U.S. patent application number 14/509985 was filed with the patent office on 2015-01-22 for medical device inserters and processes of inserting and using medical devices.
This patent application is currently assigned to Abbott Diabetes Care Inc.. The applicant listed for this patent is Abbott Diabetes Care Inc.. Invention is credited to Daniel H. Lee, Michael Love, Louis George Pace, Phillip Yee.
Application Number | 20150025338 14/509985 |
Document ID | / |
Family ID | 44673643 |
Filed Date | 2015-01-22 |
United States Patent
Application |
20150025338 |
Kind Code |
A1 |
Lee; Daniel H. ; et
al. |
January 22, 2015 |
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: |
Lee; Daniel H.; (Burlingame,
CA) ; Love; Michael; (Pleasanton, CA) ; Pace;
Louis George; (San Carlos, CA) ; Yee; Phillip;
(San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Diabetes Care Inc. |
Alameda |
CA |
US |
|
|
Assignee: |
Abbott Diabetes Care Inc.
Alameda
CA
|
Family ID: |
44673643 |
Appl. No.: |
14/509985 |
Filed: |
October 8, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13071497 |
Mar 24, 2011 |
|
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14509985 |
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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: |
600/309 |
Current CPC
Class: |
A61B 5/14503 20130101;
A61B 5/1513 20130101; A61B 5/150282 20130101; A61B 5/14542
20130101; A61B 5/150732 20130101; A61B 5/01 20130101; A61B 5/14532
20130101; A61B 5/1411 20130101; A61B 5/15117 20130101; A61B
5/150419 20130101; A61B 5/15194 20130101; A61B 5/14546 20130101;
A61B 5/150396 20130101; A61B 5/150427 20130101; A61B 5/150511
20130101; A61B 5/1519 20130101; A61B 5/150259 20130101; A61B 5/0002
20130101; A61B 5/15186 20130101; A61B 5/15113 20130101; A61B
5/15016 20130101; A61B 5/15107 20130101; A61B 5/150022 20130101;
A61B 5/157 20130101; A61B 5/6865 20130101; A61B 17/34 20130101;
A61B 5/15087 20130101; A61M 2005/1585 20130101; A61M 5/158
20130101 |
Class at
Publication: |
600/309 |
International
Class: |
A61B 5/145 20060101
A61B005/145 |
Claims
1-10. (canceled)
11. A device for applying an on-skin sensor assembly to skin of a
host, the device comprising: a base configured to secure a housing,
wherein the housing is configured to receive an electronics unit,
wherein the electronics unit is configured to generate analyte
information based on a signal from a sensor; a sensor insertion
mechanism configured to insert the sensor into the host; and a
trigger configured, in response to being activated, to cause the
sensor insertion mechanism to insert the sensor into the host, to
secure the electronics unit to the housing such that the sensor
electrically contacts the electronics unit, and to cause the
housing to detach from the base.
12. The device of claim 11, wherein the electronics unit is
configured, in response to the trigger being activated and/or the
electrical connection of the sensor to the electronics unit, to
generate analyte information.
13. The device of claim 11, wherein the housing is configured such
that the electronics unit cannot be removed from the housing while
the housing is adhered to the skin of the host.
14. The device of claim 11, wherein, in use, a time between sensor
insertion into the host and the electronics unit securing to the
housing is less than about 1 second.
15. The device of claim 11, wherein the device is configured to
disengage from the housing and from the electronics unit in
response to the electronics unit being released from a lock.
16. The device of claim 11, further comprising a trigger lock
configured to prevent activation of the trigger.
17. The device of claim 11, wherein the sensor insertion mechanism
is configured to insert the sensor into the host at a maximum
velocity influenced by a centrifugal brake.
18. The device of claim 17, wherein the sensor insertion mechanism
comprises a tab protruding in an axial direction from a wheel and
configured to rotate about a fixed point, wherein rotational
movement of the tab translates into a linear movement of a needle
carrier to insert the sensor into the host.
19. The device of claim 11, further comprising a protective cover
configured to cover the electronics unit and the housing after
sensor insertion and to secure the electronics unit to the
housing.
20. A device for applying an on-skin sensor assembly to skin of a
host, the device comprising: a base configured to secure a housing,
wherein the housing is configured to receive a transmitter, and the
transmitter is configured to generate analyte information based on
a signal from a sensor; and a mechanism configured to, in response
to a single action by a user, cause the sensor to be inserted into
the host, to secure the electronics unit to the housing such that
the sensor electrically contacts the electronics unit, and to cause
the housing to detach from the base.
21. The device of claim 20, wherein the mechanism includes a
trigger, and the single action comprises activating the trigger to
release stored energy and set components within the device in
motion.
22. The device of claim 21, wherein the stored energy is stored in
a torsion spring that, when released, is configured to cause a
wheel to rotate.
23. The device of claim 22, wherein rotation of the wheel is
configured to induce linear motion in a needle carrier.
24. A device for applying an on-skin sensor assembly to skin of a
host, the device comprising: a base configured to secure a housing,
wherein the housing is configured to receive an electronics unit,
wherein the electronics unit is configured to generate analyte
information based on a signal from a sensor; a sensor insertion
mechanism configured to insert the sensor into the host, and
including a needle carrying the sensor, a rotatable wheel, and a
linearly translatable needle carrier; and a trigger configured, in
response to being activated, to cause the rotatable wheel to
rotate, which in turn causes the linearly translatable needle
carrier to translate toward the host to implant the sensor, and
subsequently to translate away from the host to withdraw the needle
from the host.
25. The device of claim 24, further comprising a torsion spring
that stores energy, wherein the device is configured such that when
the trigger is activated, the energy stored in the torsion spring
is released, causing the wheel to rotate.
26. The device of claim 25, wherein the wheel includes a flange,
and the trigger bears against the flange to retain the energy
stored within the torsion spring.
27. The device of claim 24, further comprising a pushrod and a
needle, and when the trigger is activated the pushrod ejects the
sensor from a lumen of the needle and subsequently retracts into
the needle lumen.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 13/071,497 filed Mar. 24, 2011, 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; 61/411,262, filed Nov. 8, 2010, the disclosures of
which are incorporated herein by reference 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.
Published Application Nos. 2005/0182306; 2006/0091006;
2007/0056858, now U.S. Pat. No. 8,298,389; 2007/0068807, now U.S.
Pat. No. 7,846,311; 2007/0095661; 2007/0108048, now U.S. Pat. No.
7,918,975; 2007/0149873; 2007/0149875, now U.S. Pat. No. 8,515,518;
2007/0199818, now U.S. Pat. No. 7,811,430; 2007/0227911, now U.S.
Pat. No. 7,887,682; 2007/0233013; 2008/0058625, now U.S. Pat. No.
7,920,907; 2008/0064937; 2008/0066305, now U.S. Pat. No. 7,895,740;
2008/0071157; 2008/0071158; 2008/0081977, now U.S. Pat. No.
7,618,369; 2008/0102441, now U.S. Pat. No. 7,822,557; 2008/0148873,
now U.S. Pat. No. 7,802,467; 2008/0161666; 2008/0179187;
2008/0267823; 2008/0319295, now U.S. Pat. No. 8,597,188;
2008/0319296, now U.S. Pat. No. 8,617,069; 2009/0018425, now U.S.
Pat. No. 8,160,670; 2009/0247857, now U.S. Pat. No. 8,346,335;
2009/0257911, now U.S. Pat. No. 8,252,229; 2009/0281406;
2009/0294277; 2009/0054748, now U.S. Pat. No. 7,885,698;
2009/0054749; 2010/0030052; 2010/0065441, now U.S. Pat. No.
8,636,884; 2010/0081905; 2010/0081909, now U.S. Pat. No. 8,219,173;
2010/0213057; 2010/0325868, now U.S. Pat. No. 7,866,026;
2010/0326842; 2010/0326843, now U.S. Pat. No. 8,437,827;
2010/0331643; 2011/0046466; U.S. patent application Ser. Nos.
12/624,767; 12/625,185, now U.S. Pat. No. 8,354,013; Ser. No.
12/625,208; Ser. No. 12/625,524, now U.S. Pat. No. 8,390,455; Ser.
No. 12/625,525, now U.S. Pat. No. 8,358,210; Ser. No. 12/625,528,
now U.S. Pat. No. 8,115,635; Ser. No. 12/628,177; Ser. No.
12/628,198; Ser. No. 12/628,201; Ser. No. 12/628,203; Ser. No.
12/628,210; Ser. No. 12/698,124; Ser. No. 12/698,129; Ser. No.
12/699,653; Ser. No. 12/699,844; Ser. No. 12/714,439; Ser. No.
12/730,193; Ser. No. 12/794,721, now U.S. Pat. No. 8,595,607; Ser.
No. 12/807,278; Ser. No. 12/842,013; Ser. No. 12/870,818; Ser. No.
12/871,901, now U.S. Pat. No. 8,514,086; Ser. No. 12/873,301; Ser.
No. 12/873,302; Ser. No. 13/011,897; and U.S. Provisional
Application Nos. 61/238,646; 61/246,825; 61/247,516; 61/249,535;
61/317,243; 61/325,155; 61/345,562; and 61/359,265.
BACKGROUND
[0003] The detection and/or monitoring of glucose levels or other
analytes, such as lactate, oxygen, AlC, 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 through the skin
of a subject is provided, which includes a housing defining a
longitudinal cavity therein and a interference member extending
into the cavity; a biasing member; a driver member coupled to the
biasing member for movement from a proximal position to a distal
position and further configured for movement between a misaligned
configuration in which the driver member is impeded from distal
movement by the interference member and an aligned configuration in
which the driver member is not impeded from distal movement by the
interference member; and an actuator having an alignment surface
for moving the driver member from the misaligned configuration to
the aligned configuration.
[0008] In some embodiments, the actuator is movable from a proximal
position to a distal position. In some embodiments, distal movement
of the actuator compresses the first biasing member. In some
embodiments, the first position of the driver member is at an
oblique angle with respect to the longitudinal cavity. In some
embodiments, the second position of the driver member includes a
configuration substantially aligned with the longitudinal
cavity.
