(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2013/0150691 A1
`(43) Pub. Date:
`Jun. 13, 2013
`Pace et al.
`
`US 2013 O150691A1
`
`(54) ANALYTE SENSORDEVICES,
`CONNECTIONS, AND METHODS
`(71) Applicant: Abbott Diabetes Care Inc., Alameda,
`CA (US)
`(72) Inventors: Louis Pace, San Carlos, CA (US); Peter
`G. Robinson, Alamo, CA (US); Udo
`Hoss, Castro Valley, CA (US); Samuel
`Mason Curry, San Francisco, CA (US);
`Philip William Carter, Oakland, CA
`(US); Vincent Michael DiPalma,
`Hayward, CA (US); Amit Mhatre,
`Sunnyvale, CA (US); Jennifer Olson,
`San Francisco, CA (US); Manuel Luis
`Miguel Donnay, San Francisco, CA
`(US); Marc Barry Taub, Mountain
`View, CA (US)
`
`(73) Assignee: Abbott Diabetes Care Inc., Alameda,
`CA (US)
`
`(21) Appl. No.: 13/710,460
`
`
`
`(22) Filed:
`
`Dec. 11, 2012
`Related U.S. Application Data
`(60) Provisional application No. 61/569,287, filed on Dec.
`11, 2011.
`Publication Classification
`
`(2006.01)
`
`(51) Int. Cl.
`A6IB5/145
`(52) U.S. Cl.
`CPC .................................. A61 B 5/14532 (2013.01)
`USPC .......................................................... 6OO/347
`ABSTRACT
`(57)
`Devices associated with on-body analyte sensor units are
`disclosed. These devices include any of packaging and/or
`loading systems, applicators and elements of the on-body
`sensor units themselves. Also, various approaches to connect
`ing electrochemical analyte sensors to and/or within associ
`ated on-body analyte sensor units are disclosed. The connec
`tor approaches variously involve the use of unique sensor and
`ancillary element arrangements to facilitate assembly of
`separate electronics assemblies and sensor elements that are
`kept apart until the end user brings them together.
`
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`iO
`
`Container: inpack,
`inspect, and Prep
`
`Applicator: Jack,
`inspect, and Prep
`
`user Assembly:
`Merge sensor with electronics
`to form on-body device with
`sharp,
`rock applicator
`
`
`
`
`
`
`
`
`
`
`
`On-body Device Application:
`insert sensor, apply On-body
`device, and retract sharp
`
`ost Application:
`Wear and Disposai
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`US 2013/O 150691 A1
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`Jun. 13, 2013
`
`ANALYTE SENSOR DEVICES,
`CONNECTIONS, AND METHODS
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`0001. The present application claims priority to US Pro
`visional Patent Application Ser. No. 61/569.287, filedon Dec.
`11, 2011, entitled “Analyte Sensor Devices, Connections,
`And Methods,” the entirety of which is incorporated herein by
`reference.
`
`BACKGROUND
`
`0002 Diabetes Mellitus is an incurable chronic disease in
`which the body does not produce or properly utilize insulin.
`Insulin is a hormone produced by the pancreas that regulates
`blood Sugar (glucose). In particular, when blood Sugar levels
`rise, e.g., after a meal, insulin lowers the blood Sugar levels by
`facilitating blood glucose to move from the blood into the
`body cells. Thus, when the pancreas does not produce Suffi
`cient insulin (a condition known as Type 1 Diabetes) or does
`not properly utilize insulin (a condition known as Type II
`Diabetes), the blood glucose remains in the blood resulting in
`hyperglycemia or abnormally high blood Sugar levels.
`0003. The vast and uncontrolled fluctuations in blood glu
`cose levels in people Suffering from diabetes cause long-term,
`serious complications. Some of these complications include
`blindness, kidney failure, and nerve damage. Additionally, it
`is known that diabetes is a factor in accelerating cardiovas
`cular diseases such as atherosclerosis (hardening of the arter
`ies), leading to stroke, coronary heart disease, and other dis
`eases. Accordingly, one important and universal strategy in
`managing diabetes is to control blood glucose levels.
