Patent Description:
Continuous glucose monitoring is important to individuals with diabetes, as they must determine when insulin is needed to reduce glucose levels or when additional glucose is needed to raise the level of glucose. A continuous glucose monitoring device (CGM) usually adheres to a patient's skin and transmits glucose reading to a remote monitoring device. The CGM can be incorporated in a closed loop system (artificial pancreas) in which, an insulin pump automatically administers and adjusts insulin delivery according to CGM transmitted glucose readings (closed loop system).

Glucose monitoring systems according to the state of the art are for instance described in <CIT>, <CIT> and <CIT>.

There exists a need for a fully disposable sensing device for continuous monitoring of glucose. There is also a need for a planar sensor probe having a minimal surface area and maximal electrodes surface area. There is also a need for a mounting device which is easy to use, minimizes pain, and minimizes insertion trauma. There is also a need for a mounting device that is fully automatic in which insertion and retraction of introducer sharp is done by a button press with no patient's intervention in spring pre-loading. There is also a need for a one piece, disposable mounting device that is pre-assembled in the factory and includes the sterilized sensor probe and the non-sterilized components and thus, reducing mounting steps at each device replacement. There is also a need for a one piece disposable mounting device that is cheap for production in which the relatively expensive spring loaded mechanism is not sterilized.

According to the invention, there is provided a continuous glucose monitoring system according to claim <NUM>.

The disclosure presents a fully disposable, one piece continuous glucose monitoring (CGM) device (sensing device), which includes a sensor and a sensor probe, and a fully disposable, one piece, mounting assembly/unit for mounting the CGM device (mounting assembly, both mounting unit and mounting assembly used interchangeably). The device and the mounting unit are pre-assembled in the factory to a one piece, disposable, mounting assembly. The mounting assembly is comprised of sealed compartment that includes a portion of the sensor and a non-sealed compartment that includes another portion of the sensor. The mounting assembly can be partially, and preferably, fully automatic, at a button press - the sensor is adhered to the skin, and the sensor probe is inserted into the subcutaneous tissue.

The sensor probe, in some embodiments, includes a first portion which is inserted in the subcutaneous tissue and a second portion adapted to be received in a sensor housing (together the sensor probe, the glucose sensor, and sensor housing comprising a sensing device, as noted above). The sensor housing includes an upper cover and a lower cover, the lower cover including an adhesive, in some embodiments, for adhering the sensor to the skin. Following use, the sensing device (i.e., the sensor housing and sensor probe), in some embodiments, is removed from the body and disposed.

In some embodiments, the sensor comprises an electronic printed circuit board assembly ("PCBA" or "electronics") and may also include a variety of optional components, such as, for example, a receiver, a transmitter, a processing circuit, a battery, an alarm system, and/or a data storage unit. In some embodiments, the sensor includes a plurality of conductive contacts, e.g., two or more conductive contacts (e.g., conductive springs), that can be configured for coupling to two or more respective contact pads on the sensor probe. The sensor probe, in some embodiments, includes at least one working electrode, a counter electrode, at least two (<NUM>) electrical conductors, and at least two (<NUM>) contact pads. In some embodiments, the probe is planar and includes two (<NUM>) electrodes - a working electrode which can be positioned on one side of the probe, in some embodiments, at the distal end of the probe, and a counter electrode positioned, in some embodiments, on the opposite side. Both electrodes, in some embodiments, are connected with electrical conductors to contact pads that can be positioned on both sides of a contact(s) plate(s). The contact plate, in some embodiments, is perpendicular to the probe (and in some embodiments, can be a part of the probe) and can reside within the sensor housing such that at least one (<NUM>) contact pad is facing the PCBA, and another (e.g., the other) contact pad is facing the opposite direction. In some embodiments, the contacts plate is folded on one (<NUM>) side at <NUM> degrees such that both contact pads are facing the PCBA and thus, simplifying electrical connection. In some embodiments, the probe and the contact(s) plate(s) are made from a single matrix sheet (e.g. polyimide) folded such that the probe is configured to be perpendicular to the skin, the contacts plate is perpendicular to the probe (parallel to skin), and both contact pads are facing the PCBA.

A mounting unit is provided and configured for mounting the sensing device (e.g., see above embodiments) onto a patient. The mounting unit can be pre-assembled with the sensing device such that the mounting unit and the sensing device (which includes the sensor and the sensor probe) are provided in one piece (mounting assembly) that is packed in one box. The mounting unit, in some embodiments, is comprised of two compartments having two pre-assembled housings, a non-sealed, non-sterilized compartment (spring compartment) that includes the insertion and retraction mechanisms and a portion of the sensing device, and a sealed, sterilized compartment (probe compartment) that includes the sensor probe. Both compartments have housings, a spring compartment housing and a probe compartment housing, that are rigidly pre-assembled during manufacture (for example), the spring compartment housing on top of the probe compartment housing. The probe compartment is preferably sealed and sterilized with radiation (e.g., gamma or e-beam). Before device mounting, the patient removes a protecting lid from the bottom side of the sensor probe housing and adheres the mounting assembly to the skin. During device mounting, the sensor and sensor probe are displaced within the sensor probe housing and mounted onto the patient (with the probe being inserted into tissue).