[0009] An apparatus for inserting a medical device through the skin
of a subject is provided, which includes a housing defining a
cantilever member; a sharp movable within the housing from a
retracted position to a partially exposed position; and an
electrochemical sensor releasably coupled to the sharp for movement
with the sharp, and for subsequent insertion in the skin of a
subject; wherein the cantilever member resiliently contacts at
least one of the sharp and the sensor.
[0010] In some embodiments, the housing includes a distal opening
for release of the electrochemical sensor therefrom. In some
embodiments, the housing defines a longitudinal notch for reception
of a drive member of an inserter. In some embodiments, the housing
contains a desiccant. In some embodiments, the housing defines one
or more longitudinal ridges for aligning one of the sharp and the
sensor.
[0011] 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
[0012] 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.
[0013] FIG. 1 illustrates an analyte monitoring system for real
time analyte (e.g., glucose) measurement, data acquisition and/or
processing in certain embodiments;
[0014] FIGS. 2-3 are views of an electrochemical sensor in
accordance with a further embodiment of the disclosed subject
matter;
[0015] FIGS. 4-5 are schematic views of a needle hub in accordance
with one embodiment of the disclosed subject matter;
[0016] FIG. 6 is a distal end view of a sharp in accordance with
one embodiment of the disclosed subject matter;
[0017] FIG. 7 is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0018] FIG. 8 is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0019] FIG. 9 is a perspective view of a sharp in accordance with
one embodiment of the disclosed subject matter;
[0020] 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;
[0021] FIG. 11 is a perspective view of an inserter in accordance
with one embodiment of the disclosed subject matter;
[0022] FIG. 12 is a perspective view with parts separated of an
inserter in accordance with one embodiment of the disclosed subject
matter;
[0023] FIG. 13 is an enlarged sectional view with parts separated
of an inserter in accordance with one embodiment of the disclosed
subject matter;
[0024] FIG. 14 is a side view of another inserter in accordance
with the disclosed subject matter;
[0025] FIGS. 15-17 are sectional, perspective views of the inserter
of FIG. 14 in accordance with another embodiment of the disclosed
subject matter;
[0026] FIG. 18 is a perspective view of another inserter in
accordance with the disclosed subject matter;
[0027] FIGS. 19-21 are side views with transparency of the inserter
of FIG. 18 in accordance with another embodiment of the disclosed
subject matter;
[0028] FIG. 22 is a perspective view of another inserter in
accordance with the disclosed subject matter;
[0029] FIGS. 23-25 are sectional, perspective views of the inserter
of FIG. 22 in accordance with another embodiment of the disclosed
subject matter;
[0030] FIG. 26 is a sectional view in section of another embodiment
of an inserter in accordance with the disclosed subject matter;
[0031] FIG. 27 is a perspective view of the inserter of FIG. 26 in
accordance with the disclosed subject matter;
[0032] FIGS. 28-31 are perspective views of components of the
inserter of FIG. 26 in accordance with the disclosed subject
matter;
[0033] FIG. 32 illustrates an exploded view of the inserter of FIG.
26 in accordance with the disclosed subject matter;
[0034] FIG. 33 is a side view of the inserter of FIG. 26 in
accordance with the disclosed subject matter;
[0035] FIGS. 34-36 are side views with transparency of the inserter
of FIG. 26 in accordance with the disclosed subject matter;
[0036] FIG. 37 is an inserter in accordance with another embodiment
in accordance with the disclosed subject matter;
[0037] FIG. 38 is a perspective view in section of the inserter of
FIG. 37 in accordance with the disclosed subject matter;
[0038] FIG. 39 is a cross-sectional view of the inserter of FIG. 37
in accordance with the disclosed subject matter;
[0039] FIG. 40 is a side view of the inserter of FIG. 37 in
accordance with the disclosed subject matter;
[0040] FIGS. 41-44 are perspective views of components of the
inserter of FIG. 37 in accordance with the disclosed subject
matter;
[0041] FIG. 45 is an exploded view of the inserter of FIG. 37 in
accordance with the disclosed subject matter;
[0042] FIG. 46 is a side view with transparency of the inserter of
FIG. 37 in accordance with the disclosed subject matter;
[0043] FIGS. 47-51 are perspective views of another inserter in
accordance with the disclosed subject matter;
[0044] FIG. 52 is an exploded perspective view of another
embodiment of the disclosed subject matter;
[0045] FIG. 53 is a sectional view of an inserter in accordance
with the disclosed subject matter;
[0046] FIGS. 54-55 are perspective views from below of the inserter
of FIG. 53;
[0047] FIG. 56 is a perspective view of another inserter in
accordance with the disclosed subject matter;
[0048] FIGS. 57-60 are perspective views of various components of
the inserter of FIG. 56;
[0049] FIG. 61-62 are perspective views of various components of
the inserter of FIG. 56;
[0050] FIGS. 63-65 depict different subassemblies of the components
of the inserter of FIG. 56;
[0051] FIGS. 66-67 are cross-sectional views of a subassembly of
the components of the inserter of FIG. 56;
[0052] FIGS. 68-70 depict the steps used to actuate the inserter of
FIG. 56;
[0053] FIG. 71 is a perspective view of an inserter assembly in
accordance with the disclosed subject matter;
[0054] FIG. 72 is a perspective view of a component of an inserter
assembly of FIG. 71 in accordance with the disclosed subject
matter;
[0055] FIG. 73 is a perspective view of a component of an analyte
measurement system in accordance with the disclosed subject
matter;
[0056] FIG. 74 is a perspective view with parts separated of the
inserter assembly of FIG. 71 in accordance with the disclosed
subject matter;
[0057] FIG. 75 is a cross-sectional view of the inserter assembly
of FIG. 71 in accordance with the disclosed subject matter;
[0058] FIG. 76 is a side view of a portion of an inserter assembly
in accordance with the disclosed subject matter;
[0059] FIG. 77 is a view of an analyte sensor in accordance with
the disclosed subject matter;
[0060] FIGS. 78-79 are perspective views of a portion of an
inserter assembly in accordance with the disclosed subject
matter;
[0061] FIGS. 80-90 are views of analyte sensors in accordance with
the disclosed subject matter;
[0062] FIGS. 91-92 are cross-sectional views of an inserter
assembly in accordance with the disclosed subject matter;
[0063] FIGS. 93-94 are cross-sectional views of another inserter
assembly in accordance with the disclosed subject matter;
[0064] FIGS. 95-96 are cross-sectional views of a further inserter
assembly in accordance with the disclosed subject matter;
[0065] FIGS. 97-98 are views of a portion of an inserter assembly
in accordance with the disclosed subject matter;
[0066] FIG. 99 is a cross-sectional view of a portion of an
inserter assembly in accordance with the disclosed subject
matter;
[0067] FIGS. 100-101 are perspective views of a portion of an
inserter assembly in accordance with the disclosed subject
matter;
[0068] FIGS. 102-105 are side views of various inserter assemblies
in accordance with the disclosed subject matter;
[0069] FIGS. 106-112 are views of a sharp and sharp carrier in
accordance with the disclosed subject matter;
[0070] FIG. 113 is a perspective view of a portion of an inserter
assembly in accordance with the disclosed subject matter;
[0071] FIGS. 114-117 are perspective views illustrating the
operation of an inserter assembly in accordance with the disclosed
subject matter;
[0072] FIG. 118 is a side view of an inserter assembly in
accordance with the disclosed subject matter;
[0073] FIGS. 119-121 are cross-sectional views of an inserter
assembly in accordance with the disclosed subject matter;
[0074] FIG. 122 is a perspective view with parts separated of an
embodiment of a sharp/sensor cartridge in accordance with the
disclosed subject matter;
[0075] FIG. 123 is a perspective view of the cartridge of FIG. 122
in a first stage of deployment in accordance with the disclosed
subject matter;
[0076] FIG. 124 is a cross-sectional view of the cartridge of FIG.
122 in a neutral state in accordance with the disclosed subject
matter;
[0077] FIG. 125 is a perspective view of the cartridge of FIG. 122
in a neutral state in accordance with the disclosed subject
matter;
[0078] FIG. 126 is a cross-sectional view of the cartridge of FIG.
122 in a first stage of deployment in accordance with the disclosed
subject matter;
[0079] FIG. 127 is a perspective view of the cartridge of FIG. 122
in a second stage of deployment in accordance with the disclosed
subject matter;
[0080] FIG. 128 is a cross-sectional view of the cartridge of FIG.
122 in a second stage of deployment in accordance with the
disclosed subject matter;
[0081] FIG. 129 is a perspective view of the cartridge of FIG. 122
in a third stage of deployment in accordance with the disclosed
subject matter;
[0082] FIG. 130 is a cross-sectional view of the cartridge of FIG.
122 in a third stage of deployment in accordance with the disclosed
subject matter;
[0083] FIG. 131 is a perspective view with parts separated of
another embodiment of a component of an inserter in accordance with
the disclosed subject matter;
[0084] FIG. 132 is a perspective view of the cartridge of FIG. 131
in a neutral state in accordance with the disclosed subject
matter;
[0085] FIG. 133 is a cross-sectional view of the cartridge of FIG.
131 in a neutral state in accordance with the disclosed subject
matter;
[0086] FIG. 134 is a perspective view of the cartridge of FIG. 131
in a second stage of deployment in accordance with the disclosed
subject matter;
[0087] FIG. 135 is a cross-sectional view of the cartridge of FIG.
131 in a second stage of deployment in accordance with the
disclosed subject matter;
[0088] FIG. 136 is a perspective view of the cartridge of FIG. 131
in a third stage of deployment in accordance with the disclosed
subject matter; and
[0089] FIG. 137 is a cross-sectional view of the cartridge of FIG.
131 in a third stage of deployment in accordance with the disclosed
subject matter.
DETAILED DESCRIPTION
[0090] 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.
[0091] 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.
[0092] 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.
[0093] 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.
[0094] 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.
[0095] As used herein and in the appended claims, the singular
forms "a," "an," and "the" include plural referents unless the
context clearly dictates otherwise.
[0096] 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.
[0097] 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.
[0098] 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.
[0099] 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.
[0100] 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.
[0101] 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.
[0102] 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.
[0103] 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.
[0104] 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
device includes 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.
[0105] 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.
[0106] 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.
[0107] 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.
[0108] 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.
[0109] 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.
[0110] 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.
[0111] 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.
[0112] 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, 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.
[0113] 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.
