U.S. patent application number 17/454579 was filed with the patent office on 2022-03-03 for transcutaneous analyte sensor systems and methods.
The applicant listed for this patent is DexCom, Inc.. Invention is credited to Jennifer Blackwell, Justen Deering England, John Michael Gray, Jason Halac, Neal Davis Johnston, Mark Douglas Kempkey, Paul V. Neale, Kenneth Pirondini, Andrew Michael Reinhardt, Peter C. Simpson, Maria Noel Brown Wells.
Application Number | 20220061719 17/454579 |
Document ID | / |
Family ID | 1000005970881 |
Filed Date | 2022-03-03 |
United States Patent
Application |
20220061719 |
Kind Code |
A1 |
Halac; Jason ; et
al. |
March 3, 2022 |
TRANSCUTANEOUS ANALYTE SENSOR SYSTEMS AND METHODS
Abstract
Systems for applying a transcutaneous monitor to a person can
include a telescoping assembly, a sensor, and a base with adhesive
to couple the sensor to skin. The sensor can be located within the
telescoping assembly while the base protrudes from a distal end of
the system. The system can be configured to couple the sensor to
the base by compressing the telescoping assembly.
Inventors: |
Halac; Jason; (San Diego,
CA) ; Gray; John Michael; (San Diego, CA) ;
Johnston; Neal Davis; (Dallas, TX) ; England; Justen
Deering; (San Francisco, CA) ; Simpson; Peter C.;
(Cardiff by the Sea, CA) ; Neale; Paul V.; (San
Diego, CA) ; Blackwell; Jennifer; (San Diego, CA)
; Wells; Maria Noel Brown; (San Diego, CA) ;
Pirondini; Kenneth; (San Diego, CA) ; Reinhardt;
Andrew Michael; (Santee, CA) ; Kempkey; Mark
Douglas; (Vista, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DexCom, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
1000005970881 |
Appl. No.: |
17/454579 |
Filed: |
November 11, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17378491 |
Jul 16, 2021 |
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17454579 |
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17200620 |
Mar 12, 2021 |
11166657 |
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17378491 |
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15387088 |
Dec 21, 2016 |
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17200620 |
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62412100 |
Oct 24, 2016 |
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62272983 |
Dec 30, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/14865 20130101;
A61B 5/6848 20130101; A61B 5/14546 20130101; A61B 5/6849 20130101;
A61B 2560/063 20130101; A61B 5/68335 20170801; A61B 5/688 20130101;
A61B 5/14532 20130101; A61B 5/6832 20130101 |
International
Class: |
A61B 5/1486 20060101
A61B005/1486; A61B 5/00 20060101 A61B005/00; A61B 5/145 20060101
A61B005/145 |
Claims
1. A transcutaneous analyte sensor system comprising: a
transcutaneous analyte sensor; and sensor electronics operably
connectable to the transcutaneous analyte sensor.
Description
INCORPORATION BY REFERENCE TO RELATED APPLICATIONS
[0001] Any and all priority claims identified in the Application
Data Sheet, or any correction thereto, are hereby incorporated by
reference under 37 CFR 1.57. This application is a continuation of
U.S. application Ser. No. 17/378,491, filed Jul. 16, 2021, which is
a continuation of U.S. application Ser. No. 17/200,620, filed Mar.
12, 2021, now U.S. Pat. No. 11,166,657, issued Nov. 9, 2021, which
is a continuation of U.S. application Ser. No. 15/387,088, filed
Dec. 21, 2016, which, in turn, claims the benefit of U.S.
Provisional Application No. 62/272,983, filed Dec. 30, 2015 and
U.S. Provisional Application No. 62/412,100, filed Oct. 24, 2016.
Each of the aforementioned applications is incorporated by
reference herein in its entirety, and each is hereby expressly made
a part of this specification.
FIELD
[0002] Various embodiments disclosed herein relate to measuring an
analyte in a person. Certain embodiments relate to systems and
methods for applying a transcutaneous analyte measurement system to
a person.
BACKGROUND
[0003] Diabetes mellitus is a disorder in which the pancreas cannot
create sufficient insulin (Type I or insulin dependent) and/or in
which insulin is not effective (Type 2 or non-insulin dependent).
In the diabetic state, the victim suffers from high blood sugar,
which can cause an array of physiological derangements associated
with the deterioration of small blood vessels, for example, kidney
failure, skin ulcers, or bleeding into the vitreous of the eye. A
hypoglycemic reaction (low blood sugar) can be induced by an
inadvertent overdose of insulin, or after a normal dose of insulin
or glucose-lowering agent accompanied by extraordinary exercise or
insufficient food intake.
[0004] Conventionally, a person with diabetes carries a
self-monitoring blood glucose monitor, which typically requires
uncomfortable finger pricking methods. Due to the lack of comfort
and convenience, a person with diabetes normally only measures his
or her glucose levels two to four times per day. Unfortunately,
such time intervals are so far spread apart that the person with
diabetes likely finds out too late of a hyperglycemic or
hypoglycemic condition, sometimes incurring dangerous side effects.
Glucose levels may be alternatively monitored continuously by a
sensor system including an on-skin sensor assembly. The sensor
system may have a wireless transmitter which transmits measurement
data to a receiver which can process and display information based
on the measurements.
[0005] The process of applying the sensor to the person is
important for such a system to be effective and user friendly. The
application process can result in the sensor assembly being
attached to the person in a state where it is capable of sensing
glucose level information, communicating the glucose level
information to the transmitter, and transmitting the glucose level
information to the receiver.
[0006] The analyte sensor can be placed into subcutaneous tissue. A
user can actuate an applicator to insert the analyte sensor into
its functional location. This transcutaneous insertion can lead to
incomplete sensor insertion, improper sensor insertion, exposed
needles, or unnecessary pain. Thus, there is a need for a system
that more reliably enables transcutaneous sensor insertion while
being easy to use and relatively pain-free.
SUMMARY
[0007] Various systems and methods described herein enable
reliable, simple, and pain-minimizing transcutaneous insertion of
analyte sensors. Some embodiments are a system for applying an
on-skin sensor assembly to skin of a host. Systems can comprise a
telescoping assembly having a first portion configured to move
distally relative to a second portion from a proximal starting
position to a distal position along a path; a sensor module coupled
to the first portion, the sensor module including a sensor,
electrical contacts, and a seal; and/or a base coupled to the
second portion such that the base protrudes from a distal end of
the system. The base can comprise an adhesive configured to couple
the sensor module to the skin. The moving of the first portion to
the distal position can couple the sensor module to the base. The
sensor can be an analyte sensor; a glucose sensor; any sensor
described herein or incorporated by reference; and/or any other
suitable sensor.
[0008] In some embodiments (i.e., optional and independently
combinable with any of the aspects and embodiments identified
herein), the sensor module can include a sensor module housing. The
sensor module housing can include a first flex arm.
[0009] In some embodiments (i.e., optional and independently
combinable with any of the aspects and embodiments identified
herein), the sensor can be located within the second portion while
the base protrudes from the distal end of the system such that the
system is configured to couple the sensor to the base via moving
the first portion distally relative to the second portion.
[0010] In several embodiments (i.e., optional and independently
combinable with any of the aspects and embodiments identified
herein), the sensor can be coupled to the sensor module while the
first portion is located in the proximal starting position.
[0011] In some embodiments, a needle is coupled to the first
portion (of the telescoping assembly) such that the sensor and the
needle move distally relative to the base and relative to the
second portion. The system can comprise a needle release mechanism
configured to retract the needle proximally.
[0012] In several embodiments, the base comprises a distal
protrusion having a first hole. The distal protrusion can be
configured to reduce a resistance of the skin to piercing. The
sensor can pass through the first hole of the distal
protrusion.
[0013] In some embodiments, a needle having a slot passes through
the first hole of the distal protrusion. A portion of the sensor
can be located in the slot such that the needle is configured to
move distally relative to the base without dislodging the portion
of the sensor from the slot.
[0014] In several embodiments, the distal protrusion is convex such
that the distal protrusion is configured to tension the skin while
the first portion moves distally relative to the second portion to
prepare the skin for piercing. The distal protrusion can be shaped
like a dome.
[0015] In some embodiments, the adhesive comprises a second hole.
The distal protrusion can be located at least partially within the
second hole such that the distal protrusion can tension at least a
portion of the skin beneath the second hole.
[0016] In several embodiments, the adhesive covers at least a
majority of the distal protrusion. The adhesive can cover at zero
percent, at least 30 percent, at least 70 percent, and/or less than
80 percent of the distal protrusion. The distal protrusion can
protrude at least 0.5 millimeters, less than 3 millimeters, and/or
less than 5 millimeters.
[0017] In some embodiments, a sensor module is coupled to the first
portion and is located at least 3 millimeters and/or at least 5
millimeters from the base while the first portion is in the
proximal starting position. The system can be configured such that
moving the first portion to the distal position couples the sensor
module to the base.
[0018] In several embodiments, the sensor is already coupled to the
sensor module while the first portion is located in the proximal
starting position. For example, the sensor can be coupled to the
sensor module at the factory (e.g., prior to the user opening a
sterile barrier). The sensor can be located within the second
portion while the base protrudes from the distal end of the
system.
[0019] In some embodiments, the sensor is coupled to a sensor
module. During a first portion of the path, the sensor module can
be immobile relative to the first portion, and the base can be
immobile relative to the second portion. During a second portion of
the path, the system can be configured to move the first portion
distally relative to the second portion to move the sensor module
towards the base, couple the sensor module to the base, and/or
enable the coupled sensor module and the base to detach from the
telescoping assembly.
[0020] In several embodiments, a sensor module is coupled to the
sensor. The system comprises a vertical central axis oriented from
a proximal end to the distal end of the system. The sensor module
can comprise a first flex arm that is oriented horizontally and is
coupled to the base. The first flex arm can extend from an outer
perimeter of the sensor module.
[0021] In some embodiments, the base comprises a first proximal
protrusion coupled to the first flex arm to couple the sensor
module to the base. A first horizontal locking protrusion can be
coupled to an end portion of the first flexible arm. A second
horizontal locking protrusion can be coupled to the first proximal
protrusion of the base. The first horizontal locking protrusion can
be located distally under the second horizontal locking protrusion
to secure the sensor module to the base. The system can be
configured such that moving the first portion of the telescoping
assembly to the distal position causes the first flex arm to bend
to enable the first horizontal locking protrusion to move distally
relative to the second horizontal locking protrusion.
[0022] In several embodiments, the base comprises a second proximal
protrusion coupled to a second flex arm of the sensor module. The
first flex arm can be located on an opposite side of the sensor
module relative to the second flex arm.
[0023] In some embodiments, a sensor module is coupled to the
sensor. The system can comprise a vertical central axis oriented
from a proximal end to the distal end of the system. The base can
comprise a first flex arm that is oriented horizontally and is
coupled to the sensor module. The sensor module can comprise a
first distal protrusion coupled to the first flex arm to couple the
sensor module to the base.
[0024] In several embodiments, a first horizontal locking
protrusion is coupled to an end portion of the first flexible arm,
a second horizontal locking protrusion is coupled to the first
distal protrusion of the sensor module, and the second horizontal
locking protrusion is located distally under the first horizontal
locking protrusion to secure the sensor module to the base. The
system can be configured such that moving the first portion of the
telescoping assembly to the distal position causes the first flex
arm to bend to enable the second horizontal locking protrusion to
move distally relative to the first horizontal locking
protrusion.
[0025] In some embodiments, the sensor module comprises a second
distal protrusion coupled to a second flex arm of the base. The
first distal protrusion can be located on an opposite side of the
sensor module relative to the second distal protrusion.
[0026] In several embodiments, a sensor module is coupled to the
sensor. The first portion can comprise a first flex arm and a
second flex arm that protrude distally and latch onto the sensor
module to releasably secure the sensor module to the first portion
while the first portion is in the proximal starting position. The
sensor module can be located remotely from the base while the first
portion is in the proximal starting position (e.g., such that the
sensor module does not touch the base).
[0027] In some embodiments, the sensor module is located within the
second portion while the base protrudes from the distal end of the
system such that the system is configured to couple the sensor
module to the base via moving the first portion distally relative
to the second portion.
[0028] In several embodiments, the system comprises a vertical
central axis oriented from a proximal end to the distal end of the
system. The first and second flex arms of the first portion can
secure the sensor module to the first portion such that the sensor
module is releasably coupled to the first portion with a first
vertical holding strength. The sensor module can comprise a third
flex arm coupled with a first proximal protrusion of the base such
that the sensor module is coupled to the base with a second
vertical holding strength.
[0029] In some embodiments, the second vertical holding strength is
greater than the first vertical holding strength such that
continuing to push the first portion distally once the sensor
module is coupled to the base overcomes the first and second flex
arms of the first portion to detach the sensor module from the
first portion. The third flex arm can extend from an outer
perimeter of the sensor module.
[0030] In several embodiments, the base protrudes from the distal
end of the system while the first portion of the telescoping
assembly is located in the proximal starting position and the
sensor is located remotely relative to the base such that the
system is configured to couple the sensor to the base via moving
the first portion distally relative to the second portion. The base
can comprise a first radial protrusion releasably coupled with a
first vertical holding strength to a second radial protrusion of
the second portion of the telescoping assembly.
[0031] In some embodiments, the first radial protrusion protrudes
inward and the second radial protrusion protrudes outward. The
system can be configured such that moving the first portion to the
distal position moves the second radial protrusion relative to the
first radial protrusion to detach the base from the telescoping
assembly.
[0032] In several embodiments, the first portion of the telescoping
assembly comprises a first arm that protrudes distally, the second
portion of the telescoping assembly comprises a second flex arm
that protrudes distally, and the system is configured such that
moving the first portion from the proximal starting position to the
distal position along the path causes the first arm to deflect the
second flex arm and thereby detach the second flex arm from the
base to enable the base to decouple from the telescoping assembly.
When the first portion is in the proximal starting position, the
first arm of the first portion can be at least partially vertically
aligned with the second flex arm of the second portion to enable
the first arm to deflect the second flex arm as the first portion
is moved to the distal position.
[0033] In some embodiments, when the first portion is in the
proximal starting position, at least a section of the first arm is
located directly over the second flex arm to enable the first arm
to deflect the second flex arm as the first portion is moved to the
distal position.
[0034] In several embodiments, the second flex arm comprises a
first horizontal protrusion, and the base comprises a second
horizontal protrusion latched with the first horizontal protrusion
to couple the base to the second portion of the telescoping
assembly. The first arm of the first portion can deflect the second
flex arm of the second portion to unlatch the base from the second
portion of the telescoping assembly.
[0035] In some embodiments, the system is configured to couple the
sensor to the base at a first position, and the system is
configured to detach the base from the telescoping assembly at a
second position that is distal relative to the first position.
[0036] In several embodiments, a third flex arm couples the sensor
to the base at a first position, the second flex arm detaches from
the base at a second position, and the second position is distal
relative to the first position such that the system is configured
to secure the base to the telescoping assembly until after the
sensor is secured to the base.
[0037] In some embodiments, the base protrudes from the distal end
of the system while the first portion of the telescoping assembly
is located in the proximal starting position and the sensor is
located remotely relative to the base. The system can further
comprise a spring configured to retract a needle. The needle can be
configured to facilitate inserting the sensor into the skin. When
the first portion is in the proximal starting position, the spring
can be in a first compressed state. The system can be configured
such that moving the first portion distally from the proximal
starting position further increases a compression of the spring.
The first compressed state places the first and second portions in
tension.
[0038] In several embodiments, a system is configured to apply an
on-skin sensor assembly to the skin of a host (i.e., a person). The
system can include a telescoping assembly having a first portion
configured to move distally relative to a second portion from a
proximal starting position to a distal position along a path; a
sensor coupled to the first portion; and/or a latch configurable to
impede a needle from moving proximally relative to the first
portion. The sensor can be an analyte sensor; a glucose sensor; any
sensor described herein or incorporated by reference; and/or any
other suitable sensor.
[0039] In some embodiments, the first portion is releasably secured
in the proximal starting position by a securing mechanism that
impedes moving the first portion distally relative to the second
portion. The system can be configured such that prior to reaching
the distal position, moving the first portion distally relative to
the second portion releases the latch thereby causing the needle to
retract proximally into the system. The system can be configured
such that moving the first portion distally relative to the second
portion (e.g., moving the first portion to the distal position)
releases the latch thereby causing the needle to retract proximally
into the system. The securing mechanism can be an interference
between the first portion and the second portion of the telescoping
assembly.
[0040] In several embodiments, a first force profile is measured
along the path. The first force profile can comprise a first
magnitude coinciding with overcoming the securing mechanism; a
third magnitude coinciding with releasing the latch; and a second
magnitude coinciding with an intermediate portion of the path that
is distal relative to overcoming the securing mechanism and
proximal relative to releasing the latch.
[0041] In some embodiments, the second magnitude is less than the
first and third magnitudes such that the system is configured to
promote needle acceleration during the intermediate portion of the
path to enable a suitable needle speed (e.g., a sufficiently high
needle speed) at a time the needle first pierces the skin.
[0042] In several embodiments, the first magnitude is at least 100
percent greater than the second magnitude. The first magnitude can
be greater than the third magnitude such that the system is
configured to impede initiating a sensor insertion cycle unless a
user is applying enough force to release the latch. The first
magnitude can be at least 50 percent greater than the third
magnitude.
[0043] In some embodiments, an intermediate portion of the path is
distal relative to overcoming the securing mechanism and proximal
relative to releasing the latch. The system can further comprise a
second force profile coinciding with the intermediate portion of
the path. A proximal millimeter of the second force profile can
comprise a lower average force than a distal millimeter of the
second force profile in response to compressing a spring configured
to enable the system to retract the needle into the telescoping
assembly.
[0044] In several embodiments, a first force profile is measured
along the path. The first force profile can comprise a first
average magnitude coinciding with moving distally past a proximal
half of the securing mechanism and a second average magnitude
coinciding with moving distally past a distal half of the securing
mechanism. The first average magnitude can be greater than the
second average magnitude such that the system is configured to
impede initiating a sensor insertion cycle unless a user is
applying enough force to complete the sensor insertion cycle (e.g.,
drive the needle and/or the sensor to the intended insertion
depth).
[0045] In some embodiments, a first force peak (coinciding with
moving distally past the proximal half of the securing mechanism)
is at least 25 percent higher than the second average
magnitude.
[0046] In several embodiments, a first force profile is measured
along the path. The first force profile can comprise a first
magnitude coinciding with overcoming the securing mechanism and a
subsequent magnitude coinciding with terminating the securing
mechanism. The first magnitude can comprise a proximal vector and
the subsequent magnitude can comprise a distal vector.
[0047] In some embodiments, the securing mechanism can comprise a
radially outward protrusion extending from the first portion. The
radially outward protrusion can be located proximally relative to a
proximal end of the second portion while the telescoping assembly
is in the proximal starting position. The radially outward
protrusion can be configured to cause the second portion to deform
elliptically to enable the first portion to move distally relative
to the second portion.
[0048] In several embodiments, the securing mechanism comprises a
radially outward protrusion of the first portion that interferes
with a radially inward protrusion of the second portion such that
the securing mechanism is configured to cause the second portion to
deform elliptically to enable the first portion to move distally
relative to the second portion.
[0049] In some embodiments, the needle is retractably coupled to
the first portion by a needle holder configured to resist distal
movement of the first portion relative to the second portion. The
securing mechanism can comprise a flexible arm of the second
portion. The flexible arm can be releasably coupled to the needle
holder to releasably secure the first portion to the second portion
in the proximal starting position.
[0050] In several embodiments, the securing mechanism comprises a
frangible coupling between the first portion and the second portion
while the first portion is in the proximal starting position. The
system can be configured such that moving the first portion to the
distal position breaks the frangible coupling.
[0051] In some embodiments, the securing mechanism comprises a
magnet that releasably couples the first portion to the second
portion while the first portion is in the proximal starting
position. The magnet can be attracted to a metal element coupled to
the first portion or the second portion of the telescoping
assembly.
[0052] In several embodiments, an electric motor drives the first
portion distally relative to the second portion. The electric motor
can be configured to move the needle in the skin.
[0053] In some embodiments, an on-skin sensor system is configured
for transcutaneous glucose monitoring of a host. The system can
comprise a sensor module housing, in which the sensor module
housing can include a first flex arm; a sensor having a first
section configured for subcutaneous sensing and a second section
mechanically coupled to the sensor module housing; an electrical
interconnect mechanically coupled to the sensor module housing and
electrically coupled to the sensor; and/or a base coupled to the
first flex arm of the sensor module housing. The base can have an
adhesive configured to couple the base to the skin of the host. The
sensor can be an analyte sensor; a glucose sensor; any sensor
described herein or incorporated by reference; and/or any other
suitable sensor.
[0054] In several embodiments, the electrical interconnect
comprises a spring. The spring can comprise a conical portion
and/or a helical portion.
[0055] In some embodiments, the sensor module housing comprises at
least two proximal protrusions located around a perimeter of the
spring. The proximal protrusions can be configured to help orient
the spring. A segment of the sensor can be located between the
proximal protrusions.
[0056] In several embodiments, the sensor module housing is
mechanically coupled to a base having an adhesive configured to
couple the base to skin of the host.
[0057] In some embodiments, the proximal protrusions orient the
spring such that coupling an electronics unit to the base presses
the spring against a first electrical contact of the electronics
unit and a second electrical contact of the sensor to electrically
couple the sensor to the electronics unit.
[0058] In several embodiments, the sensor module housing comprises
a first flex arm that is oriented horizontally and is coupled to
the base. The first flex arm can extend from an outer perimeter of
the sensor module housing. The base can comprise a first proximal
protrusion coupled to the first flex arm to couple the sensor
module housing to the base.
[0059] In some embodiments, the electrical interconnect comprises a
leaf spring, which can include one metal layer or multiple metal
layers. The leaf spring can be a cantilever spring.
[0060] In some embodiments, the sensor module housing comprises a
proximal protrusion having a channel in which at least a portion of
the second section of the sensor is located. The channel can
position a first area of the sensor such that the first area is
electrically coupled to the leaf spring.
[0061] In some embodiments, the leaf spring arcs away from the
first area and protrudes proximally to electrically couple with an
electronics unit. At least a portion of the leaf spring can form a
"W" shape. At least a portion of the leaf spring forms a "C"
shape.
[0062] In several embodiments, the leaf spring bends around the
proximal protrusion. The leaf spring can bend at least 120 degrees
and/or at least 160 degrees around the proximal protrusion. The
leaf spring can protrude proximally to electrically couple with an
electronics unit.
[0063] In some embodiments, a seal is configured to impede fluid
ingress to the leaf spring. The sensor module housing can be
mechanically coupled to a base. The base can have an adhesive
configured to couple the base to skin of the host.
[0064] In several embodiments, the leaf spring is oriented such
that coupling an electronics unit to the base presses the leaf
spring against a first electrical contact of the electronics unit
and against a second electrical contact of the sensor to
electrically couple the sensor to the electronics unit. A proximal
height of the seal can be greater than a proximal height of the
leaf spring such that the electronics unit contacts the seal prior
to contacting the leaf spring.
[0065] In some embodiments, the sensor module housing comprises a
first flex arm that is oriented horizontally and is coupled to the
base. The first flex arm can extend from an outer perimeter of the
sensor module housing. The base can comprise a first proximal
protrusion coupled to the first flex arm to couple the sensor
module housing to the base.
[0066] In several embodiments, the sensor module housing comprises
a channel in which at least a portion of the second section of the
sensor is located. A distal portion of the leaf spring can be
located in the channel such that a proximal portion of the leaf
spring protrudes proximally out the channel. The sensor module
housing can comprise a groove that intersects the channel. The leaf
spring can comprise a tab located in the groove to impede rotation
of the leaf spring.
[0067] In some embodiments, the sensor module housing is
mechanically coupled to a base that has an adhesive configured to
couple the base to skin of the host. The sensor module housing can
comprise a first flex arm that is oriented horizontally and is
coupled to the base. The first flex arm can extend from an outer
perimeter of the sensor module housing. The base can comprises a
first proximal protrusion coupled to the first flex arm to couple
the sensor module housing to the base.
[0068] In several embodiments, electrical interconnects (such as
springs or other types of interconnects) comprises a resistance of
less than 100 ohms and/or less than 5 ohms. Electrical
interconnects can comprise a compression force of less than one
pound over an active compression range.
[0069] In some embodiments, electrical interconnects may require a
compression force of less than one pound to compress the spring 20
percent from a relaxed position, which is a substantially
uncompressed position. In some embodiments, electrical
interconnects may require a compression force of less than one
pound to compress the spring 25 percent from a relaxed position,
which is a substantially uncompressed position. In some
embodiments, electrical interconnects may require a compression
force of less than one pound to compress the spring 30 percent from
a relaxed position, which is a substantially uncompressed position.
In some embodiments, electrical interconnects may require a
compression force of less than one pound to compress the spring 50
percent from a relaxed position, which is a substantially
uncompressed position.
[0070] In several embodiments, the spring is configured such that
compressing the spring 25 percent from a relaxed position requires
a force of at least 0.05 pounds and less than 0.5 pounds, and
requires moving an end of the spring at least 0.1 millimeter and
less than 1.1 millimeter.
[0071] In some embodiments, a system for applying an on-skin sensor
assembly to a skin of a host comprises a telescoping assembly
having a first portion configured to move distally relative to a
second portion from a proximal starting position to a distal
position along a path; a sensor coupled to the first portion; and a
base comprising adhesive configured to couple the sensor to the
skin. The telescoping assembly can further comprise a third portion
configured to move distally relative to the second portion.
[0072] In some embodiments, a first spring is positioned between
the third portion and the second portion such that moving the third
portion distally relative to the second portion compresses the
first spring. In the proximal starting position of the telescoping
assembly, the first portion can be locked to the second portion.
The system can be configured such that moving the third portion
distally relative to the second portion unlocks the first portion
from the second portion.
[0073] In several embodiments, a first proximal protrusion having a
first hook passes through a first hole in the second portion to
lock the first portion to the second portion. The third portion can
comprise a first distal protrusion. The system can be configured
such that moving the third portion distally relative to the second
portion engages a ramp to bend the first proximal protrusion to
unlock the first portion from the second portion.
[0074] In some embodiments, the sensor is located within the second
portion while the base protrudes from the distal end of the system
such that the system is configured to couple the sensor to the base
by moving the first portion distally relative to the second
portion.
[0075] In several embodiments, a sensor module is coupled to a
distal portion of the first portion such that moving the first
portion to the distal position couples the sensor module to the
base. The sensor can be coupled to the sensor module while the
first portion is located in the proximal starting position.
[0076] In some embodiments, the system is configured such that
moving the third portion distally relative to the second portion
unlocks the first portion from the second portion and locks the
third portion to the second portion.
[0077] In several embodiments, the system comprises a first
protrusion that couples with a hole of at least one of the second
portion and the third portion to lock the third portion to the
second portion.
[0078] In some embodiments, the system comprises a second
protrusion that couples with a hole of at least one of the first
portion and the second portion to lock the first portion to the
second portion in response to moving the first portion distally
relative to the second portion.
[0079] In several embodiments, a first spring is positioned between
the third portion and the second portion such that moving the third
portion distally relative to the second portion compresses the
first spring and unlocks the first portion from the second portion,
which enables the compressed first spring to push the first portion
distally relative to the second portion, which pushes at least a
portion of the sensor out of the distal end of the system and
triggers a needle retraction mechanism to enable a second spring to
retract a needle.
[0080] In some embodiments, a system for applying an on-skin
assembly to a skin of a host is provided. Advantageously, the
system includes a sensor inserter assembly having a needle
assembly, a sensor module, a base, an actuation member, and a
retraction member, the sensor inserter assembly having an initial
configuration in which at least the sensor module is disposed in a
proximal starting position, the sensor inserter assembly further
having a deployed configuration in which at least the sensor module
and the base are disposed at a distal applied position. Preferably,
the actuation member is configured to, once activated, cause the
needle assembly to move a proximal starting position to a distal
insertion position, and the retraction member is configured to,
once activated, cause the needle assembly to move from the distal
insertion position to a proximal retracted position.
[0081] The sensor module may comprise a sensor and a plurality of
electrical contacts. In the initial configuration, the sensor can
be electrically coupled to at least one of the electrical contacts.
Optionally, in the initial configuration, the actuation member is
in an unenergized state. In some embodiments, the actuation member
can be configured to be energized by a user before being activated.
In alternative embodiments, in the initial configuration, the
actuation member is in an energized state.
[0082] In several embodiments the actuation member can include a
spring. In an initial configuration, the spring can be in an
unstressed state. In alternative embodiments, in the initial
configuration, the spring is in a compressed state.
[0083] In some embodiments, the sensor inserter assembly may
include a first portion and a second portion, the first portion
being fixed, at least in an axial direction, with respect to the
second portion at least when the sensor inserter assembly is in the
initial configuration, the first portion being movable in at least
a distal direction with respect to the second portion after
activation of the actuation member. The first portion may be
operatively coupled to the needle assembly so as to secure the
needle assembly in the proximal starting position before activation
of the actuation member and to urge the needle assembly toward the
distal insertion position after activation of the actuation
member.
[0084] In several embodiments, the retraction member is in an
unenergized state when in the initial configuration.
Advantageously, the retraction member is configured to be energized
by the movement of the needle assembly from the proximal starting
position to the distal insertion position. In the initial
configuration, the retraction member may be in an energized
state.
[0085] In still other embodiments, the retraction member comprises
a spring. The spring may be integrally formed with the needle
assembly. The spring may be operatively coupled to the needle
assembly. In the initial configuration, the spring may be in an
unstressed state. In other embodiments, in the initial
configuration, the spring is in compression.
[0086] In some aspects, in the second configuration, the spring is
in compression. In still other embodiments, in the second
configuration, the spring is in tension.
[0087] In some embodiments, the sensor inserter assembly can
further include a third portion, the third portion being
operatively coupled to the first portion. The actuation member may
be integrally formed with the third portion in certain embodiments.
Optionally, the actuation member is operatively coupled to the
third portion.
[0088] In some embodiments, the sensor inserter assembly includes
interengaging structures configured to prevent movement of the
first portion in the distal direction relative to the second
portion until the interengaging structures are decoupled.
Advantageously, the decoupling of the interengaging structures may
activate the actuation member. In other embodiments, the
interengaging structures may include a proximally extending tab of
the first portion and a receptacle of the second portion configured
to receive the proximally extending tab. Optionally, the sensor
inserter assembly can include a decoupling member configured to
decouple the interengaging structures. The decoupling member may
have a distally extending tab of the third portion.
[0089] In yet other embodiments, the sensor inserter assembly can
include interengaging structures configured to prevent proximal
movement of the third portion with respect to the first portion.
These interengaging structures may include a distally-extending
latch of the third portion and a ledge of the first portion
configured to engage the distally-extending latch.
[0090] In certain embodiments, the sensor inserter assembly can
include interengaging structures configured to prevent proximal
movement of the needle assembly at least when the needle assembly
is in the distal insertion position. The interengaging structures
can have radially-extending release features of the needle assembly
and an inner surface of the first portion configured to compress
the release features. Optionally, the sensor inserter assembly
includes a decoupling member configured to disengage the
interengaging structures of the first portion and the needle
assembly. The decoupling member may include an inner surface of the
second portion configured to further compress the release features.
Advantageously, the system may further include a trigger member
configured to activate the actuation member. The trigger member may
be operatively coupled to the third portion. The trigger member may
be integrally formed with the third portion. The trigger member may
include a proximally-extending button. Alternatively, the trigger
member may include a radially-extending button. The trigger member
may be configured to decouple the interengaging structure of the
first portion and the third portion.
[0091] In some embodiments, the system may further include a
releasable locking member configured to prevent activation of the
actuation member until the locking member is released. The
releasable locking member may be configured to prevent proximal
movement of the third portion with respect to the first portion
until the locking member is released. The releasable locking member
may include a proximally-extending tab of the first portion and a
latch feature of the third portion configured to receive the
proximally-extending tab. Advantageously, the releasable locking
member is configured to prevent energizing of the sensor inserter
assembly. In other aspects, the releasable locking member is
configured to prevent energizing of the actuation member.
[0092] Embodiments may further include a system for applying an
on-skin component to a skin of a host, the system may include a
sensor inserter assembly having an on-skin component being movable
in at least a distal direction from a proximal position to a distal
position, a first securing feature configured to releasably secure
the on-skin component in the proximal position, a second securing
feature configured to secure the on-skin component in the distal
position, and a first resistance configured to prevent movement of
the on-skin component in a proximal direction at least when the
on-skin component is in the distal position.
[0093] The first resistance feature can be configured to prevent
movement of the on-skin component in a proximal direction when the
on-skin component is secured in the distal position. In some
embodiments, the first securing feature is configured to releasably
secure the on-skin component to a needle assembly. The on-skin
component may have a sensor module. The sensor module may include a
sensor and a plurality of electrical contacts. Optionally, the
sensor is electrically coupled to at least one of the electrical
contacts, at least when the sensor inserter assembly is in the
first configuration.
[0094] In some embodiments, the on-skin component comprises a base.
The on-skin component may include a transmitter. The second
securing feature can be configured to secure the on-skin component
to a second on-skin component.
[0095] In other embodiments, the sensor inserter assembly includes
at least one distally-extending leg, and wherein the first securing
feature comprises an adhesive disposed on a distally-facing surface
of the leg. The sensor inserter assembly may include at least one
distally-extending member, and wherein the first securing feature
comprises a surface of the distally-extending member configured to
frictionally engage with a corresponding structure of the on-skin
component. The corresponding structure of the on-skin component may
include an elastomeric member. Optionally, the distally-extending
member includes at least one leg of the sensor inserter assembly.
The distally-extending member may include a needle.
[0096] In some embodiments of the system, the second securing
feature includes an adhesive disposed on a distally-facing surface
of the on-skin component. The second securing feature may have an
elastomeric member configured to receive the on-skin component.
[0097] In other embodiments, the first resistance feature includes
a distally-facing surface of the sensor inserter assembly. The
first resistance feature may be distal to an adhesive disposed on a
distally-facing surface of the on-skin component.
[0098] The system may further include a pusher configured to move
the on-skin component from the proximal position to the distal
position. Optionally, the system can further include a decoupling
feature configured to decouple the pusher from the on-skin
component at least after the on-skin component is in the distal
position. The decoupling feature may have a frangible portion of
the pusher. Optionally, the decoupling feature comprises a
frangible portion of the on-skin component.
[0099] The system may further comprise a sensor assembly configured
to couple with the on-skin component, wherein a third securing
feature is configured to releasably secure the sensor assembly in a
proximal position, and wherein a fourth securing feature is
configured to secure the sensor assembly to the on-skin
component.
[0100] Any of the features of each embodiment is applicable to all
aspects and embodiments identified herein. Moreover, any of the
features of an embodiment is independently combinable, partly or
wholly with other embodiments described herein in any way, e.g.,
one, two, or three or more embodiments may be combinable in whole
or in part. Further, any of the features of an embodiment may be
made optional to other aspects or embodiments. Any aspect or
embodiment of a method can be performed by a system or apparatus of
another aspect or embodiment, and any aspect or embodiment of a
system can be configured to perform a method of another aspect or
embodiment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0101] These and other features, aspects, and advantages are
described below with reference to the drawings, which are intended
to illustrate, but not to limit, the invention. In the drawings,
like reference characters denote corresponding features
consistently throughout similar embodiments.
[0102] FIG. 1 illustrates a schematic view of a continuous analyte
sensor system, according to some embodiments.
[0103] FIG. 2 illustrates a perspective view of an applicator
system, according to some embodiments.
[0104] FIG. 3 illustrates a cross-sectional side view of the system
from FIG. 2, according to some embodiments.
[0105] FIG. 4 illustrates a perspective view of an on-skin sensor
assembly, according to some embodiments.
[0106] FIGS. 5 and 6 illustrate perspective views of a transmitter
coupled to a base via mechanical interlocks, according to some
embodiments.
