U.S. patent application number 11/380883 was filed with the patent office on 2009-04-23 for introducer assembly and methods of use.
This patent application is currently assigned to Abbott Diabetes Care, Inc.. Invention is credited to Gary Ashley Stafford.
Application Number | 20090105569 11/380883 |
Document ID | / |
Family ID | 40564142 |
Filed Date | 2009-04-23 |
United States Patent
Application |
20090105569 |
Kind Code |
A1 |
Stafford; Gary Ashley |
April 23, 2009 |
Introducer Assembly and Methods of Use
Abstract
Method and apparatus for inserting at least a portion of a
sensor into a patient is provided.
Inventors: |
Stafford; Gary Ashley;
(Hayward, CA) |
Correspondence
Address: |
JACKSON & CO., LLP
6114 LA SALLE AVENUE, #507
OAKLAND
CA
94611-2802
US
|
Assignee: |
Abbott Diabetes Care, Inc.
Alameda
CA
|
Family ID: |
40564142 |
Appl. No.: |
11/380883 |
Filed: |
April 28, 2006 |
Current U.S.
Class: |
600/365 |
Current CPC
Class: |
A61B 5/1451 20130101;
Y10T 29/4978 20150115; A61B 5/14532 20130101; A61B 2562/12
20130101; A61B 5/6833 20130101; A61B 5/14503 20130101 |
Class at
Publication: |
600/365 |
International
Class: |
A61B 5/145 20060101
A61B005/145 |
Claims
1. An introducer system, comprising: an insertion device; and a
base section including a receiving structure configured to receive
at least a portion of the insertion device, the receiving structure
configured to substantially retain at least a portion of the
insertion device at a predetermined position relative to the base
section.
2. The system of claim 1 wherein the base section includes an
adhesive layer.
3. The system of claim 2 wherein the receiving structure is
disposed on the adhesive layer.
3. The system of claim 1 wherein the receiving structure includes a
retention element configured to substantially mate with the
insertion device.
4. The system of claim 3 wherein the insertion device further
includes: a sensor; and an introducer substantially engaged with at
least a portion of the sensor.
5. The system of claim 4 wherein the sensor includes an engagement
element, said engagement element configured to substantially couple
to the retention element.
6. The system of claim 4 wherein the introducer includes a piercing
member, said piercing member coupled to at least a portion of the
sensor.
7. The system of claim 6 wherein the piercing member and the at
least the portion of the sensor are configured to pierce through a
skin layer of a patient.
8. The system of claim 7 wherein the at least the portion of the
sensor is maintained in fluid contact with an analyte of the
patient.
9. The system of claim 4 wherein the sensor includes an analyte
sensor.
10. A method of positioning a sensor, comprising: aligning a sensor
relative to an insertion site; coupling the sensor to a receiving
structure; and deploying the sensor.
11. The method of claim 10 wherein the aligning step includes
positioning the sensor substantially at a predetermined angle
relative to the surface of the insertion site.
12. The method of claim 11 wherein the predetermined angle includes
one or substantially less than 90 degrees.
13. The method of claim 10 wherein the step of coupling includes
mating a portion of the sensor with a portion of the receiving
structure.
14. The method of claim 10 further including maintaining at least a
portion of the sensor in fluid contact with an analyte of a
patient.
15. The method of claim 10 further including: detecting one or more
analyte related signals associated with an analyte level of the
patient; and transmitting the detected one or more analyte related
signals.
16. The method of claim 15 wherein the detected one or more analyte
related signals are wirelessly transmitted at a predetermined
transmission rate.
17. The method of claim 10 further including: coupling an
introducer to the sensor; and retracting the introducer after
deploying the sensor.
18. The method of claim 17 wherein the introducer is substantially
decoupled from the sensor.
19. An insertion kit, comprising: an insertion unit including an
introducer coupled to a sensor; and a base unit substantially
configured to be aligned with a portion of the introducer, the base
unit configured to couple to the insertion unit during sensor
insertion, wherein the insertion unit is substantially entirely
detached from the base unit when the sensor is placed at a
predetermined position under a skin layer of a patient.
Description
BACKGROUND
[0001] Analyte monitoring systems generally include a sensor such
as a subcutaneous analyte sensor, at least a portion of which is
inserted under the skin 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 RF data
transmission protocol. The receiver may be operatively coupled to a
glucose monitor that performs glucose related calculations and data
analysis.
