Patent Application
20110082484
The present invention relates generally to an inserter device, for example, to insert an analyte sensor or an infusion set. More specifically, the present invention relates to an inserter device comprising a rotatable trigger.
The detection and/or monitoring of glucose levels or other analytes, such as lactate, oxygen, A1C, or the like, in certain individuals is vitally important to their health. For example, the monitoring of glucose is particularly important to individuals with diabetes. Diabetics generally monitor glucose levels to determine if their glucose levels 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.
Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.
Devices have been developed for the automatic monitoring of analyte(s), such as glucose, in bodily fluid such as in the blood stream or in interstitial fluid (“ISF”), or other biological fluid. Some of these analyte measuring devices are configured so that at least a portion of the devices are positioned below a skin surface of a user, e.g., in a blood vessel or in the subcutaneous tissue of a user, so that the monitoring is accomplished in vivo.
With the continued development of analyte monitoring devices and systems, there is a need for such analyte monitoring devices, systems, and methods, as well as devices for inserting and/or positioning such analyte monitoring systems that are cost effective, convenient, and with reduced pain, provide discreet monitoring to encourage frequent analyte monitoring to improve glycemic control.
In one aspect of the invention, a sensor inserter assembly is provided. The inserter assembly includes a housing and a shuttle movably connected to the housing. The shuttle can move in an insertion direction. In this regard, a driver can be included to urge the shuttle in the insertion direction. In some embodiments, a second spring can be included for urging the shuttle in a retraction direction.
In some embodiments, the sensor inserter assembly is pre-loaded with a sensor. The sensor can be received in an introducer sharp, which can be attached to the shuttle. The sensor inserter assembly further comprises a rotatable trigger that can be axially received on the tubular housing. The tubular housing can include a groove circumferentially disposed about the tubular body to engage with a flange disposed on the trigger.
In some embodiments, the housing includes one or more centrally located channels extending through the tubular body. A centrally located aperture can be formed in the tubular body to receive the shuttle and introducer sharp. The first spring can be disposed proximal to the shuttle and introducer sharp in the centrally located channel of tubular housing. In this manner, the rotatable trigger can be configured to release the shuttle and allow the first spring means to urge the shuttle and the introducer sharp in the insertion direction. The tubular housing can further include a second spring to facilitate retraction of the shuttle and introducer sharp in the retraction direction.
In some embodiments, the rotatable trigger is configured to release the shuttle from a mounting unit. For example, the rotatable trigger can be configured to rotate 180 degrees to release the shuttle. The inserter can be configured to insert the sensor at an angle. For example, in some embodiments, the sensor is inserted at a 20 degree angle relative to the user's skin.
In some embodiments, the introducer includes one or more cantilever arms to retain the sensor. Further, the sensor can be retained in the introducer of the sensor inserter assembly by various structures, including a dimple disposed on the sensor body and configured to form an interference fit with the introducer.
A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.
Before the present disclosure is described in detail, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure.
Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure.
The figures shown herein are not necessarily drawn to scale, with some components and features being exaggerated for clarity.
Generally, embodiments of the present disclosure relate to in vivo methods and devices for detecting at least one analyte such as glucose in body fluid. Accordingly, embodiments include in vivo analyte sensors configured so that at least a portion of the sensor is positioned in the body of a user (e.g., within the ISF), to obtain information about at least one analyte of the body, e.g., transcutaneously positioned in user's body. In certain embodiments, an in vivo analyte sensor is coupled to an electronics unit that is maintained on the body of the user such as on a skin surface, where such coupling provides on body, in vivo analyte sensor electronics assemblies.
In certain embodiments, analyte information is communicated from a first device such as an on body electronics unit to a second device which may include user interface features, including a display, and/or the like. Information may be communicated from the first device to the second device automatically and/or continuously when the analyte information is available, or may not be communicated automatically and/or continuously, but rather stored or logged in a memory of the first device. Accordingly, in many embodiments of the system, analyte information derived by the sensor/on body electronics (for example, on body electronics assembly) is made available in a user-usable or viewable form only when queried by the user such that the timing of data communication is selected by the user.
In this manner, analyte information is only provided or evident to a user (provided at a user interface device) when desired by the user even though an in vivo analyte sensor automatically and/or continuously monitors the analyte level in vivo, i.e., the sensor automatically monitors analyte such as glucose on a pre-defined time interval over its usage life. For example, an analyte sensor may be positioned in vivo and coupled to on body electronics for a given sensing period, e.g., about 14 days. In certain embodiments, the sensor-derived analyte information is automatically communicated from the sensor electronics assembly to a remote monitor device or display device for output to a user throughout the 14 day period according to a schedule programmed at the on body electronics (e.g., about every 1 minute or about every 5 minutes or about every 10 minutes, or the like). In certain embodiments, sensor-derived analyte information is only communicated from the sensor electronics assembly to a remote monitor device or display device at user-determined times, e.g., whenever a user decides to check analyte information. At such times, a communications system is activated and sensor-derived information is then sent from the on body electronics to the remote device or display device.
In still other embodiments, the information may be communicated from the first device to the second device automatically and/or continuously when the analyte information is available, and the second device stores or logs the received information without presenting or outputting the information to the user. In such embodiments, the information is received by the second device from the first device when the information becomes available (e.g., when the sensor detects the analyte level according to a time schedule). However, the received information is initially stored in the second device and only output to a user interface or an output component of the second device (e.g., display) upon detection of a request for the information on the second device.
