(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2007/0027381 A1
`Stafford
`(43) Pub. Date:
`Feb. 1, 2007
`
`US 20070027381A1
`
`(54) INSERTER AND METHODS OF USE
`
`Publication Classification
`
`(75) Inventor: Gary Ashley Stafford, Hayward, CA
`(US)
`
`Correspondence Address:
`JACKSON & CO., LLP
`6114 LASALLEAVENUE
`SUTE 507
`OAKLAND, CA 94611-2802 (US)
`
`(73) Assignee: TheraSense, Inc., Alameda, CA
`
`(21) Appl. No.:
`
`11/192,773
`
`(22) Filed:
`
`Jul. 29, 2005
`
`
`
`(51) Int. Cl.
`(2006.01)
`A6B 5/05
`(52) U.S. Cl. ........................... 600/347; 128/903; 600/345
`
`ABSTRACT
`(57)
`- 0
`Method and apparatus for providing a housing integrated
`with a sensor introducer and a sensor in analyte monitoring
`system to deploy the sensor and retain the introducer within
`the housing upon sensor deployment, and mounting a trans
`mitter to the housing to receive the sensor data is described.
`The housing may be placed on the skin of a patient and a
`spring biased mechanism, separately provided and coupled
`to the introducer or by integrally configuring the introducer,
`triggers the introducer to deploy the insertion mechanism for
`placement of the sensor at a predetermined depth under the
`skin of the patient.
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`Patent Application Publication Feb. 1, 2007 Sheet 1 of 7
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`US 2007/0027381 A1
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`FIGURE 2A
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`FIGURE 2B
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`Patent Application Publication Feb. 1, 2007 Sheet 2 of 7
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`US 2007/0027381 A1
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`FIGURE 3
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`FIGURE 4
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`Patent Application Publication Feb. 1, 2007 Sheet 3 of 7
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`US 2007/0027381 A1
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`FIGURE 6
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`Patent Application Publication Feb. 1, 2007 Sheet 4 Of 7
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`US 2007/0027381 A1
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`FIGURE 7
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`FIGURE 8
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`Patent Application Publication Feb. 1, 2007 Sheet 5 of 7
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`US 2007/0027381 A1
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`be
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`FIGURE 10
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`Patent Application Publication Feb. 1, 2007 Sheet 6 of 7
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`US 2007/0027381 A1
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`FIGURE 12
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`Patent Application Publication Feb. 1, 2007 Sheet 7 of 7
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`US 2007/0027381 A1
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`FIGURE 13
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`US 2007/0027381 A1
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`Feb. 1, 2007
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`INSERTER AND METHODS OF USE
`
`BACKGROUND
`0001. The present invention relates to data monitoring
`and detection systems. More specifically, the present inven
`tion relates to method and apparatus for providing a trans
`cutaneous sensor insertion into a patient for use in analyte
`monitoring systems including continuous glucose monitor
`ing Systems.
`0002 Continuous glucose monitoring systems generally
`include a sensor Such as a Subcutaneous analyte sensor for
`detecting analyte levels such as blood glucose levels, a
`transmitter (Such as an RF transmitter) in communication
`with the sensor and configured to receive the sensor signals
`and to transmit them to a corresponding receiver unit by for
`example, using RF data transmission protocol. The receiver
`may be operatively coupled to a blood glucose monitor that
`performs blood glucose related calculations and data analy
`S1S.
`0003. The transmitter may be mounted or adhered to the
`skin of a patient and also in signal communication with the
`sensor, a portion of which may be implanted into the skin of
`the patient. Generally, the sensor is configured to detect and
`measure the blood glucose levels of the patient over a
`predetermined period of time, and the transmitter is config
`ured to transmit the measured blood glucose levels over the
`predetermined period of time for further analysis. To ini
`tially set up the sensor so that the sensor contacts and
`electrodes are in fluid contact with the patient’s analyte
`fluids, it is important to properly insert the sensor through
`the patient’s skin and securely retain the sensor during the
`time that the sensor is configured to detect analyte levels. In
`addition to accurate positioning of the sensor through the
`skin of the patient, it is important to minimize the level of
`pain associated with the insertion of the sensor through the
`patient’s skin.
