U.S. patent application number 17/206013 was filed with the patent office on 2021-07-08 for medical device inserters and processes of inserting and using medical devices.
The applicant listed for this patent is ABBOTT DIABETES CARE INC.. Invention is credited to Samuel M. Curry, Manuel L. Donnay, Tuan Nguyen, Louis G. Pace, Peter G. Robinson, Phillip Yee.
Application Number | 20210204850 17/206013 |
Document ID | / |
Family ID | 1000005464688 |
Filed Date | 2021-07-08 |
United States Patent
Application |
20210204850 |
Kind Code |
A1 |
Curry; Samuel M. ; et
al. |
July 8, 2021 |
MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING AND USING
MEDICAL DEVICES
Abstract
An apparatus for insertion of a medical device in the skin of a
subject is provided, as well as methods of inserting medical
devices.
Inventors: |
Curry; Samuel M.; (Oakland,
CA) ; Donnay; Manuel L.; (San Francisco, CA) ;
Nguyen; Tuan; (Dublin, CA) ; Pace; Louis G.;
(San Carlos, CA) ; Robinson; Peter G.; (Alamo,
CA) ; Yee; Phillip; (San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBOTT DIABETES CARE INC. |
Alameda |
CA |
US |
|
|
Family ID: |
1000005464688 |
Appl. No.: |
17/206013 |
Filed: |
March 18, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17077445 |
Oct 22, 2020 |
10959654 |
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17206013 |
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14996751 |
Jan 15, 2016 |
10881340 |
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17077445 |
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13071487 |
Mar 24, 2011 |
9265453 |
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14996751 |
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61411262 |
Nov 8, 2010 |
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61361374 |
Jul 2, 2010 |
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61345562 |
May 17, 2010 |
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61317243 |
Mar 24, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/15113 20130101;
A61B 5/1519 20130101; A61B 5/14546 20130101; A61B 5/1513 20130101;
A61B 5/14542 20130101; A61B 5/1411 20130101; A61B 5/157 20130101;
A61B 5/150282 20130101; A61B 5/15186 20130101; A61M 2005/1585
20130101; A61B 5/150427 20130101; A61B 5/150396 20130101; A61B
5/15016 20130101; A61B 5/14503 20130101; A61B 5/15117 20130101;
A61B 5/150511 20130101; A61B 5/6865 20130101; A61B 5/15087
20130101; A61B 5/150022 20130101; A61B 17/34 20130101; A61B 5/15194
20130101; A61B 5/150419 20130101; A61B 5/150732 20130101; A61B
5/14532 20130101; A61M 5/158 20130101; A61B 5/01 20130101; A61B
5/0002 20130101; A61B 5/15107 20130101; A61B 5/150259 20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/145 20060101 A61B005/145; A61B 5/157 20060101
A61B005/157; A61B 5/151 20060101 A61B005/151; A61B 5/00 20060101
A61B005/00; A61B 17/34 20060101 A61B017/34; A61M 5/158 20060101
A61M005/158 |
Claims
1-19. (canceled)
20. An insertion assembly for inserting a glucose sensor into a
subject, the insertion assembly comprising: the glucose sensor,
wherein a distal end of the glucose sensor is configured to be
inserted under skin of the subject; a distal surface comprising an
adhesive layer, wherein the distal surface is configured to be
positioned on the skin of the subject such that the adhesive layer
adheres to the skin of the subject; an interior of the insertion
assembly comprising a first spring in a loaded position, a second
spring, a rotatable element, a sliding element, and a straight
track having a length, wherein the sliding element is configured to
move only within the straight track; and a button configured to be
pressed along a depression axis toward the interior of the
insertion assembly, wherein the button is further configured to
release the first spring from the loaded position upon being
pressed, such that the first spring causes the sliding element to
move within the straight track, wherein movement of the sliding
element within the straight track causes advancement of a sharp and
the glucose sensor in a distal direction along an insertion axis
different from the depression axis such that the distal end of the
glucose sensor is inserted under the skin of the subject, wherein
the sliding element is further configured to continue moving within
the straight track after the advancement of the sharp and the
glucose sensor in the distal direction along the insertion axis,
wherein the second spring is configured to expand and retract the
sharp in the proximal direction along the insertion axis while the
distal end of the glucose sensor remains under the skin of the
subject, wherein the sharp is configured to be retracted fully
within the interior of the insertion assembly, wherein the
insertion assembly comprises a maximum height parallel with the
insertion axis and a maximum width parallel with the length of the
straight track, and wherein the maximum height is greater than the
maximum width, wherein the second spring is a compression spring,
and wherein the glucose sensor is configured to operate for a
period of about seven days or more.
21. The insertion assembly of claim 20, wherein the sharp is
further configured to be inserted under the skin of the subject at
an oblique angle with respect to the skin of the subject.
22. The insertion assembly of claim 20, wherein the depression axis
is perpendicular to the insertion axis.
23. The insertion assembly of claim 20, wherein at least a part of
the glucose sensor is housed within the sharp.
24. The insertion assembly of claim 20, wherein, after the release
of the first spring from the loaded position, the first spring is
configured to cause the rotatable element to rotate less than a
full rotation.
25. The insertion assembly of claim 24, further comprising a
stopping surface, wherein the stopping surface is configured to
stop the rotation of the rotatable element.
26. The insertion assembly of claim 20, wherein the glucose sensor
is configured to operate for a period of about ten days.
27. The insertion assembly of claim 20, further comprising a mount,
wherein the mount is configured to be secured to the skin of the
subject before the advancement of the sharp and the glucose sensor
in the distal direction along the insertion axis.
28. The insertion assembly of claim 20, wherein the glucose sensor
comprises a proximal retention portion, a distal insertion portion,
and a bendable portion located therebetween, and wherein the
glucose sensor is further configured to be coupled with on body
electronics.
29. The insertion assembly of claim 28, wherein the bendable
portion of the glucose sensor is configured to bend prior to
coupling of the glucose sensor with the on body electronics.
30. The insertion assembly of claim 28, wherein the bendable
portion of the glucose sensor is configured to bend during coupling
of the glucose sensor with the on body electronics.
31. The insertion assembly of claim 20, wherein the advancement of
the sharp and the glucose sensor in the distal direction along the
insertion axis and the retraction of the sharp in the proximal
direction along the insertion axis occur automatically after the
button is pressed.
32. The insertion assembly of claim 20, wherein an end section of
the glucose sensor is configured to be in contact with interstitial
fluid of the subject after the distal end of the glucose sensor is
inserted under the skin of the subject.
33. The insertion assembly of claim 20, wherein the glucose sensor
comprises two or more electrodes.
34. The insertion assembly of claim 20, further comprising a needle
hub coupled with the sharp.
35. The insertion assembly of claim 20, wherein the adhesive layer
comprises an aperture.
36. The insertion assembly of claim 20, wherein the sliding element
is configured to move along a path that is different from the
depression axis and the insertion axis.
37. The insertion assembly of claim 25, wherein the sliding element
is configured to move along a path that is different from the
depression axis and the insertion axis.
38. An insertion assembly for inserting a glucose sensor into a
subject, the insertion assembly comprising: the glucose sensor,
wherein the glucose sensor comprises two or more electrodes, and
wherein a distal end of the glucose sensor is configured to be
inserted under skin of the subject; a distal surface comprising an
adhesive layer, wherein the adhesive layer comprises an aperture,
and wherein the distal surface is configured to be positioned on
the skin of the subject such that the adhesive layer adheres to the
skin of the subject; an interior of the insertion assembly
comprising a first spring in a loaded position, a second spring, a
rotatable element, a sliding element, and a straight track having a
length, wherein the sliding element is configured to move only
within the straight track; and a button configured to be pressed
along a depression axis toward the interior of the insertion
assembly, wherein the button is further configured to release the
first spring from the loaded position upon being pressed, such that
the first spring causes the sliding element to move within the
straight track, wherein movement of the sliding element within the
straight track causes advancement of a sharp and the glucose sensor
in a distal direction along an insertion axis different from the
depression axis such that the distal end of the glucose sensor is
inserted under the skin of the subject, wherein the sliding element
is further configured to continue moving within the straight track
after the advancement of the sharp and the glucose sensor in the
distal direction along the insertion axis, wherein the second
spring is configured to expand and retract the sharp in the
proximal direction along the insertion axis while the distal end of
the glucose sensor remains under the skin of the subject, wherein
the sharp is configured to be retracted fully within the interior
of the insertion assembly, wherein the advancement of the sharp and
the glucose sensor in the distal direction along the insertion axis
and the retraction of the sharp in the proximal direction along the
insertion axis occur automatically after the button is pressed,
wherein the insertion assembly comprises a maximum height parallel
with the insertion axis and a maximum width parallel with the
length of the straight track, and wherein the maximum height is
greater than the maximum width, wherein the second spring is a
compression spring, and wherein the glucose sensor is configured to
operate for a period of about seven days or more.
39. The insertion assembly of claim 38, wherein the glucose sensor
further comprises a proximal retention portion, a distal insertion
portion, and a bendable portion located therebetween, and wherein
the glucose sensor is further configured to be coupled with on body
electronics.
40. The insertion assembly of claim 39, further comprising a needle
hub coupled with the sharp and wherein at least a part of the
glucose sensor is housed within the sharp.
41. The insertion assembly of claim 40, wherein, after the release
of the first spring from the loaded position, the first spring is
configured to cause the rotatable element to rotate less than a
full rotation.
42. The insertion assembly of claim 41, wherein the sharp is
further configured to be inserted under the skin of the subject at
an oblique angle with respect to the skin of the subject.
43. The insertion assembly of claim 42, wherein the bendable
portion of the glucose sensor is configured to bend prior to
coupling of the glucose sensor with the on body electronics.
44. The insertion assembly of claim 42, wherein the bendable
portion of the glucose sensor is configured to bend during coupling
of the glucose sensor with the on body electronics.
45. The insertion assembly of claim 42, further comprising a mount,
wherein the mount is configured to be secured to the skin of the
subject before the advancement of the sharp and the glucose sensor
in the distal direction along the insertion axis.
46. The insertion assembly of claim 42, further comprising a
stopping surface, wherein the stopping surface is configured to
stop the rotation of the rotatable element.
47. The insertion assembly of claim 42, wherein the depression axis
is perpendicular to the insertion axis.
48. The insertion assembly of claim 38, wherein the sliding element
is configured to move along a path that is different from the
depression axis and the insertion axis.
49. The insertion assembly of claim 42, wherein the sliding element
is configured to move along a path that is different from the
depression axis and the insertion axis.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 17/077,445, filed Oct. 22, 2020, which is a
continuation of U.S. patent application Ser. No. 14/996,751, filed
Jan. 15, 2016, which is a continuation of U.S. patent application
Ser. No. 13/071,487, filed Mar. 24, 2011, now U.S. Pat. 9,265,453,
which claims the benefit of U.S. Provisional Application Nos.
61/317,243, filed Mar. 24, 2010; 61/345,562, filed May 17, 2010;
61/361,374, filed Jul. 2, 2010; and 61/411,262, filed Nov. 8, 2010,
all of which are incorporated herein by reference in their
entireties and for all purposes.
INCORPORATION BY REFERENCE
[0002] Patents, applications and/or publications described herein,
including the following patents, applications and/or publications
are incorporated herein by reference for all purposes: U.S. Pat.
Nos. 4,545,382; 4,711,245; 5,262,035; 5,262,305; 5,264,104;
5,320,715; 5,356,786; 5,509,410; 5,543,326; 5,593,852; 5,601,435;
5,628,890; 5,820,551; 5,822,715; 5,899,855; 5,918,603; 6,071,391;
6,103,033; 6,120,676; 6,121,009; 6,134,461; 6,143,164; 6,144,837;
6,161,095; 6,175,752; 6,270,455; 6,284,478; 6,299,757; 6,338,790;
6,377,894; 6,461,496; 6,503,381; 6,514,460; 6,514,718; 6,540,891;
6,560,471; 6,579,690; 6,591,125; 6,592,745; 6,600,997; 6,605,200;
6,605,201; 6,616,819; 6,618,934; 6,650,471; 6,654,625; 6,676,816;
6,730,200; 6,736,957; 6,746,582; 6,749,740; 6,764,581; 6,773,671;
6,881,551; 6,893,545; 6,932,892; 6,932,894; 6,942,518; 7,041,468;
7,167,818; and 7,299,082; 7,381,184; 7,740,581; 7,811,231 U.S.
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61/345,562; and 61/359,265.
BACKGROUND OF THE INVENTION
[0003] The detection and/or monitoring of glucose levels or other
analytes, such as lactate, oxygen, A1C, or the like, in certain
individuals is vitally important to their health. For example, the
monitoring of glucose is particularly important to individuals with
diabetes. Diabetics generally monitor glucose levels to determine
if their glucose levels are being maintained within a clinically
safe range, and may also use this information to determine if
and/or when insulin is needed to reduce glucose levels in their
bodies or when additional glucose is needed to raise the level of
glucose in their bodies.
[0004] Growing clinical data demonstrates a strong correlation
between the frequency of glucose monitoring and glycemic control.
Despite such correlation, many individuals diagnosed with a
diabetic condition do not monitor their glucose levels as
frequently as they should due to a combination of factors including
convenience, testing discretion, pain associated with glucose
testing, and cost.
[0005] Devices have been developed for the automatic monitoring of
analyte(s), such as glucose, in bodily fluid such as in the blood
stream or in interstitial fluid ("ISF"), or other biological fluid.
Some of these analyte measuring devices are configured so that at
least a portion of the devices are positioned below a skin surface
of a user, e.g., in a blood vessel or in the subcutaneous tissue of
a user, so that the monitoring is accomplished in vivo.
