Systems, devices, and methods for inserting a test substance sensor.

Abstract

Systems, devices, and methods are provided for inserting at least a portion of an in-vivo analyte sensor for sensing analyte levels in a subject's bodily fluid. The sensor insertion component can include a small-diameter needle positioned at an angle of about 7 to about 10 degrees relative to an insertion force path perpendicular to the skin, with a soft, elongated sensor and a sharp tip supported by a U-shaped guard along an intermediate portion of the sensor. Advancing the needle into the subject along this path stretches the skin around the needle, allowing the sensor tip to enter the body. The sensor can include a distal ridge for engaging the U-shaped guard to transmit the insertion force to the sensor tip.

Description

Cross - reference to related applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 123938, filed on December 10, 2020, and all of its contents are hereby expressly incorporated herein by reference for any purpose whatsoever.

Technical Field

[0002] The subject matter described herein generally relates to systems, devices, and methods for inserting sensors of an in vivo analyte monitoring system.

Background Art

[0003] For the health of individuals with diabetes, detecting and / or monitoring analyte values such as glucose, ketones, lactate, oxygen, hemoglobin A1C, etc. can be of extremely important significance. This is because patients with diabetes mellitus are at risk of developing complications such as unconsciousness, cardiovascular diseases, retinopathy, neuropathy, and nephropathy. Generally, diabetic patients need to monitor their glucose levels to confirm that their glucose levels are maintained within a clinically safe range. Furthermore, this information can be used to determine whether insulin is needed and / or when it is needed to lower the glucose level in the body, or when it is necessary to add glucose to raise the glucose level in the body.

[0004] And clinical data has been accumulating indicating a strong correlation between the frequency of glucose monitoring and blood glucose control. However, despite such a correlation, many people diagnosed with diabetes do not monitor their glucose levels at an appropriate frequency due to factors such as annoyance, a cautious attitude towards examinations, pain and costs associated with glucose tests.

[0005] Therefore, to ensure that patients adhere more faithfully to a plan for frequent glucose monitoring, an in vivo test substance monitoring system can be used to attach a sensor control device to the body of an individual who needs to monitor a test substance. To enhance the comfort and convenience of the wearer, the sensor control device has a miniaturized form factor and can be assembled and attached by the individual using a sensor applicator. This attachment procedure involves inserting the sensor using an applicator (insertion mechanism) so that the sensor, which detects the level of the test substance in the body fluids of the user, comes into contact with the body fluids. The sensor control device can also be configured to transmit test substance data to another device, allowing the individual or their healthcare provider (HCP) to review the data and make treatment decisions.

[0006] However, while existing sensors offer high convenience to users, they have a problem in that they are prone to malfunction due to improper insertion. Such malfunctions could be caused by human error, insufficient training, inadequate communication with the user, or overly complex procedures. For example, some prior art systems used sharpened bodies that did not have an optimal configuration for creating an insertion path at the insertion site without damaging surrounding tissue. Due to the above issues, there was a risk that the sensor might be improperly inserted or damaged, resulting in a failure to properly monitor the subject's test substance levels.

[0007] For example, the cross-sectional area of ​​the sharp object is approximately 0.25 mm². 2Some sharp body designs and insertion systems, such as those described above, are thought to be related to the fact that sensor insertion trauma can cause early sensitivity attenuation (ESA). After a new sensor is inserted into tissue, the sensor may experience a decrease in sensitivity called early sensitivity attenuation (ESA) for several hours to 1-2 days. The main cause of ESA is the tissue's reaction to trauma during the sensor insertion process. In other words, due to trauma during sensor insertion, the sensor may not be able to accurately measure and report the values ​​of the test substance for a while after insertion.

[0008] Some sensor insertion systems employ flexible circuit sensors to minimize sensor insertion trauma, but this is naturally limited to sensors that can be made feasible with flexible circuits. In other words, this design cannot be used for chip sensors that have a substantially larger cross-section than flexible circuit sensors. Therefore, even though chip sensors may be necessary or advantageous for sensing specific substances or parameters, the use of this sensor insertion system to insert chip sensors is closed off. [Overview of the project] [Problems that the invention aims to solve]

[0009] Therefore, there is a need for sensor insertion devices, systems, and methods that overcome the limitations of prior art, such as those mentioned above, by, for example, suppressing trauma during sensor insertion and related problems, and enabling the insertion of chip sensors to allow for use in a wider range of applications. [Means for solving the problem]

[0010] This specification describes exemplary embodiments of systems, devices, and methods for assembling and using applicators and sensor control devices for in vivo substance monitoring systems, and in particular embodiments utilizing flexible, elongated sensors.

[0011] In one embodiment, a sensor insertion component for use in an applicator of an in vivo substance sensor may include a sensor module that holds a connector coupled to the proximal end of a flexible elongated sensor, the sensor module having at least one surface that defines an insertion force path perpendicular to the skin, and a pointed body module that is held by the sensor module and configured to move relative to the sensor module parallel to the insertion force path perpendicular to the skin.

[0012] The pointed body module may include a base configured to perform relative movement (e.g., sliding motion) relative to the sensor module. The pointed body module may further include a U-shaped protective device fixed to the base and aligned with an insertion force path perpendicular to the skin, wherein the distal portion of the flexible elongated sensor extends beyond the distal end of the U-shaped protective device, and the intermediate portion of the flexible elongated sensor is positioned along the length of the U-shaped protective device. The intermediate portion of the flexible elongated sensor may be positioned in a groove of the U-shaped protective device. The distal portion of the flexible elongated sensor may extend from the U-shaped protective device in a length ranging from 0.5 to 4.0 mm. As a further example, the U-shaped protective device may have a length extending only in the range of 1.0 to 10 mm from the base.

[0013] The sharp body module may further comprise a sharp body fixed to at least one of the base or a U-shaped protective device, having an outer diameter of 0.56 mm or less and a distal portion that extends beyond the distal end of the soft, elongated sensor at an angle of 7 to 10 degrees with respect to the insertion force path perpendicular to the skin. The sharp body may be (or comprise) a solid needle with a diameter of 0.5 mm or less, for example, a needle with a diameter of about 0.35 mm. In some embodiments, the needle may be an acupuncture needle type needle. The distal portion of the sharp body may have a length in the range of, for example, 1.0 to 5.0 mm.

[0014] In other related embodiments, the distal end of the flexible elongated sensor may be pointed, abutted against the shaft of a sharp body, or positioned along the shaft of a sharp body. The flexible elongated sensor may be further fitted with a raised portion having a traction surface. The traction surface is configured to engage with the distal end of a U-shaped protective device to transmit insertion force to the flexible elongated sensor along an insertion force path perpendicular to the skin. In further related embodiments, the raised portion may comprise a sensor chip. The sensor chip is optionally covered with a protective film and coupled to an electronic component module by a conductor positioned along the flexible elongated sensor. The sensor chip may be, for example, a thermistor for sensing body temperature.

[0015] In related embodiments, the applicator can be provided to the user in a sterile package containing the electronic component housing of the sensor control device. Furthermore, a separate structure (e.g., a container) containing the sensor module and the sharp body module can also be provided to the user as a sterile package. The user can connect the sensor module to the electronic component housing and the sharp body to the applicator by inserting the applicator into the container and assembling it in a predetermined manner. After assembly, the sensor control device can be placed on the human body using the applicator, bringing the sensor into contact with the wearer's bodily fluids. The embodiments described herein provide improvements to suppress ESA caused by insertion trauma and to reduce discomfort to the subject during insertion. Other improvements and advantages are also provided. Various configurations of these devices will be described in detail by embodiments (which are merely illustrative).

[0016] In certain embodiments, the in vivo substance sensor is fully integrated with an on-body electronic component (fixed connection during manufacturing), while in other embodiments, the in vivo substance sensor and the on-body electronic component are separate and configured to be connectable after manufacturing (e.g., before, during, or after insertion of the sensor into the body). The on-body electronic component may include an in vivo glucose sensor, an electronic component, a battery, and an antenna, all of which (excluding the sensor portion placed in the body) are housed in a waterproof enclosure. The waterproof enclosure may include an adhesive pad, or may be configured to be attachable to an adhesive pad.

[0017] This disclosure provides a system, device, and method for inserting at least a portion of an in vivo test substance sensor for sensing the level of a test substance in a subject's bodily fluids. The sensor insertion component may comprise a small-diameter needle positioned at an angle to an insertion force path perpendicular to the skin, with a flexible, elongated sensor and a pointed tip supported along the middle portion of the sensor by a U-shaped protective device. This angle can be approximately 8 to 9 degrees, or approximately 7 to 10 degrees, or approximately 6 to 11 degrees, or approximately 5 to 12 degrees, or approximately 4 to 13 degrees, or greater than approximately 7 degrees, or less than approximately 10 degrees. By advancing the needle into the subject along this path, the skin around the needle stretches, allowing the sensor tip to enter the body. The distal portion of the sensor may be provided with a protrusion for engaging with the U-shaped protective device to transmit the insertion force to the sensor tip.

[0018] Other systems, devices, methods, features, and advantages relating to the subject matter described herein will be apparent to those skilled in the art, or will become apparent upon examination of the following drawings and detailed description. All such additional systems, devices, methods, features, and advantages are included herein, within the scope of the subject matter described herein, and are intended to be covered by the appended claims. Exemplary embodiments should not be construed as limiting the appended claims unless expressly stated in the claims.

[0019] By considering the accompanying drawings, the details of the subject matter described herein will become apparent in both its structure and operation. In the accompanying drawings, like parts are designated by like reference numerals. Also, in the drawings, the components are not necessarily drawn to scale, and emphasis is placed on explaining the principles of the subject matter. Further, each drawing is for the purpose of conveying a concept, and may schematically show, and not necessarily show faithfully and accurately, detailed attributes such as relative sizes and shapes.

Brief Description of the Drawings

[0020] [Figure 1] Figure showing an overview of a system consisting of a sensor applicator, a reading device, a monitoring system, a network, and a remote system [Figure 2A] Block diagram showing an exemplary embodiment of a reading device for executing the method described herein [Figure 2B] Block diagram showing an exemplary embodiment of a sensor control device [Figure 2C] Block diagram showing an exemplary embodiment of a sensor control device [Figure 3A] Proximity perspective view showing an exemplary embodiment of the preliminary preparation that a user performs on the tray in preparation for assembly [Figure 3B] Side view showing an exemplary embodiment of the preliminary preparation that a user performs on the applicator device in preparation for assembly [Figure 3C] Proximity perspective view showing an exemplary embodiment of a user inserting the applicator device into the tray during assembly [Figure 3D] Proximity perspective view showing an exemplary embodiment of a user removing the applicator device from the tray during assembly [Figure 3E] Proximity perspective view showing an exemplary embodiment of a subject attaching a sensor using the applicator device [Figure 3F] Proximity perspective view showing an exemplary embodiment of a subject with a sensor attached and a used applicator device [Figure 4A] Perspective view showing exemplary embodiments of the pointed body module and sensor module before assembly. [Figure 4B] A perspective view showing an exemplary embodiment of Figure 4A after the assembly of the pointed body and sensor module. [Figure 5A] Enlarged side view showing details of a bladed sharpened module with a U-shaped groove formed by stamping, for comparison with a hybrid needle-shaped sharpened module. [Figure 5B] Enlarged side view showing a detailed aspect of the hybrid needle-shaped sharpened body module. [Figure 6] An enlarged perspective view showing a bent needle attached to a U-shaped protective device as an alternative embodiment of the hybrid needle-shaped sharp body module. [Figure 7] A graph showing that no ESA occurred when glucose was monitored with a prototype hybrid needle attached. [Figure 8] Enlarged perspective view of a flexible, elongated sensor with a chip sensor near its pointed tip. [Figure 9A] A side view showing a sensor module with a chip sensor and a pointed module assembled to it, and a magnified view of the chip sensor. [Figure 9B] Enlarged view showing further details of the sensor with a chip sensor. [Figure 10A] Schematic top view showing a hybrid needle assembly with a chip sensor. [Figure 10B] Side view showing a flexible, elongated sensor with a tip, and enlarged view showing the area near the tip of the flexible sensor. [Figure 11A] An enlarged view similar to Figure 9B, showing an alternative configuration in which a chip sensor is coupled to a flexible, elongated sensor. [Figure 11B] An enlarged view similar to Figure 9B, showing an alternative configuration for a flexible, elongated sensor with a rigid material that does not have a chip. [Figure 12] A flowchart illustrating a method for inserting a flexible, elongated sensor into or under the skin of a subject using the sensor insertion component described herein or an equivalent component. [Figure 13] A flowchart illustrating a method for inserting a flexible, elongated sensor into or under the skin of a subject using the sensor insertion component described herein or an equivalent component. [Figure 14A] This diagram illustrates a portion of a support material in which multiple elongated protective devices are connected. [Figure 14B] This diagram illustrates a portion of a support material in which multiple elongated protective devices are connected. [Figure 14C] This diagram illustrates a portion of a support material in which multiple elongated protective devices are connected. [Figure 14D] This diagram illustrates a portion of a support material in which multiple elongated protective devices are connected. [Figure 15A] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected. [Figure 15B] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected. [Figure 15C] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected. [Figure 15D] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected. [Figure 16A] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected via injection-molded connectors. [Figure 16B] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected via injection-molded connectors. [Figure 16C] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected via injection-molded connectors. [Figure 16D] This diagram illustrates a portion of a support material in which multiple elongated protective devices and sharp objects are connected via injection-molded connectors. [Figure 17A] A diagram illustrating a portion of a support material having a mold for an additional injection-molded connector at the end of a pointed body. [Figure 17B]A diagram illustrating a portion of a support material having a mold for an additional injection-molded connector at the end of a pointed body. [Figure 17C] A diagram illustrating a portion of a support material having a mold for an additional injection-molded connector at the end of a pointed body. [Figure 17D] A diagram illustrating a portion of a support material having a mold for an additional injection-molded connector at the end of a pointed body. [Figure 18A] Cross-sectional view showing exemplary embodiments of the applicator at each mounting stage. [Figure 18B] Cross-sectional view showing exemplary embodiments of the applicator at each mounting stage. [Figure 18C] Cross-sectional view showing exemplary embodiments of the applicator at each mounting stage. [Figure 18D] Cross-sectional view showing exemplary embodiments of the applicator at each mounting stage. [Figure 18E] Cross-sectional view showing exemplary embodiments of the applicator at each mounting stage. [Figure 18F] Cross-sectional view showing exemplary embodiments of the applicator at each mounting stage. [Modes for carrying out the invention]

[0021] Before describing the subject matter of this disclosure in detail, it should be understood that this disclosure is not limited to the specific embodiments described herein and is naturally modifiable. Furthermore, since the scope of this disclosure is limited only by the appended claims, it should be understood that the terms used herein are merely for describing specific embodiments and are not intended to be limiting.

[0022] In this specification and the appended claims, the singular forms "a," "an," and "the" shall also include references to the corresponding plural forms unless the context clearly indicates that the plural form is not included.

[0023] Where publications are mentioned in this specification, they are mentioned simply because their disclosure preceded the filing date of this application. Nothing in this specification should be construed as acknowledging that this disclosure is not entitled to prior rights to such publications on the grounds that such publications have been disclosed prior to this application. Furthermore, publication dates mentioned in this specification may differ from actual publication dates and may need to be verified on a case-by-case basis.

[0024] Generally, embodiments of this disclosure include systems, devices, and methods for using data supplied from an in vivo test substance monitoring system that is attached using a sensor insertion applicator. Therefore, many embodiments include an in vivo test substance sensor. An in vivo test substance sensor is a sensor structurally configured to acquire information about at least one test substance in the body by placing (or being able to place) at least a portion of the sensor within the user's body. This disclosure relates to the insertion of a flexible circuit sensor (sometimes referred to as a flexible elongated sensor) into human tissue.

[0025] With respect to embodiments of the methods disclosed herein, systems and devices capable of carrying out each embodiment are also included within the scope of this disclosure. For example, this specification discloses embodiments of sensor-control devices that may have one or more sensors, a substance monitoring circuit (e.g., an analog circuit), a memory (e.g., a memory for storing instructions), a power supply, a communication circuit, a transmitter, a receiver, a processor and / or controller (e.g., a processor and / or controller for executing instructions), capable of carrying out any and all of the method steps, or capable of assisting in the carrying out of any and all of the method steps. Embodiments of these sensor-control devices may be used and made available to carry out steps relating to any and all of the methods described herein by the sensor-control device.