An introducer for insertion of the sensor probe into the subcutaneous tissue is provided. The introducer, in some embodiments, includes a sharp tip at one end which is configured to penetrate the skin, and an introducer cap, at the other end, which is configured to drive the introducer in one direction during insertion and the opposite direction during retraction. The introducer, in some embodiments, is positioned within the mounting assembly and spans the non-sterilized compartment, the sterilized compartment, and an elastomeric septum (that provides sealing to the sealed, sterilized probe compartment). The introducer can be displaced through the septum in one direction during sensor probe insertion, and then, in an opposite direction during introducer retraction. Following device mounting, the mounting unit can be removed from the body leaving the sensor on the skin and the sensor probe within the subcutaneous tissue.

In some embodiments, after triggering, operation of the mounting unit is automatic. For example, upon pressing an operating button, the mounting unit adheres the sensor to the patient's skin, inserts the sensor probe into the subcutaneous tissue (mounting phase one) and retracts the sensor probe introducer while the sensor probe remains within the body (mounting phase two). After device mounting, the mounting unit can be removed from the body and disposed. In some embodiments, the mounting unit includes a spring loaded driving mechanism for mounting the device onto the patient, and a spring loaded retraction mechanism for removing the introducer while leaving the sensor on the patient. Upon pressing an operating button, a trigger releases a pre-loaded insertion spring that drives the device (including the sensor, sensor probe, and introducer) in a first direction. At the end of movement, a preloaded retraction spring is released, and the introducer is retracted in a second opposite direction such that the introducer sharp is concealed within the mounting unit. In some embodiments, the introducer is a rigid planar structure having a sharp tip and adapted to support the sensor probe during insertion. The introducer and sensor probe can concomitantly be inserted into the subcutaneous tissue; however, in some embodiments, at the end of movement of the introducer at first direction, the sensor probe is further advanced (e.g., for additional <NUM>-<NUM>) in the same first direction. Thus, in such embodiments, local trauma within the surrounding tissue can be minimized because the cross profile of the sensor probe is very low (e.g., causes minimal trauma) and the glucose sensing electrode (i.e., the working electrode), that is located at the distal end of the probe, is exposed to a minimal local inflammatory reaction.

An assembly process for the device, according to some examples, includes the following steps (which in some examples are consecutive steps):.

According to some examples, a method of mounting the device is provided, which includes the following steps (in some examples, consecutive steps): removal of the protecting lid, placement of mounting assembly on the skin, button press, and removal of mounting unit.

A continuous glucose monitoring system for continuously monitoring glucose levels of a user is provided. The system includes a mounting assembly, and a sensing device, where at least a portion of the sensing device is housed within the mounting assembly prior to mounting the sensing device on the user.

The above noted examples include one and/or another of the following additional features, functionality, structure, steps, or clarifications, yielding yet further embodiments (as is clear from the listing below, some of the additional features, functionality, structure, steps, and clarifications - as may be the case - build off of, and/or are based on, previously/earlier recited additional features, functionality, structure, steps, or clarifications):.

In some examples, <NUM>. an assembly method for assembling a mounting assembly and a sensing device for a continuous glucose monitoring system is provided and includes assembling a/the sensing device and assembling a/the mounting assembly. For assembling the sensing device, the method includes at least one of, and preferably a plurality of, and most preferably all of:.

For assembling of the mounting assembly, the method includes at least one of, and preferable a plurality of, and most preferably all of:.

Such examples, <NUM>. may also include one and/or another of the following additional features, functionality, structure, steps, or clarifications, yielding yet further embodiments (as is clear from the listing, some of the additional features, functionality, structure, steps, and clarifications - as may be the case - build off of, and/or are based on, previously/earlier recited additional features, functionality, structure, steps, or clarifications):.

These and other advantages, and objects thereof, of the present disclosure are even more evident given the detailed description of at least some of the examples which follow, as well as the figures that form part of this disclosure (a brief description of which is outlined below).

The following reference numbers and associated terms are used to describe various structures of the present disclosure.

<FIG> shows a scheme of a continuous-glucose-monitoring (CGM) system, according to some embodiments, that includes an implantable subcutaneous glucose sensitive probe for detecting glucose levels in the interstitial fluid of a patient. The CGM system, in some embodiments, includes a disposable mounting assembly <NUM> and a durable remote display unit <NUM>. Remote display unit <NUM>, in some embodiments, has a receiver for receiving glucose readings from a skin adhered glucose sensor ("sensor" or "glucose sensor" <NUM>), and may also include a screen for presenting the received glucose readings. Mounting assembly <NUM>, according to some embodiments, is a one-piece, disposable unit that includes sensor <NUM> and a mounting unit <NUM> for mounting sensor <NUM> onto a patient. Mounting unit <NUM> and sensor <NUM>, in some embodiments, are pre-assembled during manufacture, and thus, are provided in one single disposable unit - mounting assembly <NUM>. Before sensor mounting (on the body), sensor <NUM>, in some embodiments, at least a portion of the sensor is concealed, and in some embodiments, substantially all or all of the sensor is concealed, within the mounting unit <NUM>.

