U.S. patent application number 17/707515 was filed with the patent office on 2022-07-14 for medical device inserters and processes of inserting and using medical devices.
The applicant listed for this patent is ABBOTT DIABETES CARE INC.. Invention is credited to Manuel Luis Donnay, Tuan Nguyen, Louis G. Pace, Peter G. Robinson.
Application Number | 20220218247 17/707515 |
Document ID | / |
Family ID | 1000006239055 |
Filed Date | 2022-07-14 |
United States Patent
Application |
20220218247 |
Kind Code |
A1 |
Donnay; Manuel Luis ; et
al. |
July 14, 2022 |
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. Embodiments include removing a substantially cylindrical
cap from an inserter to expose a substantially cylindrical sleeve,
removing a cover from a substantially cylindrical container holding
sensor components, and fitting the sensor components into the
inserter.
Inventors: |
Donnay; Manuel Luis; (San
Francisco, CA) ; Nguyen; Tuan; (Dublin, CA) ;
Pace; Louis G.; (San Carlos, CA) ; Robinson; Peter
G.; (Alamo, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBOTT DIABETES CARE INC. |
Alameda |
CA |
US |
|
|
Family ID: |
1000006239055 |
Appl. No.: |
17/707515 |
Filed: |
March 29, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16002847 |
Jun 7, 2018 |
|
|
|
17707515 |
|
|
|
|
13436768 |
Mar 30, 2012 |
10010280 |
|
|
16002847 |
|
|
|
|
13071461 |
Mar 24, 2011 |
9215992 |
|
|
13436768 |
|
|
|
|
61411262 |
Nov 8, 2010 |
|
|
|
61361374 |
Jul 2, 2010 |
|
|
|
61345562 |
May 17, 2010 |
|
|
|
61317243 |
Mar 24, 2010 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/15113 20130101;
A61B 5/0002 20130101; A61B 5/14546 20130101; A61B 5/150259
20130101; A61B 5/15186 20130101; A61B 5/1411 20130101; A61B 5/157
20130101; A61B 5/150282 20130101; A61B 5/14542 20130101; A61B
5/1513 20130101; A61M 2005/1585 20130101; A61B 5/150427 20130101;
A61B 5/150396 20130101; A61B 5/150511 20130101; A61B 5/15016
20130101; A61B 5/15117 20130101; A61B 5/150022 20130101; A61B
5/14503 20130101; A61B 5/150732 20130101; A61B 17/34 20130101; A61B
5/15087 20130101; A61B 5/150419 20130101; A61B 5/15194 20130101;
A61B 5/14532 20130101; A61B 2560/063 20130101; A61B 17/3468
20130101; A61B 5/01 20130101; A61B 5/1519 20130101; A61B 5/15107
20130101; A61B 2017/00384 20130101; A61B 5/6848 20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/151 20060101 A61B005/151; A61B 5/145 20060101
A61B005/145; A61B 5/00 20060101 A61B005/00; A61M 5/158 20060101
A61M005/158; A61B 5/157 20060101 A61B005/157; A61B 17/34 20060101
A61B017/34 |
Claims
1-25. (canceled)
26. An insertion assembly comprising: an inserter, comprising: a
sharp hub coupled with a sharp, the sharp hub disposed in an
interior of the inserter and configured to move from a proximal
position to a distal position, wherein the sharp comprises a distal
portion including a distal tip, a first set of distal edges, and a
second set of distal edges, wherein the first set of distal edges
is proximal to the distal tip, and the second set of distal edges
is proximal to the first set of distal edges and the distal tip,
wherein the first set of distal edges forms an included angle
comprising a first acute angle, and wherein the second set of
distal edges forms a lead-in angle, wherein the lead-in angle
comprises a second acute angle that is different from the first
acute angle; and a spring disposed in the interior of the inserter
and configured to retract the sharp hub from the distal position
towards a retracted position.
27. The insertion assembly of claim 26, wherein the sharp further
comprises a U-shaped cross-sectional area.
28. The insertion assembly of claim 27, wherein the U-shaped
cross-sectional area of the sharp comprises a flat bottom
portion.
29. The insertion assembly of claim 26, wherein the included angle
is configured to facilitate piercing of skin by the distal tip.
30. The insertion assembly of claim 26, wherein the lead-in angle
is configured to strengthen the distal tip.
31. The insertion assembly of claim 26, wherein the lead-in angle
is between 20 degrees and 45 degrees.
32. The insertion assembly of claim 26, wherein the lead-in angle
is about 20 degrees.
33. The insertion assembly of claim 26, wherein the lead-in angle
is about 45 degrees.
34. The insertion assembly of claim 26, wherein the second acute
angle is less acute than the first acute angle.
35. The insertion assembly of claim 26, wherein the distal portion
of the sharp further comprises a pair of substantially parallel
side walls.
36. The insertion assembly of claim 35, wherein the second set of
distal edges is disposed between the first set of distal edges and
the pair of substantially parallel side walls.
37. The insertion assembly of claim 26, wherein the distal portion
of the sharp further comprises one or more rising edge
portions.
38. The insertion assembly of claim 37, wherein the one or more
rising edge portions form a lead-out angle.
39. The insertion assembly of claim 38, wherein the lead-out angle
is configured to facilitate separation of tissue by the one or more
rising edge portions.
40. The insertion assembly of claim 38, wherein the lead-out angle
is approximately 20 degrees.
41. The insertion assembly of claim 26, wherein at least a portion
of the sharp is formed through a die cutting process.
42. The insertion assembly of claim 26, wherein at least a portion
of the sharp is subjected to a grinding process.
43. The insertion assembly of claim 26, wherein the inserter
further comprises a button disposed on a top portion of the
inserter, wherein the button is configured to be depressed, and
wherein the button comprises a plunger portion.
44. The insertion assembly of claim 26, further comprising: an on
body unit, comprising: an on body unit housing; an analyte sensor,
wherein a portion of the analyte sensor is configured to be
inserted under skin of a subject; and sensor electronics disposed
in the on body unit housing and coupled with the analyte sensor,
wherein the on body unit is disposed in the interior of the
inserter while the sharp hub is in the proximal position.
45. The insertion assembly of claim 44, wherein the sensor
electronics comprises one or more processors, memory, a power
supply, and wireless communication circuitry configured to
communicate data indicative of an analyte level according to a
Bluetooth communication protocol.
46. The insertion assembly of claim 26, wherein after retraction of
the sharp hub, at least a portion of the sharp is disposed within
an inner circumference of the spring.
47. The insertion assembly of claim 44, further comprising an
adhesive portion configured to secure the on body unit to the skin
of the subject.
48. The insertion assembly of claim 26, further comprising a
removable cap configured to be removed from a distal end of the
inserter.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 16/002,847, filed Jun. 7, 2018, which is a
continuation of U.S. patent application Ser. No. 13/436,768, filed
Mar. 30, 2012, now U.S. Pat. No. 10,010,280, which is a
continuation of U.S. patent application Ser. No. 13/071,461, filed
Mar. 24, 2011, now U.S. Pat. No. 9,215,992, which claims the
benefit of U.S. Provisional Application Nos. 61/317,243, filed Mar.
24, 2010; 61/345,562, filed May 17, 2010; 61/361,374, filed Jul. 2,
2010; and 61/411,262, filed Nov. 8, 2010, all of which are
incorporated herein by reference in their entireties and for all
purposes.
INCORPORATION BY REFERENCE
[0002] Patents, applications and/or publications described herein,
including the following patents, applications and/or publications
are incorporated herein by reference for all purposes: U.S. Pat.
Nos. 4,545,382; 4,711,245; 5,262,035; 5,262,305; 5,264,104;
5,320,715; 5,356,786; 5,509,410; 5,543,326; 5,593,852; 5,601,435;
5,628,890; 5,820,551; 5,822,715; 5,899,855; 5,918,603; 6,071,391;
6,103,033; 6,120,676; 6,121,009; 6,134,461; 6,143,164; 6,144,837;
6,161,095; 6,175,752; 6,270,455; 6,284,478; 6,299,757; 6,338,790;
6,377,894; 6,461,496; 6,503,381; 6,514,460; 6,514,718; 6,540,891;
6,560,471; 6,579,690; 6,591,125; 6,592,745; 6,600,997; 6,605,200;
6,605,201; 6,616,819; 6,618,934; 6,650,471; 6,654,625; 6,676,816;
6,730,200; 6,736,957; 6,746,582; 6,749,740; 6,764,581; 6,773,671;
6,881,551; 6,893,545; 6,932,892; 6,932,894; 6,942,518; 7,041,468;
7,167,818; and 7,299,082; 7,381,184; 7,740,581; 7,811,231; U.S.
Published Application Nos. 2005/0182306, now U.S. Pat. No.
8,771,183; 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, now U.S.
Pat. No. 9,014,773; 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, now U.S.
Pat. No. 8,808,515; 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, now U.S. Pat. No. 8,983,568; 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.
No. 12/624,767, now U.S. Patent Publ. No. 2011/0124993; Ser. No.
12/625,185, now U.S. Pat. No. 8,354,013; Ser. No. 12/625,208, now
U.S. Pat. No. 9,042,954; 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,
now U.S. Patent Publ. No. 2010/0076289; Ser. No. 12/628,198, now
U.S. Patent Publ. No. 2010/0076291; Ser. No. 12/628,201, now U.S.
Patent Publ. No. 2010/0076280; Ser. No. 12/628,203, now U.S. Patent
Publ. No. 2010/0076292; Ser. No. 12/628,210, now U.S. Patent Publ.
No. 2010/0076293; Ser. No. 12/698,124, now U.S. Patent Publ. No.
2010/0198034; Ser. No. 12/698,129, now U.S. Patent Publ. No.
2010/03243925; Ser. No. 12/699,653, now U.S. Patent Publ. No.
2010/0198142; Ser. No. 12/699,844, now U.S. Pat. No. 8,930,203;
Ser. No. 12/714,439, now U.S. Patent Publ. No. 2010/0230285; Ser.
Nos. 12/730,193; 12/794,721, now U.S. Pat. No. 8,595,607; Ser. No.
12/807,278, now U.S. Patent Publ. No. 2011/0213225; Ser. No.
12/842,013, now U.S. Patent Publ. No. 2011/0021889; Ser. No.
12/870,818, now U.S. Patent Publ. No. 2011/0073475; Ser. No.
12/871,901, now U.S. Pat. No. 8,514,086; Ser. No. 12/873,301, now
U.S. Patent Publ. No. 2011/0054275; Ser. No. 12/873,302, now U.S.
Patent Publ. No. 2011/0060196; Ser. No. 13/011,897, now U.S. Patent
Publ. No. 2011/0184265; 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, A1C, or the like, in certain
individuals is vitally important to their health. For example, the
monitoring of glucose is particularly important to individuals with
diabetes. Diabetics generally monitor glucose levels to determine
if their glucose levels are being maintained within a clinically
safe range, and may also use this information to determine if
and/or when insulin is needed to reduce glucose levels in their
bodies or when additional glucose is needed to raise the level of
glucose in their bodies.
[0004] Growing clinical data demonstrates a strong correlation
between the frequency of glucose monitoring and glycemic control.
Despite such correlation, many individuals diagnosed with a
diabetic condition do not monitor their glucose levels as
frequently as they should due to a combination of factors including
convenience, testing discretion, pain associated with glucose
testing, and cost.
[0005] Devices have been developed for the automatic monitoring of
analyte(s), such as glucose, in bodily fluid such as in the blood
stream or in interstitial fluid ("ISF"), or other biological fluid.
Some of these analyte measuring devices are configured so that at
least a portion of the devices are positioned below a skin surface
of a user, e.g., in a blood vessel or in the subcutaneous tissue of
a user, so that the monitoring is accomplished in vivo.
[0006] With the continued development of analyte monitoring devices
and systems, there is a need for such analyte monitoring devices,
systems, and methods, as well as for processes for manufacturing
analyte monitoring devices and systems that are cost effective,
convenient, and with reduced pain, provide discreet monitoring to
encourage frequent analyte monitoring to improve glycemic
control.
SUMMARY
[0007] In certain embodiments, an apparatus for inserting a medical
device into the skin of a subject is provided, which includes a
sheath defining a distal surface for placement on the skin of the
subject; a device support movable between a proximal and distal
position, and adapted to support the medical device; a sharp
support movable between a proximal and a distal position and
adapted to support a sharp for inserting the medical device into
the skin of the subject and extending through a portion of said
device support, the device support comprising a first engagement
member for releasably coupling the sharp support to the device
support and a second engagement member for engaging the medical
device; a handle movable between a proximal position and a distal
position relative to the sheath and adapted to urge the device
support and the sharp support from a proximal to a distal position
to insert the sharp into the skin of the subject; and a driver for
advancing the sharp support towards the proximal position when the
sharp support reaches the distal position.
[0008] In some embodiments, the handle and sheath define an
interlocking configuration which prevents relative movement of the
handle with respect to the sheath which is overcome by a force
applied to the handle. In some embodiment, the second engagement
member includes one or more movable arms for engaging the device.
The one or more movable arms are normally biased in a position
spaced apart from the medical device in some embodiments. The one
or more movable arms may be maintained in engagement with the
medical device when the device support is in the proximal position.
In some embodiments, the one or more movable arms return to the
configuration space apart from the medical device when the device
support is in the distal position.
[0009] In some embodiments, the engagement member is released from
the sharp support when the device support reaches a distal
position. In some embodiments, the engagement member is maintained
in engagement with the device support by a portion of the
sheath.
[0010] In some embodiments, a stop is provided to maintain the
device support in the proximal position.
[0011] In some embodiments, the handle includes a button disposed
within an outer housing. The handle may be flush with the top of
the outer housing in an initial configuration when the medical
device is supported in the device support, and the handle may
protrude above the outer housing after the medical device is
released from the device support.
[0012] In some embodiments, the medical device is an analyte
sensor.