`0004. In view of the foregoing, it would be desirable to
`have method and apparatus which would allow for accurate
`and easy insertion of the sensor through the skin of a patient
`or otherwise to properly position the sensor transcutaneously
`so that the sensor maybe configured to detect analyte levels
`of the patient. Also, it would be desirable to have a method
`and apparatus to have an integrated sensor insertion mecha
`nism and transmitter mount or housing portion which may
`be mounted on the patient’s skin with ease and relative little
`pain to the patient.
`
`SUMMARY OF THE INVENTION
`0005. In one embodiment, there is provided a rotary
`inserter configuration incorporating an introducer for
`deployment of a sensor Such as an electrochemical sensor
`through the skin of a patient to transcutaneously place the
`sensor in fluid contact with the patient’s analyte. The rotary
`inserter configuration in one embodiment includes a spring
`biased insertion mechanism which, upon actuation or trig
`ger, is configured to deploy the introducer and the sensor,
`and upon deployment of the sensor in the patient, to retract
`the introducer from the patient and within the housing so that
`it does not interfere with the analyte monitoring. In one
`embodiment, the insertion mechanism may also include a
`"Scotch-Yoke' type mechanism configured to translate rota
`
`tional motion into linear motion. Alternatively, the insertion
`mechanism may include gears and/or a cam as well.
`0006.
`In a further embodiment of the present invention,
`the rotary inserter configuration is integrated with a mount
`ing unit of a sensor control unit, or a base housing which is
`configured to receive a data transmitter (or a transceiver). As
`Such, a single device which incorporates the sensor insertion
`mechanism as well as providing the Support structure for
`mounting the transmitter to a patient is provided. The data
`transmitter in one embodiment is configured for electrical
`communication with the sensor, where the sensor is config
`ured to detect the patients analyte level, and the transmitter
`configured to transmit (wirelessly or otherwise) to a moni
`toring unit Such as a glucose monitor unit or an insulin
`pump.
`0007. In this manner, in accordance with the various
`embodiments of the present invention, the sensor may be
`deployed using a trigger mechanism of a rotary inserter
`configuration that may be actuated by a simple rotary type
`movement of the insertion mechanism, and which is con
`figured to retain the introducer within the housing so as to be
`discarded with the housing and/or with the replacement of
`the sensor.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0008 FIG. 1 illustrates a perspective view of the rotary
`inserter configuration in pre-deployed position in accor
`dance with one embodiment of the present invention;
`0009 FIGS. 2A-2B illustrate a top planar view of the
`rotary inserter configuration shown in FIG. 1;
`0010 FIG. 3 illustrates the introducer coupled to an
`insertion mechanism in the pre-deployed position as shown
`in FIG. 1 in accordance with one embodiment of the present
`invention;
`0011 FIG. 4 illustrates a perspective view of the rotary
`inserter configuration in a deployment position in accor
`dance with one embodiment of the present invention;
`0012 FIG. 5 illustrates the introducer coupled to the
`insertion mechanism in the deployment position shown in
`FIG. 4 in accordance with one embodiment of the present
`invention;
`0013 FIG. 6 illustrates a perspective view of the rotary
`inserter configuration in deployed position in accordance
`with one embodiment of the present invention;
`0014 FIG. 7 illustrates a side planar view of the rotary
`inserter configuration in the deployed position shown in
`FIG. 6 in accordance with one embodiment of the present
`invention;
`0.015
`FIG. 8 illustrates a front planar view of a coil
`spring insertion mechanism in accordance with a further
`embodiment of the present invention;
`0016 FIG. 9 illustrates a perspective view of the coil
`spring insertion mechanism of FIG. 8 in accordance with
`one embodiment of the present invention;
`0017 FIG. 10 illustrates a side planar view of the coil
`spring insertion mechanism of FIG. 8 in accordance with
`one embodiment of the present invention;
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`US 2007/0027381 A1
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`Feb. 1, 2007
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`0018 FIG. 11 illustrates a front planar view of a flexible
`introducer insertion mechanism in accordance with still a
`further embodiment of the present invention;
`0019 FIG. 12 illustrates a perspective view of the flex
`ible introducer insertion mechanism in accordance with one
`embodiment of the present invention; and
`0020 FIG. 13 illustrates a side planar view of the flexible
`introducer insertion mechanism in accordance with one
`embodiment of the present invention.