[0107] FIGS. 7-11 illustrate cross-sectional side views of the
applicator system from FIG. 3, according to some embodiments.
[0108] FIG. 12A illustrates a cross-sectional side view of a
portion of the applicator system from FIG. 3, according to some
embodiments.
[0109] FIG. 12B illustrates a cross-sectional side view of a base
that can be used with the applicator system shown in FIG. 3,
according to some embodiments.
[0110] FIG. 13 illustrates a perspective view of a portion of the
adhesive from FIG. 4, according to some embodiments.
[0111] FIG. 14 illustrates a perspective view of a portion of the
applicator system from FIG. 3, according to some embodiments.
[0112] FIGS. 15 and 16 illustrate perspective views of cross
sections of portions of the system shown in FIG. 7, according to
some embodiments.
[0113] FIG. 17 illustrates a cross-sectional view of the first
portion of the telescoping assembly from FIG. 7, according to some
embodiments.
[0114] FIGS. 18 and 19 illustrate perspective views of portions of
the applicator system from FIG. 7, according to some
embodiments.
[0115] FIGS. 20 and 21 illustrate perspective views of the needle
after being removed from the telescoping assembly of FIG. 7,
according to some embodiments.
[0116] FIG. 22 illustrates a perspective view of a cover of the
telescoping assembly of FIG. 7, according to some embodiments.
[0117] FIG. 23 illustrates a schematic view of force profiles,
according to some embodiments.
[0118] FIG. 24 illustrates a cross-sectional side view of a portion
of an applicator system, according to some embodiments.
[0119] FIG. 25 illustrates a cross-sectional side view of a portion
of a securing mechanism, according to some embodiments.
[0120] FIG. 26 illustrates a top view of a ring, according to some
embodiments.
[0121] FIG. 27 illustrates a perspective view of a securing
mechanism, according to some embodiments.
[0122] FIG. 28 illustrates a cross-sectional perspective view of
telescoping assembly with a motor, according to some
embodiments.
[0123] FIGS. 29 and 30 illustrate cross-sectional side views of
telescoping assemblies with a motor, according to some
embodiments.
[0124] FIG. 31 illustrates a side view of a telescoping assembly
that causes rotational movement, according to some embodiments.
[0125] FIG. 32 illustrates a cross-sectional perspective view of a
telescoping assembly with a downward locking feature, according to
some embodiments.
[0126] FIG. 33 illustrates a perspective view of an on-skin senor
assembly just before the electronics unit is coupled to the base,
according to some embodiments.
[0127] FIGS. 34 and 35 illustrate perspective views of sensor
modules that have springs, according to some embodiments.
[0128] FIG. 36 illustrates a cross-sectional perspective view of a
portion of a sensor module, according to some embodiments.
[0129] FIG. 37 illustrates a perspective view of a sensor module
that has springs, according to some embodiments.
[0130] FIG. 38 illustrates a cross-sectional perspective view of a
portion of a sensor module, according to some embodiments.
[0131] FIG. 39 illustrates a perspective view of a sensor module,
according to some embodiments.
[0132] FIG. 40 illustrates a cross-sectional perspective view of
assembly that has an offset, according to some embodiments.
[0133] FIG. 41 illustrates a side view of a sensor, according to
some embodiments.
[0134] FIG. 42 illustrates a bottom view of a needle, according to
some embodiments.
[0135] FIG. 43 illustrates a front view of a needle, according to
some embodiments.
[0136] FIG. 44 illustrates a cross-sectional perspective view of an
applicator system, according to some embodiments.
[0137] FIG. 45 illustrates a cross-sectional perspective view of a
portion of an applicator system, according to some embodiments.
[0138] FIG. 46 illustrates a perspective view of a portion of an
applicator system, according to some embodiments.
[0139] FIG. 47 illustrates a perspective view of a sensor module,
according to some embodiments.
[0140] FIG. 48 illustrates a cross-sectional perspective view of an
applicator system, according to some embodiments.
[0141] FIG. 49 illustrates a cross-sectional perspective view of a
proximal portion of a telescoping assembly, according to some
embodiments.
[0142] FIG. 50 illustrates a perspective view of a distal portion
of a telescoping assembly, according to some embodiments.
[0143] FIG. 51 illustrates a perspective view of a needle with
adhesive, according to some embodiments.
[0144] FIG. 52 illustrates a perspective view of a needle that has
two separate sides, according to some embodiments.
[0145] FIG. 53 illustrates a cross-sectional top view of the needle
shown in FIG. 52, according to some embodiments.
[0146] FIG. 54 illustrates a perspective view of a needle that has
a ramp, according to some embodiments.
[0147] FIG. 55 illustrates a cross-sectional top view of four
needles, according to some embodiments.
[0148] FIGS. 56-58 illustrate cross-sectional side views of a
system that is similar to the embodiment shown in FIG. 7 except
that the system does not include a needle, according to some
embodiments.
[0149] FIG. 59 illustrates a cross-sectional side view of a system
that is similar to the embodiment shown in FIG. 7 except for the
starting position and the movement of the base, according to some
embodiments.
[0150] FIG. 60 illustrates a perspective view of a system having a
cover, according to some embodiments.
[0151] FIGS. 61-63 illustrate cross-sectional perspectives views of
a system that is similar to the embodiment shown in FIG. 7 except
that the telescoping assembly includes an extra portion, according
to some embodiments.
[0152] FIG. 64 illustrates a cross-sectional side view of the
system shown in FIGS. 61-63, according to some embodiments.
[0153] FIG. 65 illustrates a perspective view of portions of a
sensor module, according to some embodiments.
[0154] FIG. 66 illustrates a cross-sectional side view of the
sensor module shown in FIG. 65, according to some embodiments.
[0155] FIG. 67 illustrates a perspective view of portions of a
sensor module, according to some embodiments.
[0156] FIG. 68 illustrates a top view of the sensor module shown in
FIG. 67, according to some embodiments.
[0157] FIGS. 69 and 70 illustrate perspective views of an
electronics unit just before the electronics unit is coupled to a
base, according to some embodiments.
[0158] FIG. 71 illustrates a cross-sectional perspective view of an
applicator system, according to some embodiments, in a resting
state.
[0159] FIG. 72 illustrates a cross-sectional perspective view of
the applicator system of FIG. 71, with the actuation member
energized.
[0160] FIG. 73 illustrates a rotated cross-sectional perspective
view of the applicator system of FIG. 72.
[0161] FIG. 74 illustrates a cross-sectional perspective view of
the applicator system of FIG. 71, with the actuation member
activated and with the needle assembly deployed in an insertion
position.
[0162] FIG. 75 illustrates a cross-sectional perspective view of
the applicator system of FIG. 71, with the on-skin component in a
deployed position and the needle assembly retracted.
[0163] FIG. 76 illustrates a cross-sectional side view of another
applicator system, according to some embodiments, in a resting
state.
[0164] FIG. 77 illustrates a cross-sectional side view of the
applicator system of FIG. 76, with the actuation member
energized.
[0165] FIG. 78 illustrates a cross-sectional side view of the
applicator system of FIG. 76, with the actuation member activated
and with the needle assembly deployed in an insertion position.
[0166] FIG. 79 illustrates a cross-sectional side view of the
applicator system of FIG. 76, with the on-skin component in a
deployed position and the needle assembly retracted.
[0167] FIG. 80 illustrates a cross-sectional side view of another
applicator system, according to some embodiments, in a resting
state.
[0168] FIG. 81 illustrates a cross-sectional side view of the
applicator system of FIG. 80, with the actuation member
energized.
[0169] FIG. 82 illustrates a cross-sectional side view of the
applicator system of FIG. 80, with the actuation member activated
and with the needle assembly deployed in an insertion position.
[0170] FIG. 83 illustrates a cross-sectional side view of the
applicator system of FIG. 80, with the on-skin component in a
deployed position and the needle assembly retracted.
[0171] FIG. 84 illustrates a perspective view of the applicator
system of FIG. 80, with the first and third portions shown in cross
section to better illustrate certain portions of the system, and in
a resting state.
[0172] FIG. 85 illustrates a perspective view of the applicator
system of FIG. 80, with the first and third portions shown in cross
section to better illustrate certain portions of the system, and
with the actuation member energized.
[0173] FIG. 86 illustrates a cross-sectional side view of another
applicator system, according to some embodiments, in a resting
state in which the actuation member is already energized.
[0174] FIG. 87 illustrates a cross-sectional side view of the
applicator system of FIG. 86, with the actuation member activated
and with the needle assembly deployed in an insertion position.
[0175] FIG. 88 illustrates a cross-sectional side view of the
applicator system of FIG. 86, with the on-skin component in a
deployed position and the needle assembly retracted.
[0176] FIG. 89 illustrates a cross-sectional side view of another
applicator system, according to some embodiments, in a resting
state in which the actuation member is already energized.
[0177] FIG. 90 illustrates a cross-sectional side view of the
applicator system of FIG. 86, with the actuation member activated
and with the needle assembly deployed in an insertion position.
[0178] FIG. 91 illustrates a cross-sectional side view of the
applicator system of FIG. 86, with the on-skin component in a
deployed position and the needle assembly retracted.
[0179] FIG. 92 illustrates a side view of another applicator
system, according to some embodiments, with a top trigger member,
in a resting state.
[0180] FIG. 93 illustrates a side view of the applicator system of
FIG. 92, after being cocked but before being triggered.
[0181] FIG. 94 illustrates a cross-sectional perspective view of
the applicator system of FIG. 92, in a resting state.
[0182] FIG. 95 illustrates a cross-sectional perspective view of
the applicator system of FIG. 92 while being cocked.
[0183] FIG. 96 illustrates a cross-sectional perspective view of
the applicator system of FIG. 92, after being cocked but before
being triggered.
[0184] FIG. 97 illustrates a cross-sectional side view of the
applicator system of FIG. 96.
[0185] FIG. 98 illustrates a cross-sectional side view of the
applicator system of FIG. 92, during triggering.
[0186] FIG. 99 illustrates a cross-sectional side view of the
applicator system of FIG. 92, after being triggered and with the
needle assembly deployed in an insertion position.
[0187] FIG. 100 illustrates a cross-sectional side view of the
applicator system of FIG. 92, with the on-skin component in a
deployed position and the needle assembly retracted.
[0188] FIG. 101 illustrates a side view of another applicator
system, according to some embodiments, with a side trigger
member.
[0189] FIG. 102 illustrates another side view of the applicator
system of FIG. 101, with the first and third portions shown in
cross-section to illustrate the trigger mechanism.
[0190] FIG. 103 illustrates a side view of another applicator
system, according to some embodiments, with an integrated side
trigger.
[0191] FIG. 104 illustrates another side view of the applicator
system of FIG. 103, with the first and third portions shown in
cross-section and with a portion of the second portion removed to
illustrate the trigger mechanism.
[0192] FIG. 105 illustrates a perspective view of another
applicator system, according to some embodiments, with a safety
feature.
[0193] FIG. 106 illustrates a cross-sectional perspective view of a
portion of the applicator system of FIG. 105, with the safety
feature in a locked configuration.
[0194] FIG. 107 illustrates an enlarged view of the portion of the
applicator system of FIG. 106, with the safety feature in a locked
configuration.
[0195] FIG. 108 illustrates a cross-sectional perspective view of a
portion of the applicator system of FIG. 105, with the safety
feature in a released configuration.
[0196] FIG. 109 illustrates a cross-sectional perspective view of a
portion of the applicator system of FIG. 105, with the safety
feature in a released configuration and with the third portion
moved distally relative to the first portion.
[0197] FIG. 110 illustrates a cross-sectional perspective view of
an applicator system, according to some embodiments, in a resting
and locked state, with the on-skin component secured in a proximal
position.
[0198] FIG. 111 illustrates a cross-sectional perspective view of
the applicator system of FIG. 110, with the safety feature
unlocked.
[0199] FIG. 112 illustrates a cross-sectional perspective view of
the applicator system of FIG. 110, with the actuation member
energized.
[0200] FIG. 113 illustrates a cross-sectional perspective view of
the applicator system of FIG. 110, with the actuation member
activated and with the needle assembly and on-skin component
deployed in a distal position.
[0201] FIG. 114 illustrates a cross-sectional perspective view of
the applicator system of FIG. 110, with the on-skin component in a
deployed position and separated from the retracted needle
assembly.
[0202] FIG. 115 illustrates a perspective view of the needle
assembly from the system of FIG. 110, shown securing the on-skin
component during deployment, with the base removed for purposes of
illustration.
[0203] FIG. 116 illustrates another perspective view of the needle
assembly from the system of FIG. 110, shown separated from the
on-skin component, with the base removed for purposes of
illustration.
[0204] FIG. 117 illustrates a perspective view of a portion of the
system of FIG. 100.
[0205] FIG. 118 illustrates a perspective view of the sensor module
of FIG. 100, before being coupled to the base.
[0206] FIG. 119 illustrates a perspective view of the sensor module
of FIG. 100, after being coupled to the base.
[0207] FIG. 120 illustrates a side view of an on-skin component and
base, according to some embodiments, prior to coupling of the
on-skin component to the base.
[0208] FIG. 121 illustrates a perspective view of the on-skin
component and base of FIG. 120, prior to coupling of the on-skin
component to the base.
[0209] FIG. 122 illustrates a side view of the on-skin component
and base of FIG. 120, after coupling of the on-skin component to
the base.
[0210] FIG. 123 illustrates a perspective view of a portion of
another applicator system, according to some embodiments, with an
on-skin component coupled to a needle assembly in a proximal
position.
[0211] FIG. 124 illustrates a perspective view of the on-skin
component and the needle assembly of FIG. 123.
[0212] FIG. 125 illustrates a perspective view of a portion of the
applicator system shown in FIG. 123, with the on-skin component
separated from the needle assembly.
[0213] FIG. 126 illustrates a perspective view of a portion of a
securing member, shown securing an on-skin component.
[0214] FIG. 127 illustrates a perspective view of a portion of the
securing member of FIG. 126, with the sensor module of the on-skin
component shown in cross section, and illustrated with a decoupling
feature of an applicator assembly, according to some
embodiments.
[0215] FIG. 128 illustrates a perspective view of the on-skin
component of FIG. 126, after decoupling of the on-skin component
from the securing member.
[0216] FIG. 129 illustrates a perspective view of a portion of an
applicator assembly, according to some embodiments, with the second
portion shown in cross section, and with a securing member shown
securing an on-skin component in a proximal position.
[0217] FIG. 130 illustrates a perspective view of a portion of the
applicator assembly of FIG. 129, shown with a portion of the
securing member cut away to better illustrate the configuration of
the securing member.
[0218] FIG. 131 illustrates a perspective view of a portion of the
applicator assembly of FIG. 129, after decoupling of the on-skin
component from the needle assembly, shown with portions of the
on-skin component and the securing member cut away.
[0219] FIG. 132 illustrates a perspective view of a portion of an
applicator assembly, according to some embodiments, with the second
portion shown in cross section, and with a securing member shown
securing an on-skin component in a proximal position.
[0220] FIG. 133 illustrates a perspective view of the needle
assembly and on-skin component of FIG. 132, after decoupling of the
on-skin component from the needle assembly.
[0221] FIG. 134 illustrates an exploded perspective view of a
portion of an applicator assembly, according to some embodiments,
with a securing member configured to releasably couple an on-skin
component to a needle assembly.
[0222] FIG. 135 illustrates a perspective view of a portion of the
applicator assembly of FIG. 134, with the needle assembly coupled
to the on-skin component.
[0223] FIG. 136 illustrates a perspective view of a portion of the
applicator assembly of FIG. 134, with the needle assembly decoupled
from the on-skin component.
[0224] FIG. 137 illustrates a perspective view of an applicator
assembly, according to some embodiments, with an on-skin component
releasably secured in a proximal position within the applicator
assembly.
[0225] FIG. 138 illustrates a perspective view of the applicator
assembly of FIG. 137, with the on-skin component released from
securement.
[0226] FIG. 139 illustrates a perspective view of the on-skin
component of FIG. 137, with the securing feature in a secured
configuration.
[0227] FIG. 140 illustrates a perspective view of the on-skin
component of FIG. 137, with the securing feature in a released
configuration.
[0228] FIG. 141 illustrates a cross-sectional perspective view of a
portion of an applicator assembly, according to some embodiments,
with the second and third portions shown in cross section, and
showing a base coupled to an applicator.
[0229] FIG. 142 illustrates a perspective view of another
applicator assembly, according to some embodiments, showing a patch
coupled to an applicator.
[0230] FIG. 143 illustrates a perspective view of the applicator
assembly of FIG. 142, the patch decoupled from the applicator.
DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS
[0231] Although certain embodiments and examples are disclosed
below, inventive subject matter extends beyond the specifically
disclosed embodiments to other alternative embodiments and/or uses,
and to modifications and equivalents thereof. Thus, the scope of
the claims appended hereto is not limited by any of the particular
embodiments described below. For example, in any method or process
disclosed herein, the acts or operations of the method or process
may be performed in any suitable sequence and are not necessarily
limited to any particular disclosed sequence. Various operations
may be described as multiple discrete operations in turn, in a
manner that may be helpful in understanding certain embodiments;
however, the order of description should not be construed to imply
that these operations are order dependent. Additionally, the
structures, systems, and/or devices described herein may be
embodied as integrated components or as separate components.
[0232] For purposes of comparing various embodiments, certain
aspects and advantages of these embodiments are described. Not
necessarily all such aspects or advantages are achieved by any
particular embodiment. Thus, for example, various embodiments may
be carried out in a manner that achieves or optimizes one advantage
or group of advantages as taught herein without necessarily
achieving other aspects or advantages as may also be taught or
suggested herein.
System Introduction
[0233] U.S. Patent Publication No. US-2013-0267811-A1, the entire
contents of which are incorporated by reference herein, explains
how FIG. 1 is a schematic of a continuous analyte sensor system 100
attached to a host (e.g., a person). The analyte sensor system 100
communicates with other devices 110-113 (which can be located
remotely from the host). A transcutaneous analyte sensor system 102
comprising an on-skin sensor assembly 600 is fastened to the skin
of a host via a base (not shown), which can be a disposable
housing.
[0234] The system 102 includes a transcutaneous analyte sensor 200
and an electronics unit (referred to interchangeably as "sensor
electronics" or "transmitter") 500 for wirelessly transmitting
analyte information to a receiver. The receiver can be located
remotely relative to the system 102. In some embodiments, the
receiver includes a display screen, which can display information
to a person such as the host. Example receivers include computers
such as smartphones, smartwatches, tablet computers, laptop
computers, and desktop computers. In some embodiments, receivers
can be Apple Watches, iPhones, and iPads made by Apple Inc. In
still further embodiments, the system 102 can be configured for use
in applying a drug delivery device, such an infusion device, to the
skin of a patient. In such embodiments, the system can include a
catheter instead of, or in addition to, a sensor, the catheter
being connected to an infusion pump configured to deliver liquid
medicines or other fluids into the patient's body. In embodiments,
the catheter can be deployed into the skin in much the same manner
as a sensor would be, for example as described herein.
[0235] In some embodiments, the receiver is mechanically coupled to
the electronics unit 500 to enable the receiver to receive data
(e.g., analyte data) from the electronics unit 500. To increase the
convenience to users, in several embodiments, the receiver does not
need to be mechanically coupled to the electronics unit 500 and can
even receive data from the electronics unit 500 over great
distances (e.g., when the receiver is many feet or even many miles
from the electronics unit 500).
[0236] During use, a sensing portion of the sensor 200 can be under
the host's skin and a contact portion of the sensor 200 can be
electrically connected to the electronics unit 500. The electronics
unit 500 can be engaged with a housing (e.g., a base) which is
attached to an adhesive patch fastened to the skin of the host.
[0237] The on-skin sensor assembly 600 may be attached to the host
with use of an applicator adapted to provide convenient and secure
application. Such an applicator may also be used for attaching the
electronics unit 500 to a base, inserting the sensor 200 through
the host's skin, and/or connecting the sensor 200 to the
electronics unit 500. Once the electronics unit 500 is engaged with
the base and the sensor 200 has been inserted into the skin (and is
connected to the electronics unit 500), the sensor assembly can
detach from the applicator.
[0238] The continuous analyte sensor system 100 can include a
sensor configuration that provides an output signal indicative of a
concentration of an analyte. The output signal including (e.g.,
sensor data, such as a raw data stream, filtered data, smoothed
data, and/or otherwise transformed sensor data) is sent to the
receiver.
[0239] In some embodiments, the analyte sensor system 100 includes
a transcutaneous glucose sensor, such as is described in U.S.
Patent Publication No. US-2011-0027127-A1, the entire contents of
which are hereby incorporated by reference. In some embodiments,
the sensor system 100 includes a continuous glucose sensor and
comprises a transcutaneous sensor (e.g., as described in U.S. Pat.
No. 6,565,509, as described in U.S. Pat. No. 6,579,690, as
described in U.S. Pat. No. 6,484,046). The contents of U.S. Pat.
Nos. 6,565,509, 6,579,690, and 6,484,046 are hereby incorporated by
reference in their entirety.
[0240] In several embodiments, the sensor system 100 includes a
continuous glucose sensor and comprises a refillable subcutaneous
sensor (e.g., as described in U.S. Pat. No. 6,512,939). In some
embodiments, the sensor system 100 includes a continuous glucose
sensor and comprises an intravascular sensor (e.g., as described in
U.S. Pat. No. 6,477,395, as described in U.S. Pat. No. 6,424,847).
The contents of U.S. Pat. Nos. 6,512,939, 6,477,395, and 6,424,847
are hereby incorporated by reference in their entirety.
[0241] Various signal processing techniques and glucose monitoring
system embodiments suitable for use with the embodiments described
herein are described in U.S. Patent Publication No.
US-2005-0203360-A1 and U.S. Patent Publication No.
US-2009-0192745-A1, the contents of which are hereby incorporated
by reference in their entirety. The sensor can extend through a
housing, which can maintain the sensor on the skin and can provide
for electrical connection of the sensor to sensor electronics,
which can be provided in the electronics unit 500.
[0242] In several embodiments, the sensor is formed from a wire or
is in a form of a wire. A distal end of the wire can be sharpened
to form a conical shape (to facilitate inserting the wire into the
tissue of the host). The sensor can include an elongated conductive
body, such as a bare elongated conductive core (e.g., a metal wire)
or an elongated conductive core coated with one, two, three, four,
five, or more layers of material, each of which may or may not be
conductive. The elongated sensor may be long and thin, yet flexible
and strong. For example, in some embodiments, the smallest
dimension of the elongated conductive body is less than 0.1 inches,
less than 0.075 inches, less than 0.05 inches, less than 0.025
inches, less than 0.01 inches, less than 0.004 inches, and/or less
than 0.002 inches.
[0243] The sensor may have a circular cross section. In some
embodiments, the cross section of the elongated conductive body can
be ovoid, rectangular, triangular, polyhedral, star-shaped,
C-shaped, T-shaped, X-shaped, Y-shaped, irregular, or the like. In
some embodiments, a conductive wire electrode is employed as a
core. To such an electrode, one or two additional conducting layers
may be added (e.g., with intervening insulating layers provided for
electrical isolation). The conductive layers can be comprised of
any suitable material. In certain embodiments, it may be desirable
to employ a conductive layer comprising conductive particles (i.e.,
particles of a conductive material) in a polymer or other
binder.
[0244] In some embodiments, the materials used to form the
elongated conductive body (e.g., stainless steel, titanium,
tantalum, platinum, platinum-iridium, iridium, certain polymers,
and/or the like) can be strong and hard, and therefore can be
resistant to breakage. For example, in several embodiments, the
ultimate tensile strength of the elongated conductive body is
greater than 80 kPsi and less than 500 kPsi, and/or the Young's
modulus of the elongated conductive body is greater than 160 GPa
and less than 220 GPa. The yield strength of the elongated
conductive body can be greater than 60 kPsi and less than 2200
kPsi.
[0245] The electronics unit 500 can be releasably coupled to the
sensor 200. The electronics unit 500 can include electronic
circuitry associated with measuring and processing the continuous
analyte sensor data. The electronics unit 500 can be configured to
perform algorithms associated with processing and calibration of
the sensor data. For example, the electronics unit 500 can provide
various aspects of the functionality of a sensor electronics module
as described in U.S. Patent Publication No. US-2009-0240120-A1 and
U.S. Patent Publication No. US-2012-0078071-A1, the entire contents
of which are incorporated by reference herein. The electronics unit
500 may include hardware, firmware, and/or software that enable
measurement of levels of the analyte via a glucose sensor, such as
an analyte sensor 200.
[0246] For example, the electronics unit 500 can include a
potentiostat, a power source for providing power to the sensor 200,
signal processing components, data storage components, and a
communication module (e.g., a telemetry module) for one-way or
two-way data communication between the electronics unit 500 and one
or more receivers, repeaters, and/or display devices, such as
devices 110-113. Electronics can be affixed to a printed circuit
board (PCB), or the like, and can take a variety of forms. The
electronics can take the form of an integrated circuit (IC), such
as an Application-Specific Integrated Circuit (ASIC), a
microcontroller, and/or a processor. The electronics unit 500 may
include sensor electronics that are configured to process sensor
information, such as storing data, analyzing data streams,
calibrating analyte sensor data, estimating analyte values,
comparing estimated analyte values with time-corresponding measured
analyte values, analyzing a variation of estimated analyte values,
and the like. Examples of systems and methods for processing sensor
analyte data are described in more detail in U.S. Pat. Nos.
7,310,544, 6,931,327, U.S. Patent Publication No. 2005-0043598-A1,
U.S. Patent Publication No. 2007-0032706-A1, U.S. Patent
Publication No. 2007-0016381-A1, U.S. Patent Publication No.
2008-0033254-A1, U.S. Patent Publication No. 2005-0203360-A1, U.S.
Patent Publication No. 2005-0154271-A1, U.S. Patent Publication No.
2005-0192557-A1, U.S. Patent Publication No. 2006-0222566-A1, U.S.
Patent Publication No. 2007-0203966-A1 and U.S. Patent Publication
No. 2007-0208245-A1, the contents of which are hereby incorporated
by reference in their entirety.
[0247] One or more repeaters, receivers and/or display devices,
such as a key fob repeater 110, a medical device receiver 111
(e.g., an insulin delivery device and/or a dedicated glucose sensor
receiver), a smartphone 112, a portable computer 113, and the like
can be communicatively coupled to the electronics unit 500 (e.g.,
to receive data from the electronics unit 500). The electronics
unit 500 can also be referred to as a transmitter. In some
embodiments, the devices 110-113 transmit data to the electronics
unit 500. The sensor data can be transmitted from the sensor
electronics unit 500 to one or more of the key fob repeater 110,
the medical device receiver 111, the smartphone 112, the portable
computer 113, and the like. In some embodiments, analyte values are
displayed on a display device.
[0248] The electronics unit 500 may communicate with the devices
110-113, and/or any number of additional devices, via any suitable
communication protocol. Example communication protocols include
radio frequency; Bluetooth; universal serial bus; any of the
wireless local area network (WLAN) communication standards,
including the IEEE 802.11, 802.15, 802.20, 802.22 and other 802
communication protocols; ZigBee; wireless (e.g., cellular)
telecommunication; paging network communication; magnetic
induction; satellite data communication; and/or a proprietary
communication protocol.
[0249] Additional sensor information is described in U.S. Pat. Nos.
7,497,827 and 8,828,201. The entire contents of U.S. Pat. Nos.
7,497,827 and 8,828,201 are incorporated by reference herein.
[0250] Any sensor shown or described herein can be an analyte
sensor; a glucose sensor; and/or any other suitable sensor. A
sensor described in the context of any embodiment can be any sensor
described herein or incorporated by reference. Thus, for example,
the sensor 138 shown in FIG. 7 can be an analyte sensor; a glucose
sensor; any sensor described herein; and any sensor incorporated by
reference. Sensors shown or described herein can be configured to
sense, measure, detect, and/or interact with any analyte.
[0251] As used herein, the term "analyte" is a broad term, and is
to be given its ordinary and customary meaning to a person of
ordinary skill in the art (and is not to be limited to a special or
customized meaning), and refers without limitation to a substance
or chemical constituent in a biological fluid (for example, blood,
interstitial fluid, cerebral spinal fluid, lymph fluid, urine,
sweat, saliva, etc.) that can be analyzed. Analytes can include
naturally occurring substances, artificial substances, metabolites,
or reaction products.
[0252] In some embodiments, the analyte for measurement by the
sensing regions, devices, systems, and methods is glucose. However,
other analytes are contemplated as well, including, but not limited
to ketone bodies; Acetyl Co A; acarboxyprothrombin; acylcarnitine;
adenine phosphoribosyl transferase; adenosine deaminase; albumin;
alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),
histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,
tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;
arginase; benzoylecgonine (cocaine); biotinidase; biopterin;
c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin;
chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase;
cortisol; testosterone; choline; creatine kinase; creatine kinase
MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine;
dehydroepiandrosterone sulfate; DNA (acetylator polymorphism,
alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis,
Duchenne/Becker muscular dystrophy, glucose-6-phosphate
dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin
D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia,
hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic
neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual
differentiation, 21-deoxycortisol); desbutylhalofantrine;
dihydropteridine reductase; diptheria/tetanus antitoxin;
erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty
acids/acylglycines; triglycerides; glycerol; free .beta.-human
chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine
(FT4); free tri-iodothyronine (FT3); fumarylacetoacetase;
galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase;
gentamicin; glucose-6-phosphate dehydrogenase; glutathione;
glutathione perioxidase; glycocholic acid; glycosylated hemoglobin;
halofantrine; hemoglobin variants; hexosaminidase A; human
erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone;
hypoxanthine phosphoribosyl transferase; immunoreactive trypsin;
lactate; lead; lipoproteins ((a), B/A-1, .beta.); lysozyme;
mefloquine; netilmicin; phenobarbitone; phenytoin;
phytanic/pristanic acid; progesterone; prolactin; prolidase; purine
nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);
selenium; serum pancreatic lipase; sissomicin; somatomedin C;
specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta
antibody, arbovirus, Aujeszky's disease virus, dengue virus,
Dracunculus medinensis, Echinococcus granulosus, Entamoeba
histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori,
hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease),
influenza virus, Leishmania donovani, leptospira,
measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae,
Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium
falciparum, poliovirus, Pseudomonas aeruginosa, respiratory
syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni,
Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli,
vesicular stomatis virus, Wuchereria bancrofti, yellow fever
virus); specific antigens (hepatitis B virus, HIV-1); acetone
(e.g., succinylacetone); acetoacetic acid; sulfadoxine;
theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding
globulin; trace elements; transferrin; UDP-galactose-4-epimerase;
urea; uroporphyrinogen I synthase; vitamin A; white blood cells;
and zinc protoporphyrin.
[0253] Salts, sugar, protein, fat, vitamins, and hormones naturally
occurring in blood or interstitial fluids can also constitute
analytes in certain embodiments. The analyte can be naturally
present in the biological fluid or endogenous, for example, a
metabolic product, a hormone, an antigen, an antibody, and the
like. Alternatively, the analyte can be introduced into the body or
exogenous, for example, a contrast agent for imaging, a
radioisotope, a chemical agent, a fluorocarbon-based synthetic
blood, or a drug or pharmaceutical composition, including but not
limited to insulin; glucagon; ethanol; cannabis (marijuana,
tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl
nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine
(crack cocaine); stimulants (amphetamines, methamphetamines,
Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex,
Plegine); depressants (barbiturates, methaqualone, tranquilizers
such as Valium, Librium, Miltown, Serax, Equanil, Tranxene);
hallucinogens (phencyclidine, lysergic acid, mescaline, peyote,
psilocybin); narcotics (heroin, codeine, morphine, opium,
meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon,
Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine,
amphetamines, methamphetamines, and phencyclidine, for example,
Ecstasy); anabolic steroids; and nicotine. The metabolic products
of drugs and pharmaceutical compositions are also contemplated
analytes. Analytes such as neurochemicals and other chemicals
generated within the body can also be analyzed, such as, for
example, ascorbic acid, uric acid, dopamine, noradrenaline,
3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC),
homovanillic acid (HVA), 5-hydroxytryptamine (5HT),
5-hydroxyindoleacetic acid (FHIAA), and intermediaries in the
Citric Acid Cycle.
[0254] Many embodiments described herein use an adhesive (e.g., the
adhesive 126 in FIG. 7). One purpose of the adhesive can be to
couple a base, a sensor module, and/or a sensor to a host (e.g., to
skin of the host). The adhesive can be configured for adhering to
skin. The adhesive can include a pad (e.g., that is located between
the adhesive and the base). Additional adhesive information,
including adhesive pad information, is described in U.S. patent
application Ser. No. 14/835,603, which was filed on Aug. 25, 2015.
The entire contents of U.S. patent application Ser. No. 14/835,603
are incorporated by reference herein.
Distal Base Location
[0255] As noted above, systems can apply an on-skin sensor assembly
to the skin of a host. The system can include a base that comprises
an adhesive to couple a glucose sensor to the skin.
[0256] In some applicators, the base is hidden deep inside the
applicator until the user moves the needle distally with the base.
One challenge with this approach is that the insertion site (on the
skin of the host) is not ideally prepared for sensor and/or needle
insertion. For example, the distal end of the applicator may be a
hoop that presses against the skin. The pressure of the applicator
on the skin can cause the area of the skin within the hoop to form
a convex shape. In addition, the skin within the hoop can be too
easily compressed such that the skin lacks sufficient resilience
and firmness. In this state, the sensor and/or needle may press the
skin downward without immediately piercing the skin, which may
result in improper sensor and/or needle insertion.
[0257] In several embodiments, the base is coupled to a telescoping
assembly such that the base protrudes from the distal end of the
system while the glucose sensor is located remotely from the base
and is located within the telescoping assembly. This configuration
enables the base to prepare the insertion site of the skin for
sensor and/or needle insertion (e.g., by compressing the skin).
Thus, these embodiments can dramatically improve the reliability of
sensor and/or needle insertion while reducing pain associated with
sensor and/or needle insertion.
[0258] The system can hold the base in a position that is distal
relative to a glucose sensor module such that a glucose sensor is
not attached to the base and such that the glucose sensor can move
relative to the base. Moving the glucose sensor module distally
towards the base can attach the glucose sensor to the base. This
movement can occur as a result of compressing an applicator.
[0259] FIG. 2 illustrates a perspective view of an applicator
system 104 for applying at least portions of an on-skin sensor
assembly 600 (shown in FIG. 4) to skin of a host (e.g., a person).
The system can include a sterile barrier having a shell 120 and a
cap 122. The cap 122 can screw onto the shell 120 to shield
portions of the system 104 from external contaminants.
[0260] The electronics unit 500 (e.g., a transmitter having a
battery) can be detachably coupled to the sterile barrier shell
120. The rest of the applicator system 104 can be sterilized, and
then the electronics unit 500 can be coupled to the sterile barrier
shell 120 (such that the electronics unit 500 is not sterilized
with the rest of the applicator system 104).
[0261] The user can detach the electronics unit 500 from the
sterile barrier shell 120. The user can also couple the electronics
unit 500 to the base 128 (as shown in FIG. 6) after the applicator
system 104 places at least a portion of a sensor in a subcutaneous
position (for analyte sensing).
[0262] Many different sterilization processes can be used with the
embodiments described herein. The sterile barrier 120 and/or the
cap 122 can block gas from passing through (e.g., can be
hermetically sealed). The hermetic seal can be formed by threads
140 (shown in FIG. 3). The threads 140 can be compliant such that
they deform to create a seal. The threads 140 can be located
between the sterile barrier shell 120 and the cap 122.
[0263] The cap 122 can be made polypropylene and the shell 120 can
be made from polycarbonate (or vice versa) such that one of the cap
122 and the shell 120 is harder than the other of the cap 122 and
the 120. This hardness (or flexibility) difference enables one of
the components to deform to create the thread 140 seal.
