WO2007041069A2 - Analyte sensor retention mechanism and methods of use - Google Patents

Analyte sensor retention mechanism and methods of use Download PDF

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Publication number
WO2007041069A2
WO2007041069A2 PCT/US2006/037307 US2006037307W WO2007041069A2 WO 2007041069 A2 WO2007041069 A2 WO 2007041069A2 US 2006037307 W US2006037307 W US 2006037307W WO 2007041069 A2 WO2007041069 A2 WO 2007041069A2
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WO
WIPO (PCT)
Prior art keywords
sensor
introducer
patient
retention segment
skin
Prior art date
Application number
PCT/US2006/037307
Other languages
French (fr)
Other versions
WO2007041069A3 (en
Inventor
John C. Mazza
Andrew H. Naegeli
Original Assignee
Abbott Diabetes Care, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Diabetes Care, Inc. filed Critical Abbott Diabetes Care, Inc.
Publication of WO2007041069A2 publication Critical patent/WO2007041069A2/en
Publication of WO2007041069A3 publication Critical patent/WO2007041069A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus
    • A61B2560/063—Devices specially adapted for delivering implantable medical measuring apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter

Definitions

  • Continuous glucose monitoring systems generally include a sensor such as a subcutaneous analyte sensor, at least a portion of which is configured for fluid contact with interstitial fluid, for detecting analyte levels such as 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 RP data transmission protocol.
  • a transmitter such as an RF transmitter
  • the receiver may be operatively coupled to a glucose monitor that performs glucose related calculations and data analysis.
  • the transmitter may be mounted or adhered to the skin of a patient and also in signal communication with the sensor.
  • the senor is configured to detect and measure the glucose levels of the patient over a predetermined period of time, and the transmitter is configured to transmit the measured glucose levels over the predetermined period of time for further analysis.
  • a separate deployment mechanism such as a sensor inserter or introducer is used.
  • the senor is typically mounted or operatively coupled to the introducer, and using a trigger mechanism or other drive mechanism to drive the sensor, the introducer and the sensor are positioned at the appropriate or desired location on the patient's skin to transcutaneously position the sensor.
  • a trigger mechanism or other drive mechanism to drive the sensor
  • the introducer and the sensor are positioned at the appropriate or desired location on the patient's skin to transcutaneously position the sensor.
  • it is important to position the sensor within the introducer so that the sensor is not substantially displaced prior to the sensor insertion process. Otherwise, the sensor, when using the introducer, may not be positioned at the desired location on the patient's skin or at the desired depth under the patient's skin.
  • the senor is provided with a retention segment which is configured to cooperate with the housing of the sensor introducer so as to be retained in the desired position prior to or during the operation of the sensor introducer to transcutaneously position the sensor in the patient.
  • the senor includes a retention segment configured to physically cooperate with the inner walls of the introducer such that the sensor is retained in position within the desired introducer housing substantially using friction fit.
  • the retention segment of the sensor is configured to control the sensor position relative to the sensor introducer to substantially prevent the sensor from being dislodged prior to or during insertion, and without substantially impeding the extraction of the sensor after the insertion process.
  • FIG. 1 illustrates a perspective view of an introducer for use in sensor insertion in accordance with one embodiment of the present invention
  • FIGS. 2 A and 2B illustrate a front view and a side view, respectively, of the sensor configuration with retention segment for use with the introducer of FIG. 1 in accordance with one embodiment of the present invention
  • FIG. 3 illustrates the sensor in cooperation with the introducer in pre-deployment position in accordance with one embodiment of the present invention
  • FIG. 4 illustrates the sensor in cooperation with the introducer just after the sensor insertion process and during the introducer extraction process in accordance with one embodiment of the present invention
  • FIG. 5 illustrates the sensor in post-deployment position after the operation of the introducer in accordance with one embodiment of the present invention.
  • FIG. 6 illustrates a bottom planar view of the sensor with retention segment in cooperation with the introducer prior to deployment as shown in FIG. 4 in accordance with one embodiment of the present invention.
