for securing 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 relative to the recessed housing bottom of the assembly housing. In one embodiment, the needle assembly comprises a needle body having a needle body circumferential wall, a closed distal end of the needle body forming the upper part of the needle body, and an open proximal end of the needle body. Here, a needle body retaining arm is formed in the needle body circumferential wall, so that the outward-facing needle retaining arm hook surface is positioned adjacent to the closed distal end of the needle body, the needle assembly further comprises a needle housing formed in the upper part of the needle body, the needle is fixed adjacent to the distal end of the needle and extends parallel to the needle body circumferential wall for a predetermined distance beyond the open proximal end of the needle body, and a biasing element is positioned opposite the closed distal end of the needle body via the open proximal end of the needle body. The outward-facing needle is offset from the central axis of the automatic insertion applicator.

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

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

[0025] In one embodiment, the sensor upper housing has an upper housing peripheral wall extending from the upper part of the upper housing that forms a housing upper flange portion around the periphery of the upper part of the upper housing. The upper housing peripheral wall has a plurality of upper housing locking recesses adapted to mate and connect to a plurality of locking elements of the sensor lower housing.

[0026] In one embodiment, the electrical sensor assembly has a power source coupled between an electronic circuit 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 elastic deployment catches extending upward from the inner bottom surface of the sensor housing. Here, the elastic deployment catches are biased to engage the deployment catch surfaces of the one or more holes in the sensor deployment assembly.

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

[0028] Another aspect of the present invention is directed to a multilayer thin film substrate assembly used to form a subcutaneous analyte sensor. In one embodiment, the substrate assembly has a base layer made of an electrically insulating material. The base layer has a base layer substrate comprising 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 has conductive contact pads formed at the base proximal end and the base distal end respectively, and a conductive trace electrically coupling the conductive contact pad at the base proximal end to the conductive pad at the base distal end.

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

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

[0032] The upper layer made of an electrically insulating material is disposed on the intermediate layer. The upper layer has a plurality of contact openings that align with the conductive contact pads at the proximal end of the intermediate layer respectively, and a plurality of sensor openings that align with the conductive contact pads at the distal end of the intermediate layer respectively. Thereby, a substrate assembly is generated that includes 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 each electrode, and each of the conductive contact pads at the second proximal end is formed to receive an electrical contact.

[0033] In other embodiments, the multi-layer thin film substrate assembly has a plurality of intermediate layers. In another embodiment, the base layer, the circuit of the first metallized layer, the intermediate layer, the intermediate layer circuit, and the upper layer together provide a curved shape to the substrate assembly from the proximal end to the distal end of the substrate.

[0034] In another embodiment of the substrate assembly, the electrically insulating materials of the base layer, intermediate layer, and top layer are spin-formed, thermosetting polyimides. In one embodiment, for example, the base layer and the intermediate layer have a thickness of about 10 microns. In another embodiment of the substrate assembly, the top layer has a thickness of about five times that of the intermediate 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 distal end of the substrate and the middle part of the assembly each have a width of about 279 microns.

[0035] In another embodiment of the substrate assembly, the first metallized layer has a thickness ranging from about 900 angstroms to about 1500 angstroms. In other embodiments of the substrate assembly, the first and second metallized layers each contain gold. In other embodiments, the first and second metallized layers each contain layers of chromium disposed on the base substrate and the intermediate substrate, with a gold layer disposed on top of the chromium layer. In other embodiments, the second metallized layer contains a chromium layer disposed on the intermediate substrate, with a gold layer disposed on top of the chromium layer, and a platinum layer disposed on top of the gold layer.

[0036] In another embodiment of the substrate assembly, the base layer has at least two circuits, each containing a conductive pad for a circuit at the proximal and distal ends of the base layer. The intermediate layer has at least two second layer circuits, each containing a conductive pad for a second layer circuit at the proximal and distal ends of the intermediate layer. In one embodiment, for example, the first metallized layer of the base layer has at least two other conductive contact pads at the distal end of the base layer, which align with the conductive pad at the distal end of the intermediate layer.

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

[0038] The intermediate layer is disposed on the base layer and has an intermediate layer substrate made of an electrically insulating material. The intermediate layer substrate has an intermediate layer proximal end, an intermediate layer distal end, and an intermediate layer middle section. The intermediate layer is aligned with the base layer and has a plurality of second layer through-openings having side walls. Each of the plurality of second layer through-openings communicates with one of each of the conductive contact pads of at least one circuit in the base layer. The second metallized layer is disposed on the intermediate layer substrate and the side walls of the second layer through-openings. The second metallized layer defines at least two circuits, each of which has conductive contact pads formed at the intermediate layer proximal end and the intermediate layer distal end, respectively, and conductive traces that electrically couple the conductive contact pad at the intermediate layer proximal end to the conductive pad at the intermediate layer distal end. One of the at least two second layer circuits is electrically coupled to at least one circuit in the base layer by a plurality of second layer through-openings.

[0039] The upper layer of electrically insulating material is placed on top of the intermediate layer. The upper layer is located at each of the conductors at the proximal end of the intermediate layer. It has multiple contact openings that fit with conductive contact pads, and multiple sensor holes that fit with each conductive contact pad at the distal end of the intermediate layer. This generates a substrate assembly comprising a proximal end of the substrate, a distal end of the substrate, and an assembly intermediate portion that extends longitudinally between the proximal and distal ends of the substrate.

[0040] The detection layer is disposed on at least one conductive contact pad formed at the distal end of the intermediate layer to form at least one first working electrode. The reference layer is disposed on at least one conductive contact pad formed at 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, as it is used to measure background currents caused by interference in the sample rather than to measure a specific sample) are further included. In yet another embodiment, there are one or more other working electrodes adapted to measure other specific samples. In one embodiment, this at least first working electrode is a glucose measuring electrode.

[0041] In one embodiment, the detection layer has three coating layers. The base coating layer is disposed directly on the metallized pad and forms a working electrode containing PHEMA, glucose oxidase, and / or glucose dehydrogenase. The second coating layer contains PHEMA and a plurality of microspheres made of a material that is substantially impermeable to or almost impermeable to glucose but substantially permeable to oxygen. The third coating layer is disposed on top of the second coating layer and contains PHEMA and a material that prevents the release of hydrogen peroxide from the detection layer. In one embodiment, the microspheres are made of polydimethylsiloxane. In one embodiment, the third coating layer contains catalaz.

[0042] In other embodiments, the base coating layer contains PHEMA, glucose oxidase, and / or glucose dehydrogenase, and a smaller amount of microspheres than the amount of microspheres in the second coating layer.

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

[0044] In one embodiment of an electrochemical sensor assembly, the base layer substrate, the intermediate layer substrate, and the top layer substrate are each spin-formed and made of thermosetting polyimide.

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

[0046] In other embodiments of the electrochemical sensor assembly, the first metallized layer has a thickness ranging from about 900 angstroms to about 1,500 angstroms. In one embodiment, the first and second metallized layers each contain gold. In other embodiments, the first and second metallized layers each contain chromium layers disposed on a base layer substrate and an intermediate layer substrate, respectively. A layer of gold is disposed on the upper surface of the chromium layer.

[0047] In another embodiment of the electrochemical sensor assembly, the second metallized layer comprises a chromium layer disposed on an 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, with one conductive pad having a detection layer at the distal end of the intermediate layer forming the working electrode circuit, and a second conductive pad at the distal end of the intermediate layer forming the blank electrode.

[0049] In other embodiments of the electrochemical sensor assembly, the base layer has at least two circuits, and the intermediate layer has at least two circuits, each having a conductive pad for the respective distal and proximal end circuits. In other embodiments, the first metallized layer of the base layer includes at least two other conductive contact pads at the distal end of the base layer that align and fit with the conductive pad at the distal end of the intermediate layer.

[0050] Another embodiment of the present invention discloses a continuous glucose measurement system. The system comprises an automatic insertion assembly, a sensor housing cover assembly, and electronic equipment. The automatic insertion assembly comprises an automatic insertion housing, a deployment button disposed within the automatic insertion housing such that the deployment button is slidable from a first position to a second position in order to deploy a subcutaneous sensor into the subcutaneous tissue through the skin, and a sensor housing that houses and captures the sensor deployment assembly from the deployment button. The sensor deployment assembly comprises a subcutaneous sensor. The sensor housing cover assembly is configured for attachment to the sensor housing after insertion of the subcutaneous sensor, and this cover assembly has an electronic module positioned for electronic coupling to the subcutaneous sensor and capable of storing and transmitting computational data based on input signals from the sensor. The electronic equipment is equipped with wireless communication for communication with the electronic module of the sensor housing cover assembly. This electronic device has electronic circuits and software that receive input signals from the sensor, convert the input signals into sample data, store the sample data for display and retrieval on the user interface of the electronic device, and create and / or transmit data reports.