[0002] The transmitter is 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 data corresponding to
or associated with 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. More specifically, the introducer includes a sharp needle
shaped inserter that is configured to pierce through the skin of
the patient and substantially concurrently guide the sensor through
the patient's skin so as to place at least a portion of the sensor
in fluid contact with the target biological fluid of the
patient.
[0003] The inserter is typically used only during the sensor
insertion process, and once the sensor is properly and accurately
positioned, the inserter and the introducer are discarded. This
requires a level of care as the inserter is sharp and may damage
other parts of the patient's skin if not properly handled. Further,
since the tip of the inserter has come into fluid contact with the
patient's biological fluids, it is important to take particular
precautions in the handling of the inserter.
[0004] Further, to minimize data errors in the continuous or
semi-continuous monitoring system, 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. Additionally, for the period of continuous or
semi-continuous monitoring which can include, for example, 3 days,
5 days or 7 days, it is important to have the transmitter in proper
signal contact with the analyte sensor so as to minimize the
potential errors in the monitored data.
[0005] In view of the foregoing, it would be desirable to have
method and apparatus for providing simple, easy to handle and
accurate sensor introduction and retention mechanism for use in an
analyte monitoring system. More specifically, it would be desirable
to have method and apparatus that minimizes the number of
components which the patient has to handle, and which also reduces
the number of required steps to properly and accurately position
the analyte sensor in fluid contact with the patient's
analytes.
SUMMARY OF THE INVENTION
[0006] In one embodiment, there is provided a method and apparatus
for providing an a sensor introduction and retention mechanism for
use in continuous or semi-continuous monitoring systems such as
analyte monitoring systems which includes a sensor loaded insertion
device which is configured to align and correspondingly mate with a
base section disposed on the patient's skin (such as for example, a
transmitter mount unit provided on an adhesive patch that is
attached or otherwise fixedly positioned on the desired location on
the patient's skin).
[0007] In one embodiment of the present invention, the base section
is provided with a receiving structure that is configured to align
with a corresponding section of the insertion device so as to
accurately position the sensor relative to the patient's skin for
proper insertion through the skin of the patient. In one aspect,
the activation of the pre-loaded trigger mechanism by the patient
displaces the sensor in the insertion device from the insertion
device and places at least a portion of the sensor in fluid contact
with the patient's analytes. Upon sensor deployment, the insertion
device may be removed from the base section and discarded (in case
of disposable insertion devices), while the base section may be
configured to retain the sensor in proper position until the
transmitter unit is mounted or coupled to the base section so as to
be in signal contact with the deployed sensor.
[0008] These and other features and advantages of the present
invention will be understood upon consideration of the following
detailed description of the invention and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 illustrates a perspective view of the overall
assembly for sensor insertion and positioning system in accordance
with one embodiment of the present invention;
[0010] FIG. 2A illustrates a perspective view of the insertion
device for use in the sensor insertion and positioning system in
accordance with one embodiment of the present invention;
[0011] FIG. 2B illustrates a perspective view of the plunger
coupled with the sensor and sensor introducer of the insertion
device shown in FIG. 2A in one embodiment of the present
invention;
[0012] FIG. 2C illustrates a perspective view of the analyte sensor
for use in the sensor insertion and positioning system in
accordance with one embodiment of the present invention;
[0013] FIG. 2D illustrates an adhesive patch with a receiving
structure of the insertion and positioning system in accordance
with one embodiment of the present invention;
[0014] FIG. 3A illustrates a side cross sectional view of the
plunger movement during the sensor insertion process in the sensor
insertion and positioning system in accordance with one embodiment
of the present invention;
[0015] FIG. 3B illustrates a side cross sectional view of the
plunger substantially at the final position for placement of the
sensor in the sensor insertion and positioning system in accordance
with one embodiment of the present invention;
[0016] FIG. 3C illustrates a side cross sectional view of the
plunger of the insertion device in retracted position during the
insertion device removal process in the sensor insertion and
positioning system in accordance with one embodiment of the present
invention;
[0017] FIG. 3D is a cross sectional perspective view of the plunger
of the insertion device in retracted position during the insertion
device removal process shown in FIG. 3C in accordance with one
embodiment of the present invention;
[0018] FIG. 4A illustrates a side perspective view of the sensor
positioned in the patient and the insertion device removed from the
receiving structure in the sensor insertion and positioning system
in accordance with one embodiment of the present invention;
[0019] FIG. 4B illustrates a cross sectional perspective view of
the sensor positioned and secured to the retaining pin on the
adhesive patch as shown in FIG. 4A in accordance with one
embodiment of the present invention;
[0020] FIG. 4C illustrates a side cross sectional view of the
sensor positioned and secured to the retaining pin on the adhesive
patch shown in FIG. 4B in accordance with one embodiment of the
present invention; and
[0021] FIG. 5 illustrates a perspective view of the transmitter
unit mounted on the adhesive patch for signal communication with
the sensor in the sensor insertion and positioning system in
accordance with one embodiment of the present invention.
