Patent Description:
Existing CGM products provide frequent measurements of a patient's glucose levels without the need for each such measurement to be accompanied by the drawing of blood, such as by "finger sticks. " CGM products may include a sensor portion that is inserted so as to be located under the skin, and a processing portion that is adhered to the outer surface of the skin, for example the abdomen or back of the upper arm. These CGM products are worn for a number of days before being removed and replaced.

The sensor that has been inserted under the skin provides a signal to the processing portion of the CGM product, and that signal is indicative of the patient's blood glucose level. These measurements may be made automatically many times throughout the day (e.g., every <NUM> minutes or at some other interval).

The processing portion of a CGM product may include electrical circuitry for interpreting the signal provided by the sensor, and for storing and/or communicating information regarding the patient's blood glucose levels. Various CGM products are disclosed in <CIT>, <CIT>, <CIT>, and <CIT>.

In some embodiments, a sensor assembly for a continuous glucose monitoring system is provided that includes (<NUM>) a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (<NUM>) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (<NUM>) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit.

In some embodiments, an insertion device for a continuous glucose monitoring system is provided that includes (<NUM>) an insertion unit; (<NUM>) a sensor carrier positioned within the insertion unit and having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (<NUM>) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (<NUM>) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit. The insertion device also includes a removable cover attached to the insertion unit that interfaces with the sensor unit such that removal of the removable cover exposes the introducer and the sensor.

In some embodiments, a sterilized sensor unit for a continuous glucose monitor is provided that includes (<NUM>) a sensor, an introducer having an insertion shaft, and an insertion shaft cover; and (<NUM>) a sensor housing having (a) a first end configured to receive the insertion shaft of the introducer; (b) a second end having a sealing surface configured to seal against the insertion shaft cover; and (c) an insertion shaft opening that extends between the first end and the second end and having a width that allows the insertion shaft of the introducer to travel through the opening. A portion of the sensor and insertion shaft of the introducer are positioned within the insertion shaft opening of the sensor housing. The insertion shaft cover is sealingly coupled to the second end of the sensor housing, the insertion shaft cover having an inner region. The sensor housing, the introducer and the insertion shaft cover form a sealed region that includes the inner region of the insertion shaft cover. The sealed region and all components within the sealed region are sterilized.

In some embodiments, a method of forming a sensor assembly for a continuous glucose monitoring system includes (<NUM>) providing a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (<NUM>) providing a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; (<NUM>) providing electronics for the continuous glucose monitoring system; and (<NUM>) positioning the sensor unit within the sensor unit receiving area of the sensor carrier and positioning the electronics on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit.

In some embodiments, a method of forming an insertion device for a continuous glucose monitoring system includes (<NUM>) providing a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (<NUM>) providing a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; (<NUM>) providing electronics for the continuous glucose monitoring system; (<NUM>) positioning the sensor unit within the sensor unit receiving area of the sensor carrier and positioning the electronics on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit; (<NUM>) providing an insertion unit; (<NUM>) positioning the sensor carrier within the insertion unit; and (<NUM>) attaching a removable cover to the insertion unit that interfaces with the sensor unit such that removal of the removable cover exposes the introducer and the sensor.

In some embodiments, a method of forming a sterilized sensor unit for a continuous glucose monitor includes (<NUM>) providing a sensor, an introducer having an insertion shaft, and an insertion shaft cover; and (<NUM>) providing a sensor housing having (a) a first end configured to receive the insertion shaft of the introducer; (b) a second end having a sealing surface configured to seal against the insertion shaft cover; and (c) an insertion shaft opening that extends between the first end and the second end and having a width that allows the insertion shaft of the introducer to travel through the opening, a portion of the sensor and insertion shaft of the introducer positioned within the insertion shaft opening of the sensor unit. The method further includes (<NUM>) sealingly coupling the insertion shaft cover to the second end of the sensor housing, the insertion shaft cover having an inner region; (<NUM>) inserting the introducer into the first end so that the sensor housing, the introducer and the insertion shaft cover form a sealed region that includes the inner region of the insertion shaft cover; and (<NUM>) sterilizing the sealed region and all components within the sealed region.