[0051] In another embodiment, the sensor of a continuous glucose measurement system has a base layer comprising a base electrical circuit and an intermediate layer comprising an intermediate electrical circuit. The intermediate layer has an opening to the base layer that electrically connects a portion of the intermediate electrical circuit to a portion of the base electrical circuit.

[0052] In another embodiment, a method for subcutaneously inserting a sensor is disclosed. This method includes providing a measurement system comprising a comprehensive single-use subcutaneous specimen sensor applicator and an auto-insertion module coupled with a sensor module. Here, the system is pre-assembled, pre-loaded, and ready for use, so that the user does not need to assemble any part of the system before placing the system on the patient's skin, and the user does not need to operate the system to power the electronic circuits in the sensor module either before or after operating the system or inserting the sensor subcutaneously. The method further includes placing the system on the patient's skin and activating the auto-insertion assembly. This activation step causes the applicator system to substantially simultaneously automate the assembly of the sensor module as a standalone unit, implant the sensor subcutaneously, retract the needle assembly, switch on the power switch for the electrical sensor assembly, release the sensor module from the applicator module, and automatically release the applicator module from the skin surface. The system involves automatically attaching a sensor module to the patient's skin as a standalone unit, implanting the sensor subcutaneously, automatically supplying power to the electronic circuit, and automatically separating the attached sensor module and the automatically inserted module from the patient's skin.

[0053] In one embodiment, the providing step includes removing the adhesive tape cover from the bottom of the applicator housing before the placement step. In one embodiment, the operation step is that the deployment button is located at a second position on the applicator housing. The method involves pressing the deployment button from its initial preload position on the applicator housing toward the animal's skin so that the needle, including the sensor, penetrates the skin and inserts the sensor while it remains deployed, while the needle is fully retracted into the assembly housing where the deployment button is located.

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

[0055] In another embodiment, a method for creating a comprehensive single-use subcutaneous specimen sensor applicator and measurement system is disclosed. The method includes forming each of the following: (a) an applicator housing defining an applicator housing chamber and an applicator housing retaining arm; (b) a deploying 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 formed in the assembly housing and having an outward-facing housing arm hook surface; (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 upper having a housing upper opening; and (h) an electrical sensor assembly having an electronic circuit having a power switch and a sensor electrically coupled to the electronic circuit. The method includes, following this formation, arranging a biasing element within the assembly housing chamber of the assembly housing; inserting a needle assembly into the assembly housing chamber so that the needle body is in contact with the biasing element; then pushing the needle body into the assembly housing chamber to compress the biasing element until the needle body retaining arm engages with the needle assembly locking slot of the assembly housing so that the needle extends beyond the closed proximal end of the housing and through the proximal end opening of the housing; inserting the coupled needle assembly, biasing element, and assembly housing into the button chamber of the deployment button until the button retaining arm of the deployment button engages with the assembly housing locking slot of the assembly housing; attaching the sensor upper housing to the assembly housing including the needle assembly and biasing element so that the needle of the needle assembly extends through the upper housing upper opening of the sensor upper housing; and inserting an electrical sensor assembly into the sensor upper housing so that the sensor is located within the needle.The assembly housing, the biasing element, the needle assembly, the upper sensor housing, and the electrical sensor assembly form a preloaded insertion assembly. The method further includes attaching the lower sensor housing to the open proximal body end of the applicator housing, and inserting a portion of the applicator housing into the button chamber by a predetermined distance such that the applicator body wall at the open distal body end of the applicator housing slides between the assembly housing and the deployment button until the assembly housing retaining arm catches on the distal applicator housing notch of the applicator body wall.

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

[0057] [Figure 1] This is a front perspective view of one embodiment of the present invention, showing a subcutaneous sensor applicator ready for use. [Figure 1B] Figure 1 is a bottom perspective view of the applicator, showing the adhesive pad. [Figure 2] Figure 1 is a front plan view of the applicator. [Figure 3] This is a left-side plan view of the applicator shown in Figure 1. [Figure 4] Figure 1 is an exploded view of the applicator. [Figure 5] This is a front perspective view of one embodiment of the applicator's deployment button. [Figure 6] Figure 5 is a front plan view of the unfolding button. [Figure 7] This is a cross-sectional view of the unfolding button in Figure 5 along the line F7-F7. [Figure 8] Cross-sectional view of the unfolding button in Figure 5 along line F8-F8. [Figure 9] Figure 5 is a top view of the unfolding button. [Figure 10] Figure 5 is a bottom view of the unfolding button. [Figure 11] Figure 4 is a front perspective view of one embodiment of the applicator housing of the applicator. [Figure 12] Figure 11 is a front plan view of the applicator housing. [Figure 13] This is a cross-sectional view of the applicator housing in Figure 11 along line F13-F13. [Figure 13A] Figure 13 is an enlarged view of one embodiment of the cam wall surface. [Figure 13B] Figure 13 is an enlarged view of the needle assembly housing stop 38. [Figure 14] This is a cross-sectional view of the applicator housing in Figure 11 along line F14-F14. [Figure 15] Figure 11 is a top view of the applicator housing. [Figure 16] Figure 11 is a bottom view of the applicator housing. [Figure 17] Figure 4 is a front perspective view of one embodiment of the sensor-lower housing of the applicator. [Figure 18] Figure 17 is a front plan view of the sensor housing. [Figure 19] This is a cross-sectional view of the sensor lower housing in Figure 17 along line F19-F19. [Figure 20] This is a cross-sectional view of the sensor lower housing in Figure 17 along line F20-F20. [Figure 20A] This is an angled perspective view of the inner bottom of the sensor lower housing, showing one embodiment of the power activator shown in Figure 20. [Figure 21] Figure 17 is a top view of the sensor housing. [Figure 22] Figure 17 is a bottom view of the sensor housing. [Figure 23] Figure 4 is a front perspective view of one embodiment of the applicator insertion assembly housing. [Figure 24] Figure 23 is a front plan view of the insert assembly housing. [Figure 25] This is a cross-sectional view of the insert assembly housing in Figure 23 along line 25-25. [Figure 26] This is a cross-sectional view of the insertion assembly housing in Figure 23 along line 26-26. [Figure 27] Figure 23 is a top view of the insert assembly housing. [Figure 28] Figure 23 is a bottom view of the insert assembly housing. [Figure 29] Figure 23 is a lower perspective view of the insertion assembly housing. [Figure 30] This is a front perspective view of one embodiment of the applicator needle assembly. [Figure 31] Figure 30 is a front plan view of the needle assembly. [Figure 32] This is a cross-sectional view of the needle assembly in Figure 30 along line F32-F32. [Figure 33] This is a cross-sectional view of the needle assembly in Figure 30 along line F33-F33. [Figure 34] Figure 30 is a top view of the needle assembly. [Figure 35] Figure 30 is a bottom view of the needle assembly. [Figure 36] This is a front, top, and perspective view of one embodiment of a sensor housing including one embodiment of an electrical sensor assembly. [Figure 36A] Figure 36 is an exploded view of the automatic insertion assembly. [Figure 37] Figure 36 is a rear, downward perspective view of the sensor housing and electrical sensor assembly. [Figure 38] Figure 36 is a front, top, and perspective view of the sensor housing. [Figure 38A] This is a magnified view of the upper housing retention recess. [Figure 39] Figure 38 is a front plan view of the sensor housing. [Figure 40] This is a cross-sectional view of the sensor housing in Figure 38 along line F40-F40. [Figure 41]This is a cross-sectional view of the sensor housing in Figure 38 along line F41-F41. [Figure 42] Figure 37 is a rear, perspective, and bottom view of one embodiment of the electronic circuit of the electrical sensor assembly shown in Figure 37. [Figure 43] Figure 42 shows the front, perspective, and top views of the electronic circuit. [Figure 44] Figure 42 shows an enlarged, perspective, and bottom view of the electronic circuit in the area depicted by F44, which indicates the power switch. [Figure 45] This is a rear-view perspective of one embodiment of the sensor in an electrical sensor assembly. [Figure 46] Figure 45 is a front perspective view of the sensor. [Figure 47] Figure 46 is an enlarged front view of the sensor. [Figure 48] This is a left-side cross-sectional view of the applicator system in Figure 1, along line F48-F48, illustrating the applicator system in a ready-to-use state. [Figure 49] This is a front cross-sectional view of the applicator system in Figure 1 along the line F49-F49 in Figure 1. [Figure 50A] Figure 49 is an enlarged view of the applicator system in the area defined as 50A, showing the outward-facing button retaining arm engaged with the insertion assembly housing locking slot. [Figure 50B] This is an enlarged view of the applicator system in Figure 49, within the range defined as F50B. [Figure 51] Figure 48 is a left-side cross-sectional view of the applicator system, illustrating the partially deployed applicator system just before releasing contact with the various holding arms. [Figure 52] This is an enlarged cross-sectional view of the applicator system of Figure 51 within the range defined as F52, illustrating the outward-facing needle-holding arm hook surface just before full deployment and release of the needle body. [Figure 53] Figure 51 is a front cross-sectional view of the application system. [Figure 54]Figure 53 is an enlarged cross-sectional view of the applicator system within the range defined as F54, illustrating the inward-facing applicator housing retaining arm just before full deployment and release of the sensor module. [Figure 55] Figure 48 is a left-side cross-sectional view of the applicator system, illustrating the fully deployed applicator system with the needle assembly retracted into the insertion assembly housing. [Figure 56] This is an enlarged cross-sectional view of the applicator system of Figure 55 within the range defined as F56, illustrating the needle body relative to the distal end of the closed button. [Figure 57] Figure 55 shows a front cross-sectional view of the fully unfolded applicator system. [Figure 58] Figure 57 is an enlarged cross-sectional view of the applicator system within the range defined as F58, illustrating the applicator housing retaining arm, which is completely released from the sensor lower housing locking recess and facing inward. [Figure 59] This is an enlarged cross-sectional view showing the ready-to-use orientation of the elongated cam wall surface of the assembly housing retaining arm and applicator housing. [Figure 60] This is an enlarged cross-sectional view showing the fully deployed orientation of the elongated cam wall surface of the assembly housing retaining arm and applicator housing. [Figure 61] This is a right-hand plan view of a fully deployed sensor applicator system, illustrating the sensor module after it has been deployed and separated from the applicator module. [Figure 62] Figure 61 is a front plan view of the fully unfolded sensor applicator. [Figure 63] This is a perspective view of one embodiment of the sharp object of the present invention, illustrating the sharp tip, the sharp opening region, and a part of the sharp body. [Figure 64] Figure 64 is an edge perspective view of the sharpened portion, illustrating the recessed hole defined by the sharpened opening region. [Figure 65] This is a perspective view of one embodiment of the continuous measurement system of the present invention, illustrating a sensor applicator and a display module. [Figure 66] This is a schematic diagram of the continuous measurement system of the present invention in use. [Figure 67] This is a perspective view of one embodiment of a multilayer sensor. [Figure 68] Figure 67 is an enlarged perspective view of the multilayer sensor, illustrating the base layer, intermediate layer, and top layer. [Figure 69] Figure 67 is a plan view of the sensor, showing the base layer with the electrical contact area and sensor end circled. [Figure 70] Figure 69 is an enlarged view of the electrical contact area. [Figure 71] Figure 69 is a magnified view of the sensor end. [Figure 72] Figure 67 is a plan view of the sensor, showing only the intermediate layer which contains the electrical contacts and sensor end circuits. [Figure 73] Figure 72 is an enlarged view of the electrical contact area. [Figure 74] Figure 72 is a magnified view of the sensor end. [Modes for carrying out the invention]