`
`DETAILED DESCRIPTION
`FIG. 1 illustrates a perspective view of the rotary
`0021
`inserter configuration in pre-deployed position in accor
`dance with one embodiment of the present invention. Refer
`ring to the Figure, rotary inserter configuration 100 in one
`embodiment of the present invention includes a housing (or
`mount) 101 configured substantially as shown in the Figure,
`and which includes a base portion at a Substantially right
`angle to a sensor insertion portion. As shown in the Figure,
`the sensor insertion portion of the housing 101 includes a
`cavity 105 that is configured to substantially house an
`analyte sensor 104, an introducer 103 and an insertion
`mechanism 102 as discussed in further detail below. Refer
`ring again to FIG. 1, it can be seen that in a pre-deployed
`position, the sensor 104, the introducer 103 and the insertion
`mechanism 102 are substantially completely retained within
`the cavity 105 of the insertion portion of the housing.
`However, in certain embodiments some or all of these may
`be only partially retained within cavity 105.
`0022. Moreover, it can be further seen from the Figure
`that the introducer 103 is physically coupled to the senor 104
`such that, when the insertion mechanism 102 is deployed,
`the introducer 103 is configured to be physically displaced
`with the sensor 104 so as to deploy and position the sensor
`104 in a desired location (for example, at least a portion of
`the sensor in contact with the Subcutaneous tissue under the
`skin of a patient).
`0023. Additionally, the insertion mechanism 102 as
`shown in FIG. 1 is configured to be physically or mechani
`cally coupled to the introducer 103 via a coupling mecha
`nism 106. More specifically, as discussed in further detail
`below, in one embodiment of the present invention, the
`insertion mechanism 102 may be substantially configured
`as, for example, a circular thumb wheel mechanism or the
`like rotatably mounted at its center position (or otherwise)
`within the insertion portion of the housing 101. In such
`embodiments, the insertion mechanism 102 may be easily
`and readily rotated by the movement of a users thumb or
`any other finger along the opening portion of the cavity 105
`as shown. In other words, in certain embodiments, the
`circumferential edge portion of the insertion mechanism 102
`may be positioned within the cavity So as to be physically
`accessible by a patient.
`0024 Moreover, in certain embodiments, the insertion
`mechanism 102 in one embodiment is provided with a
`coupling mechanism 106 which is configured to physically
`couple to the introducer 103 as shown in FIG. 1. In this
`manner, as will be discussed in further detail below, the
`rotatable movement of the insertion mechanism 102 is
`configured to correspondingly displace the position of the
`introducer 103 within the cavity 105 of the insertion portion
`
`of the housing 101. In turn, the displacement of the intro
`ducer 103 will correspondingly move the sensor 104 within
`the cavity 105 so as to position the sensor 104 in the desired
`location.
`0025 Referring yet again to the Figure, while a pin type
`coupling mechanism 106 is shown, within the scope of the
`present invention, the introducer 103 may be coupled in
`many different ways to couple to the insertion mechanism
`102 so that the position and thus the deployment of the
`introducer 103 may be controlled by the insertion mecha
`nism 102. For example, within the scope of the present
`invention, the coupling mechanism 106 may include, but is
`not limited to, a hinged or pivotable coupling mechanism, or
`the like. In addition, within the scope of the present inven
`tion, the insertion mechanism 102 may be spring biased (or
`spring loaded) so that in the pre-deployed position as shown
`in FIG. 1, the insertion mechanism 102 may include a trigger
`function which includes the bias of the spring for the
`insertion mechanism to be in a coiled position. Thereafter,
`upon user or patient activation of the trigger function by, for
`example, the patient's movement of the patient’s finger or
`thumb over the cavity 105 of the housing 101 so as to
`displace the insertion mechanism 102, the spring loaded
`insertion mechanism 102 may be triggered so as to rotatably
`displace the introducer 103 including the sensor 104 to the
`deployment position in the cavity 105.