Other features, aspects, and advantages of embodiments in accordance with the present disclosure will become more fully apparent from the following detailed description, the subjoined claims, and the accompanying drawings by illustrating a number of example embodiments and implementations. Various embodiments in accordance with the present disclosure may also be capable of other and different applications, and its several details may be modified in various respects, all without departing from the scope of the claims. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not necessarily drawn to scale.

Embodiments of the present invention allow formation of a sensor unit having a sensor and an insertion shaft of an introducer that may be separately sterilized and then easily and securely connected to an electronic circuit of a continuous glucose monitor during assembly. The sensor unit may be sterilized using a process such as electron or gamma beam sterilization which may be effective for sterilizing sensors and insertion shafts without damaging the enzymes used by the sensors for glucose detection, but which may damage sensitive electrical circuitry of the continuous glucose monitor.

In the invention the sensor unit may include a sealed, sterilized region formed by a sensor housing, an introducer and a cover of the insertion shaft of the introducer. The sensor unit may form part of a sensor assembly that includes a sensor carrier which joins the sensor unit to electronics for a continuous glucose monitor, while maintaining sterilization of the sensor and insertion shaft of the introducer. In some embodiments, the sensor assembly may be employed within an insertion device which removes the cover of the insertion shaft to expose the sensor and insertion shaft when a cover of the insertion device is removed (e.g., prior to insertion).

In order to perform continuous glucose monitoring, a sensor is inserted into a patient and electrical circuitry is coupled to the sensor. The electrical circuitry may be used for processing information obtained from the sensor, and transmitting information to one or more external devices used by patients and/or healthcare providers to, among other things, track the patient's blood glucose level over time. A housing containing the electrical circuity is adhered to the patient's skin with the sensor extending into the patient, and remains on the patient's skin for several days (e.g., up to a week or more in some cases).

Embodiments provided herein may simplify manufacturing of continuous glucose monitoring devices by providing a sensor unit that may be separately sterilized and then easily and securely connected to an electronic circuit of a continuous glucose monitor during assembly. Embodiments provided herein may also simplify the insertion process for patients. For example, use of an insertion device which exposes the sensor and insertion shaft prior to insertion when a cover of the insertion device is removed may reduce the number of steps a patient must perform during insertion.

These and other embodiments of the present disclosure are described below with reference to <FIG>.

<FIG> are a side-perspective view and an exploded, side-perspective view, respectively, of a sensor assembly <NUM> provided in accordance with one or more embodiments. With reference to <FIG>, sensor assembly <NUM> includes a sensor unit <NUM> which fits within a sensor unit receiving area <NUM> of a sensor carrier <NUM>. As will be described below, sensor unit <NUM> includes a sensor and insertion shaft in a sterilized region of the sensor unit <NUM>, and couples to electronic circuitry within sensor carrier <NUM> when positioned within sensor unit receiving area <NUM> of sensor carrier <NUM>.

<FIG> are a side cross-sectional view and an exploded, side-perspective view, respectively, of sensor unit <NUM> provided in accordance with one or more embodiments. With reference to <FIG>, sensor unit <NUM> includes an insertion shaft cover <NUM>, a top member <NUM>, a sensor <NUM>, a spacer pad <NUM>, a bottom member <NUM>, a conductive member <NUM>, and an introducer <NUM> having an insertion shaft <NUM> and handle <NUM>.

Insertion shaft cover <NUM> covers sensor <NUM> and insertion shaft <NUM>, and in some embodiments, is sealed against top member <NUM>. For example, insertion shaft cover <NUM> may be sealed relative to top member <NUM> using an O-ring, a sealant such as silicone, or the like. Top member <NUM> includes an insertion shaft opening <NUM>, defined by cylindrical member <NUM>, that extends between a first end <NUM> (e.g., a top surface of top member <NUM>) and a second end <NUM>, and has a width that allows insertion shaft <NUM> to travel through the insertion shaft opening <NUM>.