[0058] [Detailed description of the invention] This disclosure is not limited to the specific embodiments described herein. These embodiments are modifiable, and the terms used to describe these specific embodiments should not be constrained.

[0059] The present invention is illustrated in Figures 1 to 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 only for the purpose of indicating the position 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 adhesive pad opening 14a, which aligns with the outer housing flange portion 27 of the applicator housing 21 and the needle axis L2 (shown in Figures 32 to 33). The non-adhesive side of the single-sided adhesive pad 14 is welded to the bottom of the lower housing 172 (shown in Figure 22) of the lower sensor housing 170. Figures 2 and 3 are a front plan view and a left-side plan view of the applicator 10, respectively, showing a longitudinal axis L1 extending through the center of the sensor applicator 10. A ready-to-use subcutaneous sensor applicator 10 includes an applicator housing assembly 20 and a deployment button assembly 40. A distinctive feature of the present invention compared to other similar devices is that the ready-to-use subcutaneous sensor applicator 10 is fully assembled and does not require the user to join any structural components before 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 at the bottom of the applicator housing 20 to expose the adhesive portion that aligns with the proximal outer body flange portion 27, places the subcutaneous sensor applicator at a predetermined position 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 Figures 3 and 61-62) onto the skin, deploys the specimen sensor subcutaneously within the skin, and automatically turns on power to the electronic circuit. The user does not need to assemble the sensor module onto the applicator, nor do they need to manipulate any structures on the applicator to remove the deployment button assembly from the sensor module or to perform any other actions to activate the electronic circuitry within the sensor module after subcutaneous insertion of the sensor.

[0060] Moving on to Figure 4, an enlarged front perspective view of the applicator 10 is shown. The applicator 10 includes an applicator module 15 and an unassembled sensor module 160. The applicator module 15 includes a button deployment assembly 40, which includes a preloaded insertion assembly 100, and an applicator housing assembly 20.

[0061] The preloaded insertion assembly 100 includes an insertion assembly housing 110, a needle assembly 140, a biasing element 149, and an electrical sensor assembly 220. The needle assembly 140 and the biasing element 149 are compressed with the biasing element 149 taut and positioned within the insertion assembly housing 110 so that the needle assembly 140 is in the ready or cocked position, and the insertion assembly housing 110 is locked within the deployment button 50. The electrical sensor assembly 220 is captured by the insertion assembly housing 110 at its lower or proximal end so that a portion of the sensor 250 is removably positioned within the needle 155 of the needle assembly 140 when the needle assembly 140 is in the ready or cocked position.

[0062] The applicator housing assembly 20 includes an applicator housing 21 and a sensor under housing 170 that is captured by the applicator housing 21, the sensor under housing 170 being 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 insertion assembly housing 110 is inside the applicator housing 21 and a portion of the applicator housing 21 is inside the deployment button 50. These various structural components that are assembled are described individually here.

[0063] Moving on to Figures 5-10, various diagrams of the deployment button 50 are illustrated. Figure 5 is a front, left-side perspective view of the deployment button 50. The deployment button 50 has an elongated button body 52, a closed distal end 53, and an optional button body flange 56 disposed on the open proximal end 54. The elongated button body 52 has a peripheral wall 57 that defines the button chamber 58. Figure 6 is a front plan view of the deployment button of Figure 5. As is clear from Figures 5-10, the elongated button body 52 has a length BL that is longer than its 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 protrusions or grooves 59 to make it easier for the user's fingers and thumb to grip the deployment button 50 when it is placed on the user's / patient's skin.

[0064] Figure 7 is a cross-sectional view of the unfolding button of Figure 5 along line F7-F7. Within the button chamber 58, a plurality of arbitrary elongated spacers 70 extend at a predetermined distance from the closed distal end 53 of the button to the open proximal end 54 of the button. Also within the button chamber 58 is an arbitrary spacer wall 72 that extends at a predetermined distance along the inside of the peripheral wall 57 from the closed distal end 53 of the button to the open proximal end 54 of the button. The spacer wall 72 is located inside 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 provided solely to simplify assembly during manufacturing.

[0065] Figure 8 is a cross-sectional view of the deployment button of Figure 5 along line F8-F8. In addition to a plurality of optional elongated spacers 70 and optional spacer walls 72, there are at least a pair of outward-facing button retaining arms 60. The button retaining arms 60 are connected to the distal end 53 of the closed button and extend within the button chamber 58 at a predetermined distance in the space created between the plurality of elongated spacers 70 and spacer walls 72. The button retaining arms 60 are elastic so that they can bend toward the center of the button chamber 58 and return to their original position. At the ends of the retaining arms are button retaining arm hook structures 61. As shown in Figures 7 and 8, the distal end 53 of the closed button has an optional recess 53a on its outer surface so that an index finger can be placed when driving the subcutaneous specimen sensor applicator system 10, if desired.

