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WO2025106279A1 - Applicateur de capteurs à usages multiples - Google Patents

Applicateur de capteurs à usages multiples Download PDF

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Publication number
WO2025106279A1
WO2025106279A1 PCT/US2024/054261 US2024054261W WO2025106279A1 WO 2025106279 A1 WO2025106279 A1 WO 2025106279A1 US 2024054261 W US2024054261 W US 2024054261W WO 2025106279 A1 WO2025106279 A1 WO 2025106279A1
Authority
WO
WIPO (PCT)
Prior art keywords
carrier
puck
sharp
applicator
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/054261
Other languages
English (en)
Inventor
Sebastien Doan Ky Nam NGUYEN
Vivek S. RAO
Phillip W. Carter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Diabetes Care Inc
Original Assignee
Abbott Diabetes Care Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Diabetes Care Inc filed Critical Abbott Diabetes Care Inc
Publication of WO2025106279A1 publication Critical patent/WO2025106279A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus
    • A61B2560/063—Devices specially adapted for delivering implantable medical measuring apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set

Definitions

  • a continuous glucose monitor is a type of analyte sensing device that tracks a user's blood glucose levels.
  • analyte refers to a substance that is the subject of an analysis. For instance, the CGM tracks glucose levels, and glucose is considered the analyte.
  • a “glucose level” is also commonly referred to as a "blood sugar” level.
  • the CGM may include a very small sensor that enters or permeates at least partially through the user's skin. Typically, the CGM will acquire a new reading on a periodic basis, such as once every select number of minutes.
  • the CGM includes a wireless transmitter that then sends the reading to a receiving device, such as a smartphone.
  • analyte levels such as glucose, ketones, lactate, oxygen, hemoglobin A1C, or the like
  • analyte levels can be vitally important to the health of an individual having diabetes.
  • Patients suffering from diabetes mellitus can experience complications including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy.
  • Diabetics are generally required to monitor their glucose levels to ensure that they are being maintained within a clinically safe range and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies, or when additional glucose is needed to raise the level of glucose in their bodies.
  • analyte monitoring systems can be utilized (e.g., such as the above described CGM), in which a sensor control device may be worn on the body of an individual who requires analyte monitoring.
  • the sensor control device may have a small form-factor and can be assembled and applied by the individual with a sensor "applicator.”
  • the application process involves inserting at least a portion of a sensor, which senses a user's analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with the bodily fluid.
  • the sensor control device may also be configured to transmit analyte data to another device, from which the individual or her health care provider (“HCP”) can review the data and make therapy decisions.
  • HCP her health care provider
  • an applicator for sequentially applying a plurality of sensors to a body of a user, the plurality of sensors being housed within different containers.
  • the applicator being configured to be inserted into each of the plurality of containers to engage corresponding pucks within each of the different containers and to further engage corresponding sharps within each of the containers.
  • the applicator being configured to move a puck carrier within the applicator between first and second positions for inserting and retracting sharps into and out of the body of the user when applying the sensors of the corresponding pucks to the user's body.
  • the applicator also being configured with an eject button for ejecting the sharps after they have been retracted form the user's body.
  • the techniques described herein relate to an applicator for inserting a sensor into the body of a user, the applicator including: an outer housing; an inner housing, the inner housing being at least partially nested within the outer housing, the outer housing being slidably engaged with the inner housing for enabling the outer housing to move from a first outer housing position to a second outer housing position relative to the inner housing; a puck carrier, the puck carrier being at least partially nested within the inner housing and slidably engaged with the inner housing for enabling the puck carrier to move from a first puck carrier position to a second puck carrier position relative to the inner housing, the puck carrier including one or more puck engagement arms for detachably engaging a puck during use of the applicator when applying the puck to a user's body; a sharp carrier, the sharp carrier being at least partially nested within the inner housing and slidably engaged within the inner housing for enabling the sharp carrierto move from a first sharp carrier position to a second sharp carrier position relative to the inner housing,
  • the techniques described herein relate to an assembly including an applicator for sequentially applying a plurality of sensors to a user's body and a plurality of containers, each of the plurality of containers containing a different sensor of the plurality of sensors, the applicator including: an outer housing; an inner housing, the inner housing being at least partially nested within the outer housing, the outer housing being slidably engaged with the inner housing for enabling the outer housing to move from a first outer housing position to a second outer housing position relative to the inner housing; a puck carrier, the puck carrier being at least partially nested within the inner housing and slidably engaged with the inner housing for enabling the puck carrier to move from a first puck carrier position to a second puck carrier position relative to the inner housing, the puck carrier including one or more puck engagement arms for detachably engaging a puck during use of the applicator when applying the puck to a user's body; a sharp carrier, the sharp carrier being at least partially nested within the inner housing and slid
  • the techniques described herein relate to a method for sequentially applying a plurality of sensors to a body of a user with an applicator and a plurality of sensors contained in a plurality of separate containers including at least a first container and a second container, the method including: inserting a puck carrier of the applicator into the first container that includes a first puck until the first puck carrier engages the first puck and a sharp carrier engages a first sharp contained within the first puck and until the puck carrier is moved from a second puck carrier position to a first puck carrier position that causes a drive spring of the applicator to become compressed; moving an outer housing of the applicator to cause a release of the puck carrier from the first puck carrier position to the second puck carrier position as the drive spring becomes uncompressed when the applicator is positioned against the user's body and that further causes the sharp carrier to move the first sharp into the body of the user; after removing the applicator from being positioned against the user's body, pressing an eject button on the app
  • Figure 1 illustrates an example architecture in which sensor data is being acquired and analyzed.