[0264] In some embodiments, at least one of the shell 120 and the
cap 122 includes a gas-permeable material to enable sterilization
gases to enter the applicator system 104. For example, as explained
in the context of FIG. 60, the system can include a cover 272h.
[0265] Referring now to FIG. 3, the threads 140 can be configured
such that a quarter rotation, at least 15 percent of a full
rotation, and/or less than 50 percent of a full rotation uncouples
the cap 122 from the shell 120. Some embodiments do not include
threads 140. The cap 122 can be pushed onto the shell 120 (e.g.,
during assembly) even in some threaded embodiments.
[0266] A cap 122 can be secured to the shell 120 by a frangible
member 142 configured such that removing the cap 122 from the shell
120 brakes the frangible member 142. The frangible member 142 can
be configured like the safety ring (with a frangible portion) of a
plastic soda bottle. Unscrewing the cap from the plastic soda
bottle breaks the safety ring from the soda bottle's cap. This
approach provides evidence of tampering. In the same way, the
applicator system 104 can provide tamper evidence (due to the
frangible member 142 being broken by removing the cap 122 from the
shell 122).
[0267] U.S. Patent Publication No. US-2013-0267811-A1; U.S. Patent
Application No. 62/165,837, which was filed on May 15, 2015; and
U.S. Patent Application No. 62/244,520, which was filed on Oct. 21,
2015, include additional details regarding applicator system
embodiments. The entire contents of U.S. Patent Publication No.
US-2013-0267811-A1; U.S. Patent Application No. 62/165,837; and
U.S. Patent Application No. 62/244,520 are incorporated by
reference herein.
[0268] FIG. 3 illustrates a cross-sectional view of the system 104.
A glucose sensor module 134 is configured to couple a glucose
sensor 138 to the base 128 (e.g., a "housing"). The telescoping
assembly 132 is located in a proximal starting position such that
the glucose sensor module 134 is located proximally relative to the
base 128 and remotely from the base 128. The telescoping assembly
132 is configured such that collapsing the telescoping assembly 132
connects the glucose sensor module 134 to the base 128 via one or
more mechanical interlocks (e.g., snap fits, interference
features).
[0269] The sterile barrier shell 120 is coupled to a telescoping
assembly 132. After removing the cap 122, the system 104 is
configured such that compressing the sterile barrier shell 120
distally (while a distal portion of the system 104 is pressed
against the skin) can insert a sensor 138 (shown in FIG. 4) into
the skin of a host to place the transcutaneous, glucose analyte
sensor 138. In many figures shown herein, the sterile barrier shell
120 and cap 122 are hidden to increase the clarity of other
features.
[0270] Collapsing the telescoping assembly 132 also pushes at least
2.5 millimeters of the glucose sensor 138 out through a hole in the
base 128 such that at least 2.5 millimeters of the glucose sensor
138 that was previously located proximally relative to a distal end
of the base protrudes distally out of the base 128. Thus, in some
embodiments, the base 128 can remain stationary relative to a
distal portion of the telescoping assembly 132 while the collapsing
motion of the telescoping assembly 132 brings the glucose sensor
module 134 towards the base 128 and then couples the sensor module
134 to the base 128.
[0271] This relative motion between the sensor module 134 and the
base 128 has many benefits, such as enabling the base to prepare
the insertion site of the skin for sensor and/or needle insertion
(e.g., by compressing the skin). The starting position of the base
128 also enables the base 128 to shield people from a needle, which
can be located inside the applicator system 104. For example, if
the base 128 were directly coupled to the sensor module 134 in the
proximal starting position of the telescoping assembly, the needle
may protrude distally from the base 128. The exposed needle could
be a potential hazard. In contrast, the distal starting position of
the base 128 enables the base 128 to protect people from
inadvertent needle insertion. Needle protection is especially
important for caregivers (who are not the intended recipients of
the on-skin sensor assembly 600 shown in FIG. 4).
[0272] FIG. 4 illustrates a perspective view of the on-skin sensor
assembly 600, which includes the base 128. An adhesive 126 can
couple the base 128 to the skin 130 of the host. The adhesive 126
can be a foam adhesive suitable for skin adhesion. A glucose sensor
module 134 is configured to couple a glucose sensor 138 to the base
128.
[0273] The applicator system 104 (shown in FIG. 2) can couple the
adhesive 126 to the skin 130. The system 104 can also secure (e.g.,
couple via mechanical interlocks such as snap fits and/or
interference features) the glucose sensor module 134 to the base
128 to ensure the glucose sensor 138 is coupled to the base 128.
Thus, the adhesive 126 can couple the glucose sensor 138 to the
skin 130 of the host.
[0274] After the glucose sensor module 134 is coupled to the base
128, a user (or an applicator) can couple the electronics unit 500
(e.g., a transmitter) to the base 128 via mechanical interlocks
such as snap fits and/or interference features. The electronics
unit 500 can measure and/or analyze glucose indicators sensed by
the glucose sensor 138. The electronics unit 500 can transmit
information (e.g., measurements, analyte data, glucose data) to a
remotely located device (e.g., 110-113 shown in FIG. 1).
[0275] FIG. 5 illustrates a perspective view of the electronics
unit 500 coupled to the base 128 via mechanical interlocks such as
snap fits and/or interference features. Adhesive 126 on a distal
face of the base 128 is configured to couple the sensor assembly
600 to the skin. FIG. 6 illustrates another perspective view of the
electronics unit 500 coupled to the base 128.
[0276] Any of the features described in the context of FIGS. 1-6
can be applicable to all aspects and embodiments identified herein.
For example, many embodiments can use the on-skin sensor assembly
600 shown in FIG. 4 and can use the sterile barrier shell 120 shown
in FIG. 2. Moreover, any of the features of an embodiment is
independently combinable, partly or wholly with other embodiments
described herein in any way, e.g., one, two, or three or more
embodiments may be combinable in whole or in part. Further, any of
the features of an embodiment may be made optional to other aspects
or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
[0277] FIGS. 7-11 illustrate cross-sectional views of the
applicator system 104 from FIG. 3. The sterile barrier shell 120
and the cap 134 are hidden in FIGS. 7-11 to facilitate viewing the
telescoping assembly 132.
[0278] The telescoping assembly 132 is part of a system for
applying an on-skin sensor assembly 600 to skin of a host (shown in
FIG. 4). The telescoping assembly 132 can apply portions of the
system to the host. Additional portions of the system can be added
to the on-skin sensor assembly 600 after the applicator system 104
couples initial portions of the sensor assembly 600 to the host.
For example, as shown in FIG. 4, the electronics unit 500 (e.g., a
transmitter) can be coupled to the on-skin sensor assembly 600
after the applicator system 104 (shown in FIG. 3) couples the base
128, the glucose sensor module 134, and/or the glucose sensor 138
to the skin 130 of the host.
[0279] In some embodiments, the applicator system 104 (shown in
FIG. 3) couples at least one, at least two, at least three, at
least four, and/or all of the following items to the skin of the
host: the electronics unit 500, the glucose sensor module 134, the
glucose sensor 138, the base 128, and the adhesive 126. The
electronics unit 500 can be located inside the applicator system
104 such that the applicator system 104 is configured to couple the
electronics unit 500 to the skin of the host.
[0280] FIG. 7 illustrates a telescoping assembly 132 having a first
portion 150 (e.g., a "pusher") configured to move distally relative
to a second portion 152 (e.g., a "needle guard") from a proximal
starting position to a distal position along a path 154. FIG. 7
illustrates the telescoping assembly 132 in the proximal starting
position. FIG. 8 illustrates the telescoping assembly 132 moving
between the proximal starting position and the distal position.
FIG. 11 illustrates the telescoping assembly 132 in the distal
position. The path 154 (shown in FIG. 7) represents the travel
between the proximal starting position and the distal position.
[0281] A first set of items can be immobile relative to the first
portion 150, and a second set of items can be immobile relative to
the second portion 152 while the first set of items move relative
to the second set of items.
[0282] Referring now to FIG. 7, the glucose sensor 138 and the
sensor module 134 are coupled to the first portion 150 (e.g., such
that they are immobile relative to the first portion 150 during a
proximal portion of the path 154). The base 128 is coupled to the
second portion 152 such that the base 128 protrudes from a distal
end of the system (e.g., the base protrudes from a distal end of
the telescoping assembly 132). The base 128 comprises adhesive 126
configured to eventually couple the glucose sensor 138 to the skin
(e.g., after at least a portion of the glucose sensor 138 is
rigidly coupled to the base 128).
[0283] In FIG. 7, the glucose sensor 138 and the sensor module 134
are located within the second portion 152 while the base 128
protrudes from the distal end of the system (e.g., from the distal
end of the telescoping assembly 132) such that the system is
configured to couple the glucose sensor 138 to the base 128 via
moving the first portion 150 distally relative to the second
portion 152. The progression shown in FIGS. 7-11 illustrates moving
the first portion 150 distally relative to the second portion
152.
[0284] The sensor module 138 is coupled to a distal portion of the
first portion 150 such that moving the first portion 150 to the
distal position (as described above) couples the sensor module 134
to the base 128. The glucose sensor 138 is coupled to the sensor
module 134 (e.g., immobile relative to the sensor module 134) while
the first portion 150 is located in the proximal starting position.
The glucose sensor 138 can include a distally protruding portion
and a proximal portion. The proximal portion can be rigidly coupled
to the sensor module 134 such that the proximal portion cannot move
relative to the sensor module 134 even though the distally
protruding portion may bend relative to the sensor module 134.
[0285] A needle 156 (e.g., a "C-shaped" needle) is coupled to the
first portion 150 such that the glucose sensor 138 and the needle
156 move distally relative to the base 128 and relative to the
second portion 152. The system can further comprise a needle
release mechanism 158 configured to retract the needle 156
proximally.
[0286] The needle 156 can have many different forms. Many different
types of needles 156 can be used with the embodiments described
herein. FIGS. 51-55 illustrate various needle embodiments that can
be used with any of the embodiments described herein.
[0287] The needle 156 can guide the sensor 138 into the skin of the
host. A distal portion of the sensor 138 can be located in a
channel of the needle 156 (as shown in FIG. 42). Sometimes, a
distal end of the sensor 138 sticks out of the needle 156 and gets
caught on tissue of the host as the sensor 138 and needle 156 are
inserted into the host. As a result, the sensor 138 may buckle and
fail to be inserted deeply enough into the subcutaneous tissue. In
other words, in some embodiments, the sensor wire must be placed
within the channel of the C-shaped needle 156 to be guided into the
tissue and must be retained in the channel 330 during
deployment.
[0288] The risk of the sensor 138 sticking out of the channel 330
(and thereby failing to be property inserted into the host) can be
greatly diminished by the embodiment illustrated in FIG. 51. In
this embodiment, adhesive 376 bonds a distal portion of the glucose
sensor 138 into the channel 330 of the needle 156. Retracting the
needle 156 can break the bond of the adhesive 376 to enable a
distal portion of the sensor 138 to stay in a subcutaneous location
while the needle 156 is retracted (and even after the needle 156 is
retracted).
[0289] The risk of the sensor 138 sticking out of the channel 330
(and thereby failing to be property inserted into the host) can be
greatly diminished by the embodiment illustrated in FIGS. 52 and
53. In this embodiment, the needle 156a comprises two sides, which
can be separated by slots 378. The sensor 138 can have a width that
is larger than the width of the slots 378 such that the sensor 138
cannot come out of the channel 330a until the two sides of the
needle 156a are moved apart (to widen the slots 378).
[0290] The embodiment illustrated in FIG. 54 can be used with any
of the other embodiments described herein. The needle 156b includes
a ramp 380 at the distal end of the channel 330b. The distal end of
the needle 156b can include a conical tip 382. The ramp 380 can be
configured to push the sensor 138 out of the channel 330b of the
needle 156b as the needle 156b is retracted into the telescoping
assembly 132 (shown in FIG. 7).
[0291] FIG. 55 illustrates cross sectional views of different
needles 156c, 156d, 156e, 156f, which can be used as needle 156 in
FIG. 7 or in any other embodiment described herein. Needle 156c
includes an enclosed channel 330c. Needles 156d, 156e, 156f are
C-needles, although many other C-needle shapes can be used in
several embodiments. The ends of the needle 156d can be angled
relative to each other. In some embodiments, the ends of the needle
can be angled away from each other, in an opposite fashion as shown
by 156d. In some embodiments, the ends of the needle can have
flared edges, in which the flared edges are rounded to prevent the
sensor from contacting sharp edges. The ends of the needle 156e can
be parallel and/or flat relative to each other. The outside portion
of the channel 330f can be formed by walls that are straight and/or
parallel to each other (rather than by curved walls as is the case
for other needles 156d, 156e). Some needles 156d can be
manufactured via laser cutting, some needles 156e can be
manufactured via wire electrical discharge machining ("EDM"), and
some needles 156f can be manufactured via stamping.
[0292] As shown in FIG. 7, a needle hub 162 is coupled to the
needle 156. The needle hub includes release features 160 that
protrude outward. In some embodiments, the release features can
comprise one, two, or more flexible arms. Outward ends 164 of the
release features 160 catch on inwardly facing overhangs 166 (e.g.,
undercuts, detents) of the first portion 150 such that moving the
first portion 150 distally relative to the second portion 152
causes the needle retraction mechanism 158 to move distally until a
release point.
[0293] At the release point, proximal protrusions 170 of the second
portion 152 engage the release features 160 (shown in FIG. 9),
which forces the release features 160 to bend inward until the
release features 160 no longer catch on the overhangs 166 of the
first portion 150 (shown in FIG. 10). Once the release features 160
no longer catch on the overhangs 166 of the first portion 150, the
spring 234 of the needle retraction mechanism 158 pushes the needle
156 and the needle hub 162 proximally relative to the first portion
150 and relative to the second portion 152 until the needle no
longer protrudes distally from the base 128 and is completely
hidden inside the telescoping assembly 132 (shown in FIG. 11).
[0294] The needle 156 can be removed from the embodiment
illustrated in FIG. 7 to make a needle-free embodiment. Thus, a
needle 156 is not used in some embodiments. For example, a distal
end of the glucose sensor 138 can be formed in a conical shape to
enable inserting the glucose sensor 138 into the skin without using
a needle 156. Unless otherwise noted, the embodiments described
herein can be formed with or without a needle 156.
[0295] In several embodiments, a needle can help guide the glucose
sensor 138 (e.g., at least a distal portion of the glucose sensor)
into the skin. In some embodiments, a needle is not part of the
system and is not used to help guide the glucose sensor 138 into
the skin. In needle embodiments and needle-free embodiments, skin
piercing is an important consideration. Failing to properly pierce
the skin can lead to improper placement of the glucose sensor
138.
[0296] Tensioning the skin prior to piercing the skin with the
glucose sensor 138 and/or the needle 156 can dramatically improve
the consistency of achieving proper placement of the glucose sensor
138. Tensioning the skin can be accomplished by compressing the
skin with a distally protruding shape (e.g., a convex shape) prior
to piercing the skin and at the moment of piercing the skin with
the glucose sensor 138 and/or the needle 156.
[0297] FIG. 12A illustrates a portion of the cross section shown in
FIG. 7. The base 128 includes an optional distally facing
protrusion 174 located distally relative to the second portion 152
(and relative to the rest of the telescoping assembly 132). The
distal protrusion 174 is convex and is shaped as a dome. In some
embodiments, the distal protrusion 174 has block shapes, star
shapes, and cylindrical shapes. Several base 128 embodiments do not
include the protrusion 174.
[0298] The distal protrusion 174 can be located farther distally
than any other portion of the base 128. The distal protrusion 174
can extend through a hole 176 in the adhesive 126 (as also shown in
FIG. 5). A distal portion of the convex protrusion 174 can be
located distally relative to the adhesive 126 while a proximal
portion of the convex protrusion 174 is located proximally relative
to the adhesive 126.
[0299] The distal protrusion 174 has a hole 180 through which the
needle 156 and/or the glucose sensor 138 can pass. The distal
protrusion 174 can compress the skin such that the distal
protrusion 174 is configured to reduce a resistance of the skin to
piercing.
[0300] FIG. 12B illustrates a cross sectional view of a base 128b
that is identical to the base 128 illustrated in FIGS. 7 and 12B
except for the following features: The base 128b does not include a
protrusion 174. The base 128b includes a funnel 186 (e.g., a
radius) on the distal side of the hole 180b.
[0301] Like the embodiment shown in FIG. 12A, the sensor 138 (e.g.,
an analyte sensor) and/or the needle 156 (shown in FIG. 12A) can
pass through the hole 180b (shown in FIG. 12B). The funnels 182,
186 can be mirror images of each other or can be different shapes.
The base 128b can be used with any of the embodiments described
herein.
[0302] FIG. 13 illustrates a perspective view of a portion of the
adhesive 126. The needle 156 can have many different shapes and
cross sections. In some embodiments, the needle 156 includes a slot
184 (e.g., the channel 330 shown in FIGS. 42 and 43) into which at
least a portion of the glucose sensor 138 can be placed.
[0303] The needle 156 having a slot 184 passes through the hole 180
of the distal protrusion and through the hole 176 of the adhesive
126. A portion of the glucose sensor 138 is located in the slot 184
such that the needle 156 is configured to move distally relative to
the base 128 (shown in FIG. 12A) without dislodging the portion of
the glucose sensor 138 from the slot 184. The distal protrusion 174
is convex such that the distal protrusion 174 is configured to
tension the skin while the first portion 150 moves distally
relative to the second portion 152 of the telescoping assembly 132
(shown in FIG. 7) to prepare the skin for piercing.
[0304] As mentioned above, the adhesive 126 comprises a hole 176
through which at least a portion of the distal protrusion 174 of
the base 128 can pass. The distal protrusion 174 is located within
the hole 176 of the adhesive 126 such that the distal protrusion
174 can tension at least a portion of the skin within the second
hole (e.g., located under the hole 176). The hole 176 can be
circular or any other suitable shape. The hole 176 can be sized
such that at least a majority of the distal protrusion 174 extends
through the hole 176. A perimeter of the hole 176 can be located
outside of the distal protrusion 174 such that the perimeter of the
hole 176 is located radially outward relative to a perimeter of the
protrusion 174 where the protrusion 174 connects with the rest of
the base 128.
[0305] In some embodiments, the hole 176 of the adhesive 126 is
large enough that the adhesive 126 does not cover any of the distal
protrusion 174. In some embodiments, the adhesive 126 covers at
least a portion of or even a majority of the distal protrusion 174.
Thus, the adhesive 126 does not have to be planar and can bulge
distally in an area over the distal protrusion 174.
[0306] In several embodiments, the adhesive 126 has a non-uniform
thickness such that the thickness of the adhesive 126 is greater in
an area surrounding a needle exit area than in other regions that
are farther radially outward from the needle exit area. Thus, the
distal protrusion 174 can be part of the adhesive 126 rather than
part of the base 128. However, in several embodiments, the base 128
comprises the adhesive 126, and the distal protrusion 174 can be
formed by the plastic of the base 128 or by the foam adhesive 126
of the base 128.
[0307] The needle 156 includes a distal end 198 and a heel 194. The
heel 194 is the proximal end of the angled portion of the needle's
tip. The purpose of the angled portion is to form a sharp end to
facilitate penetrating tissue. The sensor 138 has a distal end
208.
[0308] During insertion of the needle 156 and the sensor 138 into
the tissue; as the needle 156 and the sensor 138 first protrude
distally from the system; and/or while the needle 156 and the
sensor 138 are located within the telescoping assembly, the end 208
of the sensor 138 can be located at least 0.1 millimeter proximally
from the heel 194, less than 1 millimeter proximally from the heel
194, less than 3 millimeters proximally from the heel 194, and/or
within plus or minus 0.5 millimeters of the heel 194; and/or the
end 208 of the sensor 138 can be located at least 0.3 millimeters
proximally from the distal end 198 of the needle 156 and/or less
than 2 millimeters proximally from the distal end 198.
[0309] Referring now to FIG. 12A, the distal protrusion 174 can
protrude at least 0.5 millimeters and less than 5 millimeters from
the distal surface of the adhesive 126. In embodiments where the
adhesive 126 has a non-planar distal surface, the distal protrusion
174 can protrude at least 0.5 millimeters and less than 5
millimeters from the average distal location of the adhesive
126.
[0310] As described above, in some embodiments the base is coupled
to a telescoping assembly such that the base protrudes from the
distal end of the system while the glucose sensor is located
remotely from the base and is located within the telescoping
assembly. In other embodiments, however, the base is coupled to a
telescoping assembly such that the base is located completely
inside the telescoping assembly and the base moves distally with
the sensor as the first portion is moved distally relative to the
second portion of the telescoping assembly.
[0311] For example, FIG. 59 illustrates a base 128 coupled to the
sensor module 134 and to the sensor 138 while the first portion 150
of the telescoping assembly 132f is located in the proximal
starting position. The base 128 moves distally as the first portion
150 is moved distally relative to the second portion 152. The base
128 can be coupled to a distal end portion of the first portion 150
while the first portion 150 is located in the proximal starting
position. All of the features and embodiments described herein can
be configured and used with the base 128 positioning described in
the context of FIG. 59.
[0312] All of the embodiments described herein can be used with the
base coupled to a telescoping assembly such that the base is
located completely inside the telescoping assembly and the base
moves distally with the sensor as the first portion is moved
distally relative to the second portion of the telescoping
assembly. All of the embodiments described herein can be used with
the base coupled to a telescoping assembly such that the base
protrudes from the distal end of the system while the glucose
sensor is located remotely from the base and is located within the
telescoping assembly.
Sensor Module Docking and Base Detachment
[0313] As explained above, maintaining the base against the skin
during insertion of the sensor and/or needle enables substantial
medical benefits. Maintaining the base against the skin, however,
can necessitate moving the sensor relative to the base during the
insertion process. Once inserted, the sensor needs to be coupled to
the base to prevent the sensor from inadvertently dislodging from
the base. Thus, there is a need for a system that enables the
sensor to move relative to the base and also enables locking the
sensor to the base (without being overly burdensome on users).
[0314] Maintaining the base against the skin during the distal
movement of the sensor and/or needle is enabled in many embodiments
by unique coupling systems that secure the sensor (and the sensor
module) to a first portion of a telescoping assembly and secure the
base to a second portion of the telescoping assembly. Moving the
first portion towards the second portion of the telescoping
assembly can align the sensor with the base while temporarily
holding the sensor. Then, the system can couple the sensor to the
base. Finally, the system can detach the base and sensor from the
telescoping assembly (which can be disposable or reusable with a
different sensor).
[0315] As illustrated in FIG. 4, the sensor module 134 and the
glucose sensor 138 are not initially coupled to the base 128.
Coupling the sensor module 134 and the glucose sensor 138 to the
base 128 via compressing the telescoping assembly 132 and prior to
detaching the base 128 from the telescoping assembly 132 can be a
substantial challenge, yet is enabled by many of the embodiments
described herein.
[0316] As illustrated in FIGS. 7 and 14, the sensor module 134 (and
the glucose sensor 138) can be located remotely from the base 128
even though they are indirectly coupled via the telescoping
assembly 132. In other words, the sensor module 134 (and the
glucose sensor 138) can be coupled to the first portion 150 of the
telescoping assembly 132 while the base 128 is coupled to the
second portion 152 of the telescoping assembly 132. In this state,
the sensor module 134 and the glucose sensor 138 can move relative
to the base 128 (e.g., as the sensor module 134 and the glucose
sensor 138 move from the proximal starting position to the distal
position along the path to "dock" the sensor module 134 and the
glucose sensor 138 to the base 128).
[0317] After the sensor module 134 and the glucose sensor 138 are
"docked" with the base 128, the system can detach the base 128 from
the telescoping assembly 132 to enable the sensor module 134, the
glucose sensor 138, and the base 128 to be coupled to the skin by
the adhesive 126 while the telescoping assembly 132 and other
portions of the system are discarded.
[0318] As shown in FIG. 7, the sensor module 134 is coupled to the
first portion 150 and is located at least 5 millimeters from the
base 128 while the first portion 150 is in the proximal starting
position. The system is configured such that moving the first
portion 150 to the distal position couples the sensor module 134 to
the base 128 (as shown in FIG. 11). The glucose sensor 138 is
coupled to the sensor module 134 while the first portion 150 is
located in the proximal starting position. The glucose sensor 138
is located within the second portion 152 while the base 128
protrudes from the distal end of the system.
[0319] Arrow 188 illustrates the proximal direction in FIG. 7.
Arrow 190 illustrates the distal direction in FIG. 7. Line 172
illustrates a horizontal orientation. As used herein, horizontal
means within plus or minus 20 degrees of perpendicular to the
central axis 196.
[0320] FIG. 15 illustrates a perspective view of a cross section of
portions of the system shown in FIG. 7. The cross section cuts
through the hole 180 of the base 128. Visible portions include the
sensor module 134, the sensor 138, a seal 192, the needle 156, the
base 128, and the adhesive 126. The sensor module 134 is in the
proximal starting position. The seal 192 is configured to block
fluid (e.g., bodily fluid) from entering the glucose sensor module
134.
[0321] The glucose sensor 138 is mechanically coupled to the sensor
module 134. The glucose sensor 138 runs into an interior portion of
the sensor module 134 and is electrically coupled to interconnects
in the interior portion of the sensor module 134. The interconnects
are hidden in FIG. 15 to facilitate seeing the proximal portion of
the glucose sensor 138 inside the interior portion of the sensor
module 134. Many other portions of the system are also hidden in
FIG. 15 to enable clear viewing of the visible portions.
[0322] In many embodiments, the sensor module 134 moves from the
position shown in FIG. 15 until the sensor module 134 snaps onto
the base 128 via snap fits that are described in more detail below.
FIG. 11 illustrates the sensor module 134 snapped to the base 128.
This movement from the proximal starting position to the "docked"
position can be accomplished by moving along the path 154 (shown in
FIG. 7 and illustrated by the progression in FIGS. 7-11). (The
arrow representing the path 154 is not necessarily drawn to
scale.)
[0323] Referring now to FIGS. 7 and 15, during a first portion of
the path 154, the sensor module 134 is immobile relative to the
first portion 150, and the base 128 is immobile relative to the
second portion 152 of the telescoping assembly 132. During a second
portion of the path 154, the system is configured to move the first
portion 150 distally relative to the second portion 152; to move
the sensor module 134 towards the base 128; to move at least a
portion of the sensor 138 through a hole 180 in the base 128; to
couple the sensor module 134 to the base 128; and to enable the
coupled sensor module 134 and the base 128 to detach from the
telescoping assembly 132.
[0324] FIG. 7 illustrates a vertical central axis 196 oriented from
a proximal end to the distal end of the system. (Part of the
central axis 196 is hidden in FIG. 7 to avoid obscuring the arrow
that represents the path 154 and to avoid obscuring the needle
156.)
[0325] FIG. 15 illustrates a flex arm 202 of the sensor module 134.
The flex arm 202 is oriented horizontally and is configured to
secure the sensor module 134 to a protrusion of the base 128. In
some embodiments, the flex arm 202 is an alignment arm to prevent
and/or impede rotation of the sensor module 134 relative to the
base 128.
[0326] FIG. 16 illustrates a perspective view of a cross section in
which the sensor module 134 is coupled to the base 128 via flex
arms 202. Interconnects 204 protrude proximally to connect the
sensor module 134 to the electronics unit 500 (e.g., a
transmitter).
[0327] Referring now to FIGS. 15 and 16, the flex arms 202 extend
from an outer perimeter of the sensor module 134. The base 128
comprises protrusions 206 that extend proximally from a planar,
horizontal portion of the base 128.
[0328] Referring now to FIG. 16, each of the proximal protrusions
206 of the base 128 are coupled to a flex arm 202 of the sensor
module 134. Thus, the coupling of the proximal protrusions 206 to
the flex arms 202 couples the sensor module 134 to the base
128.
[0329] Each proximal protrusion 206 can include a locking
protrusion 212 that extends at an angle of at least 45 degrees from
a central axis of each proximal protrusion 206. In some
embodiments, the locking protrusions 212 extend horizontally (e.g.,
as shown in FIG. 15). Each horizontal locking protrusion 212 is
coupled to an end portion 210 of a flexible arm 202.
[0330] The end portion 210 of each flexible arm 202 can extend at
an angle greater than 45 degrees and less than 135 degrees relative
to a central axis of the majority of the flexible arm 202. The end
portion 210 of each flexible arm 202 can include a horizontal
locking protrusion (e.g., as shown in FIG. 15).
[0331] In FIGS. 15 and 16, a first horizontal locking protrusion is
coupled to an end portion 210 of the first flexible arm 202. A
second horizontal locking protrusion 212 is coupled to the first
proximal protrusion 206 of the base 128. In FIG. 16, the first
horizontal locking protrusion is located distally under the second
horizontal locking protrusion 212 to secure the sensor module 134
to the base 128. The system is configured such that moving the
first portion 150 of the telescoping assembly 132 to the distal
position (shown in FIG. 11) causes the first flex arm 202 to bend
to enable the first horizontal locking protrusion of the flex arm
202 to move distally relative to the second horizontal locking
protrusion 212. Thus, the flex arm 202 is secured between the
locking protrusion 212 and the distal face of the base 128.
[0332] At least a portion of the flex arm 202 (e.g., the end
portion 210) is located distally under the horizontal locking
protrusion 212 of the base 128 to secure the sensor module 134 to
the base 128. The system is configured such that moving the first
portion 150 of the telescoping assembly 132 to the distal position
causes the flex arm 202 (e.g., the end portion 210) to bend away
(e.g., outward) from the rest of the sensor module 134 to enable
the horizontal locking protrusion of the flex arm 202 to go around
the locking protrusion 212 of the proximal protrusion 206. Thus, at
least a portion of the flex arm 202 can move distally relative to
the horizontal locking protrusion 212 of the proximal protrusion
206 of the base 128.
[0333] The sensor module 134 can have multiple flex arms 202 and
the base can have multiple proximal protrusions 206 configured to
couple the sensor module 134 to the base 128. In some embodiments,
a first flex arm 202 is located on an opposite side of the sensor
module 134 relative to a second flex arm 202 (e.g., as shown in
FIGS. 15 and 16).
[0334] In some embodiments, the base 128 comprises flex arms (e.g.,
like the flex arms 202 shown in FIGS. 15 and 16) and the sensor
module 134 comprises protrusions that couple to the flex arms of
the base 128. The protrusions of the sensor module 134 can be like
the protrusions 206 shown in FIGS. 15 and 16 except that, in
several embodiments, the protrusions extend distally towards the
flex arms of the base 128. Thus, the base 128 can be coupled to the
sensor module 134 with flex arms and mating protrusions regardless
of whether the base 128 or the sensor module 134 includes the flex
arms.
[0335] In several embodiments, a sensor module is coupled to the
glucose sensor. The system comprises a vertical central axis
oriented from a proximal end to the distal end of the system. The
base comprises a first flex arm that is oriented horizontally and
is coupled to the sensor module. The sensor module comprises a
first distal protrusion coupled to the first flex arm to couple the
sensor module to the base. A first horizontal locking protrusion is
coupled to an end portion of the first flexible arm. A second
horizontal locking protrusion is coupled to the first distal
protrusion of the sensor module. The second horizontal locking
protrusion is located distally under the first horizontal locking
protrusion to secure the sensor module to the base. The system is
configured such that moving the first portion of the telescoping
assembly to the distal position causes the first flex arm to bend
to enable the second horizontal locking protrusion to move distally
relative to the first horizontal locking protrusion. The sensor
module comprises a second distal protrusion coupled to a second
flex arm of the base. The first distal protrusion is located on an
opposite side of the sensor module relative to the second distal
protrusion.
[0336] Docking the sensor module 134 to the base 128 can include
securing the sensor module 134 to the first portion 150 of the
telescoping assembly 132 while the first portion 150 moves the
sensor module 134 towards the base 128. This securing of the sensor
module 134 to the first portion 150 of the telescoping assembly 132
needs to be reliable, but temporary so the sensor module 134 can
detach from the first portion 150 at an appropriate stage. The
structure that secures the sensor module 134 to the first portion
150 of the telescoping assembly 132 generally needs to avoid
getting in the way of the docking process.
[0337] FIG. 17 illustrates a cross-sectional view of the first
portion 150 of the telescoping assembly 132. FIG. 17 shows the
glucose sensor module 134 and the needle 156. Some embodiments do
not include the needle 156. Many items are hidden in FIG. 17 to
provide a clear view of the flex arms 214, 216 of the first portion
150.
[0338] The first portion 150 comprises a first flex arm 214 and a
second flex arm 216 that protrude distally and latch onto the
sensor module 134 to releasably secure the sensor module 134 to the
first portion 150 while the first portion 150 is in the proximal
starting position (shown in FIG. 7). The flex arms 214, 216 can
couple to an outer perimeter of the sensor module 134 such that
distal ends of the flex arms 214, 216 wrap around a distal face of
the sensor module 134. In some embodiments, the distal ends of the
flex arms 214, 216 are located distally of the sensor module 134
while the first portion 150 is in the proximal starting
position.
[0339] The base 128 is hidden in FIG. 17, but in the state
illustrated in FIG. 17, the sensor module 134 is located remotely
from the base 128 to provide a distance of at least 3 millimeters
from the sensor module 134 to the base 128 while the first portion
150 is in the proximal starting position. This distance can be
important to enable the base to rest on the skin as the needle 156
and/or the glucose sensor 138 pierce the skin and advance into the
skin during the transcutaneous insertion.
[0340] Referring now to FIGS. 7 and 17, the sensor module 134 is
located within the second portion 152 while the base 128 protrudes
from the distal end of the system such that the system is
configured to couple the sensor module 134 to the base 128 via
moving the first portion 150 distally relative to the second
portion 152. The sensor module 134 is located within the second
portion 152 while the base 128 protrudes from the distal end of the
system even though the sensor module 134 is moveable relative to
the second portion 152 of the telescoping assembly 132. Thus, the
first portion 150 moves the sensor module 134 through an interior
region of the second portion 152 of the telescoping assembly 132
without moving the base 128 through the interior region of the
second portion 152.
[0341] The system comprises a vertical central axis 196 oriented
from a proximal end to the distal end of the system. The first flex
arm 214 and the second flex arm 216 of the first portion 150 secure
the sensor module 134 to the first portion 150 such that the sensor
module 134 is releasably coupled to the first portion 150 with a
first vertical holding strength (measured along the vertical
central axis 196).
[0342] As shown in FIGS. 15 and 16, the sensor module 134 is
coupled to the base 128 via at least one flex arm 202 such that the
sensor module 134 is coupled to the base 128 with a second vertical
holding strength. The flex arms 202 can extend from an outer
perimeter of the sensor module 134. The flex arms 202 can be part
of the base 128.
[0343] Referring now to FIG. 17, in some embodiments, the second
vertical holding strength is greater than the first vertical
holding strength such that continuing to push the first portion 150
distally once the sensor module 134 is coupled to the base 128
overcomes the first and second flex arms 214, 216 of the first
portion 150 to detach the sensor module 134 from the first portion
150.
[0344] In some embodiments, the second vertical holding strength is
at least 50 percent greater than the first vertical holding
strength. In several embodiments, the second vertical holding
strength is at least 100 percent greater than the first vertical
holding strength. In some embodiments, the second vertical holding
strength is less than 400 percent greater than the first vertical
holding strength.
[0345] FIG. 6 illustrates the on-skin sensor assembly 600 in a
state where it is attached to a host. The on-skin sensor assembly
600 can include the glucose sensor 138 and/or the sensor module 134
(shown in FIG. 7). In some embodiments, the on-skin sensor assembly
600 includes the needle 156. In several embodiments, however, the
on-skin sensor assembly 600 does not include the needle 156.
[0346] As explained above, maintaining the base against the skin
during insertion of the sensor and/or needle enables substantial
medical benefits. Maintaining the base against the skin, however,
can complicate detaching the base from the applicator. For example,
in some prior-art systems, the base detaches after the base moves
downward distally with a needle. This relatively long travel can
enable several base detachment mechanisms. In contrast, when the
base is maintained in a stationary position as the needle moves
towards the base, releasing the base can be problematic.