DETAILED DESCRIPTION
[0022] FIG. 1 illustrates a perspective view of the overall
assembly for sensor insertion and positioning system in accordance
with one embodiment of the present invention. Referring to FIG. 1,
the sensor insertion and positioning system 100 in one embodiment
of the present invention includes an insertion device comprising,
for example, a plunger handle portion 101 and a plunger body
portion 102, and coupled therewith an introducer such as a sharp or
a needle (not shown) and a sensor (not shown). The insertion device
further includes a sleeve portion 103 which is configured to mate
with a receiving structure 104 disposed on an adhesive layer 105.
The adhesive layer 105 is configured to be fixedly positioned on
the skin of a patient, and further, where the receiving structure
104 in one embodiment is positioned on a predetermined position on
the adhesive layer 105.
[0023] Referring to FIG. 1, in one embodiment of the present
invention, the handle portion of the plunger 101, the body portion
102 of the plunger 102, the sensor and introducer provided
substantially within the body portion 102 of the plunger and the
sleeve 103 are provided as a single integrated insertion device for
use by patients, for example. The adhesive layer 105 with the
receiving structure 104 are further provided in one embodiment as a
separate integrated device such that the patient may in one
embodiment, position the adhesive layer 105 at a desired location
on the patient's skin, with relative ease, and where the position
of the receiving structure 104 disposed on the adhesive layer 105
substantially defines the position where the sensor is to be placed
in the patient.
[0024] Referring again to FIG. 1, as discussed in further detail
below, the receiving structure 104 in one embodiment of the present
invention is configured to align the insertion device (for example,
the sleeve portion 103 of the insertion device so as to accurately
position the sensor and the sensor introducer prior to the
insertion process. That is, the sleeve portion 103 of the insertion
device is configured to substantially mate or securely latch with
the receiving structure 104 such that, upon placement of a
predefined length of the sleeve portion 103 in the receiving
structure 104, the insertion device is securely positioned with the
sensor and the introducer aligned for proper subcutaneous placement
in the patient.
[0025] In this manner, in one embodiment of the present invention,
the patient may easily and with relative simple process, accurately
position the sensor for placement under the skin layer. Moreover,
in one embodiment, the insertion device is configured to predefine
the depth of insertion of the introducer and sensor. As discussed
in further detail below, in one embodiment of the present
invention, after positioning the sleeve portion 103 of the
insertion device so as to be aligned with the receiving structure
104, the patient applies pressure upon the handle portion 101 of
the insertion device which in turn displaces the body portion 102
of the insertion device (which also correspondingly moves the
sensor and the introducer provided therein).
[0026] When the body portion 102 of the insertion device has
traveled a predetermined distance in response to the applied
pressure on the handle portion 101 of the insertion device, in one
embodiment, the body portion 102 is configured to so that
additional application of pressure on the handle portion 101 of the
insertion device will not displace the body portion 102 (and thus
the introducer and the sensor). Accordingly, in one embodiment, the
patient may conveniently and accurately position the sensor to a
desired and/or predetermined depth under the skin, and thus
substantially remove significant variation in the sensor insertion
depth.
[0027] Referring back to FIG. 1, in one embodiment of the present
invention, when the patient removes the applied pressure on the
handle portion 101 of the insertion device (for example, after
fully driving the sensor and introducer to the predetermined depth
under the skin layer), a retraction mechanism (not shown) within
the insertion device may be configured to automatically withdraw
the body portion 102 (as well as the introducer coupled to the body
portion) of the insertion device such that the positioned sensor is
retained in place while the introducer is removed from the patient.