[0026] However, before describing in detail the aspects of these multiple embodiments, it is desirable to first describe examples of devices that can be used in conjunction with the embodiments described herein, such as those included in an in vivo substance monitoring system, and examples of their operation.

[0027] There are various types of in vivo analyte monitoring systems. For example, a "Continuous Analyte Monitoring" system (or "Continuous Glucose Monitoring" system) can transmit data from a sensor control device to a reading device continuously (e.g., automatically according to a schedule) rather than on a prompting basis. Another example is a "Flash Analyte Monitoring" system (or "Flash Glucose Monitoring" system, or simply a "Flash" system). A flash analyte monitoring system can transmit data from a sensor control device in response to data scanning or data requests by a reading device, for example, using a Near Field Communication (NFC) protocol or a Radio Frequency Identification (RFID) protocol. Furthermore, in vivo analyte monitoring systems can operate without requiring fingertip calibration.

[0028] In vivo test substance monitoring systems can be distinguished from in vitro systems, which come into contact with biological samples outside the body (i.e., "ex vivo"). Typically, in vitro systems have a measuring device with a port that receives a test substance sample carrying the user's bodily fluids, and the user's blood glucose level can be determined by analyzing that sample.

[0029] In vivo monitoring systems can be equipped with sensors. When sensors are placed in the body, they come into contact with the user's bodily fluids and sense the levels of a test substance contained in those fluids. Sensors can be part of a sensor control device. A sensor control device is a device implanted on the user's body and contains electronic components and a power supply responsible for realizing and controlling the detection of the test substance. Sensor control devices and their variations may also be called "sensor control units," "on-body electronics" devices or units, "on-body" devices or units, "sensor data communication" devices or units, etc., and these are just a few examples of alternative names for sensor control devices.

[0030] Furthermore, the in vivo monitoring system may further include a device that receives substance sensor data from a sensor control device and processes the substance sensor data and / or displays the data to the user in any number of forms. Such devices and their variations may be referred to as “handheld reader device,” “reader device” (or simply “reader”), “handheld electronics” (or simply “handheld”), “portable data processing” device or unit, “data receiver,” “receiver” device or unit (or simply “receiver”), or “remote” device or unit. Other devices, such as personal computers, may also be used with or incorporated into the in vivo or in vitro monitoring system.

[0031] Figure 1 is a conceptual diagram showing an exemplary embodiment of a substance monitoring system 100 comprising a sensor applicator 150, a sensor control device 102, and a reading device 120. The sensor applicator 150 can be used to deliver the sensor control device 102 to a monitoring location on the user's skin. Once the sensor control device 102 is delivered to the monitoring location, the flexible elongated sensor 104 is held in the appropriate position for a certain period of time by an adhesive patch 105. As further illustrated in Figures 2B and 2C, the sensor control device 102 can communicate with the reading device 120 via a communication channel 140 using any wired or wireless technology. Examples of wireless protocols include Bluetooth®, "Bluetooth" Low Energy (BLE, BTLE, "Bluetooth" SMART, etc.), and Near Field Communication (NFC). The user can monitor applications installed in the memory of the reading device 120 using the screen 122 and input unit 121, and can charge the device's battery using the power port 123. The reading device 120 will be described in detail in the following explanation of Figure 2A. The reading device 120 can communicate with the local computer system 170 via the communication channel 141 using wired or wireless technology. The local computer system 170 may consist of one or more computing devices such as a notebook computer, desktop computer, tablet terminal, phablet (a device combining a telephone and a tablet terminal), smartphone, set-top box, or video game console. For wireless communication, numerous wireless network protocols are available, including Bluetooth, Bluetooth Low Energy (BTLE), and WiFi, and any of these wireless network protocols can be used. Using the wired or wireless technology described above, the local computer system 170 can communicate with the network 190 via the communication channel 143, and similarly, the reading device 120 can also communicate with the network 190 via the communication channel 142.Network 190 can be any of several types of networks, including private networks, public networks, local area networks, or wide area networks. The trusted computer system 180 can be equipped with a server and can provide authentication services and secure data storage. Furthermore, the trusted computer system 180 can communicate with network 190 via communication channel 144 using wired or wireless technology.

[0032] In some embodiments, the sensor control device (e.g., a substance sensor device) may have a one-piece architecture incorporating sterilization techniques specifically designed for one-piece construction. A one-piece architecture allows the sensor control device assembly to be shipped to the user in a single, sealed package, eliminating the need for any final assembly by the user. Specifically, the user is required only to open one package and then deliver the sensor control device to the target monitoring location. The one-piece system configurations described herein have been shown to be advantageous in eliminating the number of components, various manufacturing processes, and user assembly work. This also reduces packaging and waste, as well as the risk of user error or system contamination.

[0033] According to some embodiments, a sensor sub-assembly (SSA) can be constructed and sterilized. Sterilization can be performed by radiation irradiation, such as electron beam irradiation, but other sterilization methods can be used instead. Other sterilization methods include, but are not limited to, gamma ray irradiation, X-ray irradiation, or any combination thereof. Below, an embodiment of a method for manufacturing a substance monitoring system using an SSA will be described, as an embodiment of a sensor control device having the SSA and an applicator used therewith. The SSA can be sterilized after manufacturing. The SSA at the time of sterilization can be configured to include a substance sensor and an insertion tip. Next, the sterilized SSA can be assembled to form a sensor control device (for example, the sterilized SSA can be assembled into the sensor control device), and the sterilized SSA can be positioned, for example, so that the sensor makes electrical contact with any electronic component in the sensor electronic component carrier. Next, this sensor control device can be assembled (for example, as a one-part assembly) to form an applicator (for example, the sensor control device can be assembled into the applicator). The applicator (also called a substance sensor inserter) is configured to attach a sensor control device to the user's body. This one-piece assembly can be packaged and / or distributed (e.g., shipped) to the user or healthcare professional. Further details relating to the sensor control device are described in European Patent Application Publication No. 3897790, all of which are expressly incorporated herein by reference for any purpose.

[0034] Figure 2A is a block diagram showing an exemplary embodiment of a reading device 120 configured as a smartphone. The reading device 120 may comprise a display 122, an input component 121, and a processing core 206, the processing core 206 may comprise a communication processor 222 coupled to memory 223 and an application processor 224 coupled to memory 225. Memory 225 may contain instructions for performing the operations described in the following description with respect to Figures 4A to 7. Instructions encoded in memory 225 can be organized into a plurality of functional modules. Each functional module may be a means (or include a means) for performing its function. This means may include one or more of the processors 224, 206, and 222. Processors 224, 206, and 222 are coupled to their respective memories and execute algorithms based on program instructions stored in memory. Such algorithms may include more detailed sequences of operations described in the description with respect to Figures 4A to 7. Although the diagram shows the reading device 120 having three processors 206, 222, and 224, any number of useful processors can be used in or provided within the reading device 120.

[0035] The reading device 120 may further comprise a separate memory 230, an RF transceiver 228 having an antenna 229, and a power supply 226 having a power management module 238. Alternatively or in addition, the reading device 120 may also comprise a multifunction transceiver 232 capable of communicating with the antenna 234 via WiFi, NFC, Bluetooth, BTLE, and GPS. As those skilled in the art will understand, these components are electrically and communicatively coupled to form a functional device.

[0036] Figures 2B and 2C are block diagrams illustrating exemplary embodiments of a sensor control device 102 having a substance sensor 104 and a sensor electronic component 160 (equipped with a substance monitoring circuit). The sensor electronic component 160 is responsible for most of the processing power for rendering the final result data in a format suitable for display to the user. The substance sensor 104 can be configured in a flexible and elongated form factor for subcutaneous insertion. Figure 2B shows a single semiconductor chip 161. The semiconductor chip 161 can be a custom-made application-specific integrated circuit (ASIC). Inside the ASIC 161 are several higher-order functional units, including an analog front-end (AFE) 162, a power management (control) circuit 164, a processor 166, and a communication circuit 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, etc., according to the communication protocol). In this embodiment, both the AFE162 and the processor 166 are used as the substance monitoring circuit, but in other embodiments, the substance monitoring function can be performed by either one of the circuits. The processor 166 may comprise one or more processors, microprocessors, controllers, and / or microcontrollers, which may each be on a separate chip or distributed across several different chips (and some thereof).

[0037] Furthermore, the ASIC161 also includes a memory 163. The memory 163 can be shared by various functional units present in the ASIC161, or it can be distributed among two or more of these functional units. The memory 163 can also be a separate chip. The memory 163 can be a volatile memory and / or a non-volatile memory. In this embodiment, the ASIC161 is coupled to a power supply 170, which can be a coin cell battery or the like. The AFE162 interfaces with the in vivo substance sensor 104 to receive measurement data from the sensor 104 and outputs this data to the processor 166 in digital format. The processor 166 then processes this data to obtain the final results, such as discrete values ​​and trend values ​​of glucose. Next, this data can be supplied to the communication circuit 168 and transmitted to the reading device 120 via the antenna 171. The reading device 120 can selectively display the relevant parts of the sensor data by performing further processing on this data using, for example, a resident software application.

[0038] Figure 2C is similar to Figure 2B, except that it includes two different semiconductor chips 162 and 174. The semiconductor chips 162 and 174 can be packaged together or individually. In this example, the AFE 162 is located on the ASIC 161. The processor 166 is provided on chip 174 together with the power management circuit 164 and the communication circuit 168. The AFE 162 includes memory 163, and chip 174 includes memory 165. The memory may be separate or integrated as distributed memory. In one exemplary embodiment, the AFE 162 is provided on one chip in combination with the power management circuit 164 and the processor 166, and the communication circuit 168 is provided on a separate chip. In another exemplary embodiment, the AFE 162 and the communication circuit 168 are provided on one chip, and the processor 166 and the power management circuit 164 are provided on separate chips. Furthermore, other chip configurations are possible, such as equipping the chips with three or more functions. Each chip can independently perform the functions described herein, and one or more functions can be shared among the chips for fail-safe redundancy.

[0039] The user can obtain the sensor control device 102 in multiple packages containing its various components. In this case, the sensor control device 102 can only be delivered to the appropriate user site after the user performs the final assembly. Figures 3A to 3D show exemplary embodiments of the user assembly process for the sensor control device 102. The illustrated process includes pre-preparation of each component before joining the separate components to make the sensor deliverable. Figures 3E to 3F show exemplary embodiments of delivering the sensor control device 102 to the appropriate user site by selecting an appropriate delivery location and mounting the sensor control device 102 in that location.

[0040] Figure 3A is a close perspective view showing an exemplary embodiment of the preparatory work that a user can perform on the container 310 in preparation for the assembly process. In the illustrated example, the container 310 is configured as a tray (other packages may also be used). The user can complete this preparatory work by removing the lid 312 from the tray 310 to expose the platform 308. This can be done, for example, by peeling the non-adherent portion of the lid 312 from the tray 310 and removing the adhesive portion of the lid 312. The removal of the lid 312 can be performed appropriately in various embodiments, provided that the platform 308 inside the tray 310 is sufficiently exposed. The lid 312 can then be set aside.

[0041] Figure 3B is a side view illustrating an exemplary embodiment of the pre-assembly of the applicator device 150 performed by the user in preparation for assembly. The applicator device 150 may be provided in a sterile package sealed with a removable cap 314 to maintain a sterile environment for the medical device and sharp objects it contains. The pre-assembly of the applicator device 150 may include the step of releasing the cap 314 from the housing 302 to expose the sheath 304 (Figure 3C). This step can be achieved by twisting (or otherwise releasing) the cap 314 from the housing 302. The cap 314 can then be set aside.

[0042] In some embodiments, the removable cap 314 can be secured to the applicator assembly by male and female threading. By fitting the end cap 314 onto the applicator, a sterile package can be formed that encloses the inside of the applicator. Thus, the need for separate packaging to maintain the sterile state inside the applicator 150 can be eliminated. In some embodiments, the removable end cap may have one or more openings at the end, and a sealed state can be formed by sealing these openings with a suitable material, such as a sterile barrier material like DuPont® Tyvek®. This configuration allows ethylene oxide (ETO) sterilization to be performed with the applicator closed and sealed. In some embodiments, the removable cap 314 may not have openings, and the removable cap 314 may be made of a material permeable to the sterilization process. This allows sterilization to be performed inside the applicator with the cap 314 engaged with the applicator, and the sterile state inside the cap can be maintained after exposure to the sterilization process. In some embodiments, ETO sterilization is also suitable for electronic components and accompanying adhesive patches in electronic component assemblies. In this case, the electronic components and adhesive patch can be kept removable within the applicator assembly until they are installed by the user. As shown in the figure, the applicator assembly comprises a housing with an integrally formed gripping configuration and a translation sheath (guide sleeve).

[0043] The container 310 and the applicator 150 can be sterilized using different sterilization methods. For example, the type of sterilization required for the sensor housed in the container 310 may differ from the type of sterilization required for the inside of the applicator 150 (e.g., the electronic components built into the applicator). The versatility of the separable and connectable two-piece system (i.e., the container 310 and the applicator) allows for the sterilization of each component individually before connecting and integrating them during use. In other words, sealing the container 310 and the applicator 150 separately allows for the use of sterilization methods that would not be suitable if these two components were not sealed separately. For example, the applicator 150, which includes an electronic component assembly such as an adhesive patch, can be sterilized using a type of sterilization that may impair the chemical properties of the sensor. Similarly, the container 310 containing the sensor can be sterilized using other sterilization methods that may damage the electronic components of the electronic component assembly (and / or the adhesive patch used to attach the electronic component assembly to the user's skin). Furthermore, considering the different shelf lives of active elements (electronic elements, chemical elements, etc.), other advantages may also be considered. In some embodiments, all components can be sterilized using the same sterilization technique. Examples of sterilization techniques used in this case include, but are not limited to, ETO sterilization and electron beam sterilization.

[0044] Figure 3C is a close perspective view showing an exemplary embodiment in which a user inserts the applicator device 150 into the tray 310 during assembly. First, the user aligns the housing orientation portion 1302 (i.e., the slot opening or recess) with the tray orientation portion 924 (the contact portion or return portion), and then inserts the sheath 304 into the platform 308 inside the tray 310. Inserting the sheath 304 into the platform 308 temporarily releases the locking of the sheath 304 from the housing 302, and also temporarily releases the locking of the platform 308 from the tray 310. If the applicator device 150 is removed from the tray 310 at this stage, it returns to the state before the applicator device 150 was first inserted into the tray 310 (i.e., at this point the operation can be undone or canceled, and the operation can be repeated without any particular impact).

[0045] As the housing 302 is advanced distally, the sheath 304 maintains its position within the platform 308 relative to the housing 302, and engages with the platform 308, allowing the platform 308 to advance distally toward the tray 310. This process releases the platform 308's locking within the tray 310, causing the platform 308 to fold. When the sheath 304 comes into contact with a locking element (not shown) within the tray 310, it can disengage the locking element. This releases the sheath 304 from the housing 302, and even if the housing 302 is advanced to continue advancing the platform 308 distally, the sheath 304 will no longer move (its relative movement is stopped). Once the forward movement of the housing 302 and platform 308 is complete, the sheath 304's locking to the housing 302 is permanently released. Once the distal forward movement of the housing 302 is complete, the pointed body and sensor (not shown) in the tray 310 can be coupled to the electronic component housing (not shown) in the housing 302. The operation and interaction of the applicator device 150 and the tray 310 will be described further later.

[0046] Figure 3D is a close-up perspective view showing an exemplary embodiment in which a user removes the applicator device 150 from the tray 310 during assembly. The user can remove the applicator 150 from the tray 310 by advancing the housing 302 proximal to the tray 310, or by performing other movements that ultimately achieve a similar effect of disengaging the applicator 150 from the tray 310. When the applicator device 150 is removed, the assembly of the sensor control device 102 (not shown) is completed (the pointed body, sensor, and electronic components are complete) within the applicator device 150, and the sensor control device 102 is set in a position suitable for delivery.

[0047] Figure 3E is a close-up perspective view showing an exemplary embodiment in which a subject uses the applicator device 150 to attach the sensor control device 102 to a target area on the skin (e.g., an appropriate location such as the abdomen). As the housing 302 is advanced distally, the sheath 304 retracts within the housing 302, attaching the sensor to the target position and the adhesive layer on the bottom of the sensor control device 102 adheres to the skin. When the housing 302 is advanced to its maximum extent, the pointed body is automatically retracted into the applicator assembly, leaving the sensor in the user's hands, and the body-worn device becomes waterproof and sealed, while the sensor (not shown) remains in place, allowing for measurement of the level of the substance being tested. The operation of the applicator 216 during the attachment of the body-worn device 102 is designed to give the user the impression that the internal mechanism of the applicator 216 is automatically performing both the insertion and retraction of the pointed body 1030.