Accordingly, in certain embodiments once a sensor electronics assembly is placed on the body so that at least a portion of the in vivo sensor is in contact with bodily fluid such as ISF and the sensor is electrically coupled to the electronics unit, sensor derived analyte information may be communicated from the on body electronics to a display device on-demand by powering on the display device (or it may be continually powered), and executing a software algorithm stored in and accessed from a memory of the display device, to generate one or more request commands, control signal or data packet to send to the on body electronics. The software algorithm executed under, for example, the control of the microprocessor or application specific integrated circuit (ASIC) of the display device may include routines to detect the position of the on body electronics relative to the display device to initiate the transmission of the generated request command, control signal and/or data packet.
Display devices may also include programming stored in memory for execution by one or more microprocessors and/or ASICs to generate and transmit the one or more request command, control signal or data packet to send to the on body electronics in response to a user activation of an input mechanism on the display device such as depressing a button on the display device, triggering a soft button associated with the data communication function, and so on. The input mechanism may be alternatively or additionally provided on or in the on body electronics which may be configured for user activation. In certain embodiments, voice commands or audible signals may be used to prompt or instruct the microprocessor or ASIC to execute the software routine(s) stored in the memory to generate and transmit the one or more request command, control signal or data packet to the on body device. In the embodiments that are voice activated or responsive to voice commands or audible signals, on body electronics and/or display device includes a microphone, a speaker, and processing routines stored in the respective memories of the on body electronics and/or the display device to process the voice commands and/or audible signals. In certain embodiments, positioning the on body device and the display device within a predetermined distance (e.g., close proximity) relative to each other initiates one or more software routines stored in the memory of the display device to generate and transmit a request command, control signal or data packet.
Different types and/or forms and/or amounts of information may be sent for each on demand reading, including but not limited to one or more of current analyte level information (i.e., real time or the most recently obtained analyte level information temporally corresponding to the time the reading is initiated), rate of change of an analyte over a predetermined time period, rate of the rate of change of an analyte (acceleration in the rate of change), historical analyte information corresponding to analyte information obtained prior to a given reading and stored in memory of the assembly. Some or all of real time, historical, rate of change, rate of rate of change (such as acceleration or deceleration) information may be sent to a display device for a given reading. In certain embodiments, the type and/or form and/or amount of information sent to a display device may be preprogrammed and/or unchangeable (e.g., preset at manufacturing), or may not be preprogrammed and/or unchangeable so that it may be selectable and/or changeable in the field one or more times (e.g., by activating a switch of the system, etc). Accordingly, in certain embodiments, for each on demand reading, a display device will output a current (real time) sensor-derived analyte value (e.g., in numerical format), a current rate of analyte change (e.g., in the form of an analyte rate indicator such as a arrow pointing in a direction to indicate the current rate), and analyte trend history data based on sensor readings acquired by and stored in memory of on body electronics (e.g., in the form of a graphical trace). Additionally, the on skin or sensor temperature reading or measurement associated with each on demand reading may be communicated from the on body electronics to the display device. The temperature reading or measurement, however, may not be output or displayed on the display device, but rather, used in conjunction with a software routine executed by the display device to correct or compensate the analyte measurement output to the user on the display device.
As described, embodiments include in vivo analyte sensors and on body electronics that together provide body wearable sensor electronics assemblies. In certain embodiments, in vivo analyte sensors are fully integrated with on body electronics (fixedly connected during manufacture), while in other embodiments they are separate but connectable post manufacture (e.g., before, during or after sensor insertion into a body). On body electronics may include an in vivo glucose sensor, electronics, battery, and antenna encased (except for the sensor portion that is for in vivo positioning) in a waterproof housing that includes or is attachable to an adhesive pad. In certain embodiments, the housing withstands immersion in about one meter of water for up to at least 30 minutes. In certain embodiments, the housing withstands continuous underwater contact, e.g., for longer than about 30 minutes, and continues to function properly according to its intended use, e.g., without water damage to the housing electronics where the housing is suitable for water submersion.
Embodiments include sensor insertion devices, which also may be referred to herein as sensor delivery units, or the like. Insertion devices may retain on body electronics assemblies completely in an interior compartment, i.e., an insertion device may be “pre-loaded” with on body electronics assemblies during the manufacturing process (e.g., on body electronics may be packaged in a sterile interior compartment of an insertion device). In such embodiments, insertion devices may form sensor assembly packages (including sterile packages) for pre-use or new on body electronics assemblies, and insertion devices configured to apply on body electronics assemblies to recipient bodies.
Embodiments include portable handheld display devices, as separate devices and spaced apart from an on body electronics assembly, that collect information from the assemblies and provide sensor derived analyte readings to users. Such devices may also be referred to as meters, readers, monitors, receivers, human interface devices, companions, or the like. Certain embodiments may include an integrated in vitro analyte meter. In certain embodiments, display devices include one or more wired or wireless communications ports such as USB, serial, parallel, or the like, configured to establish communication between a display device and another unit (e.g., on body electronics, power unit to recharge a battery, a PC, etc). For example, a display device communication port may enable charging a display device battery with a respective charging cable and/or data exchange between a display device and its compatible informatics software.
Compatible informatics software in certain embodiments include, for example, but not limited to stand alone or network connection enabled data management software program, resident or running on a display device, personal computer, a server terminal, for example, to perform data analysis, charting, data storage, data archiving and data communication as well as data synchronization. Informatics software in certain embodiments may also include software for executing field upgradable functions to upgrade firmware of a display device and/or on body electronics unit to upgrade the resident software on the display device and/or the on body electronics unit, e.g., with versions of firmware that include additional features and/or include software bugs or errors fixed, etc.
