JP2013524872A - Medical device inserter and method for inserting and using medical device - Google Patents

Abstract

An apparatus for inserting a medical device into a subject's skin and a method for inserting the medical device are provided.

Description

Related applications

  This application is based on US Provisional Application No. 61 / 317,243 filed on Mar. 24, 2010, U.S. Provisional Application No. 61 / 345,562, filed on May 17, 2010, and No. 6/2010. Claims the benefit of US Provisional Application No. 61 / 361,374, filed on Feb. 2, and US Provisional Application No. 61 / 411,262, filed on Nov. 8, 2010, each disclosure Are incorporated herein by reference for all purposes.

Citation of literature

  The patents, patent applications and / or patent application publications described herein, including the following patents, patent applications and / or patent application publications, are incorporated herein by reference for all purposes. U.S. Pat.Nos. 4,545,382, 4,711,245, 5,262,035, 5,262,305, 5,264,104, 5, 320,715, 5,356,786, 5,509,410, 5,543,326, 5,593,852, 5,601,435, 5,628,890, 5,820,551, 5,822,715, 5,899,855, 5,918,603, 6,071 391, 6,103,033, 6,120,676, 6,121,009, 6,134,461, 6,143,164, No. 6,144,837, No. 6,161,095, No. 6,175,752, No. 6,2 No. 0,455, No. 6,284,478, No. 6,299,757, No. 6,338,790, No. 6,377,894, No. 6,461,496, 6,503,381, 6,514,460, 6,514,718, 6,540,891, 6,560,471, 6,579 , 690, 6,591,125, 6,592,745, 6,600,997, 6,605,200, 6,605,201, 6,616,819, 6,618,934, 6,650,471, 6,654,625, 6,676,816, 6,730, No. 200, No. 6,736,957, No. 6,746,582, No. 6,749,740, No. 6,764,581, 6,773,671, 6,881,551, 6,893,545, 6,932,892, 6,932,894 No. 6,942,518, No. 7,041,468, No. 7,167,818, No. 7,299,082, No. 7,381,184, No. 7,740 , 581 and 7,811,231, US Patent Application Publication Nos. 2005/0182306, 2006/0091006, 2007/0056858, 2007/0068807, 2007/0095661, 2007/0108048, 2007/0149873, 2007/0149875, 2007/0199818, 2007/022 No. 7911, No. 2007/0233013, No. 2008/0058625, No. 2008/0064937, No. 2008/0066305, No. 2008/0071157, No. 2008/0071158, No. 2008/0081977 No., 2008/0102441, No. 2008/0148873, No. 2008/0161666, No. 2008/0179187, No. 2008/0267823, No. 2008/0319295, No. 2008/0319296 No. 2009/0018425, No. 2009/0247857, No. 2009/0257911, No. 2009/0281406, No. 2009/0294277, No. 2009/0054748, No. 2009/005 No. 749, No. 2010/0030052, No. 2010/0065441, No. 2010/0081905, No. 2010/0081909, No. 2010/0213057, No. 2010/0325868, No. 2010/0326842 Nos. 2010/0326843, 2010/0331643 and 2011/0046466, US patent applications 12 / 624,767, 12 / 625,185, 12 / 625,208, 12 / 625,524, 12 / 625,525, 12 / 625,528, 12 / 628,177, 12 / 628,198 12 / 628,201, 12 / 628,203, 12 / 628,210, 12 / 698,124, 12 / 698,129, 12 / 699,653, 12 / 699,844, 12 / 714,439, 12 / 730,193 No. 12, No. 12 / 794,721, No. 12 / 807,278, No. 12 / 842,013, No. 12 / 870,818, No. 12 / 871,901, No. 12 / 873,301, 12 / 873,302 and 13 / 011,897, as well as US provisional applications 61 / 238,646 and 61 / 246,825, 61 / 247,516, 61 / 249,535, 61 / 317,243, 61 / 325,155, 61 / 345,562 and 61/359. , 265 specification.

  The present invention relates to a device for inserting a medical device through the skin of a subject.

  Detecting and / or monitoring a particular individual's glucose level and other analytes such as lactic acid, oxygen, A1C, etc. is crucial to their health. For example, glucose monitoring is particularly important for diabetic individuals. Diabetic patients typically monitor glucose levels to determine if their glucose levels are maintained within a clinically safe range, and this information can also be used to It may be determined whether insulin is required (and / or when) to reduce glucose levels, or whether additional glucose is required to increase glucose levels in their body. Increasing clinical data indicate that there is a strong correlation between glucose monitoring frequency and glycemic control. Despite such correlations, many individuals diagnosed with a diabetic condition can monitor glucose levels by a combination of factors including convenience, discretion in testing, pain and costs associated with glucose testing. I don't go there often.

  Devices have been developed for automatically monitoring analytes such as glucose in body fluids such as blood flow and interstitial fluid (ISF) and other biological fluids. Such an analyte measurement device is configured such that at least a portion of the device is placed below the surface of the user's skin (eg, within the user's blood vessels or subcutaneous tissue) to achieve in vivo monitoring. There is.

  Sample monitoring that provides cost-effective, simple, pain-free and careful monitoring to encourage frequent sample monitoring and improve blood glucose management, along with continued development of sample monitoring devices and systems There is a need for devices, systems and methods, and methods for manufacturing analyte monitoring devices and systems.

  An apparatus is provided for inserting a medical device through a subject's skin. The device includes a housing defining a longitudinal cavity therein, an interference member extending into the cavity, a biasing member, and movement from a proximal position to a distal position connected to the biasing member. And a misaligned configuration in which the interference member prevents distal movement of the drive member and an aligned configuration in which the interference member does not prevent distal movement of the drive member And a drive member further configured for movement between and an actuator having an alignment surface for moving the drive member from the misaligned configuration to the aligned configuration.

  In some embodiments, the actuator is movable from a proximal position to a distal position. In some embodiments, distal movement of the actuator compresses the first biasing member. In some embodiments, the first position of the drive member is at an oblique angle with respect to the longitudinal cavity. In some embodiments, the second position of the drive member includes a configuration that is generally aligned with the longitudinal cavity.

  An apparatus is provided for inserting a medical device through a subject's skin. The device includes a housing defining a cantilever member, a sharp member movable from a retracted position within the housing to a partially exposed position, and for moving with the sharp member and subsequent to the subject's skin. An electrochemical sensor releasably connected to the sharp member for insertion, wherein the cantilever member is in elastic contact with at least one of the sharp member and the sensor.

  In some embodiments, the housing includes a distal opening for releasing the electrochemical sensor from the housing. In some embodiments, the housing defines a longitudinal notch for receiving the drive member of the inserter. In some embodiments, the housing contains a desiccant. In some embodiments, the housing defines one or more longitudinal ridges for aligning one of the sharp member and the sensor.

  These and other features, objects and advantages of the presently disclosed subject matter will be apparent to those of ordinary skill in the art upon reading the detailed description, which is more fully described below.

FIG. 4 illustrates an analyte monitoring system for performing real-time analyte (eg, glucose) measurement, data acquisition and / or processing in certain embodiments. FIG. 4 illustrates an electrochemical sensor according to a further embodiment of the presently disclosed subject matter. FIG. 4 illustrates an electrochemical sensor according to a further embodiment of the presently disclosed subject matter. Schematic of a needle hub according to an embodiment of the presently disclosed subject matter. Schematic of a needle hub according to an embodiment of the presently disclosed subject matter. FIG. 5 illustrates a distal end of a sharp member according to an embodiment of the presently disclosed subject matter. A side view of a sharp member according to an embodiment of the presently disclosed subject matter. A side view of a sharp member according to an embodiment of the presently disclosed subject matter. 1 is a perspective view of an inserter according to one embodiment of the presently disclosed subject matter. FIG. Schematic of an alternative embodiment for forming a sharp member for use with an inserter according to an embodiment of the presently disclosed subject matter. 1 is a perspective view of an inserter according to one embodiment of the presently disclosed subject matter. FIG. FIG. 7 is a perspective view with parts separated of an inserter according to an embodiment of the presently disclosed subject matter. An enlarged cross-sectional view of an inserter according to an embodiment of the presently disclosed subject matter. Side view of another inserter according to the presently disclosed subject matter FIG. 14 is a cross-sectional perspective view of the inserter of FIG. 14 according to another embodiment of the presently disclosed subject matter. FIG. 14 is a cross-sectional perspective view of the inserter of FIG. 14 according to another embodiment of the presently disclosed subject matter. FIG. 14 is a cross-sectional perspective view of the inserter of FIG. 14 according to another embodiment of the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. FIG. 18 is a perspective side view of the inserter of FIG. 18 according to another embodiment of the presently disclosed subject matter. FIG. 18 is a perspective side view of the inserter of FIG. 18 according to another embodiment of the presently disclosed subject matter. FIG. 18 is a perspective side view of the inserter of FIG. 18 according to another embodiment of the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. FIG. 22 is a cross-sectional perspective view of the inserter of FIG. 22 according to another embodiment of the presently disclosed subject matter. FIG. 22 is a cross-sectional perspective view of the inserter of FIG. 22 according to another embodiment of the presently disclosed subject matter. FIG. 22 is a cross-sectional perspective view of the inserter of FIG. 22 according to another embodiment of the presently disclosed subject matter. Sectional view of another embodiment of an inserter according to the presently disclosed subject matter 26 is a perspective view of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. 26 is a perspective view of the components of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. 26 is a perspective view of the components of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. 26 is a perspective view of the components of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. 26 is a perspective view of the components of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. 26 is an exploded view of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. 26 is a side view of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. A perspective side view of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. A perspective side view of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. A perspective side view of the inserter of FIG. 26 in accordance with the presently disclosed subject matter. FIG. 6 illustrates an inserter according to another embodiment in accordance with the presently disclosed subject matter. 37 is a cross-sectional perspective view of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. 37 is a cross-sectional view of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. Side view of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. FIG. 37 is a perspective view of components of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. FIG. 37 is a perspective view of components of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. FIG. 37 is a perspective view of components of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. FIG. 37 is a perspective view of components of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. 37 is an exploded view of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. A perspective side view of the inserter of FIG. 37 in accordance with the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. An exploded perspective view of another embodiment of the presently disclosed subject matter Sectional view of an inserter according to the presently disclosed subject matter The perspective view seen from the lower part of the inserter of FIG. The perspective view seen from the lower part of the inserter of FIG. FIG. 7 is a perspective view of another inserter according to the presently disclosed subject matter. 56 is a perspective view of various components of the inserter of FIG. 56 is a perspective view of various components of the inserter of FIG. 56 is a perspective view of various components of the inserter of FIG. 56 is a perspective view of various components of the inserter of FIG. 56 is a perspective view of various components of the inserter of FIG. 56 is a perspective view of various components of the inserter of FIG. 56 shows different subassemblies of the components of the inserter of FIG. 56 shows different subassemblies of the components of the inserter of FIG. 56 shows different subassemblies of the components of the inserter of FIG. 56 is a cross-sectional view of the component subassembly of the inserter of FIG. 56 is a cross-sectional view of the component subassembly of the inserter of FIG. FIG. 56 shows the process used to operate the inserter of FIG. FIG. 56 shows the process used to operate the inserter of FIG. FIG. 56 shows the process used to operate the inserter of FIG. Perspective view of an inserter assembly according to the presently disclosed subject matter. 71 is a perspective view of components of the inserter assembly of FIG. 71 in accordance with the presently disclosed subject matter. Perspective view of components of an analyte measurement system according to the presently disclosed subject matter 71 is a perspective view with parts separated of the inserter assembly of FIG. 71 according to the presently disclosed subject matter. 71 is a cross-sectional view of the inserter assembly of FIG. 71 in accordance with the presently disclosed subject matter. Side view of a portion of an inserter assembly according to the presently disclosed subject matter Diagram of an analyte sensor according to the presently disclosed subject matter A perspective view of a portion of an inserter assembly according to the presently disclosed subject matter. A perspective view of a portion of an inserter assembly according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. FIG. 4 illustrates an analyte sensor according to the presently disclosed subject matter. Sectional view of an inserter assembly according to the presently disclosed subject matter Sectional view of an inserter assembly according to the presently disclosed subject matter Sectional view of another inserter assembly according to the presently disclosed subject matter Sectional view of another inserter assembly according to the presently disclosed subject matter Sectional view of a further inserter assembly according to the presently disclosed subject matter Sectional view of a further inserter assembly according to the presently disclosed subject matter FIG. 5 illustrates a portion of an inserter assembly according to the presently disclosed subject matter. FIG. 5 illustrates a portion of an inserter assembly according to the presently disclosed subject matter. Sectional view of a portion of an inserter assembly according to the presently disclosed subject matter A perspective view of a portion of an inserter assembly according to the presently disclosed subject matter. A perspective view of a portion of an inserter assembly according to the presently disclosed subject matter. Side views of various inserter assemblies according to the presently disclosed subject matter Side views of various inserter assemblies according to the presently disclosed subject matter Side views of various inserter assemblies according to the presently disclosed subject matter Side views of various inserter assemblies according to the presently disclosed subject matter FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. FIG. 4 illustrates a sharp member and a sharp member carrier in accordance with the presently disclosed subject matter. A perspective view of a portion of an inserter assembly according to the presently disclosed subject matter. A perspective view illustrating the operation of an inserter assembly according to the presently disclosed subject matter. A perspective view illustrating the operation of an inserter assembly according to the presently disclosed subject matter. A perspective view illustrating the operation of an inserter assembly according to the presently disclosed subject matter. A perspective view illustrating the operation of an inserter assembly according to the presently disclosed subject matter. Side view of an inserter assembly according to the presently disclosed subject matter Sectional view of an inserter assembly according to the presently disclosed subject matter Sectional view of an inserter assembly according to the presently disclosed subject matter Sectional view of an inserter assembly according to the presently disclosed subject matter FIG. 7 is a perspective view with parts separated of an embodiment of a sharp member / sensor cartridge according to the presently disclosed subject matter. A perspective view of a first stage of the arrangement of the cartridge of FIG. 122 in accordance with the presently disclosed subject matter. 122 is a neutral cross-sectional view of the cartridge of FIG. 122 in accordance with the presently disclosed subject matter. 122 is a neutral perspective view of the cartridge of FIG. 122 in accordance with the presently disclosed subject matter. 122 is a cross-sectional view of a first stage of the arrangement of the cartridge of FIG. 122 in accordance with the presently disclosed subject matter. A perspective view of the second stage of the arrangement of the cartridge of FIG. 122 in accordance with the presently disclosed subject matter. 122 is a second stage cross-sectional view of the arrangement of the cartridge of FIG. 122 according to the presently disclosed subject matter. FIG. 122 is a third stage perspective view of the cartridge arrangement of FIG. 122 in accordance with the presently disclosed subject matter. 122 is a cross-sectional view of a third stage of the arrangement of the cartridge of FIG. 122 according to the presently disclosed subject matter. FIG. 7 is a perspective view with parts separated of another embodiment of an inserter component according to the presently disclosed subject matter. FIG. 131 is a neutral perspective view of the cartridge of FIG. 131 in accordance with the presently disclosed subject matter. 131 is a neutral cross-sectional view of the cartridge of FIG. 131 in accordance with the presently disclosed subject matter. A perspective view of a second stage of the arrangement of the cartridge of FIG. 131 in accordance with the presently disclosed subject matter. Sectional view of a second stage of the arrangement of the cartridge of FIG. 131 according to the presently disclosed subject matter. A perspective view of a third stage of the arrangement of the cartridge of FIG. 131 in accordance with the presently disclosed subject matter. FIG. 131 is a cross-sectional view of a third stage of the arrangement of the cartridge of FIG.

  The details of various aspects, features, and embodiments of the subject matter described in this specification are set forth with reference to the accompanying drawings. These drawings are for illustrative purposes and are not necessarily drawn to scale, and some components and features are highlighted for clarity. These drawings illustrate various aspects and features of the present subject matter and may illustrate, in whole or in part, one or more embodiments or examples of the present subject matter.

  The present disclosure is described in detail herein. With respect to the following description, it is to be understood that the present subject matter is not limited to the specific embodiments described, and the specific embodiments of the present subject matter can, of course, vary. Also, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the subject matter of the present disclosure, and the scope of the subject matter of the present disclosure is It should be understood that the invention is limited only by the following claims.

