TW202000135A - Flexible ultra low profile transcutaneous continuous monitoring sensor - Google Patents

Abstract

A flexible monitoring system for continuous monitoring of a fluid in a user is disclosed. The flexible monitoring system includes a transmitter support assembly and a sensor assembly. The transmitter support assembly includes a base substrate layer having a first surface for contact with the skin of the user. A circuit board layer is located on an opposite second surface of the base substrate layer. A cover layer is placed over the circuit board and the base substrate layer. The sensor assembly is supported by the transmitter support assembly and includes a sensor extending through the base substrate layer. The sensor is insertable in the skin when the first surface of the base is placed in contacts with the skin.

Description

Flexible ultra-low profile percutaneous continuous monitoring sensor

The present invention relates generally to a flexible sensor for analytes (eg, blood glucose), and more particularly to a flexible skin-adhesive continuous blood glucose monitor.

The quantitative determination of analytes in body fluids is extremely important in diagnosing and maintaining certain physiological conditions. For example, individuals with diabetes (PWD) frequently check the glucose content in their body fluids. The results of such tests can be used to adjust the glucose intake in their diet and/or determine whether insulin or other medications are required. PWD generally uses a measuring device (eg, a blood glucose meter) that calculates the glucose concentration in a fluid sample from the PWD, where the fluid sample is collected on a test sensor received by the measuring device. Failure to take corrective action may have serious medical effects on the patient.

One method of monitoring the blood glucose level of PWD is to use a portable test device. The portability of these devices allows users to easily test the blood glucose levels at different locations. One type of device uses an electrochemical test sensor to analyze blood samples. The user uses a lancet to obtain a blood sample for testing the sensor. Electrochemical test sensors usually include electrodes, which when paired with a meter, electrically measure the reaction of the blood sample to determine the analyte concentration. Therefore, the user must carry a special metering device to determine the analysis result of the blood sample.

Traditional test sensors and meters rely on PWD to perform tests. In addition, because such tests are only performed periodically, sudden changes in glucose levels cannot be detected immediately. To provide continuous monitoring, several solutions have been proposed for continuous glucose monitors. Such sensors are currently implanted in patients and are therefore cumbersome. In addition, such devices are not easy to replace. Other continuous sensors have been designed for attachment to the patient's skin. Current skin-adhesive sensors have hard disks, or have hard bottom plates and modular transmitters.

Such current body sensors for continuous glucose monitoring therefore have one or more of the following: it does not ensure that it can be comfortably worn under clothing; it does not have a low profile and avoid impact; it does not appear soft The feeling and appearance of scratching; it does not shape the dynamics of tissue flexion, expansion and contraction and moves with the dynamics of tissue flexion, expansion and contraction; it does not protect the sensor site and internal hardware from fluids Entry and other use hazards; or it does not provide breathability/air flow at the skin adhesion area.

Therefore, there is a need for a skin-adhesive continuous glucose monitoring system that can be comfortably worn on the skin. There is also another need for a continuous glucose monitoring system that has sufficient flexibility to move with the dynamics of tissue flexion, expansion and contraction. There is also a need for a skin-adhesive continuous glucose monitoring system that has a low profile but provides a long operating life.

According to an example, a flexible sensor system for continuous monitoring of users is disclosed. The sensor system includes a base substrate layer configured to contact the user's skin. A circuit board layer is positioned adjacent to the base substrate layer. A sensor extends through the base substrate layer. The sensor can be inserted into the skin. The cover layer covers the circuit board layer.

Another example is a support assembly for a continuous monitoring system for skin attachment. The support assembly includes a base substrate layer having a surface for adhesion to the skin. A circuit board layer is positioned above an opposite surface of the base substrate layer. The cover layer encapsulates the flexible circuit board layer. The pores are formed by the base substrate layer and a cover layer for holding a sensor guide module.

In view of the detailed description of various embodiments produced with reference to the drawings, additional aspects of the invention will be apparent to those of ordinary skill in the art, and a brief description of these embodiments is provided below.

This application claims the priority of US Provisional Application No. 62/683,967 filed on June 12, 2018. The content of his application is incorporated by reference in its entirety.

Figure 1A shows a flexible and ultra-low profile continuous glucose monitoring system 100 according to one embodiment. As will be explained, the monitoring system 100 in FIG. 1A is an example of a continuous skin-based analyte monitoring system. The principles described below can include a variety of construction methods and design elements incorporated in many different ways. The system 100 includes a sterile module 102 and a conveyor support assembly 104. The sterile module 102 includes a protective cover for a sensor inserted into the skin as will be explained below. In this example, the transmitter support assembly 104 is constructed using a layer type construction. As will be explained below with reference to FIGS. 3A-3B, canned type conveyor support assemblies can also be used.

Each of the two types of construction methods (layering and canning) can be used to produce transmitter assemblies with various shapes, such as round, rectangular/strip, elliptical, three-lobe, or four-lobe. In addition, the conveyor support assembly may include a flexible support screen to assist the stability of the structure.

FIG. 1B is a side view of the transmitter support assembly 104 of the flexible monitoring assembly 100, which can be attached to the skin of a patient. FIG. 1B shows the removal of the protective cover and the insertion member, leaving the sensor 150 ready to be inserted into the skin. As explained above, the transmitter support assembly 104 in FIG. 1B is constructed using a layered method of construction. The transmitter support assembly 104 includes a skin-adhesive base substrate layer 110, a base layer 112, a flexible circuit board layer 114, a foam layer 116, and a top cover layer 118. The ring member 120 is installed in the aperture 122 formed by the layers 110, 112, 114, 116, and 118. As shown in FIG. 1A, the ring member 120 holds the sterile module 102. In this example, the base substrate layer 110 is a non-woven fabric-like material such as 3M 1776 single-sided polyester non-woven medical tape.