[0006] With the continued development of analyte monitoring devices
and systems, there is a need for such analyte monitoring devices,
systems, and methods, as well as for processes for manufacturing
analyte monitoring devices and systems that are cost effective,
convenient, and with reduced pain, provide discreet monitoring to
encourage frequent analyte monitoring to improve glycemic
control.
SUMMARY
[0007] An apparatus for inserting a medical device at least
partially through the skin of a subject is provided, which includes
a first subassembly and a second subassembly. The first subassembly
includes a sheath defining a distal surface for placement on the
skin of the subject, a handle movable between a proximal position
and distal position, a device support for supporting the medical
device and defining an aperture therethrough, the device support
coupled to the handle, a sharp support for supporting a sharp
extending through said aperture and coupled to the device support,
and a first driver for biasing the sharp support towards the
proximal position. The second subassembly includes a housing
configured for removable attachment to the first subassembly, and a
second driver for advancing the sharp support towards the distal
position.
[0008] In some embodiments, the first subassembly and the second
subassembly are modular components. In some embodiments, the first
subassembly is capable of independent operation without the second
subassembly. In some embodiments, the driver of the first
subassembly is capable of operation by a user without the second
subassembly. In some embodiments, the driver of the first
subassembly is actuable by depressing an actuation switch or
button. In some embodiments, the second subassembly is configured
to actuate the actuation switch or button of the first
subassembly.
[0009] In some embodiments, the second driver includes a rotatable
cam or a torsion spring. In some embodiments, the second driver
includes either an axial driver and a crank assembly or a
compression spring. In some embodiments, the first driver includes
a compression spring, or a torsion spring.
[0010] In some embodiments, the handle is at least partially
disposed surrounding the sheath. In some embodiments, a retention
member for retaining the device support in the distal position is
provided. The device support may be coupled to the handle until the
device support reaches a distal position.
[0011] In some embodiments, the first subassembly is configured for
a single use. In some embodiments, the second subassembly is
configured for multiple uses.
[0012] Embodiments of analyte sensors are provided which include a
body having a proximal section and a distal section. The distal
section may be longitudinally aligned with the proximal section. An
intermediate section may be included between the proximal and
distal sections, and in some embodiments the intermediate section
is laterally displaced from at least the distal member.
[0013] In some embodiments, the proximal end is received within a
needle seat to create an anchor region to allow the sensor body to
slide into an opening defined in the insertion sharp but prevent
the sensor body from inadvertently slipping out of the insertion
needle. In some embodiments, a width of the distal section of the
sensor body is sized to fit within the opening of the insertion
sharp. In certain embodiments, the opening in the sharp has a
diameter of about 20 gauge to about 26 gauge, e.g., 21 gauge to
about 25 gauge, where in certain embodiments the sharp is 21 gauge
or 23 gauge or 25 gauge. Such sharp may be used with a sensor
having a width or diameter--at least the portion that is carried by
the sharp--of about 0.20 mm to about 0.80 mm, e.g., about 0.25 mm
to about 0.60 mm, where in some embodiments the width or diameter
of least a portion of a sensor is 0.27 mm or 0.33 mm or 0.58
mm.
[0014] In some embodiments, the intermediate member includes a
plane-altering portion. The plane-altering portion allows the
proximal section of the sensor body to be in a plane different than
the distal section of the sensor body. In some embodiments, the
proximal section and the distal section are in planes substantially
perpendicular to each other, e.g., the area may define an angle of
about 120.degree. to about 60.degree., e.g., about 90.degree..
[0015] In certain embodiments, apparatuses for inserting a medical
device at least partially through the skin of a subject are
provided which include a sheath defining a distal surface for
placement on the skin of the subject; a handle movable between a
proximal position and distal position; a device support for
supporting the medical device and defining an aperture
therethrough, the device support coupled to the handle; a sharp
support for supporting a sharp extending through said aperture and
coupled to the device support; and driver for biasing the sharp
support towards the proximal position.
[0016] In some embodiments, the driver includes a compression
spring. In some embodiments, the handle is at least partially
disposed surrounding the sheath. In some embodiments, a stop
portion for retaining the device support in the distal position is
included. In some embodiments, the device support is coupled to the
handle until the device support reaches a distal position. In some
embodiments, the device support is uncoupled from the sharp support
when the device support reaches the distal position.
[0017] In some embodiments, a second assembly interfaces with the
insertion devices or first subassembly. The second assembly
automates the insertion segment motion of the described inserter.
The second assembly may include a housing configured for removable
attachment to the first subassembly, a handle configured for
longitudinal movement with respect to the housing, an actuator
configured for longitudinal movement with respect to the housing, a
release member either located on the actuator or handle which is
actuated upon the handle reaching a predetermined position, a
driver element coupled between the handle and the actuator,
energized upon distal movement of the handle, which drives the
actuator distally once the release member is actuated, and a second
driver which is also energized upon distal movement of the handle,
that applies a proximal force on the handle that returns the handle
to a proximal position after pressure is relieved from the handle
post insertion. The second driver, coupled through the handle, also
provides a proximal force to return the actuator to its proximal
position where the release member is reengaged.
[0018] In some embodiments, the first driver includes a compression
spring, or a torsion spring. In some embodiments, the handle is at
least partially disposed surrounding the sheath. In some
embodiments, a retention member for retaining the device support in
the distal position is provided. The device support may be coupled
to the handle until the device support reaches a distal
position.
[0019] In some embodiments, the first subassembly is configured for
a single use. In some embodiments, the first subassembly is
configured for multiple uses. In some embodiments, the second
subassembly is configured for multiple uses.
[0020] These and other features, objects, and advantages of the
disclosed subject matter will become apparent to those persons
skilled in the art upon reading the detailed description as more
fully described below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] A detailed description of various aspects, features, and
embodiments of the subject matter described herein is provided with
reference to the accompanying drawings, which are briefly described
below. The drawings are illustrative and are not necessarily drawn
to scale, with some components and features being exaggerated for
clarity. The drawings illustrate various aspects and features of
the present subject matter and may illustrate one or more
embodiment(s) or example(s) of the present subject matter in whole
or in part.
[0022] FIG. 1 illustrates an analyte monitoring system for real
time analyte (e.g., glucose) measurement, data acquisition and/or
processing in certain embodiments;
[0023] FIGS. 2-3 are views of an electrochemical sensor in
accordance with a further embodiment of the disclosed subject
matter;
[0024] FIGS. 4-5 are schematic views of a needle hub in accordance
with one embodiment of the disclosed subject matter;
[0025] FIG. 6 is a distal end view of a sharp in accordance with
one embodiment of the disclosed subject matter;
[0026] FIG. 7 is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0027] FIG. 8 is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0028] FIG. 9 is a perspective view of a sharp in accordance with
one embodiment of the disclosed subject matter;
[0029] FIG. 10 is a schematic view of an alternate embodiment for
forming a sharp to be used in an inserter in accordance with one
embodiment of the disclosed subject matter;
[0030] FIG. 11 is a perspective view of an inserter in accordance
with one embodiment of the disclosed subject matter;
[0031] FIG. 12 is a perspective view with parts separated of an
inserter in accordance with one embodiment of the disclosed subject
matter;
[0032] FIG. 13 is an enlarged sectional view with parts separated
of an inserter in accordance with one embodiment of the disclosed
subject matter;
[0033] FIG. 14 is a perspective view of another embodiment of an
inserter in accordance with the disclosed subject matter;
[0034] FIG. 15 is a side view of the inserter of FIG. 14 in
accordance with the disclosed subject matter;
[0035] FIGS. 16-17 are cross-sectional views of the inserter of
FIG. 14 in accordance with the disclosed subject matter;
[0036] FIGS. 18-19 are perspective views of an inserter in
accordance with another embodiment of the disclosed subject
matter;
[0037] FIGS. 20-21 are perspective views of the inserter of the
embodiment of FIG. 18 in combination with the inserter of FIG. 14
in accordance with another embodiment of the disclosed subject
matter;
[0038] FIGS. 22-24 are side views of the inserter of the embodiment
of FIG. 18 in combination with the inserter of FIG. 14 in
accordance with another embodiment of the disclosed subject
matter;
[0039] FIGS. 25-26 are perspective views of an inserter in
accordance with another embodiment of the disclosed subject
matter;
[0040] FIGS. 27-28 are perspective views of the inserter of the
embodiment of FIG. 25 in combination with the inserter of FIG. 14
in accordance with another embodiment of the disclosed subject
matter;
[0041] FIGS. 29-31 are side views of the inserter of the embodiment
of FIG. 25 in combination with the inserter of FIG. 14 in
accordance with another embodiment of the disclosed subject
matter;
[0042] FIG. 32 is a side view of an inserter in accordance with
another embodiment of the disclosed subject matter;
[0043] FIG. 33 is a perspective view of an inserter in accordance
with another embodiment of the disclosed subject matter;
[0044] FIGS. 34-43 are views of the inserter of FIGS. 32-33 showing
the inserter actuation process;
[0045] FIG. 44 is a cross-sectional view of another inserter in
accordance with the disclosed subject matter;
[0046] FIG. 45 is an exploded perspective view of the inserter of
FIG. 44 in accordance with the disclosed subject matter;
[0047] FIGS. 46-53 are perspective views of the inserter of FIG. 44
showing the assembly of various components in accordance with the
disclosed subject matter;
[0048] FIGS. 54-58 are cross-sectional views of the inserter of
FIG. 44 in accordance with the disclosed subject matter;
[0049] FIG. 59 illustrates a process for utilizing a sterilized
version of the inserter of FIG. 44 in accordance with the disclosed
subject matter;
[0050] FIG. 60 illustrates an alternate process for utilizing a
sterilized version of the inserter of FIG. 44 in accordance with
the disclosed subject matter;
[0051] FIG. 61 is a perspective view of an inserter in accordance
with the disclosed subject matter;
[0052] FIGS. 62-66 are cross-sectional views of the inserter of
FIG. 61 in accordance with the disclosed subject matter;
[0053] FIGS. 67-69 are perspective views of components of the
inserter of FIG. 61 in accordance with the disclosed subject
matter;
[0054] FIG. 70 is a perspective view of an inserter in accordance
with the disclosed subject matter;
[0055] FIG. 71 is a perspective view with parts separated of the
inserter of FIG. 70 in accordance with the disclosed subject
matter; and
[0056] FIGS. 72-79 are cross-sectional views of the inserter of
FIG. 70 in accordance with the disclosed subject matter.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0057] A detailed description of the disclosure is provided herein.
It should be understood, in connection with the following
description, that the subject matter is not limited to particular
embodiments described, as the particular embodiments of the subject
matter may, of course, vary. It is also to be understood that the
terminology used herein is for the purpose of describing particular
embodiments only, and is not intended to be limiting, since the
scope of the disclosed subject matter will be limited only by the
appended claims.
[0058] Where a range of values is provided, it is understood that
each intervening value between the upper and lower limit of that
range, and any other stated or intervening value in that stated
range, is encompassed within the disclosed subject matter. Every
range stated is also intended to specifically disclose each and
every "subrange" of the stated range. That is, each and every range
smaller than the outside range specified by the outside upper and
outside lower limits given for a range, whose upper and lower
limits are within the range from said outside lower limit to said
outside upper limit (unless the context clearly dictates
otherwise), is also to be understood as encompassed within the
disclosed subject matter, subject to any specifically excluded
range or limit within the stated range. Where a range is stated by
specifying one or both of an upper and lower limit, ranges
excluding either or both of those stated limits, or including one
or both of them, are also encompassed within the disclosed subject
matter, regardless of whether or not words such as "from," "to,"
"through," or "including" are or are not used in describing the
range.
[0059] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this disclosed subject matter
belongs. Although any methods and materials similar or equivalent
to those described herein can also be used in the practice or
testing of the present disclosed subject matter, this disclosure
may specifically mention certain exemplary methods and
materials.
[0060] All publications mentioned in this disclosure are, unless
otherwise specified, incorporated by reference herein for all
purposes, including without limitation to disclose and describe the
methods and/or materials in connection with which the publications
are cited.
[0061] The publications discussed herein are provided solely for
their disclosure prior to the filing date of the present
application. Nothing herein is to be construed as an admission that
the present disclosed subject matter is not entitled to antedate
such publication by virtue of prior invention. Further, the dates
of publication provided may be different from the actual
publication dates, which may need to be independently
confirmed.
[0062] As used herein and in the appended claims, the singular
forms "a," "an," and "the" include plural referents unless the
context clearly dictates otherwise.
[0063] Nothing contained in the Abstract or the Summary should be
understood as limiting the scope of the disclosure. The Abstract
and the Summary are provided for bibliographic and convenience
purposes and due to their formats and purposes should not be
considered comprehensive.
[0064] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discrete components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present disclosed subject matter.
Any recited method can be carried out in the order of events
recited, or in any other order which is logically possible.
[0065] Reference to a singular item includes the possibility that
there are plural of the same item present. When two or more items
(for example, elements or processes) are referenced by an
alternative "or," this indicates that either could be present
separately or any combination of them could be present together
except where the presence of one necessarily excludes the other or
others.
[0066] Generally, embodiments of the present disclosure relate to
an apparatus for inserting a medical device at least partially into
the skin of the patient. Some embodiments relate to in vivo methods
and devices for detecting at least one analyte such as glucose in
body fluid. Accordingly, embodiments include in vivo analyte
sensors configured so that at least a portion of the sensor is
positioned in the body of a user (e.g., within the ISF), to obtain
information about at least one analyte of the body, e.g.,
transcutaneously positioned in user's body. In certain embodiments,
an in vivo analyte sensor is coupled to an electronics unit that is
maintained on the body of the user to process information obtained
from the sensor.