[0114] 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.
[0115] 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.
[0116] 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.
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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).
[0123] 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
[0124] 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 100 in
accordance with embodiments of the present disclosure. As shown, in
certain embodiments, analyte monitoring system 100 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.
[0125] 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.
[0126] Referring back to the FIG. 1, analyte monitoring system 100
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.
[0127] 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.
[0128] 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.
[0129] 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.
[0130] 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.
[0131] 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.
[0132] 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.
[0133] 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.
[0134] 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.
[0135] 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.
[0136] Referring still to FIG. 1, also shown in analyte monitoring
system 100 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
100. 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.
[0137] 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.
[0138] In certain embodiments, a separate, optional data
communication/processing device such as data processing module 1600
may be provided in analyte monitoring system 100. 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.
[0139] 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.
[0140] 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.
[0141] 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 100 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.
[0142] 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.
[0143] 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.
[0144] 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.
[0145] 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 100. 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 100 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.
[0146] 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.
[0147] 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.
[0148] 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.
[0149] 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, Ser. No. 12/699,653, and Ser. No. 12/699,844, 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
[0150] The analyte sensor 14 of the analyte measurement system 100
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.
[0151] 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.
[0152] 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.
[0153] 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).
[0154] 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.
[0155] 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.
[0156] 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.
[0157] 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.
[0158] 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.
[0159] 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
[0160] 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.
[0161] In some embodiments, an insertion assembly includes an
inserter, a medical device, such as an analyte sensor, and a mount
for supporting the medical device at least partially in or on the
skin of the subject. In some embodiments, the mount is a support
structure, plate and/or member which is attached, adhered, or
otherwise secured to the skin of the subject. The mount may be
inserted simultaneously with the medical device by the inserter. In
other embodiments, the mount is installed after or before
installation of the medical device. A mount may be applied by the
inserter or separately. The mount may include features or
structures (e.g., adhesive, guides, barbs, tabs, etc.) to maintain
the sensor in position with respect to the skin after insertion
and/or maintain the sensor in relative position with respect to the
sensor control unit. In some embodiments, an adhesive pad or strip
is used to secure the medical device, e.g., the sensor and/or the
sensor control unit, and no mount is used.
[0162] In some embodiments, an insertion assembly includes an
inserter, an analyte sensor, a mount, and a power supply. The mount
and power supply may be inserted simultaneously with the analyte
sensor by the inserter. In other embodiments, the mount and battery
are installed after or before installation of the analyte sensor.
In such case, the mount and/or 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.
[0163] In some embodiments, an insertion assembly includes an
inserter, a medical device such as an analyte sensor, a mount, and
a sensor control unit. The mount and sensor control unit may be
deployed and/or installed simultaneously with the analyte sensor by
the inserter. In other embodiments, the mount and sensor control
unit are installed after or before installation of the analyte
sensor. For example, the mount and the analyte sensor may be
installed by the inserter, and the sensor control unit may be
subsequently installed. In other embodiments, the mount is
installed, followed by insertion of the analyte sensor by the
inserter, and further followed by installation of the sensor
control unit. In other embodiments, the mount and sensor control
unit are installed first, and the analyte sensor is subsequently
installed.
[0164] In some embodiments, electronics of the sensor control unit
provide a voltage or current to the analyte sensor. In some
embodiments, the electronics processes signals are provided by the
analyte sensor. In further embodiments, the electronics may include
communication 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 RFID antenna or
other communications circuitry, 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.
[0165] An inserter may 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
sensor control unit and/or mounting structure 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 and
speed applied by the subject 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 and an advanced position. In some embodiments, the sensor
and sensor control unit and/or mounting structure 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 sensor control unit and/or mounting
structure are temporarily maintained operatively between the
support structure and the projections disposed on the interior wall
of the sheath.
[0166] An inserter can also include one or more components for
retracting the sharp, while allowing the analyte sensor and
optional mount and/or 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.
[0167] 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.
[0168] 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
[0169] 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.
[0170] 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 as 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 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 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.
[0171] 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.
[0172] 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.
[0173] 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. 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 of
the sensor control unit (e.g., a printed circuit board containing
electronics components of the on-body unit) 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. 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.
[0174] 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 1500 (see FIG. 52). 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 (e.g., 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 (e.g., "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, e.g., by allowing vertical positioning
of the notch 56 with respect to a vertical landmark of the on body
housing 122.
[0175] 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 on body 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.
[0176] 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.
[0177] An embodiment of an inserter is illustrated in FIGS. 14-17.
An inserter 900 includes a handle 902 and may include a removable
distal cap or seal (not shown) for maintaining a sterile
environment for the medical device and sharp housed therein. As
illustrated in FIG. 14, distal cap or seal is removed from handle
902. Inserter 900 includes a base 942 that defines a distal surface
912 for placement on the skin of a subject. Inserter 900 may be
utilized to advance a medical device into the skin of the subject.
In some embodiments, handle 902 is advanced relative to base 942 in
order to advance the sensor into the skin of the patient.
[0178] As illustrated in FIG. 15, the inserter 900 includes an
initial configuration in which the handle 902 is disposed in a
proximal position with respect to the base 942. In such
configuration, the sharp 924 is disposed in a configuration spaced
apart from the aperture 920 of the adhesive layer 918. Extending
distally from the upper surface of handle 902 are side walls 974,
which terminate in a shoulder portion 975.
[0179] Needle carrier 934 is axially slidable within handle 902 and
base 942 in the direction of arrow N. Needle carrier 934 supports
needle hub 936, from which sharp 924 extends longitudinally within
the inserter 900. In some embodiments, the sharp is supported at an
oblique angle, e.g., between 0.degree. and 90.degree. with respect
to the skin surface. Initially, needle carrier 934 is coupled to
inner rail 928 through inter-engagement of finger 986 of needle
carrier 934 with shoulder 987 of inner rail 928.
[0180] Inserter 900 includes an advancement spring 947. Inner rail
928 includes a spring retention portion 984 for advancement spring
947. The inner surface of handle 902 serves as an upper engagement
surface for advancement spring 947. In some embodiments, spring
retention portion 984 is fabricated having several projections that
extend through an aperture 982 in the wall of base 942. Spring
retention portion 984 is resiliently movable. As downward force is
applied to handle 902, the ledge 937 of handle 902 contacts spring
retention portion 984, driving such projections inward. Such inward
motion releases the inner rail 928, and allows advancement spring
947 to advance the inner rail 928 distally, thereby advancing the
sharp 924 into the skin of the subject, as illustrated in FIG.
16.
[0181] Refraction spring 946 is disposed between spring retention
portion 948 of base 942 and shoulder portion 949 of needle carrier
934. Initially, retraction spring 946 is in a compressed state. As
carriage 930 reaches a distal position, the distal surface of the
on body housing 122 engages the upper surface of adhesive pad 918,
thereby becoming adhered to the skin surface S of the subject. At
the same time, flanges 970 of base 942 engage fingers 986 disposed
on the needle carrier 934. Fingers 986 are pivoted outwards by
flanges 970. Such pivoting of fingers causes fingers 986 to become
disengaged from shoulder 984 of inner rail 928. Shuttle 934 is
thereby disengaged from inner rail 928.
[0182] As illustrated in FIG. 17, disengagement of the shuttle 934
from the inner rail 928 permits the spring 946 to expand, thereby
advancing the needle carrier 934 to a proximal position, thereby
withdrawing the sharp 924 from the skin of the subject, while
leaving the sensor 14 in the skin.
[0183] A further embodiment of an inserter is illustrated in FIGS.
18-21 and designated inserter 1000. Inserter 1000 is substantially
identical to inserter 900 described herein, with the substantial
differences noted herein and illustrated in the accompanying
figures.
[0184] An inserter 1000 includes a housing 1002, and may include a
removable distal cap or seal (not shown) for maintaining a sterile
environment for the medical device and sharp housed therein. As
illustrated in FIG. 18, distal cap or seal is removed from housing
1002. Inserter 1000 includes a base 1042 which defines a distal
surface 1012 for placement on the skin of a subject. Inserter 1000
may be utilized to advance a medical device into the skin of the
subject. In some embodiments, side buttons 1084 are depressed
relative to base 1042 in order to advance the medical device into
the skin of the patient.
[0185] As illustrated in FIG. 19, the inserter 1000 includes an
initial configuration in which the sharp 1024 is disposed in a
configuration spaced apart from distal portion 1012 of the base
1042. It is understood that inserter 1000 may incorporate an
adhesive layer (not shown) positioned across the distal portion
1012 of base 1042.
[0186] On-body unit inserter 1028 includes carriage 1030 for
supporting on body housing 122. On-body unit inserter 1028 also
includes flange 1029 which normally rests on shoulder portions 1086
(as illustrated in FIGS. 19-21). When side buttons 1084 are
depressed inwardly, latch portions on flange 1029 are deflected
from engagement with shoulder portions 1086. As illustrated in FIG.
20, advancement spring 1047 is released from compression, thereby
advancing on-body unit inserter 1028 as elsewhere, along with
needle carrier 1034 into the skin of the subject.
[0187] Refraction spring 1046 is disposed between needle carrier
1034 and housing 1002. Initially, retraction spring 1046 is in a
compressed state. As carriage 1028 reaches a distal position,
on-body unit inserter 1028 is disengaged from needle carrier 1034.
The distal surface of the on body housing 122 engages the skin or
the upper surface of adhesive pad (not shown), thereby becoming
adhered to the skin surface S of the subject. Latches on needle
carrier 1034 attach it to on-body unit inserter 1028. Upon firing
the inserter by pressing tabs 1084, the on-body unit inserter 1028
is pushed by spring 1047 towards the skin surface, bringing along
needle carrier 1034 and loading extension spring 1046. As on-body
unit inserter 1028 reaches the distal position (towards the skin of
the subject), protrusions on housing 1002 disengage latches on
needle carrier 1034, connecting it to on-body unit inserter 1028.
Extension spring 1046 now pulls needle carrier 1034 back into the
proximal position.
[0188] As illustrated in FIG. 21, disengagement of the needle
carrier 1034 from the inner rail 1028 permits the spring 1046 to
contract with the bias, thereby advancing the needle carrier 1034
to a proximal position and withdrawing the sharp 1024 from the skin
of the subject, while leaving the sensor 14 in the skin.