[0048] Figure 3F is a close-up perspective view showing an exemplary embodiment in which the sensor control device 102 is attached to the mounting position of the subject. After installation, the user can remove the applicator 150 from the mounting site.

[0049] The system 100 described in this specification, including the descriptions of Figures 3A to 3F, can reduce or eliminate the possibility of accidentally damaging, permanently deforming, or incorrectly assembling the applicator components compared to prior art systems. Because the applicator housing 302 engages directly with the platform 308 by releasing the lock of the sheath 304, rather than indirectly engaging with the platform 308 via the sheath 304, the relative angle between the sheath 304 and the housing 302 does not cause damage or permanent deformation of components such as the arm. (Unlike conventional devices) the likelihood of relatively large forces being applied during assembly is low, improving the safety and effectiveness of user assembly. The illustrated sensor control device 102 and applicator device are considered useful for use with the needle devices and methods described later. However, other applicators and sensor control devices may also be useful for use with the sensor insertion components and methods described herein.

[0050] Test substance monitoring systems allow for simple and easy continuous measurement and monitoring of subcutaneous test substance levels, such as glucose. However, after a new sensor is inserted into tissue, it may experience a decrease in sensitivity called "initial sensitivity decay (ESA)" for several hours to one or two days. At least part of the cause of ESA is the tissue's reaction to trauma during the sensor insertion process. Therefore, minimizing trauma during sensor insertion is a crucial strategy to suppress ESA, allowing newly inserted sensors to measure and report test substance concentrations immediately after insertion.

[0051] Referring to Figures 4A and 4B, Figure 4A shows the sharpened body module 410 detached from the sensor control module 412 with which it is fitted. The sharpened body module 410 can also be called a hybrid needle insertion device. Figure 4B shows the sharpened body module 410 attached to the sensor control module 412 to form a sensor module assembly 400. The sensor module assembly 400 is provided in an applicator device illustrated and described herein (see, for example, Figures 3A-3F and 18A-18F). For comparison, Figure 5A shows a conventional sharpened body configuration 500 using a U-shaped sharpened body 504 with a blade. The sharpened body 504 has a groove in the center, which holds a soft, elongated sensor 502 with a rounded tip. The sensor module 506 holds the U-shaped sharpened body 504 so that it can be inserted perpendicularly into the tissue. The pointed body 504 can be a stamping-formed U-shaped metal pointed body with an etching blade at its tip. During insertion, the etching blade of the pointed body 504 makes a cut in the skin, and the sensor, protected by a metal groove, is pushed into the skin along with this groove. In the illustrated embodiment, the cross-section of the metal groove inserted into the skin is approximately 0.60 × 0.53 = 0.32 mm. 2 This is greater than the level desired to prevent ESA due to insertion trauma. Furthermore, it is not possible to manufacture this relatively complex sharp body 504 in a size that does not cause insertion trauma greater than that caused by the assemblies shown in Figures 4A, 4B, and 5B, while still maintaining its function. Therefore, in the case of the sharp body assembly 500, there was a risk that some degree of ESA would occur.

[0052] On the other hand, ESA can be suppressed by using a "hybrid needle" instead of a grooved, stamping-molded sharp body. The "hybrid needle" is configured to use a small needle that pierces the skin in combination with a pointed sensor, and the sensor can be inserted into a puncture hole made by a needle that does not have a U-shaped groove at the insertion site. In some embodiments, the needle can be a thin acupuncture needle. This can significantly reduce insertion trauma. For example, the cross-sectional area of ​​a needle with a diameter of 0.35 mm is 0.10 mm². 2It is less than one-third of the pointed body 504 shown in the illustration. This novel hybrid needle insertion process significantly reduces trauma to the insertion site by minimizing skin incisions and greatly reducing the volume of the pointed body pushed into the tissue. A U-shaped protective device may be used to support the sensor piece before insertion, but the U-shaped protective device will not come into contact with the user's body.

[0053] In some embodiments, an elongated longitudinal opening (gap) can be provided in the wall of the needle (sharp body), as described in European Patent No. 3766408. All disclosures of this patent specification, regardless of their purpose, are expressly incorporated herein by reference. In some embodiments, the needle can be manufactured to define a longitudinal recess by bending a thin metal sheet so that its cross-section is substantially V-shaped, U-shaped, or C-shaped.

[0054] The bent metal sheet that forms the sharp point (needle) can be manufactured using various techniques. For example, the sharp point can be formed using metal sheet etching technology. In this way, the sharp point can be formed to have a very sharp edge, thus reducing pain when the sharp point penetrates the skin during insertion. In other embodiments, complex metal sheet shapes with sharp edges can also be formed using progressive die technology. In some embodiments, the sharp point can be formed with a plastic cap so that it can be handled during the inserter assembly process. Furthermore, plastic sharp points can be formed by punching to reinforce V-shaped, U-shaped, or C-shaped metal sheet configurations. In some embodiments, a U-shaped cross-section with flat walls instead of curved walls can be provided. The U-shaped configuration has the advantage of holding the sensor more securely and without gaps. The U-shaped configuration also has the advantage of allowing for a smaller cross-section compared to an equivalent circular cross-section. The sharp point can have a flat section, which can be provided, for example, at the bottom of the U-shaped configuration. The tip can be formed by a first distal edge closest to the distal tip and a second distal edge located between the first distal edge and a side wall substantially parallel to each other. In some embodiments, the two first distal edges form an included tip angle of about 15 degrees, about 30 degrees, or about 60 degrees. Such angles are symmetrical, i.e., equal to the left and right angles from the longitudinal axis of the sharp body. The two second distal edges form a slightly larger acute angle than the first distal edges. In some embodiments, this lead-in angle can be about 20 degrees, about 45 degrees, or about 65 degrees. By defining the tip with two angles—a small first tip angle and a large second lead-in angle—the tip can achieve several purposes. Firstly, the small tip angle can minimize trauma when the tip penetrates the skin. Secondly, by widening the angle from that point, the overall length of the tip is shortened, and the strength of the tip is improved.

[0055] Referring again to Figures 4A and 4B, the pointed module 410 has a cross-section of approximately 0.25 mm. 2 The sharp body module 410 may be provided with the following thin needle 402. The thin needle 402 is a needle for piercing the skin and inserting a soft, elongated sensor 404 (which may be referred to herein as the soft sensor or sensor) with a pointed tip into the body. The sharp body module 410 may further be provided with an elongated U-shaped protective device 406 for protecting and stabilizing the middle portion of the soft sensor 404 during insertion. The U-shaped protective device 406 may be formed from any structural material suitable for medical applications (e.g., stainless steel), and the U-shaped protective device 406 may be fixed perpendicularly to the base 408 of the sharp body module 410 so that the U-shaped protective device 406 can be held perpendicular to the skin surface when the sensor module assembly 400 is assembled into an applicator and attached to a subject. The pointed body module 410 can be slidably mounted to the sensor module 416 so that it can slide along a path parallel to the elongated protective device 406 (for example, towards the upper side when the sensor module assembly 400 is oriented as shown in Figure 4B). This makes it possible to withdraw the pointed body 402 from the subject's body after the sensor 404 has been inserted, leaving the embedded sensor in place.

[0056] To increase the strength of the sensor during insertion, the flexible elongated sensor can be protected by an elongated U-shaped protective device 406. The distal portion 420 of the flexible sensor can be left exposed as the initial insertion portion. The distal portion 420 can be of an appropriate length, such as approximately 3.0 mm, 1.0 mm, 2.0 mm, or 4.0 mm. It is assumed that further portions of the flexible sensor body will continue to penetrate the tissue when the hybrid needle is withdrawn from the skin. The base component 408 holds the needle 402 while maintaining a constant relationship between the needle 402 and the U-shaped metal groove. The base component 408 can be formed by an injection molding process, and the needle 402 can be incorporated into the base component 408, which is formed from any suitable polymer, by injection molding. In this embodiment, as shown in the figures, it is possible to support a relatively long needle that penetrates the skin at an angle. An exemplary method for manufacturing the pointed body module 410 will be described with reference to Figures 14A to 17D. Other exemplary manufacturing methods are described in International Publication No. 2020 / 041571, all of which are expressly incorporated herein by reference, regardless of their purpose.

[0057] The sensor control module 412 may include a flexible sensor 404. The flexible sensor 404 is coupled to a connector 418 and held in the sensor module 416. The connector 418 may be made of silicone rubber and enclose a flexible carbon-impregnated polymer module that functions as a conductive contact between the sensor and the electrical circuit contacts to the electronic components within the housing of the body-worn unit. The connector can function as a moisture barrier for the sensor when it is assembled in a compressed state after being transferred from the container to the applicator, and after it is attached to the user's skin. Multiple sealing surfaces can be used to seal and waterproof the electrical contacts and sensor contacts. One or more hinges can connect the two parts of the connector 418, the distal and proximal portions.

[0058] The sensor module 416 can be configured to house the sharp body module 410 such that the soft sensor 404 fits snugly into the central groove of the U-shaped protective device 406. When assembled to the sensor module 416, the elongated U-shaped protective device 406 is held in place by the sensor module assembly 400. This holding ensures that the U-shaped protective device 406 is perpendicular to the skin surface of the subject when the sensor module 416 is incorporated into the applicator device and attached to the subject's skin.

[0059] The sharp body module 410 may be equipped with a pointed cylindrical needle 402. The cylindrical needle 402 is held in a fixed orientation, which is such that it pierces the skin at a small angle of approximately 7 to 10 degrees from the insertion direction perpendicular to the skin surface (the direction indicated by the orientation of the U-shaped protective device 406). This small angle causes the opening in the skin to widen slightly after the needle pierces the skin, and the soft sensor 404, whose tip is located right next to the needle 402, enters the puncture hole created by the sharp body (needle). The distal portion 422 of the needle 402 can extend beyond the end of the soft sensor 404 by a distance approximately equal to the desired insertion depth, for example, by about 1.0 mm, or about 1.5 mm, or about 2.0 mm, or about 2.5 mm, or about 3.0 mm, or about 3.5 mm, or about 4.0 mm, or about 4.5 mm, or about 5.0 mm.

[0060] The magnitude of the angle α between the sharpened body 402 and the normal to the skin surface is considered to greatly affect the success of the sensor insertion process. Figure 5B schematically shows the angle α with respect to the normal to the skin surface 405, indicated by a dashed line. If the angle α is greater than approximately 10 degrees, the needle 402 may bend at the first moment of engagement with the skin surface, and in that state, the needle may push the sensor, causing it to dislodge from its predetermined position. Conversely, if the angle α is less than approximately 7 degrees, the skin may not be stretched sufficiently, making it impossible to insert the tip of the sensor into the puncture wound. Since the flexible sensor 404 has essentially the same physical properties as a thin thin film PET film, it does not have enough rigidity to be inserted into the tissue by itself without creating and widening a puncture hole with the sharpened body 402. In addition, to help insert the flexible sensor into the puncture hole created by the sharpened body 402, the distal tip of the flexible sensor 404 can be sharpened, as shown in the enlarged view of Figure 5B.

[0061] A slender, pointed body with a suitable angle can be provided on the sensor mounting device using various other methods. For example, as shown in Figure 6, the proximal portion 608 of a pre-bent needle 602 can be attached (for example, by spot welding) to the outer surface of the U-shaped protective device 604 near its distal end. The bend of the pointed body 602 separates the proximal portion 608 from the distal portion 606, and the angle is the same as the angle α described above. The proximal portion 608 of the pointed body 602 is aligned with the U-shaped protective device 604 along a common longitudinal axis shared by the pointed body 602 and the U-shaped protective device 604. The U-shaped protective device 604 can be the same as or identical to the U-shaped protective device 406 and can be incorporated into the pointed body module 410 in the same way as the U-shaped protective device 406. An advantage of the assembly 600 is that the length of the needle can be shortened, improving mechanical rigidity and operational precision.

[0062] Referring to Figures 4A, 4B, 5B, and 6 in general, the needle 402 (sometimes referred to as the sharp body) can be made of stainless steel or a similar elastic material (for example, in some embodiments, a material used in the manufacture of needles such as acupuncture needles) and can be sized so that at least a portion of the sensor 404 can be inserted or penetrated into human tissue by the applicator. According to certain embodiments, the cross-sectional diameter (width) of the sharp body can be 0.1 mm to 0.5 mm. For example, the diameter of the sharp body can be about 0.1 mm to about 0.3 mm, for example, about 0.15 mm to about 0.25 mm, for example, about 0.16 mm to about 0.22 mm. A given sharp body may have a constant (i.e., uniform) width along its entire length, or its width may vary (i.e., fluctuate) along at least a portion of its length, such as the tip used to pierce the skin surface. In some embodiments, the cross-section of the sharp body 402 perpendicular to the long axis of the sharp body 402 is approximately 0.25 mm 2 The following is possible. Incidentally, if we use a pointed body with a circular cross-section as a reference, the upper limit is 0.25 mm. 2 This corresponds to a diameter of approximately 0.56 mm.

[0063] For example, the length of the pointed body can be such that the sensor can be inserted to a desired depth, but not to a depth beyond that. The insertion depth can be controlled by the length of the pointed body and the configuration of other applicator components that limit the base and / or insertion depth. The length of the pointed body can be approximately 1.5 mm to approximately 25 mm. For example, the length of the pointed body can be approximately 1 mm to 3 mm, 3 mm to 5 mm, 5 mm to 7 mm, 7 mm to 9 mm, 9 mm to 11 mm, 11 mm to 13 mm, 13 mm to 15 mm, 15 mm to 17 mm, 17 mm to 19 mm, 19 mm to 21 mm, 21 mm to 23 mm, 23 mm to 25 mm, or more than 25 mm. While the sharpened body can have a maximum length of approximately 25 mm, in certain embodiments, it will be understood that the entire length of the sharpened body is not inserted into the subject, as doing so would cause the sharpened body to extend beyond the desired depth. The presence of a portion of the sharpened body that is not inserted allows for handling and manipulation of the sharpened body within the applicator set. Therefore, although the sharpened body can have a maximum length of approximately 25 mm, as will be described in more detail below, the insertion depth of the sharpened body into the subject's skin in the particular embodiments described above can be limited to a desired depth (e.g., approximately 1.5 mm to approximately 4 mm) depending on the location of the skin. For example, in some embodiments disclosed herein, the sharpened body can be configured to extend into (or completely penetrate) the subcutaneous tissue (e.g., tissue approximately 3 mm to approximately 10 mm below the surface of the skin, depending on the location of the skin on the body). Furthermore, in some exemplary embodiments, the sharpened body described herein may comprise a hollow or partially hollow insertion needle having an internal space or lumen. However, in other embodiments, the sharpened body described herein may comprise a solid insertion needle that has neither an internal space nor a lumen. Furthermore, the sharpened body of the applicator set for attachment to the subject may or may not have a blade.

[0064] Because the depth and thickness of the epidermis and dermis vary to some extent depending on the location on the skin, the dimensions of the sensor (e.g., length) can be selected according to the body part of the person into which the sensor is inserted. For example, the thickness of the epidermis is only about 0.05 mm in the eyelid, but about 1.5 mm in the palm of the hand or sole of the foot. The dermis is the thickest of the three layers of skin, and although it varies depending on the location on the skin, its thickness ranges from about 1.5 mm to 4 mm. This method may include the steps of determining the insertion site on the user's body and identifying the depth of the layer at that site, and selecting an applicator set of a size appropriate for that site.

[0065] In some embodiments, the sensor 404 is an elongated sensor having a maximum dimension (or "length") of 1.0 mm to 10 mm. In embodiments in which only a portion of the sensor is inserted, the insertion length of the sensor is in the range of approximately 0.5 mm to approximately 7 mm, for example, in the range of approximately 4 mm to approximately 6 mm, for example, approximately 5 mm or approximately 6 mm. The flexible elongated sensor can have an aspect ratio, which is the ratio of length to width (diameter), of 3:1 or more, for example, 10:1, 20:1, etc. The insertion portion of the sensor has a chemical sensing configuration.