[0067] In certain embodiments, analyte information is communicated
from a first device such as an on body electronics unit to a second
device which may include user interface features, including a
display, and/or the like. Information may be communicated from the
first device to the second device automatically and/or continuously
when the analyte information is available, or may not be
communicated automatically and/or continuously, but rather stored
or logged in a memory of the first device. Accordingly, in many
embodiments of the system, analyte information derived by the
sensor/on body electronics (for example, on body electronics) is
made available in a user-usable or viewable form only when queried
by the user such that the timing of data communication is selected
by the user. In some embodiments, the display of information is
selected by the user, while the timing of data communication is
not.
[0068] In this manner, analyte information is only provided or
evident to a user (provided at a user interface device) in some
embodiments when desired by the user even though an in vivo analyte
sensor automatically and/or continuously monitors the analyte level
in vivo, i.e., the sensor automatically monitors analyte such as
glucose on a pre-defined time interval over its usage life. For
example, an analyte sensor may be positioned in vivo and coupled to
on body electronics for a given sensing period, e.g., about 14
days. In certain embodiments, the sensor-derived analyte
information is automatically communicated from the sensor
electronics assembly to a remote monitor device or display device
for output to a user throughout the 14 day period according to a
schedule programmed at the on body electronics (e.g., about every 1
minute or about every 5 minutes or about every 10 minutes, or the
like). In certain embodiments, sensor-derived analyte information
is only communicated from the sensor electronics assembly to a
remote monitor device or display device at user-determined times,
e.g., whenever a user decides to check analyte information. At such
times, a communications system is activated, and sensor-derived
information is then sent from the on body electronics to the remote
device or display device.
[0069] In still other embodiments, the information may be
communicated from the first device to the second device
automatically and/or continuously when the analyte information is
available, and the second device stores or logs the received
information without presenting or outputting the information to the
user. In such embodiments, the information is received by the
second device from the first device when the information becomes
available (e.g., when the sensor detects the analyte level
according to a time schedule). However, the received information is
initially stored in the second device and only output to a user
interface or an output component of the second device (e.g.,
display) upon detection of a request for the information on the
second device.
[0070] Accordingly, in certain embodiments an inserter as described
herein is used to place a sensor electronics assembly on the body
so that at least a portion of the in vivo sensor is in contact with
bodily fluid such as ISF. Once the sensor is electrically coupled
to the electronics unit, sensor derived analyte information may be
communicated from the on body electronics to a display device
on-demand by powering on the display device (or it may be
continually powered), and executing a software algorithm stored in
and accessed from a memory of the display device, to generate one
or more request commands, control signal or data packet to send to
the on body electronics. The software algorithm executed under, for
example, the control of the microprocessor or application specific
integrated circuit (ASIC) of the display device may include
routines to detect the position of the on body electronics relative
to the display device to initiate the transmission of the generated
request command, control signal and/or data packet.
[0071] Display devices may also include programming stored in
memory for execution by one or more microprocessors and/or ASICs to
generate and transmit the one or more request command, control
signal or data packet to send to the on body electronics in
response to a user activation of an input mechanism on the display
device such as depressing a button on the display device,
triggering a soft button associated with the data communication
function, and so on. The input mechanism may be alternatively or
additionally provided on or in the on body electronics which may be
configured for user activation. In certain embodiments, voice
commands or audible signals may be used to prompt or instruct the
microprocessor or ASIC to execute the software routine(s) stored in
the memory to generate and transmit the one or more request
command, control signal or data packet to the on body device. In
the embodiments that are voice activated or responsive to voice
commands or audible signals, on body electronics and/or display
devices include a microphone, a speaker, and processing routines
stored in the respective memories of the on body electronics and/or
the display device to process the voice commands and/or audible
signals. In certain embodiments, positioning the on body
electronics and the display device within a predetermined distance
(e.g., close proximity) relative to each other initiates one or
more software routines stored in the memory of the display device
to generate and transmit a request command, control signal or data
packet.
[0072] Different types and/or forms and/or amounts of information
may be sent for each on demand reading, including but not limited
to one or more of current analyte level information (i.e., real
time or the most recently obtained analyte level information
temporally corresponding to the time the reading is initiated),
rate of change of an analyte over a predetermined time period, rate
of the rate of change of an analyte (acceleration in the rate of
change), historical analyte information corresponding to analyte
information obtained prior to a given reading and stored in memory
of the assembly. Some or all of real time, historical, rate of
change, rate of rate of change (such as acceleration or
deceleration) information may be sent to a display device for a
given reading. In certain embodiments, the type and/or form and/or
amount of information sent to a display device may be preprogrammed
and/or unchangeable (e.g., preset at manufacturing), or may not be
preprogrammed and/or unchangeable so that it may be selectable
and/or changeable in the field one or more times (e.g., by
activating a switch of the system, etc.). Accordingly, in certain
embodiments, for each on demand reading, a display device will
output a current (real time) sensor-derived analyte value (e.g., in
numerical format), a current rate of analyte change (e.g., in the
form of an analyte rate indicator such as an arrow pointing in a
direction to indicate the current rate), and analyte trend history
data based on sensor readings acquired by and stored in memory of
on body electronics (e.g., in the form of a graphical trace).
Additionally, the on skin or sensor temperature reading or
measurement associated with each on demand reading may be
communicated from the on body electronics to the display device.
The temperature reading or measurement, however, may not be output
or displayed on the display device, but rather, used in conjunction
with a software routine executed by the display device to correct
or compensate the analyte measurement output to the user on the
display device.
[0073] As described, embodiments include inserters for in vivo
analyte sensors and on body electronics that together provide body
wearable sensor electronics assemblies. In certain embodiments, in
vivo analyte sensors are fully integrated with on body electronics
(fixedly connected during manufacture), while in other embodiments
they are separate but connectable post manufacture (e.g., before,
during or after sensor insertion into a body). On body electronics
may include an in vivo glucose sensor, electronics, battery, and
antenna encased (except for the sensor portion that is for in vivo
positioning) in a waterproof housing that includes or is attachable
to an adhesive pad. In certain embodiments, the housing withstands
immersion in about one meter of water for up to at least 30
minutes. In certain embodiments, the housing withstands continuous
underwater contact, e.g., for longer than about 30 minutes, and
continues to function properly according to its intended use, e.g.,
without water damage to the housing electronics where the housing
is suitable for water submersion.
[0074] Embodiments include sensor insertion devices, which also may
be referred to herein as sensor delivery units, or the like.
Insertion devices may retain on body electronics assemblies
completely in an interior compartment, i.e., an insertion device
may be "pre-loaded" with on body electronics assemblies during the
manufacturing process (e.g., on body electronics may be packaged in
a sterile interior compartment of an insertion device). In such
embodiments, insertion devices may form sensor assembly packages
(including sterile packages) for pre-use or new on body electronics
assemblies, and insertion devices configured to apply on body
electronics assemblies to recipient bodies.
[0075] Embodiments include portable handheld display devices, as
separate devices and spaced apart from an on body electronics
assembly, that collect information from the assemblies and provide
sensor derived analyte readings to users. Such devices may also be
referred to as meters, readers, monitors, receivers, human
interface devices, companions, or the like. Certain embodiments may
include an integrated in vitro analyte meter. In certain
embodiments, display devices include one or more wired or wireless
communications ports such as USB, serial, parallel, or the like,
configured to establish communication between a display device and
another unit (e.g., on body electronics, power unit to recharge a
battery, a PC, etc.). For example, a display device communication
port may enable charging a display device battery with a respective
charging cable and/or data exchange between a display device and
its compatible informatics software.
[0076] Compatible informatics software in certain embodiments
include, for example, but not limited to stand alone or network
connection enabled data management software program, resident or
running on a display device, personal computer, a server terminal,
for example, to perform data analysis, charting, data storage, data
archiving and data communication as well as data synchronization.
Informatics software in certain embodiments may also include
software for executing field upgradable functions to upgrade
firmware of a display device and/or on body electronics unit to
upgrade the resident software on the display device and/or the on
body electronics unit, e.g., with versions of firmware that include
additional features and/or include software bugs or errors fixed,
etc. Embodiments may include a haptic feedback feature such as a
vibration motor or the like, configured so that corresponding
notifications (e.g., a successful on-demand reading received at a
display device), may be delivered in the form of haptic
feedback.
[0077] Embodiments include programming embedded on a computer
readable medium, i.e., computer-based application software (may
also be referred to herein as informatics software or programming
or the like) that processes analyte information obtained from the
system and/or user self-reported data. Application software may be
installed on a host computer such as a mobile telephone, PC, an
Internet-enabled human interface device such as an Internet-enabled
phone, personal digital assistant, or the like, by a display device
or an on body electronics unit. Informatics programming may
transform data acquired and stored on a display device or on body
unit for use by a user.
[0078] Embodiments of the subject disclosure are described
primarily with respect to glucose monitoring devices and systems,
and methods of glucose monitoring, for convenience only and such
description is in no way intended to limit the scope of the
disclosure. It is to be understood that the analyte monitoring
system may be configured to monitor a variety of analytes at the
same time or at different times.
[0079] As described in detail below, embodiments include devices,
systems, kits and/or methods to monitor one or more physiological
parameters such as, for example, but not limited to, analyte
levels, temperature levels, heart rate, or user activity level,
over a predetermined monitoring time period. Also provided are
methods of manufacturing. Predetermined monitoring time periods may
be less than about 1 hour, or may include about 1 hour or more,
e.g., about a few hours or more, e.g., about a few days of more,
e.g., about 3 or more days, e.g., about 5 days or more, e.g., about
7 days or more, e.g., about 10 days or more, e.g., about 14 days or
more, e.g., about several weeks, e.g., about 1 month or more. In
certain embodiments, after the expiration of the predetermined
monitoring time period, one or more features of the system may be
automatically deactivated or disabled at the on body electronics
assembly and/or display device.
[0080] For example, a predetermined monitoring time period may
begin with positioning the sensor in vivo and in contact with a
body fluid such as ISF, and/or with the initiation (or powering on
to full operational mode) of the on body electronics.
Initialization of on body electronics may be implemented with a
command generated and transmitted by a display device in response
to the activation of a switch and/or by placing the display device
within a predetermined distance (e.g., close proximity) to the on
body electronics, or by user manual activation of a switch on the
on body electronics unit, e.g., depressing a button, or such
activation may be caused by the insertion device, e.g., as
described in U.S. patent application Ser. No. 12/698,129 filed on
Feb. 1, 2010 and U.S. Provisional Application Nos. 61/238,646,
61/246,825, 61/247,516, 61/249,535, 61/317,243, 61/345,562, and
61/361,374, the disclosures of each of which are incorporated
herein by reference for all purposes.
[0081] When initialized in response to a received command from a
display device, the on body electronics retrieves and executes from
its memory software routine to fully power on the components of the
on body electronics, effectively placing the on body electronics in
full operational mode in response to receiving the activation
command from the display device. For example, prior to the receipt
of the command from the display device, a portion of the components
in the on body electronics may be powered by its internal power
supply such as a battery while another portion of the components in
the on body electronics may be in powered down or maintained in a
low power state including no power state, inactive mode, or all
components may be in an inactive, powered down mode. Upon receipt
of the command, the remaining portion (or all) of the components of
the on body electronics is switched to active, fully operational
mode.
[0082] Embodiments of on body electronics may include one or more
printed circuit boards with electronics including control logic
implemented in ASIC, microprocessors, memory, and the like, and
transcutaneously positionable analyte sensors forming a single
assembly. On body electronics may be configured to provide one or
more signals or data packets associated with a monitored analyte
level upon detection of a display device of the analyte monitoring
system within a predetermined proximity for a period of time (for
example, about 2 minutes, e.g., 1 minute or less, e.g., about 30
seconds or less, e.g., about 10 seconds or less, e.g., about 5
seconds or less, e.g., about 2 seconds or less) and/or until a
confirmation, such as an audible and/or visual and/or tactile
(e.g., vibratory) notification, is output on the display device
indicating successful acquisition of the analyte related signal
from the on body electronics. A distinguishing notification may
also be output for unsuccessful acquisition in certain
embodiments.
[0083] In certain embodiments, the monitored analyte level may be
correlated and/or converted to glucose levels in blood or other
fluids such as ISF. Such conversion may be accomplished with the on
body electronics, but in many embodiments will be accomplished with
display device electronics. In certain embodiments, glucose level
is derived from the monitored analyte level in the ISF.
[0084] Analyte sensors may be insertable into a vein, artery, or
other portion of the body containing analyte. In certain
embodiments, analyte sensors may be positioned in contact with ISF
to detect the level of analyte, where the detected analyte level
may be used to infer the user's glucose level in blood or
interstitial tissue.
[0085] Embodiments include transcutaneous sensors and also wholly
implantable sensors and wholly implantable assemblies in which a
single assembly including the analyte sensor and electronics are
provided in a sealed housing (e.g., hermetically sealed
biocompatible housing) for implantation in a user's body for
monitoring one or more physiological parameters.
[0086] Embodiments include analyte monitors that are provided in
small, lightweight, battery-powered and electronically-controlled
systems. Such systems may be configured to detect physical
parameters of subjects, such as signals indicative of in vivo
analyte levels using an electrochemical sensor, and collect such
signals, with or without processing. Any suitable measurement
technique may be used to obtain signals from the sensors, e.g., may
detect current, may employ potentiometry, etc. Techniques may
include, but are not limited to amperometry, coulometry, and
voltammetry. In some embodiments, sensing systems may be optical,
colorimetric, and the like. In some embodiments, the portion of the
system that performs this initial processing may be configured to
provide the raw or at least initially processed data to another
unit for further collection and/or processing. Such provision of
data may be affected, for example, by a wired connection, such as
an electrical, or by a wireless connection, such as an IR or RF
connection.
[0087] In certain systems, the analyte sensor is in communication
with on body electronics. The on body unit may include a housing in
which the on body electronics and at least a portion of the sensor
are received.