  Where multiple values in a range are given, each value intervening between the upper and lower limits of the range, and any other value described or intervening within the stated range Is intended to be encompassed by the subject matter of this disclosure. Also, all stated ranges are intended to disclose each or every “partial range” of the stated range. That is, each or all ranges smaller than the outer range specified by the outer upper limit and outer lower limit given to a range (unless otherwise specified) that upper and lower limits are from the outer lower limit to the outer lower limit. It is to be understood that any range or limit specifically included in the subject matter of the present disclosure is also included in the subject matter of this disclosure and is specifically excluded from the stated range. When a range is described by specifying one or both of an upper limit and a lower limit, is the expression “from”, “to”, “to”, “including”, etc. used in the description of the range? Ranges that exclude or include one or both of the stated limits, whether or not, are also encompassed by the subject matter of this 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 the subject matter of the present disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the presently disclosed subject matter, the present disclosure is not limited to particular exemplary methods and materials. Can be specifically mentioned.

  Unless stated otherwise, reference is made to all publications mentioned in this disclosure for any purpose, including but not limited to disclosing and describing the methods and / or materials cited in the publications. Incorporated herein.

  The publications discussed herein are set forth solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the subject matter of the present disclosure is not entitled to antedate such publication by virtue of prior invention. Furthermore, the publication date described herein may differ from the actual publication date and may need to be individually confirmed.

  In the present specification and the appended claims, the singular forms “a”, “an”, and “the” include plural meanings unless otherwise specified.

  Nothing in the abstract or summary of the invention should be construed as limiting the scope of the disclosure. The abstract and summary of the invention are described for bibliographic and expedient purposes and should not be considered comprehensive due to their form and purpose.

  As would be apparent to one of ordinary skill in the art upon reading this disclosure, the individual components and features of each individual embodiment described and shown herein depart from the scope and spirit of the subject matter of this disclosure. Rather, it can be easily separated or combined with the features of any of the other embodiments. Any of the methods described can be performed in the order of events described or in any other logically possible order.

  When a single item is referred to, the possibility that a plurality of the same items exist is included. Where two or more items (eg, multiple elements or multiple processes) are referenced with “or” indicating an option, either may exist separately, or one presence necessarily requires the other. Indicates that they can be present together in any combination, unless otherwise excluded.

  Embodiments of the present disclosure generally relate to a device for inserting a medical device at least partially into a patient's skin. Some embodiments relate to an in vivo method and apparatus for detecting at least one analyte (such as glucose) in a bodily fluid. Thus, embodiments provide that at least a portion of the sensor is disposed within the user's body (eg, within the ISF) (eg, within the user's body) to obtain information regarding at least one specimen of the body. An in vivo analyte sensor configured to be disposed (cutaneously). In certain embodiments, the in-vivo analyte sensor is connected to an electronic device unit maintained on the user's body to process information obtained from the sensor.

  In certain embodiments, analyte information is communicated from a first device, such as a body-worn electronic device unit, to a second device that may include user interface features including a display or the like. The information may be communicated automatically and / or continuously from the first device to the second device when specimen information is available, or not automatically and / or continuously communicated. Alternatively, it may be stored or recorded in the memory of the first device. Thus, in many embodiments of the system, analyte information obtained by a sensor / body-worn electronic device (eg, a body-worn electronic device assembly) is available or viewed by the user only when queried by the user. The timing of data communication is selected by the user. In some embodiments, the display of information is selected by the user, while the timing of data communication is not selected by the user.

  In this way, an in vivo analyte sensor automatically and / or continuously monitors in vivo analyte levels (ie, the sensor automatically monitors an analyte such as glucose at predetermined time intervals over its lifetime. In some embodiments, the analyte information is provided or revealed to the user (provided at the user interface device) only when desired by the user. For example, the analyte sensor can be placed in-vivo and connected to a body-worn electronic device for a given detection period (eg, about 14 days). In certain embodiments, the analyte information obtained by the sensor is passed through for 14 days according to a schedule programmed in the body-worn electronic device (eg, about every 1 minute, about every 5 minutes, or about every 10 minutes, etc.). Automatically communicated from the sensor electronics assembly to the remote monitor or display device and output to the user. In certain embodiments, the analyte information obtained by the sensor is only monitored at a time determined by the user (e.g., whenever the user decides to verify the analyte information) or a remote monitoring device or display from the sensor electronics assembly. Communicated to the device. At such timing, the communication system is activated, and information obtained by the sensor is sent from the body-worn electronic device to a remote device or display device.

  In yet other embodiments, the information may be communicated automatically and / or continuously from the first device to the second device when the analyte information is available, Store or record the received information without presenting or outputting it to the user. In such an embodiment, information from the first device is received by the second device when the information becomes available (eg, when the sensor detects the analyte level according to the time schedule). However, the received information is first stored in the second device and only on the second device's user interface or output element (eg, display) when a request for information on the second device is detected. Is output.

  Thus, in certain embodiments, the sensor electronics assembly is placed on the body such that at least a portion of the in vivo sensor is in contact with a bodily fluid such as ISF using the inserter described herein. When the sensor is electrically connected to the electronic device unit, the display device is turned on (or the display device may be continuously supplied with power) and stored in the memory of the display device. Execute the accessed software algorithm, generate one or more request commands, control signals or data packets and send them to the body-worn electronic device so that the analyte information obtained by the sensor is on-demand for body-worn The electronic device can communicate with the display device. For example, a software algorithm executed under the control of the display device's microprocessor or application specific integrated circuit (ASIC) may cause the display device to initiate transmission of generated request commands, control signals and / or data packets. A routine for detecting the position of the body-worn electronic device may be included.

  The display device is sent to the body-worn electronic device in response to the operation of the input mechanism on the display device by the user (pressing a button on the display device, triggering a soft button associated with the data communication function, etc.) It may also include programming stored in memory, executed by one or more microprocessors and / or ASICs, to generate and send a request command, control signal or data packet. Alternatively or in addition, an input mechanism may be provided that may be configured to be actuated by a user on or in the body-worn electronic device. In certain embodiments, a voice command or audible signal is used to execute a software routine stored in memory on a microprocessor or ASIC to generate one or more request commands, control signals or data packets to wear on the body. The device may be prompted or directed to transmit. In embodiments activated by voice or responsive to voice commands or audible signals, the body-worn electronic device and / or display device includes a microphone, a speaker, and a body for processing voice commands and / or audible signals. Processing routines stored in respective memories of the mounting electronic device and / or the display device. In certain embodiments, the body-worn electronic device and the display device are placed within a predetermined distance (eg, in close proximity) relative to each other to generate and transmit a request command, control signal, or data packet. One or more software routines stored in the memory of the display device are started.

  Different types, forms and / or quantities of information may be sent for each on-demand reading. This information includes current sample level information (ie, real-time or most recently obtained sample level information temporally corresponding to the start time of the reading), sample change rate over a given period, sample rate change rate (Acceleration of rate of change), including but not limited to one or more of historical specimen information corresponding to the specimen information obtained prior to a given reading and stored in the memory of the assembly. For a given reading, some or all of the real-time information, historical information, rate of change information, rate of change rate (acceleration, deceleration, etc.) information may be sent to the display. In certain embodiments, the type, form and / or amount of information sent to the display device may be pre-programmed and / or immutable (eg, preset at the time of manufacture) or pre- It may be unprogrammed and / or non-changeable and selectable and / or changeable one or more times in the field (eg, by actuating a system switch or the like). Thus, in certain embodiments, for each on-demand reading, the display device may display the current (real-time) analyte value (eg, numeric format) obtained by the sensor, the current rate of change of the analyte (eg, or Specimen change rate indicator such as an arrow indicating the current rate of change indicating the current direction), and a sensor trend based on sensor measurement values obtained by the body-worn electronic device and stored in the memory of the body-worn electronic device History data (for example, the form of graph lines) is output. Further, skin temperature or sensor temperature readings or measurements associated with each on-demand reading may be communicated from the body-worn electronic device to the display device. However, the temperature reading or measurement may not be output or displayed on the display device, but may be used with a software routine executed by the display device to correct or compensate for the analyte measurement output on the display device to the user. Good.

  As described above, embodiments include an inserter for an in vivo analyte sensor and a body-worn electronic device, both of which provide a body-worn sensor electronic assembly. In certain embodiments, the in vivo analyte sensors are fully integrated with the body-worn electronic device (fixed and connected during manufacture), while in other embodiments they are separate and manufactured It can be connected later (eg, before, during, or after insertion of the sensor into the body). The body-worn electronic device may include an in vivo glucose sensor, an electronic device, a battery, and an antenna, which are housed in a waterproof housing (except for the sensor portion that is placed in the living body). This housing has or can be attached to an adhesive pad. In certain embodiments, the enclosure resists flooding for up to at least 30 minutes in about 1 meter of water. In certain embodiments, the housing, for example, withstands continuous contact with water for a period of time greater than about 30 minutes and is appropriate for the intended use (eg, the housing is suitable for flooding). In some cases, the electronics of the housing will continue to function (without being damaged by water).

  Embodiments include a sensor insertion device (also referred to herein as a sensor delivery unit or the like). The insertion device can hold the body-worn electronic device assembly completely within the interior compartment. That is, the insertion device can be preloaded with a body-worn electronic device assembly during the manufacturing process (eg, the body-worn electronic device can be packed into a sterilized internal compartment of the insertion device). In such embodiments, the insertion device may constitute a sensor assembly package (including a sterilization package) of the pre-use, ie new body-worn electronic device assembly, including the body-worn electronic device assembly. Configured to apply to the recipient's body.

  Embodiments include a portable display device that can be held and operated by hand as a separate device spaced from the body-worn electronic device assembly, wherein the display device collects information from the assembly and is obtained by a sensor. Provide the sample measurement value to the user. Such a device may also be referred to as a meter, reader, monitor, receiver, human interface device, companion, etc. Certain embodiments may include an integrated in vitro analyte meter. In certain embodiments, the display device is configured to establish communication between the display device and another device (eg, a body-worn electronic device, a power supply for charging a battery, a PC, etc.). Includes wired or wireless communication ports (USB port, serial port, parallel port, etc.). For example, the communication port of the display device may allow the battery of the display device to be charged using a separate charging cable and / or allows data exchange between the display device and the corresponding informatics software. Also good.

  Suitable informatics software in certain embodiments resides in, for example, display devices, personal computers, server terminals, for example, for data analysis, chart entry, data storage, data storage and data communication, and data synchronization. Including, but not limited to, data management software programs that can be used or run on a stand-alone or network connection. The informatics software in certain embodiments upgrades the resident software of the display device and / or the body-worn electronic device unit with, for example, a firmware version that includes additional features and / or correction of software bugs and errors, etc. To that end, it may also include software that performs field upgradable functions for upgrading the firmware of the display device and / or the body-worn electronic device unit. Embodiments include tactile feedback features (vibration motors, etc.) configured such that corresponding notifications (eg, receipt of good on-demand measurements at a display device) are delivered in the form of tactile feedback. Can be included.

  Embodiments include programming embedded in a computer readable medium, ie, computer-based application software (herein, for processing sample information obtained from the system and / or data reported by the user himself / herself. , Also called informatics software or programming). The application software can be installed on a host computer such as a mobile phone, a PC, a human interface device that can be connected to the Internet (a phone that can be connected to the Internet, a personal digital assistant, etc.) by a display device or a body-worn electronic device unit. Informatics programming can transform the data acquired and stored in a display device or body-worn unit for use by a user.

  While embodiments of the subject disclosure are described primarily with respect to glucose monitoring devices and systems, and glucose monitoring methods for convenience, such descriptions are in no way intended to limit the scope of the present disclosure. Not what you want. It should be understood that the analyte monitoring system can be configured to monitor various analytes simultaneously or at different times.

  As described in detail below, embodiments may include, for example, but not limited to, one or more physiological levels such as, but not limited to, analyte level, temperature level, heart rate, user activity level, etc. over a predetermined monitoring period. Includes devices, systems, kits and / or methods for monitoring parameters. A manufacturing method is also provided. The predetermined monitoring period may be less than about 1 hour, or about 1 hour or more (eg, about several hours or more, eg, about several days or more, eg, about 3 days or more, eg, about 5 days or more, eg, about 7 Days or more, for example about 10 days or more, for example about 14 days or more, for example about several weeks, for example about 1 month or more). In certain embodiments, one or more features of the system may be automatically deactivated or disabled in the body-worn electronic device assembly and / or display device after the end of a predetermined monitoring period.

  For example, during a predetermined monitoring period, the sensor is placed in the living body and brought into contact with a bodily fluid such as ISF, and / or by the start of a body-worn electronic device (or power on to enter full operation mode) Can start). Initialization of the body-worn electronic device may be in response to actuation of the switch and / or by placing the display device within a predetermined distance (eg, in close proximity) from the body-worn electronic device, or It may be implemented by a command generated and transmitted by the display device by a user manually actuating a switch on the body-worn electronic device unit (eg, pressing a button). Alternatively, such operations are described, for example, in US patent application Ser. No. 12 / 698,129 filed Feb. 1, 2010, and US provisional application Nos. 61 / 238,646, 61/61. 246,825, 61 / 247,516, 61 / 249,535, 61 / 317,243, 61 / 345,562 and 61 / 361,374. An insertion device may be created as described in each specification (the respective disclosures are incorporated herein by reference for all purposes).

  When the body-worn electronic device is initialized in response to a command received from the display device, it retrieves and executes a software routine from its memory to fully power on the body-worn electronic device components. By doing so, the body-worn electronic device is put into the full operation mode in response to receiving the operation command from the display device. For example, before receiving a command from the display device, power may be supplied to some of the components of the body-worn electronic device by the internal power supply (battery etc.) of the body-worn electronic device, Another part of the components of the electronic device may be in a power off state or may be maintained in a low power state (no power supply, including inactive mode), or all components may be An inactive mode or a power-off mode may be used. Upon receipt of the command, the remaining (or all) components of the body-worn electronic device are switched to the active full mode of operation.

  Embodiments of a body-worn electronic device include one or more printed circuit boards having an electronic device that includes control logic implemented in an ASIC, microprocessor, memory, etc., and a percutaneously displaceable analyte sensor. Thus, a single assembly can be constructed. The body-worn electronic device is within a predetermined proximity over a period of time (eg about 2 minutes, eg 1 minute or less, eg about 30 seconds or less, eg about 10 seconds or less, eg about 5 seconds or less, eg about 2 seconds or less). Confirmation (eg, audible notification, visual notification and / or tactile notification (e.g. Vibrations, etc.) may be configured to provide one or more signals or data packets associated with the monitored analyte level until output to the display device. In certain embodiments, distinct notifications may also be output for acquisition failures.

  In certain embodiments, monitored analyte levels can be correlated and / or converted to glucose levels in blood or other fluids (such as ISF). Such a conversion may be accomplished using a body-worn electronic device, but in many embodiments is accomplished using a display device electronic device. In certain embodiments, the glucose level is obtained from the analyte level in the monitored ISF.

  The analyte sensor may be insertable into veins, arteries, or other parts that contain bodily analytes. In certain embodiments, the analyte sensor can be placed in contact with the ISF to detect the level of the analyte. In this case, the detected analyte level can be used to infer the glucose level in the user's blood or interstitial tissue.

  Embodiments include a transcutaneous sensor, a fully implantable sensor, and a fully implantable assembly, where a single assembly containing an analyte sensor and an electronic device is sealed (E.g., a sealed biocompatible housing) and is implanted in the user's body for monitoring one or more physiological parameters.

  Embodiments include an analyte monitor provided in a small, lightweight system powered by a battery and electronically controlled. Such a system is configured to use an electrochemical sensor to detect a subject's physical parameters, such as signals indicative of in vivo analyte levels, and collect such signals with or without processing. obtain. Any suitable measurement technique may be used to obtain the signal from the sensor (eg, current may be detected, potentiometry or the like may be used). Techniques can include, but are not limited to, amperometry, coulometry and voltammetry. In some embodiments, the detection system can be an optical system, a colorimetric analysis system, or the like. In some embodiments, this initial processing portion of the system is configured to provide the raw data or at least the initial processed data to another device for further collection and / or processing. Can be done. Providing such data can be done, for example, by a wired connection such as an electrical connection, or a wireless connection such as an IR or RF connection.

  In certain systems, the analyte sensor communicates with a body-worn electronic device. The body wearing unit may include a housing in which the body wearing electronic device and at least a portion of the sensor are received.