As shown in <FIG>, a portion of sensor <NUM> and insertion shaft <NUM> are positioned within insertion shaft opening <NUM>. In some embodiments, handle <NUM> of introducer <NUM> may seal against the second end <NUM> of insertion shaft opening <NUM> (e.g., using an O-ring, a sealant such as silicone, or the like). In this manner, insertion shaft cover <NUM>, insertion shaft opening <NUM> and introducer <NUM> may form a sealed region <NUM> that houses a portion of sensor <NUM> and a portion of insertion shaft <NUM> that may extend within a patient during insertion. As described further below, sealed region <NUM> and all components within sealed region <NUM>, such as sensor <NUM> and insertion shaft <NUM>, may be sterilized (e.g., using an electron beam, a gamma beam, or the like).

Spacer pad <NUM> is configured to hold sensor <NUM> in position within sensor unit <NUM>. In the invention spacer pad <NUM> extends the height and width of the internal space defined by top member <NUM> and bottom member <NUM>, and surrounds sensor <NUM> as sensor <NUM> extends into the internal space defined by top member <NUM> and bottom member <NUM>. In some embodiments, spacer pad <NUM> may be a polymer, rubber or other elastomer member and/or may be slightly compressed when positioned within sensor unit <NUM> between top member <NUM> and bottom member <NUM>.

Space pad <NUM> includes a first opening <NUM> through which cylindrical member <NUM> of top member <NUM> extends and a second opening <NUM> through which conductive member <NUM> extends Conductive member <NUM> may be a conductive elastomer pad, for example, that makes electrical contact to a contact portion <NUM> of sensor <NUM> and allows sensor <NUM> to make electrical contact with a substrate that supports electronic circuitry of a continuous glucose monitor as described further below.

Bottom member <NUM> attaches to top member <NUM>. For example top member <NUM> may be glued or otherwise attached to bottom member <NUM>, defining an inner space for sensor <NUM>, spacer pad <NUM> and conductive member <NUM> as shown. Bottom member <NUM> includes a first opening <NUM> through which cylindrical member <NUM> of top member <NUM> may extend, and a second opening <NUM> through which conductive member <NUM> may extend.

In some embodiments, insertion shaft cover <NUM>, top member <NUM>, bottom member <NUM>, and/or handle <NUM> of introducer <NUM> may be made from acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (peek), polypropylene, high-density polyethylene (HDPE), low-density polyethelene (LDPE) or a similar material. Other materials may be used.

In some embodiments, sensor <NUM> may be made from one or more sheets, including a substrate layer such as a vinyl polymer with subsequent layers of gold, silver chloride, and/or various coatings and enzymes suitable for the sensor's use in determining blood glucose levels. Other sensor materials may be used.

In some embodiments, insertion shaft <NUM> may be a hollow cylinder with a sharply pointed end used to introduce a sensor into a patient's interstitial fluid. Insertion shaft <NUM> may be used to insert sensor <NUM> into a patient such that sensor <NUM>, or at least a portion of sensor <NUM>, is located under the patient's skin.

In some embodiments, insertion shaft <NUM> of introducer <NUM> may be made from a metal such as stainless steel or from another material such as plastic. In some embodiments, insertion shaft <NUM> is insert-molded with a plastic handle <NUM>, and insertion shaft <NUM> may be, but is not limited to, a round C-channel tube, a round U-channel tube, a stamped sheet metal part folded into a square U-profile, a molded/cast metal part with a square U-channel profile, or a solid metal cylinder with an etched or ground square U-channel. In some example embodiments, for insertion shaft <NUM> implemented as a C-channel or U-channel tube insertion shaft, the tube may have an inner diameter in the range of <NUM> to <NUM> and a thickness in the range of <NUM> to <NUM>. In some example embodiments, for insertion shaft <NUM> implemented as stamped sheet metal folded into a square U-profile, the inner width and height may be in a range from <NUM> to <NUM>, with a wall thickness in a range from <NUM> to <NUM>. In some example embodiments, for insertion shaft <NUM> implemented as a molded or cast metal part, the outer diameter of insertion shaft <NUM> may be in the range of <NUM> to <NUM>, and inner channel of insertion shaft <NUM> may have a width and height between <NUM> to <NUM>. In some example embodiments, the length of introducer <NUM> including handle <NUM> and insertion shaft <NUM> may be approximately <NUM> to <NUM>, and the length of insertion shaft <NUM> of introducer <NUM> may be about be approximately <NUM> to <NUM>. Other introducer and/or insertion shaft configurations, sizes and/or materials may be used.