[0088] Certain embodiments are modular. The on body unit may be
separately provided as a physically distinct assembly from a
monitor unit, e.g., which displays or otherwise indicates analyte
levels to a user. The on body unit may be configured to provide the
analyte levels detected by the sensor and/or other information
(such as temperature, sensor life, etc.) over a communication link
to the monitor unit. The monitor unit, in some embodiments, may
include, e.g., a mobile telephone device, an in vitro glucose
meter, a personal digital assistant, or other consumer electronics
such as MP3 device, camera, radio, personal computer, etc., or
other communication-enabled data-processing device.
[0089] The display unit may perform a variety of functions such as
but not limited to data storage and/or processing and/or analysis
and/or communication, etc., on the received analyte data to
generate information pertaining to the monitored analyte levels
and/or process the other information. The monitor unit may
incorporate a display screen, which can be used, for example, to
display measured analyte levels, and/or an audio component such as
a speaker to audibly provide information to a user, and/or a
vibration device to provide tactile feedback to a user. It is also
useful for a user of an analyte-monitoring system to be able to see
trend indications (including the magnitude and direction of any
ongoing trend, e.g., the rate of change of an analyte or other
parameter, and the amount of time a subject is above and/or below a
threshold, such as a hypoglycemic and/or hyperglycemic threshold,
etc.); such data may be displayed either numerically, or by a
visual indicator such as an arrow that may vary in visual
attributes, like size, shape, color, animation, or direction. The
monitor unit may further be adapted to receive information from or
about an in vitro analyte test strip, which may be manually or
automatically entered into the monitor unit. In some embodiments, a
monitor unit may incorporate an in vitro analyte test strip port
and related electronics in order to be able to make discrete (e.g.,
blood glucose) measurements using an in vitro test strip (see,
e.g., U.S. Pat. No. 6,175,752, the disclosure of which is
incorporated by reference herein for all purposes).
[0090] The modularity of these systems may vary where one or more
components may be constructed to be single use and one or more may
be constructed to be re-useable. In some embodiments, the sensor is
designed to be attachable and detachable from the on body
electronics (and the on body unit may be reusable), e.g., so that
one or more of the components may be reused one or more times,
while in other embodiments, the sensor and on body electronics may
be provided as an integrated, undetachable package, which may be
designed to be disposable after use, i.e., not re-used.
Embodiments of In Vivo Monitoring Systems
[0091] For purpose of illustration, and not limitation, the
inserters described herein may be used in connection with an
exemplary analyte monitoring system as depicted in FIG. 1. It is
understood that the inserters described herein may be used with any
medical device on its own or in connection with a system. FIG. 1
shows an exemplary in vivo-based analyte monitoring system 1000 in
accordance with embodiments of the present disclosure. As shown, in
certain embodiments, analyte monitoring system 1000 includes on
body electronics 1100 electrically coupled to in vivo analyte
sensor 14 (a proximal portion of which is shown in FIG. 1), and
attached to adhesive layer 218 for attachment on a skin surface on
the body of a user. On body electronics 1100 includes on body
housing 122 that defines an interior compartment.
[0092] Also shown in FIG. 1 is insertion device 200 (or insertion
devices 300, 400, 2400, 2500, 2700, 3700 described herein) that,
when operated, transcutaneously positions a portion of analyte
sensor 14 through a skin surface and in fluid contact with ISF, and
positions on body electronics 1100 and adhesive layer 218 on a skin
surface, as will be described in greater detail herein. In certain
embodiments, on body electronics 1100, analyte sensor 14 and
adhesive layer 218 are sealed within the housing of insertion
device 200 before use, and in certain embodiments, adhesive layer
218 is also sealed within the housing or the adhesive layer can
provide a seal for preserving the sterility of the apparatus.
Additional details regarding insertion devices are discussed, e.g.,
in U.S. patent application Ser. No. 12/698,129 and U.S. Provisional
Application Nos. 61/238,646, 61/246,825, 61/247,516, 61/249,535,
and 61/345,562, the disclosures of each of which are incorporated
herein by reference for all purposes.
[0093] Referring back to the FIG. 1, analyte monitoring system 1000
includes display device 1200 which includes a display 1220 to
output information to the user, an input component 1210 such as a
button, actuator, a touch sensitive switch, a capacitive switch,
pressure sensitive switch, jog wheel or the like, to input data or
command to display device 1200 or otherwise control the operation
of display device 1200. It is noted that some embodiments may
include display-less devices or devices without any user interface
components. These devices may be functionalized to store data as a
data logger and/or provide a conduit to transfer data from on body
electronics and/or a display-less device to another device and/or
location. Embodiments will be described herein as display devices
for exemplary purposes which are in no way intended to limit the
embodiments of the present disclosure. It will be apparent that
display-less devices may also be used in certain embodiments.
[0094] In certain embodiments, on body electronics 1100 may be
configured to store some or all of the monitored analyte related
data received from analyte sensor 14 in a memory during the
monitoring time period, and maintain it in memory until the usage
period ends. In such embodiments, stored data is retrieved from on
body electronics 1100 at the conclusion of the monitoring time
period, for example, after removing analyte sensor 14 from the user
by detaching on body electronics 1100 from the skin surface where
it was positioned during the monitoring time period. In such data
logging configurations, real time monitored analyte level is not
communicated to display device 1200 during the monitoring period or
otherwise transmitted from on body electronics 1100, but rather,
retrieved from on body electronics 1100 after the monitoring time
period.
[0095] In certain embodiments, input component 1210 of display
device 1200 may include a microphone and display device 1200 may
include software configured to analyze audio input received from
the microphone, such that functions and operation of the display
device 1200 may be controlled by voice commands. In certain
embodiments, an output component of display device 1200 includes a
speaker for outputting information as audible signals. Similar
voice responsive components such as a speaker, microphone and
software routines to generate, process and store voice driven
signals may be provided to on body electronics 1100.
[0096] In certain embodiments, display 1220 and input component
1210 may be integrated into a single component, for example a
display that can detect the presence and location of a physical
contact touch upon the display such as a touch screen user
interface. In such embodiments, the user may control the operation
of display device 1200 by utilizing a set of pre-programmed motion
commands, including, but not limited to, single or double tapping
the display, dragging a finger or instrument across the display,
motioning multiple fingers or instruments toward one another,
motioning multiple fingers or instruments away from one another,
etc. In certain embodiments, a display includes a touch screen
having areas of pixels with single or dual function capacitive
elements that serve as LCD elements and touch sensors.
[0097] Display device 1200 also includes data communication port
1230 for wired data communication with external devices such as
remote terminal (personal computer) 1700, for example. Example
embodiments of the data communication port 1230 include USB port,
mini USB port, RS-232 port, Ethernet port, Firewire port, or other
similar data communication ports configured to connect to the
compatible data cables. Display device 1200 may also include an
integrated in vitro glucose meter, including in vitro test strip
port 1240 to receive an in vitro glucose test strip for performing
in vitro blood glucose measurements.
[0098] Referring still to FIG. 1, display 1220 in certain
embodiments is configured to display a variety of information--some
or all of which may be displayed at the same or different time on
display 1220. In certain embodiments the displayed information is
user-selectable so that a user can customize the information shown
on a given display screen. Display 1220 may include but is not
limited to graphical display 1380, for example, providing a
graphical output of glucose values over a monitored time period
(which may show important markers such as meals, exercise, sleep,
heart rate, blood pressure, etc., numerical display 1320, for
example, providing monitored glucose values (acquired or received
in response to the request for the information), and trend or
directional arrow display 1310 that indicates a rate of analyte
change and/or a rate of the rate of analyte change, e.g., by moving
locations on display 1220.
[0099] As further shown in FIG. 1, display 1220 may also include
date display 1350 providing for example, date information for the
user, time of day information display 1390 providing time of day
information to the user, battery level indicator display 1330 which
graphically shows the condition of the battery (rechargeable or
disposable) of the display device 1200, sensor calibration status
icon display 1340 for example, in monitoring systems that require
periodic, routine or a predetermined number of user calibration
events, notifying the user that the analyte sensor calibration is
necessary, audio/vibratory settings icon display 1360 for
displaying the status of the audio/vibratory output or alarm state,
and wireless connectivity status icon display 1370 that provides
indication of wireless communication connection with other devices
such as on body electronics, data processing module 1600, and/or
remote terminal 1700. As additionally shown in FIG. 1, display 1220
may further include simulated touch screen button 1250, 1260 for
accessing menus, changing display graph output configurations or
otherwise for controlling the operation of display device 1200.
[0100] Referring back to FIG. 1, in certain embodiments, display
1220 of display device 1200 may be additionally, or instead of
visual display, configured to output alarms notifications such as
alarm and/or alert notifications, glucose values etc., which may be
audible, tactile, or any combination thereof In one aspect, the
display device 1200 may include other output components such as a
speaker, vibratory output component and the like to provide audible
and/or vibratory output indication to the user in addition to the
visual output indication provided on display 1220. Further details
and other display embodiments can be found in, e.g., U.S. patent
application Ser. No. 12/871,901, U.S. Provisional Application Nos.
61/238,672, 61/247,541, 61/297,625, the disclosures of each of
which are incorporated herein by reference for all purposes.
[0101] After the positioning of on body electronics 1100 on the
skin surface and analyte sensor 14 in vivo to establish fluid
contact with ISF (or other appropriate body fluid), on body
electronics 1100 in certain embodiments is configured to wirelessly
communicate analyte related data (such as, for example, data
corresponding to monitored analyte level and/or monitored
temperature data, and/or stored historical analyte related data)
when on body electronics 1100 receives a command or request signal
from display device 1200. In certain embodiments, on body
electronics 1100 may be configured to at least periodically
broadcast real time data associated with monitored analyte level
which is received by display device 1200 when display device 1200
is within communication range of the data broadcast from on body
electronics 1100, i.e., it does not need a command or request from
a display device to send information.
[0102] For example, display device 1200 may be configured to
transmit one or more commands to on body electronics 1100 to
initiate data transfer, and in response, on body electronics 1100
may be configured to wirelessly transmit stored analyte related
data collected during the monitoring time period to display device
1200. Display device 1200 may in turn be connected to a remote
terminal 1700 such as a personal computer and functions as a data
conduit to transfer the stored analyte level information from the
on body electronics 1100 to remote terminal 1700. In certain
embodiments, the received data from the on body electronics 1100
may be stored (permanently or temporarily) in one or more memory of
the display device 1200. In certain other embodiments, display
device 1200 is configured as a data conduit to pass the data
received from on body electronics 1100 to remote terminal 1700 that
is connected to display device 1200.
[0103] Referring still to FIG. 1, also shown in analyte monitoring
system 1000 are data processing module 1600 and remote terminal
1700. Remote terminal 1700 may include a personal computer, a
server terminal a laptop computer or other suitable data processing
devices including software for data management and analysis and
communication with the components in the analyte monitoring system
1000. For example, remote terminal 1700 may be connected to a local
area network (LAN), a wide area network (WAN), or other data
network for uni-directional or bi-directional data communication
between remote terminal 1700 and display device 1200 and/or data
processing module 1600.
[0104] Remote terminal 1700 in certain embodiments may include one
or more computer terminals located at a physician's office or a
hospital. For example, remote terminal 1700 may be located at a
location other than the location of display device 1200. Remote
terminal 1700 and display device 1200 could be in different rooms
or different buildings. Remote terminal 1700 and display device
1200 could be at least about one mile apart, e.g., at least about
100 miles apart, e.g., at least about 1000 miles apart. For
example, remote terminal 1700 could be in the same city as display
device 1200, remote terminal 1700 could be in a different city than
display device 1200, remote terminal 1700 could be in the same
state as display device 1200, remote terminal 1700 could be in a
different state than display device 1200, remote terminal 1700
could be in the same country as display device 1200, or remote
terminal 1700 could be in a different country than display device
1200, for example.
[0105] In certain embodiments, a separate, optional data
communication/processing device such as data processing module 1600
may be provided in analyte monitoring system 1000. Data processing
module 1600 may include components to communicate using one or more
wireless communication protocols such as, for example, but not
limited to, infrared (IR) protocol, Bluetooth.RTM. protocol,
Zigbee.RTM. protocol, and 802.11 wireless LAN protocol. Additional
description of communication protocols including those based on
Bluetooth.RTM. protocol and/or Zigbee.RTM. protocol can be found in
U.S. Patent Publication No. 2006/0193375 incorporated herein by
reference for all purposes. Data processing module 1600 may further
include communication ports, drivers or connectors to establish
wired communication with one or more of display device 1200, on
body electronics 1100, or remote terminal 1700 including, for
example, but not limited to USB connector and/or USB port, Ethernet
connector and/or port, FireWire connector and/or port, or RS-232
port and/or connector.
[0106] In certain embodiments, data processing module 1600 is
programmed to transmit a polling or query signal to on body
electronics 1100 at a predetermined time interval (e.g., once every
minute, once every five minutes, or the like), and in response,
receive the monitored analyte level information from on body
electronics 1100. Data processing module 1600 stores in its memory
the received analyte level information, and/or relays or
retransmits the received information to another device such as
display device 1200. More specifically in certain embodiments, data
processing module 1600 may be configured as a data relay device to
retransmit or pass through the received analyte level data from on
body electronics 1100 to display device 1200 or a remote terminal
(for example, over a data network such as a cellular or WiFi data
network) or both.
[0107] In certain embodiments, on body electronics 1100 and data
processing module 1600 may be positioned on the skin surface of the
user within a predetermined distance of each other (for example,
about 1-12 inches, or about 1-10 inches, or about 1-7 inches, or
about 1-5 inches) such that periodic communication between on body
electronics 1100 and data processing module 1600 is maintained.