The skin adhesive substrate layer 110 has a bottom base surface coated with a skin adhesive 130 and an opposite top surface coated with a base adhesive 132 that bonds the skin to the base substrate layer 110 and the bottom surface of the base layer 112 . The opposite top surface of the base layer 112 includes a flexible circuit adhesive 134 that joins the flexible circuit board layer 114 and the base layer 112. Therefore, the order from the top to the bottom of the transmitter assembly 104 in FIG. 1B is as follows. The ring 120 will adhere to the top cover layer 118 and the base layer 112. The top cover layer and the base layers 118 and 112 will also adhere to each other at opposite ends. The base layer 112 will adhere to the skin and adhere to the substrate 110. The skin adhesive substrate 110 contains a skin adhesive, which will adhere to the patient's skin when the glucose monitoring system 100 is attached to the patient.

The flexible circuit board layer 114 supports electronic components, such as an analog front-end circuit, a transmitter module 140, and a battery pack 142. The flexible circuit board layer 114 may be made of materials such as copper, kapton, polyester (PET), polyethylene naphthalate (PEN), polyamide, glass fiber, and acrylic adhesive. The flexible circuit board layer 114 includes electronic components in the form of printed circuits and electronic components. The printed circuit is used to connect all the electrical and transmitter components inserted through the sensor assembly 102, the battery pack 142, and the sensor 150. As will be explained below, the transmitter module 140 operates measurement and analysis functions, and may include internal memory and internal transmitters for the sensed data.

In this example, the battery pack 142 is a thin flexible battery pack and powers electronic components on the flexible circuit board layer 114. Other types of battery packs may be used, such as small button battery packs that conform to the size of the transmitter support assembly 104. Example button battery packs may be lithium manganese, zinc oxide, and alkaline button battery packs, such as CR 2032, SR516, and LR60 type button battery packs, respectively. It is desirable to minimize the height of the battery pack 142 to allow the transmitter to support the low overall height of the assembly 104. In this way, once the system 100 is attached to the skin, it is inconspicuous. It is assumed that the battery pack 142 has various shapes and sizes to accommodate various transmitter shapes. In addition, multiple battery packs can be connected together to form a single power unit to provide flexibility for the overall sensor system.

The sensor 150 is assembled with a flexible printed circuit formed on the flexible circuit board layer 114 and will remain assembled during its entire service life. As will be explained below, the sensor 150 includes a support member 152 and a sensor member 154 to be inserted through the user's skin.

In this example, the sensor component 154 is designed for subcutaneous insertion. Therefore, when the sensor component 154 is inserted into the user, the sensor component 154 will come into contact with, for example, interstitial fluid. The sensor 150 in this example is a glucose sensor having a series of electrodes on the sensor part 154, the electrodes being coated with enzymes that react with glucose in the interstitial fluid. An electrical input signal is applied to the electrodes on the sensor 150 to provide an output signal indicative of the concentration of analyte in the interstitial fluid.

Examples of types of analytes may be collected include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A1 _C, fructose, lactate, or bilirubin. It is expected that other analyte concentrations can also be determined. It is also expected that more than one analyte can be determined. Analytes can be in, for example, whole blood samples, serum samples, plasma samples, other body fluids (such as urine), and non-body fluids. As used in this application, the term "concentration" refers to analyte concentration, activity (e.g., enzymes and electrolytes), potency (e.g., antibody), or any other measured concentration used to measure the desired analyte .

The sensor 150 may be made of one or more sheets including a substrate layer, such as having gold, silver, silver chloride, polyimide and/or suitable for the sensor to determine the blood glucose level Ethylene polymer for various coatings and subsequent layers of enzymes. Other sensor materials can be used.

As explained above, the sensor 150 is inserted under the skin and provides the output signal to the components on the flexible circuit board layer 114 in response to the input signal. The output signal indicates the user's blood sugar level. These measurements can be made automatically multiple times throughout the day (eg, every 10 seconds, 30 seconds, 1 minute, 5 minutes, or at some other interval).

The flexible transmitter assembly can be attached to the skin, and the sensor 150 can be inserted under the skin using the previously disclosed plug-in method. One specific adjustment would be that the transmitter support assembly 104 carrying the transmitter (eg, the transmitter module 140) may be composed of a softer conformable layer such as a foam layer 116. The body of the transmitter is fixed in some way to the transmitter support assembly, which drives the transmitter towards the surface of the skin. As will be explained below, the needle/guide in the sterile module 102 is also driven into the skin by the insert. The soft adaptable layer is placed between the transmitter support assembly and the transmitter assembly. Similar to the pad, this layer protects the surface of the transmitter assembly from the direct pressure of the transmitter support assembly 104 pressed down on the transmitter.

The layered method of construction uses layers of films of different materials adhered together to create the transmitter support assembly 104. The top cover layer 118 is used to cover the flexible circuit board layer 114, the transmitter module 140, and the battery pack 142. The top cover layer 118 protects the electronic components on the flexible circuit board layer 114 from liquid and dust. The foam layer 116 is positioned on the inner surface of the top layer 118 to provide additional insulation against compression forces against the top cover layer 118. The top cover layer 118 is preferably composed of a soft and flexible material that is comfortable for the user, such as thermoplastic polyurethane (TPU). In this example, the foam layer 116 is composed of TPU foam. The layered construction method depends on the type of lamination method or the sealing method of adhering each layer to other layers. Such methods may include adhesives, RF/ultrasonic welding or heat sealing.

2A is a side cross-sectional view of the aseptic module 102 in FIG. 1A and FIG. 2B is a perspective view. The sterile module 102 includes a ring member 120 and a sensor 150. The sterile module 102 is a sub-assembly, which includes a sensor holding member 210, a guide member 212, a guide member cover 214, and a capsule-shaped central body 216 to contain the aforementioned components. The aseptic module 200 undergoes a sterilization process before being assembled with the conveyor support assembly. For example, all components within the sterile module 200, such as the sensor 150, the sensor holder 210, and the guide 212 may be sterilized (eg, using an electron beam, gamma beam, or the like). The sterile module 200 is therefore designed so that the sensor 150 and the guide 212 maintain their sterility, but prevent the electronic components in the transmitter support assembly from being damaged during the sterilization process.