[0013] A method for using a medical device is provided which
includes providing an apparatus comprising a sheath defining a
distal surface, a device support adapted to support the medical
device, a sharp support adapted to support a sharp extending
through a portion of said device support, a handle movable relative
to the sheath, and a driver for displacing the sharp support;
disposing the distal surface of the sheath on the skin of the
subject; and displacing the handle in a first longitudinal
direction; displacing the sharp support in the first longitudinal
direction, the sharp support displacing the sharp and the medical
device. The method further includes inserting the sharp into the
skin of the subject; delivering the medical device to the subject;
releasing the driver; and displacing the sharp in the second
longitudinal direction by the driver.
[0014] In some embodiments, the method further includes locking at
least a portion of the sheath to the handle.
[0015] 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
[0016] 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.
[0017] FIG. 1 illustrates an analyte monitoring system for real
time analyte (e.g., glucose) measurement, data acquisition and/or
processing in certain embodiments;
[0018] FIG. 2 is a view of an electrochemical sensor in accordance
with an embodiment of the disclosed subject matter;
[0019] FIG. 3 is a view of the electrochemical sensor of FIG. 2 in
a folded configuration in accordance with the disclosed subject
matter;
[0020] FIG. 4 is a perspective view of an embodiment of an inserter
in accordance with one embodiment of the disclosed subject
matter;
[0021] FIGS. 5-6 are perspective views of the inserter of FIG. 4 in
accordance with the disclosed subject matter;
[0022] FIGS. 7-8 are sectional, perspective views of the inserter
of FIG. 4 in accordance with the disclosed subject matter;
[0023] FIGS. 9-10 are schematic views of a needle hub in accordance
with one embodiment of the disclosed subject matter;
[0024] FIG. 11 is a distal end view of a sharp in accordance with
one embodiment of the disclosed subject matter;
[0025] FIG. 12 is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0026] FIG. 13 is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0027] FIG. 14 is a perspective view of a sharp in accordance with
one embodiment of the disclosed subject matter;
[0028] FIGS. 14A-B are top views of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0029] FIG. 14C is a side view of a sharp in accordance with one
embodiment of the disclosed subject matter;
[0030] FIG. 15 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;
[0031] FIG. 16 is a perspective view of an inserter in accordance
with one embodiment of the disclosed subject matter;
[0032] FIG. 17 is a perspective view with parts separated of an
inserter in accordance with one embodiment of the disclosed subject
matter;
[0033] FIG. 17A is an enlarged perspective view of a portion of an
inserter in accordance with one embodiment of the disclosed subject
matter.
[0034] FIG. 18 is an enlarged sectional view with parts separated
of an inserter in accordance with one embodiment of the disclosed
subject matter;
[0035] FIGS. 19-21 depict an alternative method for retaining a
sharp and sensor within the on body housing;
[0036] FIG. 22 is a sectional, perspective views of the inserter of
FIG. 4 in accordance with the disclosed subject matter;
[0037] FIGS. 23-24 are perspective views of the inserter of FIG. 4
in accordance with the disclosed subject matter;
[0038] FIGS. 25-26 are perspective views of another embodiment of
an inserter in accordance with the disclosed subject matter;
[0039] FIGS. 27-32 are perspective views of components of the
inserter of FIG. 25 in accordance with the disclosed subject
matter;
[0040] FIG. 33 is a sectional view of the inserter of FIG. 25 in
accordance with the disclosed subject matter;
[0041] FIG. 34 is a sectional, perspective view of the inserter of
FIG. 25 in accordance with the disclosed subject matter;
[0042] FIG. 35 is a perspective view of the inserter of FIG. 25 in
accordance with the disclosed subject matter;
[0043] FIGS. 36-37 are sectional, perspective views of the inserter
of FIG. 25 in accordance with the disclosed subject matter;
[0044] FIGS. 38-39 are perspective views of the inserter of FIG. 25
in accordance with the disclosed subject matter;
[0045] FIGS. 40-41 are perspective views of another embodiment of
an inserter in accordance with the disclosed subject matter;
[0046] FIGS. 42-46 are perspective views of components of the
inserter of FIG. 40 in accordance with the disclosed subject
matter;
[0047] FIG. 47 is a sectional views of the inserter of FIG. 40 in
accordance with the disclosed subject matter;
[0048] FIGS. 48-50 are sectional, perspective views of the inserter
of FIG. 40 in accordance with the disclosed subject matter;
[0049] FIG. 51 is a cross-sectional view of another inserter in
accordance with the disclosed subject matter;
[0050] FIG. 52 is an exploded perspective view of the inserter of
FIG. 51 in accordance with the disclosed subject matter;
[0051] FIGS. 53 and 54 are side views of the inserter of FIG. 51
showing the assembly of various components in accordance with the
disclosed subject matter;
[0052] FIGS. 55-60 are perspective views of the inserter of FIG. 51
showing the assembly of various components in accordance with the
disclosed subject matter;
[0053] FIGS. 61-65 are cross-sectional views of the inserter of
FIG. 51 in accordance with the disclosed subject matter;
[0054] FIGS. 66-68 illustrate a process for utilizing a sterilized
versions of the inserter of FIG. 51 in accordance with the
disclosed subject matter;
[0055] FIG. 69-72 illustrates an alternate process for utilizing a
sterilized versions of the inserter of FIG. 51 in accordance with
the disclosed subject matter;
[0056] FIG. 73 is a perspective view of another inserter in
accordance with the disclosed subject matter;
[0057] FIG. 74 is a perspective view of a component of the inserter
of FIG. 73 in accordance with the disclosed subject matter;
[0058] FIG. 75 is a cross-sectional view of a component of the
inserter of FIG. 73 in accordance with the disclosed subject
matter;
[0059] FIGS. 76-80 are perspective views of components of the
inserter of FIG. 73 in accordance with the disclosed subject
matter;
[0060] FIGS. 81-87 are cross-sectional views of the inserter of
FIG. 73 in accordance with the disclosed subject matter;
[0061] FIGS. 88-90 illustrate a process for utilizing a sterilized
version of the inserter of FIG. 73 in accordance with the disclosed
subject matter;
[0062] FIG. 91 is a perspective view of another inserter in
accordance with the disclosed subject matter;
[0063] FIGS. 92-99 are additional views of the components of the
inserter of FIG. 91 in accordance with the disclosed subject
matter;
[0064] FIGS. 100-106 are cross-sectional views of the inserter of
FIG. 91 in accordance with the disclosed subject matter;
[0065] FIGS. 107-108 are views of an alternate embodiment of the
inserter of FIG. 91 in accordance with the disclosed subject
matter; and
[0066] FIGS. 109-134 are views of an alternate embodiment of the
inserter of FIG. 73 in accordance with the disclosed subject
matter.
[0067] FIGS. 135-136 illustrate bottom and top views, respectively,
of the medical device carrier in accordance with the disclosed
subject matter.
[0068] FIGS. 137-138 illustrate the sheath component of an inserter
in accordance with the disclosed subject matter.
[0069] FIGS. 139-140 illustrate, in cross section, the progressive
advancement of the on body housing in accordance with the disclosed
subject matter.
[0070] FIGS. 141-144 illustrate the advancement of the on body
housing within an inserter in accordance with the disclosed subject
matter.
[0071] FIGS. 145a-147b illustrate the attachment of a two piece on
body housing in accordance with the disclosed subject matter.
[0072] FIG. 148 illustrates a two-piece on body housing in
accordance with the disclosed subject matter.
[0073] FIG. 149 illustrates another two-piece on body housing in
accordance with the disclosed subject matter.
[0074] FIGS. 150-156 illustrate the advancement of a two piece on
body housing in accordance with the disclosed subject matter.
[0075] FIGS. 157-158 illustrate the assembly of the two piece on
body housing in accordance with the disclosed subject matter.
[0076] FIGS. 159-164 illustrate two piece on body housings in
accordance with the disclosed subject matter.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0077] 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.
[0078] 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.
[0079] 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.
[0080] 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.
[0081] 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.
[0082] As used herein and in the appended claims, the singular
forms "a," "an," and "the" include plural referents unless the
context clearly dictates otherwise.
[0083] 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.
[0084] 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.
[0085] 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.
[0086] 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.
[0087] 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.
[0088] 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.
[0089] 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.
[0090] 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.
[0091] 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.
[0092] 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.
[0093] 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.
[0094] 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.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] 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.
[0099] 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.
[0100] 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.
[0101] 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.
[0102] 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.
[0103] 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.
[0104] 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.
[0105] 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.
[0106] 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.
[0107] 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.
[0108] 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.
[0109] 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.
[0110] 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).
[0111] 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
[0112] 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.
[0113] 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.
[0114] 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.
[0115] 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.
[0116] 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.
[0117] 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.
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] 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.
[0124] Referring still to FIG. 1, also shown in analyte monitoring
system 1000 are data processing module 1600 and remote terminal
1700. Remote terminal 1700 may include a personal computer, a
server terminal a laptop computer or other suitable data processing
devices including software for data management and analysis and
communication with the components in the analyte monitoring system
1000. For example, remote terminal 1700 may be connected to a local
area network (LAN), a wide area network (WAN), or other data
network for uni-directional or bi-directional data communication
between remote terminal 1700 and display device 1200 and/or data
processing module 1600.
[0125] 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.
[0126] In certain embodiments, a separate, optional data
communication/processing device such as data processing module 1600
may be provided in analyte monitoring system 1000. Data processing
module 1600 may include components to communicate using one or more
wireless communication protocols such as, for example, but not
limited to, infrared (IR) protocol, Bluetooth.RTM. protocol, Zigbee
protocol, and 802.11 wireless LAN protocol. Additional description
of communication protocols including those based on Bluetooth.RTM.
protocol and/or Zigbee 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.
[0127] 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.
[0128] 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.
[0129] Referring again to FIG. 1, in certain embodiments, data
processing module 1600 is programmed to transmit a command or
signal to on body electronics 1100 at a predetermined time interval
such as once every minute, or once every 5 minutes or once every 30
minutes or any other suitable or desired programmable time interval
to request analyte related data from on body electronics 1100. When
data processing module 1600 receives the requested analyte related
data, it stores the received data. In this manner, analyte
monitoring system 1000 may be configured to receive the
continuously monitored analyte related information at the
programmed or programmable time interval, which is stored and/or
displayed to the user. The stored data in data processing module
1600 may be subsequently provided or transmitted to display device
1200, remote terminal 1700 or the like for subsequent data analysis
such as identifying frequency of periods of glycemic level
excursions over the monitored time period, or the frequency of the
alarm event occurrence during the monitored time period, for
example, to improve therapy related decisions. Using this
information, the doctor, healthcare provider or the user may adjust
or recommend modification to the diet, daily habits and routines
such as exercise, and the like.
[0130] 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.
[0131] 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.
[0132] 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.
[0133] Information, such as variation or fluctuation of the
monitored analyte level as a function of time over the monitored
time period providing analyte trend information, for example, may
be determined by one or more control logic or microprocessors of
display device 1200, data processing module 1600, and/or remote
terminal 1700, and/or on body electronics 1100. Such information
may be displayed as, for example, a graph (such as a line graph) to
indicate to the user the current and/or historical and/or and
predicted future analyte levels as measured and predicted by the
analyte monitoring system 1000. Such information may also be
displayed as directional arrows (for example, see trend or
directional arrow display 1310) or other icon(s), e.g., the
position of which on the screen relative to a reference point
indicated whether the analyte level is increasing or decreasing as
well as the acceleration or deceleration of the increase or
decrease in analyte level. This information may be utilized by the
user to determine any necessary corrective actions to ensure the
analyte level remains within an acceptable and/or clinically safe
range. Other visual indicators, including colors, flashing, fading,
etc., as well as audio indicators including a change in pitch,
volume, or tone of an audio output and/or vibratory or other
tactile indicators may also be incorporated into the display of
trend data as means of notifying the user of the current level
and/or direction and/or rate of change of the monitored analyte
level. For example, based on a determined rate of glucose change,
programmed clinically significant glucose threshold levels (e.g.,
hyperglycemic and/or hypoglycemic levels), and current analyte
level derived by an in vivo analyte sensor, the system 1000 may
include an algorithm stored on computer readable medium to
determine the time it will take to reach a clinically significant
level and will output notification in advance of reaching the
clinically significant level, e.g., 30 minutes before a clinically
significant level is anticipated, and/or 20 minutes, and/or 10
minutes, and/or 5 minutes, and/or 3 minutes, and/or 1 minute, and
so on, with outputs increasing in intensity or the like.
[0134] 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.
[0135] 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.
[0136] 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.
[0137] 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, 12/699,653, and
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
[0138] 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.
[0139] 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.
[0140] 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.
[0141] 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).
[0142] 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.
[0143] 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.
[0144] 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.
[0145] 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.
[0146] 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.
[0147] 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
[0148] 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 removing 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.
[0149] In some embodiments, an insertion assembly includes an
inserter, an analyte sensor, and a power supply. The power supply
may be applied to the patient, e.g., to the surface of the skin,
simultaneously with the analyte sensor by the inserter. In other
embodiments, the battery is installed after or before installation
of the analyte sensor. In such case the power supply may be applied
by the inserter or separately. The power supply may be used to
provide a current or a potential to the sensor and/or to provide
power for communication of one or more signals to the monitor
unit.
[0150] In some embodiments, an insertion assembly includes an
inserter, a medical device such as an analyte sensor, and on body
electronics. The on body electronics may be deployed and/or
installed simultaneously with the analyte sensor by the inserter.
In other embodiments, the on body electronics are installed after
or before installation of the analyte sensor. For example, the
analyte sensor may be installed by the inserter, and the on body
electronics may be subsequently installed.
[0151] In some embodiments, the on body electronics provide a
voltage or current to the analyte sensor. In some embodiments, the
on body electronics process signals provided by the analyte sensor.