Mounting assembly <NUM> is comprised of two (<NUM>) compartments: a non-sterilized, non-sealed compartment, which may also be referred to as a first or spring compartment <NUM>, and a second, sterilized, sealed compartment, which may also be referred to as a probe compartment <NUM>. The sensor, in some embodiments, comprises at least two (<NUM>) components that can be pre-assembled during manufacture: a sensor control unit, which in some embodiments, includes a housing adapted for placement on the skin, and a sensor probe <NUM> that has a first portion configured for insertion in the subcutaneous tissue and a second portion configured for being received in a sensor housing. Sensor probe <NUM>, in some embodiments, includes a glucose sensitive enzyme configured for detecting glucose levels in the interstitial fluid within the subcutaneous tissue. Sensor <NUM> is positioned within mounting assembly <NUM> such that at least a first portion of sensor <NUM> can be received in the sealed, sterilized compartment (second/probe compartment <NUM>), and at least another portion (e.g., second portion) of sensor <NUM>, which includes a PCBA <NUM>, which is adopted to be received in the non-sealed, non-sterilized compartment (spring compartment <NUM>).

In some examples, which are not claimed, both compartments of mounting assembly <NUM> are sterilized. In this configuration, second/probe compartment <NUM> is sterilized with, for example, an e-beam or gamma radiation, and spring compartment <NUM> is sterilized with a gas (e.g., ethylene oxide). The portion of sensor <NUM> which includes PCBA <NUM> is configured to be received in a sterilized compartment (spring compartment <NUM>).

An introducer <NUM> is included, which is configured for inserting sensor probe <NUM> into subcutaneous tissue. Introducer <NUM>, in such embodiments, may be positioned within mounting assembly <NUM>, and can span non-sterilized spring compartment <NUM>, sterilized probe compartment <NUM>, and an elastomeric septum <NUM>. Probe compartment <NUM> can include a housing <NUM>, a removable lid <NUM>, a portion of sensor <NUM>, and a portion of introducer <NUM>. Sealing can be provided by a protecting lid seal <NUM>, probe compartment seal <NUM>, and septum <NUM>.

The spring compartment, in some embodiments, includes a housing <NUM>, a portion of introducer <NUM>, and spring mechanisms (not shown) for driving introducer <NUM> in a first direction (e.g., probe <NUM> insertion), and a second direction, opposite to the first direction (e.g., introducer <NUM> retraction). In some embodiments, before use, a patient removes protecting lid <NUM> providing a free forward movement (e.g., in <FIG> - downward movement) of sensor <NUM> and sensor probe <NUM> within probe compartment housing <NUM>.

<FIG> show cross-sectional (2A), spatial (2B), and oblique cross-sectional (2C) views of mounting assembly <NUM> that, in some embodiments, is comprised of mounting unit <NUM> and sensor <NUM>. <FIG> shows mounting unit <NUM> that can be comprised of probe compartment <NUM> and spring compartment <NUM>. Probe compartment <NUM>, spring compartment <NUM>, and sensor <NUM>, in some embodiments, can be pre-assembled during manufacture, forming mounting assembly <NUM>. The probe compartment can include probe compartment housing <NUM>, removable protecting lid <NUM>, a portion of sensor <NUM>, sensor probe (not shown), and at least a portion of introducer <NUM>. Sealing of probe compartment <NUM> can be provided by protecting lid seal <NUM>, probe compartment seal <NUM>, and septum <NUM>. Spring compartment <NUM> can include a spring compartment housing <NUM>, a portion of introducer <NUM> including introducer cap <NUM>, and one or more spring mechanisms (e.g., insertion and retraction spring loaded mechanisms).

The spring mechanisms, in some embodiments, include at least a plurality of (and in some embodiments, all of) an operating button <NUM>, a trigger <NUM>, trigger latches <NUM>, a sleeve <NUM>, hammer <NUM>, insertion spring <NUM>, retraction spring <NUM>, and retraction spring latch <NUM>. Accordingly, following a press of operating button <NUM>, trigger <NUM> releases hammer <NUM>, insertion spring <NUM> drives hammer <NUM> in a first direction (e.g., forward) which drives introducer cap <NUM>, introducer <NUM>, and sensor <NUM> in the same direction. When introducer cap <NUM> reaches the end of the forward movement (e.g., end of a first mounting phase), in some embodiments, it releases retraction spring latch <NUM> and retraction spring <NUM> drives introducer cap <NUM> and introducer <NUM> in a second direction, opposite to the first direction (e.g., backward) direction.