[0066] Figure 9 is a top view of the deployment button 50. In this figure, a pair of arbitrary closed end ports 53b are shown, and looking down through these arbitrary closed end ports 53b, the hook structure 61 of the button retaining arm 60 is visible. The opening 53b is a result of the mold used when the part was injection molded.

[0067] Figure 10 is a bottom view of the deployment button 50. This figure more clearly illustrates the relationship between the multiple elongated spacers 70 and the spacer wall 72, including the button holding arm 60 and an optional button flange 56.

[0068] The structure of the applicator housing 21 is described in Figures 11-16. 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 defining the 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 an important feature of the applicator 10. The purpose of the flange is to passively apply solid, uniform pressure to the adhesive tape by utilizing the unfolding force of the mechanism. A resultant force of 3-5 lbs of the unfolding force is intentionally used to firmly fix the pressure-sensitive adhesive (PSA) of the adhesive tape to the user / patient's skin. This is a key aspect of the invention in achieving overall integrated passivity of the mechanism for the user. After the sensor and applicator are inserted and released simultaneously, 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 within the applicator perimeter wall 25. The applicator housing retaining arm 30 extends at a predetermined angle from the applicator perimeter 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 perimeter wall 25. Multiple spacer slots 39 extend from the open distal body end 23 of the elongated body 22 of the applicator at a predetermined distance sufficient to accommodate multiple elongated spacers 70 of the deployment button 50.

[0069] Figure 13 is a cross-sectional view of the applicator housing of Figure 11 along line F13-F13. In addition to the inwardly facing applicator housing retaining arm 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. Figure 13A is an enlarged view of the cam wall surface 32 defined by range F13A. As can be seen, the upper surface 32a has a first surface recess 33, a first inclined surface 34a extending away from the first surface recess 33 along the cam wall surface 32 and inclined toward the applicator housing chamber 28, and a second inclined surface 34b extending away from the first inclined surface 34 along the cam wall surface 32 and inclined toward the applicator housing chamber 28. The cam surface 36 extends along the central surface 32b away from the second inclined surface 34a and inclined toward the applicator housing chamber 28. The cam surface 36 terminates at the lower surface 32c having a second surface recess 35. Figure 13B is an enlarged view of the insertion assembly housing stop 38 defined by range F13B. The insertion assembly housing stop 38 is positioned to generate the endpoint of the movement of the deployment housing assembly 40 when the deployment button 50 is activated. Figure 14 is a cross-sectional view of the applicator housing of Figure 11 along line F14-F14. This figure illustrates an inwardly facing applicator housing retaining arm 30 having a retaining arm hook end 30a and showing the retaining arm 30 extending at a predetermined angle toward the open proximal body end 24.

[0070] Figure 15 is a top view of the applicator housing 21. This figure shows not only the retaining arm hook end 30a but also the proximal inner body flange portion 26. Figure 16 shows the proximal inner body flange The flange portion 26 includes a flange recess 26a. This recess is designed to accommodate the sensor lower housing 200, with the purpose of providing a coplanar surface between the open proximal body end 24 and the sensor lower housing 200, and the inwardly facing applicator housing retaining arm 30 holds the sensor lower housing 200 until the subcutaneous specimen sensor applicator system is deployed.

[0071] Moving on to Figures 17-22, various diagrams of one embodiment of the sensor lower housing 170 are illustrated. Figures 17 and 18 are a front, left-side perspective view and a front plan view of the sensor lower housing 170, respectively. The sensor lower housing 170 has a lower housing bottom 172, a lower housing wall 173 extending upward from the lower housing bottom 172 and defining a lower housing chamber 184, and a perimeter bottom flange 171 extending orthogonally away from the lower housing wall 173. At least two opposing positions on the lower housing wall 173 are lower housing locking elements 174 facing inward and used to hold the sensor upper housing 200 and the electrical sensor assembly 220 after the applicator system 10 has been deployed. Furthermore, at least two opposing positions on the lower housing wall 173 are lower housing retaining recesses 178 that receive applicator housing retaining arms 30 that hold the sensor lower housing 170 at the open proximal body end 24 of the applicator housing 21 before the applicator system 10 is deployed. Also illustrated are a number of optional flange notches 182 on the periphery bottom flange 171. These notches are optional and are used only to simplify the assembly of the sensor lower housing 170 to the applicator housing 21, and are not an essential aspect of the present invention. A power actuator 175 extends from the bottom of the lower housing 172 into the lower housing chamber 182, so that when the sensor upper and lower housings 170, 200 are coupled when the sensor applicator system 10 is deployed, the power switch contacts the electrical sensor assembly 220. In this embodiment, the power actuator 175 is resilient to have a cross-sectional shape that slopes from the bottom of the lower housing 172 into the lower housing chamber 184. This is illustrated in Figure 20A. When the sensor applicator system is deployed by coupling the upper and lower sensor housings 170 and 200, causing the power switch 240 to press the power actuator 175, this inclined shape provides a biasing tension from the power actuator 175 to the power switch 240 (shown in Figure 44) on the electronic circuit 230. This inclined shape maintains the biasing tension on the power switch 240.

[0072] Figures 19 and 20 are cross-sectional views of the sensor lower housing 170 of Figure 17 along line F19-F19 and line F20-F20, respectively. These figures provide a clearer view of the inwardly facing lower housing locking element 174, the lower housing retaining recess 178, and the power actuator 175.

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

[0074] Moving on to Figures 23-29, various diagrams of one embodiment of the insertable assembly housing 110 are shown. Figures 23 and 24 are a front perspective view and a front plan view of the insertable assembly housing 110. The insertable 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 an assembly peripheral wall 111 defining the assembly housing chamber 118. The assembly peripheral wall 111 accommodates the button retaining arm 60 which faces outward when the insertable assembly housing 110 is assembled to the deployment button 50, and the open housing distal It has an assembly housing locking slot 130 spaced apart from the position end 113. When the inserted assembly housing 110 is inserted into and held 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 assembly perimeter wall 111 also has a plurality of assembly housing retaining arms 120. Each retaining arm 120 has an outward-facing housing arm hook surface 121. The retaining arms 120 remain within the first surface recess 33 of the elongated cam wall and lock the insert assembly housing 110 within the applicator housing 21. This effectively locks the deploy button 50 to the applicator housing 21 by the button retaining arm 60 of the deploy button 50, which is locked into the assembly housing locking slot 130 of the assembly perimeter wall 111 of the insert assembly housing 110. During the deployment of the sensor applicator system, each assembly housing retaining arm 120 slides along the elongated cam wall from the first surface recess 33 when ready for use to the second surface recess 35 when oriented for deployment.

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

[0077] Moving on to Figures 25 and 26, cross-sectional views of the insertion assembly housing 110 along lines F25-F25 and F26-F26 are shown, respectively. As illustrated in these figures, the bottom of the assembly housing 115 is recessed to accommodate the sensor housing 200. Multiple housing retaining fingers 124 hold the sensor housing 200 within this recessed housing bottom 115 until released by the operation of the sensor applicator system 10.

[0078] Figures 27 and 28 are top and bottom views of the insertion assembly housing 110. In these figures, it is clearly illustrated that the housing arm hook surface 121 facing outward on the assembly housing retaining arm 120 extends beyond the periphery of the assembly wall 111 to engage with 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 accommodating the needle 155 of the needle assembly 140. At least one optional assembly housing rail 117 is also illustrated. This assembly housing rail 117 also extends along the main portion of the assembly wall 111 between the open housing distal end 113 and the closed housing proximal end 114, and beyond the periphery of the assembly wall 111. If included, this optional rail 117 is positioned within the corresponding applicator housing groove 29 to simplify the alignment of the insertion assembly housing 110 within the applicator housing 21. Figure 29 is a bottom perspective view of the insertion assembly housing 110, illustrating the structural relationship between the assembly housing bottom 115, the assembly housing retaining arm 120, the housing retaining finger 124, and the needle assembly locking slot 132.

[0079] Moving on to Figures 30-35, various diagrams of one embodiment of the needle assembly 140 are shown. Figures 30 and 31 are a front perspective view and a front plan view of the needle assembly 140. The 40 comprises a needle body 142 and a tubular needle 155 having a needle wall 155a (not shown) fixedly attached to the needle body 142. Here, the tubular needle 155 defines the needle axis L2 (shown in Figures 32, 32).