In further embodiments, the on body electronics may include
communications functionality for providing signal relating to
signal provided by the analyte sensor to a further component, such
as, e.g., a monitor unit, a computer, or other component. In some
embodiments, communications circuitry, such as an RFID antenna, is
provided. The power supply may be used to power some or all of
these functions. In some embodiments, power is provided from the
monitor unit, e.g., via inductive coupling.
[0152] An inserter can include a plurality of different components.
For example, an inserter may include one or more components for
advancing a sharp towards the skin of the subject. The sensor and
on body electronics may be supported by a support structure, such
as a carriage. A driver may be provided for advancing the sharp
and/or the analyte sensor/support structure towards the skin of the
patient. In some embodiments, the actuator is directly or
indirectly coupled to the sharp and/or support structure, such that
manual force applied by the user to the actuator is transferred to
the sharp and/or support structure. In some embodiments, the
applied force drives the sharp and/or support structure between a
retracted position (disposed within the insertion device) and an
advanced position (disposed towards the skin of the patient). In
some embodiments, the sensor and on body electronics is maintained
in a retracted position prior to installation by contacting
projections extending inwardly from a recess in the inserter. In
accordance with this embodiment, the sensor and on body electronics
are temporarily maintained operatively between the support
structure and the projections disposed on the interior wall of the
sheath.
[0153] An inserter can also include one or more components for
retracting the sharp, while allowing the analyte sensor and
optional on body electronics to remain on the subject. The
components for retracting the sharp can include a retractor. It is
understood that the retractor and the actuator may be the same
structure or include some common components. In some embodiments,
the retractor is directly or indirectly coupled to the sharp such
that the manual force applied by the user is transferred from the
retractor to the sharp to retract the sharp from the skin. In other
embodiments, a drive assembly may be provided to retract the sharp.
For example, the drive assembly may include a spring, motor,
hydraulic piston, etc., to retract the sharp away from the skin of
the subject. The drive assembly may also include a linear drive
component.
[0154] 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.
[0155] 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
[0156] An inserter 200 in accordance with an exemplary embodiment
is illustrated in FIG. 4. Inserter 200 includes a housing 202 and a
removable distal cap 204 for maintaining a sterile environment for
the medical device and sharp housed therein. In some embodiments,
inserter 200 has a maximum diameter, of about 30 mm to about 60 mm,
e.g., about 40 mm, about 43 mm, about 43.5 mm, about 50.5 mm, about
54.5 mm, etc. In some embodiments, inserter 200 has a maximum
height of about 40 mm to about 80 mm, e.g., about 44 mm, about 46
mm, about 50 mm, about 53 mm, about 67 mm, about 71 mm, etc. In
some embodiments, inserter 200 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. In the case of inserter
200, the dimensions are defined with respect to the housing
202.
[0157] Housing 202 and distal cap 204 may be fabricated from any
suitable materials such as metal, plastic, etc. In some embodiments
cap 204 may be fabricated from a polymer or plastic material. Also
provided is a removable proximal cover 206, which, among other
things, prevents accidental deployment of the inserter 200 and
maintains a sterile environment. In some embodiments, proximal
cover 206 is a sheet of material such as a foil sheet or the like
secured to the upper surface of housing 202 using an adhesive, and
may include a tab 208 to assist removal of the cover 206. Proximal
cover 206 may also be a plastic sheet or member that forms a seal
with housing 202. In some embodiments, proximal cover 206 may
include a pull tab or a perforated section for easy removal.
[0158] As illustrated in FIG. 5, proximal cover 206 and distal cap
204 are shown removed from inserter 200. Distal cap 204 is secured
to housing 202, e.g., by use of threads 210. In some embodiments,
distal cap 204 is secured by a friction fit, snap fit, a bayonet
mount, an adhesive, etc. The distal portion of cap 204 may include
a recess for retaining a desiccant therein. In some embodiments, a
silica gel or molecular sieves may be used. Such material can be in
granular form (pellets) or pressed into tablets, or otherwise. In
some embodiments, silica gel tablets are used. Embodiments may
include desiccant and/or packaging as described in U.S. patent
application Ser. No. 12/714,439, which is incorporated by reference
herein for all purposes. Cap 204 may be provided with one or more
apertures, which allows for passage of air to the desiccant to
remove moisture from the interior of the inserter 200.
[0159] Housing 202 includes a distal portion 212 for placement on
the skin of a subject. Inserter 200 includes an actuator 214 to
advance a medical device into the skin of the subject. In some
embodiments, actuator 214 is disposed within an opening 216 in
housing 202 and can be longitudinally moveable within housing
202.
[0160] The distal portion of inserter 200 is illustrated in FIG. 6.
In some embodiments, an adhesive pad 218, having adhesive material
218 on both faces, is provided across the distal portion 212 of the
housing 202. A central aperture 220 may be provided in adhesive pad
218. As will be described in greater detail herein, inserter 200
supports a medical device, such as on body housing 122 (not shown)
and a sharp 224. In some embodiments, on body housing 122, includes
an analyte sensor 14. During insertion, sharp 224 passes through
aperture 220 and into the skin of the subject carrying at least the
sensor 14 with it.
[0161] FIG. 7 illustrates inserter 200 in cross-section, in an
initial configuration prior to use, after removal of the distal cap
204. Actuator 214 may be cylindrical in shape (or other shape as
appropriate) and, including an upper contact surface 226, capable
of being depressed by a user and/or a mechanism, as described
herein. Actuator 214 may further include side walls 228 extending
downwardly from upper surface 226, and which engage or otherwise
contact the upper surface of carriage 230. Carriage 230 provides a
support for holding the medical device, such as on body housing
122, prior to and during installation. In some embodiments,
carriage 230 includes a distal portion 232, which may be configured
to form a substantially concave recess 232a as shown in this
embodiment, for supporting the medical device therein. In some
embodiments, the on body housing 122 is supported within the recess
232a of carriage 230 in a snap-fit or other relationship. In some
embodiments, carriage 230 does not include a recess. In such
embodiments, carriage may include one or more projections which
contact and/or advance the on body housing 122. (See, e.g., FIGS.
122, 135-136 herein.)
[0162] In FIG. 8 the longitudinal axis L of the inserter 200 is
illustrated. Extending distally from the upper surface 226 of
actuator 214 and substantially parallel to the longitudinal axis is
a support member 234, which may have an elongated configuration.
Support member 234 supports needle hub 236, from which sharp 224
extends longitudinally within the inserter 200. In some
embodiments, the sharp 224 is supported at an oblique angle, e.g.,
between about 0.degree. and 90.degree. with respect to the skin
surface. Needle hub 236 can be secured to support member 234 via an
interlocking O-ring configuration, adhesive, or other techniques
known in the art. Support member 234 can be omitted and needle hub
236 can be secured to the actuator 214 directly in some
embodiments, e.g., by manufacturing needle hub 236 as a single
component with actuator 214 or by otherwise adhering needle hub 236
to actuator 214.
[0163] In some embodiments, sharp 224 is a solid needle, for
example, if inserter 200 is used to insert a cannula. In some
embodiments, sharp 224 is provided with a substantially cylindrical
configuration defining an interior bore, e.g., a rigid cylindrical
member or a hypodermic-style needle. Sharp 224 may also be provided
with an elongated longitudinal opening or gap in the wall of the
sharp 224 (see, sharp 224 in FIGS. 11-18). In some embodiments,
sharp 224 is fabricated from a sheet of metal, and folded into a
substantially "V" or "U" or "C" configuration in cross-section to
define the longitudinal recess.
[0164] Needle hub 236 is further illustrated in FIGS. 9-10. Needle
hub 236 supports sharp 224, having a sharpened distal portion 260.
In some embodiments, as discussed herein, a longitudinal wall
opening or gap 262 is provided in at least a portion of the wall of
the sharp 224. The length N of the gap 262 is selected to be
commensurate with the length of the insertion portion 30 through to
the proximal retention portion 48 of the sensor 14 where the bend
at line B occurs (See FIGS. 2-3), 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 224 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. (See, spacing 257 in FIG. 11).
[0165] The distal portion 260 of sharp 224 is illustrated in
greater detail in FIGS. 11-13. As illustrated in FIG. 11, sharp 224
has a substantially "C"- or "U"-shaped profile in this embodiment,
but may have other configurations, e.g., substantially "V"-shaped.
A longitudinal gap 262 is provided in the wall of the sharp 224.
FIG. 12 illustrates distal portion 260 is provided with an angled
tip. In some embodiments, the angled tip may be provided with a
first angled tip portion 264 and a second steep-angled tip portion
266. 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 262 of the insertion sharp
224 having a diameter less than about 20 to about 26 gauge, e.g.,
21 gauge to about 25 gauge, where in certain embodiments the sharp
is 21 gauge or 23 gauge or 25 gauge. Such sharp may be used with a
sensor having a width or diameter--at least the portion that is
carried by the sharp--of about 0.20 mm to about 0.80 mm, e.g.,
about 0.25 mm to about 0.60 mm, where in some embodiments the width
or diameter of at least a portion of a sensor is 0.27 mm or 0.33 mm
or 0.58 mm. In some embodiments, sharp 224 is fabricated from a
sheet of metal and folded into a substantially "V" or "U" or "C"
configuration in cross-section.
[0166] Various technologies can be used to manufacture a folded
sheet of metal to form sharp 224. For example, etched-sheet metal
technology can be used to form the sharp 224. 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.
14. In some embodiments, the sharp 224 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
some embodiments, a "U" shaped cross-section can be provided with
having flat, rather than curved walls. The "U" shaped configuration
provides the advantage that they can more securely and closely hold
the sensor. Also, the "U" shaped configuration provides the
advantage that it has a reduced cross-section when compared with a
comparable circular cross section. Further details of the tip of
sharp 224 are illustrated in FIGS. 14A-C. As illustrated in FIGS.
14A-B, a top view of the sharp 224 is shown. This represents a flat
portion of the sharp, e.g., the bottom of the "U" configuration. A
tip is formed by first distal edges 263 closest to the distal tip
and second distal edges 265 between the first distal edges 263 and
the substantially parallel side walls 269. In some embodiments, the
first distal edges 263 form an "included tip" angle of about 15
degrees, about 30 degrees, or about 60 degrees. Such angle is
symmetrical, that is, equal angles from the longitudinal axis of
the sharp 224. The second distal edges 265 provide a somewhat less
acute angle than the first distal edges 263. In some embodiments,
the "lead in" angle may be about 20 degrees, about 45 degrees, or
about 65 degrees. By having a tip defined by two angles, a first,
smaller "included angle" and a second, larger "lead in angle,"
allows the tip to meet several objectives. First, the small
included angle allows the tip to pierce the skin with less trauma.
Second, by broadening out to a larger angle, the overall length of
the tip is reduced, and strength of the tip is increased. FIG. 14C
illustrates a side view of the sharp 224 and illustrates the side
walls 269. An additional angle, i.e., the "lead-out" angle is
provided by the rising edge 267 of the sharp. The edge 267 provides
the ability to separate the tissue to allow placement of the sensor
14. 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 262
and first-angled tip portion 264 and a second, steep-angled tip
portion 266.
[0167] In another embodiment, sharp 224 may be formed from a
standard hypodermic needle utilizing the method depicted in FIG.
15. First, the hypodermic needle (having a circular cross-section)
is cut to the desired length for sharp 224. 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, electropolish, etc.). The
resulting sharp 224 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.
[0168] Due to the compression step, a user may initially start with
a larger diameter hypodermic needle so that the finished sharp 224
will have similar dimensions to the previously described
sharps.
[0169] FIGS. 16-18 illustrate the position of on body housing 122
with respect to the needle hub 236 and sharp 224. The on body
housing 122 can be configured to hold at least a portion of sensor
14 and on body electronics 1100 (also referred to herein as
electronics 80). As illustrated in FIG. 16, the sharp 224 extends
through an aperture 168 in the on body housing 122. Thus, in some
embodiments, the sharp 224 is uncoupled to on body housing 122. The
distal portion of sensor 14 is positioned within the sharp 224. As
further illustrated in FIG. 17, on body electronics 1100 and sensor
hub 123 are positioned within on body housing 122. Sensor 14 may
include an optional 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 optionally provided.
[0170] FIG. 17A illustrates a detail of sensor hub 123, which
includes an aperture 190 through which sharp 224 and sensor 14 are
configured to pass through. In some embodiments, aperture 190 is
provided with an additional side channel 192 continuous with the
aperture 190. Side channel 192 is positioned in the location in
which the pointed tip 260 of the sharp 224 would first pass through
the aperture. Ideally, the tip 260 passes through the aperture
without contacting the sensor hub 123. However, if there is any
misalignment, the tip 260 makes contact with the sensor hub 123 and
may be damaged and/or it may become jammed or otherwise unable to
pass through the aperture. The side channel 192 provides additional
clearance for the tip 260 to pass through the aperture
undamaged.
[0171] FIG. 18 illustrates in cross-section the orientation of the
on body housing 122 with respect to the sharp 224 of inserter 200.
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 the inserter 200 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 on body electronics
1100. The sensor tab 50 can be encapsulated in the plastic of the
on body housing 122 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 the on body housing 122.
[0172] The sensor 14, mounted with the on body housing 122, can be
disposed within a recess of the carriage 230 such as a concave
recess in the carriage 230. 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 242 (not shown). 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 224. 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 200 (see, e.g., FIG. 7) the sharp 224
extends through a longitudinal aperture 168 formed in a carriage
230. In some embodiments, the aperture 168 is appropriately sized,
such that neither the sharp 224 nor needle hub 236 is in contact
with the carriage 230. Accordingly, the needle hub 236 (and sharp
224) on the one hand, and the carriage 230 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.
[0173] The insertion portion 30 and proximal retention portion 48
of the sensor 14 are disposed within a longitudinal bore 162 within
the sharp 224 (See, e.g., FIG. 7). The proximal retention portion
48 is disposed within the longitudinal bore of the sharp 224 and
provides additional stability to the mounting of the sensor 14
within the sharp 224. The longitudinal wall gap or opening 262 of
sharp 224 is aligned with the sensor 14, such that the tab 50 and
the contact portion 32 extend laterally outward from the sharp
224.