[0347] Many embodiments described herein enable maintaining the
base 128 against the skin during insertion of the sensor 138 and/or
the needle 156. As mentioned above in the context of FIGS. 7-11,
after the sensor module 134 is coupled to the base 128, the sensor
module 134 and the base 128 need to detach from the telescoping
assembly 132 to secure the glucose sensor 138 to the host and to
enable the telescoping assembly to be thrown away, recycled, or
reused.
[0348] As shown in FIGS. 7-11, several embodiments hold the base
128 in a stationary position relative to the second portion 152 of
the telescoping assembly 132 as the sensor module 134 moves towards
the base 128. Referring now to FIG. 18, once the sensor module 134
is attached to the base 128, the system can release the base 128 by
bending flex arms 220 that couple the base 128 to the second
portion 152. FIG. 18 shows the system in a state prior to the
sensor module 134 docking with the base 128 to illustrate distal
protrusions 222 of the first portion 150 aligned with the flex arms
220 such that the distal protrusions 222 are configured to bend the
flex arms 220 (via the distal protrusions 222 contacting the flex
arms 220).
[0349] The distal protrusions 222 bend the flex arms 220 to detach
the base 128 from the telescoping assembly 132 (shown in FIG. 7)
after the sensor module 134 is coupled to the base 128 (as shown in
FIGS. 11 and 16). The flex arms 220 can include a ramp 224. A
distal end of the distal protrusions 222 can contact the ramp 224
and then can continue moving distally to bend the flex arm 220 as
shown by arrow 228 in FIG. 18. This bending can uncouple the flex
arm 220 from a locking feature 230 of the base 128. This unlocking
is accomplished by the first portion 150 moving distally relative
to the second portion 152, which causes the distal protrusions 222
to move as shown by arrow 226.
[0350] An advantage of the system shown in FIG. 18 is that the
unlocking movement (of the arm 220 bending as shown by arrow 228)
is perpendicular (within plus or minus 20 degrees) to the input
force (e.g., as represented by arrow 226). Thus, the system is
designed such that the maximum holding capability (e.g., of the
locking feature 230) can be many times greater than the force
necessary to unlock the arm 220 from the base 128. As a result, the
system can be extremely reliable and insensitive to manufacturing
variability and normal use variations.
[0351] In contrast, if the holding force and the unlocking force
were oriented along the same axis (e.g., within plus or minus 20
degrees), the holding force would typically be equal to or less
than the unlocking force. However, the unique structure shown in
FIG. 18 allows the holding force to be at least two times larger
(and in some cases at least four times larger) than the unlocking
force. As a result, the system can prevent inadvertent unlocking of
the base 128 while having an unlocking force that is low enough to
be easily provided by a user or by another part of the system
(e.g., a motor).
[0352] Another advantage of this system is that it controls the
locking and unlocking order of operation. In other words, the
structure precludes premature locking and unlocking. In a medical
context, this control is extremely valuable because reliability is
so critical. For example, in several embodiments, the process
follows this order: The sensor module 134 couples to the base 128.
Then, the first portion 150 releases the sensor module 134. Then,
the second portion 152 releases the base 128. In several
embodiments, the vertical locations of various locking and
unlocking structures are optimized to ensure this order is the only
order that is possible as the first portion 150 moves from the
proximal starting position to the distal position along the path
described previously. (Some embodiments use different locking and
unlocking orders of operation.)
[0353] FIG. 7 illustrates the base 128 protruding from the distal
end of the system while the first portion 150 of the telescoping
assembly 132 is located in the proximal starting position. The
sensor module 134 and at least a majority of the glucose sensor 138
are located remotely relative to the base 128. The system is
configured to couple the sensor module 134 and the glucose sensor
138 to the base 128 via moving the first portion 150 distally
relative to the second portion 152.
[0354] Referring now to FIGS. 18 and 19, the base 128 comprises a
first radial protrusion 230 (e.g., a locking feature) releasably
coupled with a first vertical holding strength to a second radial
protrusion 232 (e.g., a locking feature) of the second portion 152
of the telescoping assembly 132 (shown in FIG. 7). The first radial
protrusion 230 protrudes inward and the second radial protrusion
protrudes outward 232. The system is configured such that moving
the first portion 150 to the distal position moves the second
radial protrusion 232 relative to the first radial protrusion 230
to detach the base 128 from the telescoping assembly 132.
[0355] The first portion 150 of the telescoping assembly 132
comprises a first arm 222 that protrudes distally. The second
portion 152 of the telescoping assembly 132 comprises a second flex
arm 220 that protrudes distally. The first arm 222 and the second
flex arm 220 can be oriented within 25 degrees of each other (as
measured between their central axes). The system is configured such
that moving the first portion 150 from the proximal starting
position to the distal position along the path 154 (shown in FIG.
7) causes the first arm 222 to deflect the second flex arm 220, and
thereby detach the second flex arm 220 from the base 128 to enable
the base 128 to decouple from the telescoping assembly 132 (shown
in FIG. 7). Thus, the flex arm 220 is configured to releasably
couple the second portion 152 to the base 128.
[0356] When the first portion 150 is in the proximal starting
position, the first arm 222 of the first portion 150 is at least
partially vertically aligned with the second flex arm 220 of the
second portion 152 to enable the first arm 222 to deflect the
second flex arm 220 as the first portion is moved to the distal
position.
[0357] The first arm 222 and the second arm 220 can be oriented
distally such that at least a portion of the first arm 222 is
located proximally over a protrusion (e.g., the ramp 224) of the
second arm 220. This protrusion can be configured to enable a
collision between the first arm 222 and the protrusion to cause the
second arm 220 to deflect (to detach the base 128 from the second
portion 152).
[0358] In the embodiment illustrated in FIG. 18, when the first
portion 150 is in the proximal starting position, at least a
section of the first arm 222 is located directly over at least a
portion of the second flex arm 220 to enable the first arm 222 to
deflect the second flex arm 220 as the first portion 150 is moved
to the distal position described above. The second flex arm 220
comprises a first horizontal protrusion (e.g., the locking feature
232). The base 128 comprises a second horizontal protrusion (e.g.,
the locking feature 230) latched with the first horizontal
protrusion to couple the base 128 to the second portion 152 of the
telescoping assembly 132. The first arm 222 of the first portion
150 deflects the second flex arm 220 of the second portion 152 to
unlatch the base 128 from the second portion 152, which unlatches
the base 128 from the telescoping assembly 132.
[0359] Referring now to FIG. 7, the system is configured to couple
the glucose sensor 138 to the base 128 at a first position. The
system is configured to detach the base 128 from the telescoping
assembly 132 at a second position that is distal relative to the
first position.
[0360] A third flex arm (e.g., flex arm 202 in FIG. 15) couples the
glucose sensor 138 to the base 128 at a first position. The second
flex arm (e.g., flex arm 220 in FIG. 18) detaches from the base at
a second position. The second position is distal relative to the
first position such that the system is configured to secure the
base 128 to the telescoping assembly 132 until after the glucose
sensor 138 is secured to the base 128.
Spring Compression
[0361] Needles used in glucose sensor insertion applicators can be
hazardous. For example, inadvertent needle-sticks can transfer
diseases. Using a spring to retract the needle can reduce the risk
of needle injuries.
[0362] Referring now to FIG. 7, a spring 234 (e.g., a coil spring)
can be used to retract the needle hub 162 that supports the
c-shaped needle 156. The needle hub 162 can be released at the
bottom of insertion depth (to enable the needle 156 to retract).
For example, when the needle 156 reaches a maximum distal position,
a latch 236 can release to enable the spring 234 to push the needle
156 proximally into a protective housing (e.g., into the first
portion 150, which can be the protective housing).
[0363] Many applicators use pre-compressed springs. Many
applicators use substantially uncompressed springs that are
compressed by a user as the user compresses the applicator. One
disadvantage of a pre-compressed spring is that the spring force
can cause the components to creep (e.g., change shape over time),
which can compromise the reliability of the design. One
disadvantage of an uncompressed spring is that the first and second
portions of the telescoping assembly can be free to move slightly
relative to each other (when the assembly is in the proximal
starting position). This "chatter" of the first and second portions
can make the assembly seem weak and flimsy.
[0364] Many of the components described herein can be molded from
plastic (although springs are often metal). Preventing creep in
plastic components can help ensure that an applicator functions the
same when it is manufactured and after a long period of time. One
way to reduce the creep risk is to not place the parts under a load
(e.g., in storage) that is large enough to cause plastic
deformation during a storage time.
[0365] Generating the retraction energy by storing energy in a
spring during deployment limits the duration of load on the system.
For example, the retraction force of the spring can be at least
partially generated by collapsing the telescoping assembly (rather
storing the system with a large retraction force of a fully
pre-compressed spring).
[0366] Transcutaneous and implantable sensors are affected by the
in vivo properties and physiological responses in surrounding
tissues. For example, a reduction in sensor accuracy following
implantation of the sensor is one common phenomenon commonly
observed. This phenomenon is sometimes referred to as a "dip and
recover" process. Dip and recover is believed to be triggered by
trauma from insertion of the implantable sensor, and possibly from
irritation of the nerve bundle near the implantation area,
resulting in the nerve bundle reducing blood flow to the
implantation area.
[0367] Alternatively, dip and recover may be related to damage to
nearby blood vessels, resulting in a vasospastic event. Any local
cessation of blood flow in the implantation area for a period of
time leads to a reduced amount of glucose in the area of the
sensor. During this time, the sensor has a reduced sensitivity and
is unable to accurately track glucose. Thus, dip and recover
manifests as a suppressed glucose signal. The suppressed signal
from dip and recover often appears within the first day after
implantation of the signal, most commonly within the first 12 hours
after implantation. Dip and recover normally resolves within 6-8
hours.
[0368] Identification of dip and recover can provide information to
a patient, physician, or other user that the sensor is only
temporarily affected by a short-term physiological response, and
that there is no need to remove the implant as normal function will
likely return within hours.
[0369] Minimizing the time the needle is in the body limits the
opportunity for tissue trauma that can lead to phenomena such as
dip and recover. Quick needle retraction helps to limit the time
the needle is in the body. A large spring retraction force can
quickly retract the needle.
[0370] The embodiment illustrated in FIG. 7 solves the "chatter"
problem, avoids substantial creep, and enables quick needle
retraction. The embodiment places the spring 234 in a slight
preload between the first portion 150 and the second portion 152 of
the telescoping assembly 132. In other words, when the first
portion 150 is in the proximal starting position, the spring 234 is
in a slightly compressed state due to the relaxed length of the
spring 234 being longer than the length of the chamber in which the
spring 234 resides inside the telescoping assembly 132.
[0371] In some embodiments, the relaxed length of the spring 234 is
at least 4 percent longer than the length of the chamber. In
several embodiments, the relaxed length of the spring 234 is at
least 9 percent longer than the length of the chamber. In some
embodiments, the relaxed length of the spring 234 is less than 18
percent longer than the length of the chamber. In several
embodiments, the relaxed length of the spring 234 is less than 30
percent longer than the length of the chamber.
[0372] The spring 234 is compressed farther when the first portion
150 is moved distally relative to the second portion 152. In some
embodiments, this slight preload has a much shorter compression
length than the compression length of typical fully pre-compressed
springs. In several embodiments, the preload causes a compression
length of the spring 234 that is less than 25 percent of the
compression length of the fully compressed spring 234. In some
embodiments, the preload causes a compression length of the spring
234 that is greater than 3 percent of the compression length of the
fully compressed spring 234. The slight preload eliminates the
"chatter" while having a force that is too small to cause
substantial creep of non-spring components in the system.
[0373] The spring 234 can be inserted into the first portion 150
via a hole 238 in the proximal end of the first portion 150. Then,
the needle hub 162 (and the attached C-shaped needle 156) can be
loaded through the proximal side of the first portion 150 of the
telescoping assembly (e.g., via the hole 238 in the proximal end of
the first portion 150).
[0374] The needle hub 162 is slid through the first portion 150
until radial snaps (e.g., the release feature 160 of the needle hub
162) engage a section of the first portion 150 (see the latch 236).
Thus, the spring 234 is placed with a slight preload between the
needle hub 162 and a distal portion of the first portion 150 of the
telescoping assembly 132.
[0375] During applicator activation and the telescoping (e.g.,
collapsing of the first portion 150 into the second portion 152),
the spring 234 is compressed farther. At the bottom of travel
(e.g., at the distal ending position), the radial snaps of the
needle hub 162 are forced radially inward by features (e.g., the
protrusions 170) in the telescoping assembly 132 (as shown by the
progression of FIGS. 7-11). This releases the needle hub 162 and
allows the spring 234 to expand to drive the needle 156 proximally
out of the host (and into the first portion 150 and/or the second
portion 152).
[0376] As shown in FIG. 7, the base 128 protrudes from the distal
end of the system while the first portion 150 of the telescoping
assembly 132 is located in the proximal starting position and the
glucose sensor 138 is located remotely relative to the base 128.
The glucose sensor 138 is moveably coupled to the base 128 via the
telescoping assembly 132 because the glucose sensor 138 is coupled
to the first portion 150 and the base 128 is coupled to the second
portion 152 of the telescoping assembly 132.
[0377] The system includes a spring 234 configured to retract a
needle 156. The needle 156 is configured to facilitate inserting
the glucose sensor 138 into the skin. In some embodiments, the
system does not include the needle 156.
[0378] When the first portion 150 is in the proximal starting
position, the spring 234 is in a first compressed state. The system
is configured such that moving the first portion 150 distally from
the proximal starting position increases a compression of the
spring 234. The first compressed state places the first portion 150
and second portion 152 in tension. Latching features hold the first
portion 150 and second portion 152 in tension. In other words, in
the proximal starting position, the latching features are
configured to prevent the spring 234 from pushing the first portion
150 proximally relative to the second portion 152. The latching
features resist the first compressed state.
[0379] In several embodiments, the potential energy of the first
compressed state is less than the amount of potential energy
necessary to retract the needle 156. This low potential energy of
the partially pre-compressed spring 234 is typically insufficient
to cause creep, yet is typically sufficient to eliminate the
"chatter" described above.
[0380] Redundant systems can help ensure that the needle 156 (and
in some cases the sensor 138) can always be removed from the host
after they are inserted into the host. If in extreme cases the
necessary needle removal force is greater than the spring
retraction force, the user can pull the entire telescoping assembly
132 proximally to remove the needle 156 and/or the sensor 138 from
the host.
[0381] Some embodiments include a secondary retraction spring. In
other words, in some embodiments, the spring 234 in FIG. 7 is
actually two concentric springs. (In several embodiments, the
spring 234 is actually just one spring.) The secondary spring can
be shorter than the primary retraction spring. The secondary
retraction spring can provide additional needle retraction force
and can enable additional tailoring of the force profile.
[0382] Many users desire to minimize the amount of material they
throw away (as trash). Moving the needle 156 to the back of the
applicator post deployment enables easy access to remove the needle
156 post deployment.
[0383] FIG. 20 illustrates a perspective view of the needle 156,
the needle hub 162, and the spring 234 just after they were removed
proximally from the hole 238 in a proximal end of the first portion
150 of the telescoping assembly 132.
[0384] The hole 238 is an opening at a proximal end of the
applicator. The hole 238 is configured to enable removing the
needle 156, the needle hub 162, and/or the spring 234. This opening
can be covered by a removable cover (e.g., a sticker, a hinged
lid).
[0385] FIGS. 21 and 22 illustrate perspective views where a
removable cover 272 is coupled to the first portion 150 to cover
the hole 238 through which the needle 156 can be removed from the
telescoping assembly 132. A hinge 274 can couple the cover 272 to
the first portion 150 such that the cover 272 can rotate to close
the hole 238 (as shown in FIG. 22) and rotate to open the hole 238
(as shown in FIG. 21).
[0386] Removing the cover 272 can enable a user to remove the
needle 156 from the applicator (e.g., the telescoping assembly 132)
such that the user can throw the needle 156 in a sharps container
and reuse the applicator with a new needle. Removing the needle 156
from the applicator can also enable throwing the rest of the
applicator into a normal trash collector to reduce the amount of
trash that needs to be held by the sharps container.
[0387] The features described in the context of FIGS. 20-22 and 60
can be combined with any of the embodiments described herein.
[0388] FIG. 60 illustrates a perspective view of another
telescoping assembly embodiment 132h. The cover 272h is adhered to
a proximal end of the telescoping assembly 132h to cover a hole
configured to retrieve a needle after the needle retracts (e.g., as
described in the context of FIGS. 21 and 22). Peeling the cover
272h from the telescoping assembly 132h can enable a user to dump
the needle 156 (shown in FIG. 7) into a sharps container.
[0389] In this embodiment, the cover 272h is a flexible membrane
such as a Tyvek label made by E. I. du Pont de Nemours and Company
("DuPont"). The cover 272h can include an adhesive to bond the
cover 272h to the proximal end of the telescoping assembly
132h.
[0390] In some embodiments, a second cover 272 is adhered to a
distal end of the telescoping assembly 132h to cover the end of the
telescoping assembly 132h through which the sensor 138 (shown in
FIG. 7) passes. The distal end of the telescoping assembly 132h can
also be covered by a plastic cap 122h.
[0391] The cover 272h can be configured to enable sterilization
processes to pass through the material of the cover 272h to
facilitate sterilization of the interior of the telescoping
assembly 132h. For example, sterilization gases can pass through
the cover 272h.
[0392] Any of the features described in the context of FIG. 60 can
be applicable to all aspects and embodiments identified herein. For
example, the embodiments described in the context of FIG. 60 can be
combined with the embodiments described in the context of FIGS.
1-59 and 61-70.
[0393] The telescoping assembly 132h can use the same interior
features and components as described in the context of FIG. 7. One
important difference is that the first portion 150h slides on an
outer surface of the second portion 152 (rather than sliding inside
part of the second portion 152 as shown in FIG. 7). Also, the
telescoping assembly 132h does not use a sterile barrier shell 120
(as shown in FIG. 2).
[0394] Any of the features described in the context of FIGS. 7-22
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS. 7-22
can be combined with the embodiments described in the context of
FIGS. 23-70. Moreover, any of the features of an embodiment is
independently combinable, partly or wholly with other embodiments
described herein in any way, e.g., one, two, or three or more
embodiments may be combinable in whole or in part. Further, any of
the features of an embodiment may be made optional to other aspects
or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
Force Profiles
[0395] Referring now to FIG. 7, in some embodiments, moving the
first portion 150 of the telescoping assembly 132 distally relative
to the second portion 152 typically involves placing the distal end
of the system against the skin of the host and then applying a
distal force on the proximal end of the system. This distal force
can cause the first portion 150 to move distally relative to the
second portion 152 to deploy the needle 156 and/or the glucose
sensor 138 into the skin.
[0396] The optimal user force generated axially in the direction of
deployment is a balance between preventing accidental premature
deployment and ease of insertion. A force that is ideal at a
certain portion of distal actuation may be far less than ideal at
another portion of distal actuation.
[0397] The user places the applicator (e.g., the telescoping
assembly 132) against the skin surface and applies a force distally
on the applicator (e.g., by pushing down on the proximal end of the
applicator). When the user-generated force exceeds a threshold, the
applicator collapses (e.g., telescopes distally) and the user
drives the sensor into the body.
[0398] Several embodiments include unique force profiles that
reduce accidental premature deployment; dramatically increase the
likelihood of complete and proper deployment; and reduce patient
discomfort. Specific structures enable these unique force profiles.
For example, the following structures can enable the unique force
profiles described herein: structures that hold the telescoping
assembly 132 in the proximal starting position; structures that
attach the sensor module 134 to the base 128; structures that
release the sensor module 134 from the first portion 150;
structures that prevent the needle 156 from retracting prematurely;
structures that retract the needle 156; structures that release the
base 128 from the second portion 152; structures that pad the
collision at the distal position; and structures that hold the
telescoping assembly 132 in a distal ending position. These
structures are described in various sections herein.
[0399] Several embodiments include a system for applying an on-skin
sensor assembly 600 to a skin 130 of a host (shown in FIG. 4).
Referring now to FIG. 7, the system can comprise a telescoping
assembly 132 having a first portion 150 configured to move distally
relative to a second portion 152 from a proximal starting position
to a distal position along a path 154; a glucose sensor 138 coupled
to the first portion 150; and a latch 236 configurable to impede a
needle 156 from moving proximally relative to the first
portion.
[0400] The first portion 150 is releasably secured in the proximal
starting position by a securing mechanism (e.g., the combination of
240 and 242 in FIG. 7) that impedes moving the first portion 150
distally relative to the second portion 152. The system is
configured such that prior to reaching the distal position and/or
by reaching the distal position, moving the first portion 150
distally relative to the second portion 152 releases the latch 236
thereby causing the needle 156 to retract proximally into the
system.
[0401] In several embodiments, the securing mechanism is formed by
an interference between the first portion 150 and the second
portion 152. The interference can be configured to impede the first
portion 150 from moving distally relative to the second portion
152. For example, a radially outward protrusion 240 of the first
portion 150 can collide with a proximal end 242 of the second
portion 152 such that moving the first portion 150 distally
requires overcoming a force threshold to cause the first portion
150 and/or the second portion 152 to deform to enable the radially
outward protrusion 240 to move distally relative to the proximal
end 242 of the second portion 152.
[0402] The system can include a first force profile measured along
the path 154. As shown in FIG. 23, the force profile 244 can
include force on the Y axis and travel distance on the X axis.
Referring now to FIGS. 7 and 23, the force profile 244 can be
measured along the central axis 196.
[0403] One way in which the force profile 244 can be measured is to
place the telescoping assembly 132 against the skin; place a force
gauge such as a load cell on the proximal end of the telescoping
assembly 132; calibrate the measurement system to account for the
weight of the force gauge; and then press on the proximal side of
the force gauge to drive the telescoping assembly 132 from the
proximal starting position to the distal position along the path
154. FIG. 23 illustrates force versus distance from the proximal
starting position based on this type of testing procedure.
[0404] The first force profile 244 can comprise a first magnitude
246 coinciding with overcoming the securing mechanism (e.g., 240
and 242), a third magnitude 250 coinciding with releasing the latch
236 (e.g., releasing the needle retraction mechanism), and a second
magnitude 248 coinciding with an intermediate portion of the path
154 that is distal relative to overcoming the securing mechanism
and proximal relative to releasing the latch 236.
[0405] In several embodiments, the second magnitude 248 is a peak
force associated with compressing a needle retraction spring (e.g.,
the spring 234 in FIG. 7) prior to beginning to release the latch
236. This peak force can be at least 0.5 pounds, at least 1.5
pounds, less than 4 pounds, and/or less than 6 pounds.
[0406] In several embodiments, the third magnitude 250 is a peak
force associated with releasing the needle retraction mechanism.
This peak force can be at least 1 pound, at least 2 pounds, less
than 4 pounds, and/or less than 6 pounds.
[0407] In some embodiments, the second magnitude 248 is less than
the first magnitude 246 and the third magnitude 250 such that the
system is configured to promote needle acceleration during the
intermediate portion of the path 154 to enable a suitable needle
speed at a time the needle 156 (or the glucose sensor 138) first
pierces the skin.
[0408] The first magnitude 246 can be the peak force required to
overcome the securing mechanism (e.g., 240 and 242). This peak
force can be at least 5 pounds, at least 6 pounds, less than 10
pounds, and/or less than 12 pounds. The first magnitude 246 can be
at least 100 percent greater than the second magnitude 248. The
first magnitude 246 can be at least 200 percent greater than the
second magnitude 248. The second magnitude 248 can be during a
portion of the force profile 244 where the compression of the
spring 234 is at least 50 percent of the maximum spring compression
reached just before the needle 156 begins to retract proximally.
The slope of the force profile 244 can be positive for at least 1
millimeter during the time at which the second magnitude 248 is
measured (due to the increasing spring force as the spring
compression increases).
[0409] The first magnitude 246 can be greater than the third
magnitude 250 (and/or greater than the second magnitude 248) such
that the system is configured to impede initiating a glucose sensor
insertion cycle unless a user is applying enough force to release
the latch 236. For example, the force necessary for the protrusion
240 to move distally relative to the proximal end 242 can
deliberately be designed to be greater than the force necessary to
retract the needle 156.
[0410] To provide a sufficient safety margin, the first magnitude
246 can be at least 50 percent greater than the third magnitude
250. In some embodiments, the first magnitude 246 is at least 75
percent greater than the third magnitude 250. To avoid a system
where the first magnitude 246 is unnecessarily high in light of the
forces required along the path 154 distally relative to the first
magnitude 246, the first magnitude 246 can be less than 250 percent
greater than the third magnitude 250.
[0411] A second force profile 252 can coincide with the
intermediate portion of the path 154. For example, the second
magnitude 248 can be part of the second force profile 252. This
second force profile 252 can include a time period in which the
slope is positive for at least 1 millimeter, at least 2.5
millimeters, less than 8 millimeters, and/or less than 15
millimeters (due to the increasing spring force as the spring
compression increases).
[0412] A proximal millimeter of the second force profile 252
comprises a lower average force than a distal millimeter of the
second force profile 252 in response to compressing a spring 234
configured to enable the system to retract the needle 156 into the
telescoping assembly 132.
[0413] The system also includes a first force profile 254 (measured
along the path 154). The first force profile 254 comprises a first
average magnitude coinciding with moving distally past a proximal
half of the securing mechanism and a second average magnitude
coinciding with moving distally past a distal half of the securing
mechanism. The first average magnitude is greater than the second
average magnitude such that the system is configured to impede
initiating a glucose sensor insertion cycle unless a user is
applying enough force to complete the glucose sensor insertion
cycle.
[0414] A first force peak 256 coincides with moving distally past
the proximal half of the securing mechanism. The first force peak
256 is at least 25 percent higher than the second average
magnitude.
[0415] The first force profile 254 comprises a first magnitude 246
coinciding with overcoming the securing mechanism and a subsequent
magnitude coinciding with terminating the securing mechanism (e.g.,
moving past the distal portion of the securing mechanism). The
first magnitude 246 comprises a proximal vector and the subsequent
magnitude comprises a distal vector. FIG. 23 is truncated at zero
force, so the distal vector appears to be have a magnitude of zero
in FIG. 23, although the actual value is negative (e.g., negative 2
pounds).
[0416] The proximal vector means the system is resisting the distal
movement of the first portion 150 relative to the second portion
152. The distal vector means that the second half of the securing
mechanism can help propel the needle 156 and the sensor 138 towards
the skin and/or into the skin. In other words, the distal vector
assists the distal movement of the first portion 150 relative to
the second portion 152.
[0417] The third force profile 260 can include many peaks and
values due to the following events: the sensor module 134 docking
to the base 128; the base detaching from the second portion 152
(and thus detaching from the telescoping assembly 132); the release
feature 160 of the needle hub 162 defecting inward due to the
proximal protrusions 170 of the second portion 152; the latch 236
releasing; the needle 156 retracting into an inner chamber of the
first portion 150; and/or the first portion 150 hits the distal
position (e.g., the end of travel).
[0418] As shown in FIG. 7, the securing mechanism can be a radially
outward protrusion 240 (of the first portion 150) configured to
collide with a proximal end 242 of the second portion 152 such that
moving the first portion 150 distally requires overcoming a force
threshold to cause the first portion 150 and/or the second portion
152 to deform to enable the radially outward protrusion 240 to move
distally relative to the proximal end 242 of the second portion
152. The radially outward protrusion 240 is configured to cause the
second portion 152 to deform elliptically to enable the first
portion 150 to move distally relative to the second portion
152.
[0419] FIG. 24 illustrates another securing mechanism. At least a
section of the first portion 150 interferes with a proximal end 242
of the second portion 152 such that pushing the first portion 150
distally relative to the second portion 152 requires a force
greater than a force threshold. The force threshold is the minimum
force necessary to deform at least one of the first portion 150 and
the second portion 152 to overcome the interference 266, which is
shown inside a dashed circle in FIG. 24.
[0420] Many different interference geometries and types are used in
various embodiments. The interference can be between the first
portion 150 and the second portion 152. The interference can be
between the needle hub 162 and the second portion 152. For example,
the interference can resist the distal movement of the needle hub
162.
[0421] In some embodiments, the first portion 150 includes a taper
262. Once an interfering section of the first portion 150 moves
distally past the interference area 266, the taper 262 makes the
system such that the interference 266 no longer impedes distal
movement of the first portion 150.
[0422] The second portion 152 can also have a taper 263. The taper
263 can be on an interior surface of the second portion 152 such
that the interior size gets larger as measured proximally to
distally along the taper 263.
[0423] The interfering portion 242 of the second portion 152 can
include a ramp (as shown in FIG. 24) to aid the deformation
described above. The interfering section of the first portion 150
is located proximally relative to the interfering section of the
second portion 152.
[0424] The securing mechanism can comprise a radially outward
protrusion (e.g., 240 in FIG. 7) of the first portion 150 that
interferes with a radially inward protrusion of the second portion
152 (e.g., as shown by the interference 266 in FIG. 24) such that
the securing mechanism is configured to cause the second portion
152 to deform elliptically to enable the first portion 150 to move
distally relative to the second portion 152.
[0425] Any of the features described in the context of FIGS. 24-32
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS.
24-32 can be combined with the embodiments described in the context
of FIGS. 1-23 and 33-70. Moreover, any of the features of an
embodiment is independently combinable, partly or wholly with other
embodiments described herein in any way, e.g., one, two, or three
or more embodiments may be combinable in whole or in part. Further,
any of the features of an embodiment may be made optional to other
aspects or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
[0426] FIG. 25 illustrates a cross sectional view of a portion of
an embodiment in which the needle holder (e.g., the needle hub 162)
is configured to resist distal movement of the first portion 150
relative to the second portion 152b. The second portion 152b is
like other second portions 150 described herein (e.g., as shown in
FIG. 7) except that the second portion 152b includes flex arms 276
that are at least part of the securing mechanism. The flex arms 276
are releasably coupled to the needle holder to releasably secure
the first portion 150 to the second portion 152b in the proximal
starting position (as shown in FIG. 7).
[0427] The needle 156 (shown in FIG. 7) is retractably coupled to
the first portion 150 by the needle holder 162. The needle holder
162 is configured to resist distal movement of the first portion
150 relative to the second portion 152b due to a chamfer and/or a
ramp 278 interfering with flex arms 276. Pushing the first portion
150 distally requires overcoming the force necessary to deflect the
flex arms 276 outward such that the flex arms 276 move out of the
way of the ramp 278.
[0428] FIG. 27 illustrates a perspective view of another securing
mechanism, a frangible release 280. FIG. 26 illustrates a top view
of a frangible ring 282. The ring 282 includes two frangible tabs
284 that protrude radially inward. In some embodiments, the tabs
284 are radially inward protrusions on opposite sides of the ring
282 relative to each other. The frangible member (e.g., the ring
282) can be part of the first portion 150, the second portion 152,
or any other portion of the system. For example, the frangible
member can be a feature of a molded second portion 152.
[0429] The ring 282 can be made of a brittle material configured to
enable the tabs 284 to break when the first portion 150 is pushed
distally relative to the second portion 152. For example, a section
of the first portion 150 can be located proximally over the tab 284
when the first portion 150 is in the proximal starting position (as
shown in FIG. 27 by the frangible release 280). Moving the first
portion 150 distally can cause the section of the first portion 150
to bend and/or break the tab 284.
[0430] In some embodiments, a radially outward protrusion 286 of
the first portion 150 is configured to bend and/or break the tab
284. The ring 282, the tab 284, and the other components described
herein can be molded from a plastic such as acrylonitrile butadiene
styrene, polyethylene, and polyether ether ketone. (Springs,
interconnects, and needles can be made of steel.) In some
embodiments, the ring 282 is at least 0.2 millimeters thick, at
least 0.3 millimeters thick, less than 0.9 millimeters thick,
and/or less than 1.5 millimeters thick.
[0431] The ring 282 can be secured between the first portion 150
and the second portion 152 of the telescoping assembly 132. The
ring 282 can wrap around a perimeter of the first portion 150 and
can be located proximally relative to the second portion 152 such
that the ring 282 rests against a proximal end of the second
portion 152.
[0432] The ring 282 enables a frangible coupling between the first
portion 150 and the second portion 152 while the first portion 150
is in the proximal starting position. In FIG. 27, the system is
configured such that moving the first portion 150 to the distal
position breaks the frangible coupling (e.g., the frangible release
280).
[0433] In some embodiments, the tabs 284 are not part of a ring
282. The tabs 284 can be part of the second portion 152 or part of
the first portion 150.
[0434] FIG. 27 also includes a magnet system 290. The magnet system
290 includes a magnet and a metal element in close enough proximity
that the magnet is attracted to the metal element (e.g., a metal
disk). For example, the second portion 152 can include a magnet,
and the first portion 150 can include the metal element. In several
embodiments, the second portion 152 can include a metal element,
and the first portion 150 can include the magnet.
[0435] The magnet and metal element can be located such that they
are located along a straight line oriented radially outward from
the central axis 196 (shown in FIG. 7). This configuration can
position the magnet for sufficient attraction to the metal element
to resist movement of the first portion 150. For example, when the
first portion 150 is in the proximal starting position, the
magnetic force of the magnet system 290 can resist distal movement
of the first portion. Thus, the magnet releasably couples the first
portion 150 to the second portion 152 while the first portion 150
is in the proximal starting position.
[0436] In several embodiments, a user can compress an internal
spring or the spring can be pre-compressed (e.g., compressed fully
at the factory). The telescoping assembly can include a button 291
configured to release the spring force to cause the needle and/or
the sensor to move into the skin.
[0437] The cover 272h described in the context of FIG. 60 can be
adhered to the proximal end of the first portion 150 shown in FIG.
27. The cover 272h can be used with any of the embodiments
described herein.
[0438] FIG. 31 illustrates a side view of a telescoping assembly
132e having a first portion 150e and a second portion 152e. The
first portion 150e includes a radially outward protrusion 286e
configured to engage a radially inward ramp 296 located on an
interior wall of the second portion 152e. When a user applies a
distal, axial force on the first portion 150e, the protrusion 286e
collides with the ramp 296. The angle of the ramp causes the first
portion 150e to rotate relative to the second portion 152e. This
rotation resists the distal force and acts as a securing mechanism.
Once the protrusion 286e moves beyond the distal end of the ramp
296, the ramp 296 no longer causes rotation, and thus, no longer
acts as a securing mechanism.
[0439] Many of the embodiments described herein rely on a
compressive force of a person. Many unique structures enable the
force profiles described herein. The structures help ensure the
compressive force caused by a person pushing distally on a portion
of the system results in reliable performance. One challenge of
relying on people to push downward on the system to generation
appropriate forces is that the input force can vary substantially
by user. Even a single user can apply different input forces on
different occasions.
[0440] One solution to this variability is to replace the need for
a user-generated input force with a motor-generated force. The
motor can provide reliable input forces. Motors also enable varying
the force at different sections of the path from the proximal
starting position to the distal position.
[0441] FIGS. 28-30 illustrates embodiments of telescoping
assemblies 132c, 132d that include motors 290c, 290d to drive a
needle 156 and/or a glucose sensor 138 into the skin. The motors
290c, 290d can be linear actuators that use an internal magnetic
system to push a rod distally and proximally. The linear actuators
can also convert a rotary input into linear motion to push a rod
distally and proximally. The movement of the rod can move various
portions of the system including the needle 156, the needle hub
162c, the first portion 150c, 150d of the telescoping assembly
132c, 132d, the sensor module 134, and/or the sensor 138. The
motors 290c, 290d can include internal batteries to supply
electricity for the motors 290c, 290d.
[0442] FIG. 28 illustrates a perspective, cross-sectional view of
an embodiment in which the motor 290c pushes the needle hub 162c
distally relative to the motor 290c and relative to the second
portion 152c. The needle hub 162c can include a rod that slides in
and out of the housing of the motor 292c. The distal movement of
the needle hub 162c can push at least a portion of the needle 156
and/or the sensor 138 (shown in FIG. 7) into the skin. The distal
movement of the needle hub 162c can move the sensor module 134
distally such that the sensor module 134 docks with the base 128.