  • Figure 2 illustrates an example of an analyte sensor in the form of a continuous glucose monitor.
  • Figures 3 and 4 illustrate different examples of sensor containers that contain pucks with the sensors and sharps used to insert the sensors into the body of a user.
  • Figure 5 illustrates an applicator assembly that includes an applicator and a sensor container.
  • Figure 6 illustrates the different states of springs included in the applicator.
  • Figures 7-15 illustrate different views and components the applicator and container of Figure 5.
  • Figure 16 illustrates a flow diagram of acts associated with sequentially applying a plurality of sensors to a user's body with the applicator of Figure 5.
  • embodiments of the present disclosure relate to applicators and methods involving the use of those applicators for applying sensors to the body of a user.
  • a disclosed herein a single applicator can be used to sequentially apply a plurality of different sensors that are previously contained in different sensor containers to the body of the user.
  • the disclosed applicators are structured in a manner for re-use or multiple sequential sensor applications so as to result in a reduced amount of waste being generated.
  • the disclosed embodiments also include various electronics, such as a "puck” (aka a “sensor control device”).
  • a "puck” refers to a component that is typically disposed on a user's skin via an applicator and that includes the analyte sensor.
  • These devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps.
  • analyte monitoring circuits e.g., an analog circuit
  • memories e.g., for storing instructions
  • power sources e.g., for storing instructions
  • communication circuits e.g., for storing instructions
  • transmitters e.g., transmitters, receivers, processors and/or controllers
  • processors and/or controllers e.g., for executing instructions
  • the disclosed embodiments provide for the improved assembly and use of an analyte sensor insertion device (aka an "applicator”) for use with in vivo analyte monitoring systems. That is, by configuring the applicators to be reused multiple times, it is possible to reduce the waste associated with disposing applicators after only a single use. This also beneficially reduces the medical costs associated with manufacturing, shipping and using the applicators.
  • an analyte sensor insertion device aka an "applicator”
  • Continuous Analyte Monitoring systems
  • Continuous Glucose Monitoring can transmit data from a sensor control device to a reader device continuously without prompting, e.g., automatically according to a schedule.
  • Flash Analyte Monitoring systems (or “Flash Glucose Monitoring” systems or simply “Flash” systems), as another example, can transfer data from a sensor control device in response to a scan or request for data by a reader device, such as with a Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol.
  • NFC Near Field Communication
  • RFID Radio Frequency Identification
  • In vivo analyte monitoring systems can also operate without the need for finger stick calibration.
  • In vivo analyte monitoring systems can be differentiated from “in vitro" systems that contact a biological sample outside of the body (or “ex vivo") and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user's blood sugar level.
  • In vivo monitoring systems can include a sensorthat, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein.
  • the sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing.
  • the sensor control device and variations thereof, can also be referred to as a "sensor control unit,” an "on-body electronics” device or unit, an "on-body” device or unit, or a “sensor data communication” device or unit, to name a few.
  • I n vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user.
  • This device can be referred to as a "handheld reader device,” “reader device” (or simply a “reader”), “handheld electronics” (or simply a “handheld”), a “portable data processing” device or unit, a "data receiver,” a “receiver” device or unit (or simply a “receiver”), ora "remote” device or unit, to name a few.
  • Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.
  • FIG. 1 illustrates an example architecture 100 that can be used to achieve the benefits mentioned above.
  • Architecture 100 is shown as including a service 105.
  • service refers to an automated program that is tasked with performing different actions based on input.
  • service 105 can be a deterministic service that operates fully given a set of inputs and without a randomization factor.
  • service 105 can be or can include an artificial intelligence (Al) or machine learning (ML) engine, as shown by ML engine 110. With the ML engine 110, service 105 can operate even when faced with various different randomization factors.