[0174] In some embodiments, a resilient member 70 may be included
to provide frictional contact with the sharp 224 and/or the sensor
14. Such frictional contact provides additional stability between
the on body housing 122 and sharp 224, as depicted in FIGS. 19-21.
In some embodiments, resilient member 70 may be formed as a
spherical, ovoid, cylindrical, cube-shaped member, etc. Resilient
member 70 may be formed from any elastomeric material, e.g., molded
plastic components, rubber, nitrile, viton, urethane, etc.
[0175] In some embodiments, resilient member 70 is press-fit into a
recess, such as an eccentric bore 72 located in on body housing 122
(FIG. 21). When sharp 224 is inserted within an aperture in the on
body housing 122, the resilient member 70 exerts a pressure on
sharp 224 and sensor 14 to hold them firmly in groove 74. In some
embodiments, groove 74 is a V-shape. Alternatively, groove 74 may
be U-shaped depending on the configuration of sensor 14 and sharp
224. In some embodiments, resilient member 70 is provided with a
flattened or recessed surface which abuts sharp 224.
[0176] The sensor 14, mounted with the on body housing 122, is
carried by the carriage, e.g., disposed within the concave recess
232a in the carriage 230, as described hereinabove (see, e.g.,
FIGS. 16-21). In the initial configuration of the inserter 200
(see, e.g., FIG. 7), the sharp 224 extends through a longitudinal
aperture formed in the carriage 230. In some embodiments, the
aperture is appropriately sized, such that neither the sharp 224
nor needle hub 236 is in contact with the carriage 230. In other
words, in some embodiments a clearance may be provided between the
surfaces of the carriage and the sharp and needle hub. In some
cases, sharp 224 is capable of substantial lateral movement or
"play" with respect to aperture. Accordingly, the needle hub 236
(and sharp 224) on the one hand, and the carriage 230 and the on
body housing 122, on the other hand, can move simultaneously but
independently from one another.
[0177] Referring back to FIG. 17, the insertion portion 30 and
proximal retention portion 48 of the sensor 14 are disposed within
a longitudinal bore of the sharp 224. The proximal retention
portion 48 is disposed within the longitudinal bore 225 of the
sharp 224 and provides additional stability to the disposition of
the sensor 14 within longitudinal bore 225 of the sharp 224. The
longitudinal wall gap of sharp 224 is aligned with the sensor 14,
such that the tab 50 and the contact portion 32 extend laterally
outward from the sharp 224.
[0178] With continued reference to FIG. 7, an optional sheath 242
is positioned within housing 202, having an annular configuration
and including a circumferential recess 244 in which a retraction
spring 246 is positioned. The distal portion of spring 246 contacts
a spring retention portion 248 in sheath 242. The proximal portion
of spring 246 contacts one or more tabs 250 extending laterally
outwardly from actuator 214. In the initial configuration, the
spring 246 may be in a semi-compressed state, i.e., not fully
compressed, nor fully extended. It is understood that sheath 242
may be omitted from inserter 200, and a recess, such as recess 244,
provided within housing 202. Similarly, recess 244 may be omitted
entirely, and spring 246 or other actuator may be disposed between
stops in housing 202.
[0179] Depression of the actuator 214 causes distal longitudinal
movement of the carriage 230 and sharp 224, from a proximal
position (spaced apart from the skin of the subject) to a distal
position (closer to the skin of the subject). During such downward,
distal movement, spring 246 is further compressed between spring
retention portion 248 and flanges 270.
[0180] As illustrated in FIG. 8, depression of the contact surface
226 moves the actuator side walls 228 and the tabs 250 downwardly
distally against the bias of spring 246. Contact of the side wall
228 of the actuator 214 with the upper surface of the carriage 230
during depression of the actuator 214 imposes a downward force and
consequential distal movement of the carriage 230. As the sharp 224
is urged distally, it carries the sensor insertion portion 30 into
the subcutaneous portion of the subject's skin S.
[0181] As illustrated in FIG. 7, flanges 270 are disposed in the
inner wall of sheath 242. When carriage 230 reaches a distal
position, as shown in FIG. 8, the flanges 270 engage the proximal
(upper) surface of the carriage 230, and thereby inhibit proximal
movement of the carriage 230 (see also FIG. 24). The distal (lower)
surface of the on body housing 122 engages the upper surface of
adhesive pad 218, thereby becoming adhered to the skin surface S of
the subject. As the flanges 270 engage the carriage 230, the
flanges 270 also engage fingers 274 disposed on the proximal face
of the carriage 230. Fingers 274 are pivoted inwards by flanges
270. Such pivoting of fingers 274 causes fingers 274 to become
disengaged from retention tab 250 on actuator 214. Spring 246 is
thereby permitted to decompress and expand, and thereby provide an
upward force on actuator 214. If the user or some apparatus
provides no downward force, or minimal downward force to overcome
the bias of spring 246, the actuator 214, along with needle hub 236
and sharp 224 move proximally, withdrawing the sharp 224 from the
skin S of the subject.
[0182] As shown in FIGS. 22 and 23, the actuator 214 and coupled
sharp 224 advances to a more proximal position than at the initial
configuration illustrated in FIGS. 5 and 7 due to the decoupling of
actuator 214 from carrier 30. Thus, the sharp 224 retracts from a
distal position to a proximal position after installation of the on
body housing 122 and insertion of at least a portion of the
sensor.
[0183] A further embodiment of an inserter is illustrated in FIGS.
25-39 and designated inserter 300. In some embodiments, inserter
300 has a maximum diameter of about 30 mm to about 60 mm, e.g.,
about 40 mm, about 43 mm, about 43.5 mm, about 50.5 mm, about 54.5
mm, etc. In some embodiments, inserter 300 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
50 mm, about 53 mm, about 67 mm, about 71 mm, etc. Such height is
defined by the total length of the housing 302 and the sheath 342.
In some embodiments, inserter 300 has a volume of about 35 cm.sup.3
to about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. Such dimensions are
defined by the total length of the housing 302 and the sheath
342.
[0184] As illustrated in FIGS. 25-26, inserter 300 in certain
embodiments includes, e.g., a handle 302, a sheath 342, and a
removable distal cap 304 for maintaining a sterile environment for
the medical device and sharp housed therein. FIG. 26 illustrates
that distal cap 304 is removed from handle 302. Distal cap 304 is
secured to handle 302 by one of a number of securement means, e.g.,
by use of threads 310. Sheath 342 defines a distal surface 312 for
placement on the skin of a subject. Inserter 300 may be utilized to
advance a medical device into the skin of the subject. In some
embodiments, handle 302 is advanced relative to sheath 342 in order
to advance the medical device into the skin of the patient.
[0185] The components of inserter 300 in certain embodiments are
illustrated in FIGS. 27-32. As illustrated in FIG. 27, handle 302
may include threads 310 for attachment of cap 304 via threads 311
(as illustrated in FIG. 29). It is understood that other securement
techniques, such as a snap-fit or friction-fit may be used to
secure cap 304. Cap 304 may include a receptacle 325 for
positioning of the sharp 324. Sheath 342, as illustrated in FIG.
28, includes longitudinal notches 382.
[0186] Projections 386 on carriage 330, as illustrated in FIG. 30,
are configured to engage sheath to secure carriage 330 within the
inserter 300, thereby preventing release of the carriage 330 from
the inserter 300. When the projections 386 of carrier reach the
bottom of the notches 382, such bottom surface acts as the
retention portion that prevents the carriage 330 from falling out
of the inserter 300. Projections 375 engage with the triangular
latch features 370 of the sheath 342 as illustrated in FIGS. 34 and
36.
[0187] Carriage 330 also is provided with fingers 375 which engage
a shoulder wall 376 of sharp 324 (as illustrated in FIG. 34), as
will be described in greater detail herein.
[0188] In certain embodiments, inserter 300 also includes a spring
retention component 348, as illustrated in FIG. 31. Spring
retention component 348 defines an upper surface 349, which engages
spring 346 (as illustrated in FIG. 34). Spring retention component
348 also includes locking towers 351 including projections, which
engage apertures 328 of needle carrier 334 to prevent accidental
deployment of the sharp 324 after use of the inserter 300 is
completed.
[0189] Inserter 300 is illustrated in cross-section in FIG. 33
prior to use. Cap 304 is attached to the distal portion of inserter
300, via securement means, such as inter-engagement of threads 310
and 311. Cap 304 includes a desiccant tablet 390; a seal, such as a
foil seal 392; and a Tyvek.RTM. layer 394, which allows
breathability between the desiccant tablet 390 and the interior of
the inserter 300.
[0190] As illustrated in FIG. 34, the inserter 300 includes an
initial configuration in which the handle 302 is disposed in a
proximal position with respect to the sheath 342. In such
configuration, the sharp 324 is disposed in a configuration spaced
apart from the aperture 320 of the adhesive layer 318. The distal
portion of inserter 300 is illustrated in FIG. 35.
[0191] With continued reference to FIG. 34, the longitudinal axis L
of the inserter 300 is illustrated. Extending distally from the
upper surface of handle 302 is an inner wall portion 326 and
intermediate wall portion 374. Support member 334 extends from wall
portion 326 and supports needle hub 336, from which sharp 324
extends longitudinally within the inserter 300. 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.
[0192] Sheath 342 is positioned within handle 302, having an
annular configuration in which a retraction spring 346 is
positioned. The distal portion of spring 346 contacts a surface 349
of spring retention component 348. The proximal portion of spring
346 contacts the inner surface 350 of handle 302. In the initial
configuration, the spring 346 is in an extended or semi-extended
configuration.
[0193] FIG. 36 illustrates inserter 300 in cross-section, during
insertion. Depression of handle 302 with respect to sheath 342
against the bias of spring 346 causes distal longitudinal movement
of the carriage 330 and sharp 324, from a proximal position towards
a distal position. During such downward, distal movement, spring
346 is compressed between surface 349 of spring retention component
348 and surface 350 of handle 302. As the sharp 324 is urged
distally by housing 302, it carries the sensor insertion portion 30
of sensor 14 into the subject's skin S.
[0194] As carriage 330 reaches a distal position, the distal
surface of the on body housing 122 engages the upper surface of
adhesive pad 318, thereby becoming adhered to the skin surface S of
the subject. Also, flange 370 engages fingers 375 disposed on the
carriage 330. Fingers 375 are pivoted outwards by flanges 370 in
direction T. Such pivoting of fingers 375 causes fingers 375 to
become disengaged from slots 376 in intermediate housing walls 374.
Carriage 330 is thereby disengaged from handle 302 and needle
carrier 334.
[0195] As illustrated in FIG. 37, handle 302, along with needle hub
336 and sharp 324 are permitted to move proximally, while the
sheath 342 and on body housing 122 remain adjacent to the skin of
the subject. If the user or some apparatus provides no downward
force, or minimal downward force to the handle 302 to overcome the
bias of spring 346, spring 346 is permitted to expand, thereby
withdrawing the sharp 324 from the skin S of the subject.
[0196] Upon reaching the proximal position, flanges 328 on needle
carrier 334 engage locking towers 351 of needle floor component
348. The inter-engagement of flanges 328 and locking towers 351
prevents inadvertent deployment of sharp 324 after installation of
the medical device.
[0197] A further embodiment of an inserter is illustrated in FIGS.
40-50, and designated inserter 400. In some embodiments, inserter
400 has a maximum diameter of about 30 mm to about 60 mm, e.g.,
about 40 mm, about 43 mm, about 43.5 mm, about 50.5 mm, about 54.5
mm, etc. In some embodiments, inserter 400 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
50 mm, about 53 mm, about 67 mm, about 71 mm, etc. In some
embodiments, inserter 400 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. The maximum height is
measured from the top of the housing 402 to the distal surface 412.
The volume is measured as the combined volume of the housing 402
and the sheath 442 in an expanded position.
[0198] Inserter 400 generally includes, e.g., a handle 402, sheath
442, and a removable distal cap 404 for maintaining a sterile
environment for the medical device and sharp housed therein. As
illustrated in FIG. 41, distal cap 404 is shown removed from handle
402. Distal cap 404 is detachably secured to handle 402, e.g., by
use of threads 410. Sheath 442 includes a distal surface 412 for
placement on the skin of a subject. Inserter 400 may be utilized to
advance a medical device into the skin of the subject. In some
embodiments, handle 402 is advanced relative to sheath 442 in order
to advance the medical device distally and into the skin of the
patient.
[0199] The components of inserter 400 are illustrated in FIGS.
42-46. As illustrated in FIG. 42, handle 402 includes threads 410
for attachment of cap 404 via threads 411 (as illustrated in FIG.
44). Cap 404 may include a receptacle 425 for positioning of the
sharp 424. Sheath 442, as illustrated in FIG. 43, includes
longitudinal notches 482. Projections 486 on carriage 430, as
illustrated in FIG. 45, are configured to engage sheath 442 to
secure carriage 430 within inserter 400, thereby preventing release
of the carriage from the inserter. Sheath 442 also includes notches
484 which receive projection 475 of carriage 430. The bottom of the
notches acts as the retention portion that prevents the carriage
430 from falling out of the inserter 400. Projections 475 engage
with the latch features 470 of the sheath 442 as illustrated in
FIGS. 49 and 50. Carriage 430 also is provided with fingers 474
which engage a shoulder wall 476 of needle carrier 436, as
illustrated in FIGS. 48-49, and as will be described in greater
detail herein.
[0200] Sheath 442 also includes a spring retention portion 448,
provided at the distal end of circumferential notch 496, as
illustrated in FIG. 48. Needle carrier 434, as illustrated in FIG.
46, includes wings 450, which provide an upper engagement surface
for spring 446. Wings 450 also include a shoulder 476 for
engagement with fingers 474 of carriage 430.