<FIG> shows a spatial view of one-piece mounting unit <NUM>, including probe compartment <NUM>, probe compartment housing <NUM>, spring compartment <NUM>, spring compartment housing <NUM>, and operating button <NUM>. <FIG> shows an oblique cross-sectional view of mounting assembly <NUM>, according to some embodiments, that includes probe compartment housing <NUM>, spring compartment housing <NUM>, sensor <NUM>, sensor probe <NUM>, and introducer <NUM>. Removable protecting lid <NUM> can include a protecting lid base <NUM>, and can be connected to probe compartment housing <NUM> with a protecting lid thread <NUM>. In some embodiments, protecting lid supporting ribs <NUM> provide support to the probe compartment and sensor probe protection. Introducer <NUM> can be connected at one end (e.g., proximal end) to an introducer cap <NUM>, that, in some embodiments, is comprised of introducer cap snap <NUM>, introducer cap snap holder <NUM>, and introducer knob <NUM>.

In some embodiments, the insertion mechanism includes operating button <NUM>, trigger <NUM>, sleeve <NUM>, hammer <NUM>, and insertion spring <NUM>. The hammer <NUM> can include the introducer pulling lever <NUM>, and sensor pushing lever <NUM> (e.g., three (<NUM>) levers). In some embodiments, the release mechanism includes retraction spring <NUM> and retraction spring latch <NUM>. In some embodiments, before use, the protecting lid is removed by patient, and upon pressing of operating button <NUM>, trigger <NUM> releases the hammer <NUM> and insertion spring <NUM> drives hammer <NUM> in a (first) forward direction within sleeve <NUM>. In some embodiments, hammer introducer pulling lever <NUM>, that is connected to introducer cap snap <NUM>, drives introducer <NUM> in the (first) forward direction, and concomitantly (in some embodiments), the hammer sensor pushing levers <NUM> drive sensor <NUM> and sensor probe <NUM> also in the (first) forward direction. At the end of forward movement of hammer <NUM> (end of the first mounting phase), introducer cap knob <NUM> releases retraction spring <NUM> which drives introducer cap <NUM> in an opposite (second), e.g., backward, direction.

<FIG> show exploded (3A) and cross-sectional (3B) views of the sealed, sterilized, probe compartment <NUM>, according to some embodiments. <FIG> shows parts of probe compartment <NUM> (stacked, e.g., from the bottom up): protecting removable lid <NUM>, protecting lid seal <NUM>, probe compartment seal <NUM>, probe compartment housing <NUM>, sensor housing lower cover <NUM> and adhesive <NUM>, introducer <NUM>, sensor base plate <NUM> (not shown), base plate seal <NUM>, sensor probe <NUM>, and contacts plate <NUM>. Protecting lid seal <NUM> and probe compartment seal <NUM> can be included so as to provide sealing to the probe compartment <NUM> before mounting the sensor <NUM> to a patient's body. Sensor base plate seal <NUM> can be included to provide sealing to the sensor after sensor mounting while the sensor is adhered to the patient's skin. <FIG> shows a cross-sectional view of an assembled probe compartment <NUM>: sensor probe housing <NUM>, introducer <NUM>, and protective lid <NUM> (shown).

<FIG> shows a cross-sectional view of mounting assembly <NUM> after removal of protecting lid <NUM> (before sensor mounting), according to some embodiments. Accordingly, mounting assembly <NUM> can include spring compartment housing <NUM>, sensor probe housing <NUM>, insertion spring <NUM>, retraction spring <NUM>, and introducer cap knob <NUM>. Protecting lid <NUM>, can include protecting lid base <NUM>, protecting lid thread <NUM>, and protecting lid ribs <NUM>. Before sensor <NUM> mounting, the protecting lid <NUM>, in some embodiments, is removed by the patient by unscrewing the thread <NUM> from the probe compartment housing worm <NUM>.

<FIG> shows a cross-sectional view of mounting assembly <NUM> at the end of hammer <NUM> forward (first direction) movement (end of the first mounting phase). Accordingly, sensor <NUM> is adhered to the skin <NUM> with adhesive <NUM> and introducer <NUM> and sensor probe (not shown) are inserted within the subcutaneous tissue <NUM>. Mounting assembly <NUM>, in such embodiments, can include a plurality of, and in some embodiments, all of, spring compartment housing <NUM>, probe compartment housing <NUM>, operating button <NUM>, trigger <NUM>, trigger latches <NUM>, sleeve <NUM>, hammer <NUM>, hammer sensor pushing levers <NUM>, insertion spring <NUM>, retraction spring <NUM>, introducer <NUM>, and introducer knob <NUM>. Following the pressing of operating button <NUM>, trigger <NUM> releases the hammer <NUM> and insertion spring <NUM> drives hammer <NUM> in a forward (first) direction within the sleeve <NUM>. In some embodiments, at the end of forward movement of hammer <NUM>, introducer knob <NUM> is positioned within the loaded retraction spring <NUM>, sensor <NUM> is adhered to the skin <NUM>, and introducer <NUM> and sensor probe <NUM> are inserted within the subcutaneous tissue <NUM>.