Embodiments may include a haptic feedback feature such as a vibration motor or the like, configured so that corresponding notifications (e.g., a successful on-demand reading received at a display device), may be delivered in the form of haptic feedback.
Embodiments include programming embedded on a computer readable medium, i.e., computer-based application software (may also be referred to herein as informatics software or programming or the like) that processes analyte information obtained from the system and/or user self-reported data. Application software may be installed on a host computer such as a mobile telephone, PC, an Internet-enabled human interface device such as an Internet-enabled phone, personal digital assistant, or the like, by a display device or an on body electronics unit. Informatics programming may transform data acquired and stored on a display device or on body unit for use by a user.
Embodiments of the subject disclosure are described primarily with respect to glucose monitoring devices and systems, and methods of glucose monitoring, for convenience only and such description is in no way intended to limit the scope of the disclosure. It is to be understood that the analyte monitoring system may be configured to monitor a variety of analytes at the same time or at different times.
For example, analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored. In those embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times, with a single sensor or with a plurality of sensors which may use the same on body electronics (e.g., simultaneously) or with different on body electronics.
As described in detail below, embodiments include devices, systems, kits and/or methods to monitor one or more physiological parameters such as, for example, but not limited to, analyte levels, temperature levels, heart rate, user activity level, over a predetermined monitoring time period. Also provided are methods of manufacturing. Predetermined monitoring time periods may be less than about 1 hour, or may include about 1 hour or more, e.g., about a few hours or more, e.g., about a few days of more, e.g., about 3 or more days, e.g., about 5 days or more, e.g., about 7 days or more, e.g., about 10 days or more, e.g., about 14 days or more, e.g., about several weeks, e.g., about 1 month or more. In certain embodiments, after the expiration of the predetermined monitoring time period, one or more features of the system may be automatically deactivated or disabled at the on body electronics assembly and/or display device.
For example, a predetermined monitoring time period may begin with positioning the sensor in vivo and in contact with a body fluid such as ISF, and/or with the initiation (or powering on to full operational mode) of the on body electronics. Initialization of on body electronics may be implemented with a command generated and transmitted by a display device in response to the activation of a switch and/or by placing the display device within a predetermined distance (e.g., close proximity) to the on body electronics, or by user manual activation of a switch on the on body electronics unit, e.g., depressing a button, or such activation may be caused by the insertion device, e.g., as described in U.S. patent application Ser. No. 12/698,129 filed on Feb. 1, 2010 and U.S. Provisional Application Nos. 61/238,646, 61/246,825, 61/247,516, 61/249,535, 61/317,243, 61/345,562, and 61/361,374, the disclosures of each of which are incorporated herein by reference for all purposes.
When initialized in response to a received command from a display device, the on body electronics retrieves and executes from its memory software routine to fully power on the components of the on body electronics, effectively placing the on body electronics in full operational mode in response to receiving the activation command from the display device. For example, prior to the receipt of the command from the display device, a portion of the components in the on body electronics may be powered by its internal power supply such as a battery while another portion of the components in the on body electronics may be in powered down or low power including no power, inactive mode, or all components may be in an inactive mode, powered down mode. Upon receipt of the command, the remaining portion (or all) of the components of the on body electronics is switched to active, fully operational mode.
Embodiments of on body electronics may include one or more circuit boards with electronics including control logic implemented in ASIC, microprocessors, memory, and the like, and transcutaneously positionable analyte sensors forming a single assembly. On body electronics may be configured to provide one or more signals or data packets associated with a monitored analyte level upon detection of a display device of the analyte monitoring system within a predetermined proximity for a period of time (for example, about 2 minutes, e.g., 1 minute or less, e.g., about 30 seconds or less, e.g., about 10 seconds or less, e.g., about 5 seconds or less, e.g., about 2 seconds or less) and/or until a confirmation, such as an audible and/or visual and/or tactile (e.g., vibratory) notification, is output on the display device indicating successful acquisition of the analyte related signal from the on body electronics. A distinguishing notification may also be output for unsuccessful acquisition in certain embodiments.
In certain embodiments, the monitored analyte level may be correlated and/or converted to glucose levels in blood or other fluids such as ISF. Such conversion may be accomplished with the on body electronics, but in many embodiments will be accomplished with display device electronics. In certain embodiments, glucose level is derived from the monitored analyte level in the ISF.
Analyte sensors may be insertable into a vein, artery, or other portion of the body containing analyte. In certain embodiments, analyte sensors may be positioned in contact with ISF to detect the level of analyte, where the detected analyte level may be used to infer the user's glucose level in blood or interstitial tissue.
Embodiments include transcutaneous sensors and also wholly implantable sensors and wholly implantable assemblies in which a single assembly including the analyte sensor and electronics are provided in a sealed housing (e.g., hermetically sealed biocompatible housing) for implantation in a user's body for monitoring one or more physiological parameters.
Referring back to the
In certain embodiments, on body electronics 102 may be configured to store some or all of the monitored analyte related data received from analyte sensor 302 in a memory during the monitoring time period, and maintain it in memory until the usage period ends. In such embodiments, stored data is retrieved from on body electronics 102 at the conclusion of the monitoring time period, for example, after removing analyte sensor 302 from the user by detaching on body electronics 102 from the skin surface where it was positioned during the monitoring time period. In such data logging configurations, real time monitored analyte level is not communicated to display device 120 during the monitoring period or otherwise transmitted from on body electronics 102, but rather, retrieved from on body electronics 102 after the monitoring time period.