[0080] Figures 32 and 33 are cross-sectional views of the needle assembly of Figure 30 along line 32-32 and line 33-33, respectively. The needle 155 is positioned aligned with the housing proximal end opening 116 of the insertion assembly housing 110. The needle body 142 has a closed distal end 143, an open proximal end 144, an upper part 145, a needle body retaining arm 150, and a needle housing 154. The needle 155 has a needle wall 155a that forms a needle body 156 having a distal end 157 and a proximal end 158. The distal end 157 is fixed to the needle housing 154 of the needle body 142. More specifically, the needle is fixed to a firm, durable needle housing 154. The usable fastener is UV epoxy. This fixing is important because the portion of the needle wall to be removed needs to be precisely aligned with the sensor 250. The proximal end 158 of the needle has a needle sharp portion 159.

[0081] The needle 155 has a needle release region 156a from which a portion of the needle wall 155a is removed. The needle release region 156a extends a predetermined distance from the proximal end 158 of the needle. The needle release region 156a is necessary to house the sensor 150 and retract the needle 155 after deploying the sensor 150 subcutaneously. Figure 32 shows the structure of the needle body retaining arm 150. Here, the retaining arm 150 has an outward-facing needle retaining arm hook surface 151 that extends beyond the needle body peripheral wall 141 when the needle body retaining arm 150 is in a relaxed state. The needle body retaining arm 150 is flexible and configured to compress toward and within the needle body peripheral wall 141. Figure 33 shows one embodiment of the needle housing portion 154 of the needle body 142. The needle housing 154 is configured to define the range in which the biasing element 149 remains between the closed distal end 143 of the needle body and the closed 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 held in the needle assembly locking slot 132 of the insertion assembly housing 110 until it is 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 pushes the needle body retaining arm 150 into the needle body 142, the biasing element 149 moves to a less compressed state, allowing the needle assembly 140 to slide toward the open distal end 113 of the housing, resulting in the needle 155 being pushed away from the sensor housing 200.

[0082] Figures 34 and 35 are top and bottom views of the needle assembly 140. These figures illustrate the position of the needle body retaining arm 150 relative to the needle body 142. A needle body side groove 146 is also shown, which is included for two reasons: (a) to prevent accidental detachment of the button retaining arm 60, which faces outward from the assembly housing locking slot 130, and (b) to prevent possible interference with the needle body 142 when the needle body 142 slides upward toward the upper part 55 of the deploying button after the sensor 250 has been implanted in the subcutaneous tissue. In the bottom view, the outline 149a of the biasing element 149 is shown to indicate the relative position of the biasing element 149 with respect to the inner upper surface of the upper part 145 of the needle body.

[0083] Moving on to Figures 36 and 37, front, top, perspective views and rear, bottom perspective views of one embodiment of the sensor upper housing 200 including the electrical sensor assembly 220 are shown. The electrical sensor assembly 220 includes an electronic circuit 230 and a sensor 250. Figure 36 shows the subcutaneous sensor 250 extending a predetermined distance below the sensor upper housing 200. Figure 37 shows the electrical sensor assembly 220 remaining within the sensor upper housing 200. After the electrical sensor assembly 220 is assembled within the sensor upper housing 200, the potting compound 215 is applied to the sensor The potting compound 215 is applied to the upper housing 200 by an automatic dispenser (not shown). The potting compound 215 seeps under the electronic circuit 230 and is poured until it is uniform at the base of the drive switch 240 (shown in Figure 44) and spreads to the inner circumference of the sensor upper housing 200 and the electronic circuit holder 209. The potting compound is usually a waterproof material and preferably a two-part fast-curing material. Figure 36A is an exploded view of Figure 36, showing the electrical sensor assembly 220 and the sensor upper housing 200.

[0084] Figures 38, 38A, and 39 are a front perspective view of the sensor upper housing 200, an enlarged view of the upper housing retaining recess, and a front plan view of the sensor upper housing 200, respectively. The sensor upper housing 200 has an upper housing upper part 205, an upper housing upper opening 206, a circumferential upper housing wall 207 extending perpendicularly away from the upper housing upper part 205 and defining an upper housing chamber 212 (shown in Figures 40 and 41), and an upper housing flange portion 208 extending perpendicularly beyond the circumferential upper housing wall 207 from the upper housing upper part 205. The circumferential upper housing wall 207 also includes an upper housing locking recess 210 adjacent to the upper housing flange portion 208. The upper housing locking recess 210 is positioned to engage with the corresponding lower housing locking element 174 when coupled to form the sensor module 160 and deployed on the user's skin. Inside the circumferential upper housing wall 207, there is at least one electronic circuit holding portion 209 that holds the electronic circuit 230 within the upper housing chamber 212.

[0085] Figures 40 and 41 are cross-sectional views of the upper sensor housing of Figure 38 along line F40-F40 and along line F41-F41, respectively. The tubular upper housing needle guide 211 descends from the upper opening 206 of the upper housing. The upper housing needle guide 211 has a distal guide end 211a and a proximal guide end 211b. Furthermore, since the needle guide 211 extends by a predetermined distance, as a result, when the upper sensor housing 200 is coupled with the lower sensor housing 170, the proximal guide end 211b of the upper housing needle guide 211 does not extend beyond the bottom 172 of the lower housing. The proximal guide end 211b has a portion 211c that is removed to accommodate the sensor 250. The sensor 250 has a bent portion located within this portion 211c, and a portion of the sensor 250 is located within the needle-opening region of the needle 155. Figure 41 is a cross-sectional view of the upper housing of the sensor in Figure 38 along line F41-F41, showing the upper housing locking recess 210.

[0086] Proceeding to Figures 42 and 43, the electronic circuit 230 excluding the sensor 250 is illustrated. Figure 42 is a bottom perspective view, and Figure 43 is a top perspective view. Figure 43 clearly shows the battery 235 that supplies power to the electronic circuit 230. Figure 42 shows the circuit power switch 240 in the normal off position. Figure 44 is a magnified view of the area F44 defined in Figure 42. The circuit power switch 240 is frustoconical in shape near the top of the electronic components of the electronic circuit 230. The circuit power switch 240 is located on the electronic circuit 230 and connects to the power actuator 175 of the lower sensor housing 170 when the upper sensor housing 200 and the lower sensor housing 170 connect during operation and deployment of the sensor applicator system. Upon connection, the power actuator 175 is pressed against the circuit power switch 240, and then power from the battery 232 is connected to the electronic circuit 230 and the sensor 250. When this movement occurs, the sensor module 160 is automatically powered on. In other words, this movement 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 embedded subcutaneously. The electronic circuit 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, as in the device described later.

[0087] Figures 45 and 46 are a front view and a rear view of one embodiment of the sensor 250, respectively. The sensor 250 has a distal end 260, an intermediate part 270, and a proximal part 280. The sensor distal end 260 has a plurality of contact pads 262 that are electrically coupled to the electronic circuit 230. The sensor proximal end 280, along with a portion of the sensor intermediate end 270, is implanted subcutaneously in the user / patient's skin. A plurality of electrodes 282 are exposed at the sensor proximal end 280, and at least one of the electrodes 282 is configured to measure a sample, such as glucose. If the others of the electrodes 282 are configured in the same way, one or more samples may be measured. In this embodiment, the sensor 250 has a bend such that the sensor proximal end 280 is transverse, preferably perpendicular, to the sensor distal end 260.

[0088] Figure 47 is an enlarged, rear view of the sensor 250, showing the sensor proximal portion 280 and a plurality of electrodes 282, along with the sensor distal end 260 extending away from the viewer and toward the plane of the figure. As can be seen, this embodiment of the sensor 250 has one or more friction surfaces 284 that appear as bumps along the sensor proximal portion 280 side. These "bumps" are in contact with the inner surface of the needle wall 155a of the needle release region 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 embed 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 withdrawn while the sensor proximal portion 280 remains embedded.