Referring yet again to FIG. 1, upon retraction of the introducer
from the patient, the insertion device may be removed from the
receiving structure 104 and discarded.
[0028] Referring yet again to FIG. 1, as discussed in further
detail in conjunction with FIG. 5, upon removal of the insertion
device, a transmitter unit may be positioned on the adhesive layer
105 such that the electrical contacts on the transmitter unit are
in signal communication with the electrodes of the sensor, and
where the sensor is in fluid communication with the patient's
analytes.
[0029] Referring still again to FIG. 1, the insertion device may be
provided with a spring loaded retraction mechanism with forward
biasing, such that, when the patient applies pressure on the handle
portion 101, the body portion (including the introducer and the
sensor) are driven substantially towards the patient's skin to
pierce the desired location on the skin so that the sensor and the
introducer are placed at a predetermined depth under the skin
layer. Thereafter, by simply removing the applied pressure on the
handle portion 101 of the insertion device, the body portion 102
and the coupled introducer are removed or retracted.
[0030] In the manner described above, accordance with the various
embodiments of the present invention, there are provided simple and
easy to use mechanism to position the sensor or any other device
accurately with minimal complication. Moreover, with the forward
biasing mechanism in the insertion device for automatically
retracting the introducer after sensor position, among other
features, within the scope of the present invention, the patient
may position the sensor and mount the transmitter unit using one
hand. Moreover, the receiving structure 104 provided on the
adhesive layer 105 in one embodiment provides simple insertion
process without significant visual aid--that is, a patient is able
to position the sensor by simply aligning the insertion device with
the receiving structure 104 and drive the handle portion 102 of the
insertion device to accurately position the sensor, remove the
introducer, and subsequently couple the transmitter unit so as to
be in signal communication with the sensor.
[0031] In addition, by reducing the number of components needed for
sensor placement, within the scope of the present invention, other
benefits such as reduction in material cost, weight, packaging, and
associated handling and disposal may be achieved.
[0032] FIG. 2A illustrates a perspective view of the insertion
device for use in the sensor insertion and positioning system in
accordance with one embodiment of the present invention. Referring
to FIG. 2A, in one embodiment of the present invention, the body
portion 102 of the insertion device as shown is configured to
slidably move relative to the sleeve portion to displace introducer
201 coupled to the body portion 102 of the insertion device.
[0033] FIG. 2B illustrates a perspective view of the plunger
coupled with the sensor and sensor introducer of the insertion
device shown in FIG. 2A in one embodiment of the present invention.
Referring to FIG. 2B, it can be seen that the introducer 201 is
positioned and aligned such that the sensor comprising the
insertion section 202B, is configured to move with the movement of
the introducer 201. In addition, as can be seen, in one embodiment,
the contact section 202A of the sensor is positioned substantially
within the body portion 102 of the insertion device.
[0034] Moreover, referring again to FIG. 2B, the contact section
202A of the sensor is provided with an engagement element 202C such
as a hole which is configured to correspondingly mate with a
retainer element (not shown) provided on the receiving structure
104. Accordingly, upon final positioning of the sensor, the
engagement element 202C in one embodiment is configured to engage
the retainer element so that the sensor may be substantially
fixedly positioned to minimize potential error or undesirable
displacement when the transmitter unit is mounted on the adhesive
layer 105 to establish electrical contact with the sensor
electrodes.
[0035] FIG. 2C illustrates a perspective view of the analyte sensor
for use in the sensor insertion and positioning system in
accordance with one embodiment of the present invention. As can be
seen, in one embodiment, the sensor is provided with a contact
section 202A which is substantially retained outside of the
patient's body, while the insertion section 202B is configured to
be substantially positioned under the skin layer of the patient so
as to be in fluid contact with the patient's analytes for
monitoring. The sensor electrodes are configured to be in signal
communication with the corresponding contact points on the
transmitter unit for each of the working, counter and reference
electrode of the sensor. Moreover, the engagement element 202C as
shown in FIG. 2C is configured to retain the sensor substantially
in the inserted position upon deployment by, for example, engaging
with the retainer element disposed on the receiving structure 104
(FIG. 1) on the adhesive layer 105.
[0036] While a circular engagement element 202C and a substantially
circular contact section 202A of the sensor are shown in the
Figures, within the scope of the present invention, the engagement
element 202C and the contact section 202A of the sensor may
comprise any other shapes.