In this example, the sensor holder 210 extends from the bottom of the guide cover 214 and supports the sensor component 154 beyond its length. The guide 212 is at the end of the sensor holder 210 and may have a blade shape to assist penetration of the skin. The guide cover 214 includes a handle 218 extending from the top of the guide cover 214. As will be explained below, when the sensor system is applied, the capsule-shaped central body 216 is removed to expose the sensor holder 210, the guide 212, and the sensor part 154. The sensor holder 210 and the guide 212 are inserted into the skin of the patient. The guide cover 214 is then pulled out and discarded with the attached sensor holder 210 and guide 212, leaving the sensor component 154 inserted into the patient's skin.

In this example, the guide cover 214 and the central body 216 may be made of acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), poly lanthanum, Made of polyether ballast, polyetheretherketone (peek), polypropylene, high density polyethylene (HDPE), low density polyethylene (LDPE) or similar materials. Other materials can be used.

In this example, the sensor holder 210 and the guide 212 may be made of metal such as stainless steel or another suitable material such as hard plastic. In some embodiments, the sensor holder 210 and the guide 212 may be (but not limited to) a circular C-channel sleeve, a circular U-channel sleeve, a stamped sheet metal part folded into a square U-profile, Molded/cast metal parts with square U-profiles or solid metal cylinders with etched or ground square U-channels. The sensor holder 210 and the guide 212 may be implemented as a stamped sheet metal folded into a square U-profile, and the internal width and height may range from about 400 µm to about 700 µm, and the wall thickness may be from about 100 µm to Within the range of about 250 µm. The sensor holder 210 and the guide 212 may be implemented as molded or cast metal parts. Other guides and/or cover configurations, sizes and/or materials can be used.

As described above, the ring member 120 is a small cylindrical tube having a top surface that interfaces with the bottom of the guide cover 214 from which the sensor support 210 extends. As shown in FIG. 2A, the sensor support 210 and the guide 212 extend through the body of the ring member 120. The ring member 120 serves several important functions. First, the ring member 120 acts as a carrier for the sterile module 200 and receives the sterile module 200 during the assembly process of joining the sterile module 102 to the conveyor support assembly 104. The ring member 120 also serves as a molding shut-off surface (both top and bottom) in the canned assembly method explained below, or as a clamping surface in the case where the layered construction method is selected. Finally, when assembling these components around the main axis of the ring member 120, the ring member 120 helps to hold the flexible circuit board layer 114 and optionally the flexible support screens in place. Alternatively, the ring member 120 may include a mesh group sleeve as part of a one-piece molding. It should be understood that other similar supporting members may be used for the ring member 120 depending on the shape of the aperture and the shape of the inserted sensor. For example, similar support members may be square-shaped, oval-shaped, triangular-shaped and may have central pores with different shapes.

FIG. 2B shows the connection between the sterile module 200 and the contact tab 220 connected to the flexible circuit board layer 114. The contact tab 220 is preferably manufactured as part of the sensor 150 and is preferably the same insulator material. The electrodes of the sensor 150 are connected to corresponding electrical traces on the contact tab 220. The contact tab 220 is connected to the flexible circuit board layer 114 and assembled with the battery pack 142, the sensor 150, and the ring member 120. The flexible circuit may have a thin reinforcing plate for protecting components and connecting areas. For example, a reinforcement board may be provided to support an integrated circuit such as a microprocessor.

FIG. 3A shows a side view of a flexible continuous monitoring system 300 according to another embodiment. The flexible continuous monitoring system 300 includes the aseptic module 102 and the conveyor support assembly 310 in FIGS. 2A-2B. In this example, the conveyor support assembly 310 is formed by the canning assembly method and supports the ring member 120 of the sterile module 102. FIG. 3B shows a relative side view of the flexible continuous monitoring system 300. FIG. 3C shows a top perspective cross-sectional view of the canned support structure 310 and the installed aseptic module 102. 3D shows a side cross-sectional view of the canned conveyor support assembly 310 in FIG. 3A.

The canned conveyor support assembly 310 includes a base substrate layer 320, a canned cover layer 322, a ring member 120, and a flexible circuit board layer 324. In this example, the base substrate layer 320 is a non-woven fabric-like material such as 3M 1776 single-sided polyester non-woven medical tape. In this example, the potted cover layer 322 may be an elastic material, such as liquid silicone rubber (LSR) or thermoplastic elastomer (TPE), urethane, silicone rubber, or the like. The base substrate layer 320 may be made of materials such as polyurethane, polyolefin, and polyester. These and other flexible materials will be used in sheets/films. The cover layer 322 has a flat bottom surface, which is attached to the top surface of the base substrate layer 320 via the adhesive 330. The cover layer 322 has a generally domed outer surface 326. The cover layer 322 includes a central aperture 328 that holds the ring member 120. Like the layered support structure 110 in FIGS. 1A-1B, the ring 120 supports the sensor 150 for insertion under the skin of the patient.

The cover layer 322 covers and protects the electronic components mounted on the flexible circuit board layer 324. A collection of such components includes a transmitter module 340, a battery pack 342, and a contact interface 344. The contact interface 344 is connected to the contact tab 220 of the sensor 150. In this example, the transmitter module 340 includes a processor, internal memory, internal transmitter, and internal antenna. One non-limiting example of a transmitter may be a Bluetooth Low Energy (BLE) transmitter. A non-limiting example of a suitable microprocessor with internal components is the MBN52832 BLE transmitter module manufactured by Murata, which has a Nordic BLE chip and an ARM Cortex processor. Of course, other types of transmitters can be used, including NFC or RF transmitters. The shape and total area of the transmitter assembly can vary significantly and can be optimized to promote a better user experience. In addition, circuit components (such as memory and transmitter) may be separate components from the microprocessor. The total thickness of the transmitter support assembly is less than about 2.5 mm and preferably less than 2 mm. However, different sizes of transmitter support assemblies can be used. The battery pack 342 is attached to the flexible circuit board layer 324 via the battery pack adhesive 346.