`0026 FIGS. 2A-2B illustrate a top planar view of the
`rotary inserter configuration shown in FIG. 1. Referring to
`the Figures, in can be seen that the cavity 105 may be
`configured in one embodiment to Substantially physically
`retain the introducer 103, the sensor 104 and the insertion
`mechanism 102. Moreover, while not shown in the Figures,
`a transmitter unit in one embodiment is configured to be
`removably placed on the base portion of the housing 101 so
`that when the transmitter unit is positioned substantially on
`the base portion of the housing, the transmitter unit is
`configured to be in electrical contact with the sensor 104. In
`this manner, the detected analyte levels from the sensor 104
`may be transmitted to the transmitter unit, which is, in one
`embodiment, configured to wirelessly transmit the sensor
`signals to a receiver unit Such as a glucose monitor unit, an
`insulin pump unit, or a computer terminal.
`0027. In certain embodiments, the transmitter may be
`integrated into the base portion of the housing, e.g., inte
`grated in or on the base portion, so as to provide a unitary
`piece of construction. Such embodiments reduce the number
`of separate components and reduce the number of steps a
`user performs by omitting or minimizing the steps of attach
`ing or mounting a transmitter to the base portion. More
`specifically, in one embodiment, the transmitter may be
`partially attached before the insertion of the sensor 104.
`Indeed, these steps can be performed with less difficulty and
`with more reliability, as both hands of the patient can be used
`for tabletop assembly before the housing 101 is applied to
`the skin. After the insertion of the sensor 104, the transmitter
`may be easily moved to the final position using one hand.
`Indeed, the steps of attaching and detaching an inserter in
`one embodiment of the present invention is eliminated
`because the insertion mechanism in accordance with the
`various embodiments of the present invention is integrated
`and built into the housing 101 of the transmitter. Additional
`information on the detection, monitoring and analysis of
`analyte levels are described in further detail in U.S. Pat. No.
`
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`US 2007/0027381 A1
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`Feb. 1, 2007
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`6,175,752 entitled “Analyte Monitoring Device and Meth
`ods of Use' the disclosure of which is incorporated herein by
`reference for all purposes.
`0028 FIG. 3 illustrates the introducer coupled to an
`insertion mechanism in the pre-deployed position as shown
`in FIG. 1 in accordance with one embodiment of the present
`invention. Referring to the Figure, the insertion mechanism
`102 and the introducer 103 coupled with the sensor 104 is
`shown outside of the cavity 105 of the insertion portion of
`the housing 101. It can be seen that as discussed in detail
`above, the coupling mechanism 106 of the insertion mecha
`nism 102 is configured in one embodiment to mechanically
`couple with the introducer 103.
`0029. In this manner, when the patient rotates the inser
`tion mechanism 102 along the rotational direction of the
`insertion mechanism 102 as shown by the directional arrow
`301, the introducer 103 and the sensor 104 are configured to
`be displaced to the desired location. More specifically, as
`discussed in further detail below, the rotational movement of
`the insertion mechanism 102 in one embodiment is config
`ured to displace the introducer 103 so that the introducer 103
`deploys the sensor 104 through the skin of the patient (or the
`Surface on which the housing 101) is placed, e.g., to trans
`cutaneously position the sensor with respect to the skin of
`the patient.
`0030 FIG. 4 illustrates a perspective view of the rotary
`inserter configuration in a deployment position in accor
`dance with one embodiment of the present invention. Refer
`ring to the Figure, it can be seen that in the deployment
`position, the introducer tip portion 401 is configured to
`protrude beyond the bottom surface of the housing 101 so as
`to extend out of the cavity 105 and thus pierce the skin of the
`patient to which the bottom portion of the housing 101 is in
`contact. More specifically, in the deployment position as
`shown in FIG. 4, the insertion mechanism 102 when actu
`ated, in one embodiment of the present invention, is con
`figured to.displace the introducer 103 and the sensor 104 in
`a downward direction within the cavity 105, and as shown
`by the directional arrow 402 shown in FIG. 4.
`0031
`Indeed, as can be seen from FIG. 4, the deployment
`position of the rotary inserter configuration in one embodi
`ment of the present invention is configured to physically
`translate the position of the introducer 103 and the sensor
`104 such that the introducer 103 is placed in motion to
`deploy the sensor 104 to the desired location relative to the
`housing 101, and also, relative to the patient’s skin or body.