  • Al artificial intelligence
  • ML engine 110 machine learning
  • any type of ML or Al may include any type of ML algorithm or device, convolutional neural network(s), multilayer neural network(s), recursive neural network(s), deep neural network(s), decision tree model(s) (e.g., decision trees, random forests, and gradient boosted trees) linear regression model(s), logistic regression model(s), support vector machine(s) (“SVM”), Al device(s), or any other type of intelligent computing system. Any amount of training data may be used (and perhaps later refined) to train the ML algorithm to dynamically perform the disclosed operations.
  • service 105 is a cloud service operating in a cloud environment, such as cloud 115.
  • service 105 is a local service operating on a local device (e.g., sensor 130A, device 125, and/or any other device).
  • service 105 is a hybrid service that includes a cloud component operating in the cloud 115 and a local component operating on a local client device. These two components can communicate with one another.
  • Service 105 is tasked with various operations that include collecting sensor data, analyzing that sensor data, and determining the impact of that sensor data with respect to a user associated with the sensor data.
  • service 105 can include an analytics 120 component that is capable of performing data analysis on the collected sensor data.
  • analytics 120 and ML engine 110 can be the same component.
  • service 105 can communicate with a device 125.
  • Device 125 can be any type of personal device, including any type of wearable device or mobile device. Examples of device 125 include, but certainly are not limited to, any type of device reader, smart phone, tablet, laptop, desktop, wearable device (e.g., a watch), and so on.
  • Device 125 is shown as communicating with a sensor 130A and is further shown as receiving sensor data 135 from the sensor 130A (included as a part of a puck).
  • Sensor 130A is the component that collects the sensor data 135. In some cases, device 125 and sensor 130A can be implemented on the same device.
  • Sensor 130A is applied to a user's body via an applicator 130B. That is, the applicator 130B applies the puck onto the user's body, and the puck includes the sensor.
  • Sensor 130A can be any type of sensor.
  • sensor 130A includes a CGM.
  • a CGM operates by inserting a small sensing unit under a person's skin. This sensing unit then measures that person's interstitial glucose levels. Typically, this sensing unit acquires new data at a periodic rate, such as once every select number of minutes, although the data could also be collected continuously. That data is represented as sensor data 135 in Figure 1.
  • Device 125 communicates with sensor 130A using any type of near-field wireless communication technology, such as BLUETOOTH. As a result, sensor data 135 is transmitted from sensor 130A to device 125 over that communication protocol.
  • Service 105 can communicate with device 125 via any type of wireless communication protocol as well.
  • the communication protocol is a BLUETOOTH protocol.
  • the protocol is a wireless fidelity (Wi-Fi), near field communication (NFC), and/or Internet Protocol (IP).
  • Wi-Fi wireless fidelity
  • NFC near field communication
  • IP Internet Protocol
  • device 125 transmits the sensor data 135 to the cloud 115, where that sensor data 135 is then stored in a repository that is accessible to service 105.
  • the sensor data 135 is encrypted or otherwise integrity protected to ensure tampering does not occur. Also, in some implementations, any personally identifiable information (PI I) is stripped from sensor data 135 prior to it being stored in the cloud 115.
  • PI I personally identifiable information
  • Service 105 then uses its analytics 120 component and/or the ML engine 110 to analyze the sensor data 135.
  • Service 105 generates output data 140 as a result of performing that analysis.
  • the output data 140 can reflect glycemic insights such as a glycemic impact for the user.
  • Glycemic impact generally refers to a patient's bodily state with respect to blood sugar levels.
  • Figure 2 provides another example.
  • FIG 2 shows a device 200, which is representative of device 125 from Figure 1.
  • Device 200 i.e. a puck
  • CGM 205 is currently affixed to the user's arm and is tracking the user's glucose levels.
  • Device 200 is hosting an application (or simply "app") 210.
  • App 210 provides a visualization of the tracked data (e.g., a graph or trace of glucose levels over a period of time).
  • Figures 3 and 4 illustrate different sensor containers 300, 340 and 350.
  • These containers may all be essentially identical with corresponding pucks, 320 and sharp hubs 330, as well as the sharps connected to the sharp hubs that pass through the pucks, and as well as the sensors that are integrated into the pucks and that have distal ends that are put into the body of the user with the sharps when the sharps are inserted and retracted into the body of the user.
  • the sensor containers also include sealing caps that are, in this configuration, shown to be screw caps 360 that threadably engage threads on the outer walls of the sensor container, as shown.
  • the sensor container also includes puck holder tines 375 that create a friction fit against the puck for securing the pucks within the container until the pucks are removed by a puck carrier of an applicator (described more below).