As mentioned, sensor unit <NUM> includes sealed region <NUM> in which a portion of sensor <NUM> and insertion shaft <NUM> are housed. Following assembly of sensor unit <NUM>, sealed region <NUM>, and sensor <NUM> and insertion shaft <NUM> residing therein, may be sterilized. Example sterilization methods include electron beam sterilization, gamma beam sterilization or any other suitable sterilization method.

<FIG> is an exploded cross-sectional view and <FIG> is a cross-sectional view, respectively, of a sensor assembly <NUM> in accordance with an example embodiment of the disclosure. With reference to <FIG>, sensor assembly <NUM> includes sensor carrier <NUM> having sensor unit receiving area <NUM> and an electronics receiving area <NUM> formed therein. Sensor carrier <NUM> includes a top carrier member <NUM> coupled to a bottom carrier member <NUM> which couple to define the electronics receiving area <NUM>. In some embodiments, top carrier member <NUM> and/or bottom carrier member <NUM> may be formed from the same material used to form top member <NUM> and bottom member <NUM> of sensor unit <NUM>, although other materials may be used. Bottom carrier member <NUM> includes an opening <NUM> through which cylindrical member <NUM> of sensor unit <NUM> may pass when sensor unit <NUM> is positioned within sensor unit receiving area <NUM> of sensor carrier <NUM>.

Sensor assembly <NUM> includes a substrate <NUM> positioned within electronics receiving area <NUM>. In one or more embodiments, substrate <NUM> may be, for example, a <NUM>-layer printed circuit board, a laminated circuit board, a flex circuit, a flex printed circuit board, or any other suitable substrate for positioning and/or interconnecting electronic circuitry (e.g., one or more insulating or dielectric materials with electrical conductors for connecting circuitry). Substrate <NUM> may be electrically non-conductive, and may have electrically conductive traces formed thereon and therein, for example. In some example embodiments, substrate <NUM> may have a thickness in a range of, but not limited to, about <NUM> to <NUM>. Other substrate and/or printed circuit board configurations, sizes and/or materials may be employed.

Substrate <NUM> may have electrical circuitry <NUM> disposed on, and/or in, substrate <NUM>. Electrical circuitry <NUM> may include circuits housed in packages that are mounted directly to substrate <NUM>, and/or coupled to corresponding sockets, which are attached to substrate <NUM>. Example electrical circuitry <NUM> may include one or more processors, memory, a battery, a transmitter and/or receiver for communicating information to and/or receiving information from an external device, or the like. In some embodiments, electrical circuitry <NUM> may be used for processing information obtained from sensor <NUM>, and transmitting information to one or more external devices used by patients and/or healthcare providers to, among other things, track the patient's blood glucose level over time.

As shown in <FIG>, when sensor unit <NUM> is positioned within sensor unit receiving area <NUM>, conductive member <NUM> contacts substrate <NUM>. For example, conductive member <NUM> may make electrical contact to one or more electrical contacts (not shown) present on substrate <NUM> that are (electrically) coupled to, or which may be configured to couple to (e.g., via a switch or other similar mechanism (not shown)), electronic circuitry <NUM>. Conductive member <NUM> thereby allows sensor <NUM> to be in electrical contact with electronics (e.g., electrical circuitry <NUM>). In some embodiments, conductive member <NUM> may define multiple, separate electrical paths between sensor <NUM> and substrate <NUM> (and thus electronic circuitry <NUM>). For example, only predefined portions of conductive member <NUM> may be electrically conductive (e.g., one or more vertical contacts that extend between sensor <NUM> and substrate <NUM>).