`0004 One element of managing blood glucose levels is the
`monitoring of blood glucose levels. Conventional in vitro
`techniques, such as drawing blood samples, applying the
`blood to a test strip, and determining the blood glucose level
`using colorimetric, electrochemical, or photometric test
`meters, may be employed. Another technique for monitoring
`glucose levels uses an in vivo analyte monitoring system,
`which measures and stores sensor data representative of glu
`cose levels automatically over time.
`0005. Unlike conventional in vitro blood glucose monitor
`ing approaches, in vivo analyte monitoring systems use an
`insertable or implantable in vivo sensor that is positioned to
`be in contact with interstitial fluid of a user for a period of time
`to detect and monitor glucose levels. Prior to use of an in vivo
`sensor, at least a portion of the sensor is positioned under the
`skin. An applicator assembly can be employed to insert the
`sensor into the body of the user. For insertion of the sensor, a
`sharp engaged with the sensor, pierces the skin of the user and
`is then removed from the body of the user leaving the sensor
`in place. The in vivo-positioned sensor can be connected to
`other system components such as sensor electronics con
`tained in a unit that can be held onto the skin.
`0006 To realize fully the advantages associated with such
`systems, what is needed are applicator Systems configured to
`handle insertion, as well as packaging and user interface
`issues, that are easy-to-use, reliable and minimize both user
`inconvenience and pain. The present invention provides Such
`Solutions and additional or alternative advantages as
`described below and/or as may be appreciated by those of
`skill in the art upon review of the subject disclosure.
`
`SUMMARY
`0007. The present invention includes packaging, loading
`systems, applicators, and elements of the on-body devices
`themselves. According to embodiments of the present inven
`tion, an on-body device includes an electronics assembly and
`a sensor assembly. The sensor assembly includes a sensor and
`a connector for coupling the sensor to the electronics assem
`bly. In addition, a sharp can be provided that Supports the
`sensor and allows a distal end of the sensor to be placed under
`a user's skin. In some embodiments, the invention includes
`the connection of electrochemical analyte sensors to and/or
`within associated other monitoring components such as sys
`tem devices that are configured to be held in place on body.
`The approaches variously involve the use of unique sensor
`and unique ancillary element arrangements to facilitate
`assembly of separate on-body devices and sensor assembly
`units that are kept apart until the user brings them together.
`Methods associated with such use also form part of the inven
`tive subject matter.
`0008 Certain embodiments are described that include an
`analyte sensor (e.g., a glucose sensor) and an applicator
`assembly to position a portion of the sensor beneath a skin
`Surface, as well as methods of positioning at least a portion of
`the sensor and methods of analyte testing or monitoring.
`Further methods include the manner of preparing the appli
`cator assembly. Namely, such acts associated with user
`assembly and mating of the component parts of a monitoring
`system.
`0009. As mentioned above, such a monitoring system
`includes an electronics assembly adapted to adhere to a skin
`of a subject, a sensor assembly coupled to the electronics
`assembly to form an on-body device, and an insertion sharp
`having a longitudinal body including a longitudinal opening
`to receive at least a portion of the sensor body. The details of
`the sensor may vary. Exemplary chemistries and construc
`tions are described in any of U.S. Pat. Nos. 5,593,852, 6,284,
`478, and 6,329,161, each incorporated by reference herein in
`its entirety. Exemplary form-factors or configurations (e.g.,
`for associated use with an insertion “sharp') are described in
`any of U.S. Pat. Nos. 6,175,752, 6,565,509, 6,134,461 and
`6,990,366 and in US Publication No. 2010/0230285, each
`incorporated by reference herein in its entirety.
`0010. Likewise, the details of the on-body device may
`vary. For instance, the on-body device may include sensor
`electronics and other adaptation to communicate with a moni
`toring device. Various options for communications facilities
`(e.g., wireless transmitters, transponders, etc.) are described
`in detail in US Publication Nos. 2010/0198034 and 2011/
`0213225, the entirety of the applications hereby incorporated
`by reference, including cited and incorporated references.
`0011. In some embodiments, systems and methods are
`provided for assembling and applying the on-body device
`including assembling the sensor assembly to the electronics
`assembly and inserting a portion of the sensor under the skin
`of a user. Thus, the sensor assembly includes a sensor that has
`a distal portion for operative contact with a fluid of the user.