[0037] FIG. 2D illustrates an adhesive patch with a receiving
structure of the insertion and positioning system in accordance
with one embodiment of the present invention. As shown in FIG. 2D,
the receiving structure 104 is configured to receive the sleeve
portion 103 of the insertion device so as to substantially fixedly
retain the insertion device in position during the sensor placement
and introducer removal process. For example, in one embodiment, the
receiving structure 104 may be biased with a latch mechanism such
that when the sleeve portion 103 of the insertion device is
cooperatingly aligned and coupled to with the receiving structure
104, the receiving structure may be configured to fixedly retain
the sleeve portion 103 of the insertion device with the
pre-configured biasing force to retain the walls of the insertion
device in position, and thereafter, to release the sleeve portion
103 of the insertion device when the patient pull the insertion
device away from the receiving structure 104 after sensor
deployment and introducer retraction.
[0038] FIG. 3A illustrates a side cross sectional view of the
plunger movement during the sensor insertion process in the sensor
insertion and positioning system in accordance with one embodiment
of the present invention. In particular, referring to FIG. 3A, the
retainer element 301 is shown. As can be seen from the Figure, as
the sensor and the introducer 201 is driven through the skin layer
of the patient, the engagement element 202C of the sensor contacts
the retainer element 301. In one embodiment, the retainer element
301 is configured with a predefined groove or indentation
substantially around the outer surface thereof, which is configured
to retain the engagement element 202C in a substantially fixed
position relative to the retainer element 301.
[0039] Referring back to FIG. 3A, while a tapered structure is
shown in the Figure for the retainer element 301, within the scope
of the present invention, the retainer element 301 may include, for
example, a barb, a miniature rivet, a hook, a button snap, a
combination thereof, or any other equivalent alternatives.
Similarly, the sensor engagement element 202C within the scope of
the present invention may include a hole of any shape. In addition,
the sensor engagement element 202C may, within the scope of the
present invention, include a button snap, a socket, a lock washer,
a combination thereof, or any other equivalent shape or structure
to correspondingly mate with retainer element 301.
[0040] FIG. 3B illustrates a side cross sectional view of the
plunger substantially at the final position for placement of the
sensor in the sensor insertion and positioning system in accordance
with one embodiment of the present invention, while FIG. 3C
illustrates a side cross sectional view of the plunger of the
insertion device in retracted position during the insertion device
removal process in the sensor insertion and positioning system in
accordance with one embodiment of the present invention.
[0041] More specifically, in FIG. 3B, the patient has applied
sufficient pressure on the handle portion 101 of the insertion
device to position the sensor and the introducer 201 at the desired
position under the skin layer, and in FIG. 3C, upon release of the
applied pressure on the handle portion 101 of the insertion device,
the body portion 102 of the insertion device is retracted while
removing the introducer 201 with the retraction of the body portion
102 of the insertion device. As shown in FIG. 3C, when the
introducer 201 is removed, the insertion section 202B of the sensor
is retained in position under the skin layer.
[0042] FIG. 3D a cross sectional perspective view of the plunger of
the insertion device in retracted position during the insertion
device removal process shown in FIG. 3C in accordance with one
embodiment of the present invention. Referring to FIG. 3D, it can
be seen that the engagement element 202C of the sensor is coupled
to the retainer element 301 so as to substantially fixedly position
the sensor post insertion process.
[0043] FIG. 4A illustrates a side perspective view of the sensor
positioned in the patient and the insertion device removed from the
receiving structure, FIG. 4B illustrates a cross sectional
perspective view of the sensor positioned and secured to the
retaining pin on the adhesive patch as shown in FIG. 4A, and FIG.
4C illustrates a side cross sectional view of the sensor positioned
and secured to the retaining pin on the adhesive patch shown in
FIG. 4B in accordance with one embodiment of the present
invention.
[0044] FIG. 5 illustrates a perspective view of the transmitter
unit mounted on the adhesive patch for signal communication with
the sensor in the sensor insertion and positioning system in
accordance with one embodiment of the present invention. Referring
to FIG. 5, transmitter unit 501 in one embodiment is configured to
be coupled to the sensor so as to be in electrical contact with the
sensor electrodes which are in fluid contact with the patient's
analytes. Upon deployment, the transmitter unit 501 is configured
in one embodiment to be securely positioned on the adhesive layer,
and in signal communication with the sensor.