  • the sensor container may also include puck alignment ribs 385 for aligning with corresponding slots or ribbing of the applicator (not shown).
  • the sensor containers also include container pins 380, in some embodiments, that can be used to bias against latches (e.g., latch 705 of Figure 7) in the applicator that lock elements of the applicator in place until they are released by the biasing of the container pin 380 against the latches.
  • This biasing may occur, for example, when the puck carrier of the applicator is inserted into the container, within the container walls, to engage the puck (e.g., see Figure 7 before engagement).
  • Figures 5-15 illustrate different components of the applicator and sensor containers (also referred to more simply as the containers or singly as a/the container).
  • the applicator 500 comprises an outer housing 505, an inner housing 510, the inner housing being at least partially nested within the outer housing, the outer housing being slidably engaged with the inner housing for enabling the outer housing to move from a first outer housing position to a second outer housing position relative to the inner housing.
  • the applicator also includes a puck carrier 515, the puck carrier being at least partially nested within the inner housing and slidably engaged with the inner housing for enabling the puck carrier to move from a first puck carrier position to a second puck carrier position relative to the inner housing, the puck carrier including one or more puck engagement arms 905 ( Figure 9) for detachably engaging a puck 320 during use of the applicator when applying the puck to a user's body.
  • the applicator also includes a sharp carrier 520, the sharp carrier being at least partially nested within the inner housing and slidably engaged within the inner housing for enabling the sharp carrier to move from a first sharp carrier position to a second sharp carrier position relative to the inner housing, the sharp carrier including hub retention arms 535 for detachably engaging a sharp hub during use of the applicator for applying the puck to the user's body.
  • the applicator also includes an eject button 536 or eject pin that is at least partially contained within the inner housing and that is at least partially exposed through the outer housing, the eject button being slidably engaged with the sharp carrier when the eject button moves from a non-retraction position to a sharp retraction position, wherein the eject button causes the hub retention arms of the sharp carrier to flex away from the eject button when the eject button is positioned in the sharp retraction position, (see Figure 15).
  • an eject button 536 or eject pin that is at least partially contained within the inner housing and that is at least partially exposed through the outer housing, the eject button being slidably engaged with the sharp carrier when the eject button moves from a non-retraction position to a sharp retraction position, wherein the eject button causes the hub retention arms of the sharp carrier to flex away from the eject button when the eject button is positioned in the sharp retraction position, (see Figure 15).
  • the applicator also includes a drive spring 525 positioned between the inner housing and the puck carrier, the drive spring being configured to compress from a first state comprising a relatively uncompressed state in which the drive spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the drive spring is more compressed than the uncompressed state.
  • the applicator also includes a sharp retraction spring 530 positioned between the sharp carrier and the puck carrier, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Figure 6 illustrates the different states of the springs.
  • the sharp retraction spring is in the first and compressed state when the sharp carrier is in the first sharp carrier position (see Figure 14) and the sharp retraction spring is in the second and relatively uncompressed state when the sharp carrier is in the second sharp carrier position (see Figure 11).
  • the sharp carrier is positioned further from the outer housing in the second sharp carrier position than the first puck carrier position.
  • the drive spring is in the first state when the puck carrier is in the first puck carrier position (see Figure 14) and the drive spring is in the second and compressed state when the puck carrier is in the second puck carrier position (see Figure 11).
  • the puck carrier being positioned furtherfrom the outer housing in the first puck carrier position than the second puck carrier position.
  • the puck carrier comprises one or more puck carrier latches 540 and the inner housing comprises one or more puck carrier latch engagement hooks 545 configured to engage the puck carrier latch(es) to secure the puck carrier in the first puck carrier position when the drive spring is in the compressed state.
  • the outer housing comprises a firing pin 550 that is positioned to bias against the puck carrier latch engagement hook(s) in such a manner as to cause the puck carrier latch engagement hook(s) to flex and release an engagement with the puck carrier latch(es) when the puck carrier is in the first puck carrier position and to enable the puck carrier to move to the second puck carrier position in response to force caused by the drive spring as the drive spring uncompresses from the compressed state to the relatively uncompressed state.
  • Figure 7 illustrates the inner housing of the applicator starting to be inserted into the sensor container.
  • the container pin 380 will bias against the inner portions of the puck carrier housing latch 705 that is attached to the puck carrier and that will release the puck carrier to move from the second puck carrier position to the first puck carrier position.
  • the drive spring and the sharp retraction spring will be compressed, as described earlier.
  • Figure 8 illustrates the applicator inner housing inserted into the container sufficiently to cause the puck carrier to move to the first puck carrier position during which the puck carrier has engaged the puck.