In certain embodiments, input component 121 of display device 120 may include a microphone and display device 120 may include software configured to analyze audio input received from the microphone, such that functions and operation of the display device 120 may be controlled by voice commands. In certain embodiments, an output component of display device 120 includes a speaker for outputting information as audible signals. Similar voice responsive components such as a speaker, microphone and software routines to generate, process and store voice driven signals may be provided to on body electronics 102.
In certain embodiments, display 122 and input component 121 may be integrated into a single component, for example a display that can detect the presence and location of a physical contact touch upon the display such as a touch screen user interface. In such embodiments, the user may control the operation of display device 120 by utilizing a set of pre-programmed motion commands, including, but not limited to, single or double tapping the display, dragging a finger or instrument across the display, motioning multiple fingers or instruments toward one another, motioning multiple fingers or instruments away from one another, etc. In certain embodiments, a display includes a touch screen having areas of pixels with single or dual function capacitive elements that serve as LCD elements and touch sensors.
Display device 120 also includes data communication port 123 for wired data communication with external devices such as remote terminal (personal computer) 170, for example. Example embodiments of the data communication port 123 include USB port, mini USB port, RS-232 port, Ethernet port, Firewire port, or other similar data communication ports configured to connect to the compatible data cables. Display device 120 may also include an integrated in vitro glucose meter, including in vitro test strip port 124 to receive an in vitro glucose test strip for performing in vitro blood glucose measurements.
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As further shown in
Referring to
After the positioning of on body electronics 102 on the skin surface and analyte sensor 302 in vivo to establish fluid contact with interstitial fluid (or other appropriate body fluid), on body electronics 102 in certain embodiments is configured to wirelessly communicate analyte related data (such as, for example, data corresponding to monitored analyte level and/or monitored temperature data, and/or stored historical analyte related data) when on body electronics 102 receives a command or request signal from display device 120. In certain embodiments, on body electronics 102 may be configured to at least periodically broadcast real time data associated with monitored analyte level which is received by display device 120 when display device 120 is within communication range of the data broadcast from on body electronics 102, i.e., it does not need a command or request from a display device to send information.
For example, display device 120 may be configured to transmit one or more commands to on body electronics 102 to initiate data transfer, and in response, on body electronics 102 may be configured to wirelessly transmit stored analyte related data collected during the monitoring time period to display device 120. Display device 120 may in turn be connected to a remote terminal 170 such as a personal computer and functions as a data conduit to transfer the stored analyte level information from the on body electronics 102 to remote terminal 170. In certain embodiments, the received data from the on body electronics 102 may be stored (permanently or temporarily) in one or more memory of the display device 120. In certain other embodiments, display device 120 is configured as a data conduit to pass the data received from on body electronics 102 to remote terminal 170 that is connected to display device 120.
Referring still to
Remote terminal 170 in certain embodiments may include one or more computer terminals located at a physician's office or a hospital. For example, remote terminal 170 may be located at a location other than the location of display device 120. Remote terminal 170 and display device 120 could be in different rooms or different buildings. Remote terminal 170 and display device 120 could be at least about one mile apart, e.g., at least about 10 miles apart, e.g., at least about 100 miles apart. For example, remote terminal 170 could be in the same city as display device 120, remote terminal 170 could be in a different city than display device 120, remote terminal 170 could be in the same state as display device 120, remote terminal 170 could be in a different state than display device 120, remote terminal 170 could be in the same country as display device 120, or remote terminal 170 could be in a different country than display device 120, for example.
In certain embodiments, a separate, optional data communication/processing device such as data processing module 160 may be provided in analyte monitoring system 100. Data processing module 160 may include components to communicate using one or more wireless communication protocols such as, for example, but not limited to, infrared (IR) protocol, Bluetooth protocol, Zigbee protocol, and 802.11 wireless LAN protocol. Additional description of communication protocols including those based on Bluetooth protocol and/or Zigbee protocol can be found in U.S. Patent Publication No. 2006/0193375 incorporated herein by reference for all purposes. Data processing module 160 may further include communication ports, drivers or connectors to establish wired communication with one or more of display device 120, on body electronics 102, or remote terminal 170 including, for example, but not limited to USB connector and/or USB port, Ethernet connector and/or port, FireWire connector and/or port, or RS-232 port and/or connector.
In certain embodiments, data processing module 160 is programmed to transmit a polling or query signal to on body electronics 102 at a predetermined time interval (e.g., once every minute, once every five minutes, or the like), and in response, receive the monitored analyte level information from on body electronics 102. Data processing module 160 stores in its memory the received analyte level information, and/or relays or retransmits the received information to another device such as display device 120. More specifically in certain embodiments, data processing module 160 may be configured as a data relay device to retransmit or pass through the received analyte level data from on body electronics 102 to display device 120 or a remote terminal (for example, over a data network such as a cellular or WiFi data network) or both.
In certain embodiments, on body electronics 102 and data processing module 160 may be positioned on the skin surface of the user within a predetermined distance of each other (for example, about 1-12 inches, or about 1-10 inches, or about 1-7 inches, or about 1-5 inches) such that periodic communication between on body electronics 102 and data processing module 160 is maintained. Alternatively, data processing module 160 may be worn on a belt or clothing item of the user, such that the desired distance for communication between the on body electronics 102 and data processing module 160 for data communication is maintained. In a further aspect, the housing of data processing module 160 may be configured to couple to or engage with on body electronics 102 such that the two devices are combined or integrated as a single assembly and positioned on the skin surface. In further embodiments, data processing module 160 is detachably engaged or connected to on body electronics 102 providing additional modularity such that data processing module 160 may be optionally removed or reattached as desired.