[0189] A further embodiment of an inserter is illustrated in FIGS.
22-25. Inserter 1100 is substantially identical to inserters 900
and 1000 described herein, with the substantial differences noted
herein and illustrated in the accompanying figures.
[0190] An inserter 1100 includes a housing 1102 and may include a
removable distal cap or seal (not shown) for maintaining a sterile
environment for the medical device and/or sharp housed therein. As
illustrated in FIG. 22, distal cap or seal is removed from housing
1102. Inserter 1100 includes a base 1142 which defines a distal
surface 1112 for placement on the skin of a subject. Inserter 1100
may be utilized to advance a medical device into the skin of the
subject. In some embodiments, a manual actuator bar 1114 is
depressed relative to base 1142 in order to advance the medical
device into the skin of the patient. It is understood that inserter
1100 may incorporate an adhesive layer (not shown) which is
positioned across the distal portion 1112 of base 1142.
[0191] As illustrated in FIG. 23, the inserter 1100 includes an
initial configuration in which the sharp 1124 is disposed in a
configuration spaced apart from distal portion 1112 of the base
1142. Manual advancement of the actuator may be performed by distal
advancement of actuator bar 1114.
[0192] On-body unit inserter 1128 includes carriage 1130 for
supporting on body housing 122. Refraction spring 1146 is disposed
between needle carrier 1134 and base 1142. Initially, retraction
spring 1146 is in a compressed state. As actuator bar 1114 is moved
distally, carriage 1128 is moved distally and reaches a distal
position, such that flanges 1188 of base 1142 engage fingers 1186
disposed on the shuttle 1134. Fingers 1186 are pivoted outwards by
flanges 1188. Such pivoting of fingers 1186 causes fingers 1186 to
become disengaged from shoulder 1187 of inner rail 1128. Shuttle
1134 is thereby disengaged from inner rail 1128. The distal surface
of the on body housing 122 engages the skin or the upper surface of
adhesive pad (not shown), thereby becoming adhered to the skin
surface of the subject (FIG. 24).
[0193] As illustrated in FIG. 25, disengagement of the shuttle 1136
from the inner rail 1028 permits the spring 1146 to expand with the
bias, thereby advancing the needle carrier 1136 to a proximal
position and withdrawing the sharp 1124 from the skin of the
subject, while leaving the sensor 14 in the skin. Once the sharp
1124 has been withdrawn from the subject, it is no longer
accessible from the distal portion of the inserter 1100, and unable
to make contact by accident with the subject's skin.
[0194] A further embodiment of an inserter is illustrated in FIGS.
26-36. Inserter 1200 is substantially identical to inserters 900,
1000, and 1100 described herein, with the substantial differences
noted herein and illustrated in the accompanying figures.
[0195] Inserter 1200 includes a housing 1202, an on-body unit
inserter 1228, a needle retractor 1234, and a rotor 1208 with a
torsion spring (not shown), all of which are depicted separately in
FIGS. 28-31. As illustrated in FIGS. 28-31, housing 1202 includes
slots 1254; on-body unit inserter 1228 includes slots 1252, tabs
1253, and opening 1262; needle retractor 1234 includes tabs 1250
and opening 1260; and rotor 1208 includes rotor follower 1264.
[0196] FIG. 32 illustrates an exploded view of inserter 1200. As
illustrated, in some embodiments, inserter 1200 includes housing
1202, on-body unit inserter 1228, needle retractor 1234, and rotor
1208. Tabs 1250 can be disposed on needle refractor 1234 and
configured to engage slots 1252 disposed on on-body unit inserter
1228 when assembled as shown in FIG. 33. Tabs 1253 can be disposed
on on-body unit inserter 1228 and configured to engage slots 1254
disposed on housing 1202. Needle retractor 1234 and on-body unit
inserter 1228 can each contain openings (1260, 1262) to receive
rotor follower 1264 disposed on rotor 1208 after rotor 1208 has
been inserted into housing 1202. Additionally, on-body unit
inserter 1228 can provide support for on body housing 122 (not
shown) for installation to the skin of a subject.
[0197] As illustrated in FIG. 34, in some embodiments, manually
depressing the on-body unit inserter 1228 can cause the torsion
spring to wind as the rotor 1208 rotates, guided by the cam path.
As illustrated in FIG. 35, continued distal advancement of the
on-body unit inserter 1228 causes the rotor follower 1264 to go
"over center" within cam 1264. At such point, the torsion spring
(not shown) is allowed to unwind (FIG. 93). With reference to FIG.
36, further unwinding of the torsion spring pulls up the needle
retractor 1234 from the insertion site, while leaving the on-body
unit inserter in place.
[0198] A further embodiment of an inserter is illustrated in FIGS.
37-46. Inserter 1300 is substantially identical to inserters 900,
1000, 1100, and 1200 described herein, with the substantial
differences noted herein and illustrated in the accompanying
figures.
[0199] Inserter 1300 includes a housing 1302, an on-body unit
inserter 1334, a needle retractor 1328, and a rotor 1308 with
torsion spring 1365. As illustrated in FIGS. 37, 38, 39, 45 and 46,
the on-body unit inserter 1334 and needle retractor 1328 are
disposed within the housing 1302. Rotor 1308 includes a rotor
follower 1364 which engages a slot 1362 provided in the needle
retractor 1328 and a slot 1360 in the on-body unit inserter 1334.
The on-body unit inserter 1334 provides a support portion for
supporting on body housing 1302 (not shown).
[0200] In operation, torsion spring 1365 is loaded. A release
button (not shown) is depressed in order to release torsion spring
1365. Rotor 1308 drives on-body unit inserter 1334 and needle
retractor 1328 downwardly simultaneously. A compression spring 1367
holds down on-body unit inserter 1334. As rotor 1308 continues to
rotate, slot 1360 allows on-body unit inserter 1334 to travel down
and then be held down, while slot 1362 allows needle retractor 1328
to travel down and then back up to lift the needle from insertion
site.
[0201] A further embodiment of an inserter is illustrated in FIGS.
47-51. Inserter 1400 is substantially identical to inserters 900,
1000, 1100, 1200, and 1300 described herein, with the substantial
differences noted herein and illustrated in the accompanying
figures.
[0202] Inserter 1400 may be used for installation of a medical
device, e.g., on body housing 122, in connection with a cartridge
or carrier 1406. In some embodiments, inserter 1400 includes a body
1402 and an actuator 1404. The carrier 1406 may include a needle
hub 1436 including a sharp (not shown) as well as an on body
housing 122. In use, the body 1402 is placed on a mount 1408
attached to subject by use of an adhesive pad 1418. As shown in
FIG. 47, carrier 1406 is loaded into inserter 1400 laterally as
shown.
[0203] With reference to FIG. 48, a first disposable portion of
inserter 1400 includes adhesive pad 1418 and mount 1408. The second
disposable portion of inserter 1400 includes carrier 1406 which
removably contains needle hub 1436 and sensor hub 1437 (not shown)
which is substantially identical to on body housing 122 described
herein. Inserter 1400 further includes body 1402, actuator 1404,
and return spring 1409 (not shown). Mount 1408 is removably
attached to body 1402. Carrier 1406 can be slid on to body 1402 to
transfer needle hub 1436 and carrier 1406 to inserter 1400. As
shown in FIG. 48, carrier 1406 can then be removed from inserter
1400. Needle hub 1436 and sensor hub 1437 remain in inserter 1400.
Adhesive pad 1418 is then adhesively applied to the skin of a
subject. Alternatively, adhesive pad 1418 may be applied to the
skin of a subject before attaching body 1402 and mount 1408.
[0204] In FIG. 49, actuator 1404 is pressed down, performing a
manual insertion of needle hub 1436 and sensor hub 1437, with the
needle located in needle hub 1436 and a distal sensor portion
penetrating the skin of the subject. When pressure is released from
actuator 1404, return spring 1409 (not shown) retracts the needle
from the skin of the subject and out of sensor hub 1437. As shown
in FIG. 50, body 1402 can be removed from mount 1408, leaving
sensor hub 1437 in mounting base 1408. In FIG. 51, in some
exemplary embodiments, carrier 1406 is slid on to housing 1402,
transferring needle 1436 to carrier 1406. Carrier 1406, with needle
1436, is then removed from housing 1402 and may be disposed of
properly, and inserter 1400 is ready to be used again.
Communication electronics (not shown) are then attached to mounting
base 1408, making electrical contact with sensor hub 1437.
[0205] A further embodiment of an inserter is illustrated in FIG.
52. Inserter 1500 is substantially identical to inserters 900,
1000, 1100, 1200, 1300, and 1400 described herein, with the
substantial differences noted herein and illustrated in the
accompanying figures.
[0206] Inserter 1500 includes a housing 1502, which may be
fabricated as a molded plastic tube and may further include a
living hinge cap 1504. In some embodiments, a living hinge is a
thin flexible plastic junction that connects two mating parts. The
hinge keeps the parts attached and may be folded completely without
failure to allow the two parts to fully mate.
[0207] Cap 1504 may be further provided with a cutout portion to
provide access to the index finger and restrict the insertion
motion along a desired axis. Cap 1504 is closed up and bonded to
the housing through chemical or ultrasonic bonding after the
bellow-button assembly (described herein) is provided.
[0208] Inserter further includes bellows 1506, which, in some
embodiments, is constructed from molded thin wall plastic with an
integrated compression spring which collapses during the insertion
action, and which provides the force to retract sharp 1524 after
insertion. Bellows 1506 also hides sharp 1524 from exposure. The
top portion 1520 of the bellows 1506 is secured to button 1514, and
bottom portion 1521 is secured to housing 1502.
[0209] A button 1514 provides the capability of the user to insert
on body housing 122 into the skin of the subject. Button 1514 may
be fabricated from plastic and may further include anti-rotation
features, e.g., recess 1515 which glides along longitudinal ridge
1517, restricting motion to the desired longitudinal axis. Needle
hub 1536 is glued or directly molded onto button 1514. Sharp 1524
is securely held on to on body housing 122, as described herein
(See, e.g., FIGS. 11-13).