[0066] Those skilled in the art will understand that the dimensions and configuration of embodiments of the sensor control device can be made suitable for use with a sensor configured to sense the level of a test substance in bodily fluids within the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the dimensions and configuration of the pointed body and the distal portion of the test substance sensor can be set so that both the pointed body and the distal portion of the test substance sensor disclosed herein can be positioned at a specific end depth (i.e., the deepest position reached by penetrating the tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). Furthermore, with respect to some embodiments of the applicator, those skilled in the art will understand that the dimensions and configuration of the pointed body of a particular embodiment can be set so that it can be positioned at an end depth different from the final end depth of the test substance sensor in the subject's body. In some embodiments, for example, the position of the pointed body before retraction can be a first end depth in the subject's epidermis, and the position of the distal portion of the test substance sensor can be a second end depth in the subject's dermis. In other embodiments, for example, the position of the pointed body before withdrawal may be defined as the first end depth in the subject's dermis, and the position of the distal part of the test substance sensor may be defined as the second end depth in the subject's subcutaneous tissue. In yet another embodiment, for the first and second end depths within the same layer or tissue of the subject's body, the position of the pointed body before withdrawal may be defined as the first end depth, and the position of the distal part of the test substance sensor may be defined as the second end depth.

[0067] When using a thin, sharp object with an angle of approximately 7 to 10 degrees, inserting the needle (sharp object) vertically may result in a lateral force being applied to the needle toward the sensor tip. This lateral force is a function of the skin's hardness and resistance. In the case of hard skin, the lateral force becomes larger, which may cause the tip of the sharp object to bend or move, shifting its position away from the sensor tip and potentially leading to insertion failure. On the other hand, initial tests conducted with 13 subjects using the configurations shown in Figures 4A and 4B, involving multiple insertions, showed an insertion success rate exceeding 96%. Most of the failures were due to misfiring of the prototype applicator. If the device can be manufactured under proper control during normal production, sensor failures caused by lateral forces from hard skin should be reduced even with the sharp object configuration shown in Figure 6. Therefore, insertion failures are expected to be far less frequent than with the prototype.

[0068] However, even the prototype demonstrated a significant reduction in ESA. Graph 700 in Figure 7 shows an example of glucose data from four sensors implanted in the same subject using a hybrid needle insertion device. Two sensors were initially inserted, and approximately 24 hours later, two more sensors (corresponding to the graphs with "_350" appended to the legend) were inserted. Throughout the test period, the sensor data showed good consistency. There was little to no indication of system malfunction. There was also no indication of ESA caused by insertion trauma.

[0069] Figures 18A–18F illustrate exemplary details of an embodiment of the internal device mechanism, which includes "firing" the applicator 216 to attach the sensor control device 102 to the user and safely retracting the pointed body 1030 into the applicator 216 after use. Figures 18A–18F as a whole illustrate an example of a series of steps in which the pointed body 1030 (supporting the sensor coupled to the sensor control device 102) is fired into the user's skin, the pointed body is withdrawn leaving the sensor in operable contact with the user's interstitial fluid, and the sensor control device is adhesively attached to the user's skin. Those skilled in the art will be able to understand what modifications to this procedure of use may be made when using other embodiments or components of applicator assemblies by considering those embodiments and components. The applicator 216 may also be a one-component or two-component sensor applicator as disclosed herein.

[0070] Referring here to Figure 18A, the sensor 1102 is supported within the pointed body 1030 at a position just above the user's skin 1104. Rails 1106 (optionally, three rails 1106) can be provided on the upper guide section 1108 to control the relative movement of the applicator 216 with respect to the sheath 318. The sheath 318 is held within the applicator 216 by a retaining mechanism 1110, and when an appropriate downward force is applied along the longitudinal axis of the applicator 216, the retaining mechanism 1110 overcomes the resistance force, allowing the pointed body 1030 and the sensor control device 102 to translate along the longitudinal axis into (and above) the user's skin 1104. Furthermore, the retaining arm 1112 of the sensor carrier 1022 engages with the pointed body pull-back assembly 1024 to maintain the pointed body 1030 in the correct position relative to the sensor control device 102.

[0071] In Figure 18B, the user applies a force that pushes over (overcomes) the retaining mechanism 1110, causing the sheath 318 to contract into the housing 314, resulting in the sensor control device 102 (along with its accessories) translating in the longitudinal axis direction indicated by arrow L. Throughout the entire sensor / sharp body insertion process, the position of the carrier arm 1112 is restricted by the inner diameter of the upper guide portion 1108 of the sheath 318. The stopper surface 1114 of the carrier arm 1112 is held against the complementary surface 1116 of the sharp body pull-back assembly 1024, thereby maintaining the position of the member while maximizing the energy stored in the return spring 1118.

[0072] In Figure 18C, the sensor 1102 and the sharp body 1030 have reached their maximum insertion depth. This releases the carrier arm 1112 from the inner diameter of the upper guide portion 1108. The compressive force of the coil return spring 1118 pushes the angled stopper surface 1114 radially outward, and the resulting released force moves the sharp body carrier 1102 of the sharp body pull-back assembly 1024, as shown by arrow R in Figure 18D, and pulls the sharp body 1030 (which has a configuration such as having a groove (slot)) out of the user's body, leaving the sensor 1102 behind.

[0073] As shown in Figure 18E, when the pointed body 1030 is fully retracted, the upper guide portion 1108 of the sheath 318 is fixed to the final locking mechanism 1120. Then, as shown in Figure 18F, the used applicator assembly 216 is removed from the insertion site, leaving the sensor control device 102 behind. At this point, the pointed body 1030 is securely fixed inside the applicator assembly 216. The used applicator assembly 216 is now ready for disposal.

[0074] In some embodiments, the pull-back device withdraws the sharp object when activated by the user. In this case, the user activates the pull-back device when they want to withdraw the sharp object. For example, the pull-back device may be equipped with a release switch. Activating the release switch causes the drive assembly (e.g., a drive such as a spring) to pull the sharp object back from the skin. In other embodiments, the pull-back device and the actuator are composed of common components. In this case, the user can withdraw the sharp object from the skin by the drive assembly after activating the actuator to advance the sharp object and the substance sensor and then releasing the actuator.

[0075] In some embodiments, after insertion is activated, the retractor can withdraw the sharp body without further user interaction. For example, the inserter may be equipped with a function or component that automatically retracts the sharp body when the sharp body and support structure have advanced by a predetermined amount. In this specification, an insertion device that does not require further user operation to begin withdrawing the sharp body after insertion may also be described as having an "automatic" withdrawal operation for the sharp body.

[0076] The operation of the applicator 216 during the installation of the sensor control device 102 is designed to give the user the impression that the internal mechanism of the applicator 216 is automatically performing both the insertion and withdrawal of the sharp body 1030. In other words, the present invention does not give the user the impression that they are manually driving the sharp body 1030 into their skin. Therefore, a user who applies enough force to overcome the resistance from the applicator 216's retaining mechanism perceives the resulting operation of the applicator 216 as having been "triggered" and automatically responded to by the applicator 216. The force driving the sharp body 1030 to penetrate their skin is applied solely by the user, and although no additional biasing / driving means are used to insert the sharp body 1030, the user is not aware that they are applying such additional driving force. As explained in detail in Figure 18C above, the retraction of the pointed body 1030 is performed automatically by the coil return spring 1118 of the applicator 216.

[0077] Those skilled in the art will understand that any embodiment of the applicator described herein, and any component thereof (including, but not limited to, embodiments of the sharp body, sharp body module, and sensor module), can be made suitable for use with a sensor configured to sense the level of a test substance in bodily fluids within the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, the dimensions and configuration of the sharp body and the distal portion of the test substance sensor can be set so that both the sharp body and the distal portion of the test substance sensor disclosed herein can be positioned at a specific end depth (i.e., the deepest position reached by penetrating the tissue or layer of the subject's body, e.g., the epidermis, dermis, or subcutaneous tissue). Furthermore, with respect to some embodiments of the applicator, those skilled in the art will understand that the dimensions and configuration of the sharp body of a particular embodiment can be set so that it can be positioned at an end depth different from the final end depth of the test substance sensor in the subject's body. In some embodiments, for example, the position of the pointed body before withdrawal may be defined as the first end depth of the subject's epidermis, and the position of the distal part of the test substance sensor may be defined as the second end depth of the subject's dermis. In other embodiments, for example, the position of the pointed body before withdrawal may be defined as the first end depth of the subject's dermis, and the position of the distal part of the test substance sensor may be defined as the second end depth of the subject's subcutaneous tissue. In yet another embodiment, for the first and second end depths within the same layer or tissue of the subject's body, the position of the pointed body before withdrawal may be defined as the first end depth, and the position of the distal part of the test substance sensor may be defined as the second end depth.

[0078] Furthermore, with respect to any embodiment of the applicator described herein, those skilled in the art will understand that the substance sensor and one or more structural components coupled thereto (including, but not limited to, one or more spring mechanisms) can be positioned within the applicator at eccentric locations with respect to one or more axes of the applicator. In some embodiments of the applicator, for example, the substance sensor and spring mechanism can be positioned at a first eccentric position eccentric to a first side of the applicator with respect to the axis of the applicator, and the sensor electronic component can be positioned at a second eccentric position eccentric to a second side of the applicator with respect to the axis of the applicator. In other embodiments of the applicator, the substance sensor, the spring mechanism, and the sensor electronic component can be positioned at eccentric locations on the same side with respect to the axis of the applicator. Also, those skilled in the art will understand that any or all of the applicator components, such as the substance sensor, spring mechanism, and sensor electronic component, can be rearranged or configured to be positioned concentrically or eccentrically with respect to one or more axes of the applicator, and that these are all also within the scope of the present disclosure.

[0079] This specification describes, but is not limited to, a number of flexible structures, including flexible locking snap members 1402, flexible locking arms 1412, sharp body carrier locking arms 1524, sharp body holding arms 1618, and modular snap members 2202. These flexible structures are made of elastic materials such as plastic, metal (or other), and their modes of operation are well known to those skilled in the art. Each flexible structure has a stationary state or stationary position, and the elastic material is biased in the direction of this stationary state (position). If a force is applied that causes the flexible structure to bend or move from this stationary state (position), when the force is removed (or weakened), the bias of the elastic material causes the flexible structure to return to the stationary state (position). These flexible structures are often configured as arms with locking parts or snap-fit ​​parts, but other structures and configurations that have similar characteristics of flexibility and return to the stationary position can also be used. Examples of such structures and configurations include, but are not limited to, flexible member legs, clips, catches, and abutments.

[0080] In certain embodiments, the sensor placement process is performed automatically. This "automatic" means that the sensor placement process can be initiated simply by the user activating the device (for example, by operating a button or lever, or by touching the device to a skin surface), and the process will proceed to completion without further user intervention.

[0081] Further details of preferred devices, systems, methods, components, and their operation and associated features are described in International Publication No. 2018 / 136898 by Rao et al., International Publication No. 2019 / 236850 by Thomas et al., International Publication No. 2019 / 236859 by Thomas et al., International Publication No. 2019 / 236876 by Thomas et al., and U.S. Patent Application Publication No. 2020 / 0196919 filed on June 6, 2019, all of which are incorporated herein by reference. Further details regarding embodiments of the applicator, its components, and variations thereof are described in U.S. Patent Publication Nos. 2019 / 0282137, 2021 / 0219887, 2019 / 0347086, 2013 / 0150691, 2016 / 0331283, and 2018 / 0235520, all of which are incorporated herein by reference for any purpose. Furthermore, further details regarding embodiments of the sharpened body module, sharpened bodies, their components, and variations thereof are described in U.S. Patent Publication No. 2014 / 0171771, all of which are incorporated herein by reference for any purpose.

[0082] Furthermore, with respect to any embodiment of the applicator described herein, a sensor module assembly 400 comprising an elongated protective element 604 and a pointed body 402 oriented at an angle to the longitudinal axis of the elongated protective element 604 can be used in combination with the applicator 216 described with reference to Figures 18A to 18F.

[0083] The embodiments described above are considered useful for inserting lab-on-chip sensors manufactured using MEMS or wafer technology into tissue for continuous sensor sensing. The slender needles, eccentrically positioned with respect to the axis as described in the description of the hybrid needle embodiment, are suitable for inserting the sensor assembly 800. The sensor assembly 800 may include a flexible elongated sensor 802 with a pointed tip. A chip sensor 804 is mounted near the tip 810 of the flexible elongated sensor 802. The chip sensor 804 can be relatively small, for example, about 0.4 × 0.2 × 0.2 mm. A separate conductor 806 connects the chip sensor 804 to the electronic circuitry of a supporting sensor module 808. The chip sensor 804 can be used to monitor parameters different from those of the flexible sensor 802. For example, the chip sensor 804 may be (or include) a thermistor for measuring the temperature of the sensor installation site.

[0084] Similar to the hybrid needle described above, a thin needle is used to puncture the skin, and a pointed-tip sensor 802 with a chip sensor 804 attached can be inserted into the puncture hole created by this needle. The U-shaped metal protector described above supports and protects the flexible sensor, and during the insertion process, it can assist in insertion by pressing the attached sensor chip 804 with the front end of the protector. Therefore, as demonstrated with the hybrid needle device, the chip sensor and flexible sensor for continuous monitoring of the test substance can be inserted into the sensor site while minimizing insertion trauma and reducing initial sensitivity attenuation (ESA).

[0085] The chip sensor 804 may be (or include) a sensor manufactured using MEMS technology or wafer technology. In several embodiments, the chip sensor 804 has a structure in which layers are attached to a substrate, and is therefore thicker than the soft sensor 802. Consequently, it is considered very difficult to insert the chip sensor assembly 800 shown in Figure 8 using a guide sharp body as shown in Figure 5A or Figure 11A, or using a hollow needle in which the sensor assembly must fit snugly into the cavity inside the sharp body (hollow needle). Inserting the stacked chip sensor assembly 800 would require a sharp body much larger than those currently in practical use, and if that were the case, it is thought that pain and trauma would occur when inserting a composite sensor that combines a chip sensor and a soft sensor. In contrast, with a hybrid needle assembly, it is possible to insert the lab-on-chip type composite sensor 800 into the subcutaneous tissue with minimal trauma and perform continuous measurements.

[0086] Advantageously, by attaching tip 804 to the tip, the required alignment precision for the hybrid needle device, which is necessary for sensor insertion, can be reduced. As mentioned above, the success of sensor insertion when inserting a flexible sensor with a hybrid needle depends on the alignment precision between the sensor and the needle. To connect to the connector, the base of the sensor is bent at approximately 90°, and the force that pushes the flexible sensor into the skin was applied to this base of the sensor. Therefore, the insertion force was applied relatively far from the sensor tip, and this force traveled through the body of the thin flexible sensor, working to push the sensor tip into the skin. However, although most of the flexible sensor body is protected by a U-shaped metal protector, the portion up to a few millimeters proximal to the sensor tip is exposed from the end of the U-shaped metal protector. Therefore, even a slight misalignment of the sensor tip could cause the flexible sensor tip to bend during insertion, potentially leading to insertion failure.

[0087] On the other hand, as shown in Figure 9A, if a small non-flexible tip 804 is added to the side near the tip of the flexible sensor, with the end of the U-shaped metal protector 907 aligned with the surface of the tip, the protector 907 can be used to push the tip 905 and the sensor tip into the puncture hole made by the needle 902. The distal portion 901 of the needle 902 is inclined with respect to the insertion path perpendicular to the skin (the protector 907 is positioned to be oriented toward this insertion path) and extends beyond the end of the sensor assembly 906 by a distance equal to or greater than the desired insertion depth. Such inclination is an angle of about 7 to 10 degrees, or about 6 to 11 degrees, or about 5 to 12 degrees, or about 4 to 13 degrees, or greater than about 7 degrees, or less than about 10 degrees. As shown in Figure 9A, at least a portion of the distal portion 901 of the needle 902 is tapered.

[0088] To protect against mechanical and electrical damage, the tip 905 can be covered with a protective film 903, such as a biocompatible polymer film. In the illustrated configuration, attaching the non-flexible tip 905 improves the rigidity of the sensor tip, making it easier to insert, and allows the insertion force from the U-shaped metal protector to be applied to the tip attached near the distal end (tip) of the sensor 904, rather than at the base of the sensor, which is far from the distal end (tip) of the sensor 904. Therefore, by combining the tip and protector in this way, it is possible to reliably push the sensor tip into the hole made by the thin needle and then withdraw the needle and the U-shaped metal protector.