  • the subject invention includes sensors and sensor introducers having cooperating structures for maintaining the sensor in a fixed position with respect to the introducers until introduction of at least a portion of the sensor beneath a skin surface of a patient.
  • a portion of the sensor is held in position in/on an introducer using friction such that the sensor includes a part friction-fittable with a part of an inserter.
  • FIG. 1 illustrates a perspective view of an introducer for use in sensor insertion in accordance with one embodiment of the present invention.
  • sensor introducer 101 in one embodiment of the present invention includes a first sensor guide segment 102 and a second sensor guide segment 103. As can be seen from FIG.
  • the first sensor guide segment 102 includes a tip portion 104 that is substantially pointed and sharp.
  • the tip portion 104 of the first sensor guide segment is configured to pierce through the skin of the patient during the sensor insertion process, and substantially concurrently retaining a portion of the sensor through the patient's skin so as to place a portion of the sensor in fluid contact with the patient's biological fluids.
  • the first and second sensor guide segments 102, 103 in one embodiment of the present invention includes folded metal channels that substantially form a U- like shape.
  • a sensor may be positioned in the introducer 101 such that the side edges of the sensor are substantially retained within the respective folded metal channels of the first and second sensor guide segments 102, 103.
  • the tip portion of the first sensor guide segment 102 is configured to substantially retain the portion of the sensor that is to be transcutaneously positioned in the patient during the insertion process.
  • FIGS. 2A and 2B illustrate a front view and a side view, respectively, of an exemplary embodiment of a sensor configuration with retention segment for use with the introducer of FIG.
  • sensor 200 includes a tail portion 201 that is substantially configured to be transcutaneously positioned in the patient to be in fluid contact with the biological fluids of the patient such as the interstitial fluid.
  • the sensor 200 also includes a retention segment 202 which in one embodiment, is provided substantially on the opposite side of the sensor 200 relative to the tail portion 201 of the sensor 200, but may be provided in any suitable location of the sensor.
  • the retention segment 202 of the sensor 200 in one embodiment includes a protrusion formed on the planar surface of the sensor 200.
  • the first sensor guide segment 102 of the introducer 101 in one embodiment is configured to substantially retain a portion of the sensor 200 including the tail portion 201, while the second sensor guide segment 103 of the introducer is configured to substantially retain the side of the sensor 202 where the retention segment 202 is disposed.
  • FIG. 3 illustrates the sensor in cooperation with the introducer in pre-deployment position
  • FIG. 4 illustrates the sensor in cooperation with the introducer during the final stage of the sensor insertion process as the introducer is being extracted out of the patient
  • FIG. 5 illustrates the sensor in post-deployment position after the operation of the introducer in accordance with one embodiment of the present invention.
  • the introducer 101 is removed from the patient substantially in the direction shown by the directional arrow 302.
  • the tail portion 201 of the sensor 200 is configured to remain in the inserted position in the patient.
  • a transmitter unit (not shown) may be coupled to the sensor so as to receive signals from the sensor 200 which correspond to one or more of the analyte levels of the patient.
  • FIG. 6 illustrates a bottom planar view of the sensor with retention segment in cooperation with the introducer prior to deployment as shown in FIG. 4 in accordance with one embodiment of the present invention.
  • the sensor retention segment of the sensor is frictionally engaged with the introducer and specifically in this particular embodiment the bottom planar view of the sensor 200 with the retention segment 202 is frictionally engaged with the second sensor guide segment 103 as can be seen in the direction along the directional arrow 301 of FIG. 3.
  • the retention segment 202 provided on the sensor 200 may be configured so as to provide sufficient frictional force engaged with an introducer, e.g., the second sensor guide segment 103 of the introducer 101, prior to and during the sensor insertion process, so that the sensor 200 is properly retained and positioned within the introducer 101 prior to and during the insertion process.
  • the retention segment 202 of the sensor 200 is configured such that the frictional force between the retention segment 202 and the introducer such as the second sensor guide segment 103 of the introducer 101 does not impede the removal of the tip portion 104 of the introducer 101 from the patient, and retaining the sensor 200 in the inserted position and at least the tip portion 201 of the sensor 200 in fluid contact with the biological fluid of the patient.