  • Figure 9 illustrates the bottom of the applicator with the sensor cap removed and in which the puck 320 is held in place by the puck engagement arms 905 of the puck carrier.
  • Figure 10 illustrates another view of the puck carrier housing latch 705 before it is flexed inwardly towards the sharp carrier when the inner housing of the applicator is inserted into the container and the container pin 380 is forced up to bias against the housing latch 705.
  • the applicator and the sharp carrier also include one or more torsion spring member 1105 that is positioned on an outer surface of the sharp carrier and that extends away from the sharp carrier towards the outer housing.
  • Each torsion spring member is configured to rotate during engagement of an puck carrier inner arm 1110 as the puck carrier is moved from the second puck carrier position to the first puck carrier position. See, for example, the progression from Figures 11 to Figures 13.
  • each torsion spring member is configured to bias against a corresponding enlarged end of the puck carrier arm for releasably holding the sharp carrier in a first position that is nearer to the outer applicator housing when the sharp retraction spring is in the first and compressed state compressed state.
  • the puck carrier arm(s) will flex away from the torsion spring member (flexing not shown).
  • Figure 14 illustrates the applicator assembly when the applicator has engaged the puck and removed the puck and sharp hub and sharp from the corresponding sensor container.
  • the applicator In this position (the first carrier and first sharp carrier positions), the applicator is ready to apply the sensor to the body of a user.
  • the sensor has a tail or distal end that passes into the sharp 390. Then, when the sharp is inserted into the user's body and then retracted, the sensor (sensor tail) remains in the user's body.
  • the sensor can be held in place by an adhesive on the back of the puck that also remains on the user's body during this application process.
  • the firing pin releases the puck carrier under the force of the drive spring to drive into the second puck carrier position, along with the sharp carrier moving into the second sharp carrier position, and insert the sharp into the user's body. Then, the sharp carrier retracts under the force of the sharp retraction spring back into the first sharp carrier position.
  • the sharp can be removed and the applicator can be re-used to apply a different/second sensor from a different container, as just described with regard to the first/previously mentioned sensor.
  • Figure 15 illustrates how the eject pin/button 536 has been depressed, pushed or otherwise moved from a non-retraction position (shown in Figure 5) to a sharp retraction position, wherein the eject button causes the hub retention arms 1505 of the sharp carrier to flex away from the eject button when the eject button is positioned in the sharp retraction position. This releases the hub retention arms away from the sharp hub so that the sharp hub and connected sharp can be discarded.
  • Some acts associated with this process are shown in the flow diagram 1600 of Figure 16. As shown, these acts correspond to methods for sequentially applying a plurality of sensors to a body of a user with an applicator and a plurality of sensors contained in a plurality of separate containers including at least a first container and a second container.
  • the sensors being applied can include transcutaneous sensors and may be any type of analyte sensors, including, but not limited to glucose sensors.
  • the referenced applicator and containers can be the applicators and containers described above and in the numbered clauses below.
  • the illustrated acts include an act of inserting a puck carrier of the applicator into the first container that includes a first puck until the first puck carrier engages the first puck and a sharp carrier engages a first sharp contained within the first puck and until the puck carrier is moved from a second puck carrier position to a first puck carrier position that causes a drive spring of the applicator to become compressed (act 1605).
  • the illustrated acts also include an act of moving an outer housing of the applicator to cause a release of the puck carrier from the first puck carrier position to the second puck carrier position as the drive spring becomes uncompressed when the applicator is positioned against the user's body and that further causes the sharp carrier to move the first sharp into the body of the user (act 1610).
  • the method includes pressing an eject button on the applicator to release the first sharp from the sharp carrier (act 1615).
  • the method includes inserting the puck carrier of the applicator into the second container that includes a second puck until the puck carrier engages the second puck and a sharp carrier engages a second sharp contained within the second puck and until the puck carrier is moved from a second puck carrier position to a first puck carrier position that causes a drive spring of the applicator to become compressed (act 1620).
  • the method includes moving an outer housing of the applicator to cause a release of the puck carrier from the first puck carrier position to the second puck carrier position as the drive spring becomes uncompressed when the applicator is positioned against the user's body and that further causes the sharp carrier to move the second sharp into the body of the user (act 1625) and pressing an eject button on the applicator to release the second sharp from the sharp carrier after removing the applicator from being positioned against the user's body (act 1630).