Referring to
In another embodiment, data processing module 160 transmits a command or signal to on body electronics 102 to receive the analyte related data in response to a user activation of a switch provided on data processing module 160 or a user initiated command received from display device 120. In further embodiments, data processing module 160 is configured to transmit a command or signal to on body electronics 102 in response to receiving a user initiated command only after a predetermined time interval has elapsed. For example, in certain embodiments, if the user does not initiate communication within a programmed time period, such as, for example about 5 hours from last communication (or 10 hours from the last communication, or 24 hours from the last communication), the data processing module 160 may be programmed to automatically transmit a request command or signal to on body electronics 102. Alternatively, data processing module 160 may be programmed to activate an alarm to notify the user that a predetermined time period of time has elapsed since the last communication between the data processing module 160 and on body electronics 102. In this manner, users or healthcare providers may program or configure data processing module 160 to provide certain compliance with analyte monitoring regimen, so that frequent determination of analyte levels is maintained or performed by the user.
In certain embodiments, when a programmed or programmable alarm condition is detected (for example, a detected glucose level monitored by analyte sensor 302 that is outside a predetermined acceptable range indicating a physiological condition which requires attention or intervention for medical treatment or analysis (for example, a hypoglycemic condition, a hyperglycemic condition, an impending hyperglycemic condition or an impending hypoglycemic condition), the one or more output indications may be generated by the control logic or processor of the on body electronics 102 and output to the user on a user interface of on body electronics 102 so that corrective action may be timely taken. In addition to or alternatively, if display device 120 is within communication range, the output indications or alarm data may be communicated to display device 120 whose processor, upon detection of the alarm data reception, controls the display 122 to output one or more notification.
In certain embodiments, control logic or microprocessors of on body electronics 102 include software programs to determine future or anticipated analyte levels based on information obtained from analyte sensor 302, e.g., the current analyte level, the rate of change of the analyte level, the acceleration of the analyte level change, and/or analyte trend information determined based on stored monitored analyte data providing a historical trend or direction of analyte level fluctuation as function time during monitored time period. Predictive alarm parameters may be programmed or programmable in display device 120, or the on body electronics 102, or both, and output to the user in advance of anticipating the user's analyte level reaching the future level. This provides the user an opportunity to take timely corrective action.
Information, such as variation or fluctuation of the monitored analyte level as a function of time over the monitored time period providing analyte trend information, for example, may be determined by one or more control logic or microprocessors of display device 120, data processing module 160, and/or remote terminal 170, and/or on body electronics 102. Such information may be displayed as, for example, a graph (such as a line graph) to indicate to the user the current and/or historical and/or and predicted future analyte levels as measured and predicted by the analyte monitoring system 100. Such information may also be displayed as directional arrows (for example, see trend or directional arrow display 131) or other icon(s), e.g., the position of which on the screen relative to a reference point indicated whether the analyte level is increasing or decreasing as well as the acceleration or deceleration of the increase or decrease in analyte level. This information may be utilized by the user to determine any necessary corrective actions to ensure the analyte level remains within an acceptable and/or clinically safe range. Other visual indicators, including colors, flashing, fading, etc., as well as audio indicators including a change in pitch, volume, or tone of an audio output and/or vibratory or other tactile indicators may also be incorporated into the display of trend data as means of notifying the user of the current level and/or direction and/or rate of change of the monitored analyte level. For example, based on a determined rate of glucose change, programmed clinically significant glucose threshold levels (e.g., hyperglycemic and/or hypoglycemic levels), and current analyte level derived by an in vivo analyte sensor, the system 100 may include an algorithm stored on computer readable medium to determine the time it will take to reach a clinically significant level and will output notification in advance of reaching the clinically significant level, e.g., 30 minutes before a clinically significant level is anticipated, and/or 20 minutes, and/or 10 minutes, and/or 5 minutes, and/or 3 minutes, and/or 1 minute, and so on, with outputs increasing in intensity or the like.
Referring to
Examples of smart phones include Windows®, Android™, iPhone® operating system, Palm® WebOS™, Blackberry® operating system, or Symbian® operating system based mobile telephones with data network connectivity functionality for data communication over an internet connection and/or a local area network (LAN). PDAs as described above include, for example, portable electronic devices including one or more microprocessors and data communication capability with a user interface (e.g., display/output unit and/or input unit, and configured for performing data processing, data upload/download over the internet, for example. In such embodiments, remote terminal 170 may be configured to provide the executable application software to the one or more of the communication devices described above when communication between the remote terminal 170 and the devices are established.
In still further embodiments, executable software applications may be provided over-the-air (OTA) as an OTA download such that wired connection to remote terminal 170 is not necessary. For example, executable applications may be automatically downloaded as software download to the communication device, and depending upon the configuration of the communication device, installed on the device for use automatically, or based on user confirmation or acknowledgement on the communication device to execute the installation of the application. The OTA download and installation of software may include software applications and/or routines that are updates or upgrades to the existing functions or features of data processing module 160 and/or display device 120.
Referring to remote terminal 170 of
In accordance with one embodiment of the invention, a sensor is positioned at least partially under the skin of a user by an inserter to measure analyte levels or concentrations, for example, glucose. As illustrated in
The inserter assembly 202, which can be preloaded with the sensor, is employed to insert the sensor through the skin of a user. Generally, as illustrated in
In some embodiments, the rotatable trigger 206 is engaged to shuttle 304. A first driver member 310 is disposed between the rotatable trigger 206 and the shuttle 310. The shuttle is connected to an medical device to be inserted into a subject of a user, such as sensor 302. First driver member 310 can be configured to travel along a linear path, which includes the insertion path and retraction path. In this manner, as first driver member 310 moves along its linear path, shuttle 304 coupled to the first driver member also moves in a linear direction. The linear path of shuttle 304 includes an insertion direction, insertion point, retraction direction, and retraction point. Accordingly, at the insertion point of the linear path, the object to be inserted into the subject is released from shuttle 304.