  • the retention segment 202 of the sensor 200 may be formed on the sensor body in any portion of the sensor 200 so that the retention segment 202 may provide the necessary frictional force to engage with a corresponding section of the introducer 101.
  • the retention segment 202 may be formed on the front surface or the bottom surface of the sensor 200, or alternatively, substantially axially along the tip portion 201 of the sensor 200 or otherwise so as to frictionally engage with an introducer, e.g., the first sensor guide segment 102 of the introducer 101.
  • a plurality of retention members may be provided to the sensor 200 to obtain sufficient frictional force to engage with the introducer 101 and retain the sensor 200 in position prior to the insertion process, and where the combined frictional force of the multiple retention members do not substantially impede the disengagement of the introducer 101 from the sensor 200 and the removal of the introducer 101 from the patient after the insertion process.
  • the one or more retention members may be provided within the folded channels of the first or second sensor guide segments 102, 103 of the introducer 101.
  • the introducer may be configured in other geometric configuration such that the introducer is configured to substantially retain the sensor in position prior to and during the insertion process, while the patient is aligning the introducer in the suitable direction on the patient's skin for the transcutaneous placement of the sensor.
  • the electrodes of the sensor are configured to detect the analyte level (for example, glucose, ketones, lactate, and the like) and are provided to a transmitter unit that is in electrical communication with the sensor.
  • the analyte level for example, glucose, ketones, lactate, and the like
  • the analytes that may be detected and/or monitored include, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.
  • creatine kinase e.g., CK-MB
  • the concentration of drugs may also be detected and/or monitored.
  • the transmitter unit is configured to wirelessly (or otherwise) transmit data corresponding to the detected analyte levels from the sensor to a receiver unit, where the receiver unit may include a glucose monitor unit, an insulin pump unit, or a computer terminal, or any other electronic device capable of being configured for wireless communication.
  • the receiver unit functions may be integrated into portable electronic devices such as a watch, a pager, a mobile telephone, and a personal digital assistant.
  • 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 a radio frequency (RF) communication unit, a Bluetooth communication unit, an infrared communication unit, an 801.1 Ix communication unit, or a Zigbee communication unit.
  • the receiver unit may be configured to support one more or of the above-referenced wireless communication protocols to communicate with the transmitter unit.
  • an apparatus including a biosensor in one embodiment of the present invention includes a sensor body, which may include a tail portion, having a retention segment, the tail portion if provided is configured for transcutaneous placement, where the retention segment is formed on the sensor body so as to protrude from a surface such as a planar surface of the sensor body.
  • Embodiments may include an introducer configured to engage with a retention segment of a sensor body.
  • the retention segment may be configured to frictionally engage with the introducer so as to retain the sensor body in position prior to and/or during sensor insertion into a patient.
  • the introducer may include a tip portion configured to substantially retain a portion of the sensor, e.g., a tail portion of a sensor body, where tip portion of the introducer may be configured to pierce through a skin of a patient. Further, when the skin of the patient is pierced with the tip portion of the introducer, the tail portion of the sensor may be substantially retained within the tip portion of the introducer and displaced into the skin of the patient.
  • the senor may include an analyte sensor, where the analyte sensor may include a glucose sensor, lactate sensor, or other analyte sensor.
  • the tail portion of the sensor body may be configured to be in fluid contact with a biological fluid of a patient, where the biological fluid of the patient may include interstitial fluid, blood, and the like.
  • An insertion kit in a further embodiment of the present invention includes a sensor having a sensor retention segment, e.g. ,a friction-fit segment, where the sensor may include a tail portion (or a portion of the sensor configured to be positioned under the skin and in fluid contact with the patient's biological fluids) and a retention segment, the retention segment disposed substantially on a surface of the sensor, an introducer configured to engage with the sensor, the introducer further configured to engage, e.g., frictionally, with the retention segment of the sensor, and a drive mechanism configured to operatively engage with the introducer to pierce through a skin of a patient, the introducer configured to substantially retain the sensor when driven through the skin of the patient, the drive mechanism further configured to position at least a portion of the sensor in fluid contact with a biological fluid of the patient.