  • An applicator for inserting a sensor into the body of a user comprising: an outer housing; an inner housing, the inner housing being at least partially nested within the outer housing, the outer housing being slidably engaged with the inner housing for enabling the outer housing to move from a first outer housing position to a second outer housing position relative to the inner housing; a puck carrier, the puck carrier being at least partially nested within the inner housing and slidably engaged with the inner housing for enabling the puck carrier to move from a first puck carrier position to a second puck carrier position relative to the inner housing, the puck carrier including one or more puck engagement arms for detachably engaging a puck during use of the applicator when applying the puck to a user's body; a sharp carrier, the sharp carrier being at least partially nested within the inner housing and slidably engaged within the inner housing for enabling the sharp carrier to move from a first sharp carrier position to a second sharp carrier position relative to the inner housing, the sharp carrier including hub retention arms
  • Clause 2 The applicator of clause 1 further comprising a sharp retraction spring positioned between the sharp carrier and the puck carrier, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Clause 3 The applicator of clause 1 further comprising a drive spring positioned between the inner housing and the puck carrier, the drive spring being configured to compress from a first state comprising a relatively uncompressed state in which the drive spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the drive spring is more compressed than the uncompressed state.
  • Clause 4 The applicator of clause 3, the applicator further comprising a sharp retraction spring positioned between the sharp carrier and the puck carrier and at least partially within the drive spring, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Clause 8 The applicator of clause 7, the outer housing comprising a firing pin that is positioned to bias against the puck carrier latch engagement hook in such a manner as to cause the puck carrier latch engagement hook to flex and release an engagement with the puck carrier latch when the puck carrier is in the first puck carrier position and to enable the puck carrier to move to the second puck carrier position in response to force caused by the drive spring as the drive spring uncompresses from the compressed state to the relatively uncompressed state.
  • the sharp carrier further including at least one torsion spring member positioned on an outer surface of the sharp carrier and extending away from the sharp carrier towards the outer housing, the at least one torsion spring member being configured to rotate during engagement of an inner arm of the puck carrier as the puck carrier is moved from the second puck carrier position to the first puck carrier position.
  • torsion spring member being further configured to bias against an enlarged end of the puck carrier arm for releasably holding the sharp carrier in the first position that is nearer to the outer applicator housing when the sharp retraction spring is in the first and compressed state compressed state.
  • the puck carrier further includes a puck carrier housing latch that biases into a slot formed into the inner applicator housing when the puck carrier is in the second puck carrier position, the puck carrier housing latch being configured to flex inwardly towards the sharp carrier by a container pin of a container when the inner applicator housing and puck carrier are inserted into a container containing the container pin.
  • Clause 14 The applicator of clause 13, wherein the container also includes an outer container wall sized to fit around a circumference of the puck carrier and the outer applicator housing and to slidably engage with the outer applicator housing when the outer applicator housing is inserted into the container to engage the puck with the puck carrier.
  • An assembly comprising an applicator for sequentially applying a plurality of sensors to a user's body and a plurality of containers, each of the plurality of containers containing a different sensor of the plurality of sensors, the applicator comprising: an outer housing; an inner housing, the inner housing being at least partially nested within the outer housing, the outer housing being slidably engaged with the inner housing for enabling the outer housing to move from a first outer housing position to a second outer housing position relative to the inner housing; a puck carrier, the puck carrier being at least partially nested within the inner housing and slidably engaged with the inner housing for enabling the puck carrier to move from a first puck carrier position to a second puck carrier position relative to the inner housing, the puck carrier including one or more puck engagement arms for detachably engaging a puck during use of the applicator when applying the puck to a user's body; a sharp carrier, the sharp carrier being at least partially nested within the inner housing and slidably engaged within the inner housing
  • Clause 19 The assembly of clause 18, the applicator further comprising a sharp retraction spring positioned between the sharp carrier and the puck carrier, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Clause 20 The assembly of clause 18, the applicator further comprising a drive spring positioned between the inner housing and the puck carrier, the drive spring being configured to compress from a first state comprising a relatively uncompressed state in which the drive spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the drive spring is more compressed than the uncompressed state.
  • Clause 21 The assembly of clause 20, the applicator further comprising a sharp retraction spring positioned between the sharp carrier and the puck carrier and at least partially within the drive spring, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Clause 22 The assembly of clause 21, wherein the sharp retraction spring is in the first and compressed state when the sharp carrier is in the first sharp carrier position and the sharp retraction spring is in the second and relatively uncompressed state when the sharp carrier is in the second sharp carrier position, the sharp carrier being positioned closer to the outer housing in the second sharp carrier position than the first puck carrier position.
  • Clause 25 The assembly of clause 24, the outer housing comprising a firing pin that is positioned to bias against the puck carrier latch engagement hook in such a manner as to cause the puck carrier latch engagement hook to flex and release an engagement with the puck carrier latch when the puck carrier is in the first puck carrier position and to enable the puck carrier to move to the second puck carrier position in response to force caused by the drive spring as the drive spring uncompresses from the compressed state to the relatively uncompressed state.