<FIG> shows a cross-sectional view of the mounting assembly at the end of introducer <NUM> retraction (end of a second mounting phase). The mounting assembly, in some embodiments, can include a plurality of, and in some embodiments, all of, probe compartment housing <NUM>, spring compartment housing <NUM>, operating button <NUM>, trigger <NUM>, sleeve <NUM>, hammer <NUM>, hammer introducer pulling lever <NUM>, hammer sensor pushing levers <NUM>, insertion spring <NUM>, retraction spring <NUM>, introducer <NUM>, introducer cap <NUM>, and introducer knob <NUM>. Accordingly, in some embodiments, sensor <NUM> is adhered to skin (not shown) and sensor probe <NUM> is inserted within the subcutaneous tissue (not shown). Following introducer <NUM> insertion, (i.e., the end of forward/first movement of hammer <NUM>), retraction spring <NUM> is released and the introducer cap <NUM>, introducer knob <NUM>, and introducer <NUM> are driving at the opposite direction (backward/second-direction movement). At the end of the second mounting phase, introducer <NUM> is concealed within mounting assembly <NUM>.

<FIG> show spatial (7A) and cross-sectional (7B) views of mounting assembly <NUM> after removal from the body, sensor <NUM>, in some embodiments, is mounted on the skin (not shown) and sensor probe <NUM> is inserted in the subcutaneous tissue (not shown). Mounting assembly <NUM> includes probe compartment housing <NUM>, spring compartment housing <NUM>, operating button <NUM>, and introducer <NUM>.

<FIG> show spatial (8A) and cross-sectional (8B) views of sensor <NUM>, according to some embodiments. <FIG> shows sensor <NUM> and sensor probe <NUM>, with sensor <NUM> including, in some embodiments, sensor housing upper cover <NUM>, sensor housing lower cover <NUM>, septum <NUM>, and adhesive <NUM>. <FIG> shows the sensor housing upper cover <NUM>, sensor housing lower cover <NUM>, PCBA <NUM>, septum <NUM>, and adhesive <NUM>. The sensor housing lower cover <NUM>, sensor base plate <NUM> (not shown), septum <NUM>, and adhesive <NUM> can be configured to be received in the sterilized compartment (e.g., probe compartment <NUM>), and PCBA <NUM> and sensor housing upper cover <NUM> are configured to be received in the non-sterilized compartment (e.g., spring compartment <NUM>). <FIG> shows a cross section view of the sensor <NUM> on a patient skin, the sensor probe <NUM> is inserted within the subcutaneous tissue. The sensor <NUM> includes the sensor housing upper cover <NUM>, sensor housing lower cover <NUM>, septum <NUM>, and adhesive <NUM>.

<FIG> shows the spring release mechanisms, according to some embodiments. <FIG> shows a cross-sectional view (cross-section plan is <NUM>° rotated vs. <FIG> cross section plan) of the spring release mechanisms. <FIG> are magnified views of the release mechanisms of insertion spring <NUM> (9B) and retraction spring <NUM> (9C), respectively. <FIG> shows mounting assembly <NUM> that includes at least a plurality of, and in some embodiments, all of: spring compartment housing <NUM>, operating button <NUM>, trigger <NUM>, sleeve <NUM>, hammer <NUM>, insertion spring <NUM>, retraction spring <NUM>, introducer <NUM>, introducer cap snap <NUM>, and introducer cap knob <NUM>. During insertion, and in some embodiments, hammer <NUM> is displaced in a forward (e.g., first) direction by loaded spring <NUM>. The introducer cap snap <NUM> is displaced by hammer <NUM> in the same (forward/first) direction and concomitantly drives introducer <NUM> and introducer cap knob <NUM> in the same (forward/first) direction. <FIG> shows the release mechanism of insertion spring <NUM>, according to some embodiments, where upon pressing operating button <NUM>, the trigger <NUM> is displaced in the same (forward/first) direction and rotates (in some embodiments, slightly, e.g., less than one rotation) such that hammer <NUM> is released and displaced (e.g., forward) within sleeve <NUM> by loaded spring <NUM>.

<FIG> shows the retraction mechanism of retraction spring <NUM>, according to some embodiments. Here, retraction spring latch <NUM> is laterally displaced by the introducer cap knob <NUM>, and releases the retraction spring <NUM>. Retraction spring <NUM> is then displaces the introducer <NUM> in a second/backward direction opposite to the first/forward direction.

<FIG> shows an exploded view of parts/components of sensor <NUM> and sensor probe <NUM>, according to some embodiments. Sensor <NUM> and sensor probe <NUM> can include (in a stacked arrangement, e.g., stacking bottom-up) at least a plurality of, and in some embodiments, all of: adhesive <NUM>, sensor housing lower cover <NUM>, sensor probe <NUM>, contacts plate <NUM>, sensor base plate <NUM>, PCBA <NUM>, septum <NUM>, and sensor housing upper cover <NUM>. The adhesive <NUM>, sensor housing lower cover <NUM>, sensor base plate <NUM>, sensor probe <NUM>, contacts plate <NUM>, septum <NUM> and a portion of introducer <NUM> are sterilized (according to some embodiments); PCBA <NUM> and sensor housing upper cover <NUM> are not sterilized (according to some embodiments).