  • a sensor retention segment e.g. , a friction-fit segment
  • the sensor may include a tail portion (or a portion of the sensor configured to be positioned under the skin and in fluid contact with
  • the drive mechanism may further include a retraction mechanism configured to substantially completely withdraw the introducer from the patient after the sensor is transcutaneously positioned in fluid contact with the biological fluid of the patient.
  • the drive mechanism may include a spring biased mechanism.
  • the retention segment of the sensor may be configured to apply a predetermined frictional force upon the introducer prior to transcutaneous insertion of the sensor such that the sensor is retained in position prior to insertion, and further, wherein the retraction mechanism is configured to substantially completely counter or overcome the predetermined frictional force so as to withdraw the introducer from the patient without the sensor.
  • An analyte sensor in accordance with still another embodiment of the present invention includes an introducer retention segment for Motional engagement with an analyte sensor introducer.
  • the retention segment may include a protrusion, and further, where the segment may be a groove
  • a method in accordance with yet still a further embodiment includes the step of retaining an analyte sensor within an introducer during the sensor insertion into a patient such that the sensor is positioned at a relatively fixed position with respect to the introducer.
  • the method may also include positioning the analyte to be in fluid contact with a biological fluid of a patient, where the biological fluid includes one of an interstitial fluid and blood.
  • sensors including analyte sensors that are capable of being retained in position with the introducer prior to the insertion process, so that the patient does not experience the cumbersome need to manually attempt to properly align and position the sensor in the introducer during the insertion alignment process to transcutaneously position the sensor in the patient.

Abstract

An apparatus retains a biomedical sensor as an aid to accurately position during transcutaneous introduction. A retention mechanism holds the sensor in pre-deployment position within the introducer when the sensor insertion mechanism is activated to facilitate sensor insertion. The sensor can include a retention segment configured to physically cooperate with the inner walls of the introducer such that the sensor is retaind in position in a introducer housing using friction.

Description

ANALYTE SENSOR RETENTION MECHANISM AND METHODS OF USE
PRIORITY
This PCT application claims priority to United States Patent Application No. 11/240,258, filed September 30, 2005 and is hereby incorporated by reference.
BACKGROUND
Continuous glucose monitoring systems generally include a sensor such as a subcutaneous analyte sensor, at least a portion of which is configured for fluid contact with interstitial fluid, for detecting analyte levels such as 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 RP data transmission protocol. The receiver may be operatively coupled to a glucose monitor that performs glucose related calculations and data analysis. The transmitter may be mounted or adhered to the skin of a patient and also in signal communication with the sensor. Generally, the sensor is configured to detect and measure the glucose levels of the patient over a predetermined period of time, and the transmitter is configured to transmit the measured glucose levels over the predetermined period of time for further analysis. To initially deploy the sensor so that the sensor contacts and electrodes are in fluid contact with the patient's analyte fluids, a separate deployment mechanism such as a sensor inserter or introducer is used.
In operation, the sensor is typically mounted or operatively coupled to the introducer, and using a trigger mechanism or other drive mechanism to drive the sensor, the introducer and the sensor are positioned at the appropriate or desired location on the patient's skin to transcutaneously position the sensor. Prior to driving or firing the sensor using the sensor inserter mechanism, it is important to position the sensor within the introducer so that the sensor is not substantially displaced prior to the sensor insertion process. Otherwise, the sensor, when using the introducer, may not be positioned at the desired location on the patient's skin or at the desired depth under the patient's skin. In view of the foregoing, it would be desirable to have a method and apparatus for retaining the sensor in cooperation with the sensor introducer such that the sensor is sufficiently retained by the sensor introducer such that the sensor is accurately positioned during the insertion process to transcutaneously place the sensor in the patient.
SUMMARY OF THE INVENTION
In accordance with embodiments of the present invention, the sensor is provided with a retention segment which is configured to cooperate with the housing of the sensor introducer so as to be retained in the desired position prior to or during the operation of the sensor introducer to transcutaneously position the sensor in the patient.