`0032 FIG. 5 illustrates the introducer coupled to the
`insertion mechanism in the deployment position shown in
`FIG. 4 in accordance with one embodiment of the present
`invention. Referring to the Figure, similar to the embodi
`ment shown in FIG. 3, the insertion mechanism 102 coupled
`to the introducer 103 and the sensor 104 is shown outside of
`the cavity 105 of the housing 101. As shown in the Figure,
`it can be seen that the coupling mechanism 106 physically
`coupling the introducer 103 to the insertion mechanism 102,
`is displaced so as to fully deploy the sensor 104 coupled to
`the introducer 103.
`0033. In other words, at the deployment position shown
`in FIG. 5, the tip portion 401 of the introducer 103 which in
`one embodiment is configured to guide a portion of the
`sensor 104, is configured to correspondingly deploy the
`
`sensor 104 by guiding the portion of the sensor 104 with the
`force provided by the insertion mechanism 102 in displacing
`the introducer 103. In one embodiment, as discussed above,
`the insertion mechanism 102 may be spring loaded so as to
`provide the force needed to trigger the introducer 103 to be
`deployed through a surface such as a patient’s skin.
`0034 FIG. 6 illustrates a perspective view of the rotary
`inserter configuration in deployed position in accordance
`with one embodiment of the present invention. Referring to
`the Figure, it can be seen that upon the deployment of the
`introducer 103 and correspondingly the sensor 104, the
`insertion mechanism 102 is configured to be displaced
`within the cavity 105 of the housing to return to the initial
`pre-deployment position. This can also be seen by the
`directional arrow 602 shown in FIG. 6 which illustrates the
`direction along which the introducer 103 is configured to
`OW.
`0035) Referring back to FIG. 6, in the deployed position
`of the rotary inserter configuration, the sensor 104 is con
`figured to be substantially and permanently displaced Such
`that the sensor portion which is configured to be placed in
`fluid contact with the patients analyte-containing fluid is
`thus position as such and out of the cavity 105 of the housing
`101. This is shown in FIG. 6 where tip portion 601 of the
`sensor 104 in the deployed position is securely positioned
`out of the cavity 105 of the housing 101.
`0036) The relative position of the insertion mechanism
`102, the introducer 103 and the sensor 104 upon deployment
`and in deployed position can be also seen in FIG. 7 which
`illustrates a side planar view of the rotary inserter configu
`ration in the deployed position shown in FIG. 6 in accor
`dance with one embodiment of the present invention. In this
`manner, as shown in the Figures and in accordance with one
`embodiment of the present invention, the insertion mecha
`nism 102 is configured to deploy the introducer 103 and the
`sensor 104 by a simple trigger function of the patients
`rotatable displacement of the insertion mechanism 102.
`0037 Upon actuation of the trigger function, the spring
`biased insertion mechanism 102 in one embodiment is
`configured to rapidly displace the introducer 103 (and thus
`the sensor) through the skin of a patient, so as to pierce the
`skin Surface, and deploy the sensor 104, and also to retract
`the introducer 103 out of the patient, leaving behind the
`sensor 104 in, for example, fluid contact with the patients
`analyte levels. Thereafter, the sensor 104 positioned within
`the housing 101 is configured to transmit analyte levels to
`the transmitter unit mounted onto the housing. It should be
`noted that in one embodiment, the speed of insertion of the
`introducer 103 and the sensor 104 is substantially a function
`of the speed at which the patient manipulates or activates the
`insertion mechanism 102.
`0038 Moreover, while a spring loaded mechanism is
`discussed, within the scope of the present invention, other
`equivalent trigger mechanism may be used to deploy the
`introducer 103, and thus to provide the functionality of the
`insertion mechanism.
`0.039
`FIG. 8 illustrates a front planar view of a coil
`spring insertion mechanism in accordance with a further
`embodiment of the present invention. Referring to the Fig
`ure, the coil spring insertion mechanism 800 in one embodi
`ment of the present invention includes a torsion spring 801
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`Feb. 1, 2007
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`which is coupled to an introducer 802, and which in one
`embodiment is configured to be controlled by a lever 803
`mounted thereon. Referring to FIG. 8, it can be seen that the
`torsion spring 801 and the introducer 802 as well as the lever
`803 is substantially positioned within the insertion portion of
`the housing 101. Furthermore, it can be seen that the analyte
`sensor 104 is integrally provided within the sensor insertion
`portion of the housing 101, and further, is coupled to the
`introducer 802 such that, when the lever 803 is actuated (for
`example, by the user or patient), the sensor 104 is configured
`to be displaced out of the housing 101 by the movement of
`the introducer 802 under the force of the torsion spring 801.