[0210] An adhesive patch 1518 secures on body housing 122 to the
skin of the subject. In some embodiments, the adhesive patch 1518
includes a high-tack (i.e., high strength adhesive) region for
contact with the skin. A protective liner is provided for removal
prior to insertion. On the side of the adhesive patch facing
inserter 1500, low-tack region 1530 is provided on the periphery of
the patch to allow easy removal of housing 1502 after insertion is
completed. A high-tack region 1532 is provided in the center
portion of the patch to secure on body housing 122 in place.
[0211] Referring to FIGS. 53-55, inserter kit 1600 is illustrated
with inserter 2310 and an adhesive mount 2312 removably attached to
the bottom thereof. Inserter 1600 is further described in U.S. Pat.
No. 7,381,184, which is incorporated by reference herein for all
purposes.
[0212] After preparing an insertion site on the skin, typically in
the abdominal region, the user removes a liner (not shown) from
adhesive mount 2312 to expose the bottom surface and a portion of
the top surface of an adhesive tape 2320 located beneath mount
2312. Mount 2312, with inserter 2310 attached, is then applied to
the subject's skin at the insertion site. Actuator button 2324 is
depressed, causing inserter 2310 to fire, thereby inserting sensor
2314 into the subject's skin with a predetermined velocity and
force. Once sensor 2314 has been inserted into the skin, the
patient removes inserter 2310 from mount 2312 by pressing release
tabs (not shown) on opposite sides of inserter 2310 and lifting
inserter 2310 away from mount 2312.
[0213] Once inserter 2310 is removed from mount 2312,
communications electronics (not shown) can be slid into place. The
circuitry of the communications electronics device makes electrical
contact with the contact pads on sensor 2314 after the
communications electronics is fully seated on mount 2312. Once
initialization and synchronization procedures are completed,
electrochemical measurements from sensor 2314 can be sent
wirelessly from the communications electronics to a receiver
unit
[0214] In some embodiments, inserter kit 1600 is assembled from the
following components: housing 2334, actuator button 2324, drive
spring 2336, shuttle 2338, introducer sharp 2340, sensor 2314,
retraction spring 2342, inserter base 2344, upper liner (not
shown), adhesive mount 2312, adhesive tape 2320, and lower liner
(not shown).
[0215] Shuttle 2338 is slidably and non-rotatably constrained on
base 2344 by arcuate guides 2360. Shuttle 2338 is generally formed
by an outer ring 2362 and an inner cup-shaped post 2364 connected
by two bridges 2366. Bridges 2366 slide between the two slots (not
shown) formed between guides 2360 and allow shuttle 2338 to travel
along guides 2360 without rotating. Retraction spring 2342 is
captivated at its outer circumference by guides 2360, at its bottom
by the floor 2370 of base 2344, at its top by bridges 2366, and at
its inner circumference by the outer surface of shuttle post 2364.
Drive spring 2336 is captivated at its bottom and outer
circumference by the inside surface of shuttle post 2364, at its
top by the ceiling 2372 inside actuator button 2324, and at its
inner circumference by stem 2374 depending from ceiling 2372. When
drive spring 2336 is compressed between actuator button 2324 and
shuttle 2338 it urges shuttle 2338 towards base 2344. When
refraction spring 2342 is compressed between shuttle 2338 and base
2344, it urges shuttle 2338 towards actuator button 2324.
[0216] Retraction spring 2342 will return shuttle 2338 to the
neutral position as shown after firing, but without sensor 2314
which remains inserted in subject's skin. Drive spring 2336 is
preferably designed to be stiffer than retraction spring 2342 so
that shuttle 2338 oscillations are quickly dampened out, and so
introducer sharp 2340 does not return to sensor 2314 or the patient
to cause injury. With sensor 2314 inserted in the subject's skin,
inserter 2310 can be removed from mount 2312 and then lifting
inserter 2310 away from mount 2312. Introducer sharp 2340 remains
protected inside housing 2334 during disposal of inserter 2310.
Communications electronics can now be slid into place on mount 2312
as previously described.
[0217] In some embodiments, a proximal portion of stem 2374 is
enlarged to create an interference fit with the coils of spring
2336. For example, one or more laterally extending ribs 2610 are
added to stem 2374. The interference fit between ribs 2610 and
spring 2336 is typically provided at the proximal (top) coils of
spring 2336.
[0218] The diameter of the coils of spring 2336 increases slightly
when compressed and decreases slightly when extended. Ribs 2610 on
stem 2374 provide greatest interference when spring 2336 is
extended. The interference fit provides increased stability of
shuttle 2338 during insertion. In some embodiments, the
interference fit prevents or minimizes distal movement of spring
2336, which may cause impact of spring 2336 against shuttle 2338
and the end of the distal travel of these components.
[0219] Referring to FIGS. 56-70, in another exemplary embodiment,
inserter 2600 generally includes: actuator button 2602 (FIG. 57),
shuttle 2604 (FIG. 58), inserter sharp 2610 with skin piercing edge
2612 (FIG. 58), retraction spring 2608 (FIG. 59), sensor 2614 (FIG.
60), housing 2616 (FIG. 61), and base 2618 (FIG. 62). It is
understood that inserter 2600 may include additional or fewer
components than described herein. Inserter 2600 is substantially
identical to inserter 1600 described herein, with the substantial
differences noted herein and illustrated in the accompanying
figures. The assembly of the different components of inserter 2600
is depicted in FIGS. 63-65. As shown in FIG. 63, actuator button is
adapted to be slidably inserted through an opening in shuttle 2604
where it locks into position. Further, as shown in FIG. 64,
retraction spring 2608 is adapted to be inserted into a second
opening on the opposite side of shuttle 2604. Additionally, in this
view, sensor 2614 has been attached to inserter sharp 2610. As
shown in FIG. 60, sensor 2614 incorporates a biasing arm 2615 that
positively seats the sensor 2614 into the inserter sharp 2610. This
allows the inserter sharp 2610 and sensor insertion portion 30 to
be smaller, reducing the trauma and pain to the subject. Any number
of the aforementioned sensor connection methods can be utilized in
conjunction with inserter 2600. For example, inserter sharp 2610
may be provided with rails and dimples, as previously described, in
order to retain sensor 2614, the sharp 2610 having a diameter of
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.
[0220] FIG. 66 depicts a cross-sectional view of the assemblage of
FIG. 65 after inserter 2600 has been fully assembled (joining
housing 2616 to base 2618). As depicted, retraction spring 2608 is
surrounded by guides 2622 on its sides and by shuttle 2604 and base
2618 when inserter 2600 is assembled. Additionally, shuttle 2604 is
adapted to slidably move on rails (not shown) within base 2618,
thereby allowing it to move in a linear direction when actuator
button 2602 is depressed. FIG. 66 depicts the actuator button 2602
locked onto the shuttle 2604 using the first of two detent grooves
2607. In this configuration, the shuttle 2604 and actuator button
2602 are in a locked state relative to the housing 2616 and base
2618, preventing accidental deployment of the shuttle during
shipping and handling. This configuration also allows for
significantly smaller packaging, resulting in lower shipping costs
and improved bulk process efficiencies such as sterilization. FIG.
67 depicts the actuator button 2602 locked onto the shuttle 2604
using the second of two detent grooves 2607. In this configuration,
the shuttle is ready to be deployed. The actuator button 2602 is
moved to the second detent groove 2607 by a user pulling axially on
the actuator button 2602 and housing 2616.
[0221] FIGS. 68-70 illustrate the steps utilized to deploy sensor
2614 using inserter 2600. FIG. 68 depicts inserter 2600 in a first
configuration. The upward force exerted by retraction spring 2608
on shuttle 2604 (and consequently actuator button 2602) keeps
inserter 2600 in its cocked position in the first configuration. As
actuator button 2602 is pressed by a user against the bias of
retraction spring 2608, it exerts a downward force on shuttle 2604
and retraction spring 2608. Introducer sharp 2610, on which sensor
2614 is mounted, is consequently driven downward and into the skin
of the subject (e.g., to a second configuration) Skin piercing edge
2612 pierces the skin of the subject and allows sensor 2614 to be
properly inserted, as shown in FIG. 69.
[0222] As the force is removed from actuator button 2602,
retraction spring 2608 exerts an upward force on shuttle 2604,
thereby causing introducer sharp 2610 to return proximally to its
original position inside of housing 2616 (e.g., to the first
configuration). Sensor 2614 remains implanted in the patient's
skin, as shown in FIG. 70. In this position, the plunger is bent
approximately 90 degrees by the user, which prevents further use of
the device, and provides obvious visual and tactile indications
that the device is used and ready to be disposed.
[0223] In another aspect of the disclosed subject matter, an
inserter assembly, as illustrated in FIG. 71, is provided which is
useful for installing a medical device, such as an analyte sensor,
in the skin of a subject. Inserter assembly 4300 may include an
inserter, a medical device, such as an analyte sensor, and a mount
for positioning the medical device at least partially in or on the
skin of the subject. In some embodiments, the mount is a support
structure, plate and/or member which is attached, adhered, or
otherwise secured to the skin of the subject. The mount may be
applied to the skin of the subject simultaneously with the medical
device by the inserter. In other embodiments, the mount is
installed after or before installation of the medical device. A
mount may be applied by the inserter or separately. The mount may
include features or structures (e.g., adhesive, guides, barbs,
tabs, etc.) to maintain the sensor in position with respect to the
skin after insertion and/or maintain the sensor in relative
position with respect to the sensor control unit.
[0224] Inserter assembly 4300 is useful for analyte measurement
systems, e.g., glucose measurement systems which include an on-body
unit that may be assembled on the skin of the subject. For example,
the on-body unit may include a sensor and a sensor control unit.
The sensor is typically installed in the patient. Subsequently, the
sensor control unit is installed and coupled to the sensor. In
other embodiments, the sensor control unit is installed at the
patient first, followed by installation of the sensor, which is
then coupled to the sensor control unit. In yet other embodiments,
the sensor and sensor control unit are simultaneously installed and
coupled. An optional mount may or may not be used to position the
sensor and/or the sensor control unit.
[0225] Generally, the inserter assembly 4300 is useful to install a
sensor in the skin of a subject. A sensor (not shown) may be
preloaded within inserter 4310 prior to installation. After
preparing an insertion site on the skin of a subject, the user
removes an upper liner 4316 and lower liner 4318 from mount 4312 to
expose the bottom surface and a portion of the top surface of an
adhesive tape located on the bottom surface of the mount 4312.