`The on-body device also includes an electronics assembly
`including a housing defining a distal Surface adapted for
`attachment to the skin of the user and a circuit coupleable to
`the sensor for detecting electrical signals from the sensor. In
`Some embodiments, the system also includes an applicator
`assembly that has a sleeve defining a distal Surface for place
`ment on the skin of the Subject, a handle for a user interface,
`and Various internal Support, coupling, guide, grasping, stop
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`and detent features as well as driver elements. In some
`embodiments, the system may also include a container that
`stores one or more of the sensor, the sharp, and/or the mount/
`electronics assembly in a sealed environment within. The
`container is configured to releasably interface with the appli
`cator assembly for the purpose of loading one or more of the
`sensor, the sharp, and/or the electronics assembly into the
`applicator assembly, and readying the applicator assembly
`for use.
`0012. The present disclosure includes the subject systems,
`devices, kits in which they are included, and methods of use
`and manufacture. A number of aspects of Such manufacture
`are discussed herein. Further details can be appreciated in
`reference to the figures and/or associated description.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0013. A detailed description of various aspects, features,
`and embodiments of the subject matter described herein is
`provided with reference to the accompanying drawings,
`which are briefly described below. The drawings are illustra
`tive and may or may not be drawn to scale, with the possibility
`of some components and features being exaggerated for clar
`ity. Similar components may be numbered identically or not.
`The drawings illustrate various aspects and features of the
`present Subject matter and may illustrate one or more embodi
`ment(s) or example(s) of the present Subject matter in whole
`or in part.
`0014 FIG. 1 is a flowchart, indicating user activity in
`handling the subject devices;
`0015 FIGS. 2A-2G illustrate such activity with additional
`detail;
`0016 FIG. 3 is an assembly view of an applicator or
`inserter,
`0017 FIG. 4 is an assembly view of a sensor container or
`loader;
`0018 FIGS.5A and 5B are section views of the container
`in FIG. 4;
`0019 FIG. 6 is an assembly view of an alternative con
`tainer,
`0020 FIG. 7 is a section view of the assembly of FIG. 6;
`0021
`FIG. 8 is an assembly view of yet another sensor
`container set or loader;
`0022 FIGS. 9A and 9B are top and section views, respec
`tively, of the container set assembly of FIG. 8 in stages of
`operation;
`0023 FIGS. 10A-10N variously illustrate the mechanics
`of preparing the applicator for use;
`0024 FIGS. 11A-11F illustrate the mechanics of applica
`tor use:
`0025 FIGS. 12A-12D are perspectives illustrating
`another applicator/container set approach in which the con
`tainer holds the electronics assembly:
`0026 FIGS. 13 A-13C variously illustrate use of the appli
`cator in FIGS. 12A-12D in connection with a locking-sleeve
`feature;
`0027 FIGS. 14A and 14B illustrate an applicator with a
`removable locking strip;
`0028 FIGS. 15A-15F variously illustrate use of the appli
`cator in FIGS. 14A and 14B;
`0029 FIGS. 16A and 16B are sectional and detail to
`views, respectively, of features of the container in FIGS.
`15A-15D;
`
`0030 FIGS. 17A and 17B are perspective assembly views
`illustrating alternative container configurations to that illus
`trated in FIGS. 16A and 16B;
`0031
`FIG. 18 is a side-section view illustrating the fea
`tures of the applicator and container sets variously shown in
`FIGS. 15A-15F;
`0032 FIGS. 19A and 19B are perspective views of a sen
`sor assembly incorporated in the system shown in FIG. 18;
`0033 FIGS. 20A and 20B are perspective views of the
`operation of a sensor assembly retention unit incorporated in
`the system shown in FIG. 18;
`0034 FIGS. 21A-21C are perspective section views illus
`trating sensor assembly receipt by the sensor mount and sharp
`withdrawal from the assembled complex:
`0035 FIG. 22 is a perspective assembly view of advanta
`geous sensor and sensor connector elements;
`0036 FIGS. 23A and 23B are perspective assembly and
`final-assembly views, respectively of the sensor components
`in FIG.22;
`0037 FIGS. 24A and 24B are top and bottom perspective
`views, respectively of circuit board components to be used
`with the assembly shown in FIGS. 23A and 23B;
`0038 FIGS. 25A and 25B are perspective views illustrat
`ing assembly of the Subject components in stages;
`0039 FIG. 26 is an assembly view of the on-body/sensor
`mount unit in FIGS. 25A and 25B illustrating an advanta
`geous seal element;
`0040 FIGS. 27A and 27B are section views further illus
`trating the seal element and its relation to the mount in FIG.