More specifically, in certain embodiment of the present invention, the sensor includes a retention segment configured to physically cooperate with the inner walls of the introducer such that the sensor is retained in position within the desired introducer housing substantially using friction fit. In this manner, the retention segment of the sensor is configured to control the sensor position relative to the sensor introducer to substantially prevent the sensor from being dislodged prior to or during insertion, and without substantially impeding the extraction of the sensor after the insertion process.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of an introducer for use in sensor insertion in accordance with one embodiment of the present invention;
FIGS. 2 A and 2B illustrate a front view and a side view, respectively, of the sensor configuration with retention segment for use with the introducer of FIG. 1 in accordance with one embodiment of the present invention; FIG. 3 illustrates the sensor in cooperation with the introducer in pre-deployment position in accordance with one embodiment of the present invention;
FIG. 4 illustrates the sensor in cooperation with the introducer just after the sensor insertion process and during the introducer extraction process in accordance with one embodiment of the present invention; FIG. 5 illustrates the sensor in post-deployment position after the operation of the introducer in accordance with one embodiment of the present invention; and
FIG. 6 illustrates a bottom planar view of the sensor with retention segment in cooperation with the introducer prior to deployment as shown in FIG. 4 in accordance with one embodiment of the present invention.
DETAILED DESCRIPTION
As summarized above, the subject invention includes sensors and sensor introducers having cooperating structures for maintaining the sensor in a fixed position with respect to the introducers until introduction of at least a portion of the sensor beneath a skin surface of a patient. In many embodiments, a portion of the sensor is held in position in/on an introducer using friction such that the sensor includes a part friction-fittable with a part of an inserter. FIG. 1 illustrates a perspective view of an introducer for use in sensor insertion in accordance with one embodiment of the present invention. Referring to FIG. 1, sensor introducer 101 in one embodiment of the present invention includes a first sensor guide segment 102 and a second sensor guide segment 103. As can be seen from FIG. 1, the first sensor guide segment 102 includes a tip portion 104 that is substantially pointed and sharp. In one embodiment, the tip portion 104 of the first sensor guide segment is configured to pierce through the skin of the patient during the sensor insertion process, and substantially concurrently retaining a portion of the sensor through the patient's skin so as to place a portion of the sensor in fluid contact with the patient's biological fluids.
Referring back to FIG. 1, the first and second sensor guide segments 102, 103 in one embodiment of the present invention includes folded metal channels that substantially form a U- like shape. In this manner, as will be discussed in further detail below, a sensor may be positioned in the introducer 101 such that the side edges of the sensor are substantially retained within the respective folded metal channels of the first and second sensor guide segments 102, 103. Moreover, as can be seen from FIG. 1, the tip portion of the first sensor guide segment 102 is configured to substantially retain the portion of the sensor that is to be transcutaneously positioned in the patient during the insertion process. FIGS. 2A and 2B illustrate a front view and a side view, respectively, of an exemplary embodiment of a sensor configuration with retention segment for use with the introducer of FIG. 1 in accordance with one embodiment of the present invention. Referring to FIGS. 2A-2B, sensor 200 includes a tail portion 201 that is substantially configured to be transcutaneously positioned in the patient to be in fluid contact with the biological fluids of the patient such as the interstitial fluid. The sensor 200 also includes a retention segment 202 which in one embodiment, is provided substantially on the opposite side of the sensor 200 relative to the tail portion 201 of the sensor 200, but may be provided in any suitable location of the sensor. As can be seen from FIG. 2B, the retention segment 202 of the sensor 200 in one embodiment includes a protrusion formed on the planar surface of the sensor 200.
In this manner, as described in further detail below, when the sensor 200 is positioned substantially in cooperation with the introducer 101, the first sensor guide segment 102 of the introducer 101 in one embodiment is configured to substantially retain a portion of the sensor 200 including the tail portion 201, while the second sensor guide segment 103 of the introducer is configured to substantially retain the side of the sensor 202 where the retention segment 202 is disposed.