Mount 4312, with inserter 4310 attached, is then applied to the
subject's skin at the insertion site. In some embodiments, the
mount 4312 is first attached, and then the inserter is coupled to
or positioned within and/or adjacent to the mount 4312. The
inserter includes an actuator button 4324 (see FIG. 74) to be
depressed causing inserter 4310 to fire, thereby inserting a sensor
into the user's skin. As will be described herein, certain
embodiments install the sensor with a predetermined velocity and
force upon actuation. In some embodiments of the disclosed subject
matter, the inserter includes a safety member to impede actuation
of the inserter as described below.
[0226] In some embodiments, the sensor 4314 remains positioned at
the mount 4312 by one or more positioning techniques. For example,
as illustrated in FIG. 72, sensor 4314 has a surface 4356 that
extends orthogonally from main surface 4346. Surface 4356 may
include an adhesive portion that contacts the subject's skin 4328
or the mount 4312. In some embodiments, the raised end stop 4444 of
mount 4312 is provided with a raised bead or bump which is received
in an aperture in sensor 4314. Following insertion of the sensor
4314 into the skin, the user may remove the inserter 4310 from
mount 4312, e.g., by pressing release tabs 4326 on opposite sides
of inserter 4310 and lifting inserter 4310 away from mount 4312. In
some embodiments, the inserter 4310 is retained by other
techniques, e.g., a friction-fit or a snap-fit with the mount
4312.
[0227] Once inserter 4310 is removed from mount 4312, a sensor
control unit 4330 can be positioned into place with respect to the
mount 4312. The circuitry of sensor control unit 4330 makes
electrical contact with the contacts on sensor 4314 after sensor
control unit 4330 is seated on mount 4312. For example, as shown in
FIG. 72, seal has an exterior wall for surrounding electrical
contacts on sensor 4314 (not shown in FIG. 72), and interior walls
for isolating electrical contacts from each other. In some
embodiments, rails on sensor control unit 4330 are slidable within
corresponding rails or grooves 4434 on mount 4312.
[0228] In some embodiments, initialization and synchronization
procedures are completed, and then electrochemical measurements
from sensor 4314 can be provided from sensor control unit 4330 to a
monitor unit, such as, e.g., portable monitor unit 4332, shown in
FIG. 73. Sensor control unit 4330 and monitor unit 4332 communicate
via connection 20 (in this embodiment, a wireless radio frequency
(RF) connection). Communication may occur, e.g., via RF
communication, infrared communication, Bluetooth.RTM.
communication, Zigbee.RTM. communication, 802.1x communication, or
WiFi communication, etc. In some embodiments, the communication may
include a radio frequency of 433 MHz, 13.56 MHz, or the like. In
some embodiments, communication between sensor control unit 4330
and monitor unit 4332 may include radio frequency identification
(RFID) techniques, and may be active RFID or passive RFID, where,
in some embodiments, passive RFID technology and the respective
system components include the necessary components therefor. For
example, in one embodiment, the monitor unit may include a
backscatter RFID reader configured to transmit an RF field such
that when the sensor control unit is within the transmitted RF
field, an antenna is tuned and in turn provides a reflected or
response signal (for example, a backscatter signal) to the monitor
unit. The reflected or response signal may include sampled analyte
level data from the analyte sensor. Additional exemplary details
for various embodiments can be found in, e.g., U.S. patent
application Ser. No. 12/698,124 filed Feb. 1, 2010, the disclosure
of which is incorporated by reference herein for all purposes.
[0229] Sensor 4314, mount 4312 and sensor control unit 4330 can
remain in place on the subject for a predetermined maximum period
of time that may include hours, days, weeks, or a month or more.
These components are then removed so that sensor 4314 and mount
4312 can be properly discarded in some embodiments. The entire
procedure above can then be repeated with a new inserter 4310,
sensor 4314 and mount 4312, reusing sensor control unit 4330 and
monitor unit 4332. In other embodiments, inserter 4310 is
reusable.
[0230] Referring to FIG. 74, the inserter assembly 4300 according
to one embodiment can be assembled as shown from the following
components: housing 4334, actuator button 4324, drive spring 4336,
shuttle 4338, introducer sharp 4340, sensor 4314, retraction spring
4342, inserter base 4344, upper liner 4316, adhesive mount 4312,
adhesive tape 4320, and lower liner 4318.
[0231] In some embodiments, sensor main surface 4346 is slidably
mounted between U-shaped rails 4348 of introducer sharp 4340. In
addition to the holding members disposed on the introducer, as
described above, retention techniques are provided in certain
embodiments to retain the sensor 4314 in position on sharp 4340
during storage of the inserter 4300 and/or during insertion of the
sensor 4314 into the subject's skin. For example, a sensor dimple
(not shown) is provided which engages an introducer dimple (also
not shown). Introducer sharp 4340 can be mounted to face 4354 of
shuttle 4338, such as with adhesive, heat stake or ultrasonic
weld.
[0232] In some embodiments, shuttle 4338 can be slidably and
non-rotatably constrained on base 4344 by arcuate guides 4360. The
shuttle can be generally formed by an outer ring 4362 and an inner
cup-shaped post 4364 connected by two bridges 4366. Bridges 4366
can be configured to slide between the two slots 4368 formed
between guides 4360 and allow shuttle 4338 to travel along guides
4360 without rotating. In some embodiments, a retraction spring
4342 is provided, which can be captivated at its outer
circumference by guides 4360, at its bottom by the floor 4370 (see
FIG. 75) of base 4344, at its top by bridges 4366, and at its inner
circumference by the outer surface of shuttle post 4364. In some
embodiments, a drive spring is provided for advancing the sensor
4314 and the sharp 4340 into the skin of the subject. For example,
drive spring 4336 is captivated at its bottom and outer
circumference by the inside surface of shuttle post 4364, at its
top by the ceiling 4372 (see FIG. 75) inside actuator button 4324,
and at its inner circumference by stem 4374 depending from ceiling
4372. In some embodiments, a drive spring is omitted from the
inserter assembly. In such case, for example, sensor 4314 and sharp
4340 are distally advanced by manual force applied by a user.
[0233] When drive spring 4336 is compressed between actuator button
4324 and shuttle 4338 it can urge shuttle 4338 towards base 4344.
When retraction spring 4342 is compressed between shuttle 4338 and
base 4344, it urges shuttle 4338 towards actuator button 4324.
[0234] When sensor 4314, introducer sharp 4340, shuttle 4338,
retraction spring 4342, drive spring 4336 and actuator button 4324
are assembled between base 4344 and housing 4334 as shown in FIGS.
74-75 and described above, housing 4334 is snapped into place on
base 4344. Base 4344 is held onto housing 4334 by upper base barbs
4390 that engage upper openings 4392 in housing 4334, and lower
base barbs that engage lower openings in housing 4334. Further
details regarding the construction and operation of inserter 4300
is provided in U.S. Pat. No. 7,381,184 which is incorporated by
reference herein in its entirety for all purposes.
[0235] In some embodiments, retention techniques and/or structures
are provided to assist in supporting the sensor 4314 with respect
to the sharp 4340 during storage and insertion. As illustrated in
FIGS. 76-90, retention mechanisms are provided which are located on
the sensor and/or the sharp.
[0236] FIGS. 76-77 illustrate a sensor 4514 which is provided with
one or two laterally extending tabs 4560. Tabs 4560 engage the
rails 4548 of the sharp 4540 for retention. In some embodiments, a
radiused edge on the ears allow them to be formed in two punch
operations, e.g., a hole punch and a straight cut. A gap between
left hard-stop 4549 and the top of sensor 4514 produces, during
firing, a moment that biases the sensor tip into the sharp channel.
During deployment, the sensor deflects to disengage the sharp.
[0237] FIGS. 78-79 illustrate an inserter having a sensor retention
mechanism in accordance with a further embodiment of the subject
disclosure. Sharp 4640 is provided with a clip 4660 that engages a
retention window 4662 at the top of sensor 4614 to provide
retention of sensor 4614 in sharp 4640, and vertical registration.
Two drive blocks 4659 and 4661 on carrier 4654 traverse sharp 4640
to engage the top edge of sensor 4614. There is a gap between the
left drive block 4659 and the top edge of sensor 4614. Right drive
block 4661 is in contact with the top edge of sensor 4614. During
insertion, the upward drive force of the skin on sensor 4614
produces a clock-wise rotational moment on sensor 4614 that biases
sharp 4614 into the sharp channel.
[0238] The clip feature 4660 and the window 4662 can be moved to
the left to bias the tip of the sensor 4614 into the channel during
shipping. During deployment, the sensor 4614 and the clip 4662
deflect to transfer the sensor 4614 to the mount 4312.
[0239] FIG. 80 illustrates a further embodiment of a sensor
retention technique. In particular, sensor 4714 is provided with a
retention member 4760, which extends from the contact portion 4732
of the sensor 4714. Retention member 4760 is resiliently biased in
the position as shown. When the sensor 4714 is inserted within the
sharp (not shown), the retention member engages the inner portion
of rails (not shown) of the sharp, and provides a retention force
to the sensor 4714.
[0240] FIG. 81 illustrates another embodiment of a sensor retention
technique. Sensor 4814 is provided with a dimple 4860 which is
thermally formed. As shown in FIG. 82, a raised bump 4864 on the
sharp 4840 frictionally contacts thermally formed dimple 4860 in
order to provide retention force to the sensor 4814. In some
embodiments, raised bump is formed using heat. In another
embodiment, a raised bump is formed on the sensor and the dimple is
formed on the sharp.
[0241] FIGS. 83-84 illustrate an aperture 4960 which is formed in
the contact portion of the sensor 4914. A raised bump or tab 4962
is provided on the sharp 4940. The interaction of the tab 4962
within the aperture 4960 of the sensor 4914 assists in retaining
the sensor 4914 within the inserter.
[0242] FIGS. 85-86 illustrate a technique for retention of the
sensor 5014 which is similar to the techniques illustrated in FIGS.
81-84. For example, a raised bump 5062 is provided on sharp 5040
which engages the contact portion 5032 of the sensor 5014. In such
configuration, the raised bump 5062 creates a bias force against
the contact portion 5032. Such force acts as a frictional force to
assist retention of the sensor 5014 within the sharp 5040.