<FIG> shows sensor <NUM> components, according to some embodiments. <FIG> shows a top level view of sensor <NUM>, according to some embodiments, that includes adhesive <NUM>, septum <NUM>, and sensor housing upper cover <NUM>. <FIG> shows a spatial, exploded view of sensor <NUM> and sensor probe <NUM>. Sensor <NUM> can include a plurality of, and in some embodiments, all of sensor housing lower cover <NUM>, lower cover cushion pad <NUM>, contacts plate <NUM>, base plate seal <NUM>, sensor base plate <NUM>, conductive springs <NUM>, PCBA <NUM>, and PCBA opening <NUM>. The base plate seal <NUM>, in some embodiments, provides sealing (e.g., water resistance) for sensor <NUM> after connection of sensor housing lower cover <NUM> and sensor housing upper cover <NUM>. The lower cover cushion pad <NUM>, in some embodiments, can provide tight/rigid connection between contacts pad (shown in <FIG>) that are located on contacts plate <NUM> and the conductive springs <NUM>. In some embodiments, during sensor operation, electrical current generated on sensor probe <NUM> is conducted to contacts plate <NUM> and through conductive springs <NUM> to the PCBA <NUM>. <FIG> shows a cross-sectional view of a portion of sensor <NUM> that includes, according to some embodiments, sensor housing lower cover <NUM>, sensor base plate <NUM>, PCBA <NUM>, and sensor housing upper cover <NUM>. In some embodiments, introducer <NUM> crosses (e.g., through/in) septum <NUM>.

<FIG> shows the sensor components/parts, according to some embodiments. <FIG> shows a spatial view of the sensor electronic print (PCBA) <NUM>, sensor base plate <NUM>, and introducer <NUM>. Sensor base plate <NUM> can include at least one of, and preferably both of, a recess <NUM> for housing the battery (not shown), base plate opening <NUM>, and openings for the conductive springs <NUM>. Introducer <NUM> can span the sensor through openings in PCBA <NUM> and sensor base plate <NUM> (septum <NUM> that crosses these openings is not shown). <FIG> shows a spatial view of introducer <NUM>, contacts plate <NUM>, and conductive springs <NUM>, according to some embodiments. <FIG> shows an exploded view of introducer <NUM>, sensor probe <NUM>, contacts plate <NUM>, conductive springs <NUM>, and conductive spring holders <NUM> (sensor base plate <NUM> and PCBA <NUM> removed), according to some embodiments.

<FIG> shows sensor probe <NUM> and contacts plate <NUM>, according to some embodiments. Sensor probe <NUM> and contacts plate <NUM> can be made from a single, flat thin base sheet (matrix sheet, e.g., polyimide). Accordingly, electrodes, conductors, insulators, contact pads, enzyme layer, and other protective layers can be deposited on one side or both sides thereof. Following deposition of materials on the matrix sheet, it is cut (e.g., dye cut or laser cut) to a desired shape and can be folded to receive a final spatial configuration such that the contacts plate <NUM> is adopted to be received in the sensor housing and the sensor probe (perpendicular to contacts plate) is adopted to be inserted in the subcutaneous tissue. In some embodiments, the contacts plate is configured to provide electrical contact between sensor probe electrodes and the sensor PCBA. The electrodes (at least one) can be deposited on one or both sides of the matrix sheet such that, for example, the working electrode (i.e., glucose sensitive) is deposited on one side and the counter electrode is deposited on the other/second side.

In some embodiments, the working electrode and the counter electrode (and, if required, a reference electrode) are deposited on one side of the matrix sheet. <FIG> shows a side view of sensor probe <NUM> and contacts plate <NUM> after folding of the matrix sheet, according to some embodiments. Here, contacts plate <NUM> has <NUM> sides - contacts plate first side <NUM> and contacts plate second side <NUM>. In some embodiments, the contacts plate <NUM> is folded such that contacts plate first side <NUM> and contacts plate second side <NUM> are facing the same direction (e.g., upside) (magnified view). <FIG> shows a top view of the matrix sheet <NUM> after cutting and before folding, according to some embodiments. Here, matrix sheet <NUM> includes the sensor probe <NUM> and contacts palate <NUM> that is comprised of the contacts plate first side <NUM>, the contacts plate second side <NUM> (not seen in a top view), and a contacts plate fold <NUM>. <FIG> show two spatial views (mirror images) of the folded matrix sheet that forms the sensor probe <NUM> and the contacts plate <NUM>, according to some embodiments, and includes electrodes <NUM> and <NUM>, conductors <NUM> and <NUM>, and contact pads <NUM> and <NUM>. Electrode <NUM>, conductor <NUM>, and contact pad <NUM> can be deposited on one side of the matrix sheet <NUM>; the contact pad <NUM> can be deposited on the contacts plate second side <NUM>. Electrode <NUM>, conductor <NUM>, and contact pad <NUM> can be deposited on the second side of the matrix sheet <NUM>; the contact pad <NUM> can be deposited on contact plate first side <NUM>. In some embodiments, after folding of matrix sheet, contact pad <NUM> and contact pad <NUM> face the same direction.