Referring now to
In some embodiments, shuttle 304 may be molded overhangs which confine sharp 306 to a linear path as the sharp is assembled onto the shuttle. As sharp 306 reaches its assembled position, sharp finger 410 is released into the shuttle pocket 412. In this way, the sharp 306 is fully constrained and located on the shuttle 304.
Various other methods, however, can be employed to attach shuttle 304 to introducer sharp 306. For example, an adhesive or bonding agent can be used to attach shuttle 304 to introducer sharp 306.
In some embodiments, a second driver member 308 is disposed in a channel 502 formed in the tubular housing 208, as depicted in
A first driver member 310 can be disposed in a third channel 702 of tubular housing 208, as shown in
As shown in
As described, the inserter assembly can be pre-loaded with a sensor. In some embodiments, a sensor loader 902 can be employed to attach the sensor 302 to introducer sharp 306, as shown in
In another aspect, arming tool 1002 can be used to arm the inserter assembly. In this manner, arming tool 1002 can advance the shuttle 304 into channel 602 of tubular housing 208. By applying force to arming tool 1002, shuttle 304 is advanced until it abuts the end of the rotatable trigger 206 as shown in
Rotatable trigger 206 can then be rotated in a first direction about an axis extending longitudinally from the distal end to the proximal end of the inserter, e.g., clockwise when viewed from the proximal end of inserter (as shown in
In some embodiments, inserter 202 can be affixed to mount 204 as depicted in
Additionally, seal fixture 210 allows sensor 302 to be pressed flat to mount 204 (i.e., disposed in a horizontal orientation with respect to mount 202). This allows the height of the overall system to be minimized by allowing the horizontally positioned circuit board to make contact with sensor 302 in a horizontal orientation. Additionally, spikes 1112 on mount 204 align and position sensor 302 after the inserter is removed.
In some embodiments, mount 204 comprises electrical contacts 1110 to which the sensor is in communication when positioned on mount 204. The mount 204 can further include electric leads (not shown), which may be embedded in mount 204. In some embodiments, a plurality of electrodes are disposed on the sensor body. The electrodes may include a working electrode, counter electrode and reference electrode, disposed at the distal tip 908 of the sensor 302, as illustrated in
The mount can also comprise one or more latches, e.g., first latch 1102, second latch 1108, to engage electronics unit 102, such as a transmitter or transceiver component thereof. The electronics unit 102 can be configured to snap on to mount 204 or otherwise engage onto the mount. The mount 204 further includes a power compartment 212 to receive a power source, such as a battery. As shown in shown in
In some embodiments, the power compartment can further include a door or closure 1206, such as a seal to enclose the compartment and contain the power source within the compartment, as show in
In another embodiment, battery 1204 may be attached to seal fixture 210 as shown in
As described above, the mount 204 includes a surface adapted to attach to the user. Referring now to
The assembly of one embodiment of on body electronics unit 102 is shown in
As shown in
The thermocouple 1408 includes one or more leads 1410 extending from the thermocouple 1404 at thermocouple opening 1404. In this manner, the on body electronics unit can be configured to determine on-skin temperature levels for use in the analyte estimation determination based on the signals received from the sensor. For example, a measured temperature reading can be obtained for each sampled signal from the sensor by the thermocouple 1408 disposed on the on body electronics unit. In some embodiments, a second temperature measurement can be obtained, such as an ambient temperature reading by employment of a second thermocouple 1408. In some embodiments, thermocouple 1408 is a Thermometric® MC65 thermocouple.
The lid 1502 of on body electronics unit 102, is shown in
In some embodiments, the printed circuit board body 1510 is disposed on the support 1508, which can be configured to allow the printed circuit board 1510 to rest at a height above the base of lid 1502. Printed circuit board 1510 can include leads 1410 connected to thermocouple contacts 1514, as shown in
In certain embodiments, one or more application-specific integrated circuits (ASIC) may be used to implement one or more functions or routines associated with the operations of the data processing unit (and/or receiver unit) using for example one or more state machines and buffers. The electronics unit 102 illustrated in
A bonding agent, such as an epoxy, can be placed in a bead around the outer perimeter of base 1402 as shown in
The body of the on body electronics unit, as illustrated in
In some embodiments, the projection member 1506 is tubular. In this manner, the on body electronics unit can form a rotational engagement with the mount 204 and pivot in an upwardly and downwardly direction, as illustrated in
The fully assembled mount 204 is shown in
The engaged inserter 202 and mount 204 can be attached to the skin of a user (by way of the adhesive surface 214 of mount 204) at the desired location for implantation of the sensor. The rotatable trigger 206 is rotated to insert the sensor 302 into the skin. In this manner, projection 1004 disengages from groove or notch 1006, thereby releasing driver member 310. The force exerted by driver member 310 drives shuttle 304 along channel 602 until introducer sharp 306 pierces the user's skin. An adhesive, located on sensor body 302 can exert a force once contacting the skin to assist displacement of the sensor from the shuttle 304. After which a second driver, such as a driver member 308, draws shuttle 304 in an opposite retraction direction through channel 306.
Alternatively, a latch (not shown), located on the mount 204, engages a window on the sensor 302 at the insertion depth. The latch holds the sensor 302 at the inserted position even as the sharp 304 retracts upward; the second driver, such as a driver member 308, draws shuttle 304 in an opposite retraction direction through channel 306.