As explained above, the top surface of the base substrate layer 320 is attached to the flat bottom surface of the cover 322 via the adhesive 330. The opposite bottom surface is coated with a skin adhesive 350, which adheres the assembly 300 to the user's skin surface.

The potting method uses a potting material for the cover layer 322, such as liquid silicone rubber (LSR), thermoplastic elastomer (TPE), urethane or thermoplastic urethane (TPU) to completely encapsulate All components prevent liquid and dust from entering, while still maintaining the flexibility of the transmitter support assembly 310. The can construction method requires tooling, in which the LSR can be injected into the cavity containing the ring 120, the flexible circuit board layer 324, the electrical components, and the battery pack. The aseptic module 200 in FIGS. 2A-2B can also be assembled when the cover layer 322 is molded. The mold may include features that create specific surface patterns on the finished cover layer 322.

Canned polysiloxane or other materials can be laminated with thin skin-like materials or coated coatings to improve the natural feel of touch. Alternatively, the potted material may be textured to provide a more natural feel.

Although this example has a two-piece configuration of base substrate layer 320 and cover layer 322, a single-piece cover can be molded around flexible circuit board layer 324. In such a configuration, the cover layer will also have a flat bottom surface for holding the skin adhesive, and therefore the base substrate layer 320 is omitted. In such configurations, the potting material may also include a profile to assist flexibility when attaching the transmitter support assembly to the skin surface. FIG. 3E shows a bottom view of the one-piece cover 350 that has been potted. The cover layer 350 includes a central aperture 352 for holding the ring 120 and the sterile module 102 in FIGS. 2A-2B. The cover layer 350 has a mostly flat bottom 354. A series of contours 360 are formed between the central aperture 352 and the edge of the cover layer 350. The contour 360 provides the cover layer 350 with additional flexibility. The profile 360 also improves the breathability of the cover layer 350 by acting as a path for sweat and other body fluids to drain and leave the sensor area. It should be understood that these profiles can also be used for the base substrate layer 320 in FIGS. 3A-3D or the skin substrate layer 110 in FIG. 1A.

Figure 3F shows a cross-sectional view of an alternative transmitter support assembly 370. Similar components of the transmitter assembly 370 that are the same as those related to the transmitter assembly 310 in FIG. 3D are labeled with the same reference numerals. The conveyor support assembly 370 includes a separate substrate support layer 380. The base support layer 380 has a surface supporting the flexible circuit board 324. The opposite surface of the individual base support layer 380 is attached to the skin adhesive substrate 320 via the adhesive 330. In this example, the base support layer 380 may be made of materials such as silicone, urethane, TPE, or TPU.

4A-4D show an application method of the sensor system described above, such as the sensor system 300 in FIGS. 3A-3D. As shown in FIG. 4A, the user first removes the central body 216 of the sterile module 102. The sensor support 210, the guide 212, and the sensor 150 extend from the bottom of the system 300 and are thus exposed.

FIG. 4B shows the sensor system 300 attached to the patient 400. The sensor support 210 and the sensor 150 are inserted into the patient 400. The guide 212 at the end of the support 210 assists in penetrating the skin surface 410. The skin surface 410 surrounding the insertion point is in contact with the skin adhesive applied to the bottom surface of the base substrate layer 320.

After the base substrate layer 320 is attached to the skin surface 410 via the skin adhesive 350, the insert cover 214 is pulled out of the ring 120 via the handle 218 as shown in FIG. 4C. The cover 214 and the sensor support 210 are thus removed from the ring 120 and discarded. As shown in FIG. 4D, the sensor 150 remains inserted into the patient 400, and can come into contact with the sensor 150 via the transmitter module 340 and other electronic components on the flexible circuit board layer 324 Continuous sensing of the glucose content of the plasma fluid.

FIG. 5A shows a block diagram of electrical components mounted on the circuit board 314 in FIGS. 3A-3D. FIG. 5A shows the sensor 150, the connector 344, the battery pack 342, and the transmitter module 340. The sensor 150 includes three electrodes: a working electrode, a reference electrode, and a counter electrode, which are coated with an enzyme that reacts with glucose. Electrical input signals are input through the electrodes and output signals are received through the connector 344 through the contact tab 220 shown in FIGS. 2A-2B. The signal from the connector 344 is connected to the analog front-end circuit 510. The analog front-end circuit 510 applies a precision bias to the reference electrode and measures the sensor current from the working electrode. In this example, the analog front-end circuit 510 can perform accurate bias flow measurement by a 16-bit analog-to-digital converter (ADC) and performing electrochemical impedance spectroscopy (EIS). The electronic components in the analog front-end circuit 510 are designed to provide analog measurement capability at low operating power to be compatible with battery-powered devices. Serial Peripheral Interface (SPI) allows access to internal registers to program analog front-end circuit 510 and read sensor data and system voltage.

The analog front-end circuit 510 includes a system ADC with a single-ended analog voltage input and a 12-bit binary bit word output. The ADC has four multiplexed external inputs and up to 22 multiplexed internal inputs. The internal input terminal includes the sensor voltage and the supply voltage. Based on the input voltage supplied to the pins on the analog front-end circuit 510, the input reference is programmable. The analog front-end circuit 510 includes an ADC dedicated to each sensor channel and measures the unipolar current outside the working electrode. For each sensor channel and between the sensor channels for the 2-channel version and the 4-channel version, the digital-to-analog converter (DAC) is shared by the operating amplifier and the relative amplifier. The DAC is used to provide a DC bias to the sensor and can also be used to generate a sine wave to drive the sensor to measure the complex impedance of the sensor usually between the working electrode and the opposite electrode. Each sensor channel can be biased and measure the current in the 2-terminal electrochemical sensor and 3-terminal electrochemical sensor. The analog front-end circuit 510 also includes an input coupled to the temperature sensor 512 for internal monitoring purposes.