[0089] Figures 9A and 9B show, from multiple directions, a sensor module assembly 900 using a flexible sensor assembly 906 with a tip 905 attached near the tip of the sensor 904. The sensor module assembly 900 can apply insertion force to the sensor tip by a U-shaped protector 907 during the insertion process. The dimensions shown are in millimeters. The needle 902 and protector 907 can be formed from any suitable medical material, such as stainless steel, and fixed to a sliding base 908 to constitute a retractable hybrid needle module 910. After insertion of the sensor 904, the module 910 is retracted from the sensor module 916, thereby retracting the needle 902 from the subject's body. Similarly, the sharp body module 910 is held within the sensor module before attachment and, upon attachment, is pushed toward the subject's body to the position shown in Figure 9A. During installation, the lower surface 930 (Figure 9B) of the sensor module 916 is in contact with or parallel to the subject's skin, and an insertion force path perpendicular to the skin (i.e., perpendicular to the subject's skin) is established. As described above, the insertion force path is on the same line as the U-shaped protective device 907, and the needle 902 is inclined with respect to the insertion force path at an angle in the range of approximately 7 to 10 degrees, or approximately 6 to 11 degrees, or approximately 5 to 12 degrees, or approximately 4 to 13 degrees, or more than approximately 7 degrees, or less than approximately 10 degrees. Note that the insertion force path perpendicular to the skin can be determined using any suitable surface of the sensor module. Such alignment surfaces are not limited to the lower surface 930 or surfaces parallel to the skin surface, but may include any surface of the sensor module for aligning the sensor module with the applicator of the sensor control device that houses the sensor insertion module 900. The sensor module 916 holds the connector 918 and the sensor assembly 906.

[0090] Figure 9B is another enlarged view showing the tip configuration of the sensor 904 in the sensor module assembly 900. Further diagrams are shown in Figures 10A and 10B. The tip 905 and protective film 903 are positioned near the pointed tip of the sensor assembly 906, for example, within a range of about 0 to about 4 mm from the pointed tip of the sensor assembly 906, and more specifically, within ranges of about 0 to about 0.1 mm, about 0.1 mm to about 1 mm, about 0.2 mm to about 2 mm, about 0.3 mm to about 3 mm, about 0.4 mm to about 4 mm, about 1 mm to about 2 mm, or about 1 mm to about 3 mm. Those skilled in the art will be able to select an appropriate setback distance from the pointed tip based on factors such as the desired insertion depth of the sensor, the mechanical properties of the sensor substrate 904, or the parameters that the tip 905 (if any) senses.

[0091] In the illustrated embodiment, the protective device 907 is configured to be in contact with the upper surface of the tip-and-membrane composite (also called the traction surface 920, shown in Figure 10B) before insertion. In one embodiment, the tip-and-membrane composite is (or includes) a raised portion attached to the soft sensor. With the sharp body module 910 fully inserted into the sensor module and before the needle is withdrawn, the distal end of the protective device 907 is stationary near or on the subject's skin, the tip is inserted into the subject's body so that the upper surface of the tip is substantially flush with the subject's skin, and the sensor tip is inserted into the subject's body to a depth substantially equal to the distance between the upper surface of the tip and the sensor tip. During the insertion process, the U-shaped protective device 907 presses against the traction surface 920, applying an insertion force to the sensor 904 near the sharp sensor tip.

[0092] Due to the elasticity of the skin and the friction between the needle and the surrounding tissue, even after the needle 902 has penetrated the skin, the tip of the needle 902 pushes the contact point between the skin and the needle inward. This inward force creates a gap between the lower surface 930 of the sensor module and the traction surface 920, and the metal sheath 907 temporarily appears in this gap. When the needle 902 and sheath 907 are pulled back, the force pushing the skin inward is eliminated, and the skin recoils, closing the gap. However, the insertion of the sensor continues during this time, and the sensor is inserted further into the skin. Insertion of the sensor chip is not complete until the needle is completely pulled back and the skin returns to its resting position.

[0093] In alternative embodiments, as shown in Figure 11A, the tip 905 and protective film 903 are positioned on the flexible elongated sensor 1004 at a distance "d" from the end of the U-shaped protector. In these embodiments, the distance "d" can be selected so that the U-shaped protector does not come into contact with or press against the tip 905 or film 903 during insertion. In these embodiments as well, the presence of the tip 905 and film 903 helps to stiffen the distal portion of the flexible elongated sensor 1004, making it easier to be drawn into the opening created by the needle 902, thereby assisting insertion.

[0094] In other alternative embodiments, as shown in Figure 11B, the tip 905 can be omitted and replaced with a simple mechanical element 1020 (sometimes called a rigid member) to form a raised portion that receives pressure from the U-shaped protector. The simple mechanical element 1020 can provide a traction surface 920 perpendicular to the insertion direction, equivalent to the traction surface provided by the composite of the tip 905 and the protective film 903 shown in Figure 10B. Alternatively, or in addition to this, the mechanical element 1020 can also function as a rigid member that stiffens the distal end of the flexible elongated sensor 1004. The mechanical element 1020 can be formed from any suitable material, for example, from a biocompatible polymer that binds well to the sensor 904 without interfering with its sensor function, or while performing some of its sensor function. Whether the traction surface 920 is provided by a simple mechanical object 1020 or a chip sensor 905 attached near the tip of the sensor, the success rate of inserting the sensor insertion component 900 can be increased by combining the traction surface 920 or rigid element 1020 with the U-shaped protective device 907 and coordinating them. Similarly, whether or not the rigid element has a chip, the rigid element hardens the distal portions of the sensors 904 and 1004, which also contributes to improving the insertion success rate.

[0095] As a summary of the above description and to provide further examples, Figure 12 shows a method 1200 for inserting the distal end of a test substance sensor into a subject using the sensor insertion component of the applicator described herein or an equivalent device. Method 1200 includes a step 1210 in which the needle is fixed at an angle of 7 to 10 degrees, or about 6 to 11 degrees, or about 5 to 12 degrees, or about 4 to 13 degrees, or more than about 7 degrees, or less than about 10 degrees, with respect to the insertion force path perpendicular to the skin, and the needle is inserted into the subject's skin and the skin around the needle shaft is stretched. Method 1200 may further include a step 1220 in which the tip of a flexible, elongated sensor is inserted into the opening formed by the skin stretching step and brought to a desired depth. In other embodiments, a waiting period is taken in step 1230 after the needle insertion is complete and before the step of withdrawing the needle is performed. The waiting time can be any appropriate value, for example, in the range of 0.3 to 3 seconds, or 1 second. During this time, the needle is kept fully inserted, and the flexible, elongated sensor moves to the insertion position. After this, when the needle is withdrawn, the surrounding tissue recoils, leaving the sensor in place, and the relative insertion depth of the sensor to the skin surface increases. Method 1200 may further comprise step 1240, in which the needle is withdrawn from the subject's skin, leaving the distal end of the elongated sensor at a desired depth from the skin surface.

[0096] Figure 13 shows additional embodiments 1300 that can be optionally included in method 1200. In one optional embodiment 1310, the step of inserting the tip of the flexible elongated sensor may further include a step of supporting the middle portion of the flexible elongated sensor with a U-shaped protective device during insertion. In another optional embodiment 1320, the step of inserting the tip of the flexible elongated sensor may further include a step of pressing a traction surface provided on the distal portion of the flexible elongated sensor with the distal end of the U-shaped protective device.

[0097] Further details and embodiments of Method 1200 will become apparent from the above-described descriptions of the various sensor insertion components and their operating modes.

[0098] In some embodiments, a method for manufacturing a sharpened module is described. This method includes a step of pre-setting the orientation of the needle and protective device in the sharpened module. An exemplary high-throughput manufacturing method is described in U.S. Patent Application No. 2021 / 0308009, all of which are expressly incorporated herein by reference without regard to their purpose.

[0099] In some embodiments, the needle assemblies described herein may include a plurality of needles connected to a continuous support material via at least a plurality of first injection-molded connectors. In this specification, the term “continuous support material” refers to a material whose length is significantly longer than its width, for example, a material available in roll form having an aspect ratio of at least about 10, at least about 100, at least about 1000, or at least about 10000. A manufacturing process using a continuous support material involves transporting the continuous support material from a first reel to a second reel, and connecting (bonding) the needles to the continuous support material between the first and second reels. The continuous support material facilitates the production of the needle assemblies disclosed herein using a high-throughput manufacturing method. However, it should also be understood that, alternatively, the needle assemblies and processes described herein may be formed (implemented) using a support material having finite dimensions to produce needle assemblies in shorter lengths (individual units).

[0100] More specifically, the needle assemblies and processes described herein are characterized by individually setting the orientation of the needles and protective devices within a plurality of openings formed in the support material prior to the injection molding step of connecting the needles to the support material. In some embodiments, the step of setting the orientation of the needles and protective devices within the needle assembly can be performed offline (before the manufacturing step of assembling the needles into the sensor inserter), and needles set in the correct orientation can be kept in stock. For example, the needles and protective devices can be set in their initial orientation using robotic or manual "pick and place" techniques before forming the needle assembly as described herein. By having multiple needles and protective devices connected to the support material in a fixed orientation and at fixed intervals, further processing of the needle assembly can be immediately performed on a subsequent production line or a line following it. Thus, this disclosure can contribute to the high-throughput manufacturing of test substance sensors that can be inserted into target tissue with minimal trauma, thereby enabling the realization of various user benefits.

[0101] In various embodiments, the needle assembly of the present disclosure may comprise a support material having a plurality of openings and a first injection-molded connector positioned within each opening. The first injection-molded connector encloses the proximal portion of a protective device and connects the protective device to a first position on the support material. The needle can be coupled to the protective device and held in a predetermined orientation with respect to the longitudinal axis of the protective device and / or the first injection-molded connector. In this specification, the term “distal portion” refers to a position on the shaft of the needle near the pointed tip (i.e., the insertion tip), and the term “proximal portion” refers to a position on the shaft of the needle near the end opposite to the insertion tip. In this specification, the term “distal portion” includes a segment of the needle that includes at least the insertion tip, and the term “proximal portion” includes a segment of the needle that includes the end opposite to the insertion tip.

[0102] In some embodiments, each needle in a needle assembly can be held in substantially the same orientation within manufacturing tolerances. In some or other more specific embodiments, needles in adjacent openings can be positioned with substantially uniform spacing between them within manufacturing tolerances. The angular deviation (variation) between multiple needles in multiple needle assemblies can be about 1 degree or less, or about 0.5 degrees or less, or about 0.25 degrees or less. According to various embodiments, the pitch (distance between adjacent needles) can be about 15 mm or less, or about 12 mm or less, or about 10 mm or less, or about 7 mm or less, or about 5 mm or less, with a pitch variation of about 0.02 mm or less. In more specific embodiments, the pitch can constitute a spacing of about 8 mm to about 10 mm, with a pitch variation of about 0.02 mm or less. In some or other embodiments, the needle length can be about 20 mm or less, or about 15 mm or less, or about 12 mm or less, or about 10 mm or less, or about 8 mm or less, with a length variation of about 0.05 mm or less. In more specific embodiments, the needle length can be in the range of about 9 mm to about 12 mm, or in the range of about 10 mm to about 11 mm, with a length variation of about 0.05 mm or less.

[0103] According to some embodiments, the needle in each opening can be held non-parallel to the longitudinal axis of the protective device. In more specific embodiments, the needle in each opening can be held at an angle with respect to the longitudinal axis in the range of about 5° to about 15°, or about 7° to about 12°, or about 8° to about 11° (including any value and partial ranges within each range). Angling the needle allows the skin to stretch to one side as the needle penetrates the skin, creating a gap and making sensor insertion easier. In even more specific embodiments, the needle in each opening can be held at an angle with respect to the longitudinal axis in the range of about 9° to about 10° (including any value and partial ranges within each range).

[0104] In certain embodiments, the needle assembly described herein may include a second injection-molded connector positioned within each opening. The second injection-molded connector encloses the distal portion of the needle and connects the needle to a second position on the support material. The second injection-molded connector assists in protecting the insertion tip of the needle during the fabrication of the needle assembly described herein, potentially reducing the percentage of products that are rejected due to quality control defects in subsequent manufacturing processes of the substance sensor inserter. Furthermore, the second injection-molded connector can further stabilize the needle within each opening by restricting the bending behavior of the needle during the fabrication of the needle assembly. Alternatively, the second injection-molded component may enclose the distal portion of the needle but not be attached to (connected to) the support material. This configuration also similarly assists in protecting the insertion tip of the needle.

[0105] This specification also intends to describe methods for fabricating and using various needle assemblies relating to this disclosure. A method for using a needle assembly may include the steps of: individually separating a plurality of needles arranged in a predetermined orientation within a needle structure; and incorporating the needles, set in such orientation, into a test substance sensor inserter. This will be described further later.

[0106] In some embodiments, the needle assembly manufacturing method of the present disclosure may include the steps of: providing a support material having a plurality of openings and necks extending from the support material into each opening; bonding elongated protective devices having grooves to the necks extending from the support material into each opening; bonding needles to the elongated protective devices within each opening; and forming a first injection-molded connector by injection molding a polymer material. The first injection-molded connector encloses the necks and the proximal portions of the elongated protective devices within each opening, thereby connecting the needles to a first position on the support material via the necks. The needle assembly can be manufactured such that the necks coincide with the longitudinal axis of the first injection-molded connector and the needles are held in a predetermined orientation with respect to the longitudinal axis.

[0107] In some embodiments, the needle assembly manufacturing method of the present disclosure may include the steps of: providing a support material comprising a frame having a plurality of openings, elongated protective devices provided at each of the plurality of openings, and a neck portion extending from the frame to each of the elongated protective devices; attaching a sharp body to each of the elongated protective devices; and forming a first injection-molded connector that encloses a portion of the neck portion and the proximal portion of the elongated protective device by injection molding a polymer material. The sharp body comprises a proximal portion, a distal portion, and a bent portion between the proximal and distal portions, wherein the proximal portion of the sharp body is attached to the elongated protective device, but the distal portion of the sharp body is not attached to the elongated protective device. Furthermore, the distal portion of the sharp body extends beyond the distal end of the elongated protective device at an angle to the longitudinal axis of the elongated protective device. As described in the explanation of Figures 16A to 16D above, the needle assembly can be manufactured such that the neck portion coincides with the longitudinal axis of the first injection-molded connector, and the needle is held in a predetermined orientation with respect to the longitudinal axis.

[0108] In some embodiments, a portion of a continuous support material comprising a frame, a neck portion, and an elongated protective device can be placed inside a mold for injection molding.

[0109] In a more specific embodiment, the support material can be made of a continuous support material such as a continuous metal tape.

[0110] According to some further embodiments, the needle assembly manufacturing method of the present disclosure may further include the step of forming a second injection-molded connector by injection molding a polymer material. The second injection-molded connector encloses the distal portion of the needle within each opening and connects the needle to a second position on the support material. Alternatively, a second injection-molded connector (injection-molded part) may be manufactured that encloses the distal portion of the needle within each opening in the same manner as otherwise, without connection to the support material.

[0111] Suitable injection molding processes for forming a first injection-molded connector and a second injection-molded connector will be well known to those skilled in the art. Such processes may include the steps of positioning one or more molds in each opening and injecting polymer material into the molds to form a first injection-molded connector and optionally a second injection-molded connector. The injection-molded connectors may be arranged as described above. The first injection-molded connector and the second injection-molded connector may be formed in the same injection molding process or in separate injection molding processes. Furthermore, the polymer material used to form the first injection-molded connector and the polymer material used to form the second injection-molded connector may be the same or different. The first injection-molded connector and the second injection-molded connector can be formed using any suitable thermoplastic or thermosetting polymer material. For example, in some embodiments, the first injection-molded connector may be formed from a rigid polymer material that can contribute to employing a needle structure in the substance sensor inserter, and the second injection-molded connector may be formed from a flexible polymer material that allows for easy withdrawal of the needle when desired. The injection molding process may further include the step of placing an elongated protective device (e.g., an elongated U-shaped protective device) that will be coupled to the needle into each mold before injecting the polymer material into the mold. In some embodiments, the elongated protective device may also be placed into the mold using manual or automated pick-and-place techniques.

[0112] In some embodiments, the needle assembly manufacturing method of the present disclosure may further include the step of punching or stamping a support material to form a plurality of openings. The openings may have a desired size and shape to accommodate the needle, an elongated protective device, and at least a first injection-molded connector. Suitable punching or stamping processes will be well known to those skilled in the art. The punching or stamping process may be carried out integrally with the injection molding process, or it may be carried out on a separate production line before the injection molding process. In other embodiments, the support material may be available, sourced, or purchased with the plurality of openings already formed.