In one embodiment, a stationary finger tab can be located on mount 204 or tubular housing 208. A similar tab can be placed on rotatable trigger 206 so that by squeezing the two tabs together, rotation of rotatable trigger 206 occurs. This feature can reduce stress on the bond between adhesive patch 214 and a user's skin as the resistance torque required to turn rotatable trigger 206 would not be supported solely by adhesive patch 206, but also by a user's actuation hand.
After deployment of sensor 302, inserter 202 can be then be removed from mount 204 by rotating the trigger. Seal fixture 210 can pivot downward to cover sensor 302 and maintain sensor contacts 912 of sensor 302 come into electrical contact with sensor contact 1110 of mount 204.
After inserter 202 is removed from mount 204, on body electronics unit 102 can be attached as shown in
By locating battery 1204 on mount 204, the size of mount 204 can also be greatly reduced because there is no need for a user accessible battery door and a battery seal inside the on body electronics unit. Additionally, the challenge to the user of handling a small battery is removed and the power requirement is reduced to one insertion/mount wear cycle per battery. Thus, battery replacement is made transparent to the user and the burden is removed from the user to remember to replace the battery of the on body electronics unit. Likewise, in a rechargeable on body electronics unit use scenario, the burden is removed from the user of having to keep different on body electronics units regularly charged.
In some embodiments, “sleep mode” of on body electronics unit 102 is automated, as power is only supplied to on body electronics unit 102 when it is inserted into mount 204. Additionally, the limited life of battery 1204 prevents extended use of sensor 302 past recommended wear.
On body electronics unit 102 can be rotated toward mount 204 until latch 1108 engages recess 1708 (as shown in
In another aspect, after the wear cycle of sensor 302 and mount 204 are completed, on body electronics unit 102 can be used on another sensor/mount assembly because it can receive power from a fresh power source located in mount 204. This allows all disposable components to be located on mount 204. This design is advantageous because the disposable materials (such as soft durometer materials), which are ideal to create seals with minimal force requirements, are materials which are more likely to wear out with repeated use. Because the disposable materials are located on mount 204, a user can be assured that all seals are in ideal condition before each use. Additionally, the wear and tear between harder plastic or metallic mating surface on body electronics unit 102 and mount 204 will be taken care of an disposed of on each mount.
In some embodiments, sensor 302 draws its power from a power source, such as a battery, located in power compartment 212 of mount 204 (as shown in
In some embodiments, sensor 302 comprises a substrate, one or more electrodes, a sensing layer and a barrier layer, as described below and disclosed in U.S. Pat. Nos. 6,284,478 and 6,990,366, the disclosures of which are incorporated herein by reference.
In some embodiments, the substrate is formed from a relatively flexible material. Suitable materials for a flexible substrate include, for example, non-conducting plastic or polymeric materials and other non-conducting, flexible, deformable materials. Suitable plastic or polymeric materials include thermoplastics such as polycarbonates, polyesters (e.g., Mylar® and polyethylene terephthalate (PET)), polyvinyl chloride (PVC), polyurethanes, polyethers, polyamides, polyimides, or copolymers of these thermoplastics, such as PETG (glycol-modified polyethylene terephthalate). In other embodiments, the sensor includes a relatively rigid substrate. Suitable examples of rigid materials that may be used to form the substrate include poorly conducting ceramics, such as aluminum oxide and silicon dioxide. Further, the substrate can be formed from an insulating material. Suitable insulating materials include polyurethane, Teflon (fluorinated polymers), polyethyleneterephthalate (PET, Dacron) or polyimide.
Sensor 302 can include a distal end and a proximal end having different widths. In such embodiments, the distal end of the substrate may have a relatively narrow width (as best depicted in
A plurality of electrodes are disposed at the distal tip 908 of sensor 302. The electrodes can include working electrode, counter electrode and reference electrode. Other embodiments, however, can include less or more electrodes. For example, a two electrode sensor can be utilized. In some embodiments, the sensor is a self-powered analyte sensor, which is capable of spontaneously passing a currently directly proportional to analyte concentration in the absence of an external power source. Any exemplary sensor is described in U.S. application Ser. No. 12/393,921, filed Feb. 26, 2009, and entitled “Self-Powered Analyte Sensor,” which is hereby incorporated by reference in its entirety herein.
Each of the electrodes are formed from conductive material, for example, a non-corroding metal or carbon wire. Suitable conductive materials include, for example, vitreous carbon, graphite, silver, silver-chloride, platinum, palladium, or gold. The conductive material can be applied to the substrate by various techniques including laser ablation, printing, etching, and photolithography. In one embodiment, each of the electrodes are formed from gold by a laser ablation technique. As further illustrated, the sensor 302 includes conductive traces 910 extending from electrodes to corresponding, respective contacts 912 to define the sensor electronic circuitry. In one embodiment, an insulating substrate (e.g., dielectric material) and electrodes are arranged in a stacked orientation (i.e., insulating substrate disposed between electrodes). Alternatively, the electrodes can be arranged in a side by side orientation, as described in U.S. Pat. No. 6,175,752, the disclosure of which is incorporated herein by reference for all purposes.
Sensor 302 has a sensing layer including one or more components designed to facilitate the electrolysis of the analyte of interest. The components, for example, may be immobilized on the working electrode. Alternatively, the components of the sensing layer may be immobilized within or between one or more membranes or films disposed over the working electrode or the components may be immobilized in a polymeric or sol-gel matrix. Examples of immobilized sensing layers are described in U.S. Pat. Nos. 5,262,035, 5,264,104, 5,264,105, 5,320,725, 5,593,852, and 5,665,222, each of which is incorporated herein by reference for all purposes.