FIG. 3 illustrates the sensor in cooperation with the introducer in pre-deployment position, FIG. 4 illustrates the sensor in cooperation with the introducer during the final stage of the sensor insertion process as the introducer is being extracted out of the patient, and FIG. 5 illustrates the sensor in post-deployment position after the operation of the introducer in accordance with one embodiment of the present invention. Referring to FIGS. 3-5, it can be seen that during the insertion process, as the insertion force is applied upon the introducer 101 substantially in the direction as shown by the directional arrow 301, the tip portion 104 of the introducer 101 and the sensor 200 are driven through the patient's skin, guided by the sharp tip portion 104 of the introducer 101.
Thereafter, when the tail portion 201 of the sensor 200 is positioned at the desired depth under the patient's skin, the introducer 101 is removed from the patient substantially in the direction shown by the directional arrow 302. As the tip portion 104 of the introducer 101 is removed from the patient, the tail portion 201 of the sensor 200 is configured to remain in the inserted position in the patient. In other words, upon completion of the sensor insertion process using the introducer 101, and after positioning the tip portion 201 of the sensor 200 in fluid contact with the patient's biological fluids, the introducer 101 is completely removed from the patient, and a transmitter unit (not shown) may be coupled to the sensor so as to receive signals from the sensor 200 which correspond to one or more of the analyte levels of the patient.
FIG. 6 illustrates a bottom planar view of the sensor with retention segment in cooperation with the introducer prior to deployment as shown in FIG. 4 in accordance with one embodiment of the present invention. Referring to FIG. 6, it can be seen that the sensor retention segment of the sensor is frictionally engaged with the introducer and specifically in this particular embodiment the bottom planar view of the sensor 200 with the retention segment 202 is frictionally engaged with the second sensor guide segment 103 as can be seen in the direction along the directional arrow 301 of FIG. 3. Indeed, the retention segment 202 provided on the sensor 200 may be configured so as to provide sufficient frictional force engaged with an introducer, e.g., the second sensor guide segment 103 of the introducer 101, prior to and during the sensor insertion process, so that the sensor 200 is properly retained and positioned within the introducer 101 prior to and during the insertion process.
Thereafter, when the tail portion 201 of the sensor 200 is positioned under the skin in the patient, the retention segment 202 of the sensor 200 is configured such that the frictional force between the retention segment 202 and the introducer such as the second sensor guide segment 103 of the introducer 101 does not impede the removal of the tip portion 104 of the introducer 101 from the patient, and retaining the sensor 200 in the inserted position and at least the tip portion 201 of the sensor 200 in fluid contact with the biological fluid of the patient.
Within the scope of the present invention, as noted above, the retention segment 202 of the sensor 200 may be formed on the sensor body in any portion of the sensor 200 so that the retention segment 202 may provide the necessary frictional force to engage with a corresponding section of the introducer 101. Indeed, within the scope of the present invention, the retention segment 202 may be formed on the front surface or the bottom surface of the sensor 200, or alternatively, substantially axially along the tip portion 201 of the sensor 200 or otherwise so as to frictionally engage with an introducer, e.g., the first sensor guide segment 102 of the introducer 101.
Moreover, within the scope of the present invention, a plurality of retention members may be provided to the sensor 200 to obtain sufficient frictional force to engage with the introducer 101 and retain the sensor 200 in position prior to the insertion process, and where the combined frictional force of the multiple retention members do not substantially impede the disengagement of the introducer 101 from the sensor 200 and the removal of the introducer 101 from the patient after the insertion process.
Further, still within the scope of the present invention, the one or more retention members may be provided within the folded channels of the first or second sensor guide segments 102, 103 of the introducer 101. Moreover, while the folded channel configuration of the first and second sensor guide segments 102, 103 of the introducer 101 is shown, within the scope of the present invention, the introducer may be configured in other geometric configuration such that the introducer is configured to substantially retain the sensor in position prior to and during the insertion process, while the patient is aligning the introducer in the suitable direction on the patient's skin for the transcutaneous placement of the sensor.