[0113] Figures 14A to 17D show the steps of an exemplary process that can produce the first configuration of the needle assembly of this disclosure. For clarity, Figures 14A and 14B, 15A and 15B, 16A and 16B, and 17A and 17B show the production of a needle assembly with nine openings. However, by expanding the illustrated concept, it should be understood that needle assemblies can be produced simultaneously or non-simultaneously (sequentially) with 10 or more openings in the support material.

[0114] In Figures 14A and 14B, before the needle assembly is fabricated, the continuous support material 2502 (for example, a continuous metal tape having a plurality of openings 2504 of a predetermined shape) is obtained / provided (for example, from a commercially available supplier as a pre-punched tape) or formed (for example, by stamping or punching).

[0115] Figures 14A to 14D show a portion of a needle assembly of the present disclosure having a plurality of elongated protective devices 604. The elongated protective devices 604 are provided vertically within each opening 2504 of a continuous support material 2502. The continuous support material 2502 may be a continuous metal tape, a continuous metal strip, or a continuous metal film, but other materials and forms that can be processed in an open-reel manner may also be used. In some embodiments, stainless steel may be a suitable metal for producing the needle assembly. Other suitable tapes include those containing other metals or other materials that can withstand the injection molding temperature required for producing the needle assembly. In alternative embodiments, the needle assembly may also be formed on a support material having a finite length, and the needle assembly may be produced in individual units rather than in an open-reel continuous process.

[0116] The neck portion 2506 is an elongated member extending from the frame of the continuous support material 2502 into each opening 2504. The longitudinal axis of the elongated protective device 604 can be parallel to and / or aligned with the longitudinal axis of the neck portion 2506. The longitudinal axis of the elongated protective device 604 can be substantially parallel to the insertion force path perpendicular to the skin. The continuous support material 2502, the neck portion 2506, and the elongated protective device 604 can be made from a single material. In some embodiments, a metal etching or stamping process can be used to form multiple frames in each of the multiple openings 2504 of the continuous support material 2502, each having the flat metal pieces necessary to form the elongated protective device 604. The elongated protective device 604 can be formed using stamping processes known in the art. Alternatively, in other embodiments, the elongated protective device can be a separate component, and the proximal portion of the elongated protective device 604 can be connected to the distal portion of the neck portion 2506.

[0117] Next, as can be seen in Figures 15A to 15D, a pre-bent needle 602 can be connected to the distal end of an elongated protective device 604. In some embodiments, the pre-bent needle 602 can be joined (attached) to the distal end of the elongated protective device 604 by laser spot welding. As can be seen in Figures 15C to 15D, the elongated protective device 604 may have a first side with a U-shaped groove and a second side on the back of the U-shaped groove. The pre-bent needle 602 may have a proximal end 608, a bent end, and a distal end 606. The bent end may be located between the proximal end 608 and the distal end 606, and may have a bend (angle, refraction) at one point in the bent end. At the bent end, the proximal and distal ends may connect to form an angle. This angle may be obtuse. This one angle can be approximately 160° to 175°, or approximately 165° to 175°, and in some embodiments, the proximal portion 608 of the needle can be attached to the second side of the distal portion of the elongated protective device.

[0118] Next, a mold (not shown) can be placed inside each opening 2504 in preparation for injection molding. Since the neck portion 2506 extends into the mold, when injection molding is performed, the continuous support material 2502, the elongated protective device 604, and the needle 602 are connected to form the first injection-molded coupling member 2512 (base component). As can be seen in Figures 16A to 16D, the first injection-molded coupling member 2512 encloses a part of the neck portion 2506 and a part of the elongated protective device 604. A second connection portion between the continuous support material 2502 and the needle 602 can also be provided at the distal end 606 of the needle.

[0119] Figures 16A to 16D show exemplary needle assemblies 2500 after one or more injection molding steps have been completed and the molds have been removed from each opening 2504. As a result of the injection molding steps, the needle 602 is connected to the neck portion 2506 of the continuous support material 2502 via an elongated protective device 604 and a first injection-molded connector 2512, and optionally, the needle 602 is also connected to the lower part of the opening 2504 via a second injection-molded connector 2514 (see Figures 17A to 17D). As described above, the second injection-molded connector is detachably connected to the needle 602 to assist in protecting the insertion tip during assembly fabrication and needle operation.

[0120] In some embodiments, instead of using two separate molds for the proximal and distal ends of the needle assembly, a single mold can be used to surround the distal end of the neck, which is coupled to the proximal end of the elongated protective device, and the needle. Alternatively, the distal portion 606 of the needle 602 can be left outside the mold throughout the injection molding process, resulting in a configuration where the distal portion 606 is not supported.

[0121] Each mold can have a shape complementary to each opening 2504, so that each mold can fit into each opening 2504 and cover one or more desired portions of the continuous support material 2502. As shown in Figures 17A to 17D, when a second mold 2511 is used to form a second injection-molded connector, the second mold 2511 can similarly cover the lower part of the continuous support material 2502. According to some embodiments, the mold can be a two-piece mold so that a needle can be easily set inside the mold. In such embodiments, the first mold plate can be positioned adjacent to the first side of the continuous support material 2502, and the second mold plate can be positioned adjacent to the second side of the continuous support material 2502. One or more cavities can be formed between the two mold plates. One or more cavities can be configured to be bisected by the plane on which the continuous support material 2502 exists. The neck portion 2506 can extend into at least one of the cavities so that the connection between the elongated protective device 604, the needle 602, and the neck portion 2506 can be formed by injection molding. In preparation for injection molding, the two mold plates (hemispherical) of the mold can be assembled within the opening 2504. Note that the mold can be a two-piece mold to allow the needle to be easily set inside the mold, but in some alternative embodiments, it can also be a one-piece mold.

[0122] The mold contains internal cavities, which can be filled with thermoplastic or thermosetting material by a single injection molding process or by two or more separate injection molding processes to form a first injection-molded connector 2512 (see Figures 16A to 16D) and a second injection-molded connector (see Figures 17A to 17D) that covers the distal tip of the needle. The neck portion 2506 extends into the cavity of the mold, thereby allowing the first injection-molded connector 2512 (see Figures 16A to 16D) to be formed within this cavity, enclosing the neck portion 2506 and a portion of the elongated protective device 604. Similarly, the second injection-molded connector can be formed within the cavity where the distal tip of the needle is housed (this may be a cavity in a separate mold from the above-mentioned mold, or it may be a cavity in the same mold). The cavity forming the second injection-molded connector can be configured to cover the notch in the continuous support material 2502 located below the opening 2504, so that the first portion of the second injection-molded connector covers this notch, and the second portion of the second injection-molded connector is formed on the continuous support material 2502. Alternatively, the second injection-molded connector (injection-molded part) can be configured to enclose the distal portion of the needle but without forming a connection with the continuous support material 2502.

[0123] In the case of a single mold configured to form a first injection-molded connector and a second injection-molded connector, a groove can be extended along the length of the mold from the proximal cavity configured to form the first injection-molded connector to the distal cavity configured to form the second injection-molded connector. The size of the groove can be such that it accommodates the elongated protective device 604 and the needle 602, with the distal portion 606 of the needle extending into the distal cavity and the proximal portion of the elongated protective device extending into the proximal cavity. Once the first and second injection-molded connectors are formed by injection molding, the needle 602 can be connected to the continuous support material 2502 at both the distal and proximal ends and held in a predetermined orientation in preparation for further operations. Generally, the groove is not filled with thermoplastic or thermosetting material during the injection molding process.

[0124] As described above, it is also possible to have a configuration in which the distal end of the needle is not supported, as shown in the needle assemblies of Figures 16A to 16D. When forming a needle assembly in which the distal end of the needle is not supported, a mold can be used in which the groove for the needle and the elongated protective device and the distal cavity are omitted.

[0125] Once injection molding is complete and each mold has been removed, each needle assembly 2500 can be stored for subsequent use, or it can be directly incorporated into the process of manufacturing a substance sensor inserter (see, for example, the sensor applicator 150 in Figure 1). In either case, the position of each needle 602 remains fixed relative to the first injection-molded connector 2512 until further needle manipulation is performed as described later. The distance and orientation of the needles are also fixed, facilitating further needle manipulation. In a more specific embodiment, the needles can be arranged at substantially uniform intervals. The needle assembly 2500 allows for a very regular arrangement of multiple needles, making it possible to manipulate them in the same way as arrays of larger gauge needles or similar pointed bodies. Thus, as described below, the needle assemblies of this disclosure can easily carry out various manufacturing processes with only minor modifications to existing production lines. In other words, the needle assemblies of this disclosure can directly replace arrays of larger gauge needles or similar pointed bodies used in current manufacturing processes.

[0126] Each individual needle is removed from the needle assembly 2500 in the form of a needle structure before being incorporated into a device of the type such as a test substance sensor inserter. The needle structure comprises a needle 602, an elongated protective device 604, and a first injection-molded connector 2512, and is configured to hold the needle 602 in a predetermined orientation with respect to the longitudinal axis of the first injection-molded connector 2512, particularly in an orientation non-parallel to the longitudinal axis. The removal of individual needle structures can be carried out as a further step in the process of forming the needle assembly, or as an entirely separate process, according to various embodiments.

[0127] Accordingly, in further embodiments, the method of the present disclosure may include the steps of detaching the needle structure from a support material such as a continuous metal tape and a second injection-molded connector (if a second injection-molded connector is present), and incorporating the needle structure into a device of the type such as an insertion device for a substance sensor. The needle structure comprises a needle, an elongated protective element, and a first injection-molded connector, the first injection-molded connector enclosing the proximal portion of the elongated protective element. Optionally, the needle structure may also have a configuration in which the distal portion of the elongated protective element is coupled to the proximal portion of the needle.

[0128] In further embodiments, the step of detaching the needle structure may include cutting the neck portion 2506 adjacent to the first injection-molded connector 2512 and pulling the distal end 606 of the needle away from the second injection-molded connector (if a second injection-molded connector is present). In embodiments without a second injection-molded connector, the needle structure is immediately detached from the needle assembly upon cutting the neck portion adjacent to the first injection-molded connector. As described in U.S. Patent Application Publication No. 2021 / 0308009 (all disclosures in this patent specification are expressly incorporated herein by reference without regard to their purpose), when the needle structure is detached by cutting the neck, a metal core positioned to coincide with the longitudinal axis of the first injection-molded connector remains within the first injection-molded connector. The individual needle structures detached from the needle assembly are then fed into the production line for further processing.

[0129] The first connection to the continuous support material 2502 can be severed by cutting the neck portion 2506. The neck portion 2506 can be cut using any suitable method, such as guillotine cutting, punching, or scissors cutting. If a second injection-molded connector is present, the needle can be detached from the second injection-molded connector and the needle structure separated by applying a small tensile force in the longitudinal axial direction. Similarly, the needle structure in embodiments without a second injection-molded connector, or in embodiments with a second injection-molded connector that is not connected to the support material 2502, can also be separated by the same operation.

[0130] This specification describes numerous flexible structures. Such flexible structures include, but are not limited to, hybrid needle assemblies, and may or may not include chip sensors and mechanical traction surfaces. These flexible structures are made of elastic materials such as plastics and metals (or others), and their modes of operation are well known to those skilled in the art. Each flexible structure has a stationary state or stationary position, and the elastic material is biased in the direction of this stationary state (position). If a force is applied that causes the flexible structure to bend or move from this stationary state (position), when the force is removed (or weakened), the bias of the elastic material causes the flexible structure to return to the stationary state (position).

[0131] It should be noted that all features, elements, components, functions, and steps described in relation to any embodiment described herein are intended to be freely combined and substituted with those of any other embodiment. Furthermore, if a particular feature, element, component, function, or step is described in relation to only one embodiment, it should be understood that, unless otherwise explicitly stated, that feature, element, component, function, or step can be used in all other embodiments described herein. Features, elements, components, functions, and steps from different embodiments can also be combined to form new combinations. Similarly, features, elements, components, functions, and steps from one embodiment can be substituted or combined with features, elements, components, functions, and steps from another embodiment. This applies even if such combinations or substitutions are not explicitly disclosed in the above description. Such combinations and substitutions will be obvious to those skilled in the art without the need for a comprehensive disclosure of all conceivable possibilities.

[0132] While the embodiments can be modified and altered in various ways, specific examples are shown in the drawings and described in detail in the specification. However, it should be understood that these embodiments are not limited to the specific forms disclosed, but rather encompass all modifications, equivalents, and substitutions that do not depart from the spirit of the invention. Furthermore, any feature, function, step, or element of the embodiments may be described or included in the claims, and the inventive scope of the claims may also be defined by negative limitations of features, functions, steps, or elements not included in the claims.

[0133] Aspects of the present invention are described in the independent claims, and preferred features are described in the dependent claims. Preferred features of each aspect can be provided in combination with each other within a particular embodiment, and further, they can be provided in combination with other aspects.

[0134] Having described several embodiments above, various aspects of this subject matter are shown below as a summary and / or supplement. It is important to emphasize here the interrelationships and interchangeability of the embodiments described below. In other words, emphasis is placed on the fact that each feature of multiple embodiments can be combined with any other feature, unless otherwise explicitly stated or lacking logical validity. Although references to the drawings are not explicitly made below, the descriptions in the following paragraphs are reiterations and developments of the embodiments described herein.

[0135] In many embodiments, a sensor insertion component for use in an applicator for an in vivo substance sensor comprises a sensor module and a sharp body module. The sensor module holds a connector coupled to the proximal end of a flexible elongated sensor and has at least one surface that defines an insertion force path perpendicular to the skin. The sharp body module is held by the sensor module and is configured to move relative to the sensor module parallel to the insertion force path perpendicular to the skin, and comprises a base, a U-shaped protective device fixed to the base, and a sharp body fixed to at least one of the base or the U-shaped protective device. The base is configured to move relative to the sensor module. The U-shaped protective device positions the middle portion of the flexible elongated sensor along the length of the U-shaped protective device, with the distal portion of the flexible elongated sensor extending beyond the distal end of the U-shaped protective device. The pointed body has an outer diameter of 0.56 mm or less and a distal portion that extends beyond the distal end of the soft, elongated sensor at an angle of 5 to 15 degrees with respect to the insertion force path perpendicular to the skin.

[0136] In some embodiments, the sharpened body is composed of a solid needle having a diameter of approximately 0.5 mm or less. In some embodiments, the diameter of the sharpened body is approximately 0.35 mm or less.

[0137] In some embodiments, the above-described movement is a sliding movement.

[0138] In some embodiments, the pointed body is positioned within a range of approximately 7° from the insertion force path perpendicular to the skin.

[0139] In some embodiments, the middle portion of the flexible, elongated sensor is positioned within the groove of the U-shaped protective device.

[0140] In some embodiments, the distal portion of the pointed body has a length in the range of about 1.0 to about 5.0 mm.

[0141] In some embodiments, the distal portion of the flexible, elongated sensor has a length in the range of approximately 0.5 to approximately 4.0 mm.

[0142] In some embodiments, the U-shaped protective device has a length that extends from the base in the range of approximately 1.0 to approximately 10 mm.

[0143] In some embodiments, the pointed body is fixed to the base.

[0144] In some embodiments, the pointed body is fixed to a U-shaped protective device.

[0145] In some embodiments, the distal end of the flexible, elongated sensor is pointed.

[0146] In some embodiments, the distal end of a flexible, elongated sensor is in contact with the shaft of a pointed body.

[0147] In some embodiments, the distal end of the flexible, elongated sensor is positioned along the shaft of the pointed body.

[0148] In some embodiments, the insertion component further comprises a raised portion having a traction surface attached to a flexible elongated sensor, the traction surface being positioned to engage with the distal end of a U-shaped protective device to transmit insertion force to the flexible elongated sensor along an insertion force path perpendicular to the skin. In some embodiments, the raised portion comprises a sensor tip. In some embodiments, the sensor tip is covered with a protective film. In some embodiments, the sensor tip is coupled to a connector by a conductor positioned along the flexible elongated sensor. In some embodiments, the sensor tip comprises a thermistor.

[0149] In some embodiments, the insert component further comprises a rigid member coupled to the distal end of a flexible, elongated sensor. In some embodiments, the rigid member provides the sensor function.