Various other modifications and alterations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims Additional detailed description of embodiments of the disclosed subject matter are provided in but not limited to: U.S. Pat. No. 7,299,082; U.S. Pat. No. 7,167,818; U.S. Pat. No. 7,041,468; U.S. Pat. No. 6,942,518; U.S. Pat. No. 6,893,545; U.S. Pat. No. 6,881,551; U.S. Pat. No. 6,773,671; U.S. Pat. No. 6,764,581; U.S. Pat. No. 6,749,740; U.S. Pat. No. 6,746,582; U.S. Pat. No. 6,736,957; U.S. Pat. No. 6,730,200; U.S. Pat. No. 6,676,816; U.S. Pat. No. 6,618,934; U.S. Pat. No. 6,616,819; U.S. Pat. No. 6,600,997; U.S. Pat. No. 6,592,745; U.S. Pat. No. 6,591,125; U.S. Pat. No. 6,560,471; U.S. Pat. No. 6,540,891; U.S. Pat. No. 6,514,718; U.S. Pat. No. 6,514,460; U.S. Pat. No. 6,503,381; U.S. Pat. No. 6,461,496; U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,338,790; U.S. Pat. No. 6,299,757; U.S. Pat. No. 6,284,478; U.S. Pat. No. 6,270,455; U.S. Pat. No. 6,175,752; U.S. Pat. No. 6,161,095; U.S. Pat. No. 6,144,837; U.S. Pat. No. 6,143,164; U.S. Pat. No. 6,121,009; U.S. Pat. No. 6,120,676; U.S. Pat. No. 6,071,391; U.S. Pat. No. 5,918,603; U.S. Pat. No. 5,899,855; U.S. Pat. No. 5,822,715; U.S. Pat. No. 5,820,551; U.S. Pat. No. 5,628,890; U.S. Pat. No. 5,601,435; U.S. Pat. No. 5,593,852; U.S. Pat. No. 5,509,410; U.S. Pat. No. 5,320,715; U.S. Pat. No. 5,264,014; U.S. Pat. No. 5,262,305; U.S. Pat. No. 5,262,035; U.S. Pat. No. 4,711,245; U.S. Pat. No. 4,545,382; U.S. Pat. No. 5,356,786; U.S. Pat. No. 5,543,326; U.S. Pat. No. 6,103,033; U.S. Pat. No. 6,134,461; U.S. Pat. No. 6,143,164; U.S. Pat. No. 6,144,837; U.S. Pat. No. 6,161,095; U.S. Pat. No. 6,579,690; U.S. Pat. No. 6,605,200; U.S. Pat. No. 6,605,201; U.S. Pat. No. 6,618,934; U.S. Pat. No. 6,654,625; U.S. Pat. No. 6,676,816; U.S. Pat. No. 6,730,200; U.S. Pat. No. 6,736,957; U.S. Pat. No. 6,932,892; U.S. Publication No. 2004/0186365; U.S. Publication No. 2005/0182306; U.S. Publication No. 2006/0025662; U.S. Publication No. 2006/0091006; U.S. Publication No. 2007/0056858; U.S. Publication No. 2007/0068807; U.S. Publication No. 2007/0095661; U.S. Publication No. 2007/0108048; U.S. Publication No. 2007/0199818; U.S. Publication No. 2007/0227911; U.S. Publication No. 2007/0233013; U.S. Publication No. 2008/0066305; U.S. Publication No. 2008/0081977; U.S. Publication No. 2008/0102441; U.S. Publication No. 2008/0148873; U.S. Publication No. 2008/0161666; U.S. Publication No. 2008/0267823; U.S. Publication No. 2009/0054748; U.S. patent application Ser. No. 10/745,878, filed Dec. 26, 2003 and entitled “Continuous Glucose Monitoring System and Methods of Use”, U.S. patent application Ser. No. 12/143,731, filed Jun. 20, 2008 and entitled “Health Management Devices And Methods”; U.S. patent application Ser. No. 12/143,734, filed Jun. 20, 2008 and entitled “Health Monitor”; U.S. Provisional Patent Application No. 61/149,639, filed Feb. 3, 2009 and entitled “Compact On-Body Physiological Monitoring Devices And Methods Thereof”; U.S. Provisional Application No. 61/291,326 filed Dec. 30, 2009, and U.S. Provisional Application No. 61/299,924 filed Jan. 29, 2010; U.S. patent application Ser. No. 11/461,725; U.S. patent application Ser. No. 12/131,012; U.S. patent application Ser. No. 12/242,823; U.S. patent application Ser. No. 12/363,712; U.S. patent application Ser. No. 12/698,124; U.S. patent application Ser. No. 12/698,129; U.S. patent application Ser. No. 12/714,439; U.S. patent application Ser. No. 12/794,721; U.S. patent application Ser. No. 12/842,013; U.S. patent application Ser. No. 61/238,646; U.S. patent application Ser. No. 61/345,562; U.S. patent application Ser. No. 61/361,374; and elsewhere, the disclosures of each are incorporated by reference in their entirety herein for all purposes.
The foregoing only illustrates the principles of the disclosed subject matter. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will be appreciated that those skilled in the art will be able to devise numerous modifications which, although not explicitly described herein, embody the principles of the disclosed subject matter and are thus within the spirit and scope of the disclosed subject matter.
The present application claims the benefit of U.S. Provisional Application No. 61/249,535, filed Oct. 7, 2009, the disclosure of which is incorporated herein by reference for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 61249535 | Oct 2009 | US |