[0201] Inserter 400 is illustrated in cross-section in FIG. 47 in a
state prior to use and prior to removal of cap 404, which is shown
attached to the distal portion of handle 402, via inter-engagement
of threads 410 and 411. Cap 404 includes a desiccant tablet 490, a
seal such as a foil seal 492, and a Tyvek.RTM. layer 494, which
allows breathability between the desiccant tablet 490 and the
interior of the inserter 400.
[0202] As illustrated in FIG. 48, the inserter 400 is shown in an
initial configuration in which handle 402 is disposed in a proximal
position with respect to the sheath 442. In such configuration, the
sharp 424 is disposed in a configuration spaced apart from the
aperture 420 of the adhesive layer 418. The longitudinal axis L of
the inserter 400 is illustrated. Extending distally from the upper
surface of handle 402 is inner wall 475. The distal end portions of
wall 475 provide a downward force on the carriage 430 upon
depression of the handle 402 by a user. Alternatively, instead of
handle having a distally extending inner wall, the carriage can
include one or more upwardly extending walls or projections (not
shown). The one or more upwardly extending inner walls or
projections can have a length sufficient to either contact the
upper surface of 402 or, alternatively, contact corresponding
downwardly extending inner walls of the handle 402. In this manner,
depression of handle 402 by a user provides a downward force on the
one or more upwardly extending walls or projections of the carriage
to advance the carriage (and on-body unit) distally to an
installation and insertion position. (See FIGS. 49-50.) In one
embodiment a downwardly extending wall of the handle 402 and a
corresponding upwardly extending wall of the carriage are aligned
such that depression of the handle 402 by a user allows the
upwardly extending wall and the downwardly extending wall to make
direct contact, thereby permitting the carriage 430 and on-body
unit to advance distally. In such embodiment, the downwardly
extending inner wall of the handle has a distal end that is
disposed proximally of the proximal most end of sheath 442.
[0203] Needle carrier 434 can be axially moveable within handle
402. Needle carrier 434 supports needle hub 436, from which sharp
424 extends longitudinally within inserter 400. In some
embodiments, sharp 424 is supported at an oblique angle, e.g.,
between and including about 0.degree. and 90.degree. with respect
to the skin surface. Initially, needle carrier 434 is coupled to
carriage 430 via inter-engagement of fingers 474 of carriage 430
with shoulder 476 of needle carrier 434. Spring 446 is disposed
between spring retention portion 448 of sheath 442 and wings 450
(FIG. 46) of needle carrier 434. Initially, spring 446 is in an
expanded or semi-expanded state while handle 402 is disposed
proximally from sheath 442. In another exemplary embodiment, needle
carrier 434 can be secured to handle 402, for example, secured to
downwardly extending inner wall 475. In this manner, needle carrier
and carriage 430 are longitudinally moveable along the line defined
by L shown in FIG. 48 with respect to sheath 442. In this regard,
needle carrier 434 includes one or more apertures to receive one or
more downwardly extending inner walls 475 of handle 402. In some
embodiments, neither the needle carrier 434 nor the carriage 430
are in slidable contact with sheath 442, e.g., spaced apart from
sheath 442, during longitudinal movement of the needle carrier 434
and/or carriage 430.
[0204] FIG. 49 illustrates inserter 400 in cross-section, during
insertion. Depression of handle 402 with respect to sheath 442,
against the bias of spring 446, causes distal longitudinal movement
of the carriage 430 and needle carrier 434, from a proximal
position towards a distal position. During such downward proximal
movement, spring 446 is compressed between spring retention portion
448 and wings 450 (FIG. 46) of needle carrier 434. As the sharp 424
is urged distally, it carries the sensor insertion portion 30 of
sensor 14 (FIG. 17) into the subcutaneous portion of the subject's
skin S.
[0205] As carriage 430 reaches a distal position (close to the skin
of the subject), the distal surface of the on body housing 122
engages the upper surface of adhesive pad 418, thereby becoming
adhered to the skin surface S of the subject. Flange 470 engages
fingers 474 disposed on the carriage 430. Fingers 474 are pivoted
outwards by flanges 470 in direction T. Such pivoting of fingers
474 causes fingers 474 to become disengaged from shoulder 476 of
needle carrier 434. Needle carrier 434 is thereby disengaged from
carriage 430. Such pivoting of fingers 474 also engages opening in
474 with flange 470, thus locking carriage 430 in the distal
position.
[0206] As illustrated in FIG. 50, disengagement of the needle
carrier 434 from the carriage 430 permits the spring 446 to expand,
thereby advancing the needle carrier 434 to a proximal position
(away from the skin of the subject) and withdrawing the sharp 424
from under the skin surface S of the subject while leaving the
sensor 14 in the skin. Once the sharp 424 has been withdrawn from
the subject, it is no longer accessible from the distal portion of
the inserter 400 and unable to make contact by accident with the
subject's skin because it is positioned at a proximal position
within the carrier handle 402.
[0207] An inserter 2400 in accordance with another exemplary
embodiment is illustrated in FIG. 51. In some embodiments, inserter
2400 has a maximum diameter, of about 30 mm to about 60 mm, e.g.,
about 40 mm, about 43 mm, about 43.5 mm, about 50.5 mm, about 54.5
mm, etc. In some embodiments, inserter 2400 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
50 mm, about 53 mm, about 67 mm, about 71 mm, etc. In some
embodiments, inserter 2400 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. The height is measured
from the distal surface of the housing 2402 (adjacent to adhesive
218) to the top surface. The volume is measure by the volume of the
housing 2402.
[0208] With reference to FIG. 51, inserter 2400 includes a housing
2402 and a removable distal cap 2412 for protecting the medical
device and sharp housed therein. Housing 2402 and distal cap 2412
may be fabricated from any suitable materials such as metal,
plastic, etc. In some embodiments, cap 2412 may be fabricated from
a polymer or plastic material.
[0209] An exploded view of the components of inserter 2400 is
illustrated in FIG. 52. As shown, inserter 2400 generally comprises
plunger 2405, spring 2406, housing 2402, sharp 2404 (not shown in
FIG. 52), on body housing 122, sharp holder 2408, adhesive patch
218, and cap 2412 when fully assembled.
[0210] A more detailed view of sharp holder 2408 is shown in FIG.
53. Needle holder 2408 retains sharp 2404 in a fixed position with
respect to itself within inserter 2400, thereby allowing it to
safely penetrate a subject's skin during later use.
[0211] To assemble inserter 2400, sharp 2404 and hub 2408 are
inserted through an opening in on body housing 122 as shown in FIG.
54. Needle holder 2408 prevents sharp 2404 from being fully
inserted through on body housing 122. In some embodiments, on body
housing 122 includes an analyte sensor 14 and on body electronics
1100.
[0212] Next, plunger 2405, spring 2406, and housing 2402 are
assembled as shown in FIGS. 55-57. Plunger 2405 contains a spring
retention member which is inserted through the center of spring
2406. Lip 2414 of plunger 2405 engages inner wall 2416 of housing
2402 when assembled (FIG. 51). This causes spring 2406 to be
contained between lip 2418 of housing member 2402 and the bottom
surface 2424 of plunger 2405. The resulting sub-assembly of
inserter 2400 shown in allows plunger 2405 to move between a
proximal position, with spring 2406 in a preloaded condition, and a
distal position, wherein bottom surface 2424 engages wall 2426 of
housing 2402.
[0213] The on body housing assembly shown in FIG. 54 is then
inserted into the inserter sub-assembly shown in FIGS. 55-57. As
shown in FIG. 57, on body housing 122 is inserted into housing 2402
with the tip of sharp 2404 pointing away from plunger 2405. The
resulting assembly is depicted in FIG. 58. As shown in FIG. 51,
grooves on sharp holder 2408 engage tabs 2422 on plunger 2405. The
on body housing 122 is axially retained in the housing 2402 by the
housing arms detent features 2440.
[0214] Finally, adhesive patch 218 is placed over the opening of
housing 2402 and cap 2412 is friction fit over housing 2402 as
shown in FIG. 59. The fully assembled inserter 2400 is depicted in
FIG. 60. In some embodiments, adhesive pad 218 has an adhesive
material on both faces. A central aperture 220 may be provided in
adhesive pad 218 to allow sharp 2404 to be deployed into the skin
of a subject. During insertion, sharp 2404 passes through aperture
220 and into the skin of the subject carrying at least the sensor
with it.
[0215] FIG. 61 illustrates inserter 2400 in cross-section, in an
initial configuration prior to use, after removal of the distal cap
2412. As shown, sharp 2404 extends longitudinally within the
inserter 2400. In some embodiments, sharp 2404 is supported at an
oblique angle, e.g., between and including about 0.degree. and
90.degree. with respect to the skin surface.
[0216] In some embodiments, sharp 2404 is provided with a
substantially cylindrical configuration defining an interior bore,
e.g., a rigid cylindrical member or a hypodermic-style needle.
Sharp 2404 may also be provided with an elongated longitudinal
opening or gap in the wall of the sharp 2404. In some embodiments,
sharp 2404 is fabricated from a sheet of metal, and folded into a
substantially "V" or "U" or "C" configuration in cross-section to
define the longitudinal recess.
[0217] Depression of plunger 2405 causes distal longitudinal
movement of on body housing 122 and sharp 2404, from a proximal
position to a distal position. During such downward, distal
movement, spring 246 is further compressed between lip 2418 and
bottom surface 2424. Detent 2440 provides a minimum force threshold
to overcome before on body housing 122 can continue on its downward
distal movement. Beyond a minimum force threshold, detent 2440 is
pushed outward by on body housing 122, and on body housing 122 then
translates onto ramp 2442. The friction between on body housing 122
and ramp 2442 of the housing hold the on body housing 122 up
against plunger 2405.
[0218] As illustrated in FIG. 62, depression of plunger 2405
advances the inserter 2400 from an initial configuration to a
deployed configuration. Contact of plunger 2405 and hub 2408 during
depression of plunger 2405 imposes a downward force and
consequential distal movement of sharp 2404. As the sharp 2404 is
urged distally, it carries the sensor insertion portion 30 into the
subcutaneous portion of the subject's skin S. Contact of plunger
2405 and sensor housing 122 during depression of plunger 2405
imposes a downward force and consequential distal movement of
sensor housing 122. Lip features 2414 of plunger 2405 maintain
parallelism of sensor housing 122 to subject skin S during distal
movement.
[0219] When plunger 2405 reaches a distal position, as shown in
FIG. 63, bottom surface 2424 engages wall 2426 and prevents further
downward movement. The distal (lower) surface of on body housing
122 engages the upper surface of adhesive pad 218, thereby becoming
adhered to the skin surface S of the subject.
[0220] As the subject or some apparatus removes force from plunger
2405, spring 2406 urges plunger 2405 toward its proximal position
(away from the skin surface) as shown in FIG. 64, leaving on body
housing 122 adhered to the skin surface S of the subject. Tabs 2427
provide additional downward force to the on body housing 122 to
assist holding it to adhesive patch 218 while the sharp 2404 is
withdrawn through on body housing 122. Eventually, the upward force
exerted by spring 2406 returns inserter 2400 to its initial
configuration as illustrated in FIG. 65.
[0221] In some embodiments, inserter 2400 may be distributed in a
sterilized package 2480 as depicted in FIG. 66. To use inserter
2400 in this configuration, a user would first clean the insertion
site on the skin with alcohol. The user would then remove inserter
2400 from sterilized package 2480 as shown in FIG. 66. Next a user
would place the inserter on the insertion site and push down on
plunger 2405 until on body housing 122 is adhered to the subject's
skin as shown in FIGS. 67-68. The user would then release the
plunger 2405. Finally, the user would remove inserter 2400 from the
insertion site and dispose of the inserter.
[0222] A further embodiment of an inserter is illustrated in FIGS.
73-87, and designated inserter 2500. In some embodiments, inserter
2500 has a maximum diameter of about 30 mm to about 60 mm, e.g.,
about 40 mm, about 43 mm, about 43.5 mm, about 50.25 mm, about 52
mm, etc. In some embodiments, inserter 2500 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
50.25 mm, about 53 mm, about 67 mm, about 71 mm, etc. In some
embodiments, inserter 2500 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. The height of the
inserter is measured from the top of housing 2502 to the distal
surface of the sheath 2512 that is intended to contact the skin of
the subject. The volume of the inserter may be measured as the
volume of the housing and the portion of the sheath 2512 that may
extend from the housing 2502.
[0223] Inserter 2500 generally includes, e.g., a handle 2502,
sheath 2512, and a removable distal cap 2504 for maintaining a
sterile environment for the medical device and sharp housed therein
(FIG. 73). As illustrated in FIGS. 74-75, handle 2502 is shown
removed from distal cap 2504. Distal cap 2504 is detachably secured
to handle 2502, e.g., by use of threads 2506. It is understood that
cap may be secured using snap-fit or press-fit configuration.
Inserter 2500 may be utilized to advance a medical device into the
skin of the subject. In some embodiments, handle 2502 is advanced
relative to sheath 2512 in order to advance the medical device
distally and into the skin of the patient.
[0224] Handle 2502 further includes needle carrier guides 2508
which allow the needle carrier 2514 to slidingly move relative to
distal cap 2504. In an alternate embodiment, a detent prevents
sheath 2512 from moving towards a "firing position" until a minimum
force is applied. Location feature 2510 allows for the proper
positioning of carriage 2516 when engaged.
[0225] Further components of inserter 2500 are illustrated in FIGS.
76-80. Sheath 2512, as illustrated in FIG. 76, may include
longitudinal notches 2518 which snap into detents 2507. Retention
members, such as ribs 2520, pinch spring arms 2522 located on
carriage 2516 to prevent on body housing 122 from falling out of
inserter 2500. Ribs 2520 do not extend to the bottom of sheath
2512, thus allowing carriage 2516 to release on body housing 122
when it has traveled to the bottom of sheath 2512 during insertion.