Alternatively, data processing module 1600 may be worn on a belt or
clothing item of the user, such that the desired distance for
communication between the on body electronics 1100 and data
processing module 1600 for data communication is maintained. In a
further aspect, the housing of data processing module 1600 may be
configured to couple to or engage with on body electronics 1100
such that the two devices are combined or integrated as a single
assembly and positioned on the skin surface. In further
embodiments, data processing module 1600 is detachably engaged or
connected to on body electronics 1100 providing additional
modularity such that data processing module 1600 may be optionally
removed or reattached as desired.
[0108] Referring again to FIG. 1, in certain embodiments, data
processing module 1600 is programmed to transmit a command or
signal to on body electronics 1100 at a predetermined time interval
such as once every minute, or once every 5 minutes or once every 30
minutes or any other suitable or desired programmable time interval
to request analyte related data from on body electronics 1100. When
data processing module 1600 receives the requested analyte related
data, it stores the received data. In this manner, analyte
monitoring system 1000 may be configured to receive the
continuously monitored analyte related information at the
programmed or programmable time interval, which is stored and/or
displayed to the user. The stored data in data processing module
1600 may be subsequently provided or transmitted to display device
1200, remote terminal 1700 or the like for subsequent data analysis
such as identifying frequency of periods of glycemic level
excursions over the monitored time period, or the frequency of the
alarm event occurrence during the monitored time period, for
example, to improve therapy related decisions. Using this
information, the doctor, healthcare provider or the user may adjust
or recommend modification to the diet, daily habits and routines
such as exercise, and the like.
[0109] In another embodiment, data processing module 1600 transmits
a command or signal to on body electronics 1100 to receive the
analyte related data in response to a user activation of a switch
provided on data processing module 1600 or a user initiated command
received from display device 1200. In further embodiments, data
processing module 1600 is configured to transmit a command or
signal to on body electronics 1100 in response to receiving a user
initiated command only after a predetermined time interval has
elapsed. For example, in certain embodiments, if the user does not
initiate communication within a programmed time period, such as,
for example about 5 hours from last communication (or 10 hours from
the last communication, or 24 hours from the last communication),
the data processing module 1600 may be programmed to automatically
transmit a request command or signal to on body electronics 1100.
Alternatively, data processing module 1600 may be programmed to
activate an alarm to notify the user that a predetermined time
period of time has elapsed since the last communication between the
data processing module 1600 and on body electronics 1100. In this
manner, users or healthcare providers may program or configure data
processing module 1600 to provide certain compliance with analyte
monitoring regimen, so that frequent determination of analyte
levels is maintained or performed by the user.
[0110] In certain embodiments, when a programmed or programmable
alarm condition is detected (for example, a detected glucose level
monitored by analyte sensor 14 that is outside a predetermined
acceptable range indicating a physiological condition) which
requires attention or intervention for medical treatment or
analysis (for example, a hypoglycemic condition, a hyperglycemic
condition, an impending hyperglycemic condition or an impending
hypoglycemic condition), the one or more output indications may be
generated by the control logic or processor of the on body
electronics 1100 and output to the user on a user interface of on
body electronics 1100 so that corrective action may be timely
taken. In addition to or alternatively, if display device 1200 is
within communication range, the output indications or alarm data
may be communicated to display device 1200 whose processor, upon
detection of the alarm data reception, controls the display 1220 to
output one or more notification.
[0111] In certain embodiments, control logic or microprocessors of
on body electronics 1100 include software programs to determine
future or anticipated analyte levels based on information obtained
from analyte sensor 14, e.g., the current analyte level, the rate
of change of the analyte level, the acceleration of the analyte
level change, and/or analyte trend information determined based on
stored monitored analyte data providing a historical trend or
direction of analyte level fluctuation as function time during
monitored time period. Predictive alarm parameters may be
programmed or programmable in display device 1200, or the on body
electronics 1100, or both, and output to the user in advance of
anticipating the user's analyte level reaching the future level.
This provides the user an opportunity to take timely corrective
action.
[0112] Information, such as variation or fluctuation of the
monitored analyte level as a function of time over the monitored
time period providing analyte trend information, for example, may
be determined by one or more control logic or microprocessors of
display device 1200, data processing module 1600, and/or remote
terminal 1700, and/or on body electronics 1100. Such information
may be displayed as, for example, a graph (such as a line graph) to
indicate to the user the current and/or historical and/or and
predicted future analyte levels as measured and predicted by the
analyte monitoring system 1000. Such information may also be
displayed as directional arrows (for example, see trend or
directional arrow display 1310) or other icon(s), e.g., the
position of which on the screen relative to a reference point
indicated whether the analyte level is increasing or decreasing as
well as the acceleration or deceleration of the increase or
decrease in analyte level. This information may be utilized by the
user to determine any necessary corrective actions to ensure the
analyte level remains within an acceptable and/or clinically safe
range. Other visual indicators, including colors, flashing, fading,
etc., as well as audio indicators including a change in pitch,
volume, or tone of an audio output and/or vibratory or other
tactile indicators may also be incorporated into the display of
trend data as means of notifying the user of the current level
and/or direction and/or rate of change of the monitored analyte
level. For example, based on a determined rate of glucose change,
programmed clinically significant glucose threshold levels (e.g.,
hyperglycemic and/or hypoglycemic levels), and current analyte
level derived by an in vivo analyte sensor, the system 1000 may
include an algorithm stored on computer readable medium to
determine the time it will take to reach a clinically significant
level and will output notification in advance of reaching the
clinically significant level, e.g., 30 minutes before a clinically
significant level is anticipated, and/or 20 minutes, and/or 10
minutes, and/or 5 minutes, and/or 3 minutes, and/or 1 minute, and
so on, with outputs increasing in intensity or the like.
[0113] Referring again back to FIG. 1, in certain embodiments,
software algorithm(s) for execution by data processing module 1600
may be stored in an external memory device such as an SD card,
microSD card, compact flash card, XD card, Memory Stick card,
Memory Stick Duo card, or USB memory stick/device including
executable programs stored in such devices for execution upon
connection to the respective one or more of the on body electronics
1100, remote terminal 1700 or display device 1200. In a further
aspect, software algorithms for execution by data processing module
1600 may be provided to a communication device such as a mobile
telephone including, for example, WiFi or Internet enabled smart
phones or personal digital assistants (PDAs) as a downloadable
application for execution by the downloading communication
device.
[0114] Examples of smart phones include Windows.RTM., Android.TM.,
iPhone.RTM. operating system, Palm.RTM. WebOS.TM., Blackberry.RTM.
operating system, or Symbian.RTM. operating system based mobile
telephones with data network connectivity functionality for data
communication over an internet connection and/or a local area
network (LAN). PDAs as described above include, for example,
portable electronic devices including one or more microprocessors
and data communication capability with a user interface (e.g.,
display/output unit and/or input unit, and configured for
performing data processing, data upload/download over the internet,
for example. In such embodiments, remote terminal 1700 may be
configured to provide the executable application software to the
one or more of the communication devices described above when
communication between the remote terminal 1700 and the devices are
established.
[0115] In still further embodiments, executable software
applications may be provided over-the-air (OTA) as an OTA download
such that wired connection to remote terminal 1700 is not
necessary. For example, executable applications may be
automatically downloaded as software download to the communication
device, and depending upon the configuration of the communication
device, installed on the device for use automatically, or based on
user confirmation or acknowledgement on the communication device to
execute the installation of the application. The OTA download and
installation of software may include software applications and/or
routines that are updates or upgrades to the existing functions or
features of data processing module 1600 and/or display device
1200.
[0116] Referring back to remote terminal 1700 of FIG. 1, in certain
embodiments, new software and/or software updates such as software
patches or fixes, firmware updates or software driver upgrades,
among others, for display device 1200 and/or on body electronics
1100 and/or data processing module 1600 may be provided by remote
terminal 1700 when communication between the remote terminal 1700
and display device 1200 and/or data processing module 1600 is
established. For example, software upgrades, executable programming
changes or modification for on body electronics 1100 may be
received from remote terminal 1700 by one or more of display device
1200 or data processing module 1600, and thereafter, provided to on
body electronics 1100 to update its software or programmable
functions. For example, in certain embodiments, software received
and installed in on body electronics 1100 may include software bug
fixes, modification to the previously stalled software parameters
(modification to analyte related data storage time interval,
resetting or adjusting time base or information of on body
electronics 1100, modification to the transmitted data type, data
transmission sequence, or data storage time period, among others).
Additional details describing field upgradability of software of
portable electronic devices, and data processing are provided in
U.S. application Ser. Nos. 12/698,124, 12/794,721, now U.S. Pat.
No. 8,595,607, 12/699,653, and 12/699,844, now U.S. Pat. No.
8,930,203, and U.S. Provisional Application Nos. 61/359,265, and
61/325,155 the disclosures of which are incorporated by reference
herein for all purposes.
The Sensor
[0117] The analyte sensor 14 of the analyte measurement system 1000
may be used to monitor levels of a wide variety of analytes.
Analytes that may be monitored include, for example, acetylcholine,
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 monitored. One or more analyte may be monitored by a given
sensor. In those embodiments that monitor more than one analyte,
the analytes may be monitored at the same or different times, which
may use the same on body electronics (e.g., simultaneously) or with
different on body electronics.
[0118] In one embodiment of the present disclosure, sensor 14 is
physically positioned in or on the body of a user whose analyte
level is being monitored. Sensor 14 may be configured to
continuously sample the analyte level of the user and convert the
sampled analyte level, e.g., glucose concentration into a
corresponding data signal, e.g., a current or voltage, for input
into on body electronics. Alternatively, sensor 14 may be
configured to sample analyte levels on demand. The on body
electronics may amplify, filter, average, and/or otherwise process
signal provided by the sensor.
[0119] An embodiment of the sensor 14 is illustrated in FIG. 2. It
is understood that the inserters described herein can be used with
other medical devices. The shape(s) described herein are exemplary
only. Other sensor shapes are contemplated. In some embodiments,
sensor 14 includes a substrate which is a dielectric, e.g., a
polymer or plastic material, such as polyester or polyamide. In
this embodiment, the sensor is constructed so that a portion is
positionable beneath skin and a portion is above skin. Accordingly,
sensor 14 includes an insertion or internal portion 30 and an
external or electrical contact portion 32. In some embodiments, the
contact portion 32 includes several conductive contacts 36, 38, and
40 (herein shown as three contacts) for connection to other
electronics, e.g., at the on body electronics 1100. (See FIG. 1.)
The contacts provided in this embodiment are for a working
electrode, a reference electrode, and a counter electrode. In some
embodiments, two or more working electrodes are provided. The
operative portions of these electrodes, that is, working electrode,
reference electrode, and counter electrode (not individually
shown), are provided at the insertion portion, e.g., at the distal
end of insertion portion 30, e.g., portion 34. In some embodiments,
one or more electrodes may be external to the body, e.g., an
external counter electrode. The contact and operative portions of
the electrodes are connected by circuit traces 42, 44, and 46
running on the surface of the substrate. In some embodiments, the
traces are provided in channels, or may be embedded within the
substrate, or may traverse different sides of the substrate. The
conductive contacts, conductive traces, and electrodes are
fabricated from conductive material, such as platinum, palladium,
gold, carbon, or the like. More than one material may be used for a
given sensor. Further details of sensors are described, e.g., in
U.S. Pat. Nos. 6,175,572 and 6,103,033, which are incorporated by
reference herein for all purposes.
[0120] Sensor 14 may include a proximal retention portion 48. The
insertion portion 30 and the proximal retention portion 48 are
sized and configured to be positioned with a sharp for installation
into the skin of a subject, as described herein. In use, the sensor
14 may be configured to bend (e.g., along the line B) and therefore
be positioned in two substantially perpendicular, intersecting
planes. Such bending may occur prior to or during coupling to the
on body electronics as described below. (See FIG. 17).
[0121] Portions 48 and 52 provide a path for electrical
connections, e.g., the conductive traces, between the proximal and
distal portions of the sensor. Sensor 14 is further provided with a
notch or cut-out 54. Such configuration facilitates the sensor 14
to bend (e.g., along the line indicated by line B) such that
retention portion 48 remains upright and therefore be positioned in
two substantially perpendicular, intersecting planes, as
illustrated in FIG. 3. As will be described below, the sensor tab
50 can be encased in the on body housing 122 to aid in securing and
positioning the sensor 14. Proximal retention portion 48 maintains
its longitudinal alignment with insertion portion 30 for
positioning within an insertion sharp.
[0122] Embodiments of analyte sensors have been described herein to
operate electrochemically, through an arrangement of electrodes
having chemical sensing layers applied thereto, by generating an
electrical current proportional to the volume of a redox reaction
of the analyte (and indicative of analyte concentration), catalyzed
by an analyte-specific oxidizing enzyme. Embodiments exist in which
the number of electrodes provided to bring about and detect the
level of these reactions is two, three, or a greater number.
However, other types of sensors may be employed as described
herein.
[0123] A portion of sensor 14 may be situated above the surface of
the skin, with a distal portion 30 penetrating through the skin and
into the subcutaneous space in contact with the user's biofluid,
such as ISF. Further details regarding the electrochemistry of
sensor 14 is provided in U.S. Pat. Nos. 5,264,104; 5,356,786;
5,262,035; 5,320,725; and 6,990,366, each of which is incorporated
by reference herein for all purposes.
[0124] In some embodiments, the sensor is implantable into a
subject's body for a usage period (e.g., a minute or more, at least
one day or more, about one to about 30 days or even longer, about
three to about fourteen days, about three to about seven days, or
in some embodiments, longer periods of up to several weeks) to
contact and monitor an analyte present in a biological fluid. In
this regard, the sensor can be disposed in a subject at a variety
of sites (e.g., abdomen, upper arm, thigh, etc.), including
intramuscularly, transcutaneously, intravascularly, or in a body
cavity.