`26;
`FIGS. 28A-F are perspective views of another
`004.1
`advantageous sensor and sensor element arrangement;
`0042 FIGS. 29A-D are perspective views of another
`advantageous sensor and sensor connector arrangement;
`0043 FIGS. 30A-30C are perspective views illustrating
`yet another advantageous sensor approach with the sensor as
`originally produced, modified for use, and shown coupled to
`a PCB, respectively;
`0044 FIG. 30 is a perspective view illustrating the sensor
`as configured in FIG. 29B in contact with a circuit board
`assembly;
`0045 FIG. 31 is a side-section view showing a compara
`tive approach, in a final on-body sensor assembly;
`0046 FIGS. 32A and 32B are perspective views of still
`other advantageous sensor configurations, these figures illus
`trating split-sensor approaches;
`0047 FIGS. 33A-33G are plane, side, magnified, and sec
`tional views of an additional sensor configuration;
`0048 FIGS. 33H-33J are plane views of various sensor
`designs;
`0049 FIGS. 34A-34D are perspective views illustrating
`combination electrical connector and sensor isolator in yet
`another advantageous sensor arrangement;
`0050 FIGS. 35A and 35B are side assembly and section
`views, respectively, of the system shown in FIGS. 34A-34D:
`0051
`FIG. 35C is an end-section view, with detail view,
`FIG. 35D, illustrating additional sensor features:
`0.052
`FIG. 36 is a perspective assembly view illustrating a
`sensor connection approach related to that in FIGS. 34A-34D
`for a sensor with contacts on a single side;
`0053 FIG.37 is a perspective partial assembly view illus
`trating a mount-and-socket interface for the sensor assembly
`employing the components in FIG. 36:
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`0054 FIG. 38 is a complete assembly view of that illus
`trated in FIG. 37;
`0055 FIGS. 39A and 39B are perspective assembly and
`as-assembled views of a stacked non-directional sensor con
`nect arrangement;
`0056 FIG. 40 is a side partial-sectional view of the sensor
`in FIG. 39 received within an on-body device;
`0057 FIGS. 41A and 41B are partial perspective assembly
`views of another stacked non-directional sensor connection
`arrangement;
`0058 FIG.41C is a section view of the complete assembly
`of the components variously illustrated in FIGS. 41A and
`41B:
`0059 FIG. 42 is an assembly view of an advantageous
`radial arrangement sensor connector assembly;
`0060 FIGS. 43A and 43B are reversed perspective views
`of the mount-side sensor connection component for use with
`an assembly as shown in FIG. 42:
`0061
`FIG. 44 is a section view of the complete assembly
`of the components variously illustrated in FIGS. 42.43A and
`43B;
`0062 FIGS. 45A and 45B are reversed assembly views of
`an alternative advantageous sensor connection assembly that
`can be used like that in FIG. 42:
`0063 FIGS. 46A and 46B are assembly and sectional
`views, respectively of a complete on-body device employing
`the sensor and connection elements illustrated in FIGS. 45A
`and 45B;
`0064 FIG. 47A-47C are assembly and cross-sectional
`views of an on-body device including an integrated connector
`for the sensor assembly:
`0065 FIGS. 48A-48D are construction views of an on
`body subassembly;
`0066 FIG. 48E is a perspective view of a complete on
`body electronics subassembly;
`0067 FIGS. 49A-49D illustrate the process of co-mold
`ing/overmolding the assembly in FIG. 48E:
`0068 FIGS.50A-50C areassembly and sectional views of
`an alternative Snap-together approach with the assembly in
`FIG. 48E; and
`0069 FIGS. 51A-51B are assembly views illustrating
`adhesive backing application in producing a final on-body
`device ready for use as shown in perspective-view FIG. 51C.
`
`DETAILED DESCRIPTION
`0070. Before the present disclosure is further described, it
`is to be understood that this disclosure is not limited to the
`particular embodiments described, as such may, of course,
`vary. It is also to be understood that the terminology used
`herein is for the purpose of describing particular embodi
`ments only, and is not intended to be limiting, since the scope
`of the present disclosure will be limited only by the appended
`claims.