`0040 FIGS. 9 and 10 illustrate a perspective view and a
`side planar view, respectively, of the coil spring insertion
`mechanism of FIG. 8 in accordance with one embodiment of
`the present invention. Referring to the Figures, as can be
`seen, a handle portion 901 may be integrally provided to the
`lever 803 and positioned substantially partially outside of
`the housing 101 to provide access to the patient in order to
`actuate the lever 803 to trigger the introducer 802 so as to
`place the sensor 104 transcutaneously to the skin of the
`patient.
`Referring back to FIGS. 8-11, the coil spring
`0041
`insertion mechanism 800 in one embodiment of the present
`invention may be provided to the patient in fully assembled
`configuration with the sensor 104 and skin attachment or
`adhesive (not shown). In this manner, the patient may easily
`and readily place the coil spring insertion mechanism 800
`onto the skin of the patient at the desired site, and upon
`activating the lever 803 by, for example, pulling down on the
`lever 901), the sensor 104 is introduced through the skin of
`the patient at the desired site guided by the introducer 802.
`0042. In the manner described above, in accordance with
`one embodiment of the present invention, the coil spring
`insertion mechanism 800 including introducer 802 coupled
`to the torsion spring 801 allows the sensor 104 to be
`Substantially precisely guided through the opening (not
`shown) of the housing 101 and transcutaneously implanted
`into the patient to a desired specified depth. More specifi
`cally, when the lever 803 is pushed back, the torsion spring
`801 triggers the introducer 802 to be driven downward into
`the skin of the patient. When the lever 803 is released
`thereafter, the torsion spring 801 allows the introducer 802
`to retract out of the skin and remain in the up position,
`having introduced the sensor 104 through the skin of the
`patient. Thereafter, the transmitter (not shown) may be
`mounted and positioned onto the housing 101 so that the
`sensor 104 may establish an electrical communication with
`the transmitter.
`0043. In the manner described above, in accordance with
`one embodiment of the present invention, such “on-board'
`insertion configuration of analyte sensors eliminates the
`need for a sensor delivery unit (such as a separate insertion
`device), and thereby reducing the associated material costs,
`weight, packaging, handling, as well as disposal thereof.
`Additionally, the number of steps that are necessary for the
`patient to perform to introduce and position the analyte
`sensor is reduced which provides significant advantages,
`especially in continuous monitoring systems where the
`sensor typically requires replacement at a predetermined
`interval.
`0044 FIG. 11 illustrates a front planar view of a flexible
`introducer insertion mechanism in accordance with still a
`
`further embodiment of the present invention. Additionally,
`FIGS. 12 and 13 respectively illustrate a perspective view
`and a side planar view of the flexible introducer insertion
`mechanism in accordance with one embodiment of the
`present invention. Referring to the Figures, the flexible
`introducer insertion mechanism 1100 includes a plunger
`1101 coupled to an introducer 1102 (which is coupled to the
`sensor 104 for placement) provided within the housing 101.
`0045. In particular, as can be seen from FIGS. 11-13,
`when the plunger 1101 is pushed down by the patient, the
`introducer 1102 is configured to drive the introducer 1102
`and the sensor 104 into the skin of the patient to be placed
`at a predetermined depth under the skin of the patient.
`Thereafter, the release of the plunger 1101 allows the
`introducer 1102 to be retracted from the deployed position
`and return to the original pre-deployment position within the
`housing 101. In other words, in the embodiment shown in
`FIGS. 11-13, the actuation of the plunger 1101 is configured
`to drive the introducer 1102 and the sensor 104 through the
`skin of the patient so as to place the sensor 104 transcuta
`neously, for example, through the patient’s skin at a prede
`termined and precise depth.