In a non-limiting embodiment, the transmitter module 340 includes an internal memory 520 and a transmitter 522, which may be a BLE transmitter. In this example, the transmitter module 340 also includes a microprocessor 524, which is an ARM cortex processor. The memory 520 may store algorithms or programs that control the functions of the microprocessor 524. For example, the microprocessor 524 may be programmed for interpreting the signals provided by the sensor 150, and for storing and/or communicating information about the blood glucose level of the patient.

The memory 520 stores the reading from the sensor 150, and the transmitter 522 sends the data to an external device. Such external devices may be used by patients and/or health care providers to especially track the blood glucose levels of patients over time.

FIG. 5B shows a block diagram of the transmitter 522 in FIG. 5A. The transmitter 522 includes an integrated antenna 540. The antenna 540 is connected to the RF matching circuit 542. The microcontroller 544 operates the transmitter function for the transmitter 522. The microcontroller 544 is attached to the timing crystal 546 and the antenna timing crystal 548. The microcontroller 544 can communicate with other components via a serial bus 560. The microcontroller 544 can also receive input/output signals for the I/O connector 562.

In this example, the input signal is sent to the sensor 150 periodically (such as every 10 seconds, every 30 seconds, every minute, or every five minutes). The output signal is read and converted by the program run by the microprocessor 524 to determine the glucose concentration. The transmitter module 340 stores the glucose concentration content data in the internal memory 520. The transmitter module 340 will also include a handshake agreement to an external device to download glucose concentration data.

6A-6E show different examples of the shape of the transmitter support assembly other than the circular shapes of the transmitter support assemblies 104 and 310 in FIGS. 1A and 3A. The different transmitter support substrate shapes in FIGS. 6A-6E can be manufactured using the different layering and canning assembly methods described above. Figure 6A shows the transmitter support assembly 600, which has a three-lobed shape. Figure 6B shows the transmitter support assembly 610, which also has a three-lobed shape. Figure 6C is a transmitter support assembly 620, which has a four-lobed shape. FIG. 6D shows the transmitter support assembly 630, which has a rectangular shape. FIG. 6E shows the transmitter support assembly 640, which has an oval shape. Similar to the transmitter support assembly in FIGS. 1A and 3A, all the support assemblies 600, 610, 620, 630, and 640 shown in FIGS. 6A-6E are provided for holding the sterile module 102 in FIGS. 2A-2B. The central aperture 602 of the ring 120.

As stated above, it has been envisaged that the shape of the coverage area of the transmitter support assembly includes different shapes such as circular, rectangular/strip, elliptical, 3-lobed and 4-lobed. It is worth noting that in terms of user experience and comfort, some shapes may be better than others, and some shapes may require unique flexible circuit board and/or battery pack configurations. For example, the three-lobe transmitter support assemblies 600 and 610 in FIGS. 6A-6B can be configured with a flexible printed circuit board that includes two battery packs, each battery pack occupying one petal and all other electrical components occupying The third petal. Design and position crease lines or areas with higher flexibility to improve consistency and comfort.

Figures 7A and 7B show different screen designs for support within the conveyor support assembly, such as those shown in Figures 1A and 3A. 7A shows a support screen 700 including five arms 702 each having two extended support members 704 and 706. Each of the arms 702 extends from the center member 710 at equal radial intervals. 7B shows another exemplary support screen 750 including three arms 752 each having two extended support members 754 and 756. The three arms 752 extend from the center member 760 at equal radial intervals. The support screen assemblies may have different numbers of arms and support members. In addition, different screen configurations can be used.

The flexible support screens 700 and 750 are thin structures designed for two tasks. The first is to serve as a platform for assembling other components, especially in the injection mold tool processing cavity. The second purpose of the flexible support screen 700 or 750 is to provide ridge structures in some areas of the sensor system to improve structural stability while allowing flexibility in other areas of the sensor system. In this example, the screen designs 700 and 750 may be materials such as nylon, polycarbonate, or ABS and the like.

The battery pack in the above example is more flexible than fully flexible. The ability to bend is similar to thick aluminum foil, which maintains its shape when no force is applied, as opposed to more elastic types of rubber. If larger relatively inelastic components such as battery packs break into smaller parts and are spaced apart on the body of the transmitter support assembly, the overall flexibility/ductility of the sensor system will increase. This will allow the device to bend at specific contacts or areas not covered by the surface area of the battery pack. For example, the battery pack can be split into more than one part in order to increase the flexibility of the device. This can be seen in the three-lobe transmitter assemblies 600 and 610 shown in FIGS. 6A-6B, where the two lobes can each hold a smaller size battery pack that has a larger single-piece battery when wired in parallel Groups have the same storage capacity.

FIG. 8 shows a transmitter support assembly 800 according to another embodiment. The transmitter support assembly 800 includes three petal parts 802, 804, and 806. The petal members 802, 804, and 806 extend from the central body 810. The center body 810 includes an aperture 812 that allows insertion of sensors such as those contained in the sterile module 102 shown in FIGS. 2A and 2B.

The flap members 802 and 804 each mount respective thin battery packs 822 and 824. The battery pack 822 and the battery pack 824 are wired in parallel and provide power to the electronic components on the third lobe part 806 via the trace 826. The electronic components on the third lobe part 806 may include a microprocessor 830 and an analog front-end circuit 832 for receiving signals from the sensor. As explained above, the use of flap members 804 and 802 allows for a larger battery pack and thus increases the service life of the device.