<FIG> show spatial views of introducer <NUM>, probe <NUM>, and contacts plate <NUM>, according to some embodiments. <FIG> shows an exploded view of introducer <NUM> and sensor probe <NUM> before assembly. Accordingly, introducer cap <NUM> is connected to the introducer <NUM> at one end (e.g., proximal end) and is comprised of introducer cap snap <NUM> and introducer cap snap holder <NUM>. The introducer cap snap <NUM> can be configured to couple with the hammer (e.g., <FIG>) and drives introducer <NUM> during insertion. <FIG> shows a spatial view of introducer <NUM>, introducer cap <NUM>, sensor probe <NUM>, and contacts plate <NUM>, according to some embodiments, and a magnified view of the introducer tip <NUM> and sensor probe tip <NUM> before sensor probe <NUM> insertion.

<FIG> shows a spatial view of introducer <NUM> and introducer cap <NUM> before sensor probe insertion, according to some embodiments. <FIG> shows a spatial view of introducer <NUM>, introducer cap <NUM>, sensor probe <NUM>, and contacts plate <NUM>, and a magnified view of the introducer tip <NUM> and sensor probe tip <NUM> after sensor probe <NUM> insertion within the subcutaneous tissue and before retraction of introducer <NUM> (end of the first mounting phase), according to some embodiments.

<FIG> shows the introducer tip <NUM> and sensor tip <NUM>, according to some embodiments. <FIG> show side view (15A1), top view (15A2), and cross-sectional view (15A3) of introducer tip <NUM>, according to some embodiments. Introducer <NUM>, in some embodiments, includes a U-shape cross section having at least one and preferably two longitudinal protrusions: sensor probe holders <NUM>, configured to support sensor probe <NUM> when it is coupled with introducer <NUM>. <FIG> show a side view (15B1) and a top view (15B2) of introducer tip <NUM> and sensor probe tip <NUM>. In some embodiments, sensor tip <NUM> has a rectangular shape. <FIG> shows a top view of a sharp tip <NUM> of the introducer, and sensor tip <NUM> of probe <NUM> (here, sensor tip <NUM> has a square shape). <FIG> show schemes, according to some embodiments, of the senor probe tip having a sharp end.

<FIG> show spatial (16A-C) and magnified (16A1-C1) views, of the sensor <NUM>, sensor probe <NUM>, introducer tip <NUM>, and sensor tip <NUM>, according to some embodiments, during a first mounting phase and a second mounting phase. Since it is desired to minimize traumatic injury at the tissue surrounding the sensor probe tip and minimize the consequent inflammatory reaction because inflammation reduces the electrodes sensitivity to glucose, in the first mounting phase, the coupled introducer <NUM> and sensor probe <NUM> are concomitantly inserted into the subcutaneous tissue. In some embodiments, at the end of forward/first direction displacement of introducer <NUM> and sensor probe <NUM>, sensor probe <NUM> is further displaced (e.g., <NUM>-<NUM>) in the same (first/forward) direction (i.e., there is a relative movement between introducer <NUM> and sensor probe <NUM>). Thus, at the end of the first mounting phase, in some embodiments, sensor probe tip <NUM> is located distally to the introducer tip <NUM>. The sensor probe <NUM> is relatively thin <NUM>-<NUM> microns such that and movement within the subcutaneous tissue causes minimal trauma. <FIG> show sensor probe <NUM> coupled with introducer <NUM> before insertion - sensor probe tip <NUM> resides within the introducer <NUM>. <FIG> show the introducer tip <NUM> and the sensor probe tip <NUM> at the end of the first mounting phase, with the sensor probe tip <NUM> protruding from the introducer tip <NUM> (e.g., positioned <NUM>-<NUM> apart). <FIG> - C1 show sensor <NUM> and probe <NUM> after removal of introducer <NUM> (not shown) (end of second mounting phase).

<FIG> and <FIG> show an assembly process of mounting assembly <NUM>, according to some embodiments. In a first assembly stage, probe compartment <NUM> is assembled and then sterilized (e.g., gamma, e-beam radiation). The probe compartment <NUM> is then sealed and provides protection to sensor probe <NUM> against biologic and chemical contamination. In some embodiments, probe compartment <NUM> is comprised of at least a portion of mounting assembly <NUM> and at least a portion of sensor <NUM> (e.g., <FIG>). Following sterilization of the probe compartment <NUM>, the non-sterilized spring compartment <NUM> can be assembled adjacent (e.g., on-top) of sterilized probe compartment <NUM> (e.g., in a clean room). The spring compartment <NUM>, in some embodiments, comprises at least a portion of mounting assembly <NUM> and at least a portion of sensor <NUM> (see e.g., <FIG>). The introducer <NUM>, according to some embodiments, spans mounting assembly <NUM> and is configured to be received in both probe compartment <NUM> and spring compartment <NUM>.