  Certain embodiments are modular. The body-worn unit may be provided separately as an assembly that is physically distinguishable from, for example, a monitor unit that displays or otherwise indicates the analyte level to the user. The body-worn unit may be configured to supply the analyte level and / or other information (temperature, sensor lifetime, etc.) detected by the sensor to the monitor unit via a communication link. In some embodiments, the monitor unit may be, for example, a mobile phone device, an in vitro glucose meter, a personal digital assistant, other consumer electronic devices (eg, MP3 devices, cameras, radios, personal computers, etc.), or other communications Possible data processing devices and the like may be included.

  The monitor unit performs various functions such as, but not limited to, data storage, data processing, data analysis, and / or data communication on the received sample data, and generates and / or generates information on the monitored sample level. Alternatively, other information processing can be performed. The monitor unit provides, for example, a display screen that can be used to display the measured analyte level, an audible component such as a speaker for providing audio information to the user, and / or tactile feedback to the user A vibration device can be incorporated. Also, for users of the sample monitoring system, the trend display (the magnitude and direction of any ongoing trend (eg, the rate of change of the sample or other parameters, the subject is higher than a threshold, such as a hypoglycemia and / or hyperglycemia threshold) And / or a low amount of time, etc.). Such data may be displayed numerically or by a visual indicator such as an arrow (visual attributes such as its size, shape, color, animation or direction may vary). The monitor unit may be further configured to receive information from or relating to in vitro sample strips that may be manually or automatically placed in the monitor unit. In some embodiments, the monitor unit incorporates an in vitro analyte strip port and associated electronic device so that individual (eg, blood glucose) measurements can be made using the in vitro strip. (See, eg, US Pat. No. 6,175,752, incorporated herein by reference for all purposes).

  The modularity of these systems may vary, and one or more components may be configured for a single use, and one or more components may be configured to be reusable. In some embodiments, the sensor is designed to be attachable to and detachable from the body-worn electronic device (the body-worn unit may be reusable), for example, one or more of the components are once or more It may be reused. In other embodiments, on the other hand, the sensor and the body-worn electronic device may be provided as an integrated, non-removable package that is designed to be discarded after use, i.e. not reused. Can be done.

In Vivo Monitoring System Embodiments For purposes of illustration and not limitation, the inserter described herein may be used in conjunction with the exemplary analyte monitoring system shown in FIG. It should be understood that the inserter described herein can be used with any medical device by itself or in conjunction with a system. FIG. 1 illustrates an exemplary in vivo-based analyte monitoring system 100 according to embodiments of the present disclosure. As shown, in certain embodiments, the analyte monitoring system 100 includes a body-worn electronic device 1100 that includes the in-vivo analyte sensor 14 (shown in its proximal portion in FIG. 1). And attached to the adhesive layer 218 for attachment to the skin surface of the user's body. Body-worn electronic device 1100 includes a body-worn housing 122 that defines an internal compartment.

  Also shown in FIG. 1 is an insertion device 200 (or insertion devices 300, 400, 2400, 2500, 2700, 3700 as described herein), as described in more detail herein. The device, when operated, places a portion of the analyte sensor 14 percutaneously in fluid contact with the ISF through the skin surface and places the body-worn electronic device 1100 and the adhesive layer 218 on the skin surface. Deploy. In certain embodiments, the body-worn electronic device 1100, analyte sensor 14, and adhesive layer 218 are sealed within the housing of the insertion device 200 prior to use, and in certain embodiments, the adhesive layer 218 is also within the housing. It may be sealed, or the adhesive layer may provide a seal to keep the device sterile. Further details regarding insertion devices can be found, for example, in US patent application Ser. No. 12 / 698,129, as well as US provisional applications 61 / 238,646, 61 / 246,825, 61/247. , 516, 61 / 249,535 and 61 / 345,562, the disclosures of which are incorporated herein by reference for all purposes.

  Returning to FIG. 1, the sample monitoring system 100 includes a display device 1200, the display device 1200 for outputting information to the user, and for inputting data and commands to the display device 1200, or otherwise. Input elements 1210 (for example, buttons, actuators, touch sensor type switches, capacitive switches, pressure sensitive switches, jog wheels, etc.) for controlling the operation of the display device 1200. Note that some embodiments may include a device without a display or a device without any user interface elements. These devices store data as a data logger and / or provide conduits for transferring data from a wearable electronic device and / or a device without a display to another device and / or location. A function may be provided. This specification describes several embodiments as display devices for illustrative purposes, but they are in no way intended to limit the embodiments of the present disclosure. It will be appreciated that devices without a display can also be used in certain embodiments.

  In certain embodiments, the body-worn electronic device 1100 stores in memory some or all of the data associated with the monitored analyte received from the analyte sensor 14 during the monitoring period, and the memory until the end of the usage period. Can be configured to remain within. In such an embodiment, the stored data is removed from the user at the end of the monitoring period (eg, by removing the body-worn electronic device 1100 from the skin surface on which it was placed during the monitoring period). And then removed from the body-worn electronic device 1100. In such a data recording configuration, the analyte level monitored in real time is not communicated or otherwise transmitted from the body-worn electronic device 1100 to the display device 1200 during the monitoring period, and after the monitoring period the body level It is taken out from the mounting electronic device 1100.

  In certain embodiments, the input element 1210 of the display device 1200 may include a microphone so that the functionality and operation of the display device 1200 can be controlled by voice commands, and the display device 1200 can receive voice input received from the microphone. Software configured to analyze may also be included. In certain embodiments, the output element of display device 1200 includes a speaker for outputting information as an audible signal. Body-worn electronic device 1100 may also be provided with similar components that are responsive to voice, such as speakers, microphones, and software routines for generating, processing and storing voice driven signals.

  In certain embodiments, display 1220 and input element 1210 are integrated as a single component (eg, a display that can detect the presence and location of physical contact on the display, such as a touch screen user interface, etc.). obtain. In such an embodiment, the user taps the display once or twice, drags a finger or tool on the display, moves multiple fingers or tools toward each other, or moves multiple fingers or tools to each other. The operation of the display device 1200 may be controlled using a set of pre-programmed motion commands, including but not limited to moving away from the device. In certain embodiments, the display includes a touch screen having a pixel area with a single-function or dual-function capacitive element that acts as an LCD element and a touch sensor.

  The display device 1200 includes a data communication port 123 for wired data communication with an external device such as a remote terminal (personal computer) 1700, for example. Exemplary embodiments of data communication port 1230 are configured to connect with a USB port, a mini USB port, an RS-232 port, an Ethernet port, a Firewire port, or a compatible data cable. Includes other similar data communication ports. Display device 1200 may also include an integrated in vitro glucose meter with an in vitro test strip port 1240 that accepts an in vitro glucose test strip for performing in vitro blood glucose measurements.

  With continued reference to FIG. 1, the display 1220 in certain embodiments may be configured to display a variety of information, some or all of which may be displayed on the display 1220 simultaneously or at different times. In certain embodiments, the information displayed is user selectable so that the user can customize the information shown on a given display screen. Display 1220 can be, for example, a graphical display 1380 that provides a graphical output of glucose values over a monitored period (which can also show important markers such as diet, exercise, sleep, heart rate, blood pressure, etc.), eg, monitored glucose values A numerical display 1320 providing (obtained or received in response to a request for information) and, for example, indicating the rate of change of the specimen and / or the rate of change of the specimen by moving position on the display 1220 A trend or direction arrow display 1310 may be included, but is not limited to such.

  As further shown in FIG. 1, the display 1220 includes, for example, a date display 1350 that provides date information to the user, a time information display 1390 that provides time information to the user, and a battery of the display device 1200 (rechargeable or disposable). A battery level indicator display 1330 that graphically shows the state of the sensor, such as a sensor calibration state that informs the user that the analyte sensor needs to be calibrated in a monitoring system that requires periodic, periodic or a predetermined number of user calibration events Icon display 1340, voice / vibration setting icon display 1360 that displays voice / vibration output or alarm status, and other devices (such as body-worn electronic devices, data processing module 1600, and / or remote terminal 1700). Wireless connectivity status icon display that provides an indication of wireless communication connections 370 may also be included. As further shown in FIG. 1, display 1220 includes pseudo touch screen buttons 1250, 1260 for accessing menus, changing display graph output settings, or otherwise controlling the operation of display device 1200. It may further include.

  Returning to FIG. 1, in certain embodiments, the display 1220 of the display device 1200 may provide an alarm notification (eg, an alarm such as a glucose level and / or an alarm notification) in addition to or in place of the visual display. May be configured to output. The alert notification can be an audible notification, a tactile notification, or any combination thereof. In one aspect, the display device 1200 may include other visual output displays provided on the display 1220, as well as other speakers, vibration output elements, etc. to provide an audible output display and / or vibration output display to the user. An output element may be included. Further details and other display embodiments are described, for example, in U.S. Patent Application No. 12 / 871,901 and U.S. Provisional Applications 61 / 238,672, 61 / 247,541 and 61 / 297,625, the disclosures of each of which are incorporated herein by reference for all purposes.

  Body wear in certain embodiments after body wear electronic device 1100 is placed on the skin surface and analyte sensor 14 is placed in vivo and fluid contact with the ISF (or other suitable body fluid) is established. When the body-worn electronic device 1100 receives a command or request signal from the display device 1200, the medical electronic device 1100 receives sample-related data (eg, data corresponding to the monitored sample level, monitored temperature data, and And / or stored historical specimen related data, etc.) wirelessly. In certain embodiments, the body-worn electronic device 1100 includes the monitored analyte level received by the display device 1200 when the display device 1200 is within a data broadcast communication distance from the body-worn electronic device 1100. The associated real-time data may be configured to broadcast at least periodically (ie, no command or request from a display device is required to transmit information).

  For example, display device 1200 may be configured to send one or more commands to initiate data transfer to body-worn electronic device 1100. In response, the body-worn electronic device 1100 can be configured to wirelessly transmit stored specimen-related data collected during the monitoring period to the display device 1200. The display device 1200 may be further connected to a remote terminal 1700 such as a personal computer and functions as a data conduit for transferring stored specimen level information from the body-worn electronic device 1100 to the remote terminal 1700. . In certain embodiments, data received from the body-worn electronic device 1100 may be stored (permanently or temporarily) in one or more memories of the display device 1200. In another particular embodiment, the display device 1200 is configured as a data conduit for passing data received from the body-worn electronic device 1100 to a remote terminal 1700 connected to the display device 1200.

  With continued reference to FIG. 1, the sample monitoring system 1000 also shows a data processing module 1600 and a remote terminal 1700. Remote terminal 1700 may include a personal computer, server terminal, laptop computer, or other suitable data processing device that includes software for data management and analysis and communication with components of analyte monitoring system 1000. For example, the remote terminal 1700 may be a local area network (LAN), wide area network (WAN), or other for unidirectional or bidirectional data communication between the remote terminal 1700 and the display device 1200 and / or the data processing module 1600. Can be connected to other data networks.

  The remote terminal 1700 in certain embodiments may include one or more computer terminals located in a surgeon's office or hospital. For example, the remote terminal 1700 can be arranged at a place other than the place of the display device 1200. The remote terminal 1700 and the display device 1200 may be in different rooms or different buildings. Remote terminal 1700 and display device 1200 may be separated by at least about 1 mile (eg, about 1.6 km) (eg, at least about 100 miles (about 160 km), eg, at least about 1000 miles (about 1600). Km) may be separated). For example, the remote terminal 1700 may be in the same city as the display device 1200, the remote terminal 1700 may be in a different city from the display device 1200, and the remote terminal 1700 may be in the same state as the display device 1200. The remote terminal 1700 may be in a state different from the display device 1200, the remote terminal 1700 may be in the same country as the display device 1200, and the remote terminal 1700 may be in a country different from the display device 1200.

  In certain embodiments, the analyte monitoring system 1000 may be provided with a data communication / processing device provided as a separate need, such as a data processing module 1600. The data processing module 1600 includes, for example, an infrared (IR) protocol, a Bluetooth (registered trademark) protocol, a Zigbee (registered trademark) protocol, and an 802.11 wireless LAN protocol, but one or more wireless communication protocols are not limited thereto. May include components for using and communicating. Further descriptions of communication protocols, including those based on the “Bluetooth” protocol and / or the “Zigbee” protocol, can be found in US Patent Publication No. 2006/0193375, the contents of which are referenced for all purposes. Incorporated herein. The data processing module 1600 can establish, for example, a USB connector and / or a USB port, an “Ethernet” connector, and / or a wired communication with one or more display devices 1200, body-worn electronic devices 1100, or remote terminals 1700. Or may further include communication ports, drivers or connectors including but not limited to ports, FireWire connectors and / or ports, or RS-232 ports and / or connectors.

  In certain embodiments, the data processing module 1600 sends polling or query signals to the body-worn electronic device 1100 at predetermined time intervals (eg, once every minute, once every five minutes, etc.) and In response, it is programmed to receive monitored sample level information from the body-worn electronic device 1100. The data processing module 1600 stores the received sample level information in its memory and / or relays or retransmits the received information to another device such as the display device 1200. More specifically, in certain embodiments, the data processing module 1600 can receive sample level data received from the body-worn electronic device 1100 using a display device 1200 or a remote terminal (eg, a cellular phone network or a WiFi data network). (Via the data network) or both, can be configured as a data relay device to retransmit or pass.

  In certain embodiments, the body-worn electronic device 1100 and the data processing module 1600 are a predetermined distance from each other such that periodic communication between the body-worn electronic device 1100 and the data processing module 1600 is maintained. (E.g., about 1-12 inches, about 1-10 inches, about 1-7 inches, or about 1-5 inches (1 inch is about 2.54 centimeters)). Alternatively, the data processing module 1600 may be worn on the user's belt or clothing so that a desired distance for communication between the body-worn electronic device 1100 and the data processing module 1600 is maintained. In a further aspect, the housing of the data processing module 1600 is body worn such that the body worn electronic device 1100 and the data processing module 1600 are combined or integrated into a single assembly and placed on the skin surface. The electronic device 1100 may be configured to connect or engage. In further embodiments, the data processing module 1600 is removably engaged or connected to the body-worn electronic device 1100 so that the data processing module 1600 can be removed or reattached as desired. Further modularity is provided.

  Referring back to FIG. 1, in certain embodiments, the data processing module 1600 may be configured to use a predetermined time interval (eg, once every minute, once every five minutes, once every 30 minutes, or any other suitable At any desired or programmable time interval), the body-worn electronic device 1100 is programmed to send a command or signal to request specimen-related data from the body-worn electronic device 1100. When the sample related data requested by the data processing module 1600 is received, the data processing module 1600 stores the received data. As such, the analyte monitoring system 1000 can be configured to receive continuously monitored analyte related information at programmed or programmable time intervals. The received specimen related information is stored and / or displayed to the user. The data stored in the data processing module 1600 is then used for subsequent data analysis to improve treatment decisions (eg, frequency of blood glucose level excursions over the monitoring period and alarm events occurred during the monitoring period) Frequency identification etc.) may be supplied or transmitted to display device 1200, remote terminal 1700, etc. With this information, a physician, health care provider or user may recommend adjusting daily routines such as diet, lifestyle and exercise, or modifying them.

  In another embodiment, the data processing module 1600 causes the body-worn electronic device 1100 to respond to a sample activation in response to a user activation of a switch provided in the data processing module 1600 or a user activation command received from the display device 1200. Send a command or signal to receive data. In a further embodiment, the data processing module 1600 is configured to send a command or signal to the body-worn electronic device 1100 in response to receiving a user-activated command only after a predetermined time interval has elapsed. For example, in certain embodiments, if the user does not initiate communication within a programmed period (eg, about 5 hours from the previous communication, 10 hours from the previous communication, or 24 hours from the previous communication). The data processing module 1600 can be programmed to automatically send a request command or signal to the body-worn electronic device 1100. Alternatively, the data processing module 1600 can be programmed to activate an alarm that notifies the user that a predetermined period has elapsed since the previous communication between the data processing module 1600 and the body-worn electronic device 1100. In this way, the user or healthcare provider can program the data processing module 1600 to provide a certain consistency with the sample monitoring regimen so that the user can maintain or perform frequent sample level determinations. Or you can set.

  In certain embodiments, if a programmed or programmable alarm condition is detected (eg, the detected glucose level monitored by the analyte sensor 14 is outside a predetermined acceptable range, Corrective action may be taken in a timely manner for physiological conditions that require attention or intervention for analysis (eg, indicating hypoglycemic conditions, hyperglycemic conditions, urgent hyperglycemic conditions, or urgent hypoglycemic conditions) As such, one or more output displays may be generated by the control logic or processor of the body-worn electronic device 1100 and output to the user on the 1100 user interface of the body-worn electronic device. In addition or alternatively, if the display device 1200 is within communication range, the output display or alarm data may be communicated to the display device 1200 and upon detection of the alarm data being detected, the display device 1200. The processor controls the display 1220 and outputs one or more notifications.