Other examples of sensor transmitter assemblies may incorporate the principles disclosed herein. 9A is a side cross-sectional view of a flexible continuous monitoring assembly 900 with an integrated transmitter support assembly and sensors. The assembly 900 eliminates a separate sterile module containing the sensor as shown in FIGS. 2A-2B. The flexible continuous monitoring assembly 900 includes a base substrate layer 910, a canned cover layer 912, a flexible circuit board layer 914, and an optional base support layer 916. In this example, the base substrate layer 910 is a non-woven fabric-like material such as 3M 1776 single-sided polyester non-woven medical tape. In this example, the canned cover layer 912 may be an elastic material, such as liquid silicone rubber (LSR) or thermoplastic elastomer (TPE), urethane, silicone rubber, or the like. The base substrate layer 910 may include materials such as polyester (PET), PP, and TPU. These and other flexible plastic materials will be used in sheets/films. In this example, the cover layer 912 has a generally domed outer surface 918. It should be understood that other shapes may be used for the cover layer 912, such as a mesa shape with a flat top and tapered edges or with a non-circular base footprint.

The cover layer 912 covers and protects the electronic components mounted on the flexible circuit board layer 914. A collection of such components includes a transmitter module 920 and a battery pack 922. The transmitter module 920 and battery pack 922 may be similar to the transmitter and battery pack described above with respect to FIGS. 3A-3D. The upper surface of the base substrate layer 910 is attached to the flat surface of the base support 916 via the adhesive 930. The opposite surface of the substrate support 916 supports the flexible printed circuit board 914. The opposite lower surface of the base substrate layer 910 is coated with a skin adhesive 932, which adheres the assembly 900 to the skin surface of the user.

The central aperture 940 is formed through the base substrate layer 910, the cover layer 912, the flexible circuit board layer 914, and the base support layer 916. The sensor 942 extends through the central aperture 940 and extends outward from the base substrate layer 910 for insertion into the skin. The support arm 944 of the sensor 942 is embedded in the cover layer 912. The sensor 942 is therefore fixed to the assembly 900. Since the sensor 942 extends from the base substrate 910, the sensor 942 may be inserted into the skin until the base substrate layer 910 contacts the skin surface. The skin adhesive 932 keeps the assembly 900 attached to the skin.

Another example of an assembly 950 with a pluggable sensor module is shown in FIGS. 9B-9C. 9B is a side cross-sectional view of the assembly 950 showing the insertable sensor module 952 removed from the transmitter support assembly 954. FIG. 9C is a side cross-sectional view of the sensor module 952 assembled with the transmitter support assembly 954. FIG.

The transmitter support assembly 950 includes a base substrate layer 960, a canned cover layer 962, and a flexible circuit board layer 964. The cover layer 962 has a generally domed outer surface 966. The socket member 970 is supported by the opening 972 formed in the center of the cover layer 962. The socket member 970 includes a side wall 974 and a bottom plate 976. An aperture 978 is formed in the bottom plate 976 for insertion of a sensor.

The cover layer 962 covers and protects the electronic components mounted on the flexible circuit board layer 964. A collection of such components includes a transmitter module 980 and a battery pack 982. The transmitter module 980 and battery pack 982 may be similar to the transmitter and battery pack described above with respect to FIGS. 3A-3D. The upper surface of the base substrate layer 960 is attached to the flat surface of the cover layer 962 via an adhesive 984. The opposite lower surface of the base substrate layer 960 is coated with a skin adhesive 986, which adheres the transmitter support assembly 954 to the user's skin surface.

The sensor module 952 includes a support body 990 that is shaped to match the area formed by the wall 974 and bottom plate 976 of the socket member 970. The support body 990 holds a sensor 992 that extends through the central aperture 978 and extends outward from the base substrate layer 960 for insertion into the skin. The support arm 994 of the sensor 992 is embedded in the support body 990.

The transmitter support assembly 954 is attached to the area of the skin via the skin adhesive 986. Then, the sensor module 952 is inserted into the socket part 970. The sensor 992 extends through the aperture 978, and thus is inserted into the user's skin when the support body 990 is inserted into the socket member 970.

The flexible and ultra-low profile continuous blood glucose monitor system described above has several advantages over current sensor systems. The height of the system can be less than about 2.5 mm, and therefore the thin profile height of the system is half the height of some existing sensor systems. This reduction in total height will less disturb clothing, be more rigorous, and will increase the overall comfort of the system.

The second advantage is to exemplify the flexibility of the sensor system. The flexible configuration and components allow the sensor system to contour the user's body through a series of movements and to increase overall user comfort. Key components can be supported by hard reinforcements in specific locations while maintaining overall flexibility. The battery pack will contain a thin flexible material that allows the battery pack to potentially be split into multiple cells in parallel.

It should be understood that the exemplary monitoring system disclosed herein combines novel design elements to provide a device that ensures comfortable wearing under clothing, has a low profile and avoids impact, presents a soft and flexible feel and appearance, and shapes tissue flexibility The contour of the dynamics of flexion, expansion and contraction moves with the dynamics of tissue flexion, expansion and contraction. The disclosed device also protects the sensor site and internal hardware from fluid entry and other use hazards, is easy and comfortable to apply, provides breathability/air flow at the skin adhesion area and produces generally more user-friendly experience .

As used in this application, the terms "component", "module", "system" or the like generally refer to computer-related entities, hardware (eg, circuits), a combination of hardware and software, software or Entities related to operating machines with one or more specific functionalities. For example, a component may be (but not limited to) a program, processor, object, executable, thread, program, and/or computer running on a processor (eg, digital signal processor). By way of illustration, both the application running on the controller and the controller can be components. One or more components can reside within a program and/or thread of execution, and a component can be localized on one computer and/or distributed between two or more computers. In addition, "devices" can appear in the following forms: specially designed hardware; general-purpose hardware, which is made special by executing software on it, which enables the hardware to perform specific functions; stored on computer-readable media On the software; or a combination thereof.

Although the present invention has been illustrated and described in relation to one or more embodiments, those skilled in the art will think of or be aware of equivalent changes and modifications after reading and understanding this specification and the accompanying drawings. In addition, although specific features may have been disclosed with respect to only one of several embodiments, such features may be similar to one or more of other embodiments when it is desired and advantageous for any given or specific application Other feature combinations.