[0045] In this manner, in one embodiment, the sensor detected
analyte levels are provided to the transmitter unit 501, for
example, as current signals, and which are in turn, converted to
respective digital signals for transmission (including, for
example, RF transmission) to a receiver unit for further data
processing and data analysis (including drug (e.g., insulin)
therapy management, infusion control, and health monitoring and
treatment, for example). That is, the monitored analyte data may be
used by the patient and/or the patient's healthcare provider to
modify the patient's therapy such as an infusion protocol (such as
basal profile modifications in the case of diabetics) as necessary
to improve insulin infusion therapy for diabetics, and further, to
analyze trends in analyte levels for better treatment.
[0046] While glucose is described as an example of the detected
and/or monitored analyte, within the scope of the present
invention, analytes that may be detected or monitored also 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, drugs of abuse,
theophylline, and warfarin, may also be detected and/or
monitored.
[0047] While the sensor is described as substantially
transcutaneously placed in the patient, within the scope of the
present invention, the sensor may be wholly implantable under the
skin of the patient, or at least a portion of the sensor may be
provided under the skin of the patient so as to be in fluid contact
with the patient's analyte.
[0048] Referring back to FIG. 5, the detected analyte signals from
the sensor are provided to transmitter unit 501, which is, in one
embodiment, 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 an analyte,
e.g., glucose, monitor unit and/or an insulin pump unit and/or a
computer terminal and/or any other electronic device capable of
being configured for wireless communication. A physical connection
may be provided in certain embodiments.
[0049] 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.
Pat. No. 6,175,752 entitled "Analyte Monitoring Device and Methods
of Use". In certain embodiments, the transmitter may also be
capable of wirelessly or otherwise receiving signal from a receiver
such that a receiver may also be capable of transmitting
information to the transmitter.
[0050] In a further embodiment, the transmitter unit 501 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 801.11x
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.
[0051] Accordingly, an introducer system in accordance with one
embodiment of the present invention includes an insertion device,
and a base section including a receiving structure configured to
receive at least a portion of the insertion device, the receiving
structure configured to substantially retain at least a portion of
the insertion device at a predetermined position relative to the
base section.
[0052] The base section may include an adhesive layer, where the
receiving structure may be disposed on the adhesive layer.
[0053] In one embodiment, the receiving structure may include a
retention element configured to substantially mate with the
insertion device, where the insertion device may further include a
sensor and an introducer substantially engaged with at least a
portion of the sensor. Moreover, the sensor may include an
engagement element, said engagement element configured to
substantially couple to the retention element.
[0054] The introducer may include a piercing member, said piercing
member coupled to at least a portion of the sensor, where the
piercing member and the at least the portion of the sensor may be
configured to pierce through a skin layer of a patient, and
further, where the at least the portion of the sensor is maintained
in fluid contact with an analyte of the patient.
[0055] The sensor may include an analyte sensor.
[0056] A method of positioning a sensor in accordance with another
embodiment of the present invention includes aligning a sensor
relative to an insertion site, coupling the sensor to a receiving
structure, and deploying the sensor.
[0057] In addition, aligning may include positioning the sensor
substantially at a predetermined angle relative to the surface of
the insertion site, where the predetermined angle may include one
or substantially less than 90 degrees.
[0058] Also, coupling may include mating a portion of the sensor
with a portion of the receiving structure.
[0059] The method may also include maintaining at least a portion
of the sensor in fluid contact with an analyte of a patient.
Moreover, the method may also include detecting one or more analyte
related signals associated with an analyte level of the patient,
and transmitting the detected one or more analyte related signals.
Also, detected one or more analyte related signals may be
wirelessly transmitted at a predetermined transmission rate.
[0060] The method may also include coupling an introducer to the
sensor, and retracting the introducer after deploying the sensor,
where the introducer may be substantially decoupled from the
sensor.
[0061] An insertion kit in accordance with a further embodiment of
the present invention includes an insertion unit including an
introducer coupled to a sensor, and a base unit substantially
configured to be aligned with a portion of the introducer, the base
unit configured to couple to the insertion unit during sensor
insertion, wherein the insertion unit is substantially entirely
detached from the base unit when the sensor is placed at a
predetermined position under a skin layer of a patient.
[0062] 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.
* * * * *