As discussed briefly above, once the sensor is transcutaneously positioned so that at least a portion of the sensor (for example, the tip portion 201 of the sensor 200) is in fluid contact with the patient's biological fluid, the electrodes of the sensor (working, reference and counter electrodes, for example) are configured to detect the analyte level (for example, glucose, ketones, lactate, and the like) and are provided to a transmitter unit that is in electrical communication with the sensor.
More specifically, within the scope of the present invention, the analytes that may be detected and/or monitored include, for example, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drags of abuse, theophylline, and warfarin, may also be detected and/or monitored. In one embodiment, the transmitter unit is configured to wirelessly (or otherwise) transmit data corresponding to the detected analyte levels from the sensor to a receiver unit, where the receiver unit may include a glucose monitor unit, an insulin pump unit, or a computer terminal, or any other electronic device capable of being configured for wireless communication. Within the scope of the present invention, the receiver unit functions may be integrated into portable electronic devices such as a watch, a pager, a mobile telephone, and a personal digital assistant. Additional information on the detection, monitoring and analysis of analyte levels are described in further detail in U.S. Patent No. 6,175,752 entitled "Analyte Monitoring Device and Methods of Use" the disclosure of which is incorporated herein by reference for all purposes.
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 a radio frequency (RF) communication unit, a Bluetooth communication unit, an infrared communication unit, an 801.1 Ix communication unit, or a Zigbee communication unit. Similarly, the receiver unit may be configured to support one more or of the above-referenced wireless communication protocols to communicate with the transmitter unit.
Accordingly, an apparatus including a biosensor in one embodiment of the present invention includes a sensor body, which may include a tail portion, having a retention segment, the tail portion if provided is configured for transcutaneous placement, where the retention segment is formed on the sensor body so as to protrude from a surface such as a planar surface of the sensor body.
Embodiments may include an introducer configured to engage with a retention segment of a sensor body.
In one embodiment, the retention segment may be configured to frictionally engage with the introducer so as to retain the sensor body in position prior to and/or during sensor insertion into a patient.
Additionally, the introducer may include a tip portion configured to substantially retain a portion of the sensor, e.g., a tail portion of a sensor body, where tip portion of the introducer may be configured to pierce through a skin of a patient. Further, when the skin of the patient is pierced with the tip portion of the introducer, the tail portion of the sensor may be substantially retained within the tip portion of the introducer and displaced into the skin of the patient.
In a further embodiment, the sensor may include an analyte sensor, where the analyte sensor may include a glucose sensor, lactate sensor, or other analyte sensor.
The tail portion of the sensor body may be configured to be in fluid contact with a biological fluid of a patient, where the biological fluid of the patient may include interstitial fluid, blood, and the like.
An insertion kit in a further embodiment of the present invention includes a sensor having a sensor retention segment, e.g. ,a friction-fit segment, where the sensor may include a tail portion (or a portion of the sensor configured to be positioned under the skin and in fluid contact with the patient's biological fluids) and a retention segment, the retention segment disposed substantially on a surface of the sensor, an introducer configured to engage with the sensor, the introducer further configured to engage, e.g., frictionally, with the retention segment of the sensor, and a drive mechanism configured to operatively engage with the introducer to pierce through a skin of a patient, the introducer configured to substantially retain the sensor when driven through the skin of the patient, the drive mechanism further configured to position at least a portion of the sensor in fluid contact with a biological fluid of the patient.
In one embodiment, the drive mechanism may further include a retraction mechanism configured to substantially completely withdraw the introducer from the patient after the sensor is transcutaneously positioned in fluid contact with the biological fluid of the patient. Also, the drive mechanism may include a spring biased mechanism.
In addition, in still another embodiment, the retention segment of the sensor may be configured to apply a predetermined frictional force upon the introducer prior to transcutaneous insertion of the sensor such that the sensor is retained in position prior to insertion, and further, wherein the retraction mechanism is configured to substantially completely counter or overcome the predetermined frictional force so as to withdraw the introducer from the patient without the sensor. An analyte sensor in accordance with still another embodiment of the present invention includes an introducer retention segment for Motional engagement with an analyte sensor introducer.