  In certain embodiments, the control logic or microprocessor of body-worn electronic device 1100 may provide information obtained from analyte sensor 14 (eg, current analyte level, rate of change of analyte level, acceleration of change in analyte level, and (Or specimen trend information that provides a historical trend or direction of specimen level variation as a function of time during the monitored period) determined based on stored monitored specimen data), Includes a software program for determining future or expected analyte levels. The forecast alert parameter can be programmed or programmable in the display device 1200, the body-worn electronic device 1100, or both, before the user's analyte level is expected to reach its future level. Can be output to the user. This gives the user an opportunity to take timely corrective action.

  Information such as changes or fluctuations in the monitored analyte level as a function of time over the monitoring period that provides such analyte trend information may be, for example, display device 1200, data processing module 1600, remote terminal 1700 and / or body wear. May be determined by one or more control logic or microprocessors of the electronic device 1100. Such information may be, for example, a graph (line graph or the like) that indicates to the user the current sample level, historical sample level, and / or predicted future sample level as measured and predicted by the sample monitoring system 1000. ). Such information may include direction arrows (see, eg, trend or direction arrow display 1310) or other icons (eg, the position of the icon relative to a reference point on the screen may indicate an increase or decrease in sample level, and It may also be displayed as indicating acceleration or deceleration of the increase or decrease of the analyte level. This information can be used by the user to determine any corrective action necessary to ensure that the analyte level remains within an acceptable range and / or clinically safe range. Other visual indicators (eg, color, flash, fade, etc.), as well as audio indicators (eg, changes in pitch, volume or tone of audio output) and / or tactile indicators such as vibration are also monitored analyte levels As a means of notifying the user of the current level, direction, and / or rate of change, it can be incorporated into the display of trend data. For example, based on the determined rate of glucose change, the programmed clinically significant glucose threshold level (e.g., high and / or low blood glucose level), and the current analyte level obtained by the in vivo analyte sensor, The system 1000 may include an algorithm stored in a computer readable medium for determining the time it takes to reach a clinically significant level, before the clinically significant level is reached (eg, clinically significant). 30 minutes before, 20 minutes before, 10 minutes before, 5 minutes before, 3 minutes before, and / or 1 minute before expected to become a significant level, etc. While increasing).

  Returning again to FIG. 1, in certain embodiments, the software algorithms executed by the data processing module 1600 are external memory devices (eg, SD card, micro SD card, CompactFlash card, XD card, memory stick). Card, memory stick Duo card, USB memory stick / device, etc.). Such an external memory device stores an executable program that is executed when connected to one or more of the body-mounted electronic device 1100, the remote terminal 1700, and the display device 1200. In a further aspect, the software algorithm executed by the data processing module 1600 can be downloaded to a communication device such as a mobile phone (eg, including a WiFi or Internet enabled smartphone or personal digital assistant (PDA)). Can be provided as a downloadable application executed by

  Examples of smart phones include Windows (registered trademark), Android (trademark), and iPhone (registered trademark) operating systems having a data network connection function for data communication via the Internet connection and / or a local area network (LAN). , Palm (R) WebOS (TM), Blackberry (R) operating system, or Symbian (R) operating system. The PDA described above has, for example, one or more microprocessors and a data communication function, and has a user interface (for example, a display / output unit and / or an input unit), for example, data processing or data via the Internet. Mobile electronic devices configured to upload / download. In such an embodiment, remote terminal 1700 may be configured to provide executable application software to one or more of the communication devices described above when communication between the device and remote terminal 1700 is established.

  In further embodiments, the executable software application may be provided as an OTA download over the air (OTA) so that a wired connection to the remote terminal 1700 is not required. For example, the executable application is automatically downloaded to the communication device as a software download and is used by the user according to the settings of the communication device, or confirmation by the user for execution of installation of the application on the communication device. Or it can be installed on the device based on the approval. Software OTA download and installation may include software applications and / or routines that are updates or upgrades to existing functions or features of data processing module 1600 and / or display device 1200.

  Returning to the remote terminal 1700 of FIG. 1, in certain embodiments, when communication between the remote terminal 1700 and the display device 1200 and / or the data processing module 1600 is established, the remote terminal 1700, in particular, the display device 1200. New software and / or software updates (such as software patches or modifications), firmware updates or software driver upgrades for the body-worn electronic device 1100 and / or the data processing module 1600 may be provided. For example, software upgrades, executable programming changes or modifications for the body-worn electronic device 1100 are received from the remote terminal 1700 by one or more of the display device 1200 or the data processing module 1600 and then the body-worn electronic device. It may be provided to the body-worn electronic device 1100 to update the 1100 software or programmable functionality. For example, in certain embodiments, software received and installed on the body-worn electronic device 1100 may include software bug fixes, previously installed software parameter modifications (particularly specimen related data storage time intervals). Modification of the time reference or information of the body-worn electronic device 1100, modification of the transmitted data type, data transmission sequence, or data storage period). Further details of field upgradeability and data processing of software for portable electronic devices are described in US patent application Ser. Nos. 12 / 698,124, 12 / 794,721, 12 / 699,653, and 12 No./699,844 and U.S. provisional applications 61,359,265 and 61 / 325,155, the disclosures of which are incorporated by reference for all purposes. Are incorporated herein.

Sensor The analyte sensor 14 of the analyte measurement system 100 can be used to monitor the level of various analytes. For example, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (eg, CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone, lactic acid, Examples include, but are not limited to oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone and troponin. For example, the concentration of drugs such as antibiotics (eg, gentamicin, vancomycin, etc.), digitoxin, digoxin, drugs of abuse, theophylline and warfarin can also be monitored. One or more analytes can be monitored by a given sensor. In these embodiments monitoring two or more analytes, the analytes can be monitored simultaneously or at different times using the same body-worn electronic device (eg, simultaneously) or using different body-worn electronic devices. .

  In one embodiment of the present disclosure, the sensor 14 is physically located in or on the user's body whose analyte level is monitored. The sensor 14 continuously samples the user's analyte level and the sampled analyte level (eg, glucose concentration) into a corresponding data signal (eg, current or voltage) for input to the body-worn electronic device. Can be configured to convert. Alternatively, the sensor 14 can be configured to sample the analyte level on demand. The body-worn electronic device may amplify, filter, average and / or otherwise process the signal provided by the sensor.

  One embodiment of sensor 14 is shown in FIG. It should be understood that the inserter described herein can be used with other medical devices. The shapes described herein are merely exemplary. Other sensor shapes are also conceivable. In some embodiments, sensor 14 includes a substrate that is a dielectric (eg, a polymer such as polyester or polyamide, or a plastic material). In this embodiment, the sensor is configured to be partly placed under the skin and partly over the skin. Thus, the sensor 14 includes an insert or interior 30 and an exterior or electrical contact 32. In some embodiments, the contact portion 32 includes a plurality of conductive contacts 36, 38, and 40 (here, as three contacts, for example, for connection to other electronic devices in the body-worn electronic device 1100). Included). (See FIG. 1.) The contacts provided in this embodiment are for the working electrode, the reference electrode and the counter electrode. In some embodiments, more than one working electrode is provided. The working parts of these electrodes, i.e. the working electrode, the reference electrode and the counter electrode (not shown individually) are provided at the insert (e.g. the distal end of the insert 30 e.g. part 34). In some embodiments, one or more electrodes can be outside the body (eg, an external counter electrode). The operation parts of the contacts and the electrodes are connected by circuit wirings 42, 44 and 46 provided on the surface of the substrate. In some embodiments, the wiring may be provided in the channel, embedded in the substrate, or may traverse different surfaces of the substrate. The conductive contacts, conductive wiring and electrodes are made of a conductive material such as platinum, palladium, gold, and carbon. More than one material can be used for a given sensor. Further details of the sensors are described in, for example, US Pat. Nos. 6,175,572 and 6,103,033, which are incorporated herein for all purposes with reference thereto. .

  The sensor 14 can include a proximal retainer 48. The size of the insert 30 and the proximal retainer 48 is configured to be placed with a sharp member for placement in the subject's skin, as described herein. In use, the sensor 14 can be configured to bend (eg, along line B) and be disposed in two planes that intersect substantially perpendicularly. Such bending can occur before or during connection with the body-worn electronic device, as described below. (See FIG. 17).

  Portions 48 and 52 provide a path (eg, conductive wiring) for electrical connection between the proximal and distal portions of the sensor. The sensor 14 is further provided with a notch 54. With such a configuration, as shown in FIG. 3, the sensor 14 (e.g., indicated by line B) is such that the retainer 48 remains upright and is disposed in two planes that intersect substantially perpendicularly. It is easy to bend (along the line that is). As will be described later, the sensor tab 50 may be housed within the body-worn housing 122 to assist in securing and positioning the sensor 14. The proximal retainer 48 maintains longitudinal alignment of the proximal retainer 48 and the insert 30 so that it is positioned within the insertion sharp member.

  Through an electrode configuration to which a chemical detection layer has been applied, an electrochemical current is generated (indicating analyte concentration) proportional to the amount of analyte redox reaction catalyzed by the analyte-specific oxidase, thereby allowing electrochemical Embodiments of an analyte sensor that operate in an automated manner have been described herein. There are embodiments in which the number of electrodes provided to generate these reactions and detect their levels is two, three, or more. However, other types of sensors may be used as described herein.

  A portion of the sensor 14 may be positioned above the surface of the skin, with the distal portion 30 penetrating through the skin and into the subcutaneous space and contacting the user's biological fluid (eg, ISF). Additional details regarding the electrochemistry of sensor 14 can be found in US Pat. Nos. 5,264,104, 5,356,786, 5,262,035, 5,320,725, and No. 6,990,366, each of which is incorporated herein by reference for all purposes.

  In some embodiments, the sensor is used for a period of use (eg, 1 minute or more, at least 1 day or more, about 1 day to about 30 days, or more, for monitoring in contact with an analyte present in the biological fluid. As such, it can be implanted into the subject's body for about 3 days to about 14 days, about 3 days to about 7 days, or in some embodiments, longer periods up to several weeks). In this regard, sensors can be placed at various locations (eg, abdomen, upper arm, thighs, etc.) of the subject (eg, intramuscularly, percutaneously, within a blood vessel, or within a body cavity).

  In some embodiments, the sensor 14 is used by being inserted and / or implanted in the user's body for some trial period. In such embodiments, the substrate can be formed of a relatively flexible material.

  Although the embodiment shown in FIGS. 2-3 has three electrodes, other embodiments may include fewer or more electrodes. For example, a two-electrode sensor can be used. The sensor 14 may be powered externally and pass a current proportional to the amount of analyte present. Alternatively, in some embodiments, sensor 14 itself can act as a current source. In some embodiments of the two electrodes, the sensor may be self-biased, in which case no reference electrode is required. An exemplary self-powered two-electrode sensor is US patent application Ser. No. 12 / 393,921, filed Feb. 26, 2009, entitled “Self-Powered Analyte Sensor”. Which is incorporated herein by reference for all purposes. In certain embodiments, the level of current supplied by the self-powered sensor can be as low as, for example, nanoamps.

Insertion assembly An insertion assembly is provided for use in installing a medical device on a subject. In some embodiments, the insertion assembly includes an inserter and a medical device. The inserter can be configured to insert various medical devices, such as, for example, an analyte sensor, an infusion set or a cannula, into the subject. In some embodiments, the inserter may be configured to place such device combinations (eg, combined sensor / infusion set, etc.) at the same or different locations at the same or different times. For example, in certain embodiments, a given inserter may be configured to install the first device and the second device at different times. In this regard, the inserter may be reusable. For example, the inserter can be modified for use with more than one medical device (including more than one type of medical device), eg, by attaching an adapter and / or removing a portion of the inserter It can be. The inserter can place the medical device under or through the subject's skin, or the medical device can be placed on the surface of the skin. The medical device may have features or structures, such as barbs, tabs, adhesives, etc., for maintaining the device in place with respect to the skin after insertion. The insertion device can also be used, for example, as a lancet for piercing the skin without inserting or installing a medical device.

  In some embodiments, the insertion assembly includes an inserter, a medical device such as an analyte sensor, and a mount that at least partially supports the medical device in or on the subject's skin. In some embodiments, the mount is a support structure, support plate and / or support member that is attached to, adhered to, or otherwise secured to the subject's skin. The mount can be inserted simultaneously with the medical device by an inserter. In other embodiments, the mount is installed before or after installation of the medical device. The mount can be applied by an inserter or separately. The mount is a feature or structure (e.g., adhesive, guide, barb, Tabs, etc.). In some embodiments, a medical device (eg, a sensor and / or sensor control unit) is secured using an adhesive pad or piece and no mount is used.

  In some embodiments, the insertion assembly includes an inserter, an analyte sensor, a mount, and a power source. The mount and power supply can be inserted simultaneously with the analyte sensor by the inserter. In other embodiments, the mount and battery are installed after or before installation of the analyte sensor. In such cases, the mount and / or power source can be applied by an inserter or separately. The power source may be used to supply current or potential to the sensor and / or to supply power to communicate one or more signals to the monitor unit.

  In some embodiments, the insertion assembly includes an inserter, a medical device such as an analyte sensor, a mount, and a sensor control unit. The mount and sensor control unit can be placed and / or installed simultaneously with the analyte sensor by an inserter. In other embodiments, the mount and sensor control unit are installed after or before installation of the analyte sensor. For example, the mount and analyte sensor may be installed by an inserter, followed by the sensor control unit. In other embodiments, the mount is installed, the analyte sensor is then inserted by the inserter, and then the sensor control unit is installed. In other embodiments, the mount and sensor control unit are installed first, followed by the analyte sensor.

  In some embodiments, the electronic device of the sensor control unit supplies a voltage or current to the analyte sensor. In some embodiments, the electronic device processes the signal provided by the analyte sensor. In further embodiments, the electronic device may include a communication function for supplying a signal related to the signal supplied by the analyte sensor to a further component (eg, a monitor unit, a computer or other component). In some embodiments, a communication circuit such as an RFID antenna or other communication circuit is provided. A power supply can be used to power some or all of these functions. In some embodiments, power is supplied from the monitor unit, for example, via inductive coupling.

  The inserter can include a plurality of different components. For example, the inserter may include one or more components for advancing the sharp member toward the subject's skin. The sensor and sensor control unit and / or mounting structure may be supported by a support structure such as a carriage. A driver for advancing the sharp member and / or the analyte sensor / support structure may be provided. In some embodiments, the actuator is directly or indirectly connected to the sharp member and / or support structure such that hand forces and speeds applied to the actuator by the subject are transmitted to the sharp member and / or support structure. . In some embodiments, the applied force drives the sharp member and / or support structure between a retracted position and an advanced position. In some embodiments, the sensor and sensor control unit and / or mounting structure are maintained in a retracted position by contacting a protrusion extending inwardly from the sheath prior to installation. According to this embodiment, the sensor and sensor control unit and / or mounting structure are temporarily maintained operatively between the support structure and the protrusions disposed on the inner wall of the sheath.

  The inserter may also include one or more components for retracting the sharp member while the analyte sensor and optionally the mount and / or electronic device remain on the subject. The component for retracting the sharp member may include a retractor. It should be understood that the retractor and actuator may have the same structure or have some common components. In some embodiments, the retractor is directly or indirectly connected to the sharp member such that hand force applied by the user is transmitted from the retractor to the sharp member, causing the sharp member to retract from the skin. In other embodiments, a drive assembly for retracting the sharp member may be provided. For example, the drive assembly may include a spring, motor, hydraulic piston, and the like for retracting the sharp member away from the subject's skin. The drive assembly may also include a linear drive element.

  In some embodiments, the retractor pulls out the sharp member when activated by the user. In such a case, the user activates the retractor when it is desired to pull out the sharp member. For example, the retractor can include a release switch. When the release switch is activated, a drive assembly (eg, a spring or other driver) retracts the sharp member from the skin. In other embodiments, the retractor and the actuator have common components. After actuating the actuator to advance the sharp member and analyte sensor, the user releases the actuator so that the drive assembly can withdraw the sharp member from the skin.