[0089] The operation of the fully assembled and ready-to-use sensor applicator system 10 is described in Figures 48-62. Figures 48 and 49 are cross-sectional views of the ready-to-use applicator system 10. Figure 48 is a left-side cross-sectional view of the applicator system 10 in Figure 1 along line F48-F48 in Figure 1, showing the ready-to-use applicator system 10. As shown, the sensor applicator system 10 is fully assembled and packaged. Therefore, the user does not need to assemble the "sensor module" into the automatic inserter, nor does the user need to physically connect a power supply to the sensor module to operate it (i.e., to operate the electronic circuitry and sensors). In this fully assembled and ready-to-use position, the needle assembly 140 is coupled inside the insertion assembly housing 110 together with a biasing element 149 in a compressed state that stores potential energy used to return the needle 155 once it has been deployed. The upper sensor housing 200 is held at the closed proximal end 114 of the insertion assembly housing 110. The needle 155 extends toward the lower sensor housing 170 via the upper housing needle guide 211. Here, the proximal end 158 of the needle is directly aligned with and positioned near the sensor opening 176c of the lower sensor housing 170. Figure 49 is a front cross section of the applicator system of Figure 1 along line F49-F49 of Figure 1. This figure shows an outward-facing button retaining arm of the deployment button 50 engaged with the assembly housing locking slot 130 of the insertion assembly housing 110. This is more clearly illustrated in Figure 50A, which is an enlarged view of the area defined by F50A in Figure 49. This figure also illustrates an inward-facing applicator housing retaining arm 30 coupled to a housing locking recess 178 to hold the lower sensor housing 170 in the applicator housing 21. This is clearly illustrated in Figure 50B, which is an enlarged view of the area defined by F50b in Figure 49.

[0090] Figures 51 and 53 are cross-sectional views of the applicator system 10 in the deployed orientation just before the completion of the embedding of the sensor 250, before the needle 155 is retracted and before the upper and lower housings, 200 are coupled to each other. The purpose is to show the spatial relationship between the relevant retaining arm and the corresponding locking recesses of the various components. Substantially simultaneously, the sensor module 160 is completed, the needle 155 and sensor 250 are in the user's subcutaneous tissue, the needle assembly 140 is automatically retracted, and the sensor module 160 is released from the applicator housing 21. Figure 51 is a left-side cross-sectional view of the applicator system of Figure 48, showing a partially deployed applicator system slightly less than fully deployed. Figure 52 is a magnified view of the area defined by F52 in Figure 51, showing the needle itself Figure 53 shows where the body holding arm 150 contacts the applicator assembly housing stop 38. Figure 53 is a front cross-sectional view of the applicator system of Figure 51, showing where the closed proximal housing end 114 of the insertion assembly housing 110 contacts the inwardly facing applicator housing holding arm 30. Figure 54 is an enlarged view of the area defined by F54 in Figure 53.

[0091] Figures 55 and 57 are cross-sectional views of the applicator system 10 in its deployed orientation after the sensor 250 has been embedded. Figure 55 is a left-side cross-sectional view of the applicator system of Figure 48, showing the fully deployed applicator system 10 with the needle assembly 140 retracted into the insertion assembly housing 110. As shown, the upper sensor housing 170 is coupled to the lower sensor housing 200, and the needle assembly 140 is moved by the kinetic energy of the released biasing element 149. Here, the upper part of the needle body 145 is in contact with the upper part of the deployment button 55. Figure 56 is a magnified view of the area defined by F56 in Figure 55. Figure 55 shows the contact between the upper part of the needle body 145 and the upper part of the deployment button 55 more clearly. Figure 57 is a front cross-sectional view of the fully deployed applicator system 10 of Figure 55. In this figure, the closed proximal end 114 of the housing contacts the inwardly facing applicator housing retaining arm 30, and further forward, the retaining arm 30 is completely pushed away from the lower sensor housing 170, releasing the now formed sensor module 160 from the applicator module 15. Figure 58 is a magnified view of the area defined by F58 in Figure 57, showing more clearly how the retaining arm 30 is released from the lower sensor housing 170.

[0092] Figures 59 and 60 are cross-sectional views of the assembly housing retaining arm 120 and the elongated cam wall surface 32 of the applicator housing 21 in their 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 generated by the first inclined surface 34a of the cam wall surface 32. The first inclined surface 34a biases the assembly housing retaining arm 120 toward the assembly housing chamber 118 (i.e., slides on / along the first inclined surface 34a) until the assembly housing retaining arm 120 reaches the second inclined surface 34b of the cam wall surface 32. The initial force applied to the deployment button 50, coupled with the force of the biased arm 120, causes the deployment button to continue moving to its fully deployed position without requiring any further force, while the assembly housing holding arm 120 follows along the cam surface 36, which continues to tilt away from (i.e., outward from) the second inclined surface 34b and the applicator housing chamber 28, until the assembly housing holding arm 120 reaches the second surface recess 35 of the elongated cam wall surface 32. At this point, the sensor module 160 is fully deployed, and the downward movement of the deployment button assembly 50 stops.

[0093] Figures 61 and 62 are right-side and front-side plan views of the 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 user / patient's skin.

[0094] Needle / Sharp part Figures 63 and 64 are perspective views of one embodiment of the needle / sharp portion 300 of the present invention. The needle / sharp portion 300 has a sharp body 302, a sharp opening region 304, and a sharp tip 306. The sharp body 302 is an annular portion of the sharp portion 300 that extends longitudinally and defines the enclosed tube 301 through it.

[0095] Wired EDM processing or laser processing is used to remove a portion of the tubular wall 303 along the sharp object 300 for a predetermined distance in order to define the sharp opening region 304. This reduces the total height 310 of the sharp object 300. Both wired EDM processing and laser processing are used on the tubular tube. It can be implemented in flat, elliptical tubes. The sharp opening region 304 is part of a ring that extends longitudinally along the length of the sharp opening region 304, together with the tubular wall 303, defining 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 a continuous measuring sensor 250.

[0096] CGM System Referring to Figures 65 and 66, one embodiment of the CGM system 1000 of the present invention is illustrated. The CGM system 100 comprises a subcutaneous specimen sensor applicator 10 and electronic devices 900, 902 provided for wireless communication. An adhesive pad 14, welded only to the bottom of the sensor subhousing 170, also has an adhesive layer on the opposite side of the adhesive pad 14, which 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 Figure 1B.

[0097] Figure 66 shows one embodiment of the system 1000 in use after the sensor 250 has been inserted into the subcutaneous tissue. As shown, Figure 66 shows an example of electronic equipment 902, 902', and a transmitter 1004 located in the patient's arm (which is a sensor module 160 including a lower sensor housing 170, an upper sensor housing 200, and an electrical sensor assembly 220). The transmitter 1004 communicates specimen measurement data from the continuous measurement sensor 250 (which has been subcutaneously deployed in the patient) to the electronic equipment 902. This data is displayed to the user via the user interface 918.

[0098] System 1000 also includes system software installed on electronic device 902 provided for wireless communication with transmitter 1004. Optionally, System 1000 utilizes a calibration sample strip reader 906 (not shown) capable of wireless communication with electronic device 902. While a smartphone with software is illustrated, these electronic devices may be smartphone-sized dedicated readers / meters, or integrated instruments including a dedicated continuous glucose measuring instrument integrated with a blood glucose meter for calibration. Examples of electronic device 902 include computers, tablet computers, smartphones, data loggers, watches, automotive information / entertainment systems, or other electronic devices. Wireless communication may be via radio frequency (RF) communication, Wi-Fi, Bluetooth, proximity 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 transmits calibration data to the electronic device 902 and asks the patient about their willingness to use the new calibration data point.

[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, other wireless communication protocols that are generally effective within a range of several centimeters to several meters may be used for communication. In some embodiments, for example, the system software is configured to communicate using an Android and / or Apple software platform installed on a mobile phone or the like, with an area of ​​up to 30 feet (approximately 9.2 meters).

[0100] In one embodiment, the transmitter 1004 is designed to conserve power and operate via the standard Bluetooth BLE protocol. For example, sensor readouts from the continuous measurement sensor 250 are transmitted from the transmitter 1004 every 5 minutes, and the sensor readouts are quickly displayed to the user after being received by the user's electronic device 902. Generally, the transmitter 1004 establishes a good connection with the electronic device 902 after one or two attempts. .

[0101] In one embodiment, system 100 uses a universally unique identifier (UUID) filter to avoid unwanted communication from other devices. In particular, when the user is in a densely populated area such as a subway, concert hall, or other public place, it is expected that multiple devices may be present and detectable near the electronic device 902.

[0102] In one embodiment, system 1000 utilizes calibration data wirelessly acquired from another strip reader. For example, a finger reading for glucose is performed and then manually or automatically entered into system 1000 for calibration. In one embodiment, the system 1000's software application has means for the user to manually input a one-point calibration value acquired from any instrument. For example, the user uses the interface of electronic device 902 to input a calibration reading of 100 mg / dl acquired using another strip reader. After inputting the calibration data, the user can approve, reject, or manually re-enter the calibration data. In another embodiment, the system software receives BLE calibration information from an external instrument. After system 1000 receives the calibration data, the user can approve, reject, or manually re-enter this calibration data into the user interface.