Interfering structure, such as locking beam 2524, prevents inserter
2500 from being used again once needle carrier 2514 passes the
locking beam (FIG. 87). Specifically, locking feature 2526 of
needle carrier 2514 engages with locking beam 2524 to prevent
further use of inserter 2500.
[0226] Needle carrier 2514 is illustrated in greater detail in
FIGS. 77-78. In some embodiments, needle carrier 2514 includes
guides, such as rail guides 2528, which interface with rail guides
2508, thereby allowing needle carrier 2514 to slidingly move
relative to handle 2502. Notches 2527 are provided in sheath 2512
which has a larger dimension than the wings of needle carrier 2514,
such that the needle carrier 2514 does not contact sheath 2512
during longitudinal movement of needle carrier 2514. Needle carrier
2514 also comprises detents/notches 2530 which interface with the
upper edge of the spring when inserter 2500 is fully assembled (see
FIGS. 81-87). In some embodiments, needle carrier 2514 comprises an
attachment feature 2532 capable of accommodating a custom needle
hub or attachment.
[0227] Carriage 2516 is illustrated in greater detail in FIGS.
79-80. As shown, carriage 2516 may comprise latches 2538 which
connect it to needle carrier 2514 by locking with latches 2540.
Spring hook 2542 allows for support for retaining on body housing
122 when the inserter has not been fired and allows for release of
on body housing 122 when it has been attached to the skin of the
user. (See, FIGS. 122, 125, 135-140.)
[0228] Inserter 2500 is illustrated in cross-section in FIG. 81 in
a state prior to use in which handle 2502 is disposed in a proximal
position with respect to the sheath 2512. In such configuration,
the sharp 2550 is disposed in a configuration spaced apart from the
aperture 420 of the adhesive layer (not shown). The longitudinal
axis L of the inserter 2500 is illustrated. The upper surface of
spring 2544 is retained in inserter 2500 by detents/notches 2530
located on needle carrier 2514. The bottom surface of spring 2544
is retained by spring floor 2545 located on sheath 2512. Initially,
spring 2544 is in an expanded or semi-expanded state while handle
2502 is disposed proximally from sheath 2512.
[0229] Extending distally from the upper surface of handle 2502 is
inner wall 2508. In some embodiments, the distal end portions of
wall 2508 provide a downward force on carriage 2516 upon depression
of handle 2502 by a user. Alternatively, instead of handle 2502
having a distally extending inner wall 2508, carriage 2516 can
include one or more upwardly extending walls or projections (not
shown). The one or more upwardly extending inner walls or
projections of the carriage 2516 can have a length sufficient to
either contact the inside of the upper surface of handle 2502 or,
alternatively, contact corresponding downwardly extending inner
walls of handle 2502. In this manner, depression of handle 2502 by
a user provides a downward force on the one or more upwardly
extending walls or projections of carriage 2516 to advance carriage
2516 (and on body housing 122) distally to an installation and
insertion position (FIG. 84). In such embodiment, the downwardly
extending inner wall of the handle has a distal end that is
disposed proximally of the proximal most end of sheath 2512.
[0230] Sharp 2550 extends longitudinally from needle carrier 2514
within inserter 2500. In some embodiments, sharp 2550 is supported
at an oblique angle, e.g., between about 0.degree. and 90.degree.
with respect to the skin surface.
[0231] FIG. 82 illustrates inserter 2500 in cross-section after a
user applies an initial downward force to button 2502. Further
depression of handle 2502 with respect to sheath 2512, against the
bias of spring 2544, causes distal longitudinal movement of the
carriage 2516 and needle carrier 2514, from a proximal position
towards a distal position as shown in FIG. 83. During such downward
proximal movement, spring 2544 is compressed between
detents/notches 2530 and retention tab 2546. As sharp 2550 is
further urged distally, it carries the sensor insertion portion 30
of sensor 14 (FIG. 17) into the subject's skin S.
[0232] As carriage 2516 reaches a distal position (near the
subject's skin) as shown in FIG. 83, the distal surface of the on
body housing 122 engages the upper surface of adhesive pad (not
shown), thereby becoming adhered to the skin surface S of the
subject. Latch 2538 engages the upper surface of retention tab 2546
as shown in FIG. 84. As a result, the top portion of latch 2538 is
pivoted outward in direction T. Such pivoting of latch 2538 causes
needle carrier to become disengaged from carriage 2516.
[0233] As illustrated in FIG. 85, disengagement of the needle
carrier 2514 from the carriage 2516 permits spring 2544 to expand,
thereby advancing the needle carrier 2514 to a proximal position
and withdrawing the sharp 2550 from the skin S of the subject while
leaving the on body housing 122 attached to the skin. As the sharp
is withdrawn (FIG. 86), locking feature 2526 advances past locking
beam 2524 because of the upward force exerted on needle carrier
2514 by spring 2544.
[0234] Referring now to FIG. 87, once the sharp 2550 has been
withdrawn from the subject, button 2502 cannot be pressed again
because any downward movement will be blocked by the interaction of
locking beam 2524 and locking feature 2526.
[0235] In some embodiments, inserter 2500 may come in a sterilized
package which is capable of a one-time use as shown in FIGS. 88-90.
To use inserter 2500 in this manner, a user would first sterilize
the insertion site on the skin with alcohol. The subject would then
twist off cap 2504 as shown in FIG. 88. Next a subject would place
the inserter on the sterilized insertion site and push down on
inserter 2500 until on body housing 122 is adhered to the subject's
skin as shown in FIGS. 89-90. Finally, the subject would remove
inserter 2500 from the insertion site and dispose of the inserter.
In this manner, the inserter 2500 itself serves as its own
sterilized packaging. This procedure applies also to the other
inserters described herein.
[0236] A further embodiment of an inserter is illustrated in FIGS.
91-108, and designated inserter 2700. In some embodiments, inserter
2700 has a maximum diameter of about 30 mm to about 60 mm, e.g.,
about 40 mm, about 43 mm, about 43.5 mm, about 46 mm, about 50 mm,
etc. In some embodiments, inserter 2700 has a maximum height of
about 40 mm to about 80 mm, e.g., about 44 mm, about 46 mm, about
49.5 mm, about 55 mm, about 67 mm, about 71 mm, etc. In some
embodiments, inserter 2700 has a volume of about 35 cm.sup.3 to
about 110 cm.sup.3, e.g., about 40 cm.sup.3, about 41 cm.sup.3,
about 50 cm.sup.3, about 60 cm.sup.3, about 61 cm.sup.3, about 62
cm.sup.3, about 69 cm.sup.3, about 70 cm.sup.3, about 79 cm.sup.3,
about 90 cm.sup.3, about 106 cm.sup.3, etc. The maximum height
refers to the height defined from the top of the housing 2702 to
the portion of the sheath 2708 that contacts the subject's skin.
The volume is measured as the volume of the housing 2702 and the
portion of the sheath 2708 extending from the housing.
[0237] Inserter 2700 generally includes, e.g., a housing 2702
(FIGS. 92-93), sheath 2708 (FIGS. 94-95), and a removable distal
cap 2704 for maintaining a sterile environment for the medical
device and sharp housed therein (FIG. 91). As illustrated in FIGS.
92-93, housing 2702 is shown removed from distal cap 2704. Distal
cap 2704 is detachably secured to housing 2702, e.g., by use of
threads 2706. It is understood that cap may be secured using
snap-fit or press-fit configuration. Inserter 2700 may be utilized
to advance a medical device into the skin of the subject. Sheath
2708 generally defines a cavity or open space, within which sharp
carrier 2716 and medical device carrier 2730 are moveable. In some
embodiments, housing 2702 is advanced relative to sheath 2708 in
order to advance the medical device distally and into the skin of
the patient.
[0238] Housing 2702 includes sheath guide rail 2710 which
interfaces with rail guides 2712 located on sheath 2708 (FIG. 94),
thereby allowing housing 2702 to slidingly move longitudinally
relative to sheath 2708. Housing 2702 may further include sharp
carrier guide rail 2714 which interfaces with rail guides 2718
located on sharp carrier 2716 (FIG. 97). Sheath 2708, sharp carrier
2716, and housing 2702 may alternatively move relative to one
another without the use of guide rails.
[0239] Ledge 2720 and/or ledge 2722 are provided on an interior
portion of housing 2702. Ledge 2720 engages sheath 2708 to hold
sheath 2708 in a pre-use position prior to insertion of the medical
device. Ledge 2722 engages sheath 2708 to secure sheath 2708 in a
post-use position after insertion of the medical device. Housing
2702 further includes detent 2724 which prevents housing 2702 from
moving relative to sheath 2708 until a minimum force has been
applied, e.g., distally by user to housing 2702. The sheath 2708 is
secured to the housing 2702 via snap 2726. Snap 2726 snaps into the
housing detent 2724. (In some embodiments, it is pinched between
ledge 2720 and detent 2724, thus controlling its longitudinal
position relative to the housing 2702). The needle carrier 2716 is
located and secured to the medical device carrier 2730 (located via
interaction of locating features 2748 and 2750 and secured via
interaction of carrier arms 2732 and angled top surface of 2716).
The ledge 2720 is a controlled surface onto which the top of sheath
surface 2728 will engage at the end of the insertion stroke to
prevent further relative movement in some embodiments.
[0240] Further components of inserter 2700 are illustrated in FIGS.
94-99. Sheath 2708 is a generally cylindrical component. As
illustrated in FIGS. 94-95, sheath 2708 may include attachment
snaps 2726 which are biased into detent 2724 of housing 2702 to
create a minimum force that must be overcome in order to advance
sharp 224 into the subject's skin and install the on body housing
122. The interaction of the snap 2726 with the detent 2724 and
ledge 2720 holds the assembly in a slop/rattle free position. In
some embodiments, the force to be overcome can be about 0.5 lbf to
about 5 lbf, e.g., about 1 lbf, about 2 lbf, about 3 lbf, about 4
lbf, etc. Support wall 2728 prevents carrier arms 2732 on carrier
2730 from bending outwardly, clear of sharp carrier 2716. Ribs 2734
pinch carrier arms 2732 on carrier 2730, thus preventing on body
housing 122 from falling out of inserter 2700 when sheath 2708 is
in the extended position. Ribs 2734 are not present at the bottom
of sheath 2708, thus allowing room for spring arms 2736 on carrier
2730 to release on body housing 122 when carrier 2730 has traveled
to the bottom of sheath 2708. Slot 2738, located on sheath 2708,
interfaces with locating feature 2740 on carrier 2730, thus
orienting carrier 2730 to sheath 2708 during assembly. Once force
is overcome to allow carrier 2730 to move distally towards the
subject's skin, no further force is required to retract the sharp
324 from the subject's skin.
[0241] Referring next to FIGS. 96-97, depicted is sharp carrier
2716 in a perspective and cross-sectional view, respectively. Sharp
carrier 2716 contains notches 2724 which allow clearance for the
passage of carrier arms 2732 located on medical device carrier
2730. Guidance walls 2744 securely hold spring 2746 in place (FIG.
100). Locating features 2748, e.g., bosses or tabs, align with
locating features 2750, e.g., recesses or apertures, on carrier
2730. Snap features 2752 secure sharp 224 securely within inserter
2700. It is contemplated that sharp 224 may be secured to sharp
carrier 2716 by other techniques, e.g., friction fit, adhesive,
welding, etc.
[0242] Medical device carrier 2730 is depicted in more detail in
FIGS. 98-99. As shown, carrier 2730 contains spring locating ring
2754 which receives one end of spring 2746. In some embodiments,
spring 2746 surrounds spring locating ring 2754. In some
embodiments, the inner area remains clear to leave room for the
deflection of sharp carrier feature snaps 2752 that move outwardly
when the sharp is inserted. Carrier 2730 further comprises locating
features 2756 which interface with locating features on housing
2702. (See FIGS. 135-136).
[0243] Inserter 2700 is illustrated in cross-section in FIG. 100 in
a state prior to use in which housing 2702 is disposed in a
proximal position with respect to the sheath 2708. In such
orientation, sharp 224 is disposed in a configuration spaced apart
from the aperture 420 of the adhesive layer 118. The upper surface
of spring 2746 is retained in inserter 2700 by sharp carrier 2716.
The bottom surface of spring 2746 is retained by spring location
ring 2754. Initially, spring 2746 is in a compressed or
semi-compressed state while housing 2702 is disposed proximally
from sheath 2708.
[0244] Sharp 224 extends longitudinally from sharp carrier 2716
within inserter 2700. In some embodiments, sharp 224 is supported
at an oblique angle, e.g., between and including about 0.degree.
and 90.degree. with respect to the skin surface.
[0245] FIG. 101 illustrates inserter 2700 in cross-section after a
user applies an initial downward force to housing 2702. In some
embodiments, a predetermined minimum force must be used so that
attachment snaps 2726 advance past detent 2724.
[0246] After detent 2724 has been overcome, e.g., snap 2726 is
radially displaced, further depression of housing 2702 with respect
to sheath 2708 causes distal longitudinal movement of the carrier
2730 and sharp carrier 2716, from a proximal position towards a
distal position as shown in FIG. 103. As sharp 224 is further urged
distally, it carries the sensor insertion portion 30 of sensor 14
(FIG. 17) into the subcutaneous portion of the subject's skin
S.
[0247] As carrier 2716 reaches a distal position (FIG. 103), the
distal surface of the on body housing 122 engages the upper surface
of adhesive pad 2718, thereby becoming adhered to the skin surface
S of the subject. Concurrently, carrier arms 2732 are advanced
distally and clear the support wall 2728. This allows carrier arms
2732 to deflect radially outwardly. (See, FIG. 104). When carrier
arms 2732 deflect radially outwardly, shoulder portions of carrier
arms 2732 are no longer in an interference relationship with the
sharp carrier 2716. Thus spring 2746 is permitted to expand as
shown in FIG. 105, thereby advancing the sharp carrier 2716 to a
proximal position and withdrawing the sharp 224 from the skin S of
the subject while leaving the on body housing 122 attached to the
skin. Handle 2702 is maintained in the distal position. Sheath snap
2726 of the sheath 2708 have now moved up to lock over feature 2722
of the housing 2702. Now the housing 2702 and the sheath 2708 can
no longer move longitudinally with respect to each other, and
provides an indication to a user that the inserter has been used.