  In some embodiments, after actuation of the insertion, the retractor pulls the sharp member without further user interaction. For example, the inserter may include features or components that automatically retract the sharp member once the sharp member and support structure have been advanced a predetermined amount. In this specification, an insertion device that does not require further action by the user to initiate withdrawal of the sharp member after insertion is referred to as having "automatic" withdrawal of the sharp member.

Insertion Device One embodiment of a needle hub for an inserter is shown in FIGS. Needle hub 136 supports sharp member 124 having a pointed distal portion 160. As described herein, in some embodiments, at least a portion of the sharp member 124 wall is provided with a longitudinal wall opening or gap 162. The length N of the gap 162 is selected to match the length of the insert 30 up to the proximal retainer 48 of the sensor 14, and in certain embodiments is about 3 mm to about 50 mm (eg, about 5 mm, about 10 mm, about 15 mm or about 20 mm). The length L of the sharp member 124 can be about 3 mm to about 50 mm (eg, 5 mm or more, about 10 mm, about 20 mm, about 30 mm, or about 50 mm), the length of the sensor insert 30 and the length of the sensor 14 insert. Selected based on 30 desired depths. In some embodiments, the distance or spacing between the two edges of the gap is from about 0.2 mm to about 0.5 mm (eg, about 0.22 mm, about 0.25 mm, etc.).

  6-8 show the distal portion 160 of the sharp member 124 in more detail. As shown in FIG. 6, in this embodiment, the sharp member 124 has a substantially C-shaped or U-shaped profile, but may have other configurations such as a substantially V-shaped profile. A longitudinal gap 162 is provided in the wall of the sharp member 124. FIG. 7 shows a distal portion 160 with an angled tip. In some embodiments, the angled tip may be provided with a first angled tip portion 164 and a second acute angle tip portion 166. An exemplary configuration that includes multiple edges and surfaces provides a sharp tip to reduce piercing forces, trauma to the subject, and bleeding. The width of the distal portion of the sensor body is sized to fit within the notch 162 of the insertion sharp member 124 having a diameter of less than about 20 gauge to about 26 gauge (eg, 21 gauge to about 25 gauge). In this embodiment, the sharp member is 21 gauge, 23 gauge or 25 gauge. Such sharp members can be used with sensors in which at least the width or diameter of the portion carried by the sharp member is about 0.20 mm to about 0.80 mm (eg, about 0.25 mm to about 0.60 mm). In some embodiments, the width or diameter of at least a portion of the sensor is 0.27 mm, 0.33 mm, or 0.58 mm. In some embodiments, the sharp member 224 is made of sheet metal and is folded to have a generally V-shaped, U-shaped or C-shaped cross section. Various techniques can be used to produce the folded sheet metal that forms the sharp member 124. For example, the sharp member 124 can be configured using an etched metal sheet technique. In this way, a sharp member having a very sharp edge can be formed so as to reduce pain when penetrating the skin during insertion. In other embodiments, a progressive die technique can be used to form complex sheet metal shapes with sharp edges as shown in FIG. In some embodiments, the sharp member 124 can be molded with a plastic cap so that the sharp member can be handled during the assembly process of the inserter. Further, a die-cut sharp member may be molded with plastic in order to reinforce a V-shaped, U-shaped or C-shaped sheet metal configuration. Furthermore, in other embodiments, a laser cut sharp member may be formed. In this manner, the laser can be used to form the wall opening or gap 162 and the first angled tip portion 164 and the second acute tip portion 166.

  In another embodiment, the sharp member 124 can be formed from a standard hypodermic needle using the method shown in FIG. First, a hypodermic needle (having a circular cross section) is cut to the desired length of the sharp member 124. Next, the hypodermic needle is compressed to permanently deform the cross section from a circular shape to an elliptical shape. Next, the tip of the hypodermic needle is slanted to create a sharp tip to reduce the force required to penetrate as described above. Finally, the top of the needle is removed by a suitable technique (eg, polishing, electropolishing, etc.). The resulting sharp member 124 has a U-shaped configuration and provides sufficient space for insertion of the sensor 14. In some embodiments, the tip polishing step and the compression step can be performed in the reverse order.

  Due to the compression process, the user may first start with a larger diameter hypodermic needle so that the finished sharp member 124 has the same dimensions as the sharp member described above.

  FIGS. 11-12 show the position of the body mounting housing 122 relative to the needle hub 136 and the sharp member 124. The body-worn housing 122 may be configured to hold at least a portion of the sensor 14 and the sensor control unit 12. As shown in FIG. 11, the sharp member 124 extends through the aperture 168 of the body-worn housing 122. Thus, in some embodiments, the sharp member 124 is not coupled to the body-worn housing 122. The distal portion of sensor 14 is disposed within sharp member 124. Further, as shown in FIG. 12, an electronic device 80 of the sensor control unit 12 (for example, a printed circuit board including the electronic device elements of the body mounting unit 16) and a sensor hub 123 are arranged in the body mounting housing 122. The Sensor 14 may include an arrangement structure or slit 127 that receives an arrangement member, such as tab 129 of sensor hub 123. A power source 82 such as a battery (eg, a disposable battery or a rechargeable battery) is provided. In some embodiments, the power source 82 is used to provide a potential or current to the sensor. In an embodiment in which a passive communication protocol such as passive RFID is used, no communication power source is provided. Such power is supplied by the monitor unit 18. In some embodiments where a sensor control unit is used to transmit one or more signals, one or more power sources may be used to provide power for such communication circuits. In some embodiments, the effective operating life of the battery may exceed the effective operating life of the sensor 14.

  FIG. 13 shows in cross section the orientation of the body mounting housing 122 relative to the sharp member 124 of an inserter such as the inserter 1500. As described herein, in some embodiments, sensor 14 is disposed in a generally bent configuration such that portions of the sensor (eg, insert 30 and proximal retainer 48) are substantially vertical. (Eg, approximately aligned with the longitudinal axis of the inserter and approximately perpendicular to the skin surface) and the contact 32 (shown in outline) in a generally horizontal configuration. Oriented and in electrical contact with the data processing device electronics, such as circuit 80. The sensor tab 50 can be encapsulated in plastic (eg, “overmolded”) in the body-worn housing 122 and secured in place. The notch 56 provides additional stability to the sensor 14, for example, by allowing the sensor tab 50 to be encapsulated by the material of the body wearable housing 122, and further, for example, of the body wearable housing 122. By allowing the notch 56 to be positioned vertically relative to a vertical landmark, a means for orienting the sensor 14 vertically during installation is provided.

  The sensor 14 attached with the body-worn housing 122 may be disposed in a recess in the carriage 130, such as a concave recess in the carriage 130. Alternatively, the sensor 14 attached with the body-worn housing 122 may be disposed between the support structure and one or more protrusions extending from the sheath wall. In yet another alternative, the sensor 14 attached with the body-worn housing 122 may be held in place by a releasable interference fit connection with the sharp member 124. Thus, the carriage need not have a recess in which the sensor attached with the body-worn housing is placed. In the initial configuration of the inserter, the sharp member 124 extends through a longitudinal aperture 168 formed in the carriage 130. In some embodiments, the aperture 168 has an appropriate size such that the sharp member 124 and the needle hub 136 do not contact the carriage 130. Accordingly, on the one hand, the needle hub 136 (and the sharp member 124), and on the other hand, the carriage 130 (FIG. 13) and the body mounting housing 122 move simultaneously independently of each other. In other embodiments, an interference fit between the aperture and the sharp member may be provided.

  The insertion portion 30 and the proximal retention portion 48 of the sensor 14 are disposed within the longitudinal bore 162 (see, eg, FIG. 6) of the sharp member 124. Proximal retainer 48 is disposed within the longitudinal bore of sharp member 124 and provides additional stability for mounting sensor 14 within sharp member 124. The longitudinal wall gap or opening 162 of the sharp member 124 is aligned with the sensor 14 such that the tab 50 and contact 32 extend laterally outward from the sharp member 124.

  An embodiment of an inserter is shown in FIGS. The inserter 900 includes a handle 902 and may include a removable distal cap or seal (not shown) for maintaining a sterile environment of the medical device and sharp member housed therein. The distal cap or seal is removed from the handle 902 as shown in FIG. The inserter 900 includes a base 942 that defines a distal surface 912 for placement on the subject's skin. The inserter 900 may be used to advance the medical device into the subject's skin. In some embodiments, the handle 902 is advanced relative to the base 942 to advance the sensor into the patient's skin.

  As shown in FIG. 15, in the initial configuration of the inserter 900, the handle 902 is disposed in a proximal position relative to the base 942. In such a configuration, the sharp member 924 is disposed in a configuration spaced from the aperture 920 of the adhesive layer 918. A sidewall 974 extends distally from the top surface of the handle 902 and terminates at a shoulder 975.

  Needle carrier 934 is slidable axially in the direction of arrow N within handle 902 and base 942. The needle carrier 934 supports a needle hub 936 from which a sharp member 924 extends longitudinally within the inserter 900. In some embodiments, the sharp member is supported at an oblique angle (eg, between 0 ° and 90 °) with respect to the skin surface. First, the needle carrier 934 is connected to the inner rail 928 by the mutual engagement of the finger portion 986 of the needle carrier 934 and the shoulder portion 987 of the inner rail.

  The inserter 900 includes an advance spring 947. Inner rail 928 includes a spring retainer 984 for advance spring 947. The inner surface of the handle 902 serves as the upper engagement surface for the advance spring 947. In some embodiments, the spring retainer 984 is manufactured to have a plurality of protrusions that extend through an aperture 982 in the wall of the base 942. The spring holding portion 984 is elastically movable. When a downward force is applied to the handle 902, the ledge 937 of the handle 902 contacts the spring retainer 984 and drives such a protrusion inward. Such inward movement releases the inner rail 928 and allows the advance spring 947 to advance the inner rail 928 distally, thereby causing the sharp member 924 to move the subject 924 as shown in FIG. Advance into the skin.

  A retraction spring 946 is disposed between the spring retainer 948 of the base 942 and the shoulder 949 of the needle carrier 934. In the initial state, the reverse spring 946 is in a compressed state. When the carriage 930 reaches the distal position, the distal surface of the body mounting housing 122 engages the upper surface of the adhesive pad 918 and thereby adheres to the skin surface S of the subject. At the same time, the flange 970 of the base 942 engages the finger 986 disposed on the needle carrier 934. The finger portion 986 is rotated outward by the flange 970. By such rotation of the finger portion 974, the finger portion 986 is disengaged from the shoulder portion 984 of the inner rail 928. Thereby, the shuttle 934 is detached from the inner rail 928.

  As shown in FIG. 17, when the shuttle 934 is disengaged from the inner rail 928, the spring 946 becomes extensible, thereby advancing the needle carrier 934 to a proximal position, leaving the sensor 14 in the skin. Then, the sharp member 934 is pulled out from the skin S of the subject.

  A further embodiment of the inserter is shown in FIGS. 18-21 and is shown as inserter 1000. The inserter 1000 is substantially the same as the inserter 900 described herein, where substantial differences are described and illustrated in the accompanying drawings.

  The inserter 1000 includes a housing 1002 and may include a removable distal cap or seal (not shown) for maintaining a sterile environment of the medical device and sharp member housed therein. The distal cap or seal is removed from the housing 1002, as shown in FIG. The inserter 1000 includes a base 1042 that defines a distal surface 1012 for placement on the subject's skin. The inserter 1000 can be used to advance a medical device into a subject's skin. In some embodiments, the side button 1084 is pressed against the base 1042 to advance the medical device into the patient's skin.

  As shown in FIG. 19, in the initial configuration of the inserter 1000, the sharp member 1024 is disposed in a configuration spaced from the distal portion 1012 of the base 1042. It should be understood that the inserter 1000 can include an adhesive layer (not shown) disposed over the distal portion 1012 of the base 1042.

  The body wearing unit inserter 1028 includes a carriage 1030 that supports the body wearing housing 122. Body wear unit inserter 1028 also includes a flange 1029 that rests on shoulder 1086 in a normal state (as shown in FIGS. 19-21). When the side button 1084 is pushed inward, the latch portion of the flange 1029 is released from the shoulder portion 1086. As shown in FIG. 20, the advance spring 1047 is released from compression, which causes the body wear unit inserter 1028 to advance with the needle carrier 1034 into the subject's skin, as well as other parts.

  A retraction spring 1046 is disposed between the needle carrier 1034 and the housing 1002. In the initial state, the backward spring 1046 is in a compressed state. When the carriage 1028 reaches the distal position, the body mount unit inserter 1028 is disengaged from the needle carrier 1034. The distal surface of the body-worn housing 122 engages the upper surface of the skin or adhesive pad (not shown), thereby adhering to the skin surface S of the subject. The needle carrier 1034 is attached to the body-mounted unit inserter 1028 by the latch of the needle carrier 1034. When the inserter is fired by pressing the side button 1084, the body wear unit inserter 1028 is pushed toward the skin surface by the spring 1047, moves with the needle carrier 1034, and biases the extension spring 1046. When the body wearable unit inserter 1028 reaches a distal position (towards the subject's skin), the protrusion of the housing 1002 unlatches the needle carrier 1034 and places the needle carrier 1034 into the body wearable unit inserter 1028. Connecting. At this point, the extension spring 1046 pulls the needle carrier 1034 back to the proximal position.

  As shown in FIG. 21, when the needle carrier 1034 is disengaged from the inner rail 1028, the spring 1046 can be urged to retract, thereby causing the needle carrier 1034 to advance to a proximal position and move the sensor 14 into the skin. With the remaining state, the sharp member 1024 is pulled out from the skin S of the subject.

  A further embodiment of the inserter is shown in FIGS. The inserter 1100 is substantially identical to the inserters 900 and 1000 described herein, where substantial differences are described and illustrated in the accompanying drawings.

  The inserter 1100 may include a housing 1102 and a removable distal cap or seal (not shown) for maintaining a sterile environment of medical devices and / or sharp members housed therein. The distal cap or seal is removed from the housing 1102 as shown in FIG. The inserter 1100 includes a base 1142 that defines a distal surface 1112 for placement on the subject's skin. The inserter 1100 can be used to advance a medical device into the subject's skin. In some embodiments, the manual actuator bar 1114 is pressed against the base 1142 to advance the medical device into the patient's skin. It should be understood that the inserter 1100 can include an adhesive layer (not shown) disposed over the distal portion 1112 of the base 1142.

  As shown in FIG. 23, in the initial configuration of the inserter 1100, the sharp member 1124 is disposed in a configuration spaced from the distal portion 1112 of the base 1142. Advancing the actuator bar 1114 distally may result in manual advancement of the actuator.

  The body wearing unit inserter 1128 includes a carriage 1130 that supports the body wearing housing 122. A retraction spring 1146 is disposed between the needle carrier 1134 and the base 1102. In the initial state, the reverse spring 1146 is in a compressed state. When the actuator bar 1114 is moved distally, the carriage 1128 is moved distally to reach the distal position and the flange 1188 of the base 1142 engages the finger 1186 disposed on the shuttle 1134. It is like that. Finger portion 1186 is rotated outward by flange 1188. By such rotation of the finger portion 1186, the finger portion 1186 is detached from the shoulder portion 1187 of the inner rail 1128. Thereby, the shuttle 1134 is detached from the inner rail 1128. The distal surface of the body-worn housing 122 engages the upper surface of the skin or adhesive pad (not shown), thereby adhering to the subject's skin surface (FIG. 24).

  As shown in FIG. 25, when the shuttle 1136 is disengaged from the inner rail 1028, the spring 1146 is biased to expand, thereby advancing the needle carrier 1136 to a proximal position and moving the sensor 14 into the skin. The sharp member 1124 is pulled out from the skin S of the subject in the state where it is left. Once the sharp member 1124 is withdrawn from the subject, the sharp member 1124 can no longer be accessed from the distal portion of the inserter 1100 and cannot accidentally contact the subject's skin.

  A further embodiment of the inserter is shown in FIGS. The inserter 1200 is substantially the same as the inserters 900, 1000, and 1100 described herein, where substantial differences are described and illustrated in the accompanying drawings.

  The inserter 1200 includes a housing 1202, a body-mounted unit inserter 1228, a needle retractor 1234, and a rotor 1208 having a torsion spring (not shown), each shown in FIGS. 28-31. ing. As shown in FIGS. 28-31, the housing 1202 includes a slot 1254, the body wear unit inserter 1228 includes a slot 1252, a tab 1253 and an opening 1262, and the needle retractor 1234 includes a tab 1250 and an opening 1260. And the rotor 1208 includes a rotor follower 1264.