This coupling can precede the detachment of the base 128 from the
telescoping assembly 132c.
[0443] FIGS. 29 and 30 illustrate side, cross-sectional views of
another motor embodiment. In this embodiment, the rod 294 of the
motor 292d is coupled to and immobile relative to the second
portion 152d of the telescoping assembly 132d. The motor 292d is
coupled to and immobile relative to the first portion 150d of the
telescoping assembly 132d. As a result, pulling the rod 294 into
the housing of the motor 292d causes the first portion 150d to move
distally relative to the second portion 152d. The glucose module
134 is coupled to a distal portion of the first portion 150d (as
described herein). Thus, the glucose sensor 138 is moved distally
into the skin of the host and the glucose module 134 is coupled to
the base 128. As illustrated in FIGS. 29 and 30, the embodiment
does not include a needle. Similar embodiments can include a
needle.
[0444] FIG. 32 illustrates a perspective, cross-section view of the
telescoping assembly 132. In some embodiments, a protrusion 302 of
the first portion 150 couples with a hole 304 of the second portion
152. The protrusion 302 can be oriented distally to latch with the
hole 304 in response to the first portion 150 reaching the distal
position.
[0445] In several embodiments, a protrusion 302 of the second
portion 152 couples with a hole 304 of the first portion 150. The
protrusion 302 can be oriented proximally to latch with the hole
304 in response to the first portion 150 reaching the distal
position.
[0446] The protrusion 302 can be a flex arm that is at least 10
millimeters long, at least 15 millimeters long, and/or less than 50
millimeters long. The protrusion 302 can include an end portion
that protrudes at an angle relative to the central axis of the
majority of the protrusion 302. This angle can be at least 45
degrees, at least 75 degrees, less than 110 degrees, and/or less
than 135 degrees.
[0447] Coupling the protrusion 302 to the hole 304 can permanently
lock the first portion 150 in a downward position (that is distal
to the proximal starting position and is within 3 millimeter of the
distal position) while the needle 156 is in a retracted state. This
locking can prevent the system from being reused and can prevent
needle-stick injuries.
[0448] Any of the features described in the context of FIG. 23 can
be applicable to all aspects and embodiments identified herein. For
example, the embodiments described in the context of FIG. 23 can be
combined with the embodiments described in the context of FIGS.
1-22 and 24-70. Moreover, any of the features of an embodiment is
independently combinable, partly or wholly with other embodiments
described herein in any way, e.g., one, two, or three or more
embodiments may be combinable in whole or in part. Further, any of
the features of an embodiment may be made optional to other aspects
or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
Interconnects
[0449] Referring now to FIG. 4, in many embodiments, the electronic
unit 500 drives a voltage bias through the sensor 138 so that
current can be measured. Thus, the system is able to analyze
glucose levels in the host. The reliability of the electrical
connection between the sensor 138 and the electronics unit 500 is
critical for accurate sensor data measurement.
[0450] In many embodiments, the host or a caregiver create the
electrical connection between the sensor 138 and the electronics
unit 500. A seal 192 can prevent fluid ingress as the electronics
unit 500 is pressed onto the glucose sensor module 134. Oxidation
and corrosion can change electrical resistance of the system and
are sources of error and noise in the signal.
[0451] The electrical connections should be mechanically stable.
Relative movement between the parts of the electrical system can
cause signal noise, which can hinder obtaining accurate glucose
data.
[0452] A low-resistance electrical connection is more power
efficient. Power efficiency can help maximize the battery life of
the electronics unit 500.
[0453] In embodiments where the host or caregiver must compress the
electrical interconnect and/or seal 192, minimizing the necessary
force increase user satisfaction. Lowering the user-applied force
makes the transmitter easier to install. If the necessary force is
too great, users and caregivers may inadvertently fail to apply
adequate force, which can jeopardize the reliability and
performance of the system. The force that the user needs to apply
to couple the electronics unit 500 to the base 128 and sensor
module 134 is strongly influenced by the force necessary to
compress the interconnect. Thus, there is a need for an electrical
interconnect with a lower compression force.
[0454] Manufacturing variability, host movement, and temperature
variations while the host is using the on-skin sensor assembly 600
necessitate providing a robust electrical connection throughout an
active compression range (which encompasses the minimum and maximum
compression states reasonably possible). Thus, there is a need for
electrical connections that are tolerant of compression variation
within the active compression range.
[0455] Metallic springs (e.g., coil or leaf springs) can be
compressed between the sensor 138 and the electronics unit 500 to
provide a robust, reliable electrical connection that requires a
low compression force to couple the electronics unit 500 to the
base 128.
[0456] FIG. 33 illustrates a perspective view of an on-skin senor
assembly just before the electronics unit 500 (e.g., a transmitter)
is snapped onto the base 128. Coupling the electronics unit 500 to
the base 128 can compress the seal 192 to prevent fluid ingress and
can compress an interconnect (e.g., springs 306) to create an
electrical connection 310 between the glucose sensor 138 and the
electronics unit 500.
[0457] Creating the electrical connection 310 and/or coupling the
electronics unit 500 to the base 128 can cause the electronics unit
500 (e.g., a transmitter) to exit a sleep mode. For example,
conductive members (e.g., of the sensor module 134 and/or of the
base 128) can touch electrical contacts of the electronics unit 500
(e.g., electrical contacts of a battery of the electronics unit
500), which can cause the electronics unit 500 to exit a sleep
mode. The conductive member of the sensor module 134 and/or of the
base 128 can be a battery jumper that closes a circuit to enable
electricity from the battery to flow into other portions of the
electronics unit 500.
[0458] Thus, creating the electrical connection 310 and/or coupling
the electronics unit 500 to the base 128 can "activate" the
electronics unit 500 to enable and/or to prepare the electronics
unit 500 to wirelessly transmit information to other devices
110-113 (shown in FIG. 1). U.S. Patent Publication No.
US-2012-0078071-A1 includes additional information regarding
transmitter activation. The entire contents of U.S. Patent
Publication No. US-2012-0078071-A1 are incorporated by reference
herein.
[0459] The distal face of the electronics unit 500 can include
planar electrical contacts that touch the proximal end portions of
the springs 306. The distal end portions of the springs 306 can
contact various conductive elements of the glucose sensor 138.
Thus, the springs 306 can electrically couple the electronics unit
500 to the various conductive elements of the glucose sensor 138.
In the illustrated embodiment, two metallic springs 306
electrically connect the glucose sensor 138 and the electronics
unit 500. Some embodiments use one spring 306. Other embodiments
use three, four, five, ten, or more springs 306.
[0460] Metallic springs 306 (e.g., gold-plated springs) are placed
above the sensor wire 138 in the sensor module 134. The sensor 138
is located between a rigid polymer base 128 and the bottom surface
of the spring 306. The top surface of the spring 306 contacts a
palladium electrode located in the bottom of the electronics module
500. The rigid electronics module 500 and the rigid polymer base
128 are brought together creating a compressed sandwich with the
sensor 138 and the spring 306.
[0461] The springs 306 can be oriented such that their central axes
are within 25 degrees of the central axis 196 of the telescoping
assembly 132 (shown in FIG. 7). The springs 306 can have a helical
shape. The springs 306 can be coil springs or leaf springs.
[0462] Springs 306 can have ends that are plain, ground, squared,
squared and ground, or any other suitable configuration. Gold,
copper, titanium, and bronze can be used to make the springs 306.
Springs 306 can be made from spring steel. In several embodiments,
the steels used to make the springs 306 can be low-alloy,
medium-carbon steel or high-carbon steel with a very high yield
strength. The springs 306 can be compression springs, torsion
springs, constant springs, variable springs, helical springs, flat
springs, machined springs, cantilever springs, volute springs,
balance springs, leaf springs, V-springs, and/or washer
springs.
[0463] Some embodiments use a spring-loaded pin system. The spring
system can include a receptacle. A pin can be located partially
inside the receptacle such that the pin can slide partially in and
out of the receptacle. A spring can be located inside the
receptacle such that the spring biases the pin outward towards the
electronics unit 500. The receptacle can be electrically coupled to
the sensor 138 such that pressing the electronics unit 500 onto the
spring-loaded pin system electrically couples the electronics unit
500 and the sensor 138.
[0464] Mill-Max Mfg. Corp. of Oyster Bay, N.Y., U.S.A. ("Mill-Max")
makes a spring-loaded pin system with a brass-alloy shell that is
plated with gold over nickel. One Mill-Max spring-loaded pin system
has a stainless steel spring and an ordering code of
0926-1-15-20-75-14-11-0.
[0465] In several embodiments, the electronics unit 500 includes a
battery to provide electrical power to various electrical
components (e.g., a transmitter) of the electronics unit 500.
[0466] In some embodiments, the base 128 can include a battery 314
that is located outside of the electronics unit 500. The battery
314 can be electrically coupled to the electrical connection 310
such that coupling the electronics unit 500 to the base 128 couples
the battery 314 to the electronics unit 500. FIGS. 22B and 22C of
U.S. Patent Publication No. US-2009-0076360-A1 illustrate a battery
444, which in some embodiments, can be part of the base (which can
have many forms including the form of base 128 shown in FIG. 33
herein). The entire contents of U.S. Patent Publication No.
US-2009-0076360-A1 are incorporated by reference herein.
[0467] FIG. 34 illustrates a perspective view of the sensor module
134. Protrusions 308 can secure the springs 306 to the sensor
module 134. (Not all the protrusions 308 are labeled in order to
increase the clarity of FIG. 34.) The protrusions 308 can protrude
distally.
[0468] At least three, at least four, and/or less than ten
protrusions 308 can be configured to contact a perimeter of a
spring 306. The protrusions 308 can be separated by gaps. The gaps
enable the protrusions 308 to flex outward as the spring 306 is
inserted between the protrusions 308. The downward force of
coupling the electronics unit 500 to the base 128 can push the
spring 306 against the sensor 138 to electrically couple the spring
306 to the sensor 138. The sensor 138 can run between at least two
of the protrusions 308.
[0469] FIG. 33 illustrates an on-skin sensor system 600 configured
for transcutaneous glucose monitoring of a host. The on-skin sensor
system 600 can be used with the other components shown in FIG. 7.
The sensor module 134 can be replaced with the sensor modules 134d,
134e shown in FIGS. 35 and 37. Thus, the sensor modules 134d, 134e
shown in FIGS. 35 and 37 can be used with the other components
shown in FIG. 7.
[0470] Referring now to FIGS. 33 and 34, the system 600 can include
a sensor module housing 312; a glucose sensor 138a, 138b having a
first section 138a configured for subcutaneous sensing and a second
section 138b mechanically coupled to the sensor module housing 312;
and an electrical interconnect (e.g., the springs 306) mechanically
coupled to the sensor module housing 312 and electrically coupled
to the glucose sensor 138a, 138b. The springs can be conical
springs, helical springs, or any other type of spring mentioned
herein or suitable for electrical connections.
[0471] The sensor module housing 312 comprises at least two
proximal protrusions 308 located around a perimeter of the spring
306. The proximal protrusions 308 are configured to help orient the
spring 306. A segment of the glucose sensor 138b is located between
the proximal protrusions 308 (distally to the spring 306).
[0472] The sensor module housing 312 is mechanically coupled to the
base 128. The base 128 includes an adhesive 126 configured to
couple the base 128 to skin of the host.
[0473] The proximal protrusions 308 orient the spring 306 such that
coupling an electronics unit 500 to the base 128 presses the spring
306 against a first electrical contact of the electronics 500 unit
and a second electrical contact of the glucose sensor 138b to
electrically couple the glucose sensor 138a, 138b to the
electronics unit 500.
[0474] Referring now to FIGS. 33 and 35-38, the system 600 can
include a sensor module housing 312d, 312e; a glucose sensor 138a,
138b having a first section 138a configured for subcutaneous
sensing and a second section 138b mechanically coupled to the
sensor module housing 312d, 312e; and an electrical interconnect
(e.g., the leaf springs 306d, 306e) mechanically coupled to the
sensor module housing 312d, 312e and electrically coupled to the
glucose sensor 138a, 138b. The sensor modules 134d, 134e can be
used in place of the sensor module 134 shown in FIG. 7. The leaf
springs 306d, 306e can be configured to bend in response to the
electronics unit 500 coupling with the base 128.
[0475] As used herein, cantilever springs are a type of leaf
spring. As used herein, a leaf spring can be made of a number of
strips of curved metal that are held together one above the other.
As used herein in many embodiments, leaf springs only include one
strip (e.g., one layer) of curved metal (rather than multiple
layers of curved metal). For example, the leaf spring 306d in FIG.
35 can be made of one layer of metal or multiple layers of metal.
In some embodiments, leaf springs include one layer of flat metal
secured at one end (such that the leaf spring is a cantilever
spring).
[0476] As shown in FIGS. 35 and 36, the sensor module housing 312d
comprises a proximal protrusion 320d having a channel 322d in which
at least a portion of the second section of the glucose sensor 138b
is located. The channel 322d positions a first area of the glucose
sensor 138b such that the area is electrically coupled to the leaf
spring 306d.
[0477] As shown in the cross-sectional, perspective view of FIG.
36, the leaf spring 306d arcs away from the first area and
protrudes proximally to electrically couple with an electronics
unit 500 (shown in FIG. 33). At least a portion of the leaf spring
306d forms a "W" shape. At least a portion of the leaf spring 306d
forms a "C" shape. The leaf spring 306d bends around the proximal
protrusion 320d. The leaf spring 306d protrudes proximally to
electrically couple with an electronics unit 500 (shown in FIG.
33). The seal 192 is configured to impede fluid ingress to the leaf
spring 306d.
[0478] The leaf spring 306d is oriented such that coupling an
electronics unit 500 to the base 128 (shown in FIG. 33) presses the
leaf spring 306d against a first electrical contact of the
electronics unit 500 and a second electrical contact of the glucose
sensor 138b to electrically couple the glucose sensor 138a, 138b to
the electronics unit 500. The proximal height of the seal 192 is
greater than a proximal height of the leaf spring 306d such that
the electronics unit 500 contacts the seal 192 prior to contacting
the leaf spring 306d.
[0479] Referring now to FIGS. 33 and 37-38, the sensor module
housing 312e comprises a channel 322e in which at least a portion
of the second section of the glucose sensor 138b is located. A
distal portion of the leaf spring 306e is located in the channel
322e such that a proximal portion of the leaf spring 306e protrudes
proximally out the channel 322e.
[0480] The sensor module housing 312e comprises a groove 326e that
cuts across the channel 322e (e.g., intersects with the channel
322e). The leaf spring 306e comprises a tab 328 located in the
groove to impede rotation of the leaf spring. At least a portion of
the leaf spring 306e forms a "C" shape.
[0481] FIGS. 36 and 38 illustrate two leaf spring shapes. Other
embodiments use other types of leaf springs. Elements shown in
FIGS. 33-38 can be combined.
[0482] Referring now to FIGS. 33-38, interconnects 306, 306d, 306e
can comprise a palladium contact, an alloy, a clad material, an
electrically conductive plated material, gold plated portions,
silver material, and/or any suitable conductor. Interconnects 306,
306d, 306e described herein can have a resistance of less than 5
ohms, less than 20 ohms, and/or less than 100 ohms. Many
interconnect embodiments enable a resistance of approximately 2.7
ohms or less, which can significantly increase battery life
compared to higher resistance alternatives.
[0483] Reducing the force necessary to compress an interconnect
306, 306d, 306e (e.g., as an electronics unit 500 is coupled to the
base 128) can reduce coupling errors and difficulties. For example,
if the necessary force is high, odds are substantial that users
will inadvertently fail to securely couple the electronics unit 500
to the base 128. In some cases, if the necessary force is too high,
some users will be unable to couple the electronics unit 500 to the
base 128. Thus, there is a need for systems that require less force
to couple the electronics unit 500 to the base 128.
[0484] Many embodiments described herein (e.g., spring embodiments)
dramatically reduce the force necessary to couple the electronics
unit 500 to the base 128. The interconnects 306, 306d, 306e can
have a compression force of at least 0.05 pounds; less than 0.5
pounds, less than 1 pound, less than 3 pounds; and/or less than 4.5
pounds over an active compression range.
[0485] In some embodiments, the interconnects 306, 306d, 306e may
require a compression force of less than one pound to compress the
spring 20 percent from a relaxed position, which is a substantially
uncompressed position. In some embodiments, the interconnects 306,
306d, 306e may require a compression force of less than one pound
to compress the spring 25 percent from a relaxed position, which is
a substantially uncompressed position. In some embodiments, the
interconnects 306, 306d, 306e may require a compression force of
less than one pound to compress the spring 30 percent from a
relaxed position, which is a substantially uncompressed position.
In some embodiments, the interconnects 306, 306d, 306e change
dependency to independent claim) may require a compression force of
less than one pound to compress the spring 50 percent from a
relaxed position, which is a substantially uncompressed
position.
[0486] Springs 306, 306d, 306e can have a height of 2.6
millimeters, at least 0.5 millimeters, and/or less than 4
millimeters. The seal 192 can have a height of 2.0 millimeters, at
least 1 millimeter, and/or less than 3 millimeters. In some
embodiments, in their relaxed state (i.e., a substantially
uncompressed state), springs 306, 306d, 306e protrude (e.g.,
distally) at least 0.2 millimeters and/or less than 1.2 millimeters
from the top of the seal 192.
[0487] When the electronics unit 500 is coupled to the base 128,
the compression of the springs 306, 306d, 306e can be 0.62
millimeters, at least 0.2 millimeters, less than 1 millimeter,
and/or less than 2 millimeters with a percent compression of 24
percent, at least 10 percent, and/or less than 50 percent. Active
compression range of the springs 306, 306d, 306e can be 16 to 40
percent, 8 to 32 percent, 40 to 57 percent, 29 to 47 percent, at
least 5 percent, at least 10 percent, and/or less than 66
percent.
[0488] In some embodiments, the electrical connection between the
sensor 138 and the electronics unit 500 is created at the factory.
This electrical connection can be sealed at the factory to prevent
fluid ingress, which can jeopardize the integrity of the electrical
connection.
[0489] The electrical connection can be made via any of the
following approaches: An electrode can pierce a conductive
elastomer (such that vertical deformation is not necessary); the
sensor can be "sandwiched" (e.g., compressed) between adjacent
coils of a coil spring; conductive epoxy; brazing; laser welding;
and resistance welding.
[0490] Referring now to FIGS. 4, 6, 7, and 33, one key electrical
connection is between the electronics unit 500 (e.g., a
transmitter) and the sensor module 134. Another key electrical
connection is between the sensor module 134 and the glucose sensor
138. Both connections should be robust to enable connecting the
sensor module 134 to the base 128, and then connecting the base 128
and sensor module 134 to the electronics unit 500 (e.g., a
transmitter). A stable sensor module 134 allows the sensor module
134 to couple to the base 128 without causing signal noise in the
future.
[0491] These two key electrical connections can be made at the
factory (e.g., prior to the host or caregiver receiving the
system). These electrical connections can also be made by the host
or caregiver when the user attaches the electronics unit 500 to the
base 128 and/or the sensor module 134.
[0492] In some embodiments, the connection between the glucose
sensor 138 and the sensor module 134 can be made at the factory
(e.g., prior to the user receiving the system), and then the user
can couple the electronics unit 500 to the sensor module 134 and/or
the base 128. In several embodiments, the electronics unit 500 can
be coupled to the sensor module 134 and/or to the base 128 at the
factory (e.g., prior to the user receiving the system), and then
the user can couple this assembly to the glucose sensor 138.
[0493] Any of the features described in the context of FIGS. 33-38
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS.
33-38 can be combined with the embodiments described in the context
of FIGS. 1-32 and 39-70. Moreover, any of the features of an
embodiment is independently combinable, partly or wholly with other
embodiments described herein in any way, e.g., one, two, or three
or more embodiments may be combinable in whole or in part. Further,
any of the features of an embodiment may be made optional to other
aspects or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
[0494] Referring now to FIG. 33, the battery 314 can be located
inside the electronics unit 500 or can be part of the base 128.
Maximizing the life of the battery 314 is important to many
reasons. For example, the electronics unit 500 may be in storage
for months or even years before it is used. If the battery 413 is
substantially depleted during this storage, the number of days that
a host can use the electronics unit (e.g., to measure an analyte)
can be dramatically diminished.
[0495] In some embodiments, the electronics unit 500 is in a
low-power-consumption state (e.g., a "sleep" mode) during storage
(e.g., prior to being received by the host). This
low-power-consumption state can drain the battery 314. Thus, there
is a need for a system that reduces or even eliminates battery
power consumption during storage and/or prior to the electronics
unit 500 being coupled to the base 128.
[0496] As described in the context of FIG. 33, creating the
electrical connection 310 and/or coupling the electronics unit 500
to the base 128 can cause the electronics unit 500 (e.g., a
transmitter) to exit a sleep mode. For example, conductive members
(e.g., of the sensor module 134 and/or of the base 128) can touch
electrical contacts of the electronics unit 500 (e.g., electrical
contacts of a battery of the electronics unit 500), which can cause
the electronics unit 500 to exit a sleep mode and/or can begin the
flow of electrical power from the battery. The conductive member of
the sensor module 134 and/or of the base 128 can be a battery
jumper that closes a circuit to enable electricity from the battery
to flow into other portions of the electronics unit 500.
[0497] Thus, creating the electrical connection 310 and/or coupling
the electronics unit 500 to the base 128 can "activate" the
electronics unit 500 to enable and/or to prepare the electronics
unit 500 to wirelessly transmit information to other devices
110-113 (shown in FIG. 1). U.S. Patent Publication No.
US-2012-0078071-A1 includes additional information regarding
electronics unit 500 activation (e.g., transmitter activation). The
entire contents of U.S. Patent Publication No. US-2012-0078071-A1
are incorporated by reference herein.
[0498] FIG. 65 illustrates a perspective view of portions of a
sensor module 134j. Some items, such as springs and sensors, are
hidden in FIG. 65 to clarify that the sensor module 134j can use
any spring or sensor described herein. The sensor module 134j can
use any of the springs 306, 306d, 306e; sensors 138, 138a, 138b;
protrusions 308; channels 322d, 322e; and grooves 326e described
herein (e.g., as shown in FIGS. 34-40). The sensor module 134j can
be used in the place of any other sensor module described herein.
The sensor module 134j can be used in the embodiment described in
the context of FIG. 7 and can be used with any of the telescoping
assemblies described herein.
[0499] FIG. 66 illustrates a cross-sectional side view of the
sensor module shown in FIG. 65. Referring now to FIGS. 65-70, the
sensor module 134j includes a conductive jumper 420f (e.g., a
conductive connection that can comprise metal). The conductive
jumper 420f is configured to electrically couple two electrical
contacts 428a, 428b of the electronics unit 500 (e.g., a
transmitter) in response to coupling the electronics unit 500 to
the sensor module 134j and/or to the base 128.
[0500] The conductive jumper 420f can be located at least partially
between two electrical connections 426 (e.g., springs 306, 306d,
306e shown in FIGS. 34-38). The conductive jumper 306f can include
two springs 306f coupled by a conductive link 422f. A first spring
306f of the jumper 420f can be coupled to a first contact 428a, and
a second spring 306f of the jumper 420f can be coupled to a second
contact 428b, which can complete an electrical circuit to enable
the battery to provide electricity to the electronics unit 500. The
springs 306f can be leaf springs, coil springs, conical springs,
and/or any other suitable type of spring. In some embodiments, the
springs 306f are proximal protrusions that are coupled with the
contacts 428a, 428b.
[0501] As shown in FIG. 66, the conductive link 422f can be arched
such that a sensor 138b (shown in FIG. 34) passes under and/or
through the arched portion of the conductive link 422f. In several
embodiments, the conductive link 422f is oriented within plus or
minus 35 degrees of perpendicular to the sensor 138b such that the
conductive link 422f crosses over the portion of the sensor 138b
that is located inside the seal area (e.g., within the interior of
the seal 192).
[0502] FIG. 67 illustrates a perspective view of portions of a
sensor module 134k that is similar to the sensor module 134j shown
in FIGS. 65 and 66. FIG. 68 illustrates a top view of the sensor
module 134k shown in FIG. 67.
[0503] Referring now to FIGS. 67 and 68, the sensor module 134k
includes a different type of conductive jumper 420g, which includes
two helical springs 306g conductively coupled by a conductive link
422g. The conductive link 422g is configured to cross over or under
the sensor 138b (shown in FIG. 34). As shown in FIGS. 67 and 68,
the springs 306g are conical springs, however, some embodiments do
not use conical springs. The springs 306g are configured to
electrically couple two electrical contacts 428a, 428b of the
electronics unit 500 to start the flow the electricity within the
electronics unit 500. Thus, the conductive jumper 420g can
"activate" the electronics unit 500. The conductive jumper 420g can
be used with any of the sensor modules described herein.
[0504] FIGS. 69 and 70 illustrate perspective views of an
electronics unit 500 just before the electronics unit 500 is
coupled to a base 128. As shown in FIG. 70, the electronics unit
500 can have two electrical contacts 428a, 428b configured to be
electrically coupled to a conductive jumper 420f (shown in FIGS. 65
and 66), 420g (shown in FIGS. 67 and 68). The electronics unit 500
can also have two electrical contacts 428c, 428d configured to be
electrically coupled to the springs 306, 306d, 306e (shown in FIGS.
34-38) and/or to any other type of electrical connection 426
between the sensor 138 (shown in FIG. 39) and the electronics unit
500.
[0505] Coupling the electronics unit 500 to the sensor module 134k
and/or to the base 128 can electrically and/or mechanically couple
the electrical contacts 428a, 428b to the conductive jumper 420f
(shown in FIG. 65), 420g (shown in FIG. 67).
[0506] Coupling the electronics unit 500 to the sensor module 134k
and/or to the base 128 can electrically and/or mechanically couple
the electrical contacts 428c, 428d to the springs 306, 306d, 306e
(shown in FIGS. 34-38) and/or to any other type of electrical
connection 426 (e.g., as shown in FIG. 67) between the sensor 138
(shown in FIG. 39) and the electronics unit 500.
[0507] Any of the features described in the context of FIGS. 65-70
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS.
65-70 can be combined with the embodiments described in the context
of FIGS. 1-64. Moreover, any of the features of an embodiment is
independently combinable, partly or wholly with other embodiments
described herein in any way, e.g., one, two, or three or more
embodiments may be combinable in whole or in part. Further, any of
the features of an embodiment may be made optional to other aspects
or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
Needle Angle and Offset
[0508] FIG. 43 shows a front view of a "C-shaped" needle 156. FIG.
42 illustrates a bottom view of the C-shaped needle 156. The needle
156 includes a channel 330. A section 138a (shown in FIG. 34) of
the glucose sensor 138 (labeled in FIG. 7) that is configured for
subcutaneous sensing can be placed in the channel 330 (as shown in
FIG. 40).
[0509] The needle 156 can guide the sensor 138 into the skin of the
host. A distal portion of the sensor 138 can be located in the
channel 330 of the needle 156. Sometimes, a distal end of the
sensor 138 sticks out of the needle 156 and gets caught on tissue
of the host as the sensor 138 and needle 156 are inserted into the
host. As a result, the sensor 138 may buckle and fail to be
inserted deeply enough into the subcutaneous tissue. In other
words, in some embodiments, the sensor wire must be placed within
the channel 330 of the C-shaped needle 156 to be guided into the
tissue and must be retained in the channel 330 during
deployment.
[0510] The risk of the sensor 138 sticking out of the channel 330
(and thereby failing to be property inserted into the host) can be
greatly diminished by placing the sensor 138 in the channel 330 of
the needle 156 with a particular angle 338 (shown in FIG. 41) and
offset 336 (shown in FIG. 40. Position B 334 in FIG. 42 illustrates
a sensor sticking out of the channel 330.
[0511] The angle 338 and offset 336 cause elastic deformation of
the sensor 138 to create a force that pushes the sensor 138 to the
bottom of the channel 300 (as shown by position A 332 in FIG. 42)
while avoiding potentially detrimental effects of improper angles
338 and offset 336. The angle 338 and offset 336 can also cause
plastic deformation of the sensor 138 to help shape the sensor 138
in a way that minimizes the risk of the sensor 138 being dislodged
from the channel 330 during insertion into the skin.
[0512] In several embodiments, the angle 338 and offset 336 shape
portions of the sensor 138 for optimal insertion performance. For
example, the angle 338 can bend the sensor 138 prior to placing
portions of the sensor 138 in the channel 330 of the needle
156.
[0513] As illustrated in FIG. 39, a portion of the glucose sensor
138b (also labeled in FIG. 34) can be placed in a distally facing
channel 342 (which, in some embodiments, is a tunnel). This channel
342 can help orient the glucose sensor 138b towards the channel 330
of the needle 156 (shown in FIG. 43).
[0514] As illustrated in FIG. 41, the glucose sensor 138 can
include an angle 338 between a portion of the glucose sensor 138
that is coupled to the sensor module housing 312 (shown in FIG. 34)
and a portion of the glucose sensor that is configured to be
inserted into the host. In some embodiments, this angle 338 can be
formed prior to coupling the sensor 138 to the sensor module house
312 (shown in FIG. 34) and/or prior to placing a portion of the
sensor 138 in the channel 330 of the needle 156 (shown in FIG.
43).
[0515] Referring now to FIG. 41, an angle 338 that is less than 110
degrees can result in deployment failures (e.g., with an offset of
0.06 inches plus 0.06 inches and/or minus 0.03 inches). In some
embodiments, an angle 338 that is less than 125 degrees can result
in deployment failures (e.g., with an offset of 0.06 inches plus
0.06 inches and/or minus 0.03 inches). An angle 338 of 145 degrees
(plus 5 degrees and/or minus 10 degrees) can reduce the probability
of deployment failures. In some embodiments, the angle 338 is at
least 120 degrees and/or less than 155 degrees.
[0516] In some embodiments, a manufacturing method includes bending
the sensor 138 prior to placing portions of the sensor 138 in the
channel 330 of the needle 156. In this manufacturing method, an
angle is measured from a central axis of a portion of the glucose
sensor 138 that is coupled to the sensor module housing 312 (shown
in FIG. 34) and a portion of the glucose sensor that is configured
to be inserted into the needle. According to this angle
measurement, an angle that is greater than 70 degrees can result in
deployment failures (e.g., with an offset of 0.06 inches plus 0.06
inches and/or minus 0.03 inches). In some embodiments, an angle
that is greater than 55 degrees can result in deployment failures
(e.g., with an offset of 0.06 inches plus 0.06 inches and/or minus
0.03 inches). An angle of 35 degrees (plus 10 degrees and/or minus
5 degrees) can reduce the probability of deployment failures. In
some embodiments, the angle is at least 25 degrees and/or less than
60 degrees.
[0517] An offset 336 (shown in FIG. 40) that is too large can
result in the sensor 138 not being reliably held in the channel 330
(shown in FIG. 42). In other words, a large offset 336 can result
in the sensor 138 being located in position B 334 rather than
securely in position A 332. An offset 336 that is too small can
place too much stress on the sensor 138, which can break the sensor
138. In light of these factors, in several embodiments, the offset
336 is at least 0.02 inches, at least 0.04 inches, less than 0.08
inches, and/or less than 0.13 inches. In some embodiments, the
offset 336 is equal to or greater than 0.06 inches and/or less than
or equal to 0.10 inches. The offset 336 is measured as shown in
FIG. 40 from the root of the needle 156.
[0518] In some embodiments, at least a portion of the bend of the
sensor 138 can include a strain relief. For example, the bend of
the sensor 138 can be encapsulated in a polymeric tube or an
elastomeric tube to provide strain relief for the sensor 138. In
some instances, the entire bend of the sensor 138 can be
encapsulated in a polymeric tube or an elastomeric tube. In some
embodiments, the tube is composed of a soft polymer. The polymeric
tube or elastomeric tube can encapsulate the sensor 138 by a heat
shrink process. In some embodiments, a silicone gel may be applied
to the sensor at or near channel 342 (shown in FIG. 39), or along
at least a portion of the underside of proximal protrusion 320d
(shown in FIG. 35).
[0519] The needle channel width 344 (shown in FIG. 42) can be 0.012
inches. In some embodiments, the width 344 is equal to or greater
than 0.010 inches and/or less than or equal to 0.015 inches. The
width 344 of the channel 330 is measured at the narrowest span in
which the glucose sensor 138 could be located.
[0520] Referring now to FIG. 40, a funnel 182 in the base 128 can
help guide the needle 156 and/or the glucose sensor 138 into the
hole 180. The funnel 182 and the hole 180 can help secure the
sensor 138 in the C-shaped needle 156 during storage and
deployment. For example, the hole 180 can be so small that there is
not extra room (within the hole 180) for the sensor 138 to exit the
channel 330 (shown in FIG. 42) of the needle 156.
[0521] Another role of the funnel 182 and hole 180 is to support
the needle 156 and/or the sensor 138 against buckling forces during
insertion of the needle 156 and/or the sensor 138 into the
host.
[0522] The funnel 182 and the hole 180 also protect against
inadvertent needle-stick injuries (because they are too small to
enable, for example, a finger to reach the needle 156 prior to
needle deployment).
[0523] The sensor module 134 is unable to pass through the funnel
182 and hole 180 (e.g., due to the geometries of the sensor module
134 and the funnel 182). Preventing the sensor module 134 from
passing through the base 128 ensures the sensor module 134 is
removed from the host's body when the base 128 is detached from the
host. The angle 338 can prevent all of the sensor 138 from passing
through the hole 180 to ensure the sensor 138 is removed from the
host's body when the base 128 is detached from the host.
[0524] Any of the features described in the context of FIGS. 39-43
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS.
39-43 can be combined with the embodiments described in the context
of FIGS. 1-38 and 44-70. Moreover, any of the features of an
embodiment is independently combinable, partly or wholly with other
embodiments described herein in any way, e.g., one, two, or three
or more embodiments may be combinable in whole or in part. Further,
any of the features of an embodiment may be made optional to other
aspects or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
Needle-Free
[0525] Some embodiments use a needle to help insert a glucose
sensor into subcutaneous tissue. Some people, however, are fearful
of needles. In addition, needle disposal can require using a sharps
container, which may not be readily available.
[0526] Many embodiments do not use a needle to insert the sensor,
which can help people feel more comfortable inserting the sensor
and can eliminate the need to use a sharps container to dispose of
the applicator or portions thereof.
[0527] U.S. Patent Publication No. US-2011-0077490-A1, U.S. Patent
Publication No. US-2014-0107450-A1, and U.S. Patent Publication No.
US-2014-0213866-A1 describe several needle-free embodiments. The
entire contents of U.S. Patent Publication No. US-2011-0077490-A1,
U.S. Patent Publication No. US-2014-0107450-A1, and U.S. Patent
Publication No. US-2014-0213866-A1 are incorporated by reference
herein.
[0528] Any of the embodiments described herein can be used with or
without a needle. For example, the embodiments described in the
context of FIGS. 1-50 can be used with or without a needle. For
example, the embodiment shown in FIG. 7 can be used in a very
similar way without the needle 156. In this needle-free embodiment,
moving the first portion 150 distally drives a distal portion of
the glucose sensor 138 into the skin (without the use of a needle
156). In needle-free embodiments, the sensor 138 can have
sufficient buckling resistance such that (when supported by the
hole 180) the sensor 138 does not buckle. Sharpening a distal tip
of the sensor 138 can also facilitate needle-free insertion into
the host.
[0529] FIG. 56 illustrates an embodiment very similar to the
embodiment shown in FIG. 7 except that the embodiment of FIG. 56
does not include a needle. The telescoping assembly 132b pushes the
sensor 138 (which can be any type of analyte sensor) into the body
of the host. The embodiment shown in FIG. 56 does not include a
needle hub 162, a spring 234, or a needle retraction mechanism 158
(as shown in FIG. 7) but can include any of the items and features
described in the context of other embodiments herein.