In a further embodiment, the retention segment may include a protrusion, and further, where the segment may be a groove
A method in accordance with yet still a further embodiment includes the step of retaining an analyte sensor within an introducer during the sensor insertion into a patient such that the sensor is positioned at a relatively fixed position with respect to the introducer.
In one embodiment, the method may also include positioning the analyte to be in fluid contact with a biological fluid of a patient, where the biological fluid includes one of an interstitial fluid and blood.
In the manner described above, within the scope of the present invention, there is provided a cost effective and relatively simple configuration for sensors including analyte sensors that are capable of being retained in position with the introducer prior to the insertion process, so that the patient does not experience the cumbersome need to manually attempt to properly align and position the sensor in the introducer during the insertion alignment process to transcutaneously position the sensor in the patient.
Various other modifications and alterations in the structure and method of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims and their equivalents be covered thereby.

Claims

WHAT IS CLAIMED IS:
1. An apparatus including a biosensor, comprising: a sensor body including a retention segment on the sensor body so as to protrude from a planar surface of the sensor body.
2. The apparatus of claim 1 further including an introducer, the introducer configured to engage with the retention segment of the sensor body.
3. The apparatus of claim 2 wherein the retention segment is configured to frictionally engage with the introducer so as to retain the sensor body in position with respect to the introducer prior to sensor insertion into a patient.
4. The apparatus of claim 2 wherein the introducer includes a tip portion configured to substantially retain at least a portion of the sensor body. . . . .. . . . . . . . - ■ -
5. The apparatus of claim 4 wherein the tip portion of the introducer is configured to pierce through a skin of a patient.
6. The apparatus of claim 5 wherein when the skin of the patient is pierced with the tip portion of the introducer, the at least the portion of the sensor is substantially retained within the tip portion of the introducer and displaced into the skin of the patient.
7. The apparatus of claim 1 wherein the sensor includes an analyte sensor.
8. The apparatus of claim 7 wherein the analyte sensor is a glucose sensor.
9. The apparatus of claim 1 wherein the at least the portion of the sensor body is configured to be in fluid contact with a biological fluid of a patient.
10. The apparatus of claim 9 wherein the biological fluid of the patient includes interstitial fluid.
11. An insertion kit, comprising: a sensor including a retention segment, the retention segment disposed substantially on a surface of the sensor; an introducer configured to engage with the sensor, the introducer further configured to frictionally engage with the retention segment of the sensor; and a drive mechanism configured to operatively engage with the introducer to pierce through a skin of a patient, the introducer configured to substantially retain the sensor when driven through the skin of the patient, the drive mechanism further configured to position at least a portion of the sensor in fluid contact with a biological fluid of the patient.
12. The insertion kit of claim 11 , wherein the drive mechanism further includes a retraction mechanism configured to substantially completely withdraw the introducer from the patient after the sensor is transcutaneously positioned in fluid contact with the biological fluid of the patient.
13. The insertion kit of claim 11 wherein the drive mechanism includes a spring biased mechanism.
14. The insertion kit of claim 11 wherein the retention segment of the sensor is configured to apply a predetermined frictional force upon the introducer prior to transcutaneous insertion of the sensor such that the sensor is retained in position prior to insertion, and further, wherein the retraction mechanism is configured to substantially completely counter the predetermined frictional force so as to withdraw the introducer from the patient without the sensor.
15. An analyte sensor, comprising: an introducer retention segment for frictional engagement with an analyte sensor introducer.
16. The sensor of claim 15 wherein the retention segment includes a protrusion
17. The sensor of claim 15 wherein the segment is a groove
18. A method, comprising the step of: retaining an analyte sensor within an introducer during the sensor insertion into a patient such that the sensor is positioned at a relatively fixed position with respect to the introducer.
19 The method of claim 18 further including the step of: positioning the analyte to be in fluid contact with a biological fluid of a patient.
20 .The method of claim 19 wherein the biological fluid includes one of an interstitial fluid and blood.
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