[0150] In many embodiments, a method for inserting the distal end of a test substance sensor into a subject using an applicator includes the steps of: fixing the needle at an angle of about 5 to about 15 degrees with respect to the insertion force path perpendicular to the skin, inserting the needle into the subject's skin and stretching the skin around the needle shaft; inserting the tip of the flexible, elongated sensor into the opening formed by the skin stretching step and reaching a desired depth, allowing a waiting period; and withdrawing the needle after the waiting period has elapsed.

[0151] In some embodiments, the step of inserting the tip of a flexible elongated sensor further includes the step of supporting the middle portion of the flexible elongated sensor with a U-shaped protective device during insertion.

[0152] In some embodiments, the method further includes the step of pressing a traction surface provided on the distal portion of a flexible, elongated sensor with the distal end of a U-shaped protective device.

[0153] In some embodiments, the method is performed using the sensor insertion component described in claim 1.

[0154] In some embodiments, the waiting time is 0.5 to 3 seconds.

[0155] In some embodiments, the waiting time is 1 second.

[0156] In many embodiments, a sensor insertion component for use in an applicator of an in vivo test substance sensor comprises a sensor module having a connector coupled to the sensor, and a sharp body module coupled to the sensor module. The sharp body module comprises a base, an elongated protective body coupled to the base, and a sharp body coupled to the elongated protective body or the base. The elongated protective body comprises a longitudinal axis and a groove, the groove being configured to receive the middle portion of the sensor positioned along the length of the groove such that the distal portion of the sensor extends beyond the distal end of the groove. The sharp body comprises a proximal portion and a distal portion, the distal portion extending beyond the distal end of the elongated protective body at an angle of about 5° to about 15° with respect to the longitudinal axis of the elongated protective body.

[0157] In some embodiments, the distal portion of the sharpened body is not attached to the elongated protective device.

[0158] In some embodiments, the proximal portion of the sharp body is attached to an elongated protective device.

[0159] In some embodiments, the pointed body further comprises a bend between its proximal and distal portions. In some embodiments, the bend has a single refraction with an angle of about 160° to about 175°, which is the angle between the proximal and distal portions of the pointed body.

[0160] In some embodiments, the elongated protective device has a first side and a second side, the first side having a groove, and the proximal portion of the sharp body is attached to the second side of the elongated protective device.

[0161] In some embodiments, the groove of the elongated protective device is U-shaped.

[0162] In some embodiments, the groove extends along the distal portion of the elongated protective device.

[0163] In some embodiments, the groove does not extend along the proximal portion of the elongated protective device.

[0164] In some embodiments, the pointed body is composed of a solid needle having a diameter of about 0.5 mm or less.

[0165] In some embodiments, the angle described above is approximately 7°.

[0166] In some embodiments, the distal portion of the pointed body has a length in the range of about 1.0 to about 5.0 mm.

[0167] In some embodiments, the sensor further comprises a raised portion, which has a traction surface positioned to engage with the distal end of an elongated protective device, and is for transmitting insertion force along an insertion force path substantially parallel to the longitudinal axis of the elongated protective device. In some embodiments, the raised portion comprises a sensor chip, which in some embodiments is covered with a protective film.

[0168] In some embodiments, the sensor further comprises a rigid member coupled to the distal end of the sensor.

[0169] In many embodiments, a method for inserting the distal end of a substance sensor into a subject using an applicator includes the step of positioning the applicator against the subject's skin surface. The applicator comprises a housing, a sensor module having a connector coupled to the proximal end of the sensor, and a sharp body module coupled to the sensor module. The sharp body module comprises a base, an elongated protective device coupled to the base, and a sharp body coupled to the elongated protective device or the base. The elongated protective device comprises a longitudinal axis and a groove, the groove being configured to receive the middle portion of the sensor positioned along the length of the groove such that the distal end of the sensor extends beyond the distal end of the groove. The sharp body comprises a proximal and a distal portion, the distal portion extending beyond the distal end of the elongated protective device at an angle of about 5° to about 15° with respect to the longitudinal axis of the elongated protective device. Furthermore, this method further includes the steps of: applying force to the proximal part of the housing to insert the distal end of the sharp body into the subject's skin, stretching the skin around the needle shaft by the angle of the distal part to form an opening; inserting the distal end of the sensor into the opening; and withdrawing the sharp body.

[0170] In some embodiments, the distal portion of the sharpened body is not attached to the elongated protective device.

[0171] In some embodiments, the proximal portion of the sharp body is attached to an elongated protective device.

[0172] In some embodiments, the pointed body further includes a bend between its proximal and distal portions.

[0173] In some embodiments, the bent portion has a single bend with an angle of approximately 160° to approximately 175°, which is the angle formed by the proximal and distal portions of the pointed body.

[0174] In some embodiments, the elongated protective device has a first side and a second side, the first side having a groove, and the proximal portion of the sharp body is attached to the second side of the elongated protective device.

[0175] In some embodiments, the groove of the elongated protective device is U-shaped.

[0176] In some embodiments, the groove extends along the distal portion of the elongated protective device.

[0177] In some embodiments, the groove does not extend along the proximal portion of the elongated protective device.

[0178] In some embodiments, the pointed body is composed of a solid needle having a diameter of about 0.5 mm or less.

[0179] In some embodiments, the angle described above is approximately 7°.

[0180] In some embodiments, the distal portion of the pointed body has a length in the range of about 1.0 to about 5.0 mm.

[0181] In many embodiments, the needle assembly comprises a support material having a plurality of openings, elongated protective devices positioned in each of the plurality of openings, a first injection-molded connector positioned within each of the plurality of openings, and sharpened bodies positioned in each of the plurality of openings. The elongated protective device comprises a U-shaped groove, a longitudinal axis, a proximal end, and a distal end coupled to the support material. The first injection-molded connector encloses the proximal end of the elongated protective device and a portion of the support material. The sharpened body comprises a proximal portion coupled to the elongated protective device, a distal portion not attached to the elongated protective device, and a bent portion between the proximal and distal portions.

[0182] In some embodiments, the support material consists of a continuous metal tape.

[0183] In some embodiments, the bent portion has a single bend.

[0184] In some embodiments, the neck extends from the support material into each of the multiple openings and connects to an elongated protective device, with a first injection-molded connector enclosing the neck and the proximal end of the elongated protective device. In some embodiments, the neck has a longitudinal axis, which is parallel to the longitudinal axis of the elongated protective device.

[0185] In some embodiments, the assembly further comprises a second injection-molded connector positioned within each of the multiple openings, the second injection-molded connector enclosing the distal end of the pointed body. In some embodiments, the second injection-molded connector connects the pointed body to a second portion of the support material.

[0186] In some embodiments, the first injection-molded connector does not enclose the proximal end of the pointed body.

[0187] In some embodiments, the elongated protective device is held at an angle ranging from approximately 5° to approximately 15° with respect to its longitudinal axis.

[0188] In some embodiments, the distal portion of the sharpened body is held non-parallel to the longitudinal axis of the elongated protective device.

[0189] In many embodiments, the method includes the steps of: providing a support material comprising a frame having a plurality of openings; elongated protective devices provided in each of the plurality of openings; and a neck portion extending from the frame to the elongated protective devices provided in each of the plurality of openings; attaching a pointed body to each of the elongated protective devices; and forming a first injection-molded connector that encloses a portion of the neck portion and the proximal portion of the elongated protective device by injection molding a polymer material. The pointed body comprises a proximal portion coupled to the elongated protective device, a distal portion not attached to the elongated protective device, and a bent portion between the proximal and distal portions. The longitudinal axis of the neck portion is parallel to the longitudinal axis of the elongated protective device, and the distal portion of the pointed body extends beyond the distal end of the elongated protective device at an angle of about 5° to about 15° with respect to the longitudinal axis of the elongated protective device.

[0190] In some embodiments, the curved portion of the pointed body has a single bend.

[0191] In some embodiments, the support material consists of a continuous metal tape.

[0192] In some embodiments, the method further includes the step of forming a second injection-molded connector that encloses the distal end of the pointed body and connects the pointed body to a second position on a support material by injection molding a polymer material.

[0193] In some embodiments, the method further includes the steps of separating a needle structure comprising a pointed body, an elongated protective element, and a first injection-molded connector from a support material and a second injection-molded connector, and incorporating the needle structure into an insertion device of a substance sensor. In some embodiments, the step of separating the needle structure includes cutting the neck portion adjacent to the first injection-molded connector.

[0194] In many embodiments, the applicator comprises a housing having a distal end configured to make contact with the skin surface, a sensor module having a connector coupled to the sensor, and a sharp body module coupled to the sensor module. The sharp body module comprises a base, an elongated protective device coupled to the base, a sharp body coupled to the elongated protective device or the base, a return spring, and sensor electronic components. The distal portion of the sharp body extends beyond the distal end of the elongated protective device at an angle to the longitudinal axis of the elongated protective device. The return spring is configured to automatically pull the sharp body module and the sharp body back in the proximal direction from the skin surface. The sensor electronic components are configured to advance from a proximal position to a distal position within the housing.

[0195] In some embodiments, the pointed body comprises a proximal portion and a bent portion between the proximal and distal portions.

[0196] In some embodiments, the elongated protective device comprises a longitudinal axis and a groove, the groove being configured to receive the middle portion of the sensor positioned along the length of the groove such that the distal portion of the sensor extends beyond the distal end of the groove. In some embodiments, the groove is U-shaped.

[0197] In some embodiments, the distal portion of the sharp body is not attached to the elongated protective device. In some embodiments, the proximal portion of the sharp body is attached to the elongated protective device. In some embodiments, the bend has a single refraction with an angle of approximately 160° to approximately 175°, which is the angle between the proximal and distal portions of the sharp body.

[0198] In some embodiments, the elongated protective device has a first side and a second side, the first side having a groove, and the proximal portion of the sharp body is attached to the second side of the elongated protective device.

[0199] In some embodiments, the groove of the elongated protective device is U-shaped.

[0200] In some embodiments, the groove extends along the distal portion of the elongated protective device.

[0201] In some embodiments, the distal portion of the pointed body has a length in the range of about 1.0 to about 5.0 mm.

[0202] In some embodiments, the pointed body is composed of a solid needle having a diameter of about 0.5 mm or less.

[0203] In some embodiments, the angle described above is approximately 5° to approximately 15°.

[0204] In some embodiments, the applicator is configured to advance the sensor electronic component in the distal direction.

[0205] In some embodiments, the sensor further comprises a raised portion, which has a traction surface positioned to engage with the distal end of an elongated protective device, and is for transmitting insertion force along an insertion force path substantially parallel to the longitudinal axis of the elongated protective device. In some embodiments, the raised portion comprises a sensor chip, which in some embodiments is covered with a protective film.

[0206] In some embodiments, the sensor further comprises a rigid member coupled to the distal end of the sensor.

[0207] Sectionalized description The following exemplary embodiments are described in separate numbered sections.

[0208] Section 1 A housing having a distal end configured to come into contact with the skin surface, A sensor module having a connector coupled to the sensor, A pointed body module coupled to the aforementioned sensor module, An applicator equipped with, The aforementioned pointed module The base and, A slender protective device attached to the base, The elongated protective device or the sharp body attached to the base, wherein the distal portion of the sharp body extends beyond the distal end of the elongated protective device at an angle to the longitudinal axis of the elongated protective device, The sharpened module and the sharpened body are configured to be automatically pulled back in a proximal direction from the skin surface by a return spring, An applicator comprising a pointed body module having a sensor electronic component configured to advance from a proximal position to a distal position within the housing.

[0209] Section 2 The applicator according to paragraph 1, wherein the pointed body comprises a proximal portion and a bent portion between the proximal portion and the distal portion.

[0210] Section 3 The aforementioned elongated protective device comprises a longitudinal axis and a groove, The applicator according to the first or second paragraph, wherein the groove is configured to receive an intermediate portion of the sensor positioned along the length of the groove such that the distal portion of the sensor extends beyond the distal end of the groove.

[0211] Section 4 The applicator according to paragraph 3, wherein the groove is U-shaped.

[0212] Section 5 The applicator according to any of the preceding items, wherein the distal portion of the pointed body is not attached to the elongated protective device.

[0213] Section 6 The applicator according to paragraph 2, wherein the proximal portion of the pointed body is attached to the elongated protective device.

[0214] Section 7 The applicator according to paragraph 2, wherein the bent portion has a single refraction having an angle of approximately 160° to approximately 175°, and this angle is the angle formed by the proximal and distal portions of the pointed body.

[0215] Section 8 The aforementioned elongated protective device has a first side and a second side, The applicator according to paragraph 3, wherein the first side is provided with the groove, and the proximal portion of the pointed body is attached to the second side of the elongated protective device.

[0216] Section 9 The applicator according to paragraph 3, wherein the groove of the elongated protective device is U-shaped.

[0217] Section 10 The applicator according to paragraph 3, wherein the groove extends along the distal portion of the elongated protective device.

[0218] Section 11 The applicator according to any of the preceding items, wherein the distal portion of the pointed body has a length in the range of approximately 1.0 to approximately 5.0 mm.

[0219] Section 12 The applicator according to any of the preceding items, wherein the pointed body is composed of a solid needle having a diameter of approximately 0.5 mm or less.

[0220] Section 13 An applicator as described in any of the preceding items, wherein the angle is approximately 5° to approximately 15°.

[0221] Section 14 The applicator according to any of the preceding items, wherein the applicator is configured to advance the sensor electronic component in the distal direction.

[0222] Section 15 The applicator according to any of the preceding paragraphs, further comprising a raised portion having a traction surface positioned to engage with the distal end of the elongated protective device, and a raised portion for transmitting insertion force along an insertion force path substantially parallel to the longitudinal axis of the elongated protective device.

[0223] Section 16 The applicator according to paragraph 15, wherein the raised portion comprises a sensor chip.

[0224] Section 17 The applicator according to paragraph 16, wherein the sensor chip is covered with a protective film.

[0225] Section 18 The applicator according to any of the preceding items, wherein the sensor further comprises a rigid member coupled to the distal portion of the sensor.

[0226] Section 19 A sensor module having a connector coupled to the sensor, A pointed body module coupled to the aforementioned sensor module, A sensor insertion component for use in an applicator of an in vivo substance sensor, comprising: The aforementioned pointed module The base and, An elongated protective device connected to the base, wherein the elongated protective device comprises a longitudinal axis and a groove, and the groove is configured to receive the intermediate portion of the sensor, which is positioned along the length of the groove such that the distal portion of the sensor extends beyond the distal end of the groove, A sensor insertion component comprising a pointed body coupled to the elongated protective device or the base, wherein the pointed body has a proximal portion and a distal portion, and the distal portion extends beyond the distal end of the elongated protective device at an angle of approximately 5° to approximately 15° with respect to the longitudinal axis of the elongated protective device.

[0227] Section 20 The component according to paragraph 19, wherein the distal portion of the pointed body is not attached to the elongated protective device.

[0228] Section 21 The component according to any of the preceding items, wherein the proximal portion of the pointed body is attached to the elongated protective device.

[0229] Section 22 The component according to any of the preceding items, wherein the pointed body further comprises a bent portion between the proximal portion and the distal portion.

[0230] Section 23 The component according to paragraph 22, wherein the bent portion has a single refraction having an angle of approximately 160° to approximately 175°, and the angle is the angle formed by the proximal and distal portions of the pointed body.

[0231] Section 24 The aforementioned elongated protective device has a first side and a second side, The component according to any of the preceding items, wherein the first side is provided with the groove, and the proximal portion of the pointed body is attached to the second side of the elongated protective device.

[0232] Section 25 The component according to any of the preceding items, wherein the groove of the elongated protective device is U-shaped.

[0233] Section 26 The component according to any of the preceding items, wherein the groove extends along the distal portion of the elongated protective device.

[0234] Section 27 The component according to any of the preceding items, wherein the groove does not extend along the proximal portion of the elongated protective device.

[0235] Section 28 The component according to any of the preceding items, wherein the pointed body is composed of a solid needle having a diameter of approximately 0.5 mm or less.

[0236] Section 29 A component as described in any of the preceding items, wherein the angle is approximately 7°.

[0237] Section 30 The component according to any of the preceding items, wherein the distal portion of the pointed body has a length in the range of approximately 1.0 to approximately 5.0 mm.

[0238] Section 31 The component according to any of the preceding paragraphs, wherein the sensor comprises a raised portion having a traction surface positioned to engage with the distal end of the elongated protective device, and further comprising a raised portion for transmitting an insertion force along an insertion force path substantially parallel to the longitudinal axis of the elongated protective device.