[0530] FIG. 57 illustrates the first portion 150 moving distally
relative to the second portion 152 of the telescoping assembly 132b
to move the sensor module 134 and the sensor 138 towards the base
128 in preparation to couple the sensor module 134 and the sensor
138 to the base 128.
[0531] FIG. 58 illustrates the first portion 150 in a distal ending
position relative to the second portion 152. The sensor module 134
and the sensor 138 are coupled to the base 128. The base 128 is no
longer coupled to the telescoping assembly 132b such that the
telescoping assembly 132b can be discarded while leaving the
adhesive 126 coupled to the skin of the host (as described in the
context of FIGS. 4-6).
[0532] The embodiment illustrated in FIGS. 56-58 can be integrated
into the applicator system 104 shown in FIGS. 2 and 3.
[0533] The items and features described in the context of FIGS.
12A-50 can also be used with the embodiment illustrated in FIGS.
56-58. Items and features are described in the context of certain
embodiments to reduce redundancy. The items and features shown in
all the drawings, however, can be combined. The embodiments
described herein have been designed to illustrate the
interchangeability of the items and features described herein.
[0534] FIGS. 44 and 45 illustrate another embodiment of a
telescoping assembly 132g. This embodiment includes a first portion
150g that moves distally relative to a second portion 152g to push
a glucose sensor 138g through a hole in a base 128g and into a
host.
[0535] The first portion 150g (e.g., a pusher) of the telescoping
assembly 132g can include a distal protrusion 352 that supports a
substantially horizontal section of the glucose sensor 138g (e.g.,
as the glucose sensor 138g protrudes out from the sensor module
134g). The end of the distal protrusion 352 can include a groove
354 in which at least a portion of the glucose sensor 138g is
located. The groove 354 can help retain the glucose sensor 138g.
The distal protrusion 352 can provide axial support to the glucose
sensor 138g (e.g., to push the glucose sensor 138g distally into
the tissue of the host).
[0536] The base 128g can include a funnel 182g that faces
proximally to help guide a distal end of the glucose sensor 138g
into a hole 180g in the base 128g. The hole 180g can radially
support the sensor 138g as the sensor 138g is inserted into the
tissue of the host.
[0537] When the first portion 150g of the telescoping assembly 132g
is in the proximal starting position, the distal end of the glucose
sensor 138g can be located in the hole 180g to help guide the
glucose sensor 138g in the proper distal direction.
[0538] The hole 180g can exit a convex distal protrusion 174g in
the base 128g. The convex distal protrusion 174g can help tension
the skin prior to sensor insertion. As described more fully in
other embodiments, the base 128g can rest against the skin of the
host as the sensor module 134g moves distally towards the base 128g
and then is coupled to the base 128g.
[0539] The telescoping assembly 132g (e.g., an applicator) does not
include a needle. As a result, there is no sharp in the applicator,
which eliminates any need for post-use sharp protection. This
design trait precludes a need for a retraction spring or needle
hub. The distal end of the sensor wire 138g can be sharpened to a
point to mitigate a need for an insertion needle.
[0540] The telescoping assembly 132g (e.g., an applicator) can
include the first portion 150g and the second portion 152g. The
base 128g can be coupled to a distal end of the first portion 150g.
The glucose sensor 138g and the sensor module 134g can be coupled
to a distal end of the first portion 150g such that he applicator
does not require a spring, needle, or needle hub; the first portion
150g is secured in a proximal starting position by an interference
between the first portion 150g and the second portion 152g of the
telescoping assembly 132g; and/or applying a distal force that is
greater than a breakaway threshold of the interference causes the
first portion 150g to move distally relative to the second portion
152g (e.g., until the sensor 138g is inserted into the tissue and
the sensor module 134g is coupled to the base 128g).
[0541] FIGS. 46 and 47 illustrate a similar needle-free embodiment.
This embodiment does not use the distal protrusion 352 shown in
FIG. 45. Instead, the sensor module 134h includes a distally
oriented channel 358 that directs the sensor 138h distally such
that the glucose sensor 138h includes a bend that is at least 45
degrees and/or less than 135 degrees. A channel cover 362 secures
the glucose sensor 138h in the distally oriented channel 358.
[0542] The embodiments illustrated in FIGS. 44-47 can be integrated
into the applicator system 104 shown in FIGS. 2 and 3. Referring
now to FIG. 2, the electronics unit 500 (e.g., a transmitter having
a battery) can be detachably coupled to the sterile barrier shell
120. The rest of the applicator system 104 can be sterilized, and
then the electronics unit 500 can be coupled to the sterile barrier
shell 120 (such that the electronics unit 500 is not sterilized
with the rest of the applicator system 104).
[0543] The items and features described in the context of FIGS.
12A-43 and 48-70 can also be used with the embodiments illustrated
in FIGS. 44-47. Items and features are described in the context of
certain embodiments to reduce redundancy. The items and features
shown in all the drawings, however, can be combined. The
embodiments described herein have been designed to illustrate the
interchangeability of the items and features described herein.
[0544] Any of the features described in the context of FIGS. 44-47
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS.
44-47 can be combined with the embodiments described in the context
of FIGS. 1-43 and 48-70. Moreover, any of the features of an
embodiment is independently combinable, partly or wholly with other
embodiments described herein in any way, e.g., one, two, or three
or more embodiments may be combinable in whole or in part. Further,
any of the features of an embodiment may be made optional to other
aspects or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
[0545] In some embodiments, the sensor 138 can be deployed (e.g.,
into the skin of the host) in response to coupling the electronics
unit 500 (e.g., a transmitter) to the base 128. The sensor 138 can
be any type of analyte sensor (e.g., a glucose sensor).
[0546] Premature deployment of the sensor 138 can cause insertion
of the sensor 138 into the wrong person and/or insufficient sensor
insertion depth. Premature deployment can also damage the sensor
138, which in some embodiments, can be fragile. Thus, there is a
need to reduce the likelihood of premature sensor deployment.
[0547] One way to reduce the likelihood of premature sensor
deployment is for the system to include an initial resistance
(e.g., to coupling the electronics unit 500 to the base 128). The
initial resistance can necessitate a force buildup prior to
overcoming the initial resistance. When the initial resistance is
overcome, the sensor 138 is typically deployed faster than would be
the case without an initial resistance (e.g., due to the force
buildup, which can be at least 0.5 pounds, 1 pound, and/or less
than 5 pounds). This fast deployment can reduce pain associated
with the sensor insertion process.
[0548] In some embodiments, the resistance to coupling the
electronics unit 500 to the base 128 after overcoming the initial
resistance is less than 10 percent of the initial resistance, less
than 40 percent of the initial resistance, and/or at least 5
percent of the initial resistance. Having a low resistance to
coupling the electronics unit 500 to the base 128 after overcoming
the initial resistance can enable fast sensor insertion, which can
reduce the pain associated with the sensor insertion process.
[0549] FIGS. 56-58 illustrate the first portion 150 deploying the
sensor 138 into the skin of the host. In some embodiments, the
first portion 150 is replaced with the electronics unit 500 shown
in FIG. 4 such that coupling the electronics unit 500 to the base
128 pushes the sensor 138 into the skin of the host. Referring now
to FIGS. 4 and 56-58, the protrusion 240 (as explained in other
embodiments) can be a portion of the electronics unit 500 such that
moving the electronics unit distally relative to the second portion
152 and/or coupling the electronics unit 500 to the base 128
requires overcoming the initial resistance of the protrusion
240.
[0550] In some embodiments configured such that the sensor 138 is
deployed (e.g., into the skin of the host) in response to coupling
the electronics unit 500 to the base 128, a telescoping assembly
132b is not used. Instead, features of the base 128 provide the
initial resistance to coupling the electronics unit 500 to the base
128. Although the locking feature 230 in FIG. 33 is used for
different purposes in some other embodiments, the locking feature
230 of the base 128 can couple with a corresponding feature of the
electronics unit 500. This coupling can require overcoming an
initial resistance.
[0551] Any of the features and embodiments described in the context
of FIGS. 1-70 can be applicable to all aspects and embodiments in
which the sensor 138 is deployed (e.g., into the skin of the host)
in response to coupling the electronics unit 500 (e.g., a
transmitter) to the base 128.
Vertical Locking
[0552] After a telescoping assembly (e.g., an applicator) has been
used to insert a glucose sensor, the needle used to insert the
glucose sensor could inadvertently penetrate another person. To
guard against this risk, the telescoping assembly can protect
people from subsequent needle-stick injuries by preventing the
first portion of the telescoping assembly from moving distally
relative to the second portion after the sensor has been inserted
into the host.
[0553] FIG. 48 illustrates a perspective, cross-sectional view of a
telescoping assembly 132i that includes a first portion 150i and a
second portion 152i. Referring now to FIGS. 48-50, the first
portion 150i is configured to telescope distally relative to the
second portion 152i. The second portion 152i of the telescoping
assembly 132i can include a proximal protrusion 364 that can slide
past a lock-out feature 366 of the first portion 150i of the
telescoping assembly 132i as the first portion 150i is moved
distally.
[0554] The proximal protrusion 364 can be biased such that elastic
deformation of the proximal protrusion 364 creates a force
configured to press the proximal protrusion 364 into the bottom of
the lock-out feature 366 once the proximal protrusion 364 engages
the lock-out feature 366.
[0555] The proximal protrusion 364 does not catch on the lock-out
feature 366 as the first portion 150i moves distally a first time.
Once the first portion 150i is in a distal ending position, a
spring can push the first portion 150i to a second proximal
position. Rather than returning to the starting proximal position,
the proximal protrusion 364 catches on the lock-out feature 366
(due to the bias of the proximal protrusion 364 and the distally
facing notch 368 of the lock-out feature 366).
[0556] Once a proximal end of the proximal protrusion 364 is
captured in the lock-out feature 366, the rigidity of the proximal
protrusion 364 prevents the first portion 150i of the telescoping
assembly 132i from moving distally a second time.
[0557] As the first portion 150i moves distally relative to the
second portion 152i, a ramp 370 of the first portion 150i pushes
the proximal protrusion 364 outward (towards the lock-out feature
366). The proximal protrusion 364 can be located between two distal
protrusions 372 of the first portion 150i. The distal protrusions
372 can guide the proximal protrusion 364 along the ramp 370.
[0558] As a portion of the proximal protrusion 364 slides along the
ramp 370 (as the first portion 150i moves distally), the ramp bends
the proximal protrusion 364 until a portion of the proximal
protrusion 364 that was previously between the two distal
protrusions 372 is no longer between the distal protrusions 372.
Once the portion of the proximal protrusion 364 is no longer
between the two distal protrusions 372, the proximal protrusion 364
is in a state to catch on the notch 368. The notch 368 can be part
of the distal protrusions 372.
[0559] The second portion 152i of the telescoping assembly 132i can
include a proximal protrusion 364, which can be oriented at an
angle between zero and 45 degrees relative to a central axis). The
first portion 150i of the telescoping assembly 132i can include
features that cause the proximal protrusion 364 to follow a first
path as the first portion 150i moves distally and then to follow a
second path as the first portion 150i moves proximally. The second
path includes a locking feature 366 that prevents the first portion
150i from moving distally a second time.
[0560] The first portion 150i can include a ramp 370 that guides
the proximal protrusion 364 along the first path. A distal
protrusion (e.g., the ramp 370) of the first portion 150i can bias
the proximal protrusion 364 to cause the proximal protrusion 364 to
enter the second path as the first portion 150i moves proximally.
The proximal protrusion 364 can be a flex arm. The lock 366 can
comprise a distally facing notch 368 that catches on a proximal end
of the proximal protrusion 364.
[0561] As shown in FIGS. 48 and 50, the telescoping assembly 132i
can include a sensor module 134i. The sensor module 134i can be any
of the sensor modules described herein.
[0562] Any of the features described in the context of FIGS. 48-50
can be applicable to all aspects and embodiments identified herein.
For example, the embodiments described in the context of FIGS.
48-50 can be combined with the embodiments described in the context
of FIGS. 1-47 and 51-70. Moreover, any of the features of an
embodiment is independently combinable, partly or wholly with other
embodiments described herein in any way, e.g., one, two, or three
or more embodiments may be combinable in whole or in part. Further,
any of the features of an embodiment may be made optional to other
aspects or embodiments. Any aspect or embodiment of a method can be
performed by a system or apparatus of another aspect or embodiment,
and any aspect or embodiment of a system can be configured to
perform a method of another aspect or embodiment.
Dual-Spring Assembly
[0563] Partial sensor insertion can lead to suboptimal sensing. In
some cases, partial sensor insertion can create a needle-stick
hazard (due to the needle not retracting into a protective
housing). Thus, there is a need for systems that ensure full sensor
insertion.
[0564] The embodiment illustrated in FIGS. 61-64 dramatically
reduces the odds of partial sensor insertion by precluding sensor
insertion until sufficient potential energy is stored in the
system. The potential energy is stored in a first spring 402.
[0565] The system includes many items from the embodiment
illustrated in FIG. 7 (e.g., the base 128 and the sensor module
134). The system includes an optional needle 156 and needle hub
162. The embodiment illustrated in FIGS. 61-64 can also be
configured to be needle-free by removing the needle 156, the second
spring 234, the needle hub 162, and the needle retraction mechanism
158.
[0566] The telescoping assembly 132k has three portions 150k, 152k,
392. Moving the third portion 392 distally relative to the second
portion 152k stores energy in the first spring 402 (by compressing
the first spring 402). Once the first portion 150k is unlocked from
the second portion 152k, the energy stored in the compressed first
spring 402 is used to push the first portion 150k distally relative
to the second portion 152k to drive the sensor 138 (shown in FIG.
7) into the skin of the host.
[0567] To ensure the first portion 150k does not move distally
relative to the second portion 152k until the first spring 402 is
sufficiently compressed (and thus has enough stored energy), the
first portion 150k is locked to the second portion 152k. Once the
first spring 402 is sufficiently compressed (and thus has enough
stored energy), the system unlocks the first portion 150k from the
second portion 152k to enable the stored energy to move the sensor
138 (and in some embodiments the needle 156) into the skin of the
host.
[0568] The telescoping assembly 132k can lock the third portion 392
to the second portion 152k in response to the third portion 392
reaching a sufficiently distal position relative to the second
portion 152k. A protrusion 408 can couple with a hole 410 to lock
the third portion 392 to the second portion 152k.
[0569] Some embodiments do not include locking protrusion 408 and
do not lock the third portion 392 to the second portion 152k in
response to the third portion 392 reaching a sufficiently distal
position relative to the second portion 152k.
[0570] In several embodiments, sufficiently distal positions are at
least 3 millimeters, at least 5 millimeters, and/or less than 30
millimeters distal relative to the proximal starting position.
[0571] The telescoping assembly 132k can lock the first portion
150k to the second portion 152k in response to the first portion
150k reaching a sufficiently distal position relative to the second
portion 152k. A protrusion 412 (e.g., a distal protrusion) can
couple with a hole 414 (e.g., in a surface that is within plus or
minus 30 degrees of perpendicular to the central axis of the
telescoping assembly 132k) to lock the first portion 150k to the
second portion 152k.
[0572] Some embodiments include a needle 156 to help insert a
sensor into skin of a host. In embodiments that include a needle
156, the telescoping assembly 132k can include the needle
retraction mechanism 158 described in the context of FIG. 7. Moving
the first portion 150k to a sufficiently distal position relative
to the second portion 152k can trigger the needle retraction
mechanism 158 (e.g., can release a latch) to enable a second spring
234 to retract the needle 156.
[0573] FIG. 61 illustrates a system for applying an on-skin sensor
assembly 600 (shown in FIGS. 4-6) to a skin of a host. The system
comprises a telescoping assembly 132k having a first portion 150k
configured to move distally relative to a second portion 152k from
a proximal starting position (e.g., the position shown in FIG. 61)
to a distal position (e.g., the position shown in FIG. 64) along a
path; a sensor 138 (shown in FIG. 64) coupled to the first portion
150k; and a base 128 comprising adhesive 126 configured to couple
the sensor 138 to the skin. The telescoping assembly 132k can
further comprise a third portion 392 configured to move distally
relative to the second portion 152k.
[0574] In some embodiments, the first portion 150k is located
inside of the second portion 152k such that the second portion 152k
wraps around the first portion 150k in a cross section taken
perpendicularly to the central axis of the telescoping assembly
132k.
[0575] In some embodiments, a first spring 402 is positioned
between the third portion 392 and the second portion 152k such that
moving the third portion 392 distally relative to the second
portion 152k compresses the first spring 402. The first spring 402
can be a metal helical spring and/or a metal conical spring. In
several embodiments, the first spring 402 is a feature molded as
part of the third portion 392, as part of the second portion 152k,
or as part of the first portion 150k. The first spring 402 can be
molded plastic.
[0576] The telescoping assembly 132k can be configured such that
the first spring 402 is not compressed in the proximal starting
position and/or not compressed during storage. In several
embodiments, the telescoping assembly 132k can be configured such
that the first spring 402 is not compressed more than 15 percent in
the proximal starting position and/or during storage (e.g., to
avoid detrimental spring relaxation and/or creep of other
components such as at least one of the third portion 392, the
second portion 152k, and the first portion 150k).
[0577] Some embodiments that include a needle 156 do not include a
needle hub 162. In these embodiments, the second spring 234 can be
located between the second portion 152k and the first portion 150k
such that moving the first portion 150k distally relative to the
second portion 152k compresses the second spring 234 to enable the
second spring 234 to push the first portion 150k proximally
relative to the second portion 152k to retract the needle 156
(e.g., after sensor insertion).
[0578] In several embodiments, the second spring 234 is compressed
while the telescoping assembly 132k is in the proximal starting
position. For example, the second spring 234 can be compressed at
the factory while the telescoping assembly 132k is being assembled
such that when the user receives the telescoping assembly 132k, the
second spring 234 is already compressed (e.g., compressed enough to
retract the needle 156).
[0579] The second spring 234 can have any of the attributes and
features associated with the spring 234 described in the context of
other embodiments herein (e.g., in the context of the embodiment of
FIG. 7).
[0580] In some embodiments, the movement of the sensor module 134
(e.g., an analyte sensor module) and the sensor 138 (e.g., an
analyte sensor) relative to the base 128 can be as described in the
context of other embodiments (e.g., as shown by the progression
illustrated by FIGS. 7-11).
[0581] In the proximal starting position of the telescoping
assembly 132k, the first portion 150k can be locked to the second
portion 152k. The system can be configured such that moving the
third portion 392 distally relative to the second portion 152k
unlocks the first portion 150k from the second portion 152k.
[0582] In several embodiments, a first proximal protrusion 394
having a first hook 396 passes through a first hole 398 in the
second portion 152k to lock the first portion 150k to the second
portion 152k. The third portion 392 can comprise a first distal
protrusion 404. The system can be configured such that moving the
third portion 392 distally relative to the second portion 152k
engages a ramp 406 to bend the first proximal protrusion 394 to
unlock the first portion 150k from the second portion 152k.
[0583] In some embodiments, the sensor 138 is located within the
second portion 152k while the base 128 protrudes from the distal
end of the system such that the system is configured to couple the
sensor 138 to the base 128 by moving the first portion 150k
distally relative to the second portion 152k.
[0584] In several embodiments, a sensor module 134 is coupled to a
distal portion of the first portion 150k such that moving the first
portion 150k to the distal position couples the sensor module 134
to the base 128. This coupling can be as described in the context
of other embodiments herein. The sensor 138 can be coupled to the
sensor module 134 while the first portion 150k is located in the
proximal starting position.
[0585] The system can be configured such that the third portion 392
moves distally relative to the second portion 152k before the first
spring 402 moves the first portion 150k distally relative to the
second portion 152k. The system can be configured such that moving
the third portion 392 distally relative to the second portion 152k
unlocks the first portion 150k from the second portion 150k and
locks the third portion 392 to the second portion 152k.
[0586] A first protrusion 408 couples with a hole 410 of at least
one of the second portion 152k and the third portion 392 to lock
the third portion 392 to the second portion 152k.
[0587] In some embodiments, the system comprises a second
protrusion 412 that couples with a hole 414 of at least one of the
first portion 150k and the second portion 152k to lock the first
portion 150k to the second portion 152k in response to moving the
first portion 150k distally relative to the second portion
152k.
[0588] In several embodiments, a first spring 402 is positioned
between the third portion 392 and the second portion 152k such that
moving the third portion 392 distally relative to the second
portion 152k compresses the first spring 402 and unlocks the first
portion 150k from the second portion 152k, which enables the
compressed first spring 402 to push the first portion 150k distally
relative to the second portion 152k, which pushes at least a
portion of the sensor 138 out of the distal end of the system and
triggers a needle retraction mechanism 158 to enable a second
spring 234 to retract a needle 156.
[0589] In yet another aspect, disclosed herein is a dual
spring-based sensor insertion device having a pre-connected sensor
assembly (i.e. an analyte sensor electrically coupled to at least
one electrical contact before sensor deployment). Such a sensor
insertion device provides convenient and reliable insertion of a
sensor into a user's skin by a needle as well as reliable
retraction of a needle after the sensor is inserted, which are
features that provide convenience to users as well as
predictability and reliability of the insertion mechanism. The
reliability and convenience of a dual spring based sensor insertion
device having an automatic insertion and automatic retraction
provide is a significant advancement in the field of sensor
insertion devices. Furthermore, such a device can provide both
safety and shelf stability.
[0590] In several embodiments, the insertion device can include a
first spring and a second spring. In such embodiments, either or
both of the first spring and the second spring can be integrally
formed with portions of a telescoping assembly, such as the first
portion and the second portion of a telescoping assembly. In
several embodiments, either or both of the first spring and the
second spring can be formed separately from and operatively coupled
to portions of the telescoping assembly. For example, in some
embodiments, the insertion spring can be integrally formed with a
portion of the telescoping assembly while the retraction spring is
a separate part which is operatively coupled to a portion of the
telescoping assembly.
[0591] In some embodiments, rather than being configured to undergo
compression during energization, either or both of the first spring
and the second spring can be configured to undergo tensioning
during energization. In these embodiments, the couplings between
the springs and the portions of the telescoping assembly, as well
as the couplings between the moving portions of the assembly (for
example in the resting state, and during activation, deployment,
and retraction) can be adjusted to drive and/or facilitate the
desired actions and reactions within the system. For example, in an
embodiment employing a tensioned retraction spring to drive the
insertion process, the retraction spring can be coupled to or
integrally formed with the second portion of the telescoping
assembly. In such an embodiment, the retraction spring can be
pre-tensioned in the resting state. In other such embodiments, the
retraction spring can be untensioned in the resting state, and
tensioned during the sensor insertion process.
[0592] In several embodiments, either or both of the first spring
and the second spring can be substantially unenergized and/or
unstressed when the system is in a resting state. In several
embodiments, either or both of the first spring and the second
spring can be energized and/or stressed when the system is in a
resting state. As used herein, the term "energized" means that
enough potential energy is stored in the spring to perform the
desired actions and reactions within the system. In some
embodiments, the first spring can be partly energized in the
resting state, such that the user can supply a lesser amount of
force to fully energize the first spring. In some embodiments, the
second spring can be partly energized in the resting state, such
that the energy stored in the first spring (either in the resting
state or after energization by a user) can provide force to
energize the second spring. In some embodiments, the energy stored
in the first spring can provide sufficient force to energize the
second spring to at least retract the needle from the skin. In some
embodiments, either or both of the first spring and the second
spring can be compressed or tensioned by 50% or more, 60% or more,
70% or more, 80% or more, 90% or more, or 100% in the resting
state. In other embodiments, either or both of the first spring and
the second spring can be compressed or tensioned by 50% or less,
40% or less, 30% or less, 20% or less, 15% or less, 10% or less, 5%
or less, or 0% in the resting state.
[0593] In embodiments in which both the first spring and the second
spring are substantially unenergized in the resting state, they can
be stressed by the same amounts, similar amounts, or entirely
different amounts. In embodiments in which both the first spring
and the second spring are effectively energized in the resting
state, they can be stressed by the same amounts, similar amounts,
or entirely different amounts. In embodiments in which the second
spring is substantially unenergized in the resting state, the first
spring can be configured to store enough energy to drive both the
desired movement in the system (e.g., the movement of the first
portion in a distal direction), as well as the energization of the
second spring.
[0594] With reference now to FIGS. 71-75, another embodiment of a
system 104m for applying an on-skin sensor assembly to skin of a
host is illustrated. The embodiment illustrated in FIGS. 71-75 may
reduce the potential of incomplete sensor insertion by precluding
sensor insertion until sufficient potential energy is stored in the
system. The potential energy for inserting the sensor can be stored
in an actuator, such as a first spring 402m. The embodiment may
provide other advantages such as controlled speed, controlled
force, and improved user experience.
[0595] The system 104m may include many features from the
embodiment illustrated in FIG. 7 (e.g., the needle 156, the base
128 and the sensor module 134). The system 104m may include
alternative elements, such as, but not limited to, a needle hub
162m, a second spring 234m, and a needle retraction mechanism 158m.
The embodiment illustrated in FIGS. 71-75 can also be configured to
be needle-free by removing the needle 156, the second spring 234m,
the needle hub 162m, and the needle retraction mechanism 158m. In
such embodiments, the sensor may be a self-insertable sensor.
[0596] The system 104m may include many features that are similar
to those of the embodiment illustrated in FIGS. 61-64 (e.g., a
telescoping assembly 132m) including a first portion 150m, a second
portion 152m, and a third portion 392m; with locking features 396m
and 398m configured to releasably lock the first portion 150m to
the second portion 152m until the third portion 392m has reached a
sufficiently distal position relative to the second portion 152m to
compress the first spring 402m and store enough energy in the
spring 402m to drive insertion of the sensor 138 (and in some
embodiments the needle 156) into the skin of a host; locking
features 408m and 410m configured to lock the third portion 392m to
the second portion 152m (e.g., to prevent proximal movement of the
third portion 392m relative to the second portion 152m) in response
to the third portion 392m reaching a sufficiently distal position
relative to the second portion 152m; unlocking features 404m and
406m configured to unlock the locking features 396m and 398m at
least after the third portion 392m is locked to the second portion
152m and/or the first spring 402m is sufficiently compressed;
locking features 412m and 414m configured to lock the first portion
150m to the second portion 152m in response to the first portion
150m reaching a sufficiently distal position relative to the second
portion 152m to drive the sensor 138 (and in some embodiments the
needle 156) into the skin of the host; and a needle retraction
mechanism 158m configured to unlock the needle hub 162m from the
first portion 150m (e.g., to allow proximal movement of the needle
hub 162m with respect to the first portion 150m) at least once the
needle hub 162m has reached a sufficiently distal position and
thereby enable a second spring 234m to retract the needle 156).
[0597] FIG. 71 illustrates a cross-sectional perspective view of
the applicator system 104m in a resting state (e.g., as provided to
the consumer, before activation by the user and deployment of the
applicator system). As illustrated in the figure, the first spring
402m can be neither in tension nor compression, such that the first
spring is substantially unenergized. In some embodiments, the first
spring 402m can be slightly in tension or slightly in compression
(e.g., neither tensioned nor compressed by more than 15 percent) in
a resting state, such that the first spring is substantially or
mostly unenergized in the resting state. In some embodiments, the
first spring can be effectively unenergized, e.g. can be minimally
energized but not to an extent that would create any type of chain
reaction in the system, in a resting state.
[0598] In the embodiment illustrated in FIGS. 71-75, the first
spring 402m is integrally formed as part of the third portion 392m.
In some embodiments, the first spring 402m can be integrally formed
as part of other components of the system 104m, such as, but not
limited to, the first portion 150m, second portion 152m, etc. An
integrally formed spring such as the one illustrated in FIGS. 71-75
offers advantages including the reduction in the number of parts in
a system as well as the reduction in the amount of assembly
processes. The first spring 402m can be molded plastic. As
illustrated in FIG. 71, in the resting state, the second spring
234m is also substantially unenergized (e.g., neither tensioned nor
compressed by more than 15 percent). The second spring 234m is
integrally formed as part of the needle hub 162m. In some
embodiments, the second spring 234m can be integrally formed as
part of other components of the system 104m, such as, but not
limited to, the first portion 150m, second portion 152m, base 128,
etc. The second spring 234m can be molded plastic. Such a
configuration can simplify manufacture and assembly of the system
104m, while avoiding detrimental relaxation and/or creep of the
first spring 402m, the second spring 234m, or other components of
the system 104m during storage and/or before deployment. It is also
contemplated that in other embodiments, the first spring 402m
and/or the second spring 234m can comprise metal.
[0599] In some embodiments, first spring 402m and/or second spring
234m can comprise a molded plastic, such as, but not limited to:
polycarbonate (PC), acrylonitrile butadiene styrene (ABS), PC/ABS
blend, Nylon, polyethylene (PE), polypropylene (PP), and Acetal. In
some embodiments, first spring 402m and/or second spring 234m have
a spring constant less than 10 lb/inch.
[0600] Applicator system 104 may be energized by moving one
component relative to another. For example, moving the third
portion 392m distally relative to the second portion 152m, when the
second portion 152m is placed against the skin of a host or another
surface can store energy in the first spring 402m as it compresses
against first portion 150m. The third portion 392m may be moved
distally until the locking features 408m and 410m (see FIG. 73)
engage together. In some embodiments, the third portion 392m may be
moved further distally until unlocking features 404m engages
locking feature 396m. Unlocking feature 404m may engage and release
locking feature 396m and allow first portion 150m to move distally.
In some embodiments, locking features 408m and 410m couple together
before locking feature 396m is disengaged from locking feature
398m. In other embodiments, unlocking feature 404m engages locking
feature 396m and causes locking feature 396m to disengage from
locking feature 398m, locking features 408m and 410m may couple
together. In some embodiments, locking feature 408m is a protrusion
featuring a hook portion, locking feature 410m is a hole featuring
an angled surface, unlocking feature 404m is a distal protrusion
featuring an angled surface, locking feature 396m is a hook
featuring a ramp 406m, and locking feature 398m is an aperture. The
sensor module 134 remains in a proximal starting position while the
first spring 402m is being energized.
[0601] FIG. 72 illustrates a cross-sectional perspective view of
the applicator system 104m, with the first spring 402m compressed
and with the unlocking features 404m and 406m engaged so as to
unlock the first portion 150m from the second portion 152m. Until
the first portion 150m is unlocked from the second portion 152m,
the sensor module 134 remains at its proximal starting position,
and the second spring 234m remains substantially unenergized. FIG.
73 illustrates a rotated cross-sectional perspective view of the
applicator system 104m, and shows the locking features 408m and
410m engaged to prevent proximal movement of the third portion 392m
with respect to the second portion 152m. In some embodiments, as
illustrated in FIG. 73, the system can include a secondary locking
feature 409m which is configured to cooperate with the opening 410m
to prevent the third portion 392 from falling off or otherwise
separating from the remainder of the system 104m prior to
deployment.
[0602] FIG. 74 illustrates a cross-sectional perspective view of
the applicator system 104m, with the system 104m having been
activated by the disengagement of the first portion 150m with
respect to the second portion 152m. As can be seen in FIG. 74, once
the first portion 150m and the second portion 152m are disengaged
or released, the potential energy stored in the first spring 402m
drives the first portion 150m in a distal direction along with the
needle hub 162m and the sensor module 134. This movement compresses
the second spring 234m and deploys the needle 156 and the sensor
module 134 distally to a distal insertion position in which the
sensor module 134 is coupled to the base 128 and the needle 156
extends distally of the base 128. Once the needle 156 and the
sensor module 134 reach the distal insertion position, the locking
features 412m, 414m (see FIG. 73) engage to prevent proximal
movement of the first portion 150m with respect to the second
portion 152m, and the unlocking features of the needle retraction
mechanism 158m (e.g., the proximal protrusions 170m, the release
feature 160m, and the latch 236m comprising ends 164m of the
release feature 160m and overhangs 166m of the first portion 150m)
cooperate to release the latch 236m. Optionally, the user may hear
a click after the second spring 243m is activated, which may
indicate to the user that the cap is locked in place.
[0603] Once the latch 236m is released, the potential energy stored
in the compressed second spring 234m drives the needle hub 162m
back in a proximal direction, while the first portion 150m remains
in a distal deployed position along with the sensor module 134. The
potential energy stored can be between 0.25 pounds to 4 pounds. In
preferred embodiments, the potential energy stored is between about
1 to 2 pounds. FIG. 75 illustrates a cross-sectional perspective
view of the applicator system 104m with the sensor module 134 in a
distal deployed position, coupled to the base 128, and with the
needle hub 162m retracted to a proximal retracted position.
[0604] Systems configured in accordance with embodiments may
provide an inherently safe and shelf stable system for insertion of
a sensor. An unloaded (i.e. substantially uncompressed and
substantially unactivated) spring may not fire prematurely. Indeed,
such a system is largely incapable of unintentional firing without
direct interaction from a user since the first spring and/or second
spring are substantially un-energized on the shelf. Moreover, it is
contemplated that a system having a substantially uncompressed
spring prior to activation possesses shelf stability since elements
of the system are not exposed to a force or phase change over time
(such as creep, environment, defects from time dependent load
conditions, etc.) as compared to pre-energized insertion devices.
Substantially uncompressed first and second springs can provide a
system where the substantially unenergized first spring 404m is
configured to load energy sufficient to drive a sensor from a
proximal position to a distal position and also to transfer energy
to the second spring 234m to drive a needle to a fully retracted
position.
[0605] Other embodiments can also be configured to achieve these
benefits. For example, FIGS. 76-79 illustrate another embodiment of
a system 104n for applying an on-skin sensor assembly to skin of a
host. The system 104n includes many features that are similar to
those of the embodiment illustrated in FIGS. 71-75 (e.g., a
telescoping assembly 132n including a first portion 150n, a second
portion 152n, and a third portion 392n; a needle hub 162n; a first
spring 402n; and a second spring 234n). In the embodiment
illustrated in FIGS. 76-79, the first spring 402n is formed
separately from and operatively coupled to the third portion 392n.
The second spring 234n is formed separately from and operatively
coupled to the needle hub 162n. The first spring and/or the second
spring can each comprise a helical spring having a circular cross
section. In some embodiments, the first spring and/or the second
spring can each comprise a helical spring having a square or
non-circular cross section. The first spring and/or the second
spring can comprise metal, such as, but not limited to, stainless
steel, steel, or other types of metals. Alternatively, in some
embodiments, one or both of the first spring and the second spring
can be integrally formed with a portion of the applicator assembly.
For example and without limitation, in some embodiments the first
spring can be integrally formed with the first portion. In some
embodiments, the second spring can be integrally formed with the
needle hub. In several embodiments, the first spring and/or the
second spring can be molded plastic, such as, but not limited to,
PC or ABS.
[0606] FIG. 76 illustrates a cross-sectional side view of the
system 104n in a resting state, in which both the first spring 402n
and the second spring 234n are unstressed and unenergized. In the
resting state, the first portion 150n can be fixed with respect to
the second portion 152n, at least in an axial direction, whereas
the third portion 392n is movable in at least a distal direction
with respect to the first portion 150n. The first portion 150n and
the second portion 152n can be fixed with respect to one another in
any suitable fashion, for example by cooperating releasable locking
features (e.g., the locking features as described in FIGS. 71-75,
or similar features) coupled to or forming part of the first
portion 150n and the second portion 152n. The system 104n includes
an on-skin component 134n which is releasably coupled to the needle
hub 162n. The on-skin component can comprise a sensor module, such
as the sensor module 134 described in connection with FIG. 3, or a
combined sensor module and base assembly, or an integrated sensor
module/base/transmitter assembly, or any other component which is
desirably applied to the skin of a host, whether directly or
indirectly, for example via an adhesive patch.
[0607] In the resting state illustrated in FIG. 76, the on-skin
component 134n is disposed at a proximal starting position, between
the proximal and distal ends of the system 104n. The distal end of
the needle 156 may also be disposed between the proximal and distal
ends of the system 104n. In the resting state, the distal end of
the first spring 402n abuts a proximally-facing surface of the
first portion 150n. The application of force against the
proximally-facing surface of the third portion 392n causes the
third portion 392n to move distally with respect to the first
portion 150n, compressing and thus energizing the first spring
402n. In some embodiments, this process may be similar to the
spring energization process described in connection with FIG.