In FIG. 106, the medical device carrier 2730 acts as a needle guard
to prevent a user for touching the needle.
[0248] In some embodiments, the changing interaction of sheath snap
2726 with the housing detent/ledges 2720, 2724, and 2722 determine
whether the sheath 2708 is locked. When snap 2726 is in the
pre-fire position, ledge 2720 prevents sheath 2708 from being
pulled out of the housing 2702. In this position, detent 2724 may
also impede the movement of pushing the sheath 2708 into the
housing 2702. When the detent is overcome by at least a minimum
force, the sheath 2704 moves longitudinally with respect to the
housing 2702 until the snap 2726 snaps over housing ledge 2722. At
this point, ledge 2722 prevents the sheath 2708 from being pulled
out of the housing again, but from a new position (this position
may be referred to as the used/post-fire position). Sharp carrier
snap 2752 function is to hold onto the sharp 224. In some
embodiments, the sharp carrier 2716 is held in the post-fire
position relative to the housing 2702 by, e.g., an interference
between the rails of the housing 2714 and the guide rails of the
sharp carrier 2718 (this interference is only present once the
sharp carrier is fully retracted) and/or by medical device carrier
projections interfering with the bottom/floor of the sharp carrier
(See, e.g., FIG. 106). In another embodiment of inserter 2700,
adhesive pad 118 may be attached directly to on body housing 122.
This necessitates a different shape of inserter 2700 as depicted in
FIG. 107. Additionally, carrier 2730 is slightly wider to
accommodate adhesive pad 118 attached to on body housing 122 (FIG.
108).
[0249] A further embodiment of an inserter is illustrated in FIGS.
109-134. In some embodiments, inserter 3700 has a maximum diameter
of about 30 mm to about 60 mm, e.g., about 40 mm, about 43 mm,
about 43.5 mm, about 46 mm, about 50 mm, etc. In some embodiments,
inserter 3700 has a maximum height of about 40 mm to about 80 mm,
e.g., about 44 mm, about 46 mm, about 49.5 mm, about 55 mm, about
67 mm, about 71 mm, etc. In some embodiments, inserter 3700 has a
volume of about 35 cm.sup.3 to about 110 cm.sup.3, e.g., about 40
cm.sup.3, about 41 cm.sup.3, about 50 cm.sup.3, about 60 cm.sup.3,
about 61 cm.sup.3, about 62 cm.sup.3, about 69 cm.sup.3, about 70
cm.sup.3, about 79 cm.sup.3, about 90 cm.sup.3, about 106 cm.sup.3,
etc. The maximum height refers to the height defined from the top
of the housing 3702 to the portion of the sheath 3708 that contacts
the subject's skin. The volume is measured as the volume of the
housing 3702 and the portion of the sheath 3708 extending from the
housing.
[0250] FIGS. 109-112 depict the various stages of insertion from an
initial stage in which the cap is attached (FIG. 109), to removal
of the cap (FIG. 110), deployment of the sharp and on body housing
unit (FIG. 111) and removal of the inserter from the subject's skin
(FIG. 112).
[0251] Inserter 3700 generally includes, e.g., a housing 3702
(FIGS. 109, 113-114), sheath 3708 (FIGS. 115-116), and a removable
distal cap 3704 (FIGS. 117-119) for maintaining a sterile
environment for the medical device and sharp housed therein. As
illustrated in FIGS. 109 and 117-119, housing 3702 is shown removed
from distal cap 3704. Distal cap 3704 is detachably secured to
housing 3702, e.g., by use of threads 3706. It is understood that
in some embodiments, the cap may be secured using snap-fit or
press-fit configuration.
[0252] Inserter 3700 may be utilized to advance a medical device
into the skin of the subject. Sheath 3708 generally encloses or
defines a cavity, within which sharp carrier 3716 (FIGS. 120-121)
and medical device carrier 3730 (FIG. 122) are moveable. In some
embodiments, housing 3702 is advanced relative to sheath 3708 in
order to advance the medical device distally and into the skin of
the patient.
[0253] Housing 3702 includes sheath guide rail 3710 which
interfaces with rail guides 3712 located on sheath 3708, thereby
allowing housing 3702 to slidingly move relative to sheath 3708.
Sheath 3708, sharp carrier 3716, and housing 3702 may alternatively
move relative to one another without the use of guide rails. The
housing can include a distally extending sidewall having a
non-linear or arcuate shape. In the embodiment illustrated in FIGS.
109-134 the housing is configured with an undulating sidewall which
transitions from a concave portion (upper portion of housing 3702)
to a convex portion (lower portion of housing 3702). (FIG. 114).
This contour enhances the user's tactile recognition and provides a
more ergonomic gripping surface which reduces accidental slippage
by the user's hand. Further, the housing is configured with a
cavity sized to receive the sheath 3708, as described in further
detail below.
[0254] Housing ledge 3720 and/or ledge 3722 are provided on an
interior portion of housing 3702. Ledge 3720 engages sheath 3708 to
hold sheath 3708 in a pre-use position prior to insertion of the
medical device. Ledge 3722 engages sheath 3708 to secure sheath
3708 in a post-use position after insertion of the medical device.
Housing 3702 further includes detent 3724 which prevents housing
3702 from moving relative to sheath 3708 until a minimum force has
been applied, e.g., distally by user to housing 3702. The sheath
3708 is secured to the housing 3702 via retention features 3726,
which can be configured, e.g., as a snap. Retention feature 3726
snaps into the housing detent 3724 (In some embodiments, it is
pinched between ledge 3720 and detent 3724, thus controlling its
height relative to the housing 3702). In some embodiments, the
surfaces of the housing ledges 3720, 3722, 3724 and retention
features 3726 are configured to engage in a single point of contact
or a plurality of discrete points of contact, e.g., line. Such
discrete points of contact are advantageous over conformal
surface-to-surface contact in that a more thorough sterilization
process can be performed. A variety of sterilization mediums can be
employed, e.g., Ethylene Oxide (EtO), wherein the gaseous medium is
delivered over the various inserter components. Accordingly, the
discrete points of contact allow for a greater surface area of each
inserter component to be exposed to the gaseous medium, thereby
providing for a more thorough and rapid sterilization process. The
housing includes distally extending protrusions 3727 which are
received in apertures 3756 of the medical device carrier 3730 to
couple the housing and medical device carrier, by such techniques
as, e.g., heat staking, ultrasonic bonding, adhesive bonding, snap
fit, etc. Coupling the housing and the medical device is performed,
in some embodiments, by e.g., heat staking, ultrasonic bonding,
adhesive bonding, snap fit, etc. Consequently, there is no relative
movement between the housing 3702 and the medical device carrier
3730.
[0255] Sheath 3708 is generally formed as a unitary tubular member
having proximal 3708a and distal 3708c cylindrical portions. In
some embodiments, the portions 3708a and 3708c have an elliptical,
square, hexagonal, or other cross-section. As illustrated in FIGS.
115-116, the distal cylindrical portion 3708c (i.e., the lower
portion) can be formed with a greater diameter than the proximal
portion 3708a, with the proximal and distal portions integrally
connected via a shelf 3708b. Accordingly, the sheath 3708 can be
formed as a single-piece and generally cylindrical member with the
proximal portion having sufficient rigidity to prevent displacement
of the carrier arms 3732, as described in further detail below.
Sheath 3708 can include retention members 3726, e.g., detent snaps,
which are biased into detent 3724 of housing 3702 to create a
minimum force that must be overcome in order to advance sharp 324
into the subject's skin and install the on body housing 322. The
retention members 3726 can extend proximally from the shelf 3708b
of the sheath and be formed as a separate member such that the
retention members are spaced or offset from the cylindrical wall of
the sheath. The actuation force of the inserter is determined by
the stiffness of retention members 3726 (which is a function of
length, thickness, and cross section) as well as the steepness of
the angle of detent 3724 of the housing. In some embodiments, the
force to be overcome can be about 0.5 lbf to about 5 lbf., e.g.,
about 1 lbf, about 2 lbf, about 3 lbf, about 4 lbf, etc.
[0256] As described above, the proximal portion 3708a of the sheath
is sized such that an interior support wall surface 3728 prevents
carrier arms 3732 on medical device carrier 3730 from displacement
or bending outwardly, clear of sharp carrier 3716. Maintaining the
carrier arms 3732 in a fixed or constrained position within the
sheath allows a user to accurately know the relative positioning of
the needle within the inserter. Conversely, the distal portion
3708c of the sheath is sized such that the diameter of the interior
wall surface is greater than the carrier arms 3732, thus allowing
room for spring arms 3732 on carrier 3730 to expand or displace
radially outward thereby releasing the sharp carrier 3716 to
retract to the proximal position. Guide rails 3712 are included on
the exterior surface of the proximal portion of the sheath 3708a.
The guide rails 3712 remain engaged with the housing guide rail
3710 of the housing throughout the insertion operation, i.e., from
advancement of the housing from the proximal position to the distal
position. Thus even prior to insertion, rotational position of the
housing and sheath is controlled, and "rocking" is minimized. In
general, rocking is minimized by increasing the length of
engagement with respect to the diameter of engagement. In the
embodiment disclosed herein, the length of engagement between the
sheath and housing, i.e. along the longitudinal axis, is relatively
large while the diameter at which the engagement occurs is
relatively small, i.e. at proximal portion of sheath 3708a.
Additionally, sheath 3708 includes a slot 3738 extending distally
from the shelf 3708b and configured to receive the guide rail 3710
of the housing upon delivery of the medical device and insertion of
the sharp into the subject.
[0257] Referring next to FIGS. 120-121, depicted is sharp carrier
3716 in a perspective and cross-sectional view, respectively. Sharp
carrier 3716 contains notches 3724 which allow clearance for the
passage of carrier arms 3732 located on medical device carrier
3730. Guidance walls 3744 securely hold spring 3746 in place (FIGS.
127-128). The top or proximal edge of the sharp carrier includes a
chamfered or sloped edge 3725. Locating features 3748, e.g.,
standoffs or distally extending protrusions, aligned with locating
features 3750, e.g., recesses or apertures, on carrier 3730.
Accordingly, the sharp carrier 3716 is located and secured to the
medical device carrier 3730 (located via interaction of locating
features 3748 and 3750 and secured via interaction of carrier arms
3732 and angled edge surface of 3725. These locating features can
extend through the medical device carrier 3730 and directly engage
the on body housing 322. Accordingly, when a user actuates the
inserter, the sharp carrier drives the on body housing 322 and
sharp 324 towards the subject via the protrusions 3748. The direct
coupling of the sharp carrier enhances the control of the
positioning of on body housing 322, and prevents skewing of the on
body housing 322 or sharp 324. Additionally, snap features 3752
secure sharp 324 securely within inserter 3700. It is contemplated
that sharp 324 may be secured to sharp carrier 3716 by other
techniques, e.g., friction fit, adhesive, welding, etc.
[0258] Medical device carrier 3730 is depicted in more detail in
FIG. 122. As shown, carrier 3730 contains spring locating ring 3754
that receives one end of spring 3746. In some embodiments, spring
3746 surrounds spring locating ring 3754. In some embodiments, the
inner area remains clear to leave room for the deflection of sharp
carrier feature snaps 3752 that deflect out when the sharp is
inserted. As described above, carrier 3730 further comprises
locating features 3756 which interface with locating features on
housing 3702. Furthermore, detents can be formed at the end of
carrier arms 3732 of the medical device carrier to abut or
otherwise the sloped edge 3725 of the sharp carrier. As described
above, the detents on carrier arms 3732 are configured to engage
the edge 3725 of the sharp carrier in a discrete point of contact
fashion in order to realize the aforementioned sterilization
advantages. Additionally, these surfaces can be configured with
rounded surfaces that ensure that there is no surface to "snag"
during the release of the sharp carrier. The medical device carrier
3700 further includes one or more housing gripping arms 3762 (e.g.,
three are depicted in FIG. 122) which hold the on body housing 322
in place. In some embodiments, gripping arms 3762 are provided with
engagement boss 3764 which are configured to engage with
corresponding recesses 3766 provided on the side walls of the on
body housing 322. Such engagement of the recesses 3766 with the
gripping arms 3762 maintains the proper height location of the on
body housing 322. Ribs 3768 or other projections on the interior
surface of the distal portion 3708c of the sheath 3708 hold these
gripping arms 3762 securely in place against the on body housing
322 while the sheath is fully extended. When the medical device
carrier 3730 advances along the sheath 3708 to reach the proximal
position during use, the gripping arms 3762 are no longer supported
by the sheath 3708 and the force of the adhesive skin patch 318
overcomes the retention force of the gripping arms 3762.
[0259] Inserter 3700 is illustrated in cross-section in FIGS.
123-125 in a state prior to use in which housing 3702 is disposed
in a proximal position with respect to the sheath 3708 and the cap
3704 secured to the housing. FIG. 126 illustrates a cross-sectional
view of the inserter in a state prior to use after the cap 3704 has
been removed. The upper surface of spring 3746 is retained in
inserter 3700 by sharp carrier 3716. The bottom surface of spring
3746 is retained by spring location ring 3754 of the medical device
carrier 3730. Initially, spring 3746 is in a compressed or
semi-compressed state while housing 3702 is disposed proximally
from sheath 3708.
[0260] Sharp 324 extends longitudinally from sharp carrier 3716
within inserter 3700. In some embodiments, sharp 324 is supported
at an oblique angle, e.g., between and including about 0.degree.
and 90.degree. with respect to the skin surface.