  FIG. 32 shows an exploded view of the inserter 1200. As shown, in some embodiments, the inserter 1200 includes a housing 1202, a body wear unit inserter 1228, a needle retractor 1234, and a rotor 1208. Tab 1250 may be disposed on needle retractor 1234, and tab 1250 engages slot 1252 disposed in body wear unit inserter 1228 when assembled, as shown in FIG. May be configured. A tab 1253 may be disposed on the body-mounted unit inserter 1228, and the tab 1253 may be configured to engage a slot 1254 disposed in the housing 1202. Needle retractor 1234 and body-worn unit inserter 1228 may each include openings (1260, 1262) that receive a rotor follower 1264 disposed on rotor 1208 after insertion of rotor 1208 into housing 1202. Further, the body wear unit inserter 1228 may provide support for placing a body wear housing 122 (not shown) on the subject's skin.

  As shown in FIG. 34, in some embodiments, when the body-worn unit inserter 1228 is manually depressed, the rotor 1208 can be guided in the cam path to rotate and wind a torsion spring. As shown in FIG. 35, as the body-worn unit inserter 1228 continues to advance distally, the rotor follower 1264 “crosses the center” within the cam 1264. At this point, the torsion spring (not shown) can be rewound. (FIG. 93). Referring to FIG. 36, the torsion spring is further rewound to lift the needle retractor 1234 from the insertion site while leaving the body-mounted unit inserter in place.

  A further embodiment of the inserter is shown in FIGS. The inserter 1300 is substantially identical to the inserters 900, 1000, 1100 and 1200 described herein, where substantial differences are described and illustrated in the accompanying drawings.

  Inserter 1300 includes a housing 1302, a body-mounted unit inserter 1334, a needle retractor 1334, and a rotor 1308 having a torsion spring 1367. As shown in FIGS. 37, 38, 39, 45 and 46, the body-mounted unit inserter 1334 and the needle retractor 1328 are disposed in the housing 1302. The rotor 1308 includes a rotor follower 1364 that engages a slot 1362 provided in the needle retractor 1328 and a slot 1360 of the body wear unit inserter 1334. The body wearing unit inserter 1334 provides a support unit that supports the body wearing housing 1302 (not shown).

  In operation, a torsion spring 1365 is loaded. A release button (not shown) is pressed to release the torsion spring 1365. The rotor 1308 drives the body-mounted unit inserter 1334 and the needle retractor 1328 downward simultaneously. A compression spring 1367 holds the body wear unit inserter 1334 down. As rotor 1308 continues to rotate, slot 1360 allows body wear unit inserter 1334 to move downward and be held down, while slot 1362 allows needle retractor 1328 to move downward. The needle can then be retracted to lift it from the insertion site.

  A further embodiment of the inserter is shown in FIGS. The inserter 1400 is substantially the same as the inserters 900, 1000, 1100, 1200 and 1300 described herein, where substantial differences are described and illustrated in the accompanying drawings.

  The inserter 1400 can be used in conjunction with a cartridge or carrier 1406 to install a medical device (eg, the body-worn housing 122). In some embodiments, the inserter 1400 includes a body 1402 and an actuator 1404. The carrier 1406 may include a needle hub 1436 that includes a sharp member (not shown) and a body-worn housing 122. In use, the body 1402 is placed on a mount 1408 that is attached to a subject using an adhesive pad 1418. As shown in FIG. 47, the carrier 1406 is loaded into the inserter 1400 laterally as shown.

  Referring to FIG. 48, the first disposable portion of the inserter 1400 includes an adhesive pad 1418 and a mount 1408. The second disposable portion of the inserter 1400 includes a carrier 1406 that attaches and detaches a needle hub 1436 and a sensor hub 1437 (not shown) that is substantially identical to the body-worn housing 122 described herein. Accommodate as possible. The inserter 1400 further includes a main body 1402, an actuator 1404, and a return spring 1409 (not shown). The mount 1408 is detachably attached to the main body 1402. The carrier 1406 can slide over the body 1402 to move the needle hub 1436 and the carrier 1406 to the inserter 1400. Next, the carrier 1406 can be removed from the inserter 1400 as shown in FIG. Needle hub 1436 and sensor hub 1437 remain within inserter 1400. Next, an adhesive pad 1418 is applied by gluing to the subject's skin. Alternatively, the adhesive pad 1418 may be applied to the subject's skin prior to attachment of the body 1402 and mount 1408.

  49, manual insertion of the needle hub 1436 and sensor hub 1437 is performed with the actuator 1404 depressed, the needle placed on the needle hub 1436, and the distal sensor portion penetrating the subject's skin. When pressure is released from the actuator 1404, a return spring 1409 (not shown) causes the needle to retract from the subject's skin and the sensor hub 1437. As shown in FIG. 50, the main body 1402 can be removed from the mount 1408 while the sensor hub 1437 remains in the mount base 1408. In FIG. 51, in some exemplary embodiments, carrier 1406 slides over housing 1402 to move needle 1436 to carrier 1406. The carrier 1406 can then be removed from the housing 1402 along with the needle 1436 and appropriately discarded, and the inserter 1400 is ready for reuse. Next, a communication electronic device (not shown) is attached to the mount base 1408 and is in electrical contact with the sensor hub 1437.

  A further embodiment of the inserter is shown in FIG. The inserter 1500 is substantially the same as the inserters 900, 1000, 1100, 1200, 1300 and 1400 described herein, where substantial differences are described and illustrated in the accompanying drawings.

  The inserter 1500 includes a housing 1502 that can be manufactured as a molded plastic tube and can further include a living hinge cap 1504. In some embodiments, the living hinge is a thin, flexible plastic joint that connects two mating parts. The hinge can be folded completely without failure to hold these parts attached and allow the two parts to fit together.

  The cap 1504 may further be provided with a notch for providing a portion for applying an index finger to restrict the insertion operation along a desired axis. After the bellows-button assembly (described herein) is provided, the cap 1504 is closed and bonded to the housing by chemical bonding or ultrasonic bonding.

  The inserter further includes a bellows 1506. In some embodiments, the bellows portion 1506 is constructed of a molded thin wall plastic and the bellows portion 1506 is integrated with a compression spring that provides a force that retracts during insertion and retracts the sharp member 1524 after insertion. Has been. Further, the bellows portion 1506 is hidden so that the sharp member 1524 is not exposed. An upper portion 1520 of the bellows portion 1506 is fixed to the button 1514, and a bottom portion 1521 is fixed to the housing 1502.

Button 1514 allows the user to insert body-worn housing 122 into the subject's skin. The button 1514 may be made of plastic and may further include an anti-rotation element that limits movement to the desired longitudinal axis (eg, a recess 1515 that slides along the longitudinal ridge 1517). Needle hub 1536 is glued to button 1514 or molded directly to button 1514. Sharp member 1524 is securely held in body-worn housing 122 described herein. (See, for example, FIGS. 11-13.)
The adhesive patch 1518 fixes the body-worn casing 122 to the subject's skin. In some embodiments, the adhesive patch 1518 includes a highly cohesive (ie, strong adhesive) region that contacts the skin. A protective liner is provided that is removed prior to insertion. A low adhesion region 1530 for facilitating removal of the housing 1502 after the insertion is completed is provided on the outer peripheral portion of the patch facing the adhesive patch inserter 1500. In the center of the patch, a high adhesion region 1532 is provided for fixing the body mounting casing 122 to an appropriate position.

  53 to 55, an inserter kit 1600 is shown, and an inserter 2310 and an adhesive mount 2312 are detachably attached to the bottom thereof. The inserter 1600 is further described in US Pat. No. 7,381,184, which is incorporated herein by reference for all purposes.

  After preparing the insertion site (generally the abdominal region) on the skin, the user removes the liner (not shown) from the adhesive mount 2312 and the bottom surface of the adhesive tape 2320 disposed under the mount 2312. Expose part of the top surface. Next, a mount 2312 with an inserter 2310 attached is applied to the subject's skin insertion site. When actuator button 2324 is depressed, inserter 2310 is fired, thereby inserting sensor 2314 into the subject's skin at a predetermined speed and force. Once the sensor 2314 has been inserted into the skin, the patient pushes the inserter 2310 from the mount 2312 by pressing release tabs (not shown) on both sides of the inserter 2310 and lifting the inserter 2310 away from the mount 2312. Remove.

  Once the inserter 2310 is removed from the mount 2312, the communication electronic device (not shown) can be slid into place. After the communication electronic device is completely placed on the mount 2312, the communication electronic device circuitry is in electrical contact with the contact pads of the sensor 2314. Once the initialization and synchronization procedure is complete, electrochemical measurements from sensor 2314 can be transmitted wirelessly from the communication electronics to the receiver unit.

  In some embodiments, housing 2334, actuator button 2324, drive spring 2336, shuttle 2338, introducer sharp member 2340, sensor 2314, retraction spring 2342, inserter base 2344, top liner (not shown), adhesive mount The inserter kit 1600 is assembled from components such as 2312, adhesive tape 2320 and a lower liner (not shown).

  Shuttle 2338 is limited on base 2344 to be slidable and non-rotating by arcuate guide 2360. The shuttle 2338 is generally formed by an outer ring 2362 and a cup-shaped inner post 2364 connected by two bridges 2366. Bridge 2366 slides between two slots (not shown) formed between guides 2360 to allow shuttle 2338 to move along guides 2360 without rotating. The outer periphery of retraction spring 2342 is captured by guide 2360, the bottom is captured by floor 2370 of base 2344, the top is captured by bridge 2366, and the inner periphery is captured by the outer surface of shuttle post 2364. The bottom and outer periphery of the drive spring 2336 are captured by the inner surface of the shuttle post 2364, the top is captured by the ceiling 2372 inside the actuator button 2324, and the inner periphery is captured by the stem 2374 extending from the ceiling 2372. As drive spring 2336 is compressed between actuator button 2324 and shuttle 2338, drive spring 2336 biases shuttle 2338 toward base 2344. As the retract spring 2342 is compressed between the shuttle 2338 and the base 2344, the retract spring 2342 biases the shuttle 2338 toward the actuator button 2324.

  As shown, after firing, the retraction spring 2342 returns the shuttle 2338 to the neutral position while the sensor 2314 remains inserted into the subject's skin. The drive spring 2336 is designed to be more rigid than the retraction spring 2342 so that the vibration of the shuttle 2338 is immediately damped so that the introducer sharp member 2340 does not return to the sensor 2314 or the patient and cause injury. It is preferable. With the sensor 2314 inserted into the subject's skin, the inserter 2310 can be removed from the mount 2312 and the inserter 2310 is then lifted away from the mount 2312. When the inserter 2310 is discarded, the introducer sharp member 2340 remains protected within the housing 2334. As described above, at this point, the communication electronic device can be slid into place on the mount 2312.

  In some embodiments, the proximal portion of stem 2374 is enlarged to create an interference fit with the coil of spring 2336. For example, the stem 2374 is provided with one or more laterally extending ribs 2610. The interference fit between the rib 2610 and the spring 2336 generally occurs in the coil proximal (upper) of the spring 2336.

  The coil diameter of spring 2336 increases slightly when compressed and decreases slightly when extended. The ribs 2610 of the stem 2374 cause maximum interference when the spring 2336 is extended. The interference fit increases the stability of the shuttle 2338 during insertion. In some embodiments, the interference fit prevents or inhibits distal movement of the spring 2336 that can cause the spring 2336 to impact the shuttle 2338 at the end of distal movement of these components.

  56-70, in another exemplary embodiment, the inserter 2600 generally includes an actuator button 2602 (FIG. 57), a shuttle 2604 (FIG. 58), and an edge 2612 that penetrates the skin. It includes an inserter sharp member 2610 (FIG. 58), a retraction spring 2608 (FIG. 59), a sensor 2614 (FIG. 60), a housing 2616 (FIG. 61), and a base 2618 (FIG. 62). It should be understood that the inserter 2600 can include additional components or fewer components than those described herein. The inserter 2600 is substantially the same as the inserter 1600 described herein, where substantial differences are described and illustrated in the accompanying drawings. An assembly of the various components of the inserter 2600 is shown in FIGS. As shown in FIG. 63, the actuator button is configured to slide through the opening of the shuttle 2604 and be locked there in place. Further, as shown in FIG. 64, the retraction spring 2608 is configured to be inserted into a second opening on the opposite side of the shuttle 2604. Further, in this view, sensor 2614 is attached to inserter sharp member 2610. As shown in FIG. 60, the sensor 2614 includes a biasing arm 2615 that positively places the sensor 2614 within the inserter sharp member 2610. Thereby, the inserter sharp member 2610 and the sensor insertion part 30 can be made smaller, and the trauma and pain of the subject can be reduced. Any number of the sensor connection methods described above can be used in connection with the inserter 2600. For example, as described above, the inserter sharp member 2610 can be provided with rails and depressions for holding the sensor 2614. Sharp member 2610 has a diameter from about 20 gauge to about 26 gauge (eg, 21 gauge to about 25 gauge), and in particular embodiments, the sharp member is 21 gauge, 23 gauge, or 25 gauge. Such sharp members can be used with sensors in which at least the width or diameter of the portion carried by the sharp member is about 0.20 mm to about 0.80 mm (eg, about 0.25 mm to about 0.60 mm). In some embodiments, the width or diameter of at least a portion of the sensor is 0.27 mm, 0.33 mm, or 0.58 mm.

  FIG. 66 shows a cross-sectional view of the assembly of FIG. 65 after the inserter 2600 is fully assembled (casing 2616 joined to base 2618). As shown, when the inserter 2600 is assembled, the retraction spring 2608 is surrounded by the sides of the guide 2622 and the shuttle 2604 and base 2618. Further, the shuttle 2604 is configured to slide on a rail (not shown) in the base 2618 so that the shuttle 2604 can move in a linear direction when the actuator button 2602 is depressed. FIG. 66 shows the actuator button 2602 locked to the shuttle 2604 using the first detent groove of the two detent grooves 2607. In this configuration, shuttle 2604 and actuator button 2602 are locked to housing 2616 and base 2618 to prevent the shuttle from being misplaced during shipping and handling. With this configuration, the package can also be made quite small, resulting in lower shipping costs and improved bulk processing efficiencies such as sterilization. FIG. 67 shows the actuator button 2602 locked to the shuttle 2604 using the second detent groove 2607 of the two detent grooves 2607. In this configuration, the shuttle is ready to be deployed. When the user pulls the actuator button 2602 and the housing 2616 in the axial direction, the actuator button 2602 is moved to the second detent groove 2607.

  68-70 illustrate the process used to position sensor 2614 using inserter 2600. FIG. FIG. 68 shows the inserter 2600 in the first configuration. The upward force exerted on the shuttle 2604 (and consequently the actuator button 2602) by the retraction spring 2608 holds the inserter 2600 in the raised position of the first configuration. When the user presses the actuator button 2602 against the bias of the reverse spring 2608, the actuator button 2602 exerts a downward force on the shuttle 2604 and the reverse spring 2608. As a result, introducer sharp member 2610 with attached sensor 2614 is driven down into the subject's skin (eg, to the second configuration). As shown in FIG. 69, an edge 2612 that penetrates the skin penetrates the subject's skin, allowing the sensor 2614 to be properly inserted.

  When the force is removed from the actuator button 2602, the retraction spring 2608 exerts an upward force on the shuttle 2604, thereby bringing the introducer sharp member 2610 into its original position within the housing 2616 (eg, the first configuration). To return proximally. As shown in FIG. 70, the sensor 2614 remains implanted in the patient's skin. In this position, the plunger is bent approximately 90 degrees by the user, preventing further use of the device and providing a clear visual and tactile indication that the device has been used and is ready for disposal. .

  In another aspect of the presently disclosed subject matter, an inserter assembly as shown in FIG. 71 is provided that is useful for placing a medical device, such as an analyte sensor, in a subject's skin. The inserter assembly 4300 may include an inserter, a medical device such as an analyte sensor, and a mount for positioning the medical device at least partially in or on the subject's skin. In some embodiments, the mount is a support structure, support plate and / or support member that is attached to, adhered to, or otherwise secured to the subject's skin. The mount can be applied to the subject's skin simultaneously with the medical device by an inserter. In other embodiments, the mount is installed before or after installation of the medical device. The mount can be applied by an inserter or separately. The mount is a feature or structure (e.g., adhesive, guide, barb, Tabs, etc.).