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

[0104] In one embodiment, for example, a rate of change having an absolute value greater than or equal to a predetermined value (e.g., 3 mg / dL / min or more) 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 to 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 to 2 mg / dL / min) is displayed as a horizontally tilted 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 a 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 sample (e.g., glucose) concentration is updated every minute by data from transmitter 1004 and displayed on main screen 909. Optionally, transmitted data may be lost if electronic device 902 is outside the area or unable to receive data during that time. In total, 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), and the electronic device 902 fills in any missing data in between.

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

[0108] The main screen 909 also displays a macro time scale 912 of data, including the data displayed in the plot 911. A portion of the data displayed in the macro time scale 912 is highlighted and corresponds to the data displayed in the plot 911. For example, the macro time scale 912 may be configured to display sample concentration data over periods of 3 hours, 6 hours, 12 hours, 24 hours, 3 days, or 1 week. Therefore, the data displayed in the plot 911 is a subset of the data displayed in the macro time scale 912. In one embodiment, the highlighting region 913 of the macro time scale 912 is an active element of the user interface 918. For example, touching or dragging the highlighting region 913 in the middle selects and moves the data in the plot 911. Similarly, touching or dragging the highlighting region 913 along its left edge 913a or right edge 913b expands or shrinks the highlighting region 913 along the time axis. When the size or position of the highlighting region 913 is adjusted, the plot 911 automatically updates to display data between the same minimum and maximum times in the highlighting region 913. The main screen 909 also displays an active service icon 915. Selecting the active service icon 915 displays indicators 910 for calibration and customization on the service screen. For example, the service screen includes indicators 910 for setting upper and lower ranges, alarm limits, display units, device pairing settings, timeframes, X-axis time ranges, etc. For example, the user accesses the service screen to set the macro time scale 912 and the time range of the data displayed on the plot 911. Selecting the calibration icon opens a calibration screen used to calibrate sample data. In some embodiments, the service screen includes instructions for use and links to access them.

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

[0110] In some embodiments, the system software may be configured to generate reports for healthcare professionals. For example, touching an icon may open reports and configurations that can be transmitted to healthcare professionals via the cloud, such as the time spent above and below a target range, alarm reports, CGM values, predicted A1C and eAG values, and sample measurements per hour.

[0111] In one embodiment, the system 1000 allows the user to manually input a one-point calibration value from another glucose strip reader. For example, the user inputs 100 mg / dl, such as obtained from a test strip measurement. After inputting the calibration value, the patient can approve, reject, or manually log the calibration data. - Re-enter into the interface.

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

[0113] In some embodiments, settings and user 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 user preferences menu.

[0114] In one embodiment, 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 = ((Channel 1 > * 0.000494) - 1) * 1000 General variables are defined as follows:

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

[0116] X is the mV reading output of channel 0 (sensor signal channel). M is the tilt correction coefficient for channel 0. B is the offset correction coefficient for channel 0.

[0117] Y is the mv reading output of channel 1 (blank signal channel). N is the tilt correction coefficient 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 a data timestamp. For example, the date, channel-0 value, channel-1 value, calculated glucose value, calculated glucose value calibration, and device ID. Optionally, another database contains patient-entered calibration data with timestamps such as date, entered calibration value, and device ID.

[0119] In one embodiment, A1 and A2 values ​​(values ​​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) result in an error message displayed in the user interface 918, such as "Reporting range exceeded." Similarly, A1 and A2 values ​​that are less than a predetermined minimum limit (e.g., 40 gm / dL or 2.2 mmol / L) result in an error message displayed to the user, such as "Reporting range not reached."

[0120] Communication between transmitter 1004 and electronic device 902 is secure. For example, the BLE-supported security management protocol is used between transmitter 1004 and electronic device 902. SMP provides 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 performance of transmitter 1004 and electronic device 902. To define.

[0121] In one embodiment, the electronic device 902 is a wristwatch configured to communicate wirelessly with a 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 wristwatch. The first screen displays the latest sample concentration and unit of measurement. For example, glucose concentration is displayed in mg / dL or mmol / L by indicator 910b and is updated every 5 minutes. A trend-indicating arrow indicator 910c shows the relative rate of change, as described above.

[0122] The second screen displays the latest glucose concentration and measurement units. The second screen displays plot 911 using the sample concentration data from the previous hour, with glucose concentration on the Y axis and time on the X axis. The upper and lower limits 916a and 916b are shown as dashed lines. The third screen displays macro time scale 912 using 24 hours of acquired data.

[0123] Sensor structure Figure 67 is a perspective view of one embodiment of a multilayer sensor assembly 500 that is ready for reagent deposition to generate a continuous measurement sensor 250. In this embodiment, the multilayer sensor assembly 500 has a reference electrode 534, a blank electrode or second working electrode 533, a counter electrode 532, and a first working electrode 530. The electrodes 530, 532, 533, and 534 are formed at the distal end 502 of the substrate and are electrically connected at the proximal end 501 of the substrate via a conductive contact pad 503 and the assembly middle section 530. The multilayer sensor substrate 500 is useful for forming subcutaneous sample sensors such as glucose measurement sensors.

[0124] A detection layer (not shown) is formed on the first and second working electrodes 530 and 533, respectively. The detection layer consists of three coating layers: a base coating layer, a second coating layer, and a third or upper coating layer. The base coating layer contains poly-2-hydroxyethyl methacrylate (PHEMA) and is a coating that is directly disposed on the metal exposed at the bottom of each hole in the distal end 502 of the substrate. Specific to the first working electrode used to measure glucose, it also contains glucose oxidase and / or glucose dehydrogenase. 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 background noise and / or interference-derived current, as well as a total current, partly driven by the amount of glucose in the subcutaneous tissue. By using an algorithm that subtracts the current derived from the second working electrode or blank electrode from the current derived from the first working electrode, glucose can be measured more accurately. The second coating layer is disposed directly on the base coating layer and contains multiple microspheres made of PHEMA and polydimethylsiloxane (PDMS). PDMS is a material that is substantially impermeable to glucose but substantially permeable to oxygen. The third coating layer or upper coating layer is disposed directly on the second coating layer and contains PHEMA and catalase. 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. With respect to 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 coated with a hydrogel film. The counter electrode 532 has metal at the bottom of the hole, which is coated only with a hydrogel film.

[0125] Referring to Figure 68, the perspective view shows the base layer 510, the intermediate layer 550, and the top layer 580, which constitute the multilayer sensor substrate 500. In this specification, "intermediate layer" means a layer adjacent to the top layer 580 without having an electrically insulating layer that interferes with other layers when there are other layers between the base layer 510 and the intermediate layer 550. The base layer 510 is electrically insulating and has a proximal end 514 and a distal end 516. The substrate has an intermediate portion 518 between the base layer 510 and the substrate metallized layer 520. The substrate metallized layer 520 is disposed on the base layer 510 and defines at least one circuit 552 that extends longitudinally along the base layer 510. Each circuit 552 has a conductive contact pad 524 formed on the proximal end 514 of the substrate, a conductive contact pad 526 formed on the distal end 516 of the substrate, and a conductive trace 528 that electrically connects the conductive contact pad 524 on the proximal end 514 of the substrate to the conductive pad 526 on the distal end 516 of the substrate.

[0126] The intermediate layer 550 is also electrically insulating and is disposed on the base layer 510, having a proximal intermediate layer end 554, a distal intermediate layer end 556, and an intermediate intermediate layer portion 558. The intermediate layer 550 has the same size and shape as the base layer 520 and is aligned with the base layer 510. The intermediate layer 550 has conductive contact pads 560 at the distal intermediate layer end 556, which are adapted to receive electrode material or reagents, and each forms an electrode. Each of the conductive contact pads 562 at the proximal intermediate layer end 554 is adapted to receive an electrical contact.

[0127] The upper layer 580 is also electrically insulating and is disposed on the intermediate layer 550. The upper layer 580 has a size and shape corresponding to the intermediate layer 550 and the base layer 510. The upper layer 580 has an upper proximal end 582, an upper distal end 584, and an upper intermediate portion 586, and the upper layer 580 is aligned with the base layer 510 and the intermediate layer 550. The upper layer 580 has a plurality of openings, including a contact opening 590 on the substrate proximal end 501 and a sensor hole 592 on the substrate distal end 502. The contact opening 590 and the sensor hole 592 correspond to the conductive contact pads 560 and 562 of the intermediate layer 550, respectively. The base layer 510, the intermediate layer 550, and the top layer 580 are manufactured together with the circuit 552 on the base layer 510 and the circuit 572 on the intermediate layer 550 to produce a multilayer sensor substrate 500 having, for example, a proximal substrate end 501, a distal substrate end 502, and an assembly intermediate portion 503 extending longitudinally between the proximal substrate end 501 and the distal substrate end 502, as shown in Figure 42. The distal substrate end 502 and the assembly intermediate portion 503 each have a width of approximately 279 microns.