  • the sharp carrier further including at least one torsion spring member positioned on an outer surface of the sharp carrier and extending away from the sharp carrier towards the outer housing, the at least one torsion spring member being configured to rotate during engagement of an inner arm of the puck carrier as the puck carrier is moved from the second puck carrier position to the first puck carrier position.
  • Clause 27 The assembly of clause 26, the torsion spring member being further configured to bias against an enlarged end of the puck carrier arm for releasably holding the sharp carrier in a first position that is nearer to the outer applicator housing when the sharp retraction spring is in the first and compressed state compressed state.
  • the puck carrier further includes a puck carrier housing latch that biases into a slot formed into the inner applicator housing when the puck carrier is in the second puck carrier position, the puck carrier housing latch being configured to flex inwardly towards the sharp carrier by a container pin of a container when the inner applicator housing and puck carrier are inserted into a container containing the container pin.
  • each of the plurality of containers comprising a corresponding puck and a corresponding sealing cap that removably seals the corresponding puck within the corresponding container until the corresponding sealing cap is removed from the corresponding container.
  • each of the plurality of containers also includes an outer container wall sized to fit around a circumference of the puck carrier and the outer applicator housing and to slidably engage with the outer applicator housing when the outer applicator housing is inserted within the outer container wall to engage the corresponding puck with the puck carrier.
  • Clause 32 The assembly of clause 30, wherein the corresponding sealing cap comprises a threaded cap.
  • Clause 33 The assembly of clause 30, wherein the corresponding puck of each container comprises a sensor and wherein each container further comprises a corresponding sharp with a corresponding sharp hub, the corresponding sharp being inserted at least partially within the corresponding puck when the corresponding sealing cap is positioned on the corresponding container for sealing the corresponding puck within the corresponding container.
  • Clause 34 The assembly of clause 33, wherein the corresponding sensor comprises a transcutaneous glucose sensor.
  • a method for sequentially applying a plurality of sensors to a body of a user with an applicator and a plurality of sensors contained in a plurality of separate containers including at least a first container and a second container comprising: inserting a puck carrier of the applicator into the first container that includes a first puck until the first puck carrier engages the first puck and a sharp carrier engages a first sharp contained within the first puck and until the puck carrier is moved from a second puck carrier position to a first puck carrier position that causes a drive spring of the applicator to become compressed; moving an outer housing of the applicator to cause a release of the puck carrier from the first puck carrier position to the second puck carrier position as the drive spring becomes uncompressed when the applicator is positioned against the user's body and that further causes the sharp carrier to move the first sharp into the body of the user; after removing the applicator from being positioned against the user's body, pressing an eject button on the applicator to release the first sharp
  • the applicator comprising: an outer housing; an inner housing, the inner housing being at least partially nested within the outer housing, the outer housing being slidably engaged with the inner housing for enabling the outer housing to move from a first outer housing position to a second outer housing position relative to the inner housing; the puck carrier, the puck carrier being at least partially nested within the inner housing and slidably engaged with the inner housing for enabling the puck carrier to move from the first puck carrier position to the second puck carrier position relative to the inner housing, the puck carrier including one or more puck engagement arms for detachably engaging the first and second pucks during use of the applicator when applying the first and second pucks to the user's body; a sharp carrier, the sharp carrier being at least partially nested within the inner housing and slidably engaged within the inner housing for enabling the sharp carrier to move from a first sharp carrier position to a second sharp carrier position relative to the inner housing, the sharp carrier including hub retention arms for detachably engaging a
  • Clause 37 The method of clause 36, the applicator further comprising a sharp retraction spring positioned between the sharp carrier and the puck carrier, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Clause 38 The method of clause 37, the applicator further comprising a drive spring positioned between the inner housing and the puck carrier, the drive spring being configured to compress from a first state comprising a relatively uncompressed state in which the drive spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the drive spring is more compressed than the uncompressed state.
  • Clause 39 The method of clause 38, the applicator further comprising a sharp retraction spring positioned between the sharp carrier and the puck carrier and at least partially within the drive spring, the sharp retraction spring being configured to compress from a first state comprising a relatively uncompressed state in which the sharp retraction spring is uncompressed or at least relatively less compressed than a second state comprising a compressed state in which the sharp retraction spring is more compressed than the uncompressed state.
  • Clause 40 The method of clause 39, wherein the sharp retraction spring is in the first and compressed state when the sharp carrier is in the first sharp carrier position and the sharp retraction spring is in the second and relatively uncompressed state when the sharp carrier is in the second sharp carrier position, the sharp carrier being positioned closer to the outer housing in the second sharp carrier position than the first puck carrier position.