`0046 Referring back to the Figures, once the introducer
`1102 is in the up position within the housing and withdrawn
`out of the patient (leaving behind the sensor 104), the
`plunger in one embodiment may be configured to be per
`manently removed from the housing 101. For example, in
`one embodiment, the plunger 1101 may be configured to be
`snapped off, twisted or broken off from the housing 101 so
`that it is less cumbersome for the patient to have the housing
`101 mounted onto the skin for a predetermined period of
`time such as 3 to 5 days during which the sensor 104 is
`configured to continuously, semi-continuously, intermit
`tently or intermittently and repeatedly detect the patients
`analyte level (for example, glucose level).
`0047. In the manner described above, in accordance with
`the various embodiments of the present invention, an inte
`grated introducer and transmitter mount may be provided.
`More specifically, it is possible for the diabetic patients to
`have to use one less device in order to monitor the glucose
`levels for insulin therapy and management. Additionally,
`since the introducer 103 in one embodiment is substantially
`and completely housed within the cavity 105 of the housing
`101 upon full deployment of the sensor 104, the patient
`likewise need not worry about disposing of the introducer
`103 including its sharp and potentially dangerous edges
`and/or segments. Moreover, while the various embodiments
`described above are discussed in the context of transcuta
`neous placement of an analyte sensor, the scope of the
`present invention may also include implantable sensors.
`0048 Indeed, there is provided an apparatus including an
`inserter in one embodiment of the present invention includ
`ing a housing for placement on a patient, the housing
`comprising a cavity, an introducer positioned at least Sub
`stantially in the cavity, the introducer configured for dis
`placement Substantially within the cavity of the housing, and
`a sensor coupled to the introducer and at least Substantially
`positioned in the cavity for transcutaneous deployment in
`the patient.
`0049. The sensor may be an electrochemical sensor.
`0050. In one embodiment, a transmitter unit may be
`provided mountable to the housing, where the transmitter
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`unit is configured to be in electrical contact with the sensor.
`Further, the transmitter unit may be configured to receive a
`signal corresponding to an analyte level detected by the
`sensor, and to transmit the signal. Additionally, in a further
`embodiment, the transmitter unit may includes a wireless
`communication unit for wireless transmission of the signal,
`where the wireless communication unit may include one or
`more of an radio frequency (RF) communication unit, a
`Bluetooth communication unit, an infrared communication
`unit, an 801.11X communication unit, or a Zigbee commu
`nication unit.
`0051. In a further embodiment, the introducer may be
`configured with a spring mechanism Such that the displace
`ment force of the introducer substantially corresponds to the
`spring mechanism. In Such embodiment, the spring mecha
`nism may include a torsion coil coupled to the introducer
`within the housing. Alternatively, the introducer may be
`configured to be substantially flexible and is provided with
`the spring mechanism.
`0.052
`Also, a plunger may be provided and coupled to the
`introducer to trigger the spring mechanism of the introducer.
`0053. In yet a further embodiment, a portion of the sensor
`may be fixedly positioned within the cavity upon deploy
`ment of the sensor by the introducer.
`0054 Also, the introducer may be substantially com
`pletely positioned within the cavity of the housing after the
`deployment of the sensor.
`In one embodiment, the sensor includes a glucose
`0055)
`SSO.
`0056. A method of introducing a sensor in accordance
`with another embodiment of the present invention includes
`the steps of placing a housing on a skin of a patient, the
`housing including a sensor and a sensor introducer, the
`housing further configured to removably couple to a trans
`mitter, activating an insertion mechanism coupled to the
`housing to insert the sensor through the skin of the patient,
`so that the transmitter may be in electrical contact with the
`SSO.
`0057 The method in a further embodiment may include
`the step of detecting an analyte level of the patient by the
`sensor, and providing the detected analyte level to the
`transmitter for signal transmission, where the signal trans
`mission includes wireless transmission of a signal corre
`sponding to the analyte level.
`0.058 An insertion kit in ye another embodiment of the
`present invention includes a housing for transcutaneously
`inserting an analyte sensor and monitoring an analyte level
`of a patient, the housing having a cavity and the analyte
`sensor therein, the housing for placement on the patient, an
`introducer positioned at least Substantially in the cavity and
`coupled to the analyte sensor, the introducer configured to
`insert the analyte sensor through a skin of the patient to a
`predetermined depth, where the inserted analyte sensor is in
`fluid contact with the analyte of the patient.
`0059 Various other modifications and alterations in the
`structure and method of operation of th