  The inserter assembly 4300 is useful in an analyte measurement system (eg, a glucose measurement system) that includes a body-worn unit that can be assembled on a subject's skin. For example, the body wearing unit may include a sensor and a sensor control unit. The sensor is generally installed inside the patient. Next, a sensor control unit is installed and connected to the sensor. In other embodiments, the sensor control unit is first installed on the patient, and then the sensor is installed and connected to the sensor control unit. In yet another embodiment, the sensor and sensor control unit are installed and connected simultaneously. In order to arrange the sensor and / or sensor control unit, a mount provided as necessary may or may not be used.

  In general, the inserter assembly 4300 is useful for placing a sensor in a subject's skin. A sensor (not shown) may be preloaded in the inserter 4310 prior to installation. After preparing the insertion site on the subject's skin, the user removes the top liner 4316 and the bottom liner 4318 from the mount 4312 to expose the bottom surface and a portion of the top surface of the adhesive tape disposed on the bottom surface of the mount 4312. Let Next, a mount 4312 with an inserter 4310 attached is applied to the subject's skin insertion site. In some embodiments, the mount 4312 is first attached and then the inserter is connected or disposed within and / or adjacent to the mount 4312. The inserter includes an actuator button 4324. When the actuator button 4324 is pressed, the inserter 4310 is fired, thereby inserting the sensor into the user's skin. As described herein, in certain embodiments, the sensor is installed at a predetermined speed and force when activated. In some embodiments of the presently disclosed subject matter, the inserter includes a safety member that prevents operation of the inserter as described below.

  In some embodiments, sensor 4314 remains disposed on mount 4312 by one or more placement techniques. For example, as shown in FIG. 72, sensor 4314 has a surface 4356 extending orthogonally from major surface 4346. The surface 4356 may include an adhesive that contacts the subject's skin 4328 or mount 4312. In some embodiments, the raised end stop 4444 of the mount 4312 is provided with a raised bead or ridge that is received in the aperture of the sensor 4314. Once the sensor 4314 has been inserted into the skin, the user then mounts the inserter 4310 by, for example, pushing the release tabs 4326 on either side of the inserter 4310 and lifting the inserter 4310 away from the mount 4312. 4312 may be removed. In some embodiments, the inserter 4310 is held by other techniques (eg, an interference or snap fit with the mount 4312).

  Once the inserter 4310 is removed from the mount 4312, the sensor control unit 4330 can be placed in an appropriate position relative to the mount 4312. After the sensor control unit 4330 is disposed on the mount 4312, the circuit of the sensor control unit 4330 is in electrical contact with the contacts of the sensor 4314. For example, as shown in FIG. 72, the seal has an outer wall that surrounds electrical contacts (not shown in FIG. 72) of sensor 4314 and an inner wall that insulates the electrical contacts from each other. In some embodiments, the rails of sensor control unit 4330 are slidable within corresponding rails or grooves 4434 of mount 4312.

  In some embodiments, once the initialization and synchronization procedure is complete, electrochemical measurements from the sensor 4314 are transferred from the sensor control unit 4330 to a monitor unit (eg, the portable monitor unit 4332 shown in FIG. 73, etc.). ). Sensor control unit 4330 and monitor unit 4332 communicate via connection 20 (in this embodiment, a wireless radio frequency (RF) connection). The communication can be performed via, for example, RF communication, infrared communication, “Bluetooth” communication, “Zigbee” communication, 802.1x communication, WiFi communication, or the like. In some embodiments, the communication may include radio frequencies such as 433 MHz, 13.56 MHz. In some embodiments, communication between sensor control unit 4330 and monitor unit 4332 may include wireless automatic identification (RFID) technology and may be active RFID or passive RFID. In some embodiments, passive RFID technology and individual system components include the components necessary to do so. For example, in one embodiment, the monitor unit may include a backscatter RFID reader configured to transmit the RF field, where the antenna is tuned when the sensor control unit is within the transmitted RF field. Then, a reflected signal or a response signal (for example, a backscatter signal) is supplied to the monitor unit. The reflected signal or response signal may include analyte level data sampled from the analyte sensor. Additional exemplary details of various embodiments can be found, for example, in US patent application Ser. No. 12 / 698,124, filed Feb. 1, 2010, with reference to that disclosure for any Intended and incorporated herein.

  Sensor 4314, mount 4312 and sensor control unit 4330 may remain in place on the subject for a predetermined maximum period of time that may include hours, days, weeks, months or longer. In some embodiments, these components are then removed so that the sensor 4314 and mount 4312 can be properly disposed of. The entire procedure described above can be repeated using a new inserter 4310, sensor 4314, and mount 4312 and reusing the sensor control unit 4330 and monitor unit 4332. In other embodiments, the inserter 4310 is reusable.

  74, an inserter assembly 4300 according to one embodiment includes a housing 4334, an actuator button 4324, a drive spring 4336, a shuttle 4338, an introducer sharp member 4340, a sensor 4314, a retraction spring 4342, as shown. It can be assembled from components such as an inserter base 4344, an upper liner 4316, an adhesive mount 4312, an adhesive tape 4320 and a lower liner 4318.

  In some embodiments, sensor major surface 4346 is slidably mounted between U-shaped rails 4348 of introducer sharpening member 4340. In certain embodiments, in addition to the retention member disposed on the introducer as described above, the sensor 4314 is placed on the sharp member 4340 during storage of the inserter 4300 and / or during insertion of the sensor 4314 into the subject's skin. A holding technique is provided for holding in place. For example, a sensor well (not shown) is provided that engages an introducer well (not shown). Introducer sharp member 4340 may be attached to surface 4354 of shuttle 4338, such as by adhesive, heat staking or ultrasonic welding.

  In some embodiments, the shuttle 4338 is constrained on the base 4344 to be slidable and non-rotating by an arcuate guide 4360. The shuttle can generally be formed by an outer ring 4362 connected by two bridges 4366 and a cup-shaped inner post 4364. The bridge 4366 may be configured to slide between two slots 4368 formed between the guides 4360 so that the shuttle 4338 can move along the guides 4360 without rotating. In some embodiments, a retraction spring 4342 is provided. The outer periphery of retraction spring 4342 can be captured by guide 4360, the bottom can be captured by floor 4370 of base 4344, the top can be captured by bridge 4366, and the inner periphery can be captured by the outer surface of shuttle post 4364. In some embodiments, a drive spring is provided for advancing sensor 4314 and sharp member 4340 into the subject's skin. For example, the bottom and outer periphery of the drive spring 4336 are captured by the inner surface of the shuttle post 4364, the top is captured by the ceiling portion 4372 inside the actuator button 4324, and the inner periphery is captured by the stem 4374 extending from the ceiling portion 4372. In some embodiments, the drive spring is omitted from the inserter assembly. In such a case, for example, sensor 4314 and sharp member 4340 are advanced distally by hand forces applied by the user.

  As the drive spring 4336 is compressed between the actuator button 4324 and the shuttle 4338, the drive spring 4336 can bias the shuttle 4338 toward the base 4344. As the retraction spring 4342 is compressed between the shuttle 4338 and the base 4344, the retraction spring 4342 biases the shuttle 4338 toward the actuator button 4324.

  As shown in FIGS. 74 to 75 and as described above, when the sensor 4314, the introducer 4340, the shuttle 4338, the retraction spring 4342, the drive spring 4336, and the actuator button 4324 are assembled between the base 4344 and the housing 4334, The housing 4334 is snapped into place on the base 4344. Base 4344 is held on housing 4334 by upper base barb 4390 that engages upper opening 4392 of housing 4334 and lower base barb 4394 that engages lower opening 4396 of housing 4334. . Further details regarding the construction and operation of inserter 4300 are set forth in US Pat. No. 7,381,184, which is incorporated herein by reference in its entirety for all purposes.

  In some embodiments, retention techniques and / or retention structures are provided to assist in supporting the sensor 4314 with the sharp member 4340 during storage and insertion. As shown in FIGS. 76 to 90, a holding mechanism disposed on the sensor and / or sharp member is provided.

  FIGS. 76-77 show a sensor 4514 provided with one or two laterally extending tabs 4560. Tab 4560 engages rail 4548 of sharp member 4540 for retention. In some embodiments, the rounded edges of the ears allow the ears to be formed by two punching operations, for example, drilling and longitudinal cutting. The gap between the left hard stop 4549 and the top of the sensor 4514 creates a moment that biases the sensor tip into the sharp member channel during firing. During placement, the sensor is distorted and disengages from the sharp member.

  78-79 illustrate an inserter having a sensor retention mechanism according to a further embodiment of the subject disclosure. The sharp member 4640 is provided with a clip 4660 that engages a retention window 4462 on top of the sensor 4614 to provide retention and vertical positioning of the sensor 4614 within the sharp member 4640. Two drive blocks 4659 and 4661 of carrier 4654 traverse sharp member 4640 and engage the upper edge of sensor 4614. There is a gap between the left drive block 4659 and the upper edge of sensor 4614. The right drive block 4661 contacts the upper edge of sensor 4614. Upon insertion, the upward driving force by the skin on sensor 4614 creates a clockwise rotational moment on sensor 4614, thereby urging sharp member 4614 into the sharp member channel.

  Upon shipment, clip element 4660 and window 4661 can be moved to the left to bias the tip of sensor 4614 into the channel. During placement, sensor 4614 and clip 4661 are distorted, causing sensor 4614 to move toward mount 4312.

  FIG. 80 shows a further embodiment of a sensor retention technique. Specifically, the sensor 4714 is provided with a holding member 4760 extending from the contact portion 4732 of the sensor 4714. The holding member 4760 is elastically biased to the illustrated position. When sensor 4714 is inserted into a sharp member (not shown), the retaining member engages the interior of the sharp member rail (not shown) to provide a holding force for sensor 4714.

  FIG. 81 illustrates another embodiment of a sensor retention technique. Sensor 4814 is provided with a thermally formed recess 4860. As shown in FIG. 82, the ridge 4864 of the sharp member 4840 is in frictional contact with the thermally formed indentation 4860 to provide a holding force for the sensor 4814. In some embodiments, the ridge is formed using heat. In another embodiment, the ridge is formed in the sensor and the depression is formed in the sharp member.

  83 to 84 show an aperture 4960 formed at the contact portion of the sensor 4914. FIG. Sharp member 4940 is provided with a ridge or tab 4962. The interaction of tab 4962 within aperture 4960 of sensor 4914 causes sensor 4914 to be retained within the inserter.

  FIGS. 85-86 show a technique for holding the sensor 5014 similar to the technique shown in FIGS. 81-84. For example, the sharp member 5040 is provided with a raised portion 5062 that engages the contact portion 5032 of the sensor 5014. In such a configuration, the raised portion 5062 generates a biasing force against the contact portion 5032. Such a force acts as a frictional force to assist in holding the sensor 5014 within the sharp member 5040.

  87 and 88 show a sensor having a retaining member that engages a raised post or button of a sharp member. FIG. 87 shows that the contact 5132 of the sensor 5114 includes a pair of “tweezer fingers” 5160 having a generally arcuate configuration that engages and surrounds a post 5162 provided on the sharp member. Similarly, FIG. 88 shows a sensor 5214 having a pair of proximally extending arms 5260 that engage a sharp member post 5262.

  FIG. 89 shows a sensor 5314 having a laterally extending arm 5360 with a channel 5364 defined between the arm 5360 and the contact 5332 of the sensor 5314. As shown, a post 5360 may be disposed within the channel 5364 to provide a frictional resistance for maintaining the sensor 5314 within the sharp member.

  FIG. 90 shows a sensor 5414 having a proximally extending arm 5460 with a channel 5362 defined between the arm 5460 and the contact 5432 of the sensor 5414. As shown, the arm 5460 is provided with a tab 5364 that is received in a gap provided in the rail of the sharp member. This interaction between tab 5364 and the gap provides a frictional resistance to maintain sensor 5414 within the sharp member.

  FIGS. 91-92 refer to a sensor holding technique that includes a holding member that provides a friction force substantially perpendicular to the surface of the sensor. 91 and 92 show a holding member provided in the housing 5534 of the inserter 5510. FIG. For example, the retention member 5560 may extend distally from the housing 5534 and the laterally extending tab 5562 that contacts the sensor 5563 and provides a frictional force to assist retention of the sensor within the sharp member 5540. Can be included.

  93 and 94 show a retaining member provided with a base 5644 of an inserter 5610. FIG. For example, the retention member can include a cantilever 5660 extending proximally from the base 5644 of the inserter 5610. The cantilever 5660 can include a laterally extending member 5562 that contacts the sensor 5661 and provides a frictional force that assists in holding the sensor within the sharp member 5640. When the carrier 5666 reaches the bottom, the cantilever 5660 stops contacting and the sensor is released.

  95 and 96 show an elastic member or an elastomeric member disposed in the housing 5734 of the inserter 5710. FIG. For example, the elastomeric member 5760 is manufactured from TPE and pushes the sensor and the resulting friction holds the sensor in place. Since TPE material produces higher friction against the sensor, the pressure required to produce the sensor holding force is lower. When the inserter 5710 is actuated, the frictional force goes up, holding the sensor in the sharp member. When the carrier reaches the bottom, contact with the friction ribs ends and releases the sensor to the mount. In some embodiments, the elastomeric member 5760 or rib is provided in the housing 5734 by a second shot injection molding process or a press fit.

  97 and 98 refer to a holding member that provides a substantially coplanar friction force on the surface of the sensor. FIG. 97 shows the holding member, that is, the cantilever 5860 biased against the side edge of the contact portion 5832 of the sensor 5814. In some embodiments, the cantilever 5860 is provided on a carrier or sharp member (not shown). FIG. 98 shows a sensor holding technique that includes a holding member, ie a cantilever 5960 biased against a sensor as described in FIG. Cantilever 5960 includes a laterally extending portion that is at least partially received in a notch 5964 that is optionally provided in sensor 5914. Further, a second holding member, ie, a holding spring 5990, is provided that is biased to engage the front of the sensor. In some embodiments, the retention spring 5990 is partially received in the notch 5994 (or slot) to capture the sensor.

  In some embodiments, an inserter assembly is provided that includes a reusable inserter device. Repeated use of the inserter involves the use of a removable and replaceable sensor and sharp member that can be connected to the inserter during sensor placement, after which the sharp member is removed and discarded.

  99-101 show a sharp member / sensor pack 6002 system that includes a plurality of sensor / sharp member combinations 6006. As shown in FIGS. 99 and 101, a support is provided that includes a plurality of trays 6004 useful for containing a sensor / sharp member configuration 6006 and a desiccant 6010 contained in a chamber 6008. One side of the tray 6004 is provided with a well-shaped portion 6012 that accommodates a sensor sharp member installed in a patient. In order to maintain the sterility of the sensor / sharp member combination until it is placed in the subject, a cover such as a metal foil lid 6014 is applied to the top of the support. FIG. 100 is a perspective view showing an exemplary configuration of the pack 6002. The metal foil lid 6014 of each tray 6004 may include a tab 6016 to facilitate removal of the lid from the tray 6004. (FIG. 100, FIG. 101).

  102-105 illustrate a plurality of reusable inserters useful in combination with the sharp member / sensor pack 6002 described herein. FIG. 102 shows an inserter 6030 that includes a body portion 6032, a loading or cocking structure 6036, and an actuator button 6040 for placing the sensor into the subject's skin. The cocking structure that can be included in the advancement structure of the inserter 6030 is, for example, pulled to the arm by pulling the cocking structure 6036 from the housing 6932 or pushed to the arm by pushing the cocking structure 6036 into the housing 6032. Or rotated to the arm, for example, by rotating the cocking structure 6036 in a rotational movement parallel to the longitudinal axis of the inserter 6030 or perpendicular to the longitudinal axis of the inserter 6030. The drive mechanism of the inserter 6030 is the drive disclosed in U.S. Patent Application Publication No. 2008/0082166, U.S. Patent No. 6,197,040, or U.S. Pat. No. 4,976,724. It is generally similar to the mechanism and is incorporated herein by reference in its entirety for all purposes.

  The metal foil lid is removed from the sharp member / sensor pack 6002 to insert the sharp member / sensor combination into the inserter 6030. As shown in the direction of arrow E, the distal end portion 6034 of the inserter 6030 is disposed within the wall 6004 of the tray 6002. The distal end portion 6034 rests on the top surface of the desiccant chamber 6008 and the insertion sharp member remains exposed.