100‧‧‧Continuous glucose monitoring system 102‧‧‧sterile module 104‧‧‧Transmitter support assembly 110‧‧‧ base substrate layer 112‧‧‧ Basement 114‧‧‧ Flexible circuit board layer 116‧‧‧Foam layer 118‧‧‧Top cover 120‧‧‧ring parts 122‧‧‧pore 130‧‧‧Skin Adhesive 132‧‧‧Base adhesive 134‧‧‧ Flexible circuit adhesive 140‧‧‧Transmitter module 142‧‧‧ battery pack 150‧‧‧sensor 152‧‧‧Supporting parts 154‧‧‧Sensor parts 210‧‧‧Sensor holding parts 212‧‧‧Guide 214‧‧‧Guide cover 216‧‧‧ Central body 218‧‧‧handle 220‧‧‧Contact tab 300‧‧‧Flexible continuous monitoring system 310‧‧‧support assembly via canned conveyor 314‧‧‧ circuit board 320‧‧‧Base substrate layer 322‧‧‧Through canned cover 324‧‧‧ Flexible circuit board layer 326‧‧‧External surface of the cover 328‧‧‧Central porosity 330‧‧‧ Adhesive 340‧‧‧Transmitter module 342‧‧‧ battery pack 344‧‧‧Contact interface 346‧‧‧Battery pack adhesive 350‧‧‧ skin adhesive 352‧‧‧Central porosity 354‧‧‧flat bottom 360‧‧‧Outline 370‧‧‧Transmitter assembly 380‧‧‧Base support layer 400‧‧‧Patient 410‧‧‧Skin surface 510‧‧‧ Analog front-end circuit 512‧‧‧Temperature sensor 520‧‧‧Memory 522‧‧‧Transmitter 524‧‧‧Microprocessor 540‧‧‧Integrated antenna 542‧‧‧RF matching circuit 544‧‧‧Microcontroller 546‧‧‧Chronograph crystal 548‧‧‧Antenna timing crystal 560‧‧‧ serial bus 562‧‧‧I/O connector 600‧‧‧Transmitter support assembly 602‧‧‧Central porosity 610‧‧‧Transmitter support assembly 620‧‧‧Transmitter support assembly 630‧‧‧Transmitter support assembly 640‧‧‧Transmitter support assembly 700‧‧‧support screen 702‧‧‧arm supporting the screen 704‧‧‧Extended support member supporting the arm of the screen 706‧‧‧Extended support member supporting the arm of the screen 710‧‧‧Central parts 750‧‧‧support screen 752‧‧‧ Arm supporting screen 754‧‧‧Extended support parts supporting the screen arm 756‧‧‧Extended support member supporting the arm of the screen 760‧‧‧Central parts 800‧‧‧Transmitter support assembly 802‧‧‧Flap parts 804‧‧‧Flap parts 806‧‧‧Flap parts 810‧‧‧Ontology 812‧‧‧pore 822‧‧‧ battery pack 824‧‧‧ battery pack 826‧‧‧Trace 830‧‧‧Microprocessor 832‧‧‧ Analog front-end circuit 900‧‧‧Flexible continuous monitoring assembly 910‧‧‧Base substrate layer 912‧‧‧Through canned cover 914‧‧‧ Flexible circuit board layer 916‧‧‧Base support layer 918‧‧‧External surface of the cover 920‧‧‧Transmitter module 922‧‧‧ battery pack 930‧‧‧ Adhesive 932‧‧‧Skin Adhesive 940‧‧‧Central porosity 942‧‧‧Sensor 944‧‧‧Sensor support arm 950‧‧‧Transmitter support assembly 952‧‧‧Sensor module can be inserted 954‧‧‧Transmitter support assembly 960‧‧‧Base substrate layer 962‧‧‧Through canned cover 964‧‧‧ Flexible circuit board layer 966‧‧‧External surface of the cover 970‧‧‧Socket parts 972‧‧‧ opening 974‧‧‧Side part side wall 976‧‧‧Bottom plate of socket part 978‧‧‧pore 980‧‧‧Transmitter module 982‧‧‧Battery pack 984‧‧‧ Adhesive 986‧‧‧Skin Adhesive 990‧‧‧Support body 992‧‧‧Sensor 994‧‧‧Sensor support arm

FIG. 1A is a side cross-sectional view of a flexible continuous monitoring system having a sensor assembly and a transmitter support assembly manufactured by a layered method according to an embodiment;

1B is a side cross-sectional view of the transmitter support assembly of the sensor system in FIG. 1A;

2A is a side cross-sectional view of the sensor assembly in FIG. 1A;

2B is a perspective view of the sensor assembly in FIG. 1A;

3A is a side cross-sectional view of a flexible continuous monitoring sensor system having a conveyor support assembly manufactured by a canned manufacturing method according to another embodiment;

3B is a cross-sectional view of the opposite side of the sensor system shown in FIG. 3A;

3C is a top perspective cross-sectional view of the sensor system shown in FIG. 3A;

3D is a side cross-sectional view of the transmitter support assembly shown in FIG. 3A;

Figure 3E is a bottom view of an alternative canned conveyor support assembly;

3F is a side cross-sectional view of another alternative transmitter support assembly with a separate base assembly;

4A shows the first step in the method of attaching the sensor system shown in FIGS. 3A-3C to the skin of a patient;

4B shows the second step in the method of attaching the sensor system shown in FIGS. 3A-3C to the skin of a patient;

4C shows the third step in the method of attaching the sensor system shown in FIGS. 3A-3C to the patient's skin;

4D shows a fourth step in the method of attaching the sensor system shown in FIGS. 3A-3C to the patient's skin;

5A is a block diagram of the transmitter module of the sensor system in FIGS. 3A-3C;

5B is a block diagram of the transmitter of the transmitter module in FIG. 5A;