Sensor unit <NUM> may be secured within sensor unit receiving area <NUM> using any suitable mechanism (e.g., friction, adhesives, etc.).

As described, sensor unit <NUM> may include a sealed, separately sterilized region <NUM> including at least a portion of sensor <NUM> and introducer <NUM>. Sensor unit <NUM> may be positioned within sensor unit receiving area <NUM> of the sensor carrier <NUM> and electronics <NUM> may be positioned within electronics receiving area <NUM> of sensor carrier <NUM> so as to form sensor assembly <NUM> having sensor <NUM> electrically connected to electronics <NUM> while maintaining sterilization of the sterilized region <NUM> of sensor unit <NUM>.

<FIG> is an exploded, perspective view of an insertion device <NUM> for sensor assembly <NUM> provided in accordance with one or more embodiments. With reference to <FIG>, in some embodiments, insertion device <NUM> includes an insertion unit <NUM> having sensor assembly <NUM> positioned therein. For example, the interior of insertion device <NUM> may serve as a receiving area for the sensor assembly <NUM>. Sensor assembly <NUM> includes sensor carrier <NUM> having sensor unit <NUM> coupled thereto. Insertion shaft cover <NUM> is also shown.

Insertion device <NUM> includes a removable cover <NUM> that has an interface unit <NUM> that interfaces with insertion shaft cover <NUM> such that removal of removable cover <NUM> removes insertion shaft cover <NUM> from sensor assembly <NUM> so as to expose insertion shaft <NUM> of introducer <NUM> and sensor <NUM> (<FIG>). For example, removable cover <NUM> may have internal threads <NUM> (e.g., forming a threaded cap) that engage with external threads <NUM> on interface unit <NUM>. Interface unit <NUM>, in some embodiments, may include one or more fingers 412a-c that engage with corresponding notch features on insertion shaft cover <NUM> (only one notch <NUM> is shown in <FIG>) so that rotation of removable cover <NUM> causes rotation of insertion shaft cover <NUM>. Other configurations for removing insertion shaft cover <NUM> are described further below. Other numbers and/or types of fingers and/or engagement mechanisms between removable cover <NUM> and insertion shaft cover <NUM> may be used.

In operation, when removable cover <NUM> is threaded onto insertion unit <NUM>, fingers 412a-c slide within guide channels on insertion shaft cover <NUM> (only two guide channels 416a-b are shown in <FIG>) until they engage in a respective notch <NUM>. This causes the fingers 412a-c to lock within each notch <NUM>. <FIG> is a cross-sectional view of insertion device <NUM> in which interface unit <NUM> of removable cover <NUM> is engaged with insertion shaft cover <NUM> in accordance with some embodiments. Thereafter, when removable cover <NUM> is unthreaded from insertion unit <NUM>, insertion shaft cover <NUM> will rotate with removable cover <NUM> and will be removed from sensor assembly <NUM> when removable cover <NUM> is removed from insertion unit <NUM>. <FIG> is a cross-sectional view of insertion device <NUM> in which insertion shaft cover <NUM> is removed from sensor assembly <NUM> with removable cover <NUM> in accordance with some embodiments. As shown in <FIG>, removal of removable cover <NUM> exposes sensor <NUM> and insertion shaft <NUM>. Insertion unit <NUM> may then be used to insert insertion shaft <NUM> and sensor <NUM> into a patient's skin. For example, sensor assembly <NUM> may be supported by a supporting member <NUM> within insertion unit <NUM>. A sliding member <NUM> may surround sensor assembly <NUM> (as shown in <FIG>) and slide relative to supporting member <NUM>. With removable cover <NUM> removed, sliding member <NUM> may be placed on the patient and insertion unit <NUM> pressed toward the patient to cause insertion shaft <NUM> and sensor <NUM> to be inserted into the patient's skin. A biasing mechanism, such as a spring (not shown), may bias sliding member <NUM> so that it is maintained in a position around sensor assembly <NUM> (as shown in <FIG>) until insertion unit <NUM> is pressed for insertion. <FIG> illustrates a cross-sectional view of insertion device <NUM> with sliding member <NUM> depressed within insertion unit <NUM> during insertion in accordance with some embodiments. Other insertion device configurations may be used.