[0125] In some embodiments, sensor 14 is employed by insertion
and/or implantation into a user's body for some usage period. In
such embodiments, the substrate may be formed from a relatively
flexible material.
[0126] While the embodiments illustrated in FIGS. 2-3 have three
electrodes, other embodiments can include a fewer or greater number
of electrodes. For example, a two-electrode sensor can be utilized.
The sensor 14 may be externally-powered and allow a current to pass
which is proportional to the amount of analyte present.
Alternatively, the sensor 14 itself may act as a current source in
some embodiments. In some two-electrode embodiments, the sensor may
be self-biasing and there may be no need for a reference electrode.
An exemplary self-powered, two-electrode sensor is described in
U.S. patent application Ser. No. 12/393,921, filed Feb. 26, 2009,
and entitled "Self-Powered Analyte Sensor," which is hereby
incorporated by reference herein for all purposes. The level of
current provided by a self-powered sensor may be low, for example,
on the order of nanoamperes, in certain embodiments.
Insertion Assembly
[0127] Insertion assemblies are provided, which are used to install
a medical device to the subject. In some embodiments, an insertion
assembly includes an inserter and the medical device itself. The
inserter can be configured to insert various medical devices into
the subject, such as for example, an analyte sensor, an infusion
set, or a cannula. In some embodiments, the inserter can be
configured to install a combination of such devices, e.g., a
combined sensor/infusion set, etc., at the same or different times
or locations. For example, in certain embodiments a given inserter
can be configured to install a first device and a second device at
different times. In this regard, the inserter can be reusable. For
example, an inserter may be modifiable to be used with more than
one medical device, to include more than one type of medical
device, e.g., by attaching an adapter and/or detaching a portion of
an inserter. The inserter can install the medical device in, under,
or through the skin of the subject, or place the medical device on
the surface of the skin. The medical device can include features or
structures, e.g., barbs, tabs, adhesive, etc., to maintain the
device in position with respect to the skin after insertion. The
inserter device may also be used as a lancet, e.g., to pierce the
skin without inserting or installing a medical device.
[0128] In some embodiments, an insertion assembly includes an
inserter, an analyte sensor, and a power supply. The power supply
may be inserted simultaneously with the analyte sensor by the
inserter. In other embodiments, the battery is installed after or
before installation of the analyte sensor. In such case the power
supply may be applied by the inserter or separately. The power
supply may be used to provide a current or a potential to the
sensor and/or to provide power for communication of one or more
signals to the monitor unit.
[0129] In some embodiments, an insertion assembly includes an
inserter, a medical device such as an analyte sensor, and on body
electronics. The on body electronics may be deployed and/or
installed simultaneously with the analyte sensor by the inserter.
In other embodiments, the on body electronics are installed after
or before installation of the analyte sensor. For example, the
analyte sensor may be installed by the inserter, and the on body
electronics may be subsequently installed.
[0130] In some embodiments, the on body electronics provide a
voltage or current to the analyte sensor. In some embodiments, the
on body electronics process signals provided by the analyte sensor.
In further embodiments, the on body electronics may include
communications functionality for providing signal relating to
signal provided by the analyte sensor to a further component, such
as, e.g., a monitor unit, a computer, or other component. In some
embodiments, communications circuitry, such as an RFID antenna, is
provided. The power supply may be used to power some or all of
these functions. In some embodiments, power is provided from the
monitor unit, e.g., via inductive coupling.
[0131] An inserter can include a plurality of different components.
For example, an inserter may include one or more components for
advancing a sharp towards the skin of the subject. The sensor and
on body electronics may be supported by a support structure, such
as a carriage. A driver may be provided for advancing the sharp
and/or the analyte sensor/support structure. In some embodiments,
the actuator is directly or indirectly coupled to the sharp and/or
support structure, such that manual force applied by the user to
the actuator is transferred to the sharp and/or support structure.
In some embodiments, the applied force drives the sharp and/or
support structure between a retracted position (within the
inserter) and an advanced position (towards the skin of the
subject). In some embodiments, the sensor and on body electronics
is maintained in a retracted position prior to installation by
contacting projections extending inwardly from a sheath. In
accordance with this embodiment, the sensor and on body electronics
are temporarily maintained operatively between the support
structure and the projections disposed on the interior wall of the
sheath.
[0132] An inserter can also include one or more components for
retracting the sharp, while allowing the analyte sensor and
optional on body electronics to remain on the subject. The
components for retracting the sharp can include a retractor. It is
understood that the retractor and the actuator may be the same
structure or include some common components. In some embodiments,
the retractor is directly or indirectly coupled to the sharp such
that the manual force applied by the user is transferred from the
retractor to the sharp to retract the sharp from the skin. In other
embodiments, a drive assembly may be provided to retract the sharp.
For example, the drive assembly may include a spring, motor,
hydraulic piston, etc., to retract the sharp away from the skin of
the subject. The drive assembly may also include a linear drive
component.
[0133] In some embodiments, the retractor withdraws the sharp upon
actuation by the user. In such cases, the user actuates the
retractor when it is desired to withdraw the sharp. For example,
the retractor may include a release switch. Upon activation of the
release switch, the drive assembly, e.g., the spring or other
driver, retracts the sharp from the skin. In other embodiments, the
retractor and the actuator include common components. After
activating the actuator to advance the sharp and the analyte
sensor, the user releases the actuator, which allows the drive
assembly to withdraw the sharp from the skin.
[0134] In some embodiments, the retractor withdraws the sharp
without further user interaction after actuation of insertion. For
example, the inserter may include features or components which
automatically retract the sharp upon advancement of the sharp and
support structure by a predetermined amount. Inserter devices, in
which no further action by the user is required to initiate
withdrawal of the sharp after insertion, are referred to herein as
having "automatic" withdrawal of the sharp.
Inserter Devices
[0135] One embodiment of a needle hub for an inserter is
illustrated in FIGS. 4-5. Needle hub 136 supports sharp 124, having
a sharpened distal portion 160. In some embodiments, as discussed
herein, a longitudinal wall opening or gap 162 is provided in at
least a portion of the wall of the sharp 124. The length N of the
gap 162 is selected to be commensurate with the length of the
insertion portion 30 through to the proximal retention portion 48
of the sensor, and in certain embodiments may be about 3 mm to
about 50 mm, e.g., about 5 mm, or about 10 mm, or about 15 mm, or
about 20 mm. The length L of the sharp 124 may be about 3 mm to
about 50 mm, e.g., 5 mm or more, or about 10 mm, or about 20 mm, or
about 30 mm, or about 50 mm, and is selected based upon the length
of the insertion portion 30 of a sensor and the desired depth of
the insertion portion 30 of the sensor 14. In some embodiments, the
distance or spacing between the two edges of the gap is about 0.2
mm to about 0.5 mm, e.g., about 0.22 mm, about 0.25 mm, etc.
[0136] The distal portion 160 of sharp 124 is illustrated in
greater detail in FIGS. 6-8. As illustrated in FIG. 6, sharp 124
has a substantially "C"- or "U"-shaped profile in this embodiment,
but may have other configurations, e.g., substantially "V"-shaped.
A longitudinal gap 162 is provided in the wall of the sharp 124.
FIG. 7 illustrates distal portion 160 is provided with an angled
tip. In some embodiments, the angled tip may be provided with a
first angled tip portion 164 and a second steep-angled tip portion
166. The exemplary configuration, which includes multiple edges and
faces, provides a sharp point to reduce penetration force, trauma,
and bleeding for the subject. The distal section of the sensor body
has a width sized to fit within the gap 162 of the insertion sharp
124 having a diameter less than about 20 to about 26 gauge, e.g.,
21 gauge to about 25 gauge, where in certain embodiments the sharp
is 21 gauge or 23 gauge or 25 gauge. Such sharp may be used with a
sensor having a width or diameter--at least the portion that is
carried by the sharp--of about 0.20 mm to about 0.80 mm, e.g.,
about 0.25 mm to about 0.60 mm, where in some embodiments the width
or diameter of at least a portion of a sensor is 0.27 mm or 0.33 mm
or 0.58 mm. In some embodiments, sharp 124 is fabricated from a
sheet of metal and folded into a substantially "V," "U" or "C"
configuration in cross-section. Various technologies can be used to
manufacture a folded sheet of metal to form sharp 124. For example,
etched-sheet metal technology can be used to form the sharp 124. In
this manner, the sharp can be formed having a very sharp edge so
that penetration through the skin during insertion is less painful.
In other embodiments, a progressive die technology may be utilized
to form a complex sheet-metal shape that has a sharp edge as
depicted in FIG. 9. In some embodiments, the sharp 124 can be
molded with a plastic cap so that the sharp can be handled during
the inserter assembly process. Further, the die cut sharp may be
molded with plastic to reinforce the "V," "U" or "C" shaped sheet
metal configuration. In other embodiments, a laser-cut sharp can be
formed. In this manner, the laser can be used to form the wall
opening or gap 162 and first-angled tip portion 164 and a second,
steep-angled tip portion 166.
[0137] In another embodiment, a sharp 124 may be formed from a
standard hypodermic needle utilizing the method depicted in FIG.
10. First, the hypodermic needle (having a circular cross-section)
is cut to the desired length for sharp 124. Next, the hypodermic
needle is compressed so that its cross-section is permanently
deformed from a circular shape to an oval shape. The tip of the
hypodermic needle is then ground to a bevel to produce a sharp
point to reduce the required penetration force, as previously
discussed. Finally, the top section of the needle is removed by
appropriate techniques (e.g., grinding, electropolishing, etc.).
The resulting sharp 124 has a "U"-shaped configuration and provides
ample space for the insertion of sensor 14. In some embodiments,
the tip-grinding step and the compression step may be carried out
in reversed order.
[0138] Due to the compression step, a user may initially start with
a larger diameter hypodermic needle so that the finished sharp 124
will have similar dimensions to the previously described
sharps.
[0139] FIGS. 11-12 illustrate the position of on body housing 122
with respect to the needle hub 136 and sharp 124. The on body
housing 122 can be configured to hold at least a portion of sensor
14 and sensor control unit 12. As illustrated in FIG. 11, the sharp
124 extends through an aperture 168 in the on body housing 122.
Thus, in some embodiments, the sharp 124 is uncoupled to on body
housing 122. The distal portion of sensor 14 is positioned within
the sharp 124. As further illustrated in FIG. 12, electronics 80 of
the sensor control unit 12 (e.g., a printed circuit board
containing electronics components of the on body unit 16) and
sensor hub 123 are positioned within on body housing 122. Sensor 14
may include a positioning structure, or slit 127, which receives a
positioning member, such as tab 129 of sensor hub 123. A power
supply 82, such as a battery, e.g., a single-use disposable battery
or rechargeable battery, is provided. The power supply 82 is used
to provide potential or current to the sensor in some embodiments.
In embodiments where a passive communications protocol such as
passive RFID is used, no power supply is provided for the
communications. Such power is provided by the monitor unit 18. In
some embodiments, where the sensor control unit is used to transmit
one or more signals, one or more power supplies may be used to
provide power for such communications circuitry. In some
embodiments, the active operational life of the battery may exceed
the active operational life of the sensor 14.
[0140] FIG. 13 illustrates in cross-section the orientation of the
on body housing 122 with respect to the sharp 124 of an inserter,
such as inserter 500 depicted in FIGS. 14-17. As discussed herein,
sensor 14 is disposed in a substantially bent configuration in some
embodiments, such that a portion of the sensor, e.g., the insertion
portion 30 and the proximal retention portion 48, are substantially
vertical (i.e., substantially aligned with the longitudinal axis of
an inserter and substantially perpendicular to the skin surface)
and the contact portion 32 (shown in profile) is oriented in a
substantially horizontal configuration, and in electrical contact
with the data-processing unit electronics, such as circuit 80. The
sensor tab 50 can be encased in the plastic of the on body housing
122 ("overmolded") and secured in place. The notch 56 provides
further stability to the sensor 14, e.g., by allowing the sensor
tab 50 to be encased by the material of the on body housing 122,
and further provides a means for vertically orienting the sensor 14
during mounting, by allowing vertical positioning of the notch 56
with respect to a vertical landmark of the on body housing 122.
[0141] The sensor 14, mounted with the on body housing 122, can be
disposed within a recess of the carriage 130 such as a concave
recess in the carriage 130. Alternatively, the sensor 14, mounted
with the on body housing 122, can be disposed between the support
structure and one or more projections extending from the wall of
the sheath. In yet another alternative, the sensor 14, mounted with
the on body housing 122, can be held in position by a releasable
friction fit coupling to the sharp 124. In this manner, the
carriage need not have a recess within which the sensor mounted
with the sensor housing is disposed. In the initial configuration
of the inserter, the sharp 124 extends through a longitudinal
aperture 168 formed in a carriage 130. In some embodiments, the
aperture 168 is appropriately sized, such that neither the sharp
124 nor needle hub 136 is in contact with the carriage 130.
Accordingly, the needle hub 136 (and sharp 124) on the one hand,
and the carriage 130 (FIG. 13) and the on body housing 122, on the
other hand, move simultaneously but independently from one another.
In other embodiments, a friction fit may be provided between the
aperture and the sharp.
[0142] The insertion portion 30 and proximal retention portion 48
of the sensor 14 are disposed within a longitudinal bore 162 within
the sharp 124 (See, e.g., FIG. 6). The proximal retention portion
48 is disposed within the longitudinal bore of the sharp 124 and
provides additional stability to the mounting of the sensor 14
within the sharp 124. The longitudinal wall gap or opening 162 of
sharp 124 is aligned with the sensor 14, such that the tab 50 and
the contact portion 32 extend laterally outward from the sharp
124.