[0239] Section 32 The component according to paragraph 31, wherein the raised portion comprises a sensor chip.

[0240] Section 33 The component according to paragraph 32, wherein the sensor chip is covered with a protective film.

[0241] Section 34 The component according to any of the preceding items, wherein the sensor further comprises a rigid member coupled to the distal portion of the sensor.

[0242] Section 35 A method of inserting the distal end of a test substance sensor into a subject using an applicator, The step of placing an applicator, which comprises a housing, a sensor module having a connector coupled to the proximal end of the sensor, and a sharp body module coupled to the sensor module, on the skin surface of the subject, wherein the sharp body module is The base and, An elongated protector coupled to the base, the elongated protector having a longitudinal axis and a groove, the groove configured to receive an intermediate portion of the sensor disposed along the length of the groove with a distal portion of the sensor extending beyond a distal end of the groove. An applicator comprising an elongated protector or a sharp body coupled to the base, the sharp body having a proximal portion and a distal portion, the distal portion extending beyond a distal end of the elongated protector at an angle of about 5° to about 15° with respect to the longitudinal axis of the elongated protector. Inserting a distal end of the sharp body into the skin of the subject by applying a force to a proximal portion of the housing, stretching the skin around a shaft of the needle by the angle of the distal portion to form an opening. Inserting a distal end of the sensor into the opening. Retracting the sharp body. A method comprising the above steps.

[0243] Item 36 The method according to item 35, wherein the distal portion of the sharp body is not attached to the elongated protector.

[0244] Item 37 The method according to any one of the preceding items, wherein the proximal portion of the sharp body is attached to the elongated protector.

[0245] Item 38 The method according to any one of the preceding items, wherein the sharp body further comprises a bent portion between the proximal portion and the distal portion.

[0246] Item 39 The method according to item 38, wherein the bent portion has a single bend having an angle of about 160° to about 175°, the angle being an angle formed by the proximal portion and the distal portion of the sharp body.

[0247] Item 40 The aforementioned elongated protective device has a first side and a second side, The method according to any of the preceding items, wherein the first side is provided with the groove, and the proximal portion of the pointed body is attached to the second side of the elongated protective device.

[0248] Section 41 The method according to any of the preceding items, wherein the groove of the elongated protective device is U-shaped.

[0249] Section 42 The method according to any of the preceding items, wherein the groove extends along the distal portion of the elongated protective device.

[0250] Section 43 The method according to any of the preceding items, wherein the groove does not extend along the proximal portion of the elongated protective device.

[0251] Section 44 The method according to any of the preceding items, wherein the pointed body is composed of a solid needle having a diameter of about 0.5 mm or less.

[0252] Section 45 The method according to any of the preceding items, wherein the angle is approximately 7°.

[0253] Section 46 The method according to any of the preceding items, wherein the distal portion of the pointed body has a length in the range of about 1.0 to about 5.0 mm.

[0254] Section 47 A sensor module holding a connector coupled to the proximal end of a flexible, elongated sensor, the sensor module having at least one surface that defines an insertion force path perpendicular to the skin, A pointed body module is held by the sensor module and configured to move relative to the sensor module in parallel with the insertion force path perpendicular to the skin, A sensor insertion component for use in an applicator of an in vivo substance sensor, comprising: the pointed body module a base configured to perform the movement relative to the sensor module, a U-shaped protector fixed to the base, with the middle part of the soft elongated sensor arranged along the length of the U-shaped protector in a state where the distal part of the soft elongated sensor extends further than the distal end of the U-shaped protector; a pointed body fixed to at least one of the base or the U-shaped protector, having an outer diameter of 0.56 mm or less and a distal part extending further than the distal end of the soft elongated sensor at an angle of 5 degrees or more and 15 degrees or less with respect to the insertion force path perpendicular to the skin, the sensor insertion component comprising.

[0255] Item 48 The sensor insertion component according to Item 47, wherein the pointed body is composed of a solid needle having a diameter of about 0.5 mm or less.

[0256] Item 49 The sensor insertion component according to Item 48, wherein the diameter of the pointed body is about 0.35 mm or less.

[0257] Item 50 The sensor insertion component according to any one of the preceding items, wherein the movement is a sliding movement.

[0258] Item 51 The sensor insertion component according to any one of the preceding items, wherein the pointed body is aligned within a range of about 7° from the insertion force path perpendicular to the skin.

[0259] Item 52 The sensor insertion component according to any one of the preceding items, wherein the middle part of the soft elongated sensor is arranged in the groove of the U-shaped protector.

[0260] Item 53 The sensor insertion component according to any of the preceding items, wherein the distal portion of the pointed body has a length in the range of approximately 1.0 to approximately 5.0 mm.

[0261] Section 54 The sensor insertion component according to any of the preceding items, wherein the distal portion of the flexible elongated sensor has a length in the range of approximately 0.5 to approximately 4.0 mm.

[0262] Section 55 The sensor insertion component according to any of the preceding items, wherein the U-shaped protective device has a length extending from the base in the range of approximately 1.0 to approximately 10 mm.

[0263] Section 56 A sensor insertion component according to any of the preceding items, wherein the pointed body is fixed to the base.

[0264] Section 57 The sensor insertion component according to any of the preceding items, wherein the pointed body is fixed to the U-shaped protective device.

[0265] Section 58 A sensor insertion component according to any of the preceding items, wherein the distal end of the flexible, elongated sensor is pointed.

[0266] Section 59 A sensor insertion component according to any of the preceding items, wherein the distal end of the flexible, elongated sensor is in contact with the shaft of the pointed body.

[0267] Section 60 A sensor insertion component according to any of the preceding items, wherein the distal end of the flexible, elongated sensor is positioned along the shaft of the pointed body.

[0268] Section 61 The sensor insertion component further comprises a raised portion having a traction surface attached to the flexible, elongated sensor, A sensor insertion component according to any of the preceding clauses, wherein the traction surface is arranged to engage with the distal end of the U-shaped protective device to transmit an insertion force to the soft, elongated sensor along an insertion force path perpendicular to the skin.

[0269] Section 62 The sensor insertion component according to paragraph 61, wherein the raised portion comprises a sensor chip.

[0270] Section 63 The sensor insertion component according to paragraph 62, wherein the sensor chip is covered with a protective film.

[0271] Section 64 The sensor insertion component according to paragraph 62, wherein the sensor chip is coupled to the connector by a conductor arranged along the flexible elongated sensor.

[0272] Section 65 The sensor insertion component according to paragraph 62, wherein the sensor chip comprises a thermistor.

[0273] Section 66 A sensor insertion component according to any of the preceding items, further comprising a rigid member coupled to the distal portion of the soft, elongated sensor.

[0274] Section 67 The sensor insertion component according to paragraph 66, wherein the rigid member provides a sensor function.

[0275] Section 68 A method of inserting the distal end of a test substance sensor into a subject using an applicator, The procedure involves fixing the needle at an angle of approximately 5 to 15 degrees relative to the insertion force path perpendicular to the skin, inserting the needle into the subject's skin, and stretching the skin around the shaft of the needle. The steps include inserting the tip of a soft, elongated sensor into the opening formed by the skin stretching step, allowing it to reach a desired depth, and then waiting for a period of time; The steps include: pulling back the needle after the aforementioned waiting time has elapsed, A method that includes this.

[0276] Section 69 The method of paragraph 68, wherein the step of inserting the tip of the flexible elongated sensor further includes the step of supporting the middle portion of the flexible elongated sensor with a U-shaped protective device during insertion.

[0277] Section 70 The method of claim 69, further comprising the step of pressing the distal end of the U-shaped protective device against a traction surface provided on the distal portion of the flexible elongated sensor.

[0278] Section 71 The method described in any of the preceding sections, performed using the sensor insertion component described in Section 47.

[0279] Section 72 The method according to paragraph 71, wherein the aforementioned waiting time is 0.5 seconds to 3 seconds.

[0280] Section 73 The method according to paragraph 71, wherein the waiting time is 1 second.

[0281] Section 74 A support material having multiple openings formed therein, An elongated protective device positioned in each of the plurality of openings, comprising a U-shaped groove, a longitudinal axis, a proximal end, and a distal end connected to the support material, A first injection-molded coupling member is disposed within each of the plurality of openings, the first injection-molded coupling member encloses the proximal end of the elongated protective device and a portion of the support material, A pointed body disposed at each of the plurality of openings, comprising a proximal portion attached to the elongated protective device, a distal portion not attached to the elongated protective device, and a bent portion between the proximal and distal portions, A needle assembly equipped with a needle.

[0282] Section 75 The assembly according to paragraph 74, wherein the support material is composed of a continuous metal tape.

[0283] Section 76 The assembly according to any of the preceding items, wherein the bent portion has a single bend.

[0284] Section 77 The neck portion extends from the support material into each of the multiple openings and is connected to the elongated protective device. The assembly according to any of the preceding items, wherein the first injection-molded connector encloses the neck portion and the proximal end of the elongated protective device.

[0285] Section 78 The aforementioned neck portion has a longitudinal axis, The assembly according to paragraph 77, wherein the longitudinal axis of the neck portion is parallel to the longitudinal axis of the elongated protective device.

[0286] Section 79 The system further comprises a second injection-molded coupling member positioned within each of the aforementioned multiple openings, The assembly according to any of the preceding paragraphs, wherein the second injection-molded connector encloses the distal end of the pointed body.

[0287] Section 80 The assembly according to paragraph 79, wherein the second injection-molded connector connects the pointed body to the second portion of the support material.

[0288] Section 81 The assembly according to any of the preceding items, wherein the first injection-molded coupling member does not enclose the proximal end of the pointed body.

[0289] Section 82 The assembly according to any of the preceding clauses, wherein the distal portion of the pointed body is held at an angle in the range of about 5° to about 15° with respect to the longitudinal axis of the elongated protective device.

[0290] Section 83 The assembly according to any of the preceding items, wherein the distal portion of the pointed body is held non-parallel to the longitudinal axis of the elongated protective device.

[0291] Section 84 A step of providing a support material comprising: a frame having multiple openings formed therein; elongated protective devices provided in each of the multiple openings; and a neck portion extending from the frame to each of the elongated protective devices provided in each of the multiple openings; The steps include attaching a sharp object to each of the aforementioned elongated protective devices, A method comprising the step of forming a first injection-molded connector that encloses a portion of the neck and the proximal portion of the elongated protective device by injection molding a polymer material, The pointed body comprises a proximal portion attached to the elongated protective device, a distal portion not attached to the elongated protective device, and a bent portion between the proximal and distal portions. The longitudinal axis of the neck portion is parallel to the longitudinal axis of the elongated protective device. A method wherein the distal portion of the pointed body extends beyond the distal end of the elongated protective device at an angle of approximately 5° to approximately 15° with respect to the longitudinal axis of the elongated protective device.

[0292] Section 85 The method according to claim 84, wherein the bent portion of the pointed body has a single bend.

[0293] Section 86 The method according to any of the preceding items, wherein the support material is composed of a continuous metal tape.

[0294] Section 87 The method according to any of the preceding items, further comprising the step of forming a second injection-molded connector that encloses the distal end of the pointed body and connects the pointed body to a second position on the support material by injection molding a polymer material.

[0295] Section 88 The steps include separating the needle structure, which comprises the pointed body, the elongated protective device, and the first injection-molded connecting member, from the support material and the second injection-molded connecting member, The method of paragraph 87, further comprising the step of incorporating the needle structure into an insertion device for a substance sensor.

[0296] Section 89 The method according to paragraph 88, wherein the step of separating the needle structure includes the step of cutting the neck portion adjacent to the first injection-molded coupling member. [Explanation of symbols]

[0297] 100 Test Substance Monitoring System 102 Sensor control devices 104, 404, 802, 904, 1004 Test substance sensor (flexible elongated sensor) 105 Adhesive Patches 120 reading devices 121 Input Components 123 Power Ports Channels 140, 141, 142, 143, and 144 150, 216 applicators 160 Sensor Electronic Components 161 ASIC 162 AFE 163, 165, 223, 225, 230 memory 164 Power management circuit 166 processors 168 Communication Circuit 171, 229, 234 antennas 174 chips 180 High-Reliability Computer Systems 190 Networks 206 processing cores (processors) 222 Communication Processors 224 Application Processors 226 Power supply 228 RF Transceiver 232 Multifunctional Transceiver 238 Power Management Modules 302 Applicator enclosure 304, 318 sheath 308 Platforms 310 Container (Tray) 312 Lid 400, 900 Sensor Module Assembly (Sensor Insertion Components, Sensor Insertion Modules) 402, 602, 902, 1030 Sharp body (needle) 405 Skin surface normal 406, 604, 907 U-shaped protective gear (metal sheath) 408, 908 Base Components 410, 910 Sharpened Module (Hybrid Needle Module) 412 Sensor control module 416, 808, 916 Sensor Modules 418, 918 connectors 420 (Distal part of the soft sensor) 422, 606, 901 (Distal part of the acuminate body) 500 Conventional pointed body assembly 502 Conventional flexible elongated sensor 504 Conventional U-shaped pointed body 506 Conventional sensor module 600 Assembly 608 Proximal part (of the acute body) 800, 906 Chip Sensor Assembly 804, 905 sensor chips 806 Conductor 903 Protective film 920 Traction surface 924 Tray orientation alignment element 930 (Bottom of the sensor module) 1020 Mechanical elements 1022 Sensor Carrier 1024 Sharp Body Retraction Assembly 1104 Skin 1106 Rail 1108 Upper guide section 1110 Retraction mechanism 1112 Carrier arm (retaining arm for sensor carrier) 1114 Stopper surface of carrier arm 1118 Return spring 1120 Final locking mechanism 2500 Needle Assembly 2502 Continuous support material 2504 Opening of continuous support material 2506 Neck 2511 Second mold 2512 First injection-molded coupling member 2514 Second injection-molded connector

Claims

1. A housing having a distal end configured to come into contact with the skin surface, A sensor module having a connector coupled to the sensor, A pointed body module coupled to the aforementioned sensor module, A return spring and Sensor electronic components, An applicator equipped with, The aforementioned pointed module The base and, A slender protective device attached to the base, The elongated protective device or the sharp body attached to the base, wherein the distal portion of the sharp body extends beyond the distal end of the elongated protective device at an angle to the longitudinal axis of the elongated protective device, It has, The return spring is configured to automatically pull back the pointed body module and the pointed body in a direction proximal to the skin surface. The sensor electronic component is configured to move forward from a proximal position to a distal position within the housing. The elongated protective device comprises a longitudinal axis and a groove, the groove being configured to receive the intermediate portion of the sensor, which is positioned along the length of the groove such that the distal portion of the sensor extends beyond the distal end of the groove, and the groove having a U-shaped cross-section. Applicator.

2. The applicator according to claim 1, wherein the pointed body comprises a proximal portion and a bent portion between the proximal portion and the distal portion.

3. The applicator according to claim 1 or 2, wherein the distal portion of the pointed body is not attached to the elongated protective device.

4. The applicator according to claim 2, wherein the proximal portion of the pointed body is attached to the elongated protective device.

5. The applicator according to claim 2, wherein the bent portion has a single refraction having an angle of 160° to 175°, and this angle is the angle formed by the proximal and distal portions of the pointed body.

6. The applicator according to claim 1, wherein the elongated protective device has a first side and a second side, the first side is provided with the groove, and the proximal portion of the sharp body is attached to the second side of the elongated protective device.

7. The applicator according to claim 1, wherein the groove extends along the distal portion of the elongated protective device.

8. The distal portion of the pointed body has a length in the range of 1.0 to 5.0 mm. The pointed body is composed of a solid needle having a diameter of 0.5 mm or less. The angle from the pointed body to the longitudinal axis of the elongated protective device is 5° to 15°, and The applicator is configured to advance the sensor electronic component in the distal direction. An applicator according to any one of claims 1 to 7, comprising at least one of the features described above.

9. The sensor comprises a raised portion having a traction surface positioned to engage with the distal end of the elongated protective device, and further comprising a raised portion for transmitting insertion force along an insertion force path substantially parallel to the longitudinal axis of the elongated protective device, and The sensor further comprises a rigid member coupled to the distal portion of the sensor. An applicator according to any one of claims 1 to 8, comprising at least one of the following features.

10. The applicator according to claim 9, wherein the raised portion includes a sensor chip.

11. The applicator according to claim 10, wherein the sensor chip is covered with a protective film.

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