`0071. As will be apparent to those of skill in the art upon
`reading this disclosure, each of the individual embodiments
`described and illustrated herein includes discrete components
`and features which may be readily separated from or com
`bined with the features of any of the other several embodi
`ments without departing from the Scope or spirit of the present
`disclosure.
`0072. Where a range of values is provided, it is understood
`that each intervening value, to the tenth of the unit of the lower
`limit unless the context clearly dictates otherwise, between
`the upper and lower limit of that range and any other stated or
`
`intervening value in that stated range, is encompassed within
`the disclosure. The upper and lower limits of these smaller
`ranges may independently be included in the Smaller ranges,
`and are also encompassed within the disclosure, Subject to
`any specifically excluded limit in the stated range. Where the
`stated range includes one or both of the limits, ranges exclud
`ing either or both of those included limits are also included in
`the disclosure.
`0073. Unless defined otherwise, all technical and scien
`tific terms used herein have the same meaning as commonly
`understood by one of ordinary skill in the art to which this
`disclosure belongs. Although any methods and materials
`similar or equivalent to those described herein can also be
`used in the practice or testing of the present disclosure, exem
`plary methods and materials are now described. All publica
`tions mentioned herein are incorporated herein by reference
`to disclose and describe the methods and/or materials in con
`nection with which the publications are cited.
`0074 As used herein and in the appended claims, the
`singular forms “a” “an.” and “the include plural referents
`unless the context clearly dictates otherwise. It is further
`noted that the claims may be drafted to exclude any optional
`element. As such, this statement is intended to serve as ante
`cedent basis for use of such exclusive terminology as “solely.”
`“only' and the like in connection with the recitation of claim
`elements, or use of a “negative' limitation.
`0075. The publications discussed herein are provided
`solely for their disclosure prior to the filing date of the present
`application. Nothing herein is to be construed as an admission
`that the present disclosure is not entitled to antedate such
`publication by virtue of prior disclosure. Further, the dates of
`publication provided may be different from the actual publi
`cation dates which may need to be independently confirmed.
`0076 Various exemplary embodiments of the disclosure
`are described below. Reference is made to these examples in
`a non-limiting sense. They are provided to illustrate more
`broadly applicable aspects of the present disclosure. Various
`changes may be made to the disclosure described and equiva
`lents may be substituted without departing from the true spirit
`and scope of the disclosure. In addition, many modifications
`may be made to adapt a particular situation, material, com
`position of matter, process, process act(s) or step(s) to the
`objective(s), spirit or scope of the present disclosure. All Such
`modifications are intended to be within the scope of the
`claims made herein.
`
`Applicator and Container Overview
`0077 Turning to FIG. 1, a flowchart depicting an example
`method 100 of using various systems of the present invention
`is provided. In some embodiments, a user starts with unpack
`ing the container (102) and unpacking the applicator (104).
`Unpacking the container (102) can include removing a cover
`that provides a sterile seal to the container contents and
`unpacking the applicator (104) can include removing an end
`cap that provides a sterile seal to the internal portion of the
`applicator. Next, in an assembly operation (106), the appli
`cator is inserted into the container to merge or connect the
`sensor assembly and the electronics assembly together to
`form an on-body device and an insertion needle or sharp. In
`Some embodiments, the user unlocks the applicator or
`removes a locking element to ready the applicator for use. The
`process of the assembly operation (106) and the constituent
`components are described in detail below.
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`0078 Next, once the user has chosen an application site,
`an on-body device application operation (108) is performed.
`In the application operation (108), the user places the appli
`cator on the skin of the insertion site and then applies a force
`to install the on-body device. The applicator is driven to insert
`the distal end of the sensor through the user's skin, adhere the
`on-body device to the skin Surface, and retract the sharp into
`the applicator for disposal. In some embodiments, the user
`performs the application operation (108) by applying force to
`the applicator where the force applied is a single, continuous
`pushing motion along the longitudinal axis of the applicator
`that once started, causes the applicator to perform the appli
`cation operation (108) such that the applicator does not stop
`operation until completion. The applicator is configured to
`relay action/audible cues to the user so that all three of the
`above listed actions happen automatically in response to
`applying the force to the applicator causing it to trigger.
`Advantageously, an adhesive of the on-body device does not
`contact the user until the application operation (108) is per
`formed. So, the even after the applicator has been place