<FIG> illustrates a cross-sectional view of an alternative embodiment of insertion device <NUM> of <FIG> which employs a peelable cover in accordance with embodiments provided herein. With reference to <FIG>, insertion device <NUM> includes insertion unit <NUM> having a peelable cover <NUM> formed thereon.

Peelable cover <NUM> may be coupled to insertion shaft cover <NUM> via a strap member <NUM>, which in turn couples to insertion shaft cover <NUM>. In this manner, when peelable cover <NUM> is removed, strap member <NUM> pulls and detaches insertion shaft cover <NUM> from sensor assembly <NUM>, exposing insertion shaft <NUM> and sensor <NUM> for insertion (as previously described).

Peelable cover <NUM> and/or strap member <NUM> may be formed from plastic, polyethylene, high density polyethylene, Tyvek® available from E. du Pont de Nemours and Company of Wilmington, Delaware or a similar material, for example. Other peelable cover and/or strap member materials may be used.

In some embodiments, such as that shown in <FIG>, insertion shaft cover <NUM> may be formed from a soft and/or flexible material (e.g., a plastic bag, polyethylene, high density polyethylene, Tyvek® available from E. du Pont de Nemours and Company of Wilmington, Delaware, or the like). A soft and/or flexible insertion shaft cover <NUM> may be used with the other embodiments described herein.

<FIG> is a flowchart of an example method <NUM> of forming a sensor assembly for a continuous glucose monitoring system in accordance with embodiments provided herein. Method <NUM> includes providing a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate (Block <NUM>); providing a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer (Block <NUM>); providing electronics for the continuous glucose monitoring system (Block <NUM>); and positioning the sensor unit within the sensor unit receiving area of the sensor carrier and positioning the electronics on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit (Block <NUM>).

<FIG> is a flowchart of an example method <NUM> of forming an insertion device for a continuous glucose monitoring system in accordance with embodiments provided herein. Method <NUM> includes providing a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate (Block <NUM>); providing a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer (Block <NUM>); providing electronics for the continuous glucose monitoring system (Block <NUM>); positioning the sensor unit within the sensor unit receiving area of the sensor carrier and positioning the electronics on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit (Block <NUM>); providing an insertion unit (Block <NUM>); positioning the sensor carrier within the insertion unit (Block <NUM>); and attaching a removable cover to the insertion unit that interfaces with the sensor unit such that removal of the removable cover exposes the introducer and the sensor (Block <NUM>).

<FIG> is a flowchart of an example method <NUM> of forming a sensor unit for a continuous glucose monitoring system in accordance with embodiments provided herein. Method <NUM> includes providing a sensor housing having a first end, a second and an insertion shaft opening (Block <NUM>). For example, the sensor unit may have a first end configured to receive an insertion shaft of an introducer, a second end having a sealing surface configured to seal against an insertion shaft cover, and an insertion shaft opening that extends between the first end and the second end and having a width that allows an insertion shaft of the introducer to travel through the opening. A portion of the sensor and insertion shaft of the introducer may be positioned within the insertion shaft opening of the sensor unit. Method <NUM> also includes sealingly coupling an insertion shaft cover to the second end of the sensor housing (Block <NUM>); inserting an introducer into the first end of the sensor housing so that the sensor housing, the introducer and the insertion shaft cover form a sealed region that includes the inner region of the insertion shaft cover (Block <NUM>); and sterilizing the sealed region and all components within the sealed region (Block <NUM>). For example, electron or gamma beam sterilization of the sealed region may be performed.