71.
[0608] FIG. 77 illustrates a cross-sectional side view of the
applicator system of FIG. 76, with the first spring 402n energized.
When the third portion 392n has been moved sufficiently distally to
energize the first spring 402n, the third portion 392n becomes
fixed, at least in an axial direction, with respect to the second
portion 152n. At or about the same time (e.g. simultaneously or
subsequently), the first portion 150n becomes movable in at least a
distal direction with respect to the second portion 152n. The third
portion 392n and the second portion 150n can be fixed with respect
to one another in any suitable fashion, for example by cooperating
locking features (e.g., the locking features described in FIGS.
71-75, or similar features) coupled to or forming part of the third
portion 392n and the second portion 152n, which are configured to
engage with one another once the third portion 392n has reached a
sufficiently distal position. The first portion 150n and the second
portion 152n can be rendered movable with respect to one another by
structure(s) (not shown in FIGS. 76-79) configured to release the
locking features which coupled them together in the resting
configuration illustrated in FIG. 76. The first portion 150n
includes overhangs (sometimes referred to as detents, undercuts,
and/or needle hub engagement features) 166n which cooperate with
release feature 160n of the needle hub 162n to fix the needle hub
162n with respect to the first portion 150n, both while the system
is in a resting state and during energization of the spring
392n.
[0609] FIG. 78 illustrates a cross-sectional side view of the
system 104n, with the first portion 150n and the second portion
152n unlocked, activating the first spring 402n and allowing the
energy stored therein to drive the first portion 150n in a distal
direction. The movement of the first portion 150n also urges the
needle hub 162n (as well as the on-skin component 134n which is
coupled to the needle hub 162n) in a distal direction, compressing
the second spring 234n against a proximally-facing surface of the
second portion 152n, coupling the on-skin component 134n to the
base 128n, and driving the needle 156 into the distal insertion
position illustrated in FIG. 78. When the needle hub 162n has
reached a sufficiently distal position to achieve these functions,
the ends of the release feature 160n contact ramps 170n of the
second portion 152n which cause the release feature 160n to
compress inward (towards the central axis of the system 104n),
disengaging the ends of the release feature 160n from the overhangs
166n. In some embodiments, this process may be similar to the
spring compression process described in connection with FIG. 74. In
some embodiments, ramps 170n are proximally facing ramps. In other
embodiments, ramps 170n are distally facing ramps (not shown). In
some embodiments, the release feature or features can be configured
to be compressed inward (or otherwise released) by relative
rotational movement of certain components of the system, such as,
for example, by twisting or other rotational movement of the first
portion with respect to the second portion. In some embodiments,
the release feature or features can extend in a direction normal to
the axis of the system, and/or can extend circumferentially about
the axis of the system, instead of (or in addition to) extending
generally parallel to the axis of the system as illustrated in FIG.
78.
[0610] FIG. 79 illustrates a cross-sectional side view of the
system 104n, with the needle hub 162n released from engagement with
the overhangs 166, activating the second spring 234n and allowing
the energy stored therein to drive the needle hub 162n in a
proximal direction. As the needle hub 162n retracts to a proximal
position, the on-skin component 134n decouples from the needle hub
162n to remain in a deployed position, coupled to the base
128n.
[0611] FIGS. 80-85 illustrate another embodiment of a system 104p
for applying an on-skin sensor assembly to skin of a host. A sensor
insertion system such as the one illustrated in FIGS. 80-85 may
provide enhanced predictability in spring displacement of the
second energized spring 234p because the second spring 234p is
already compressed. Such a configuration can aid in properly
ensuring the needle is retracted at a sufficient distance from the
skin. In some embodiments, a system incorporating a pre-energized
retraction spring can provide effective and reliable insertion and
retraction while requiring a lesser amount of user-supplied force
than, for example, a system in which both the insertion and
retraction springs are substantially unenergized prior to
deployment, making such a configuration more convenient for at
least some users. Further, in some embodiments, a system
incorporating one or more metal springs can provide effective and
reliable insertion and retraction while requiring a lesser amount
of force than a system in which both the insertion and retraction
springs comprise plastic. The system 104p includes many features
that are similar to those of the embodiment illustrated in FIGS.
76-79 (e.g., a telescoping assembly 132p including a first portion
150p, a second portion 152p, and a third portion 392p; a needle hub
162p; a first spring 402p; a second spring 234p; an on-skin
component 134n, and a base 128p). In the embodiment illustrated in
FIGS. 80-85, the first spring 402p is formed separately from and
operatively coupled to the third portion 392p. The second spring
234p is formed separately from and operatively coupled to the
needle hub 162p. The first spring and/or the second spring can
comprise metal. Alternatively, in some embodiments, one or both of
the first spring and the second spring can be integrally formed
with a portion of the applicator assembly. For example and without
limitation, in some embodiments the first spring can be integrally
formed with the first portion. In some embodiments, the second
spring can be integrally formed with the needle hub. In several
embodiments, the first spring and/or the second spring can be
molded plastic.
[0612] FIG. 80 illustrates a cross-sectional side view of the
system 104p in a resting state, in which the first spring 402p is
substantially unstressed and unenergized, but in which the second
spring 234n is pre-energized (e.g., compressed). In the resting
state illustrated in FIG. 80, the first portion 150p is locked to
the second portion 152p so as to prevent proximal or distal
movement of the first portion 150p with respect to the second
portion 152p. The first portion 150p and the second portion 152n
can be locked together in any suitable fashion, for example by
cooperating releasable locking features 396p and 398p (see FIGS. 84
and 85) coupled to or forming part of the first portion 150p and
the second portion 152p. The needle hub 162n is also releasably
fixed to the first portion 150p. The needle hub 162n can be fixed
to the first portion 150p in any suitable fashion, for example by
features of the first portion 150p configured to engage or compress
release feature (sometimes referred to as needle hub resistance
features) 160p of the needle hub 162p.
[0613] In the resting state illustrated in FIG. 80, the on-skin
component 134p is disposed at a proximal starting position, such
that the distal end of the needle 156 is disposed between the
proximal and distal ends of the system 104p. In the resting state,
the distal end of the first spring 402p abuts a proximally-facing
surface of the first portion 150p. The application of force against
the proximally-facing surface of the third portion 392p causes the
third portion 392p to move distally with respect to the first
portion 150p, compressing and thus energizing the first spring
402p. In some embodiments, this process may be similar to the
spring energization process described in connection with FIG.
76.
[0614] FIG. 81 illustrates a cross-sectional side view of the
system 104p of FIG. 80, after the third portion 392n has been moved
to a sufficiently distally position to energize the first spring
402p and optionally lock the third portion 392p to the second
portion 152p. The third portion 392n and the second portion 150n
can lock together in any suitable fashion, for example by
cooperating locking features (e.g., the locking features described
in FIGS. 76-79, or similar features) coupled to or forming part of
the third portion 392p and the second portion 152p. At or about the
same time as the third portion 392p locks to the second portion
152p (e.g. simultaneously or subsequently), the unlocking features
404p and 406p (see FIGS. 84 and 85) cooperate to release the lock
between the first portion 150p and the second portion 152p.
[0615] FIG. 82 illustrates a cross-sectional side view of the
system 104p, with the first spring 402p activated to drive the
first portion 150p in a distal direction. The movement of the first
portion 150p also urges the needle hub 162p (as well as the on-skin
component 134p which is coupled to the needle hub 162p) in a distal
direction, coupling the on-skin component 134p to the base 128p,
and also driving the needle 156 in a distal direction, past a
distal end of the system 104p. At or about the time the needle hub
162p reaches the distal insertion position illustrated in FIG. 82
(e.g., immediately before, simultaneously, or subsequently), the
ends of the release feature 160p contact ramps 170p of the second
portion 152p, causing the release feature 160p to compress inward
(towards the central axis of the system 104p), unlocking the needle
hub 162p from the first portion 150p and releasing or activating
the second spring 234p. In some embodiments, ramps 170p are
proximally facing ramps. In other embodiments, ramps 170p are
distally facing ramps (not shown). Activation of the second spring
234p urges the needle hub 162p in a proximal direction.
[0616] FIG. 83 illustrates a cross-sectional side view of the
system 104p, with the needle hub 162p unlocked from the first
portion 150p and retracted to a proximal position. As the needle
hub 162p retracts to a proximal position, the on-skin component
134p decouples from the needle hub 162p to remain in a deployed
position, coupled to the base 128p.
[0617] FIG. 84 illustrates a perspective view of the system 104p in
a resting state, with the first portion 150p and the third portion
392p shown in cross section to better illustrate certain portions
of the system 104p, such as the locking features 396p, 398p and the
unlocking features 404p, 406p. FIG. 85 illustrates another
perspective view of the system 104p, also with the first portion
150p and the third portion 392p shown in cross section, with the
first spring 402p energized but not yet activated.
[0618] FIGS. 86-88 illustrate another embodiment of a system 104q
for applying an on-skin sensor assembly to skin of a host, wherein
the insertion spring is pre-compressed and the retraction spring is
substantially uncompressed. Such a system may allow a user to
activate the insertion and retraction of a needle with fewer steps.
It is contemplated that advantages may include a relatively smaller
applicator size and more predictable spring displacement of the
first spring because the first spring is already compressed,
thereby aiding in ensuring proper needle insertion into the skin of
a user. In some embodiments, a system incorporating a pre-energized
insertion spring can provide effective and reliable insertion and
retraction while requiring a lesser amount of user-supplied force
than, for example, a system in which both the insertion and
retraction springs are substantially unenergized prior to
deployment, making such a configuration more convenient for at
least some users. The system 104q includes many items that are
similar to those of the embodiment illustrated in FIGS. 76-79
(e.g., a telescoping assembly 132q including a first portion 150q,
a second portion 152q, and a third portion 392q; a needle hub 162q;
a first spring 402q; a second spring 234q; an on-skin component
134q, and a base 128q). In the system 104q, the first spring 402q
is formed separately from and operatively coupled to the third
portion 392q. The second spring 234q is formed separately from and
operatively coupled to the needle hub 162q. The first spring and/or
the second spring can comprise metal. Alternatively, in some
embodiments, one or both of the first spring and the second spring
can be integrally formed with a portion of the applicator
assembly.
[0619] FIG. 86 illustrates a cross-sectional side view of the
system 104q in a resting state, in which the first spring 402q is
already energized but in which the second spring 234q is
substantially unenergized (e.g. mostly uncompressed or unstressed;
can be partially energized). In the resting state illustrated in
FIG. 86, the first portion 150q is locked to the second portion
152q so as to prevent proximal or distal movement of the first
portion 150q with respect to the second portion 152q. The first
portion 150q and the second portion 152q can be locked together in
any suitable fashion, for example by cooperating releasable locking
features (e.g., the locking features described in FIGS. 76-79 or
other suitable locking features) coupled to or forming part of the
first portion 150q and the second portion 152q. The needle hub 162q
is also releasably locked to the first portion 150q. The needle hub
162q can be locked to the first portion 150q in any suitable
fashion, for example by features of the first portion 150q
configured to engage or compress release feature 160q of the needle
hub 162q. The third portion 392q and the second portion 152q are
also locked together, so as to prevent relative movement of the
third portion 392p and the second portion 152q in the axial
direction. The third portion 392q and the second portion 152q can
be locked together in any suitable fashion, for example by
cooperating locking features (not shown in FIGS. 86-89), which may
be coupled to or form part of the third portion 392q and the second
portion 152q. In the resting state illustrated in FIG. 80, the
on-skin component 134q is disposed at a proximal starting position,
such that the distal end of the needle 156 is disposed between the
proximal and distal ends of the system 104q.
[0620] To trigger deployment of the system 104q, the locking
features coupling the first portion 150q to the second portion 152q
can be unlocked, decoupling these two portions and thereby
releasing or activating the first spring 402q. The locking features
can be unlocked by a user-activated trigger mechanism, such as, for
example, a button disposed on or in a top or side surface of the
system 104q, or a twist-release feature configured to disengage the
locking features when the third portion 392q is rotated about the
axis of the system, relative to the first portion 150q and/or the
second portion 152q. Some examples of triggering mechanisms are
described in connection with FIGS. 92-104.
[0621] FIG. 87 illustrates a cross-sectional side view of the
system 104q, after the first portion 150q and the second portion
152q have been unlocked. As can be seen in FIG. 87, the first
spring 402q drives the first portion 150q in a distal direction as
the first spring 402q expands. The movement of the first portion
150q also urges the needle hub 162q (as well as the on-skin
component 134q which is coupled to the needle hub 162q) in a distal
direction, coupling the on-skin component 134q to the base 128q,
compressing the second spring 234q, and driving the needle 156 in a
distal direction past a distal end of the system 104q. At or about
the time the needle hub 162q reaches the distal insertion position
illustrated in FIG. 87 (e.g., immediately before, simultaneously,
or subsequently), the ends of the release feature 160q contact
interference features 170q of the second portion 152q, causing the
release feature 160q to compress inward (towards the central axis
of the system 104q), unlocking the needle hub 162q from the first
portion 150q and activating the now-energized second spring 234q.
In some embodiments, interference features 170q are proximally
facing interference features. In other embodiments, interference
features 170q are distally facing interference features (not
shown).
[0622] Activation of the second spring 234q by the user or
mechanisms urges the needle hub 162q in a proximal direction, while
the on-skin component 134q, having been coupled to the base 128q,
remains in a deployed distal position. FIG. 88 illustrates a
cross-sectional side view of the system 104q, with the on-skin
component 134q in a deployed position and the needle hub 162q
retracted to a proximal position.
[0623] FIGS. 89-91 illustrate another embodiment of a system 104r
for applying an on-skin sensor assembly to skin of a host. It is
contemplated that the system 104r as illustrated with reference to
FIGS. 89-91 provides for predictable spring displacement of the
first spring 402r because it is compressed, thereby aiding in
proper needle insertion into the skin of the user. Moreover, it is
contemplated that the compressed second spring 234r provides
predictable spring displacement and aids in properly ensuring that
the needle is properly retracted from the skin of the user. In some
embodiments, a system incorporating pre-energized insertion and
retraction springs can provide effective and reliable insertion and
retraction while requiring a lesser amount of user-supplied force
than, for example, a system in which one or both of the insertion
and retraction springs are substantially unenergized prior to
deployment, making such a configuration more convenient for at
least some users. The system 104r includes many items that are
similar to those of the embodiment illustrated in FIGS. 76-79
(e.g., a telescoping assembly 132r including a first portion 150r,
a second portion 152r, and a third portion 392r; a needle hub 162r;
a first spring 402r; a second spring 234r; an on-skin component
134r, and a base 128r). As illustrated in FIGS. 89-91, both the
first spring 402r and the second spring 234r are pre-compressed. In
the system 104r, the first spring 402r is formed separately from
and operatively coupled to the third portion 392r. The second
spring 234r is formed separately from and operatively coupled to
the needle hub 162r. The first spring and/or the second spring can
comprise metal. Alternatively, in some embodiments, one or both of
the first spring and the second spring can be integrally formed
with a portion of the applicator assembly.
[0624] FIG. 89 illustrates a cross-sectional side view of the
system 104r in a resting state, in which both the first spring 402r
and the second spring 234r are pre-energized (e.g., compressed
sufficiently to drive the needle insertion and retraction
processes). In the resting state illustrated in FIG. 89, the first
portion 150r is locked to the second portion 152r so as to prevent
proximal or distal movement of the first portion 150r with respect
to the second portion 152r. The first portion 150r and the second
portion 152r can be locked together in any suitable fashion, for
example by cooperating releasable locking features (e.g., the
locking features described in connection with FIGS. 80-83, or other
suitable locking features) coupled to or forming part of the first
portion 150r and the second portion 152r. The needle hub 162r is
also releasably locked to the first portion 150r. The needle hub
162r can be locked to the first portion 150r in any suitable
fashion, for example by features of the first portion 150r
configured to engage or compress release feature 160r of the needle
hub 162r. The third portion 392r and the second portion 152r are
also locked together, so as to prevent relative movement of the
third portion 392p and the second portion 152r in at least the
axial direction. The third portion 392r and the second portion 152r
can be locked together in any suitable fashion, for example by
cooperating locking features (not shown in FIGS. 89-91), which may
be coupled to or form part of the third portion 392r and the second
portion 152r. In the resting state illustrated in FIG. 89, the
on-skin component 134r is disposed at a proximal starting position,
such that the distal end of the needle 156 is disposed between the
proximal and distal ends of the system 104r.
[0625] To trigger deployment of the system 104r, the locking
features coupling the first portion 150r to the second portion 152r
can be unlocked, decoupling these two portions and thereby
releasing or activating the first spring 402r. FIG. 90 illustrates
a cross-sectional side view of the system 104r, after the first
portion 150r and the second portion 152r have been unlocked. As can
be seen in FIG. 90, the first spring 402r drives the first portion
150r in a distal direction as the first spring 402r expands or
decompresses. The movement of the first portion 150r also urges the
needle hub 162r (as well as the on-skin component 134r which is
coupled to the needle hub 162r) in a distal direction until the
on-skin component 134r is coupled to the base 128r, and until the
needle 156 reaches a distal insertion position beyond a distal end
of the system 104r. At or about the time the needle hub 162r
reaches the distal insertion position illustrated in FIG. 87 (e.g.,
immediately before, simultaneously, or subsequently), the ends of
the release feature 160r contact corresponding interference
features 170r of the second portion 152r, causing the release
feature 160r to compress inward (towards the central axis of the
system 104r), unlocking the needle hub 162r from the first portion
150r and releasing or activating the second spring 234r.
[0626] Activation of the second spring 234r drives the needle hub
162r in a proximal direction, while the on-skin component 134r,
having been coupled to the base 128r, remains in a deployed distal
position. FIG. 91 illustrates a cross-sectional side view of the
system 104r, with the on-skin component 134r in a deployed position
and the needle hub 162r retracted to a proximal position. From this
configuration, the system 104r can be removed and separated from
the deployed on-skin component 134r and the base 128r.
[0627] FIGS. 92-100 illustrate yet another embodiment of a system
104s for applying an on-skin sensor assembly to skin of a host
comprising a safety feature to prevent accidental firing of the
sensor insertion device. The system 104s includes many items that
are similar to those of the embodiment illustrated in FIGS. 76-79
(e.g., a telescoping assembly 132s including a first portion 150s,
a second portion 152s, and a third portion 392s; a needle hub 162s;
a first spring 402s; a second spring 234s; an on-skin component
134s, and a base 128s). In the system 104s, the first spring 402s
may be formed separately from and operatively coupled to the third
portion 392s. The second spring 234s may be formed separately from
and operatively coupled to the needle hub 162s. The first spring
and/or the second spring can comprise metal. Alternatively, in some
embodiments, either or both of the first spring and the second
spring can be integrally formed with a portion of the applicator
assembly.
[0628] FIG. 92 illustrates a side view of the system 104s in a
resting state, in which the first spring 402s is unstressed and
unenergized, but in which the second spring 234s is already
energized (e.g., compressed). The system 104s includes a cocking
mechanism 702 by which the first spring 402s can be energized (e.g.
compressed) without automatically triggering deployment of the
first portion 150s or activation of the first spring 402s. The
system 104s also includes a trigger button 720 configured to
activate the first spring 402s after the system is cocked. FIG. 93
illustrates a side view of the applicator system 104s, after being
cocked but before being triggered.
[0629] FIG. 94 illustrates a cross-sectional perspective view of
the system 104s in a resting state, showing the first spring 402s
substantially uncompressed. The cocking mechanism 702 includes a
pair of proximally-extending lever arms 704, each with a
radially-extending angled tab 706. In some embodiments, the lever
arms 704 can be integrally formed with the second portion 152s, as
shown in FIG. 94, while in other embodiments, the lever arms 704
can be separate from and operatively coupled to the second portion
152s. In the resting state illustrated in FIG. 94, the angled tabs
706 extend through distal apertures 708 in the third portion 392s
so as to prevent proximal movement of the third portion 392s with
respect to the second portion 152s. The angled tabs 706 are also
configured to inhibit distal movement of the third portion 392s
with respect to the second portion 152s, unless and until a
sufficient amount of force is applied to the third portion 392s to
deflect the angled tabs 706 and the lever arms 704 inward, as
illustrated in FIG. 95.
[0630] As sufficient force is applied to the third portion 392s in
a distal direction (e.g. by the hand or thumb of a user), the
angled tabs 706 deflect inward and release from engagement with the
distal apertures 708, allowing the third portion 392s to move
distally with respect to the second portion 152s. This may allow
the user to compress and energize the first spring 402s. When the
third portion 392s has reached a sufficiently distal position to
compress the first spring 402s enough to drive the sensor into the
skin of a host, the angled tabs 706 engage with proximal apertures
710 of the third portion 392s to lock the position of the third
portion 392s with respect to the second portion 152s, as
illustrated in FIG. 96. The angled tabs 706 may be configured to
generate a "click" sound when engaged to proximal apertures 710 so
as to prevent proximal movement of the third portion 392s with
respect to the second portion 152s, so that a user can feel and/or
hear when these parts are engaged. In the configuration illustrated
in FIG. 96, the system 104s is energized in which the third portion
392 is in a cocked position. The system 104s is ready to deploy the
sensor, but does not deploy until further action is taken by the
user.
[0631] FIG. 97 illustrates a cross-sectional side view of the
system 104s, in a cocked but untriggered state. In this state, the
first portion 150s is locked to the second portion 152s so as to
prevent proximal or distal movement of the first portion 150s with
respect to the second portion 152s. The first portion 150s and the
second portion 152s can be locked together in any suitable fashion,
for example by cooperating releasable locking features 396s and
398s operatively coupled to or forming part of the first portion
150s and the second portion 152s. The trigger button 720 includes a
distally-extending protrusion 722 which, once depressed to a
sufficiently distal position by a user, is configured to cooperate
with an unlocking feature 406s of the locking feature 396s to
decouple the first portion 150s from the second portion 152s. The
trigger button 720 can be operatively coupled to the third portion
392s, as illustrated in FIGS. 92-100, or can be integrally formed
with the third portion, for example as a lever arm formed within a
proximal or side surface of the third portion. In some embodiments,
the trigger button can be disposed at the top of the system (such
that the application of force in the distal direction triggers the
system to activate), or at a side of the system (such that the
application of force in a radially inward direction, normal to the
direction of needle deployment, triggers system to activate).
[0632] FIG. 98 illustrates a cross-sectional side view of the
energized system 104s as the trigger button 720 has been depressed
sufficiently to cause the protrusion 722 to flex the locking
feature 396s radially inward, disengaging it from the opening 398s
and unlocking the first portion 150s from the second portion 152s.
Depressing the trigger button 720 thus activates the first spring
402, pushing the first portion 150s and the needle hub 162s, along
with the on-skin component 134s which is coupled thereto, in a
distal direction until the on-skin component is coupled to the base
128s, as illustrated in FIG. 99. At or about the time the needle
hub 162s reaches the distal insertion position illustrated in FIG.
99 (e.g., immediately before, simultaneously, or subsequently),
corresponding release features of the needle hub 162s and the first
portion 150s can engage (via, for example, the release features
described in any of FIGS. 76-91, or any other suitable release
features), releasing the needle hub 162s from the first portion
150s and releasing or activating the second spring 234s. Activation
of the second spring 234s urges the needle hub 162s in a proximal
direction.
[0633] FIG. 100 illustrates a cross-sectional side view of the
applicator system of FIG. 92, with the on-skin component 134s in a
deployed position and the needle hub 162s retracted to a proximal
position. As the needle hub 162s retracts to a proximal position,
the on-skin component 134s decouples from the needle hub 162s to
remain in a deployed position, coupled to the base 128s. From this
configuration, the remainder of the system 104s can be removed and
separated from the deployed on-skin component 134s and the base
128s.
[0634] Any of the features described in the context of any of FIGS.
61-99 can be applicable to all aspects and embodiments identified
herein. For example, the embodiments described in the context of
FIGS. 61-64 can be combined with the embodiments described in the
context of FIGS. 1-60 and 65-70. As another example, any of the
embodiments described in the context of FIGS. 92-109 can be
combined with any of the embodiments described in the context of
FIGS. 1-60 and 65-91 and 110-143. Moreover, any of the features of
an embodiment is independently combinable, partly or wholly with
other embodiments described herein in any way, e.g., one, two, or
three or more embodiments may be combinable in whole or in part.
Further, any of the features of an embodiment may be made optional
to other aspects or embodiments. Any aspect or embodiment of a
method can be performed by a system or apparatus of another aspect
or embodiment, and any aspect or embodiment of a system can be
configured to perform a method of another aspect or embodiment.
Trigger Mechanisms and Safety Locks
[0635] In some embodiments, the application of enough force to
sufficiently energize the first spring to drive insertion of the
sensor can also serve to activate the first spring. In other
embodiments, the energizing of the first spring can be decoupled
from the activation of the first spring, requiring separate actions
on the part of the user to energize (e.g. compress) the first
spring and to trigger deployment of the system.
[0636] For example, the embodiment illustrated in FIGS. 92-100
includes a trigger mechanism in the context of a user-energized
actuator. In such an embodiment, the user first cocks the system
104s to energize the first spring 402s, and then, in a separate
action, triggers the activation of the first spring 402s using the
trigger button 720. The locking feature is easy to release by the
user and when combined with a trigger mechanism, allows for single
handed use.
[0637] In some embodiments, the actuator or insertion spring is
already energized when the system is in a resting state. In these
embodiments, a trigger mechanism, such as the trigger mechanism
described in the context of FIGS. 92-100, can be used to activate
the already-energized insertion spring without any action by the
user to energize the spring.
[0638] FIG. 101 illustrates a side view of one such applicator
system 104t, with a side trigger button 730. The system 104t can be
configured substantially similar to the system 104q or the system
104r illustrated within the context of FIGS. 86-88 and 89-91,
respectively, with like reference numerals indicating like parts.
As can be seen in FIG. 101, the trigger button 730 is operatively
coupled to the third member 392t.
[0639] FIG. 102 illustrates another side view of the system 104t,
with the first portion 150t and the third portion 392t shown in
cross-section to illustrate the trigger mechanism. As can be seen
in FIG. 102, the trigger button 730 includes a protrusion 732 that
extends radially inward, toward a central axis of the system 104t.
The protrusion 732 is radially aligned with the locking feature
396t of the first portion 150t. When a user exerts a sideways
(e.g., radially inward) force on the trigger button 730, the
protrusion 732 urges the locking feature 396t radially inward,
releasing it from engagement with the ledge feature 398t (which may
be configured similarly to, for example, the ledge locking feature
398p illustrated in FIGS. 84 and 85) in the second portion 152t and
activating the first spring 402t. In other embodiments, the locking
features 396, 398 can comprise cooperating structure of a
key/keyway mechanism which is configured to release when the
features 396, 398 are brought into a certain orientation with
respect to one another (e.g., using a radially applied force, an
axially applied force, a twisting movement or rotational force, or
other type of activation).
[0640] FIG. 103 illustrates a side view of another applicator
system 104u, with an integrated side trigger button 730. The system
104u can be configured substantially similar to the system 104q or
the system 104r illustrated within the context of FIGS. 86-88 and
89-91, respectively, with like reference numerals indicating like
parts. As can be seen in FIG. 103, the trigger button 740 is a
distally-extending lever arm integrally formed in the third member
392u. FIG. 104 illustrates another side view of the system 104u,
with the first portion 150u and the third portion 392u shown in
cross-section to better illustrate the trigger mechanism. As can be
seen in FIG. 104, the trigger button 740 is radially aligned with a
radially-extending tab 742 of the first portion 150u. The tab 742
is connected to the locking feature 396u via an elongated member
394u, which acts as a lever arm. In some embodiments, tab 742
locking feature 396u, and elongated member 394u are integrally
formed together. When a user exerts a sideways (e.g., radially
inward) force on the trigger button 740, the button 740 pushes the
tab 742 radially inward, releasing the locking feature 396u from
engagement with the locking feature 398u in the second portion 152u
and activating the first spring 402u.
[0641] Trigger mechanisms such as those described in the context of
any of FIGS. 92-104 can be used in embodiments comprising
pre-energized actuators or insertion springs, as well as in
embodiments comprising user-energized actuators or insertion
springs.
[0642] In several embodiments, a sensor inserter system can include
a safety mechanism configured to prevent premature energizing
and/or actuation of the insertion spring. FIGS. 105-109 illustrate
one such system 104v, which incorporates a safety lock mechanism
750. FIG. 105 illustrates a perspective view of the system 104v.
The system 104v can be configured substantially similar to any of
the systems 104m, 104n, 104p illustrated within the context of
FIGS. 71-87, with like reference numerals indicating like parts.
The safety lock mechanism 750 includes a release button 760, which
can be integrally formed with the third portion 392v as shown in
FIG. 105 (similar to the trigger button 740 described in connection
with FIGS. 103-104), or which can be operatively coupled to the
third portion 392v. In the system 104v, the release button 760
comprises a lever arm which is integrally formed in a side of the
third portion 392v, although other configurations (e.g. a top
button) are also contemplated. The release button can be configured
to protrude radially from a side or a top of the third portion, or
can be configured with an outer surface which is flush with the
surrounding surface of the third portion 392v.
[0643] FIG. 106 illustrates a cross-sectional perspective view of a
portion of the system 104v, with the safety mechanism 750 in a
locked configuration and the first spring 402v unenergized. The
safety mechanism 750 includes a proximally-extending locking tab
752 of the second portion and an inwardly-extending overhang (or
undercut) 754 of the third portion 392v. In the locked
configuration illustrated in FIG. 106, the tab 752 is flexed
radially outward and its proximal end is constrained by the
overhang 754, preventing distal movement of the third portion 392v
with respect to the second portion 152v and thus preventing
energization of the spring 392v. The release button 760 includes a
protrusion 758 which extends inwardly, in radial alignment with a
portion of the tab 752. A lateral (e.g. radially inward) force
applied to the release button 760 pushes the tab 752 radially
inward, sliding the proximal end of the tab 752 against an angled
surface 756 of the overhang 754 and out of engagement with the
overhang 754, so that the tab 752 can release to an unstressed
configuration as shown in FIG. 108. Once the tab 752 is released,
the third portion 392v can be moved distally with respect to the
second portion 152v, for example to energize the first spring 402v.
In some embodiments, as illustrated in FIG. 109, the tab 752 can be
configured to prevent further distal movement of the third portion
392v beyond a desired threshold, for example by abutting a
distally-facing surface 762 of the third portion 392v.
[0644] Although the safety lock mechanism 750 is illustrated in the
context of a system configured to be energized by a user, in some
embodiments, a pre-energized system can also employ a safety lock
mechanism, for example to prevent premature triggering or
activation of an already energized spring.
[0645] In some embodiments, the locking and unlocking (and/or
coupling and decoupling) of the components of a sensor inserter
assembly can follow this order: The sensor inserter assembly begins
in a resting state in which the third portion 392 is locked with
respect to the first portion 150, the first portion 150 is locked
with respect to the second portion 152, and the sensor module 134
is coupled to the first portion 150 (optionally via the needle hub
162). Before energizing or triggering of the insertion spring 402,
the third portion 392 is unlocked with respect to the first portion
150 and/or the second portion 150. The insertion spring 402, if not
already energized, is then energized by distal movement of the
third portion 392. Then, the third portion 392 is locked with
respect to the second portion 152. The first portion 150 is then
released from the second portion 152 to activate the insertion
spring 402. As the insertion spring 402 deploys, the sensor module
134 couples to the base 128. Then the first portion 150 (and/or the
needle hub 162) releases the sensor module 134, and the second
portion 152 releases the base 128. In several embodiments, the
locations of the various locking and unlocking (and/or coupling and
decoupling) structures along the axis of the assembly are optimized
to ensure this order is the only order that is possible. (Some
embodiments use different locking and unlocking orders of
operation.)
[0646] Systems such as those illustrated in FIGS. 92-109 provide
reliable trigger mechanisms to release an insertion spring when the
insertion spring is in a loaded condition. It is contemplated such
systems provide several advantages to the user including ease in
firing, single handed firing (by allowing the user to hold onto the
sides of the insertion device and fire the insertion device using
the same hand). It is contemplated that a system comprising a top
trigger can provide a smaller width profile than a system having a
side button while requiring less user dexterity.
Release after Deployment
[0647] In several embodiments, a sensor inserter system is
configured to move an on-skin component (such as, for example, a
sensor module 134, a sensor assembly (for example comprising a
sensor, electrical contacts, and optionally a sealing structure), a
combination sensor module and base, an integrated sensor module and
transmitter, an integrated sensor module and transmitter and base,
or any other component or combination of components which is
desirably attached to the skin of a host) from a proximal starting
position within the sensor inserter system to a distal deployed
position in which it can attach to the skin of a host, while at the
same time inserting a sensor (which may form part of the on-skin
component) into the skin of the host. In some embodiments, the
sensor is coupled to electrical contacts of the on-skin component
during the deployment and/or insertion process. In other
embodiments, the on-skin component is pre-connected, that is to
say, the sensor is coupled to electrical contacts of the on-skin
component before the deployment and/or insertion processes begin.
The sensor assembly can be pre-connected, for example, during
manufacture or assembly of the system.
[0648] Thus, in several embodiments, a sensor inserter system can
be configured to releasably secure the on-skin component in its
proximal starting position, at least before or until deployment of
the inserter system, and can also be configured to release the
on-skin component in a distal position after the inserter system is
deployed. In some embodiments, the system can be configured to
couple the on-skin component to a base and/or to an adhesive patch
during the deployment process, either as the on-skin component is
moved from the proximal starting position to the distal deployed
position or once it reaches the distal deployed position. In some
embodiments, the system can be configured to separate from (or
become separable from) the on-skin component, base, and/or adhesive
patch after the on-skin component is deployed in the distal
position and the needle hub (if any) is retracted.
[0649] In embodiments, various mechanical interlocks (e.g., snap
fits, friction fits, interference features, elastomeric grips)
and/or adhesives can be used to couple the on-skin component to the
sensor inserter system and releasably secure it in a proximal
starting position, and/or to couple the on-skin component (and
base, if any) to the adhesive patch once the on-skin component is
deployed. In addition, various mechanical features (e.g. snap fits,
friction fits, interference features, elastomeric grips, pushers,
stripper plates, frangible members) and/or adhesives can be used to
decouple the on-skin component from the sensor inserter system once
it reaches the distal deployed position. Further, various
mechanical features, (e.g. snap fits, friction fits, interference
features, elastomeric grips, pushers, stripper plates, frangible
members) and/or adhesives can be used to separate, unlock, or
otherwise render separable the on-skin component, base, and/or
adhesive patch from the remainder of the system after the on-skin
component is deployed in the distal position and the needle hub (if
any) is retracted.
[0650] With reference now to FIGS. 110-119, a sensor inserter
system 104w according to some embodiments is illustrated. The
system 104w can be configured substantially similar to the system
104v illustrated within the context of FIGS. 105-109 and system
104m illustrated within the context of FIGS. 71-75, with like
reference numerals indicating like parts. The system 104w includes,
for example, a telescoping assembly 132w including a first portion
150w, a second portion 152w, and a third portion 392w; a safety
mechanism 750, a needle hub 162w; a first spring 402w; a second
spring 234w; an on-skin component 134w, and a base 128w.