[0243] FIGS. 87 and 88 illustrate sensors having retention members
which engage a raised post or button on the sharp. FIG. 87
illustrates that contact portion 5132 of sensor 5114 includes a
pair of "pincer fingers" 5160 having a substantially arcuate
configuration which surround and engage a post 5162 provided on the
sharp. Similarly, FIG. 88 illustrates sensor 5214 having a pair of
proximally extending arms 5260, which engage a post 5262 on the
sharp.
[0244] FIG. 89 illustrates a sensor 5314 having a laterally
extending arm 5360 which defines a channel 5364 between the arm
5360 and the contact portion 5332 of the sensor 5314. As
illustrated in the figure, a post 5360 may be positioned within the
channel 5364, and provides frictional resistance to maintain the
sensor 5314 within the sharp.
[0245] FIG. 90 illustrates a sensor 5414 having a proximally
extending arm 5460 which defines a channel 5362 between the arm
5460 and the contact portion 5432 of the sensor 5414. As
illustrated in the figure, a tab 5364 is provided on the arm 5460
and is received within a gap provided in the rails of the sharp.
This interaction of the tab 5364 with the gap provides frictional
resistance to maintain the sensor 5414 within the sharp.
[0246] FIGS. 91-92 refer to sensor retention techniques which
include a retention member which provides a frictional force
substantially normal (perpendicular) to the surface of the sensor.
FIGS. 91 and 92 illustrate a retention member which is provided
within the housing 5534 of the inserter 5510. For example, the
retention member 5560 may extend distally from the housing 5534 and
includes a laterally extending tab 5562 which contacts the sensor
5563 and provides a frictional force to assist retention of the
sensor within the sharp 5540.
[0247] FIGS. 93 and 94 illustrate a retention member which is
provided with the base 5644 of the inserter 5610. For example,
retention member may include a cantilever 5660 which extends
proximally from base 5644 of the inserter 5610. Cantilever 5660 may
include a laterally extending member 5662 which contacts the sensor
5661 and provides a frictional force to assist retention of the
sensor within the sharp 5640. When the carrier 5666 bottoms down,
the cantilever 5660 ceases contact and release of the sensor
occurs.
[0248] FIGS. 95 and 96 illustrate a resilient or elastomeric member
which is disposed within the housing 5734 of the inserter 5710. For
example, elastomeric member 5760 is manufactured from TPE and
presses against the sensor and the resulting friction keeps the
sensor in place. The TPE material creates a higher friction with
respect to the sensor, and therefore requires less pressure to
produce the sensor holding force. When the inserter 5710 is
actuated, the frictional forces are directed upward keeping the
sensor inside the sharp. When the carrier bottoms down, the contact
with the friction rib ceases and the sensor releases to the mount.
In some embodiments, the elastomeric member 5760, or rib, is
produced with a second-shot injection molded process or press-fit
into housing 5734.
[0249] FIGS. 97 and 98 refer to retention members which provide a
frictional force in a substantially coplanar direction to the
surface of the sensor. FIG. 97 illustrates a retention member or
cantilever 5860 which is biased against the side edge of the
contact portion 5832 of the sensor 5814. In some embodiments,
cantilever 5860 is provided on the carrier or sharp (not shown).
FIG. 98 illustrates a sensor retention technique which includes a
retention member, or cantilever 5960 which is biased against the
sensor, as described in FIG. 97. Cantilever 5960 includes a
laterally extending portion which is at least partially received in
an optionally provided notch 5964 in sensor 5914. In addition, a
second retention member, or retention spring 5990, is provided
which is biased to engage the front surface of the sensor. In some
embodiments, retention spring 5990 is partially received in cut-out
5994 (or a slot) to capture the sensor.
[0250] In some embodiments, an inserter assembly is provided which
includes a reusable inserter apparatus. Repeated uses of the
inserter include the use of a removable and exchangeable sensor and
sharp which may be coupled to the inserter during deployment of the
sensor, and in which the sharp is removed and discarded after
deployment.
[0251] FIGS. 99-101 illustrate a system of sharp/sensor packs 6002
which contain a plurality of sensor/sharp combinations 6006. As
illustrated in FIGS. 99 and 101, a support is provided which
includes a plurality of trays 6004 which are useful for containing
the sensor/sharp configuration 6006, and well as a desiccant 6010
which is contained in a chamber 6008. A well 6012 is provided on
one side of the tray 6004 to accommodate the sensor sharp for
installation into a patient. A cover, such as a foil lid 6014 is
applied to the top of the support to maintain the sterility of the
sensor/sharp combination until installation in a subject. FIG. 100
is a perspective view which illustrates an exemplary configuration
of pack 6002. The foil lid 6014 for each of trays 6004 may include
a tab 6016 to facilitate removal of the lid from the tray 6004
(FIGS. 100, 101).
[0252] FIGS. 102-105 illustrate a plurality of reusable inserters
which are useful in combination with the sharp/sensor packs 6002
described herein. FIG. 102 illustrates an inserter 6030 which
includes a body portion 6032, a loading or cocking structure 6036,
and an actuator button 6040 for deploying the sensor into the skin
of the subject. The advancement structure of inserter 6030 may
include a cocking structure which is pulled to arm, e.g., by
withdrawing the cocking structure 6036 from the housing 6032; which
is pushed to arm, e.g., by depressing the cocking structure 6036
into the housing 6032; or which is rotated to arm, e.g., by
rotating the cocking structure 6036 in a rotational movement
parallel to the longitudinal axis of the inserter 6030, or
perpendicular to the longitudinal axis of the inserter 6030. The
driving mechanism of inserter 6030 is substantially similar to the
driving mechanisms as disclosed in U.S. Patent Publication
2008/0082166, now U.S. Pat. No. 8,167,934, U.S. Pat. No. 6,197,040,
or U.S. Pat. No. 4,976,724, which are incorporated by reference in
their entirety herein for all purposes.
[0253] To insert the sharp/sensor combination into the inserter
6030, the foil lid is removed from sharp/sensor pack 6002. The
distal end portion 6034 of the inserter 6030 is positioned within
the walls 6004 of the tray 6002, as indicated in the direction of
arrow E. The distal end portion 6034 comes to rest on the upper
surface of desiccant chamber 6008, such that the insertion sharp
remains exposed.
[0254] FIG. 103 illustrates an inserter 6130 substantially
identical to the inserter 6030 described herein. Inserter 6130 is
used in connection with sharp/sensor trays 6102. Trays 6102 include
a desiccant chamber 6108 which is located in the center portion of
the tray 6102. Accordingly, a channel 6112 surrounds the periphery
of desiccant chamber 6108. When the inserter 6130 is applied to the
sharp/sensor tray 6102, the distal end portion 6134 can be
positioned within the channel 6112. As illustrated in FIG. 103,
this configuration allows the sensor and sharp to be completely
housed within the inserter 6130.
[0255] FIG. 104 illustrates an inserter 6230 substantially
identical to the inserters 6030 and 6130 described herein, with the
differences noted herein and illustrated in the figures. Inserter
6230 may be used in connection with sharp/sensor trays 6204. The
tray 6204 and inserter 6230 are sized and configured such that tray
6204 is capable of being positioned entirely within the distal end
portion 6234 of inserter 6230. One or more support struts 6220 are
provided adjacent the distal end portion 6234 to stabilize the
inserter with respect to any surface on which the inserter 6230 and
trays 6204 are placed for the insertion step. Support struts 6220
may also secure inserter 6230 to an adhesive mount (not shown)
during insertion.
[0256] FIG. 105 illustrates an inserter 6330 which is substantially
identical to the inserters 6030, 6130, and 6230 described herein,
with the differences noted herein and illustrated in the figures.
Inserter 6330 may be used in connection with sharp/sensor tray
6304. In some embodiment, tray 6304 includes a distally projecting
handle portion 6340 which may be grasped by the user to facilitate
insertion of the sharp/sensor into the inserter.
[0257] FIGS. 106-107 illustrate an exemplary sharp/sensor
combination for use with inserters 6030, 6130, 6230, and 6330
described herein. Sharp 6440 includes side rails 6448 for sliding
reception of a sensor therein. A locking tab 6450 is also provided
on the proximal portion of the sharp and includes cut-out portion
6452 for interlocking with the carrier of the inserter 6030 (or
6130, 6230, or 6330). As illustrated in FIGS. 108-112 carrier 6466
includes reception structure for mating reception with the sharp
6440. For example, carrier 6466 may include a pair of walls 6478
providing a channel 6480 in which said sharp 6440 may be
positioned. Walls 6478 are provided with cutout portions 6482 for
reception of undercut portion 6452 in locking tab 6450. A pair of
securement members 6484 are movably mounted on the carrier 6466.
For example, members 6484 are biased via a spring 6486 towards a
center portion of the carrier 6466. As illustrated in FIG. 111,
securement members 6484 may be moved outwardly against the spring
bias to allow for the insertion of the locking tab 6450 into the
cutout portion 6482 of the carrier. Securement member 6484 is
subsequently released and returns to a position to engage the
undercut portion 6452 to prevent accidental removal of the sharp
and sensor from the inserter (FIG. 112). It is understood that
coupling of the sharp and carrier may be provided by alternative
techniques such as frictional fit, snap-fit, bayonet mounts,
magnetic coupling, etc.
[0258] FIGS. 113-117 illustrate a further embodiment of the subject
disclosure that is reusable, and useful with the sharp/sensor packs
discussed herein. FIG. 113 illustrates a sensor pack 6504 which is
similar to the sensor packs described herein. Sharp/sensor pack
6504 also includes one or more reinforcing ribs 6574 to prevent
accidental deformation of the pack 6504 when the sensor is being
inserted into the inserter.
[0259] As illustrated in FIG. 114, inserter 6530 is provided which
is substantially similar to inserters 6030, 6130, 6230, and 6330
described herein, with the differences noted herein or illustrated
in the figures. Inserter 6530 includes a carrier (not shown) for
coupling with a sharp/sensor combination. As illustrated in the
figure, inserter 6530 is lowered onto sharp/sensor pack 6504 in
order to couple the sharp 6506 with the carrier. As illustrated in
FIG. 115, inserter 6530 which now contains the sharp/sensor 6506 is
positioned over the mount 6512. Mount 6512 may include an adhesive
for securement to the skin of the subject. Inserter 6530 includes a
locking structure 6526 which allows for temporary engagement of the
inserter 6530 with the mount 6512.