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

[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 proximal end 514 to the distal end 516 of the base substrate. In one illustrated embodiment, the substrate metallization layer 520 defines two circuits 522. Circuits 522a and 522b each have conductive contact pads 524a and 524b formed at the proximal end 514 of the substrate. Circuit 522a has conductive contact pads 526a1-526a2 formed at the distal end 516 of the substrate. Circuit 522b has a conductive contact pad 526b at the distal end 516. Circuits 522a and 522b each have conductive traces 528 (528a and 528b) that electrically connect conductive contact pads 524a1-524a2 and 524b at the proximal end 514 of the substrate to conductive pads 526a and 526b at the distal end 516 of the substrate, respectively. For example, circuit 522a is configured for the working electrode 530 of the sensor assembly 500, and circuit 522b is configured for the blank electrode 533 of the sensor assembly 500 (as shown in Figure 67).

[0130] Each of the contact pads 526a1-526a2 has a size and shape that corresponds to one or more contact pads 562 of the intermediate metallized layer 550, rather than being merely sized to match the through-holes 564 of the intermediate layer substrate 552. The advantage of this configuration is that the contact pads 526a1-526a2 reduce the stress generated in the contact pads 562 by the spin coating process described below. This stress can lead to cracking of the contact pads 562 of the intermediate metallized layer 570. In one embodiment, for example, contact pad 526a1 is sized and shaped to be substantially below the contact pad 562a of the intermediate metallized layer 570, but not the through-hole 564c. Contact pad 526a2 is sized and shaped to be substantially below the contact pads 562b, 562c and the through-hole 564d of the intermediate metallized layer 570.

[0131] In one embodiment, the substrate metallized layer 520 has an overall thickness of 1200 ± 300 A (on (Gustrom). For example, the substrate metallization layer 520 deposits a first portion of chromium (200±150A) directly opposite to the base layer substrate 512, and a second portion of gold (1000A). It is formed by directly depositing ±150A) onto the chromium and directly depositing a third portion of chromium (200±150A) onto the gold. In other words, the substrate metallization layer 520 has a thickness ranging from about 900 angstroms to about 1500 angstroms. Other conductive materials and their thicknesses are acceptable for the substrate metallization layer 520 depending on the intended use of the sensor assembly 500.

[0132] Referring to Figures 72-74, the intermediate layer 550 is shown in the plan view of Figure 72. The second proximal end 554 is shown in a magnified view in Figure 73, and the second distal end 556 is shown in a magnified view in Figure 74. The intermediate layer 550 has an intermediate layer substrate 552 which is electrically insulating and defines a plurality of intermediate layer through-openings 564 having side walls extending to the base layer 510. Here, each of the intermediate layer through-openings 564 is electrically in communication with conductive contact pads 524, 526 of the circuit 552 in the base layer 510. In one embodiment, the intermediate layer substrate 552 is made of polyimide that is spin-coated to the base layer 510 and the substrate metallization layer 520 by, for example, a method 600 for making a multilayer 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 metallized layer 570 is disposed directly on the sidewalls of the intermediate layer substrate 552 and the through-opening 564, defining at least two intermediate layer circuits 572. Each intermediate layer circuit 572 has a conductive contact pad 560 formed on the proximal end 554 of the intermediate layer, a conductive contact pad 562 formed on the distal end 556 of the intermediate layer, and a conductive trace 574 which electrically couples the contact pad 560 on the proximal end 554 with the conductive contact pad 562 on the proximal end 556 of the intermediate layer. At least one or more other conductive 560, 562 are in electrical contact with the through-opening 564. At least one or more additional conductive pads 560, 562 are electrically coupled to the base layer circuit 552 by or through the through-opening 564. For example, the intermediate metallized layer 570 is deposited on the upper surface 550a, the side wall of the through-opening 564, and a portion of the substrate metallized layer 520, generating electrical conductivity between the substrate metallized layer 520 and each contact pad 560, 562.

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

[0135] In one embodiment of the distal end 556 of the intermediate layer shown in Figure 74, for example, the intermediate layer circuit 572a includes a contact pad 562a, and the intermediate layer circuit 572b includes a contact pad 562c. The contact pads 562b and 562d are isolated from the intermediate layer circuits 572a and 572b. The intermediate layer substrate 552 has a through-opening 564c with a contact pad 562b (for example, for a blank electrode 133) that has electrical conductivity to the substrate metallized layer 520 at the contact pad 526b (shown in Figure 71). The intermediate layer substrate 552 defines the opening 564d together with a contact pad 562d that has electrical conductivity with the contact pad 526a2 (shown in Figure 71). The contact pads 562d and 562b are isolated from the intermediate layer circuits 572a and 572b. The contact pad 562a (i.e., the reference electrode 134) is subdivided into three contact pad portions 562a1, 562a2, and 562a3. The reference electrode 534 is subdivided to prevent Ag / AgCl cracking and delamination from the contact pad 562a. This is a clear advantage in this patent when the sensor 500 is implanted subcutaneously.

[0136] The advantage of the multilayer sensor assembly 500 is its ability to construct a narrow sensor that penetrates subcutaneous tissue, which can be achieved by arranging all conductive traces side by side on a single substrate. The multilayer sensor assembly 500 utilizes multiple layers for tracing, which allows for a narrower width by limiting each layer to one or two circuit traces.

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

Claims

1. A method for operating a sensor applicator (10) that operates when a predetermined operation is performed, The sensor applicator (10) is The system comprises a sensor (250), an applicator module (15), and a sensor module (160), wherein the applicator module (15) has an insertion assembly (100), the insertion assembly (100) has a needle assembly (140), and the needle assembly (140) includes a needle (155), The sensor applicator (10) operates such that when the deployment button (50) for deploying the sensor module (160) is operated once by the user, and the deployment button (50) moves from the ready position to the deployed position, power is supplied to the electrical sensor assembly (220) within the sensor module (160), and the sensor applicator (10) is ready for use. The sensor applicator (10) operates to substantially simultaneously bring about the following: unfolding the sensor module (160) before it is unfolded as a standalone unit, unfolding the sensor (250), supplying power to the electrical sensor assembly (220), and separating the sensor module (160) from the applicator module (15). The sensor module (160) is A sensor lower housing (170) having a lower housing opening (176) adapted to accommodate a needle (155) via the activation of the deployment button (50), and a power actuator (175), wherein the sensor lower housing (170) is releasably connected to the applicator housing (21) by an applicator housing retaining arm (30), A sensor upper housing (200) having an upper housing upper part (205) having an upper housing opening (206) from which the needle (155) extends, the sensor upper housing (200) being removably held relative to the insertion assembly housing (110) and spaced apart from the sensor lower housing (170), An electrical sensor assembly (220) comprising an electronic circuit (230) having a circuit power switch (240) disposed within the sensor housing (200) and configured to provide biasing tension by the power actuator (175), and a sensor (250) electrically coupled to the electronic circuit (230), wherein the sensor (250) is temporarily disposed within the needle (155) when the deployment button (50) is in the ready position, How it works.

2. The applicator module (15) has an applicator housing (21), The sensor applicator (10) is The adhesive tape cover (12) is removed from the applicator housing (21) to prepare it for use. The operating method described in claim 1.

3. The sensor applicator (10) operates such that, when the deployment button (50) is pressed from the ready position on the applicator housing (21), the deployment button (50) is deployed to the deployed position on the applicator housing (21), and the needle (155) is fully retracted into the insertion assembly housing (110) placed inside the deployment button (50), the needle (155) including the sensor (250) inserts the sensor (250) while the sensor (250) remains deployed. The operating method described in claim 1.

4. The sensor applicator (10) includes a single-sided adhesive pad (14) having an adhesive pad opening (14a) and a non-adhesive side, and a portion of the non-adhesive side is welded to the bottom of the lower housing (172) of the lower sensor housing (170) of the sensor module (160) so that the adhesive pad opening (14a) of the single-sided adhesive pad (14) is aligned with the needle shaft (L2) of the needle (155). The operating method according to claim 3.

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