  FIG. 103 shows an inserter 6130 that is substantially identical to the inserter 6030 described herein. The inserter 6130 is used in connection with a sharp member / sensor tray 6102. The tray 6102 includes a desiccant chamber 6108 disposed in the central portion of the tray 6102. Accordingly, the channel 6112 surrounds the outer periphery of the desiccant chamber 6108. When the inserter 6130 is applied to the sharp member / sensor tray 6102, the distal end portion 6134 can be disposed within the channel 6112. As shown in FIG. 103, this configuration allows the sensor and sharp member to be fully contained within the inserter 6130.

  FIG. 104 shows an inserter 6230 that is substantially identical to the inserters 6030 and 6130 described herein, where differences are noted and shown in the accompanying drawings. The inserter 6230 can be used in connection with a sharp member / sensor tray 6204. The tray 6204 and inserter 6230 are sized to allow the entire tray 6204 to be placed within the distal end portion 6234 of the inserter 6230. One or more struts 6220 are provided adjacent to the distal end portion 6234 to stabilize the inserter against any surface on which the inserter 6230 and tray 6204 are placed for the insertion process. Also, the post 6220 can secure the inserter 6230 to an adhesive mount (not shown) during insertion.

  FIG. 105 shows an inserter 6330 that is substantially identical to the inserters 6030, 6130, and 6230 described herein, where differences are noted and shown in the accompanying drawings. The inserter 6330 can be used in connection with a sharp member / sensor tray 6304. In some embodiments, the tray 6304 includes a distally protruding handle portion 6340 that can be grasped by a user to facilitate insertion of the sharp member / sensor into the inserter.

  106-107 illustrate exemplary sharp member / sensor combinations for use with the inserters 6030, 6130, 6230, and 6330 described herein. Sharp member 6440 includes a side rail 6448 that slides and receives a sensor. Also, a locking tab 6450 is provided at the proximal portion of the sharp member, and the locking tab 6450 includes a cut-down portion 6452 that connects with the carrier of the inserter 6030 (or 6130, 6230, 6330). As shown in FIGS. 108-112, carrier 6466 includes a receiving structure for receiving in combination with sharp member 6440. For example, the carrier 6466 can include a pair of walls 6478 that provide a channel 6480 in which a sharp member 6440 can be disposed. The wall 6478 is provided with a notch 6482 for receiving a cut-down 6452 of the locking tab 6450. A pair of fixing members 6484 are movably attached to the carrier 6466. For example, member 6484 is biased toward the central portion of carrier 6466 by spring 6486. As shown in FIG. 111, the securing member 6484 can be moved outward against the bias of the spring to allow insertion of the locking tab 6450 into the notch 6482 of the carrier. The securing member 6484 is then released and returned to a position that engages the undercut 6452, preventing the sharp member and sensor from being accidentally removed from the inserter (FIG. 112). It should be understood that the sharp member and carrier coupling may be provided by other techniques such as interference fit, snap fit, bayonet type attachment, magnetic coupling, and the like.

  113-117 illustrate further reusable embodiments of the subject disclosure that are useful for use with the sharp members / sensor packs described herein. FIG. 113 shows a sensor pack 6504 similar to the sensor pack 6200 described herein. The sharp member / sensor pack 6504 also includes one or more reinforcing ribs 6574 to prevent accidental deformation of the pack 6504 when the sensor is inserted into the inserter.

  As shown in FIG. 114, an inserter 6530 is provided that is generally similar to the inserters 6030, 6130, 6230, and 6330 described herein, where differences are noted and shown in the accompanying drawings. Inserter 6530 includes a carrier (not shown) for coupling with a sharp / sensor combination. As shown, the inserter 6530 is lowered onto the sharp member / sensor pack 6504 to connect the sharp member 6506 with the carrier. At this point, an inserter 6530 containing a sharp member / sensor 6506 is placed on the mount 6512, as shown in FIG. Mount 6512 may include an adhesive for fixation to the subject's skin. The inserter 6530 includes a locking structure 6526 that allows the inserter 6530 to temporarily engage the mount 6512.

  As shown in FIG. 116, the sensor is placed by depressing the activation button 6532 of the inserter 6530 to advance the sensor into the skin using an internal drive mechanism such as a spring, for example. Alternatively, it should be understood that the procedure described above may be performed using an inserter that allows the user to manually apply a distal force to position the sensor.

  After the sensor is installed, the inserter 6530 is removed from the mount, for example, by depressing the locking button 6526 of the inserter 6530. Once the inserter 6530 is separated from the mount, the user may remove and discard the sharp member. In some embodiments, the inserter 6530 includes a slide lever 6540 that allows the sharp member to be removed. Removal of the sharp member from the carrier, for example, allows the fixation member (described herein) to slide outward to allow the contact portion 6483 of the fixation member 6484 to disengage from the cut-out portion 6452 of the locking tab 6450. It should be understood that it can be implemented in one of many ways, such as a slide switch.

  FIG. 118 shows the inserter 6630 and the engagement structure for attachment to the mount 6612. The inserter 6630 includes a body portion 6640 configured to advance the sharp member / sensor cartridge into the subject's skin S along the longitudinal axis LON. The longitudinal axis LON can be substantially perpendicular to the skin surface. In some embodiments, the axis LON makes an acute angle with the skin surface. Mount 6612 and inserter 6630 are each provided with complementary mount 6612 locking structure 6662 and inserter locking structure 6664. The inserter proceeds on the mount 6612 laterally (direction LAT). The inserter 6630 can be locked at an appropriate position around the rotation shaft 6626 by the rotation locking structure 6632. After such rotation, the engaging portion 6666 of the locking structure 6632 is received in the recess 6668 of the mount 6612. Inserting the sharp member / sensor cartridge 6650 between the inserter 6630 and the mount 6612 further secures the inserter to the mount. For example, the cartridge 6650 includes a raised tab 6654 that is slidable within a complementary groove 6652 provided in the inserter 6630 and mount 6612. The cartridge is inserted in a direction perpendicular to the direction in which the inserter is attached to the mount (for example, a direction perpendicular to the page surface).

  119-121 illustrate another embodiment of an inserter according to the presently disclosed subject matter. The inserter 6730 is useful for advancing medical devices such as analyte sensors into the skin of the subject. The inserter 6730 includes a hammer member 6760 that stores advance energy to provide a faster and stronger advance stroke. As shown in FIG. 119, the hammer member 6760 is initially positioned somewhat obliquely with respect to the longitudinal axis of the device. As the alignment trigger 6734 is advanced distally, the alignment sleeve 6736 gradually rotates the hammer member 6760 to the longitudinal configuration. As the hammer member 6760 is pivoted to the proper position, the advance spring continues to be compressed. Referring to FIG. 120, the hammer member 6760 is pivoted to align with the central hole of the inserter 6730, for example, along a longitudinal axis indicated by an arrow. As a result, the tension of the advance spring 6742 is released immediately and the hammer member 6760 can move rapidly distally. When hammer member 6760 contacts carrier 6744, carrier 6744 contacts sharp member / sensor combination 6712 and moves distally.

  As shown in FIG. 121, the ledge or transverse member 6726 is provided with an inserter bore. As the hammer member 6760 is advanced distally, the distal surface of the hammer member contacts the ledge 6726. The mutual engagement between the hammer member 6760 and the ledge 6726 prevents the hammer member 6760 from moving further distally.

  FIG. 122 illustrates an exemplary embodiment of a simplified unit or cartridge 6800 that holds certain components for sterility and subsequent interaction with a subject. In some embodiments, the components include a sharp member 6840, a housing 6860, and a sensor 6814. The cartridge 6800 may be used in connection with any of the inserters 6030, 6130, 6230, 6330, 6530, and / or 6730 described herein. In some embodiments, the cartridge includes a housing and a lid that contain a sharp member and a sensor therein. In some embodiments, an elastic member or other cantilever structure is used to maintain the alignment of the sharp member and the sensor within the cartridge. The interaction between the cartridge and the inserter advances the sensor and sharp member so that the sensor is placed on the subject.

  As shown in FIGS. 123 to 124, the sharp member 6840 and the sensor 6814 may be disposed in the recess of the disposable cartridge 6800. A spring finger or cantilever 6876 on the housing lid maintains the load on the sharp member 6840 and the sensor 6814 to hold the sensor 6814 depressed in the cavity. The attachment of the lid to the base of the cartridge housing 6860 is not shown in the above drawing, but methods such as snap, heat staking, or ultrasonic welding are used to join the two housings in the assembly. Can be. The sensor 6814 is laterally transverse by the two rounded edges 6848 of the sharp member and orthogonal (in relation to the above figures) by the two bent tabs 6849 of the sharp member 6840 and the cartridge housing base cavity. In the direction, it is accommodated in the sharp member 6840. The sharp member is held in a lateral position by a raised pyramid element 6878 shown on the housing base 6870 in addition to the cavity. In the above drawing, the placement pyramid is placed in the opening 6882 caused by the curved tab of the sharp member. Engaging elements that place / attach / engage the cartridge to the inserter portion of the device are not shown in the above figures, but may include elements as shown in FIGS. 106-112 above.

  As shown in FIGS. 125 and 126, when the cartridge 6800 is loaded into the reusable inserter portion of the device, the sharp member is lifted from the cavity by a stationary element incorporated in the inserter (not shown). . The reusable portion features of the inserter enter through two short slots 6864 shown in FIG. These features remain stationary throughout the sensor delivery operation of the inserter device.

  Within the longer intermediate slot 6866, the stepped element of the inserter mates with the sharp member opening (shown as two holes 6864 in the above figure). The stepped portion of the element applies a force to the rear of the sharp member and keeps the sharp member lifted against the force of the cantilever 6876 that has sprung up the housing. This element of the inserter moves relative to the cartridge and provides sharp member drive and retraction through the insertion and delivery of the sensor. In some embodiments, this force is transmitted via a drive pin that is part of the movable part of the inserter device. The drive pin protrudes through hole 6864. When the displacement of the drive pin (not shown) is small, the sharp member is restricted from being tilted and lifted by the rib of the lid of the cartridge housing.

  Once the sharp member and sensor are lifted from the cavity portion of the cartridge, they are no longer limited by the recessed cavity portion of the housing base and the pyramid elements that maintain the position of the sharp member. The sharp member is held in a lifted position by a stationary stepped drive element of the inserter in a state balanced by the force of the cantilever fingers of the lid housing. The sensor is held in an appropriate position by being sandwiched between the cantilever fingers of the housing lid. The sharp member is limited to the retracted position by the mating drive element of the inserter.

  When the inserter is actuated, the sharpened member is driven downward as the combined inserter drive element moves through the long slot shown in the above figure (see FIGS. 127-129). To do. The driven sharp member slides along the stationary rib of the inserter, the rib-like element incorporated in the cartridge housing, and the cantilever fingers of the housing lid. The cantilever friction forces hold the sensor against the “drive block” bend of the sharp metal sheet, ensuring that the rear end is not exposed from the sharp member channel during insertion. In some embodiments, the “drive block” element is a longitudinal restriction incorporated into the sharp member or carrier to restrict the sensor from moving proximally relative to the sharp member. In another embodiment, the drive block element is a carrier protrusion or sharp member bend that pushes the sensor when the sharp member is advanced distally.

  The sensor is held against jumping on the drive block element by stationary ribs incorporated in the housing lid. When the cantilever slides on the upper edge of the sensor, the holding force is released from the sensor, and the sensor can be captured by the mount portion of the apparatus with a relatively small force. Alternatively, if geometrically possible and the fingers are properly positioned, pinching the cantilever of the sharp member is sufficient for the sharp member to return, even if the mount does not have a capture device. Resistance can be applied to hold the sensor in the inserted position. The drive element of the inserter then retracts the sharp member with the sensor left in place on the mount (attached to the skin) of the device.

  The cartridge can be removed from the inserter. When the cartridge is removed, the force from the cantilever on the housing lid pushes the sharp member back into the recess in the cartridge base housing. The base housing can be removed and discarded.

  Another embodiment of the cartridge is shown in FIGS. In this embodiment, as shown in FIG. 131, sharp member 6940 and sensor 6914 abut against ribs 6972 and 6974 and the insertion surface, and until the insertion surface, sharp member 6940 is driven into the skin by the inserter and Retreated. The sharp member and sensor are held in place by a central cantilever element 6976 incorporated in the cartridge lid housing 6970. The cantilever 6976 has a geometric shape such that the vertical portion of the end of the cantilever abuts the sharp member 6940 and the sensor 6914.

  As shown in FIGS. 132 and 133, the cartridge 6900 is loaded into the inserter. In the inserter, the stationary element (not shown) of the inserter lifts the cartridge cantilever so that the ramp of the cantilever end element coincides with the insertion surface of the sharp member. Also, an inserter drive element (not shown) fits through the slot opening of the sharp member. In the embodiments described herein, the drive element of this design does not require a step.

When the sharp member is driven downward (see FIGS. 134-135), the cantilever arm 6976 is pushed up to hold the sensor in place with respect to the sharp member 6940. The stationary rib of the housing lid ensures that the sharp member 6940 maintains its insertion surface during insertion and prevents the sensor from jumping over the drive block element integrated into the sharp member due to the clamping force of the cantilever. to be certain. (Through the insertion operation, the stationary rib holds the sensor flat against the sharp member.)
As shown in FIGS. 136-137, the sensor 6914 is captured by the mount as it moves to the bottom, as described herein above. The drive element of the inserter retracts the sharp member 6940 back to the starting position. Cantilever arm 6976 returns to its original unbiased configuration. The cartridge 6900 can be removed from the inserter and discarded.

  It should be understood that the subject matter described herein is not limited to the specific embodiments described, but can of course vary. Also, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present subject matter, which is intended to It should be understood that it is limited only by the scope of the claims.

14, 2314, 2614, 4314, 4514, 4614, 4714, 4814, 4914, 5014, 5114, 5214, 5314, 5414, 5814, 5914, 6814, 6914 Specimen sensors 124, 924, 1024, 1124, 1524, 2610, 4340 , 4640, 6440, 6840, 6940 Sharp member 900, 1000, 1100, 1200, 1300, 1400, 1500, 2310, 2600, 4300, 5610, 5710, 6030, 6130, 6230, 6330, 6530, 6630, 6730 Inserter 902 Handles 946, 1046, 1146, 2342, 2608 Retraction springs 947, 1047 Advance springs 986, 1186 Finger portions 1002, 1102, 1202, 1302, 1402 1502, 2616, 4334, 5534, 5734 Housing 1028, 1228, 1334 Body-mounted unit inserter 1084 Side button 1114 Actuator bar 1208, 1308 Rotor 1234, 1334 Needle retractor 1264, 1364 Rotor follower 1367 Torsion spring 1404 Actuator 1506 Serpentine 1514 Button 1600 Inserter kit 2324, 2602, 4324, 6040 Actuator button 2336, 4336 Drive spring 5660, 5860, 5960, 6876, 6976 Cantilever 5994 Notch 6532 Actuation button 6760 Hammer member 6734 Alignment trigger 6736 Alignment sleeve

Claims (10)

A device for inserting a medical device through the skin of a subject,
A housing defining a longitudinal cavity therein; an interference member extending into the cavity;
A biasing member;
A drive member connected to the biasing member for movement from a proximal position to a distal position, wherein the interference member prevents the drive member from moving distally; A drive member further configured for movement between an aligned configuration wherein the interference member does not impede distal movement of the drive member;
An actuator having an alignment surface for moving the drive member from the misaligned configuration to the aligned configuration;
A device comprising:   The apparatus of claim 1, wherein the actuator is movable from a proximal position to a distal position.   The apparatus of claim 1 wherein the first biasing member is compressed by distal movement of the actuator.   The apparatus of claim 1, wherein the first position of the drive member is at an oblique angle with respect to the longitudinal cavity.   The apparatus of claim 1, wherein the second position of the drive member includes a configuration that is substantially aligned with the longitudinal cavity. A device for inserting a medical device through the skin of a subject,
A housing defining a cantilever member;
A sharp member movable from a retracted position in the housing to a partially exposed position;
An electrochemical sensor releasably connected to the sharp member for movement with the sharp member and subsequent insertion into the subject's skin;
With
The cantilever member is in elastic contact with at least one of the sharp member and the sensor.   The apparatus of claim 6, wherein the housing includes a distal opening for releasing the electrochemical sensor from the housing.   The apparatus of claim 6, wherein the housing defines a longitudinal notch for receiving a drive member of an inserter.   The apparatus of claim 6, wherein the housing contains a desiccant.   7. The apparatus of claim 6, wherein the housing defines one or more longitudinal ridges for aligning one of the sharp member and the sensor.

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