[0260] As illustrated in FIG. 116, the sensor is deployed by
depressing actuation button 6532 on the inserter 6530 to advance
the sensor into the skin by use of an internal drive mechanism,
such as, e.g., a spring. It is understood that the above-described
process may alternatively be carried out by using an inserter which
allows the user to provide a manual distal force for deployment of
the sensor.
[0261] Following installation of the sensor, inserter 6530 is
decoupled from the mount, e.g., by depressing locking buttons 6526
on inserter 6530. Once the inserter 6530 is separated from the
mount, the user may remove and discard the sharp. In some
embodiments, inserter 6530 includes a sliding lever 6540 which
allows for removal of the sharp. It is understood that
disengagement of the sharp from carrier may be executed in one of
several ways, e.g., sliding switch allows securement member
(discussed herein) to slide outwardly and allow disengagement of
the contact portions 6483 of the securement members 6484 from the
undercut portions 6452 of locking tab 6450.
[0262] FIG. 118 illustrates an inserter 6630 and engagement
structure for mounting on mount 6612. Inserter 6630 includes a body
portion 6640 which is configured to advance a sharp/sensor
cartridge into the skin S of a subject along longitudinal axis LON.
The longitudinal axis LON may be substantially perpendicular to the
skin surface. In some embodiments, axis LON forms an acute angle
with the skin surface. Mount 6612 and inserter 6630 are each
provided with complementary locking structures 6662 on the mount
6612 and 6664 on the inserter. Inserter is advanced laterally
(direction LAT) over mount 6612. Inserter 6630 may be locked in
place by pivoting locking structure 6632 about pivot 6626.
Following such pivoting action, the engagement portion 6666 of
locking structure 6632 is received in recess 6668 in mount 6612.
Securement of the inserter to the mount is further provided by
insertion of the sharp/sensor cartridge 6650 between the inserter
6630 and the mount 6612. For example, cartridge 6650 includes
raised tabs 6654 which are slidable within complementary grooves
6652 provided on the inserter 6630 and mount 6612. Insertion of the
cartridge is carried out in a direction perpendicular to the
direction in which the inserter is attached to the mount, e.g., a
direction perpendicular to the plane of the page.
[0263] FIGS. 119-121 illustrate another embodiment of an inserter
in accordance with the disclosed subject matter. Inserter 6730 is
useful for advancing a medical device, such as an analyte sensor,
into the skin of a subject. Inserter 6730 includes a hammer member
6760 which accumulates advancement energy to provide a more rapid
and powerful advancement stroke. As illustrated in FIG. 119, hammer
member 6760 is initially positioned somewhat askew with respect to
the longitudinal axis of the device. As the alignment trigger 6734
is advanced distally, alignment sleeves 6736 gradually pivot the
hammer member 6760 into a longitudinal configuration. As the hammer
member 6760 is being pivoted into position, the advancement spring
continues to be compressed. With reference to FIG. 120, the hammer
member 6760 is pivoted into alignment with the central bore of the
inserter 6730, e.g., along the longitudinal axis represented by the
arrow. Consequently, the tension of advancement spring 6742 is
immediately released, which permits rapid distal movement of the
hammer member 6760. Hammer member 6760 contacts carrier 6744, which
in turn contacts sharp/sensor combination 6718 to provide distal
movement.
[0264] As illustrated in FIG. 121, a ledge or lateral member 6726
is provided with the internal bore of the inserter. As the hammer
member 6760 advances distally, the distal surface of the hammer
member contacts the ledge 6726. Interengagement of the hammer
member 6760 and the ledge 6726 inhibits further distal travel of
the hammer member 6760.
[0265] FIG. 122 illustrates an exemplary embodiment of a simplified
unit, or cartridge 6800, which holds certain components for
sterility and subsequent interaction with the subject. In some
embodiments, the components include the sharp 6840, the housing
6860, the sensor 6814. The cartridge 6800 may be used in connection
with any of the inserters 6030, 6130, 6230, 6330, 6530 and/or 6730
described herein. In some embodiments, the cartridge includes a
housing and a lid which contain the sharp and sensor therein. In
some embodiments, a resilient member or other cantilever structure
is used to maintain the alignment of the sharp and sensor within
the cartridge. Interaction of the cartridge with the inserter
advances the sensor and sharp such that the sensor is installed at
the subject.
[0266] As illustrated in FIGS. 123-124, the sharp 6840 and sensor
6814 may sit in a recessed portion of the disposable cartridge
6800. A spring finger or cantilever 6876 on the housing lid
maintains a load on the sharp 6840 and sensor 6814 to keep it
depressed in the cavity. Attachment for a lid to the base of the
cartridge housing 6860 is not shown in the figure above, but
methods such as snaps, heat stake, or ultrasonic welding may be
used to join the two housings in assembly. The sensor 6814 is
contained within the sharp 6840, laterally by the two rounded ends
6848 of the sharp, and in the orthogonal lateral direction (in
relation to the views shown above), by two bent tabs 6849 on the
sharp 6840 and the cartridge housing base cavity. The sharp is held
in its lateral position by not only the cavity, but also by the
raised pyramid feature 6878 shown on the housing base 6870. In the
figure above, the locating pyramid sits in the opening 6882 created
from the bent tab in the sharp. The engagement features to
locate/attach/engage the cartridge to the inserter portion of the
device are not shown in the figures above, but may include such
features as illustrated in FIGS. 106-112 above.
[0267] As illustrated in FIGS. 125 and 126, when the cartridge 6800
is loaded onto the reusable inserter part of the device, the sharp
is raised out of its cavity by stationary elements built onto the
inserter (not shown). Features from the reusable portion of the
inserter enter through the two shorter slots shown FIG. 122. These
features will remain stationary throughout the sensor delivery
action of the inserter device.
[0268] In the longer middle slot 6866, a stepped feature from the
inserter, mates with the opening on the sharp (shown as two holes
6864 in the figure above). The stepped portion of the feature
provides a force on the back portion of the sharp to keep it raised
against the force of the sprung cantilever 6876 on the housing.
This feature of the inserter will move in relation to the cartridge
and provide the drive and retraction movement for the sharp through
insertion and delivery of the sensor. In some embodiments, the
force is transmitted through driving pins which are part of the
movable portion of the inserter device. The driving pins protrude
through holes 6864. In case of minor misalignment of the driving
pins (not shown), ribs on the cartridge housing lid will constrain
the sharp from tilting up.
[0269] Once the sharp and sensor are raised from the cavity portion
of the cartridge, they are no longer constrained by the recessed
cavity portion of the housing base and the pyramid feature
maintaining the sharp position. The sharp is held in its raised
position by the stationary and stepped drive feature of the
inserter, balanced with the force of the cantilever finger on the
lid housing. The sensor is kept in place by being pinched against
the cantilever finger on the housing lid. The sharp is constrained
in its retracted position by the mated drive feature of the
inserter.
[0270] As the inserter is actuated, the mated inserter drive
feature drives the sharp downward as it moves through the longer
slot shown in the figure above (see FIGS. 127-129). The driven
sharp slides along the stationary ribs of the inserter, ribbed
features built into the cartridge housing, and the housing lid
cantilever finger. The friction force of the cantilever keeps the
sensor up against the `drive block` and bends in the sharp sheet
metal to assure the tail is not exposed from the sharp channel
during insertion. In some embodiments, the `drive block` features
are longitudinal constraints either built into the sharp or the
carrier which constrain the sensor from proximal movement with
respect to the sharp. In another embodiment, the drive block
features are protrusions on the carrier or bends on the sharp which
push the sensor as the sharp is propelled distally.
[0271] The sensor is kept from popping over the drive block
features by the stationary ribs built into the housing lid. As the
cantilever slides over the top edge of the sensor, the retention
force is relieved from the sensor, and it can be captured onto the
mount portion of the device with relatively little force.
Alternately, if geometry permits, and the finger is positioned
appropriately, the pinching of the cantilever on the sharp may
provide enough resistance on the return motion of the sharp to keep
the sensor in its inserted position even without a capture device
on the mount. The inserter drive feature then retracts the sharp,
leaving the sensor in place on the mount portion (that is attached
to the skin) of the device.
[0272] The cartridge can be removed from the inserter. As the
cartridge is removed, the force from the housing lid cantilever
presses the sharp back into the recess on the cartridge base
housing. The base housing is removed and can be discarded.
[0273] Another embodiment of the cartridge is illustrated in FIGS.
131-137. As illustrated in FIG. 131, the sharp 6940 and sensor 6914
in this embodiment abuts ribs 6972 and 6974 and on insertion plane
to which the sharp 6940 will be driven and refracted by the
inserter into the skin. The sharp and sensor are held in place by a
central cantilever feature 6976 built onto the cartridge lid
housing. This cantilever 6976 has geometry such that a vertical
portion of the end of the cantilever is butted against the sharp
6940 and sensor 6914.
[0274] As illustrated in FIGS. 132 and 133, the cartridge 6900 is
loaded onto the inserter, in which a stationary feature on the
inserter (not shown) raises the cartridge cantilever so that the
ramped portion of the cantilever end feature is now in line with
the insertion plane of the sharp. Also, a driving element of the
inserter (not shown) fits through the slot opening on the sharp. In
the embodiment described herein, a step is not required on the
driving element on this design.
[0275] As the sharp is driven downward (see, FIGS. 134-135), the
cantilever arm 6976 is pushed up, keeping the sensor in position
against the sharp 6940. Stationary ribs on the housing lid assure
that the sharp 6940 maintains its insertion plane during insertion,
and also assures that the pinching force of the cantilever does not
cause the sensor to hop the drive block elements integrated into
the sharp. The stationary ribs keep the sensor flat against the
sharp through the insertion motion.
[0276] As illustrated in FIGS. 136-137, the sensor 6914 is captured
at the bottom of its motion on the mount, as discussed hereinabove.
The drive elements on the inserter retract the sharp 6940 back to
its starting position. The cantilever arm 6976 returns to its
original unbiased configuration. The cartridge 6900 is removed from
the inserter and can be discarded.
[0277] 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.
* * * * *