While described primarily with regard to continuous glucose monitoring, it will be understood that the separately sterilizable regions described herein, such as within the sensor units and/or sensor assemblies of <FIG>, may be employed in other monitoring applications to monitor other body fluid levels such as cholesterol, Hb1AC, ketones, PH, oxygen saturation, etc..

An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. Likewise, an enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are comprehensive of any category, unless expressly specified otherwise. For example, the enumerated list "a computer, a laptop, a smartphone," does not imply that any or all of the three items of that list are mutually exclusive and does not imply that any or all of the three items of that list are comprehensive of any category.

A description of an embodiment with several components or features does not imply that all or even any of such components and/or features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments in accordance with this disclosure. Unless otherwise specified explicitly, no component and/or feature is essential or required.

When an ordinal number (such as "first," "second," "third," and so on) is used as an adjective before a term, that ordinal number is used (unless expressly specified otherwise) merely to indicate a particular feature, such as to distinguish that particular feature from another feature that is described by the same term or by a similar term. For example, a "first widget" may be so named merely to distinguish it from, e.g., a "second widget. " Thus, the mere usage of the ordinal numbers "first" and "second" before the term "widget" does not indicate any other relationship between the two widgets, and likewise does not indicate any other characteristics of either or both widgets. For example, the mere usage of the ordinal numbers "first" and "second" before the term "widget" (<NUM>) does not indicate that either widget comes before or after any other in order or location; (<NUM>) does not indicate that either widget occurs or acts before or after any other in time; and (<NUM>) does not indicate that either widget ranks above or below any other, as in importance or quality. In addition, the mere usage of ordinal numbers does not define a numerical limit to the features identified with the ordinal numbers. For example, the mere usage of the ordinal numbers "first" and "second" before the term "widget" does not indicate that there must be no more than two widgets.

Claim 1:
A sensor assembly (<NUM>) for a continuous glucose monitoring system, comprising:
a sensor carrier (<NUM>) having a sensor unit receiving area (<NUM>) and an electronics receiving area (<NUM>), the electronics receiving area including a substrate (<NUM>);
a sensor unit (<NUM>) having:
a top member (<NUM>) having an insertion shaft opening (<NUM>) defined by a cylindrical member (<NUM>), a bottom member (<NUM>), and a spacer pad (<NUM>) between the top member (<NUM>) and the bottom member (<NUM>), the bottom member comprising a first opening (<NUM>) and a second opening (<NUM>), the spacer pad (<NUM>) comprising a first opening (<NUM>) and a second opening (<NUM>), wherein the cylindrical member (<NUM>) extends through the first openings (<NUM>, <NUM>) of the bottom member and the spacer pad, respectively;
a sensor (<NUM>) comprising a contact portion (<NUM>);
a conductive member (<NUM>) extending through the second openings (<NUM>, <NUM>) of the bottom member and the spacer pad, respectively, and in electrical contact with the contact portion (<NUM>) of the sensor (<NUM>);
a sealed, sterilized region (<NUM>), the sealed, sterilized region (<NUM>) including
a portion of the sensor (<NUM>) and an insertion shaft (<NUM>) that are positioned within the insertion shaft opening (<NUM>); and
electronics (<NUM>) for the continuous glucose monitoring system;
wherein the sensor unit (<NUM>) is positioned within the sensor unit receiving area (<NUM>) of the sensor carrier (<NUM>) and the electronics (<NUM>) are positioned on the substrate (<NUM>) within the electronics receiving area (<NUM>) of the sensor carrier (<NUM>) so as to form a sensor assembly (<NUM>) having the sensor (<NUM>) electrically connected, via the conductive member (<NUM>), to the substrate (<NUM>) of the electronics receiving area (<NUM>) while maintaining sterilization of the sealed, sterilized region (<NUM>) of the sensor unit (<NUM>).