[0143] An embodiment of an inserter is illustrated in FIGS. 14-17
and is designated inserter 500. In some embodiments, inserter 500
has a maximum diameter of about 30 mm to about 60 mm, e.g., about
40 mm, about 43 mm, about 43.5 mm, about 50.5 mm, about 54.5 mm,
etc. In some embodiments, inserter 500 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
50 mm, about 53 mm, about 67 mm, about 71 mm, etc. In some
embodiments, inserter 500 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. The maximum height is
measured from actuator 514 to the distal surface 512 of sheath 542.
The volume is measured as the bellows portion 502 and the portion
of the sheath 542 that protrudes from bellows portion 502.
[0144] Inserter 500 includes, a bellows portion 502, a sheath 542,
and a removable distal cap 504 for maintaining a sterile
environment for the medical device and sharp housed therein. As
illustrated in FIG. 15, distal cap 504 is shown removed from sheath
542. Sheath 542 defines a distal surface 512 for placement on the
skin of a subject. Inserter 500 may be utilized to advance a
medical device into the skin of the subject. In some embodiments,
bellows portion 502 is compressed in order to advance the medical
device into the skin of the subject. Bellows portion 502 includes a
series of concentric folds, including raised portions 516 and
folded portions 518.
[0145] Inserter 500 is illustrated in cross-sectional view in FIG.
16 prior to use and prior to removal of cap 504, which is attached
to sheath 542 via inter-engagement of threads 510 on sheath and
threads on cap 504. Cap 504 includes a desiccant tablet 590. Cap
504 may further include a receptacle for maintaining the position
of the sharp 524 within the sheath 542 prior to use.
[0146] As illustrated in FIG. 16, the inserter 500 includes an
initial configuration in which the bellows portion 502 is disposed
in a relaxed, extended position. In such configuration, the sharp
524 is disposed in a position spaced apart from the aperture 520 of
the adhesive layer 518. The proximal end portion of the bellows
portion 502 includes a button or actuator portion 514. Extending
distally from the actuator portion 514 are side walls 528 and
needle hub 536. Downward force on the actuator portion 514 causes a
downward force on the needle hub 536 and on the carriage 530
(through coupling to side walls 528). Carriage 530 includes a
recess 532 for reception of the on body housing 122 therein.
Additionally, carriage 530 includes laterally acting spring arms
that engage detent features on the on body housing 122 periphery
and allow for easy release of on body housing 122 upon completion
of insertion. Sharp 524 extends longitudinally from needle hub 536
within the inserter 500. In some embodiments, the sharp is
supported at an oblique angle, between about 0.degree. and
90.degree. with respect to the skin surface.
[0147] FIG. 17 illustrates inserter 500 in cross-section during
insertion. Depression of bellows portion 502 with respect to sheath
542 against the bias of spring 546 causes distal longitudinal
movement of the carriage 530 and sharp 524 from a proximal position
toward a distal position. During such downward, proximal movement,
spring 546 is compressed between an upper (proximal) portion
adjacent to actuator 514 and a lower (distal) portion adjacent to
sheath 542. As the sharp 524 is urged distally, it carries the
sensor insertion portion 30 of sensor 14 (FIG. 12) into the
subcutaneous portion of the subject's skin S. In some embodiments,
a layer of adhesive between carriage 530 and sheath 542 may be
used, requiring the user to exceed a minimum force threshold to
break the adhesive bond, thus allowing distal motion of carriage to
occur.
[0148] By removing downward force on the actuator portion 514, the
bias of spring 546 provides an upward (proximal) force, which
permits sharp 524 to withdraw from the skin S of the subject. In
some embodiments, bellows 502 may provide the entire upward
(proximal) force to withdraw sharp 524 from the skin S.
[0149] An exemplary driver apparatus is illustrated in FIGS. 18-24
and designated driver apparatus 3600. It is understood that driver
apparatus 3600 as described herein (as well as driver apparatuses
3700, 3800, 3900, and 4000) is designed for use with any inserter
described herein, such as, e.g., inserter 500 (see FIGS. 14-17) or
alternatively inserter 2400 (see FIGS. 44-58). Moreover, in certain
embodiments, driver apparatus 3600 (and 3700, 3800, 3900, and 4000)
may be configured for use with any inserter apparatus which
includes an actuator button or driver for advancing a medical
device at least partially into the skin of a patient. Thus,
although driver apparatus 3600 (and 3700) is illustrated in
cooperation with inserter 500, it is understood that such
combination of devices is not intended to encompass all
combinations of driver apparatuses and inserters. Similarly,
although driver apparatus 3900 (and 4000) is illustrated with
inserter 2400, it is understood that such combination of devices is
not intended to encompass all combinations of driver apparatuses
and inserters. For example, the driver apparatuses disclosed herein
provide, among other features, a "button pushing" capability in
which the driver apparatus which may be coupled to the actuator
button or driver of the inserter to which the driver apparatus is
attached.
[0150] Another feature of the driver apparatuses described herein
is modularity. In some embodiments, the driver apparatus and the
inserter may each be capable of independent operation. For example,
the inserter may include an actuator button or switch to advance
the medical device into the skin of the patient without use of the
driver apparatus. The driver apparatus, to the extent provides an
actuation capability, may be used with any inserter which has an
actuation button that may be contacted by the driver of the driver
apparatus. In some embodiments, the modularity allows the driver
apparatus to be designed for multiple uses, and the inserter device
is capable of a single use. In other embodiments, the inserter is
also capable of multiple uses, for example, by replacing the sensor
and/or on body housing with each use.
[0151] Driver apparatus 3600 includes a housing 3602 for
positioning with respect to an inserter. A loading element
3604--longitudinally movable with respect to housing 3602--is
provided. In some embodiments, driver apparatus 3600 is provided
with an actuator, e.g., rotating cam 3606, which provides automatic
actuation of an inserter. In use, arming button 3620 is pressed (in
direction of arrow E) to connect rack 3610 with pinion 3612 (FIG.
18). As illustrated in FIG. 18, once arming button 3620 is pressed,
loading element 3604 is depressed downwardly (direction of arrow D)
to rotate cam 3606 in a first direction F against the bias of
torsion spring 3614. Firing button 3618 maintains the spring in the
loaded position until pressed.
[0152] As illustrated in FIG. 20, the driver apparatus 3600 is
positioned with respect to an inserter 500. Although inserter 500
is illustrated in FIGS. 20-24, it is understood that any inserter
may be used with driver apparatus 3600. In some embodiments, the
dimensions of the housing 3602 and the location and shape of cam
3606 are selected to interact with the dimensions of the inserter.
For example, the housing 3602 may be designed for snap-fit or
friction-fit cooperation of bottom edge 3608 with the sheath 542 of
inserter 500.
[0153] As illustrated in FIG. 21, cap 504 of inserter 500 is
removed (not shown), thereby allowing placement of adhesive 518
(not shown) on the skin of the subject. To insert sharp 524 (not
shown), release button 3618 may be depressed (arrow H).
[0154] FIGS. 22-24 illustrate the sequence of motions of the driver
apparatus 3600 to drive sharp 524 into the skin of the subject. As
illustrated in FIG. 22, upon depressing release button 3618,
torsion spring 3614 is released, thereby driving rotation of cam
3606 in the direction J with the bias of the torsion spring 3614.
Cam 3606 includes a surface having a protrusion 3607. As
illustrated in FIG. 23, further rotation of cam 3606 causes
protrusion 3607 to engage actuator button 514 of inserter 500.
Consequently, bellows 502 and spring 546 are compressed, and needle
hub 536 and carriage 530 are advanced distally (downwardly towards
the skin of the subject (Not shown in FIGS. 22-24. See, e.g., FIG.
16)). Sharp 524 containing sensor 14 therein is driven into the
skin of the subject and on body housing 122 is adhered to the
adhesive 518 (not shown). Further unwinding of the torsion spring
causes the cam 3606 to further rotate, which results in protrusion
3607 being spaced from the actuator button 514, as illustrated in
FIG. 24. As a result, the spring bias of retraction spring 546 (not
shown) returns bellows 502 to its expanded configuration, and
retracts the sharp 524 from the skin of the subject, leaving the
sensor at least partially implanted in the skin.
[0155] Another exemplary driver apparatus for actuation of
inserters is illustrated in FIGS. 25-31 and designated driver
apparatus 3700. In some embodiments, driver apparatus 3700 is a
reusable apparatus, whereas the inserter may be a disposable
device. Driver apparatus 3700 is substantially identical to driver
apparatus 3600, with the substantial differences noted herein and
indicated in the accompanying figures.
[0156] As illustrated in FIGS. 25 and 26, driver apparatus 3700
includes a housing 3702, which includes bottom edge 3708, for
positioning with respect to an inserter. A loading element
3704--longitudinally movable with respect to an upper housing
3705--is provided. In some embodiments, actuator 3706 is a
reciprocal element that provides automatic actuation of an
inserter. In use, loading element 3704 is advanced laterally
(direction of arrow K) along a track 3710 against the normal bias
of a drive spring 3714. Upon loading of the drive spring 3714, a
locking mechanism 3718 maintains the loading of spring 3714.
[0157] As illustrated in FIG. 27, the driver apparatus 3700 is
positioned with respect to an inserter 500. Although inserter 500
is illustrated in FIGS. 27-31, it is understood that any inserters
may be used with driver apparatus 3700. As illustrated in FIG. 28,
cap 504 of inserter 500 is removed (not shown), thereby allowing
placement of adhesive 518 (not shown) on the skin of the subject.
To insert the sharp 524 (not shown), release button 3718 may be
depressed (arrow L).
[0158] FIGS. 29-31 illustrate the sequence of motions of the driver
apparatus 3700 to drive the sharp 524 into the skin of the subject
(see FIG. 16). As illustrated in FIGS. 29-31, upon depressing
release button 3718, drive spring 3714 is released, thereby driving
sliding member 3707 in the direction M with the bias of the spring
3714. Sliding member 3707 is restrained to lateral motion due its
positioning in track 3710. Similarly, actuator 3706 is restrained
to longitudinal motion due to its positioning in track 3709.
Sliding member 3707 is coupled to actuator 3706 by a crank member
3720, which is pivotally connected to one end to sliding member
3707 and at the other end to actuator 3706. As illustrated in FIG.
30, further lateral movement of sliding member 3707 causes the
actuator 3706 to advance distally and to engage the actuator button
514 of inserter 500. Consequently, bellows 502 (not shown) is
compressed and needle hub 536 and carriage 530 are advanced
distally, thereby driving sharp 524 into the skin of the subject
and adhering on body housing 122 (see FIG. 16) to the adhesive 518
(not shown). See, e.g., FIG. 16, for adhesive 518. Further lateral
movement of sliding member 3707 causes the actuator 3706 to advance
proximally, as illustrated in FIG. 31. As a result, the spring bias
of retraction spring 546 (See, e.g., FIG. 16) returns bellows 502
to its expanded configuration, and retracts the sharp 524 from the
skin of the subject.
[0159] A driver apparatus for actuation of inserters is illustrated
in FIGS. 32-43 and designated driver apparatus 3800. In some
embodiments, driver apparatus 3800 is a reusable apparatus, whereas
the inserter may be inserter 500 described herein. Driver apparatus
3800 is substantially identical to actuators 3600 and 3700, with
the substantial differences noted herein and indicated in the
accompanying figures.
[0160] As illustrated in FIGS. 32 and 33, driver apparatus 3800
includes a housing 3802 for positioning with respect to an
inserter, such as inserter 500 described herein. A loading element
3804 is provided which is longitudinally movable with respect to
housing 3802. Depression of the loading element causes a rotor 3808
to rotate against the bias of a torsion spring (not shown). A
locking element (not shown) maintains the loading of the torsion
spring.
[0161] An enhanced view of the actuation of driver apparatus 3800
is depicted in FIGS. 34-43. As depicted in FIG. 34, driver
apparatus 3800 includes trigger 3810, cam 3808, arming button 3812,
torsion spring 3814, shaft 3816, pawl 3818, actuator 3806, and
return spring 3820. To arm driver apparatus 3800, loading element
3804 (not shown) is pressed, causing arming button 3812 to be
pushed down, winding shaft 3816 and thus torsion spring 3814 (FIG.
35). Pawl 3818 locks shaft 3816 into place (FIG. 36). After a user
depresses loading element 3804, arming button 3812 returns to its
original position while shaft 3816 is held in place by pawl 3818
(FIG. 37).
[0162] In order to actuate driver apparatus 3800, a user again
pushes loading element 3804. This causes trigger 3810 to move in a
downward motion, causing cam 3808 to be released. In some
embodiments, loading element 3804 is used to alternately depress
arming button 3812 and trigger 3810. Cam 3808 is then driven
forward by torsion spring 3814 (FIG. 38). In some embodiments, a
first loading element is used to depress arming button 3812, and a
second loading element is used to depress trigger 3810 (not
shown).
[0163] As cam 3808 rotates, it pushes down on actuator 3806 (FIGS.
39-40). At the end of the stroke, there is a slight dwell. This
allows the sensor body to be held and pressed onto the adhesive
skin patch (FIG. 41). After a full rotation, cam 3808 is stopped by
trigger 3810 as shown in FIG. 43. Return spring 3820 pushes
actuator 3806 back up, releasing pressure on the inserter. When
trigger 3810 is released by the subject, cam 3808 continues to
rotate until it is in the home position, thereby allowing driver
apparatus 3800 to be used again (FIG. 43).
[0164] With continued reference to FIG. 33, inserter 500 supports
an on body housing 122 and sensor 14. A sharp (not shown) is used
to advance the sensor into the skin of the patient. Actuator 3806
contacts actuator 114 (substantially identical to actuator 514) of
inserter 500 to drive the sharp and sensor downward towards the
subject's skin.