  • the puck carrier comprising a puck carrier latch
  • the inner housing comprising a puck carrier latch engagement hook configured to engage the puck carrier latch to secure the puck carrier in the first puck carrier position when the drive spring is in the compressed state.
  • Clause 43 The method of clause 42, the outer housing comprising a firing pin that is positioned to bias against the puck carrier latch engagement hook in such a manner as to cause the puck carrier latch engagement hook to flex and release an engagement with the puck carrier latch when the puck carrier is in the first puck carrier position and to enable the puck carrier to move to the second puck carrier position in response to force caused by the drive spring as the drive spring uncompresses from the compressed state to the relatively uncompressed state.
  • the sharp carrier further including at least one torsion spring member positioned on an outer surface of the sharp carrier and extending away from the sharp carrier towards the outer housing, the at least one torsion spring member being configured to rotate during engagement of an inner arm of the puck carrier as the puck carrier is moved from the second puck carrier position to the first puck carrier position.
  • Clause 45 The method of clause 44, the torsion spring member being further configured to bias against an enlarged end of the puck carrier arm for releasably holding the sharp carrier in a first position that is nearer to the outer applicator housing when the sharp retraction spring is in the first and compressed state compressed state.
  • Clause 46 The method of clause 45, wherein the puck carrier arm flexes away from the torsion spring member when the puck carrier is moved from the first puck carrier position to the second puck carrier position.
  • the puck carrier further includes a puck carrier housing latch that biases into a slot formed into the inner applicator housing when the puck carrier is in the second puck carrier position, the puck carrier housing latch being configured to flex inwardly towards the sharp carrier by a container pin of a container when the inner applicator housing and puck carrier are inserted into a container containing the container pin.
  • each of the plurality of containers comprising a corresponding puck and a corresponding sealing cap that removably seals the corresponding puck within the corresponding container until the corresponding sealing cap is removed from the corresponding container.
  • each of the plurality of containers also includes an outer container wall sized to fit around a circumference of the puck carrier and the outer applicator housing and to slidably engage with the outer applicator housing when the outer applicator housing is inserted within the outer container wall to engage the corresponding puck with the puck carrier.
  • Clause 50 The method of clause 48, wherein the corresponding sealing cap comprises a threaded cap.
  • each container comprises a sensor and wherein each container further comprises a corresponding sharp with a corresponding sharp hub, the corresponding sharp being inserted at least partially within the corresponding puck when the corresponding sealing cap is positioned on the corresponding container for sealing the corresponding puck within the corresponding container.
  • the corresponding sensor comprises a transcutaneous glucose sensor.

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Abstract

L'invention concerne un applicateur permettant d'appliquer séquentiellement une pluralité de capteurs sur un corps d'un utilisateur, la pluralité de capteurs étant logés à l'intérieur de différents contenants. L'applicateur est conçu pour être inséré dans chaque contenant de la pluralité de contenants pour venir en prise avec des galets presseurs correspondants à l'intérieur de chacun des différents contenants et pour venir en prise encore avec des objets pointus correspondants à l'intérieur de chacun des contenants. L'applicateur est conçu pour déplacer un support de galets presseurs à l'intérieur de l'applicateur entre des première et seconde positions pour insérer des objets pointus dans le corps de l'utilisateur et les retirer de celui-ci lors de l'application des capteurs des galets presseurs correspondants sur le corps de l'utilisateur. L'applicateur est également conçu avec un bouton d'éjection pour éjecter les objets pointus après leur retrait du corps de l'utilisateur.
PCT/US2024/054261 2023-11-13 2024-11-01 Applicateur de capteurs à usages multiples Pending WO2025106279A1 (fr)

Applications Claiming Priority (2)

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US202363548277P 2023-11-13 2023-11-13
US63/548,277 2023-11-13

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180235520A1 (en) * 2017-01-23 2018-08-23 Abbott Diabetes Care Inc. Systems, devices and methods for analyte sensor insertion
US20220167919A1 (en) * 2020-08-31 2022-06-02 Abbott Diabetes Care Inc. Systems, devices, and methods for analyte sensor insertion
US11654270B2 (en) * 2021-09-28 2023-05-23 Biolinq Incorporated Microneedle enclosure and applicator device for microneedle array based continuous analyte monitoring device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180235520A1 (en) * 2017-01-23 2018-08-23 Abbott Diabetes Care Inc. Systems, devices and methods for analyte sensor insertion
US20220167919A1 (en) * 2020-08-31 2022-06-02 Abbott Diabetes Care Inc. Systems, devices, and methods for analyte sensor insertion
US11654270B2 (en) * 2021-09-28 2023-05-23 Biolinq Incorporated Microneedle enclosure and applicator device for microneedle array based continuous analyte monitoring device

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