6A is a perspective view of a first different shape of a skin-adhesive type and a transmitter support assembly that can support the sensor module in FIGS. 2A-2B;

6B is a perspective view of a second different shape of a skin-adhesive type and a transmitter support assembly that can support the sensor module in FIGS. 2A-2B;

6C is a perspective view of a third different shape of a skin-adhesive type and a transmitter support assembly that can support the sensor module in FIGS. 2A-2B;

6D is a perspective view of a fourth different shape of a skin-adhesive type and a transmitter support assembly that can support the sensor module in FIGS. 2A-2B;

6E is a perspective view of a fifth different shape of a skin-adhesive type and a transmitter support assembly that can support the sensor module in FIGS. 2A-2B;

7A is a perspective view of an exemplary flexible support screen for the transmitter support assembly of FIGS. 1B and 2C according to one embodiment;

7B is a perspective view of another exemplary flexible support screen for the transmitter support assembly of FIGS. 1B and 2C according to another embodiment;

8 is a perspective view of a three-lobed transmitter support assembly for a sensor system that allows storage of larger battery packs;

9A is a side cross-sectional view of an integrated transmitter support assembly and sensor according to an embodiment;

9B is a side cross-sectional view of a pluggable sensor and another example of a transmitter support assembly according to another embodiment; and

9C is a side cross-sectional view of the assembled sensor and transmitter support assembly of FIG. 9B.

Although the present invention allows various modifications and alternative forms, specific embodiments have been shown with the help of examples in the drawings and will be described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the scope of the accompanying patent application.

100‧‧‧Continuous glucose monitoring system

102‧‧‧sterile module

104‧‧‧Transmitter support assembly

110‧‧‧ base substrate layer

112‧‧‧ Basement

114‧‧‧ Flexible circuit board layer

116‧‧‧Foam layer

118‧‧‧Top cover

120‧‧‧ring parts

122‧‧‧pore

130‧‧‧Skin Adhesive

150‧‧‧sensor

Claims (33)

A flexible sensor system for continuous monitoring of a user, the sensor system includes: A base substrate layer for contacting the skin of the user; A circuit board layer opposite to the skin, which is positioned adjacent to the base substrate layer; A sensor that extends through the base substrate layer, the sensor is configured to be inserted into the skin; and A cover layer covering the circuit board layer. The flexible sensor system of claim 1, wherein the sensor is a glucose sensor and wherein the sensor is configured to contact interstitial fluid when inserted into the skin. The flexible sensor system of claim 1 further includes a microprocessor operable to receive an input signal from the sensor, and the microprocessor is mounted on the circuit board layer. The flexible sensor system of claim 3 further includes a memory to store data from the sensor. The flexible sensor system of claim 4 further includes a transmitter configured to send the data from the sensor to an external device. The flexible sensor system of claim 1, wherein the base substrate layer and the cover layer form an aperture, the system further includes an annular member installed in the aperture of the base substrate layer and the cover layer. The flexible sensor system of claim 1, further comprising a removable guide member, the removable guide member including a sensor support operable to support the sensor. The flexible sensor system of claim 1, wherein the base substrate layer and the cover layer are one of circular, rectangular, elliptical, multi-lobal shape, or triangular shape. The flexible sensor system of claim 1 further includes a battery pack to power components on the circuit board layer. The flexible sensor system of claim 9, wherein the battery pack is flexible. The flexible sensor system of claim 9, wherein the battery pack is a button battery pack. The flexible sensor system of claim 1, further comprising a foam layer in contact with the cover layer. The flexible sensor system of claim 1, wherein the base substrate layer, the circuit board layer and the cover layer are assembled by a layered assembly or a potting assembly. The flexible sensor system of claim 1, wherein the cover layer is one of fluid silicone rubber, thermoplastic elastomer, urethane, silicone rubber, or thermoplastic urethane. The flexible sensor system of claim 1, wherein the cover layer and the substrate base layer are a single component. The flexible sensor system of claim 1, further comprising a support layer between the base substrate layer and the circuit board layer. The flexible sensor system of claim 1, further comprising a skin adhesive applied on the base substrate layer. A support assembly for a continuous monitoring system attached to skin. The transmitter support assembly includes: A base substrate layer for contacting the skin of a user; A circuit board layer opposite to the skin, which is adjacent to the base substrate layer; A cover layer that encapsulates the circuit board layer; and An aperture formed by the base substrate layer and the cover layer for holding a sensor guide module including a sensor. As in the support assembly of claim 18, it further includes a microprocessor operable to receive an input signal from the sensor, the microprocessor being mounted on the circuit board layer. If the support assembly of item 19 is requested, it further includes a memory to store data from the sensor. As in the support assembly of claim 20, it further includes a transmitter configured to send the data from the sensor to an external device. As in the support assembly of claim 18, it further includes an annular member installed in the aperture. The support assembly of claim 18, wherein the base substrate layer and the cover layer are one of circular, rectangular, elliptical, multi-lobal, or triangular shapes. As in the support assembly of claim 18, it further includes a battery pack to power components on the circuit board layer. The support assembly of claim 24, wherein the battery pack is flexible. As in the support assembly of claim 24, wherein the battery pack is a button battery pack. As in the support assembly of claim 18, it further includes a foam layer embedded under the cover layer. The support assembly of claim 18, wherein the base substrate layer, the circuit board layer, and the cover layer are assembled by a layered assembly or a potting assembly. The support assembly of claim 18, wherein the cover layer is one of fluid silicone rubber, thermoplastic elastomer, urethane, silicone rubber, or thermoplastic urethane. The support assembly of claim 18, wherein the base substrate layer has at least two lobes, and wherein the first lobe includes the circuit board layer, and the second lobe supports a battery pack. The support assembly of claim 18, wherein the cover layer and the substrate base layer are a single component. As in the support assembly of claim 18, it further includes a support layer between the base substrate layer and the circuit board layer. The support assembly of claim 18, further comprising a skin adhesive applied on the base substrate layer to contact the skin.

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