[0165] An inserter 2400 in accordance with another exemplary
embodiment is illustrated in FIG. 44. In some embodiments, inserter
2400 has a maximum diameter of about 30 mm to about 60 mm, e.g.,
about 40 mm, about 43 mm, about 43.5 mm, about 50.5 mm, about 54.5
mm, etc. In some embodiments, inserter 2400 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
50 mm, about 53 mm, about 67 mm, about 71 mm, etc. In some
embodiments, inserter 2400 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. The maximum height is
measured from top of housing 2402 to the bottom of housing 2402.
The volume is measured as the volume of housing portion 2402.
[0166] With reference to FIG. 44, inserter 2400 includes a housing
2402 and a removable distal cap 2412 for protecting the medical
device and sharp housed therein. Housing 2402 and distal cap 2412
may be fabricated from any suitable materials such as metal,
plastic, etc. In some embodiments, cap 2412 may be fabricated from
a polymer or plastic material.
[0167] An exploded view of the components of inserter 2400 is
illustrated in FIG. 45. As shown, inserter 2400 generally comprises
plunger 2405, spring 2406, housing 2402, sharp 2404, on body
housing 122, sharp holder 2408, adhesive patch 218, and cap 2412
when fully assembled.
[0168] A more detailed view of sharp holder 2408 is shown in FIG.
46. Needle holder 2408 retains sharp 2404 in a fixed position with
respect to itself within inserter 2400, thereby allowing it to
safely penetrate a subject's skin during later use.
[0169] To assemble inserter 2400, sharp 2404 is inserted through an
opening in on body housing 122 as shown in FIG. 47. Needle holder
2408 prevents sharp 2404 from being fully inserted through on body
housing 122. In some embodiments, on body housing 122 includes an
analyte sensor 14 and a sensor control unit.
[0170] Next, plunger 2405, spring 2406, and housing 2402 are
assembled as shown in FIGS. 48-50. Plunger 2405 contains a spring
retention member which is inserted through the center of spring
2406. Lip 2414 of plunger 2405 engages inner wall 2416 (not shown)
of housing 2402 when assembled (FIG. 44). This causes spring 2406
to be contained between lip 2418 of housing member 2402 and the
bottom surface 2424 (not shown) of plunger 2405. The resulting
sub-assembly of inserter 2400 allows plunger 2405 to move between a
proximal position, with spring 2406 fully extended, and a distal
position, wherein bottom surface 2424 engages wall 2426 of housing
2402.
[0171] The sensor housing assembly shown in FIG. 47 is then
inserted into the inserter sub-assembly shown in FIGS. 48-50. As
shown in FIG. 50, on body housing 122 is inserted into housing 2402
with the tip of sharp 2404 pointing away from plunger 2405. The
resulting assembly is depicted in FIG. 51. As shown in FIG. 44,
grooves on sharp holder 2408 engage tabs 2422 on plunger 2405. The
on body housing 122 is axially retained in the housing 2402 by the
housing arms detent features 2440 (not shown).
[0172] Finally, adhesive patch 218 is placed over the opening of
housing 2402 and cap 2412 is snap fit over housing 2402 as shown in
FIG. 52. The fully assembled inserter 2400 is depicted in FIG. 53.
In some embodiments, adhesive pad 218 has an adhesive material on
both faces. A central aperture 220 may be provided in adhesive pad
218 to allow sharp 2404 to be deployed into the skin of a subject.
During insertion, sharp 2404 passes through aperture 220 and into
the skin of the subject carrying at least the sensor with it.
[0173] FIG. 54 illustrates inserter 2400 in cross-section, in an
initial configuration prior to use, after removal of the distal cap
2412. As shown, sharp 2404 extends longitudinally within the
inserter 2400. In some embodiments, sharp 2404 is supported at an
oblique angle, e.g., between about 0.degree. and 90.degree. with
respect to the skin surface.
[0174] In some embodiments, sharp 2404 is a solid needle. In some
embodiments, sharp 2404 is provided with a substantially
cylindrical configuration defining an interior bore, e.g., a rigid
cylindrical member or a hypodermic-style needle. Sharp 2404 may
also be provided with an elongated longitudinal opening or gap in
the wall. In some embodiments, sharp 2404 is fabricated from a
sheet of metal and folded into a substantially "V," "U" or "C"
configuration in cross-section to define the longitudinal
recess.
[0175] Depression of plunger 2405 causes distal longitudinal
movement of on body housing 122 and sharp 2404 from a proximal
position to a distal position. During such downward, distal
movement, spring 2406 is further compressed between lip 2418 and
bottom surface 2424. Detent 2440 provides a minimum force threshold
to overcome before on body housing 122 can continue on its downward
distal movement. Beyond a minimum force threshold, detent 2440 is
pushed outward by on body housing 122, and on body housing 122 then
transitions onto ramp 2442. The friction between on body housing
122 and ramp 2442 of the housing hold the on body housing 122 up
against plunger 2405.
[0176] As illustrated in FIG. 55, depression of plunger 2405
advances the inserter 2400 from an initial configuration to a
deployed configuration. Contact of plunger 2405 and hub 2408 during
depression of plunger 2405 imposes a downward force and
consequential distal movement of sharp 2404. As the sharp 2404 is
urged distally, it carries the sensor insertion portion 30 into the
subcutaneous portion of the subject's skin S (not shown). Contact
of plunger 2405 and on body housing 122 during depression of
plunger 2405 imposes a downward force and consequential distal
movement of on body housing 122. Lip features 2414 of plunger 2405
maintain parallelism of on body housing 122 to subject skin S
during distal movement.
[0177] When plunger 2405 reaches a distal position, as shown in
FIG. 56, bottom surface 2424 engages wall 2426 and prevents further
downward movement. The distal (lower) surface of on body housing
122 engages the upper surface of adhesive pad 218, thereby becoming
adhered to the skin surface S of the subject.
[0178] As the subject or some apparatus removes force from plunger
2405, spring 2406 urges plunger 2405 toward its proximal position
as shown in FIG. 57, leaving on body housing 122 adhered to the
skin surface S of the subject. Tabs 2427 (not shown) provide
additional force on on body housing 122 to assist holding it to
adhesive patch 218 while the sharp 2404 is withdrawn through on
body housing 122. Eventually, the upward force exerted by spring
2406 returns inserter 2400 to its initial configuration as
illustrated in FIG. 58.
[0179] In some embodiments, inserter 2400 may be distributed in a
sterilized package 2480 as depicted in FIG. 59. To use inserter
2400 in this configuration, a user would first clean the insertion
site on the skin with alcohol. The subject would then remove
inserter 2400 from sterilized package 2480 as shown in step 1. Next
a subject would place the inserter on the insertion site and push
down on plunger 2405 until on body housing 122 is adhered to the
subject's skin as shown in steps 2-3. The subject would then
release the plunger 2405. Finally, the subject would remove
inserter 2400 from the insertion site and dispose of the
inserter.
[0180] In another embodiment, the sterilized inserter 2400 shown in
FIG. 59 may be utilized with driver apparatus 3900 (FIGS. 61-79) as
shown in FIG. 60. In this manner, insertion of sensor housing unit
is semi-automated which may deliver a more consistent user
experience and reduce the risk of user error. An exemplary driver
apparatus is illustrated in FIGS. 61-79 and designated driver
apparatus 3900.
[0181] Driver apparatus 3900 includes a housing 3902 for
positioning with respect to an inserter. A release button
3904--longitudinally movable with respect to housing 3902--is
provided. The force exerted by return spring 3906 allows release
button 3904 to be moved between a proximal and distal position, as
shown in FIGS. 62-65.
[0182] As illustrated in FIG. 61, the driver apparatus 3900 is
positioned with respect to an inserter 2400. Although inserter 2400
is illustrated in FIGS. 44-60, it is understood that any inserter
may be used with driver apparatus 3900. Since driver apparatus 3900
and the appropriate inserter may be modular, the dimensions of the
housing 3902 and the location and shape of release button 3904 are
selected to interact with the dimensions of the inserter. For
example, the housing 3902 may be designed for snap-fit or
friction-fit cooperation with the sheath 2402 of inserter 2400.
[0183] FIGS. 62-65 illustrate the sequence of motions of the driver
apparatus 3900 to drive sharp 2404 into the skin of the subject.
FIG. 62 illustrates driver apparatus 3900 before firing. As shown,
driver apparatus 3900 comprises housing 3902, release button 3904,
return spring 3906, driver spring 3908, and plunger 3910.
Three-dimensional perspective views of housing 3902, plunger 3910,
release button 3904, are depicted in FIGS. 67-69, respectively.
Release button 3904 comprises tabs 3912 which engage lip 3914 on
housing 3902 which prevent the upward force of return spring 3906
from disengaging release button 3904 and housing 3902 (see FIG.
66). Release button 3904 also comprises protrusion 3918.
[0184] Plunger 3910 comprises tabs 3916 (not shown) which confine
plunger 3910 to housing 3902. Driver spring 3908 is disposed
between the bottom of release button 3904 and the top of plunger
3910. Alternatively, the driver spring 3908 could be around the
post shown of plunger 3910 and compressed by the cylinder of button
3904.
[0185] As illustrated in FIG. 63, upon depressing release button
3904 towards housing 3902, return spring 3906 and drive spring 3908
become compressed. Concurrently, protrusion 3918 causes tab 3916 to
become disengaged from housing 3902. This allows drive spring 3908
to advance plunger 3910 towards inserter 3900 as shown in FIG. 64.
Sharp 2404 which contains sensor therein is driven into the skin of
the subject and on body housing 122 is adhered to adhesive pad
118.
[0186] As the subject releases pressure on the button 3904, the
return spring 3906 pushes it back to its initial position. As the
button 3904 returns, the arms of the button pull the arms of the
plunger 3910 back to its initial position, automatically
re-engaging the tabs 3916 with the housing 3902 (FIG. 65). The
sensor remains inserted in the subject's skin.
[0187] An exemplary driver apparatus is illustrated in FIGS. 70-79
and designated driver apparatus 4000.
[0188] Driver apparatus 4000 includes a housing 4004 for
positioning with respect to an inserter. An outer button
4002--longitudinally movable with respect to housing 4004--is
provided. The force exerted by a return spring (not shown) located
between housing 4004 and outer button 4002 allows outer button 3904
to be moved between a proximal and distal position, as shown in
FIGS. 73-79.
[0189] As illustrated in FIG. 70, the driver apparatus 4000 is
positioned on top of inserter 2400. Although inserter 2400 is
illustrated in FIGS. 44-58, it is understood that any inserter may
be used with driver apparatus 4000. Since driver apparatus 4000 and
the appropriate inserter may be modular, the dimensions of the
housing 4004 and the location and shape of cam release button 3904
are selected to interact with the dimensions of the inserter. For
example, the housing 4004 may be designed for snap-fit or
friction-fit cooperation with the sheath of inserter 2400.
[0190] FIG. 71 illustrates an exploded view of the components of
driver apparatus 4000. As shown, driver apparatus 4000 comprises
outer button 4002, return spring 4006, inner button 4008, housing
4004, drive spring 4010, and plunger 4012. The assembled driver
apparatus 4000 is shown in FIG. 72, wherein some components are
partially transparent for clarity.
[0191] FIGS. 73-79 illustrate the sequence of motions of the driver
apparatus 4000 to drive sharp 2404 into the skin of the subject.
FIG. 73 illustrates driver apparatus 4000 before firing. When
assembled, return spring 4006 is encapsulated between outer button
4002 and housing 4004.
[0192] Similarly, drive spring 4010 is encapsulated between the
bottom of inner button 4008 and surface 4020 located on plunger
4012.
[0193] Outer button 4002 comprises guides 4013 which lock inner
button 4008 in position using tabs 4022. Inner button 4008
comprises rails 4015 which allow outer button 4002 to move with
respect to housing 4004.
[0194] Plunger 4012 comprises tabs 4014 which allow it to be fit
into and retained within inner button 4008. Furthermore, plunger
4012 comprises arms 4016 having appendages 4018 with openings that
engage ledge 4017 on housing 4004.
[0195] To actuate driver apparatus 4000, a subject pushes down on
outer button 4002 in the direction of the subject's skin causing
return spring 4006 and driver spring 4010 to become compressed as
illustrated in FIG. 75. Eventually, tabs 4019 located on inner
button 4008 cause appendages 4018 to be pushed off ledge 4017 as
shown in FIG. 76.
[0196] The displacement of appendages 4018 from ledge 4017 allows
drive spring 4010 to drive plunger 4012 towards plunger 2405 of
inserter 2400 as shown in FIG. 76. Eventually, sharp 2404 is driven
into the skin of the subject and on body housing 122 is adhered to
the subject as shown in FIG. 77. If there is no inserter 2400
present, the plunger eventually stops its forward motion when the
plunger arms engage ledge 4017 or when tabs 4014 engage inner
button 4008.
[0197] To remove sharp 2404 from the subject's skin, the subject
must remove pressure from outer button 4002 which allows return
spring 4006 to exert upward pressure on outer housing 4004 as shown
in FIG. 78. The guides 4013 pull up the inner button through rails
4015. Inner button 4008 pulls up plunger 4012 by tabs 4014. The
plunger 4012 is pulled up far enough to re-engage appendages 4018
on ledge 4017. This makes the inserter instantly ready to be
re-used with no additional steps. Concurrently, the return spring
located in inserter 2400 retracts sharp 2404 from the subject's
skin. Return spring 4006 eventually returns driver apparatus 4000
to its original configuration, as shown in FIG. 79.
[0198] It is understood that the subject matter described herein is
not limited to particular embodiments described, as such may, of
course, vary. It is also understood that the terminology used
herein is for the purpose of describing particular embodiments
only, and is not intended to be limiting, since the scope of the
present subject matter is limited only by the appended claims.
* * * * *