[0261] FIGS. 127-128 depict the relationship between the medical
device carrier 3730 and the sharp carrier 3716 (with the housing
3702 and sheath 3708 omitted for sake of clarity). FIG. 127 depicts
the initial position of the medical device carrier 3730 and the
sharp carrier 3716 with the carrier arms 3732 engaged with the
sloped edge 3725 of the sharp carrier. In this position there is no
relative movement between the medical device carrier 3730 and the
sharp carrier 3716. However, the carrier arms 3732 are not of
sufficient rigidity or bias to counteract the bias of the spring
3746 in order to maintain the sharp carrier in the position shown
in FIG. 127 without support from the sheath, as shown in FIG. 129.
Accordingly, the spring 3746 urges the sharp carrier 3716 in the
proximal direction thereby displacing the carrier arms 3732
radially outward as shown in FIG. 128.
[0262] FIG. 130 illustrates inserter 3700 in cross-section after a
user applies an initial downward force to housing 3702. In some
embodiments, a predetermined minimum force must be used so that
attachment snaps 3726 advance past detent 3724.
[0263] After detent 3724 has been overcome, e.g., snap 3726 of the
sheath is displaced radially inward, further depression of housing
3702 with respect to sheath 3708 causes distal longitudinal
movement of the medical device carrier 3730 and sharp carrier 3716,
from a proximal position towards a distal position as shown in
FIGS. 131-132. During this phase of insertion, the interior surface
of proximal portion 3708a of the sheath remains engaged with the
carrier arms 3732 to prevent radial displacement of the arms 3732,
and thus maintains the coupling of the medical device carrier 3730,
on body housing 322, sharp 324 and sharp carrier 3716. As sharp 324
is further urged distally, it carries the sensor insertion portion
30 of sensor 14 (FIG. 17) into the subcutaneous portion of the
subject's skin S.
[0264] As carrier 3716 reaches a distal position, the on body
housing 322 along with the adhesive pad 318 engage the skin surface
S of the subject, thereby becoming adhered. Concurrently, carrier
arms 3732 are advanced distally beyond shelf 3708b of the sheath
and clear the support wall 3708a (as highlighted by focus point "A"
in FIG. 132). This allows carrier arms 3732 to deflect radially
outwardly into the larger diameter distal portion 3708c of the
sheath as shown in FIG. 133. When carrier arms 3732 deflect
outwardly, shoulder portions of carrier arms 3732 are no longer in
an interference relationship with the sharp carrier 3716. Thus
spring 3746 is permitted to expand as shown in FIG. 133, thereby
retracting the sharp carrier 3716 to a proximal position and
withdrawing the sharp 324 from the skin S of the subject while
leaving the on body housing 322 attached to the skin. Housing (or
handle) 3702 is maintained in the distal position and extends over
the sheath in a telescoping manner. Sheath detent or snap 3726 of
the sheath 3708 can then lock over feature 3722 of the housing
3702. Accordingly, the housing 3702 and the sheath 3708 can no
longer move longitudinally with respect to each other.
[0265] In some embodiments, the changing interaction of sheath
detent or snap 3726 with the housing detent/ledges 3720, 3724, and
3722 determine whether the sheath 3708 is locked. When snap 3726 is
in the pre-fire position, ledge 3720 prevents sheath 3708 from
being pulled out of the housing 3702. In this position, detent 3724
may also impede the movement of pushing the sheath 3708 into the
housing 3702. When the detent is overcome by at least a minimum
force, the sheath 3708 moves longitudinally with respect to the
housing 3702 until the snap 3726 snaps over housing ledge 3722. At
this point, ledge 3722 prevents the sheath 3708 from being pulled
out of the housing again, but from a new position (this position
may be referred to as the used/post-fire position). Sharp carrier
snap 3752 function is to hold onto the sharp/needle. In some
embodiments, the sharp/needle carrier 3716 is held in the post-fire
position relative to the housing 3702 by, e.g., an interference
between the rails of the housing 3710 and the guide rails of the
sharp carrier 3718 (this interference is only present once the
sharp carrier is fully retracted) and/or by medical device carrier
projections 3732 interfering with the bottom/floor of the sharp
carrier (See, e.g., FIG. 134). In another embodiment of inserter
3700, adhesive pad 318 may be attached to sheath 3708 prior to use.
Upon reaching the distal position, the distal surface of on body
housing 322 engages the upper surface of adhesive pad 318, thereby
becoming adhered to the skin surface S of the subject.
[0266] Another embodiment of the inserter 3700' is substantially
identical to the inserter 3700 discussed hereinabove with the
differences noted herein. As illustrated in FIGS. 135-136, the
medical device carrier 3730' is substantially identical to carrier
3730. However, carrier 3730' includes one or more gripping arms
3762' including an engagement boss 3764' which is configured to
engage with corresponding recesses 3766 provided on the side walls
of the on body housing 322. In some embodiments, the gripping arms
3762' are configured to be spaced radially apart from the on body
housing 322 in the relaxed, unstressed configuration. When an
inwardly directed force is applied to the gripping arms 3762', they
may be directed into contact with the on body housing 322.
[0267] Perspective and sectional views of sheath 3708' are
illustrated, respectively, in FIGS. 137-138. The inside of distal
portion 3708c' includes one or more ramp members 3768', which are
positioned to engage the gripping arms 3762' and provide a radially
inwardly directed force. As illustrated in FIG. 139, in the initial
configuration, the medical device carrier 3730' is positioned in a
proximal position with respect to the sheath 3708'. In this
configuration, the gripping arms 3762' are deflected radially
inwardly by the ramp member 3768' such that the engagement boss
3764' is in contact with the recesses 3766 of the on body housing
322. This configuration provides support for the on body housing
322. As illustrated in FIG. 140, as the carrier 3730' is advanced
distally, the gripping arms 3762' clear the ramp member 3768', the
gripping arms 3762' begin to deflect radially outwardly according
to their normal bias, thereby releasing the engagement boss 3764'
from the recesses 3768' of on body housing 322. Release of the
gripping arms 3762' facilitates the separation of the on body
housing 322 form the inserter 3700'.
[0268] In some embodiments, the on body housing is assembled on the
body of the user. For example, the on body housing may be comprised
of a mounting unit 3780 and an electronics housing 3782. The
mounting unit 3780 may include a mount and a sensor. In some
embodiments, the sensor is at least partially positioned within the
mount and the distal insertion portion extends out of the mount. An
inserter, such as inserter 3700 described herein, is used to
advance the distal portion of the sensor into the skin of the
subject and to adhere the mount to the skin of the user.
Subsequently, the electronics housing 3782 is mounted onto the
mounting unit 3780. Electrical contact is made between the
electronics housing 3782 and the sensor in order to transfer the
analyte readings from the sensor to the electronics housing
3782.
[0269] As illustrated in FIG. 141, the inserter 3700 is initially
arranged with the cap 3704 attached to the housing 3702. The
mounting unit 3780 is positioned in the medical device carrier
3730, with the sharp 324 extending distally in a surrounding
position about the sensor. FIGS. 142-144 illustrate the sequence of
inserting the sensor into the skin of the user and the attachment
of the mounting unit 3780 to the skin of the user. In FIG. 142, the
sheath 3708 is placed on the skin. In FIG. 143, the housing 3702 is
advanced distally towards the skin of the user, thereby advancing
the medical device carrier, the mounting unit 3780 and the sharp
324 towards the skin of the patient. In FIG. 144, upon reaching the
distal position of the housing 3702, the sharp carrier 3716 is
released, thereby moving to the proximal position.
[0270] As illustrated in FIGS. 145a and 145b, the mounting unit
3780 is positioned on the skin with the distal portion of the
sensor inserted into the skin. As illustrated in FIGS. 146a and
146b, the electronics housing 3782 is inserted into the mounting
unit 3780, and shown in the final configuration in FIGS. 147a and
147b.
[0271] In an exemplary embodiment of on body housing 3800
illustrated in FIG. 148, electronics housing 3882 is mounted on
mounting unit 3880. Mounting unit 3880 includes a detent 3884 for
coupling with a recess 3886 on the electronics housing 3882 in,
e.g., a toe-in snap configuration. It is understood that the detent
and recess configuration may be reversed such that the recess is on
the mounting unit and the detent is on the electronics housing. The
electronics housing 3882 electrically couples with the mounting
unit 3880 by the electrical contacts 3888 on the mounting unit 3880
which are coupled to electrical contacts (not shown) on the
electronics housing 3882. The sensor hub 3890 stores at least a
portion of the sensor which is electrically coupled to the contacts
3888.
[0272] In another exemplary embodiment illustrated in FIG. 149, the
on body housing 3900 is attached by first attaching the mounting
unit 3980 to the skin of the user. Subsequently, sensor 14 is
positioned at least partially beneath the skin of the user.
Electronics housing 3982 is coupled to the mounting unit 3980 by
inserting the flanges 3986 under a corresponding flange of the
mounting unit 3980. Contacts 3988 of the electronics housing 3982
are then coupled to contacts on the sensor 14 in order to provide
the sensor readings from the sensor to the electronics housing
3982.
[0273] In some embodiments, the on body housing is assembled on a
surface (such as a tabletop) prior to insertion into the user. For
example, as illustrated in FIGS. 150-156, the on body housing may
be comprised of a housing unit 4020 and a sensor hub 4022. The
housing unit 4020 may include a mount and on body electronics. In
some embodiments, the sensor is at least partially positioned
within the sensor hub 4022 and the distal insertion portion extends
out of the sensor hub 4022. The sensor hub 4022 is contained in the
inserter, and the housing unit 4020 is positioned in the inserter
3700. Electrical contact is made between the housing unit 4020 and
the sensor in order to transfer the analyte readings from the
sensor to the housing unit 4020. The inserter, similar to inserter
3700 described herein, is used to advance the distal portion of the
sensor into the skin of the subject and to adhere the housing unit
4020 to the skin of the user.
[0274] As illustrated in FIG. 150, the inserter 3700 is initially
arranged with the cap 3704 attached to the housing 3702. The sensor
hub 4022 is supported by the sharp carrier 3716, with the sharp 324
extending distally in a surrounding position about the sensor.
FIGS. 151-155 illustrate the sequence of inserting the sensor into
the skin of the user and the attachment of the housing unit 4020 to
the skin of the user. In FIG. 151, the cap 3704 is removed. In
FIGS. 152-153, the housing unit 4020 is positioned in the housing
support 3731, for example, by use of adhesive patch 4028. In FIG.
154, the sharp carrier 3716 is advanced distally, thereby advancing
the sensor hub 4022 distally and into engagement with the housing
unit 4020. In FIG. 155, the sharp carrier 3716 is released, thereby
allowing the sharp carrier 3716 to move proximally. The inserter
3700 is removed, leaving the sensor hub 4022 coupled to the housing
unit 4020, as illustrated in FIG. 156.
[0275] In some embodiments, the housing unit 4020 and the adhesive
patch 4028 are stored in a sealed compartment 4100 as shown in FIG.
157. The compartment 4100 includes a lower cap portion 4104 and a
cover portion 4102, manufactured from a flexible material such as
metal foil or plastic. As shown in FIG. 158, the lower cap portion
4104 stores the sterilized housing unit 4020 and adhesive patch
4028 therein until ready for use. In some embodiments, the adhesive
patch 4028 includes adhesive on both sides.
[0276] In some embodiments, on body housing 4200 includes housing
unit 4220 and sensor hub 4222 as illustrated in FIG. 159. The
sensor may be insert molded with mechanical contacts. The PCB in
the housing unit 4220 may include leaf spring contacts 4230. The
sensor hub 4222 may be mechanically attached to the housing unit
4220, e.g., the electrical contacts may function as mechanical
snaps. Sealing may be provided by an elastomeric gasket. The
housing unit 4220 may be macromelt or injection molded.
[0277] In some embodiments, on body housing 4300 includes housing
unit 4320 and sensor hub 4322 as illustrated in FIG. 160. The
sensor may have insert molded contacts. The PCB in housing unit
4320 may include exposed pads. Mechanical attachment of the housing
unit and sensor hub may be accomplished by molded snaps. The needle
guide may be injection molded or overmolded macromelt of TPE
(thermoplastic elastomer). The housing unit 4320 may be macromelt
or injection molded.
[0278] In some embodiments, on body housing 4400 includes housing
unit 4420 and sensor hub 4422 as illustrated in FIG. 161. The
sensor may have exposed pads on the flag or contact portion of the
sensor. The PCB in housing unit 4420 may include a SMT ZIF
connector, or similar 4430. Mechanical attachment of the housing
unit and sensor hub may be accomplished by molded snaps. The needle
guide may be injection molded plastic with elastomer overmold. The
housing unit 4320 may be macromelt overmold.
[0279] In some embodiments, a clamshell type arrangement 4500 is
provided which includes a needle guide 4550 having a living hinge
arrangement 4552. The sensor may include bent metal contacts that
are inserted after molding. The PCB may include PCB pads. The
mechanical attachment is performed by adhesive of mechanical snap
to PCB. The transponder housing, not shown, may be injection
molded, UV or ultrasonic bonded.
[0280] In some embodiments, on body housing 4600 includes housing
unit 4620 and sensor hub 4622 as illustrated in FIG. 163. The
sensor 14 may have exposed pads on the flag or contact portion of
the sensor. The PCB in housing unit 4620 may include concentric
exposed pads 4690. Mechanical attachment of the housing unit and
sensor hub may be accomplished by molded snaps or PSA. The needle
guide may be injection molded plastic with elastomer overmold. The
housing unit 4620 may be macromelt overmold.
[0281] In some embodiments, on body housing 4700 includes housing
unit 4720 and sensor hub 4722 as illustrated in FIG. 164. The
sensor may have exposed pads on the flag and may also include a
compressed anisotropic zebra, conductive elastomeric or similar.
The PCB in housing unit 4720 may include exposed pads. Mechanical
attachment of the housing unit and sensor hub may be accomplished
by snaps. The needle guide may overmold macromelt or TPE. The
housing unit 4720 may be macromelt overmold.
[0282] 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.
* * * * *