<FIG> show exploded view (17A) and oblique cross section view (17B) of the sterilized, sealed compartment (probe compartment <NUM>), according to some embodiments. The probe compartment <NUM> can include a plurality of, and in some embodiments, all of (parts stacked, e.g., from the bottom-up) protecting lid <NUM>, protecting lid seal <NUM>, probe compartment seal <NUM>, probe compartment housing <NUM>, adhesive <NUM>, sensor housing lower cover <NUM>, sensor base plate, <NUM>, introducer <NUM>, base plate seal <NUM>, sensor probe <NUM>, and contacts plate <NUM>.

<FIG> show spatial views (18A1 - F1) and oblique views (18A2 - F2), respectively, of the various assembly stages of the mounting assembly <NUM>, according to some embodiments. <FIG> show sterile probe compartment <NUM> after assembly (e.g., assembly process shown in <FIG>) and sterilization. The sterile probe/compartment (probe compartment <NUM>) can include a plurality of, and in some embodiments, all of protecting lid <NUM>, probe compartment housing <NUM>, sensor base plate <NUM>, and introducer <NUM>. <FIG> show the assembled PCBA <NUM>, according to some embodiments, <FIG> show the assembled sensor housing upper cover <NUM>, according to some embodiments, and <FIG> show the assembled spring compartment base <NUM> and the retraction spring <NUM>, according to some embodiments. <FIG> show the assembled introducer cap <NUM>, according to some embodiments, and <FIG> show spring compartment housing <NUM> and insertion spring loaded mechanism (operating button <NUM>, other component are shown in <FIG>), according to some embodiments.

At a later stage of assembly, according to some embodiments, spring compartment housing <NUM> can be rigidly connected to probe compartment housing <NUM> forming mounting assembly <NUM> (as shown in <FIG>). In some examples, which are not claimed, assembled mounting assembly <NUM> can be sterilized with a gas (e.g., ethylene oxide), and sealed probe compartment <NUM>, which can be pre-sterilized with radiation (e.g., gamma or e-beam), protects the gas sensitive enzyme (deposits on the probe <NUM>) from potential damage of the gas. In such a configuration, both compartments (probe compartment <NUM> and spring compartment <NUM>) can be sterilized as well as all components of the sensor <NUM> (including PCBA).

While various examples have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function, and/or obtaining the results and/or one or more of the objects/advantages described herein, and each of such variations and/or modifications is deemed to be described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, steps, and configurations described herein are meant to be merely an example and that the actual parameters, dimensions, materials, steps, and configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific examples described herein. It is therefore to be understood that the foregoing is presented by way of example only. Examples of the present disclosure are directed to each individual feature, device, system, article, material, kit, step, function/functionality, and method described herein. In addition, any combination of two or more such features, devices, systems, articles, materials, kits, steps, functions/functionality, and methods, if such features, systems, articles, materials, kits, steps, functions/functionality, and methods are not mutually inconsistent, is included.

Examples <NUM>. disclosed herein may also be combined with one or more features, as well as complete systems, devices, and/or methods, to yield yet other examples.

The acts performed as part of the method(s) may be ordered in any suitable way. Accordingly, examples may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts.

The terms "can" and "may" are used interchangeably in the present disclosure, and indicate that the referred to element, component, structure, function, functionality, objective, advantage, operation, step, process, apparatus, system, device, result, or clarification, has the ability to be used, included, or produced, or otherwise stand for the proposition indicated in the statement for which the term is used (or referred to).

Only terms clearly indicated to the contrary, such as "only one of or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e. "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of" "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

Only the transitional phrases "consisting of and "consisting essentially of' shall be closed or semi-closed transitional phrases, respectively.

Claim 1:
A continuous glucose monitoring system for continuously monitoring glucose levels of a user, the system comprising:
a mounting assembly (<NUM>) including a first, non-sealed, non-sterilized compartment (<NUM>) and a second sealed, sterilized compartment (<NUM>);
a sensing device comprising a sensor and a sensor probe (<NUM>), and
an introducer (<NUM>) configured to insert the sensor probe (<NUM>) into subcutaneous tissue of the user, wherein:
at least a first portion of the sensing device is housed within the first, non-sealed, non-sterilized compartment (<NUM>), and at least a second portion of the sensing device is housed within the second, sealed, sterilized compartment (<NUM>) prior to mounting the sensing device on the user, and
the first, non-sealed, non-sterilized compartment (<NUM>) includes an insertion means comprising a spring-loaded driving mechanism configured to mount the sensing device onto the user.