[0651] FIG. 110 illustrates a cross-sectional perspective view of
the system 104w in a resting and locked state, with the on-skin
component 134w secured in a proximal starting position. In this
state, as well as in the unlocked state illustrated in FIG. 111 and
the energized state illustrated in FIG. 112, the on-skin component
134w is secured in the proximal starting position by a securement
member 800. As can be seen in FIG. 110, the system 104w includes a
secondary locking feature 409w, configured as a ledge extending
from the distal end of the locking protrusion 408w, which is
configured to cooperate with an opening 410w to prevent the third
portion 392 from moving in a proximal direction with respect to the
second portion 152w prior to deployment. In the embodiment
illustrated in FIGS. 110-119, the securement member 800 is
integrally formed with the needle hub 162w. In other embodiments,
the securement member can be integrally formed with the first
portion 150w. In still other embodiments, the securement member can
be separately formed from and operatively coupled to the needle hub
162w and/or to the first portion 150w. The securement member 800
extends substantially parallel to the needle 158. In the embodiment
illustrated in FIGS. 110-119, the securement member 800 comprises a
pair of distally-extending legs 802 (see FIGS. 115 and 116). Some
embodiments can, however, include only one distally-extending leg
802, while others can include three, four, or more legs 802. In
embodiments comprising only one leg 802, the leg can be configured
to adhere or otherwise couple to a center region or a perimeter of
the on-skin component. In embodiments comprising more than one leg
802, the legs can be configured to adhere or otherwise couple to
the on-skin component symmetrically or asymmetrically about a
center of the on-skin component. The legs 802 can have an ovoid
cross section, or can have any other suitable cross section,
including circular, square, triangular, curvilinear, L-shaped,
O-shaped, U-shaped, V-shaped, X-shaped, or any other regular or
irregular shape or combination of shapes. In embodiments, the
securement member 800 can comprise legs, columns, protrusions,
and/or elongate members, or can have any other suitable
configuration for holding the on-skin component in the proximal
starting position.
[0652] FIG. 113 illustrates a cross-sectional perspective view of
the system 104w, in an activated state, with the insertion spring
402w activated, the retraction spring 234w energized, and the
needle hub 162w and the securement member 800 moved to a distal
deployed position. The on-skin component 134w, being coupled to the
securement member 800 until this stage, has also been moved to a
distal deployed position. When the on-skin component 134w reaches
the distal deployed position, it is coupled to the base 128w.
[0653] FIG. 114 illustrates a cross-sectional perspective view of
the system 104w after the on-skin component has been coupled to the
base 128w and the needle hub 162w (along with the securement member
800) has been retracted to a proximal position. After the on-skin
component 134w is coupled to the base 128w, a resistance member 804
facilitates decoupling of the on-skin component 134w from the
securement member 800 by resisting unwanted proximal movement of
the on-skin component 134w away from the base 128w. Generally, the
resistance member 804 can be a backstop or backing structure
configured to inhibit or prevent, or otherwise resist any tendency
of the on-skin component 134w to move in a proximal direction as
the securement member 800, which is releasably coupled to the
on-skin component 134w, moves in a proximal direction. Because the
first portion 150w is fixed to the second portion 152w at this
stage, and the needle hub 162w is released from the first portion
150w, the needle hub 162w can retract in a proximal direction while
the first portion 150w (and the resistance member 804) remains
planted in a distal position, inhibiting proximal movement of the
on-skin component 134w. The energy stored in the retraction spring
234w is sufficient to overcome a retention force and decouple the
on-skin component 134w from the securement member 800 and urge the
needle hub 162 in a proximal direction. The potential energy stored
can be between 0.25 pounds to 4 pounds. In preferred embodiments,
the potential energy stored is between about 1 to 2 pounds.
[0654] In some embodiments, a sensor inserter system can be
configured such that the on-skin component couples with the base at
approximately the same time the retraction mechanism is activated.
In some embodiments, a sensor inserter system can be configured
such that the on-skin component couples with the base before the
retraction mechanism is activated, before the second spring is
activated, or otherwise before the second spring begins retracting
the needle hub in a proximal direction away from the deployed
position. In some embodiments, a sensor inserter system can be
configured such that the second spring is activated at least 0.05
seconds, at least 0.1 seconds, at least 0.2 seconds, at least 0.3
seconds, at least 0.4 seconds, at least 0.5 seconds, at least 0.6
seconds, at least 0.7 seconds, at least 0.8 seconds, at least 0.8
seconds, at least 1 second, or longer than 1 second after the
on-skin component couples with the base. In other embodiments, a
sensor inserter system can be configured such that the second
spring is activated at most 0.05 seconds, at most 0.1 seconds, at
most 0.2 seconds, at most 0.3 seconds, at most 0.4 seconds, at most
0.5 seconds, at most 0.6 seconds, at most 0.7 seconds, at most 0.8
seconds, at most 0.8 seconds, or at most 1 second after the on-skin
component couples with the base.
[0655] The on-skin component 134w is now coupled with the base
128w. The base 128w (and adhesive patch) is initially coupled to
the second portion 152w by a latch or flex arm 220w coupled to an
undercut or locking feature 230w (similarly shown in FIGS. 18-19).
When the first portion 150w reaches its most distal position during
insertion of the sensor 138, a delatching feature of the first
portion 150w pushes the latch of the second portion 152w out of the
undercut. This decouples the base 128w from the second portion
152w, and thus allows the user to take the remainder of the system
104w off the skin, leaving only the adhesive patch, the base 128w,
and the on-skin component 134w on the skin.
[0656] In the embodiment illustrated in FIGS. 110-119, the
resistance member 804 is integrally formed with the first portion
150w. In other embodiments, the resistance member can be integrally
formed with the second portion 152w. In still other embodiments,
the resistance member can be separately formed from and operatively
coupled to the first portion 150w and/or to the second portion
152w. In the embodiment illustrated in FIGS. 110-119, the
resistance member 804 comprises a distally-facing surface of the
first portion 150w.
[0657] The system 104w can be configured to couple the on-skin
component 134w to the base 128w via an adhesive 806. FIG. 115
illustrates a perspective view of the needle hub 162w, shown
securing the on-skin component 134w during deployment, with the
base 128w removed to illustrate the adhesive 806 disposed on a
distally-facing surface of the on-skin component 134w. The adhesive
806 can be configured to couple the on-skin component 134w to the
base 128w on contact. Alternatively or in addition to the adhesive
806, some embodiments can include an adhesive disposed on a
proximally-facing surface of the base, so as to couple the on-skin
component to the base upon contact. In some embodiments, the
adhesive can be a pressure-sensitive adhesive. In some embodiments,
the securement member can be configured to couple the on-skin
component to the needle hub only along a plane extending normal to
the axial direction of the system. In addition or in the
alternative, the securement can be configured to couple the on-skin
component in a lateral or radial direction.
[0658] FIG. 116 illustrates another perspective view of the needle
hub 162w, shown decoupled from the on-skin component 134w, with the
base 128w removed to illustrate the adhesive 808 disposed on the
distally-facing surfaces of the securement member 800. The adhesive
808 can be configured to couple the on-skin component 134w to the
securement member 800 while in the proximal starting position and
during movement of the on-skin component 134w in the proximal
direction, and to allow the release of the on-skin component 134w
from the securement member 800 after the on-skin component 134w is
coupled to the base 128w. Alternatively or in addition to the
adhesive 808, some embodiments can include an adhesive disposed on
a proximally-facing surface of the on-skin component 134w. In some
embodiments, the adhesive can be a pressure-sensitive adhesive. In
some embodiments, the adhesive 808 can have a smaller surface area
and/or a lower adhesion strength than the adhesive 806, such that
the adhesion strength of the adhesive 806 which couples the on-skin
component to the base outweighs the adhesion strength of the
adhesive 808 which couples the on-skin component to the securement
member. In other embodiments, the adhesion strength of the adhesive
808 can be the same or greater than the adhesion strength of the
adhesive 806. In these embodiments, a resistance member can be
employed to facilitate the decoupling of the on-skin component 134w
from the securement member 800 after deployment.
[0659] FIG. 117 illustrates a perspective view of a portion of the
system 104w, illustrating the resistance member 804. The resistance
member 804 is configured to rest above and/or contact a
proximally-facing surface of the on-skin component 134w, at least
when the on-skin component 134w is in a distal deployed position.
The resistance member 804 can serve to inhibit proximal movement of
the on-skin component 134w as the needle hub 162w and securement
member 800 retract in a proximal direction. The resistance member
804 can function in a manner similar to a stripper plate in punch
and die manufacturing or injection molding processes.
[0660] In embodiments, the resistance member can have any
configuration suitable for resisting decoupling of the on-skin
component from the base. In the embodiment illustrated in FIGS.
110-119, the resistance member 804 has a curvilinear cross section,
and extends through an arc of roughly 300 degrees about the
perimeter of the on-skin component 134w. In some embodiments, the
resistance member 804 can extend through an arc of roughly 30
degrees, 60 degrees, 90 degrees, 120 degrees, 150 degrees, 180
degrees, 210 degrees, 240 degrees, 270 degrees, 300 degrees, or 330
degrees about the perimeter of the on-skin component 134w, or
through an arc greater than, less than, or within a range defined
by any of these numbers. In some embodiments, the resistance member
804 can extend continuously or discontinuously about the perimeter
of the on-skin component. In some embodiments, the resistance
member 804 can extend about the entire perimeter of the on-skin
component. In some embodiments, the resistance member 804 can
comprise one or more contact points or surfaces that hold the
on-skin component 134w in the distal position as the securement
feature 800 moves in an opposite (e.g., proximal) direction.
[0661] In other embodiments, the resistance member 804 can comprise
multiple discrete members (e.g., legs) configured to contact
multiple locations about the perimeter of the on-skin component
134w. For example, in some embodiments, the resistance member 804
can include at least two legs disposed apart from one another about
a center point of the on-skin component. In some embodiments, the
resistance member 804 can include two legs disposed roughly 180
degrees about a center point of the on-skin component. In some
embodiments, the resistance member 804 can include three legs
disposed roughly 120 degrees about a center point of the on-skin
component. In such an embodiment, the legs can be arranged
symmetrically about the on-skin component (e.g. with radial
symmetry, or reflectional/bilateral symmetry).
[0662] FIG. 117 also illustrates locator features 810 which can be
formed in, or integrally coupled to, the first portion 150w and/or
the resistance member 804. The locator features 810 can comprise
distally-extending tabs of the first portion 150w and/or of the
resistance member 804. The locator features 810 can be configured
to align with corresponding indentations 812 in the on-skin
component (see FIG. 119) so as to ensure proper positioning of the
sensor module 134w with respect to the first portion 150w and/or
the resistance member 804 during assembly.
[0663] FIG. 118 illustrates a perspective view of the sensor module
134w, before being coupled to the base 128w by contacting the
adhesive 806. The base 128w itself is coupled (for example by an
adhesive) to a proximal surface of an adhesive patch 900. FIG. 119
illustrates a perspective view of the sensor module 134w after
being coupled to the base 128w on the adhesive patch 900.
[0664] In embodiments, providing a resistance member can facilitate
a reliable transfer of the on-skin component to the base, by
creating a counterforce against the securement member as the needle
hub retracts in the proximal direction. The counterforce allows the
securement member to separate from the on-skin component while
inhibiting or preventing the disengagement of the on-skin component
from the base (if any) and/or from the adhesive patch. In
embodiments, the retraction spring can be configured to store and
provide sufficient energy to both retract the needle and decouple
the on-skin component from the needle hub. The combination of the
resistance member and securement member can also be configured to
provide positional control of the on-skin component from a secured
configuration (e.g., in the proximal starting position and during
movement of the on-skin component toward the distal deployed
position) to a released configuration (when the on-skin component
reaches the distal deployed position and/or couples to the base
and/or adhesive patch).
[0665] It is contemplated that providing a base which begins in the
distal deployed position when the system is in a resting or stored
state can serve to protect the needle (and the user) before the
system is deployed. For example, a base which is coupled to a
distal end of the system in a resting or pre-deployment state can
prevent a user from reaching into the distal end of the system and
pricking him or herself. This configuration can thus potentially
reduce needle stick hazards. In addition, a base which is coupled
to a distal end of the system in a resting or pre-deployment state
facilitate the setting of the adhesive patch on the skin before
deployment. For example, with such a configuration, the user can
use the body of the sensor inserter system to assist in applying a
force in a distal direction to adhere the adhesive patch to the
skin. In addition, the base can provide structural support to guide
the needle into the skin during deployment.
[0666] FIGS. 120-122 illustrate another configuration for coupling
an on-skin component to a base, in accordance with several
embodiments. FIG. 120 shows a side view of an on-skin component
134x and a base 128x, prior to coupling of the on-skin component
134x to the base 128x. The on-skin component 134x includes a
distally-extending sensor 138, and the base 128x is coupled to an
adhesive patch 900. FIG. 121 illustrates a perspective view of
these same components. The base 128x comprises a flexible
elastomeric member with a proximally-extending ridge 814 extending
about a proximally-facing surface 816. The base 128x can have a
shape configured to correspond to a shape of the on-skin component
134x. In a relaxed state, as illustrated in FIGS. 120 and 121, and
before making contact with the on-skin component 134x, the base
128x has a deformed, somewhat convex curvature. The base 128x and
the adhesive patch 900 can be coupled to the other components of a
sensor inserter assembly in this configuration. During deployment,
as the on-skin component 134x begins to contact the base 128x, the
proximally-facing surface 816 flexes up to meet the distal surface
of the on-skin component 134x, causing the ridge 814 to grip
securely about the perimeter of the on-skin component 134x, as
illustrated in FIG. 122.
[0667] FIG. 123 illustrates a perspective view of a portion of
another inserter system 104y, according to some embodiments. The
system 104y can be configured substantially similar to any of the
systems 104 illustrated herein, with like reference numerals
indicating like parts. The inserter system 104y includes an on-skin
component 134y which includes a combination sensor module and base.
In embodiments, the combination sensor module and base can be
integrally formed with one another, as illustrated in FIG. 123, or
operatively coupled to one another. The system 104y also includes a
securement member 800y which is configured to releasably secure the
on-skin component 134y in a proximal starting position, at least
until the system 104y is activated. The securement member 800y is
integrally formed with the needle hub 162y, and includes three
proximally-extending legs 802y configured to releasably couple to
(e.g. via adhesive 808) various locations on the proximal surface
of the on-skin component 134y. It is contemplated that the addition
of a third (or further) leg 802y can help to balance the sensor
module and prevent it from canting to one side or another during
deployment and/or retraction. The system 104y also includes a
resistance member 804. The resistance member 804 may be integrally
molded with first portion 150y.
[0668] FIG. 124 illustrates another perspective view of the on-skin
component 134y and the needle hub 162y, with the remainder of the
system 104y removed to illustrate the configuration of the
securement member 800y. FIG. 125 illustrates a perspective view of
a portion of the applicator system shown in FIG. 123, with the
on-skin component 134y in a released configuration and separated
from the needle hub 162y and with two of the legs 802y removed for
purposes of illustration. The resistance member 804y can be
configured to encompass or at least partially encompass the sensor
module portion of the on-skin component 134y. The resistance member
804y can comprise one or more elongate members, columns, legs,
and/or protrusions, or can have any other suitable configuration
for facilitating the release of the on-skin component from the
needle hub 162y. The resistance member 804y (or any portion
thereof) can have a curvilinear cross section, as illustrated in
FIG. 125, or can have any other suitable cross section, including
circular, square, triangular, ovoid, L-shaped, O-shaped, U-shaped,
V-shaped, X-shaped, or any other regular or irregular shape or
combination of shapes.
[0669] As shown in FIG. 125, the system 104y can include an
adhesive patch 818 disposed on the distally-facing surface of the
on-skin component 134y. The adhesive patch 818 can be configured to
couple the on-skin component 134y to the skin on contact. In some
embodiments, the adhesive patch can be a pressure-sensitive
adhesive. In some embodiments, the adhesive patch 818 is a double
sided adhesive, in which an adhesive is disposed on both the
proximally facing surface of the adhesive patch 818 and the
distally facing surface of the adhesive patch 818. The proximally
facing adhesive can be configured to couple with the distal end of
the on-skin component 134y, and the distally facing adhesive can be
configured to couple with the skin. In other embodiments, the
proximally facing surface of the adhesive patch 818 is configured
to couple with the distally facing surface of the on-skin component
by a coupling process such as, but not limited to, heat staking,
fastening, welding, or bonding. In some embodiments, the adhesive
patch 818 can be covered by a removable liner prior to deployment.
In other embodiments, the adhesive patch 818 can be exposed (e.g.,
uncovered) within the system prior to deployment.
[0670] Alternatively, in some embodiments the adhesive patch 818
can be releasably secured to the distal end of the system before
deployment, with an adhesive disposed on a proximally-facing
surface of the adhesive patch 818, so as to couple the on-skin
component to the adhesive patch 818 upon contact as part of the
sensor insertion process. In addition, in such an embodiment, the
adhesive patch 818 can include an adhesive disposed on a
distally-facing surface of the adhesive patch 818 to couple the
on-skin component to the skin.
[0671] Such a configuration can include fewer components to be
coupled and decoupled during the deployment and insertion process,
which can increase reliability of systems configured in accordance
with embodiments. For example, systems configured in accordance
with embodiments can reduce the chance of improper transfer of
system components to the skin. In addition, it is contemplated that
embodiments comprising an adhesive patch disposed within the system
in a resting state (as opposed to an adhesive patch disposed at a
distal end of the system in the resting state) can allow for the
system to be more easily re-positioned on the skin as many times as
desired before being adhered to the skin.
[0672] FIGS. 126-128 illustrate another configuration for
releasably securing an on-skin component in a proximal position, in
accordance with several embodiments. FIG. 126 illustrates a
perspective view of a portion of a securement member 800z shown
secured to an on-skin component 134z comprising a sensor module.
The securement member 800z can include at least one leg 802z. As
shown in the figure, the securement member 800z includes two
proximally-extending legs 802z. The on-skin component 134z includes
two elastomeric grips 824 extending laterally from the sensor
module. The grips 824 are sized and shaped to cooperate with
laterally-facing surfaces of the legs 802z to releasably secure the
on-skin component 134z in a proximal position. In the embodiment
illustrated in FIGS. 126-128, the grips 824 are integrally formed
with the sensor module, and have a bracket-shaped cross section, as
viewed in a plane extending normal to the axial direction. In
embodiments, the securement member 800z and the grips 824 can have
any suitable cooperating configuration to allow the on-skin
component 134z to releasably couple the securement member 800z to
the grips 824, for example via a friction fit, interference fit, or
corresponding undercut engagement features. Some embodiments can
additionally employ an adhesive disposed between the securement
member 800z and the on-skin component 134z, to provide additional
securement of the on-skin component 134z.
[0673] FIG. 127 illustrates a perspective view of a portion of the
securement member 800z, with the sensor module of the on-skin
component 134z shown in cross section to illustrate the
configuration of the grips 824. FIG. 127 also shows a decoupling
feature 804z configured to resist proximal movement of the on-skin
component 134z after deployment of the on-skin component 134z to
the distal deployed position, for example during retraction of the
needle hub 162z. The decoupling feature 804z can be fixed with
respect to the remainder of the sensor inserter system as the
needle hub 162z retracts in a proximal direction, providing enough
resistance to overcome the friction fit (and adhesive, if any)
between the securement member 800z and the grips 824 to release the
securement member 800z from the grips 824. FIG. 128 illustrates a
perspective view of the on-skin component 134z, after decoupling of
the on-skin component 134z from the securing member 800z.
[0674] FIGS. 129-131 illustrate still another configuration for
releasably securing an on-skin component, in accordance with
several embodiments. FIG. 129 illustrates a perspective view of a
portion of a sensor inserter assembly 104aa with the second portion
150aa shown in cross section, and with a securing member 800aa
shown securing an on-skin component 134aa in a proximal position.
The on-skin component 134aa may comprise an integrally formed
sensor module/base assembly. As shown in the figure, the securement
member 800aa comprises an elastomeric cap which is coupled to a
portion of the on-skin component 134aa. As shown, the securement
member 800aa can be coupled to a protrusion (or neck) 826 formed in
the on-skin component 134aa. FIG. 130 illustrates a perspective
view of a portion of the assembly 104aa of FIG. 129, shown with a
portion of the securing member 800aa cut away to better illustrate
the configuration of the securing member 800aa and the protrusion
826. The protrusion 826 can be configured to encircle, or at least
partially encircle, the needle 158 when it extends in a proximal
direction through the on-skin component 134aa. The protrusion 826
can also be configured to secure the securement member 800aa to the
on-skin component 134aa. The securement member 800aa has an opening
828 which is sized and shaped to create a friction fit between the
opening 828 and the needle 158. In the configuration illustrated in
FIGS. 129 and 130, with the needle 158 extending distally through
the securement member 800aa and the protrusion 826, the friction
fit between the securement member 800aa and the needle 158 serves
to resist at least distal movement of the on-skin component 134aa
with respect to the needle 158.
[0675] The embodiment illustrated in FIGS. 129-131 may also include
a resistance member 804aa. The resistance member may be
substantially similar to any resistance member described in FIGS.
110-128. The resistance member 804aa can include a distally-facing
surface of the first portion 150aa, and can have a similar
configuration to the resistance member 804 described in the context
of FIG. 117. The resistance member 804aa can provide enough
resistance in a distal direction to allow the second spring and
needle hub (not shown) to overcome the friction fit between the
securement member 800aa and the needle 158. It is contemplated that
this would allow the needle 158 to retract away from the skin and
at the same time allow the needle to decouple from the securement
member 800aa. FIG. 131 illustrates a perspective view of a portion
of the assembly 104aa, after decoupling of the on-skin component
134aa from the needle 158, shown with the protrusion 826 of the
on-skin component 134aa and the securing member 800aa cut away for
purposes of illustration.
[0676] FIGS. 132-133 illustrate another configuration for
releasably securing an on-skin component in a proximal position, in
accordance with several embodiments. FIG. 132 illustrates a
perspective view of a portion of a securement member 800ab shown
secured to an on-skin component 134ab comprising a sensor module,
with the second portion 150ab shown in cross section. The
securement member 800ab may include at least one engagement
feature. As shown in the figure, the at least one engagement
feature can be two proximally-extending legs 802ab. The on-skin
component 134ab may include at least one receiving feature. As
shown, the at least one receiving feature can be two elastomeric
grips 824ab extending laterally from the on-skin component 134ab.
The grips 824ab are deformable and sized and shaped to receive the
legs 802ab via friction or interference fit and thereby releasably
secure the on-skin component 134ab in a proximal position. In the
embodiment illustrated in FIGS. 132-133, the legs 802ab of the
securement member 800ab have a circular cross-section. The grips
824ab are integrally formed with the sensor module, and have an
annular-shaped cross section, as viewed in a plane extending normal
to the axial direction. The grips 824ab may each include an opening
which can be configured to receive the legs 802ab via frictional
engagement. In embodiments, the securement member 800ab and the
grips 824ab can have any suitable cooperating configuration to
releasably couple the securement member 800ab to the grips 824ab.
Some embodiments can additionally employ an adhesive disposed
axially between the securement member 800ab and the on-skin
component 134ab, to provide additional securement of the on-skin
component 134ab in the proximal starting position. FIG. 133
illustrates a perspective view of the needle hub 162ab and the
on-skin component 134ab, after decoupling of the on-skin component
134ab from the needle hub 162ab.
[0677] FIGS. 134-136 illustrate yet another configuration for
releasably securing an on-skin component in a proximal position.
FIG. 134 illustrates an exploded perspective view of a portion of
an assembly 134ac, with a securement member 800ac configured to
releasably couple an on-skin component 134ac to a needle hub 162ac.
The securement member 800ac may include at least one engagement
feature. As shown in the figure, the securement member 800ac can
include two proximally-extending legs 802ac. The on-skin component
134ac includes two elastomeric grips 824ac extending laterally from
the sensor module. The grips 824ac are sized and shaped to receive
the legs 802ac in a snap fit to securely hold the on-skin component
134ac in a proximal position. In the embodiment illustrated in
FIGS. 134-136, the legs 802ac of the securement member 800ac have a
circular cross-section, with a recessed section 832 configured to
receive the grips 824ac. The grips 824ac can be integrally formed
with the sensor module, each grip having a frangible link 830
coupling the grips 824ac to the sensor module. The grips 824ac have
an annular-shaped cross section, as viewed in a plane extending
normal to the axial direction, the grips being configured to
receive the recessed sections 832 of the legs in a secure
interlocking engagement. In embodiments, the securement member
800ab and the grips 824ab can have any suitable cooperating
configuration to securely couple the securement member 800ac to the
grips 824ac and prevent slippage of the grips along the legs 802ac
as the needle hub 162ac deploys and as it retracts after
deployment. Some embodiments can additionally employ an adhesive
disposed axially between the securement member 800ac and the
on-skin component 134ab, to provide additional securement of the
on-skin component 134ac in the proximal starting position and
during deployment.
[0678] FIG. 135 illustrates a perspective view of a portion of the
system 104ac, with the securement member 800ac securely coupled to
the on-skin component 134ac. Some embodiments can additionally
employ an adhesive disposed axially between the securement member
800ac and the on-skin component 134ac, to provide additional
securement of the on-skin component 134ac in the proximal starting
position. The frangible links 830 are configured to shear or
otherwise detach upon application of a minimum threshold of force,
as the needle hub 162 retracts in a proximal direction after
deployment, separating the grips 824ac from the remainder of the
on-skin component 134ac and leaving the on-skin component 824ac in
the deployed distal position. FIG. 136 illustrates a perspective
view of a portion of the system 104ac, with the frangible links 830
broken and the securement member 800ac decoupled from the on-skin
component 134ac. In some embodiments, a resistance member can also
be employed to prevent proximal movement of the on-skin component
134ac as the needle hub 162ac retracts, facilitating the breakage
of the frangible links 830.
[0679] Frangible couplings can also be employed between an on-skin
component and the second portion of a sensor inserter system to
releasably secure the on-skin component in a proximal starting
position prior to deployment. For example, FIGS. 137-140 illustrate
various perspective views of a sensor inserter system 104ad with an
on-skin component 134ad releasably secured in a proximal position
within the system 104ad. The on-skin component 134ad can include a
combination sensor module and base disposed on an adhesive patch
900ad. To facilitate in releasably securing the on-skin component
134ad to the second portion 152ad, the second portion 152ad can
include at least one distally-extending protrusion 834. As shown in
the figure, the second portion 152ad includes four
distally-extending protrusions 834 configured to securely couple
with corresponding sockets 836 formed in or otherwise extending
from the adhesive patch 900ad. The sockets 836 are connected to the
adhesive patch 900ad via frangible links 838, which can also be
integrally formed in the adhesive patch 900ad. In the resting state
illustrated in FIG. 137, the adhesive patch 900ad is secured in a
proximal position by the coupling of the sockets 836 to the posts
838. As the system 104ad is deployed and a force is applied to the
on-skin component 134ad in a distal direction, the frangible links
838 detach, allowing the adhesive patch 900ad (and the on-skin
component 134ad which is already coupled thereto) to move to the
distal deployed position. FIG. 138 illustrates a perspective view
of the sensor inserter system 104ad, with the frangible links 838
detached and the adhesive patch 900ad released from securement.
FIGS. 139 and 140 illustrate perspective views of the adhesive
patch 900ad and the on-skin component 134ad, with the frangible
links 838 in intact and detached configurations, respectively. Once
the frangible links 838 are detached and the on-skin component
134ad (along with the patch 900ad) is deployed in the distal
position, the remainder of the system 104ad can easily be lifted
off the skin of the host and removed.
[0680] FIG. 141 illustrates another configuration for releasably
securing a base and adhesive patch to a sensor inserter assembly.
FIG. 141 illustrates a cross-sectional perspective view of a
portion of a system 104ae, with the first portion 150ae, the second
portion 152ae, and the third portion 392ae shown in cross section.
The system 104ae includes an on-skin component 134ae which is
releasably secured in a proximal starting position. The system
104ae also includes a base 128ae coupled to an adhesive patch
900ae. The base 128ae and the adhesive patch 900ae are disposed in
a distal position, at a distal end of the system 104ae. The base
128ae is coupled to the system 104ae via a plurality of ribs 840
extending radially inward from the second portion 152ae. The ribs
840 can be sized and shaped to grip the edges of the base 128ae
with a friction/interference fit. The friction/interference fit
between the ribs 840 and the base 128ae can be configured to be
strong enough to securely couple the base 128ae to the system 104ae
during storage and prior to deployment, but weak enough that the
adhesive coupling between the adhesive patch 900ae and the skin of
the host overcomes the strength of the friction fit. Thus, once the
adhesive patch 900ae is adhered to the skin of the host, the second
portion 152ae can be lifted off the base 128ae and the sensor
system 104ae can be removed without pulling the base 128 in a
proximal direction. In some embodiments, the base 128ae may
comprise an elastomeric material. Further, in some embodiments, the
base 128ae may have a hardness value less than a hardness value of
the on-skin component 134ae. In other embodiments, the base 128ae
may have a hardness value more than a hardness value of the on-skin
component 134ae.
[0681] FIGS. 142 and 143 illustrate yet another configuration for
releasably securing an adhesive patch, optionally including a base,
to a sensor inserter system. FIG. 142 shows a sensor inserter
system 104af with an adhesive patch 900af coupled to the second
portion 152af of the system 104af. FIG. 143 shows the system 104af
with the patch 900af separated from the second portion 152af. As
shown in FIG. 143, the second portion 152af includes a plurality of
adhesive dots 842 disposed on a distally-facing surface or edge of
the second portion 152af. The adhesive dots 842 can be configured
to be strong enough to securely couple the adhesive patch 900af
(and base, if any) to the system 104af during storage and prior to
deployment, but weak enough that the adhesive coupling between the
adhesive patch 900af and the skin of the host overcomes the
strength of the adhesive dots 842. Thus, once the adhesive patch
900af is adhered to the skin of the host, the second portion 152af
can be lifted off the applicator patch 900af (and base, if any) and
the sensor system 104af can be removed without pulling the adhesive
patch 900af (or base, if any) in a proximal direction.
Alternatively or in addition to the adhesive dots 842, some
embodiments can include an adhesive disposed on a proximally-facing
surface of the adhesive patch 900af. In some embodiments, the
adhesive can be a pressure-sensitive adhesive.
Interpretation
[0682] For ease of explanation and illustration, in some instances
the detailed description describes exemplary systems and methods in
terms of a continuous glucose monitoring environment; however it
should be understood that the scope of the invention is not limited
to that particular environment, and that one skilled in the art
will appreciate that the systems and methods described herein can
be embodied in various forms. Accordingly any structural and/or
functional details disclosed herein are not to be interpreted as
limiting the systems and methods, but rather are provided as
attributes of a representative embodiment and/or arrangement for
teaching one skilled in the art one or more ways to implement the
systems and methods, which may be advantageous in other
contexts.
[0683] For example, and without limitation, described monitoring
systems and methods may include sensors that measure the
concentration of one or more analytes (for instance glucose,
lactate, potassium, pH, cholesterol, isoprene, and/or hemoglobin)
and/or other blood or bodily fluid constituents of or relevant to a
host and/or another party.
[0684] By way of example, and without limitation, monitoring system
and method embodiments described herein may include finger-stick
blood sampling, blood analyte test strips, non-invasive sensors,
wearable monitors (e.g. smart bracelets, smart watches, smart
rings, smart necklaces or pendants, workout monitors, fitness
monitors, health and/or medical monitors, clip-on monitors, and the
like), adhesive sensors, smart textiles and/or clothing
incorporating sensors, shoe inserts and/or insoles that include
sensors, transdermal (i.e. transcutaneous) sensors, and/or
swallowed, inhaled or implantable sensors.
[0685] In some embodiments, and without limitation, monitoring
systems and methods may comprise other sensors instead of or in
additional to the sensors described herein, such as inertial
measurement units including accelerometers, gyroscopes,
magnetometers and/or barometers; motion, altitude, position, and/or
location sensors; biometric sensors; optical sensors including for
instance optical heart rate monitors, photoplethysmogram
(PPG)/pulse oximeters, fluorescence monitors, and cameras; wearable
electrodes; electrocardiogram (EKG or ECG), electroencephalography
(EEG), and/or electromyography (EMG) sensors; chemical sensors;
flexible sensors for instance for measuring stretch, displacement,
pressure, weight, or impact; galvanometric sensors, capacitive
sensors, electric field sensors, temperature/thermal sensors,
microphones, vibration sensors, ultrasound sensors,
piezoelectric/piezoresistive sensors, and/or transducers for
measuring information of or relevant to a host and/or another
party.
[0686] None of the steps described herein is essential or
indispensable. Any of the steps can be adjusted or modified. Other
or additional steps can be used. Any portion of any of the steps,
processes, structures, and/or devices disclosed or illustrated in
one embodiment, flowchart, or example in this specification can be
combined or used with or instead of any other portion of any of the
steps, processes, structures, and/or devices disclosed or
illustrated in a different embodiment, flowchart, or example. The
embodiments and examples provided herein are not intended to be
discrete and separate from each other.
[0687] The section headings and subheadings provided herein are
nonlimiting. The section headings and subheadings do not represent
or limit the full scope of the embodiments described in the
sections to which the headings and subheadings pertain. For
example, a section titled "Topic 1" may include embodiments that do
not pertain to Topic 1 and embodiments described in other sections
may apply to and be combined with embodiments described within the
"Topic 1" section.
[0688] Some of the devices, systems, embodiments, and processes use
computers. Each of the routines, processes, methods, and algorithms
described in the preceding sections may be embodied in, and fully
or partially automated by, code modules executed by one or more
computers, computer processors, or machines configured to execute
computer instructions. The code modules may be stored on any type
of non-transitory computer-readable storage medium or tangible
computer storage device, such as hard drives, solid state memory,
flash memory, optical disc, and/or the like. The processes and
algorithms may be implemented partially or wholly in
application-specific circuitry. The results of the disclosed
processes and process steps may be stored, persistently or
otherwise, in any type of non-transitory computer storage such as,
for example, volatile or non-volatile storage.
[0689] Any of the features of each embodiment is applicable to all
aspects and embodiments identified herein. Moreover, any of the
features of an embodiment is independently combinable, partly or
wholly with other embodiments described herein in any way, e.g.,
one, two, or three or more embodiments may be combinable in whole
or in part. Further, any of the features of an embodiment may be
made optional to other aspects or embodiments. Any aspect or
embodiment of a method can be performed by a system or apparatus of
another aspect or embodiment, and any aspect or embodiment of a
system can be configured to perform a method of another aspect or
embodiment.
[0690] The various features and processes described above may be
used independently of one another, or may be combined in various
ways. All possible combinations and subcombinations are intended to
fall within the scope of this disclosure. In addition, certain
method, event, state, or process blocks may be omitted in some
implementations. The methods, steps, and processes described herein
are also not limited to any particular sequence, and the blocks,
steps, or states relating thereto can be performed in other
sequences that are appropriate. For example, described tasks or
events may be performed in an order other than the order
specifically disclosed. Multiple steps may be combined in a single
block or state. The example tasks or events may be performed in
serial, in parallel, or in some other manner. Tasks or events may
be added to or removed from the disclosed example embodiments. The
example systems and components described herein may be configured
differently than described. For example, elements may be added to,
removed from, or rearranged compared to the disclosed example
embodiments.
[0691] Conditional language used herein, such as, among others,
"can," "could," "might," "may," "e.g.," and the like, unless
specifically stated otherwise, or otherwise understood within the
context as used, is generally intended to convey that certain
embodiments include, while other embodiments do not include,
certain features, elements and/or steps. Thus, such conditional
language is not generally intended to imply that features, elements
and/or steps are in any way required for one or more embodiments or
that one or more embodiments necessarily include logic for
deciding, with or without author input or prompting, whether these
features, elements and/or steps are included or are to be performed
in any particular embodiment. The terms "comprising," "including,"
"having," and the like are synonymous and are used inclusively, in
an open-ended fashion, and do not exclude additional elements,
features, acts, operations and so forth. Also, the term "or" is
used in its inclusive sense (and not in its exclusive sense) so
that when used, for example, to connect a list of elements, the
term "or" means one, some, or all of the elements in the list.
Conjunctive language such as the phrase "at least one of X, Y, and
Z," unless specifically stated otherwise, is otherwise understood
with the context as used in general to convey that an item, term,
etc. may be either X, Y, or Z. Thus, such conjunctive language is
not generally intended to imply that certain embodiments require at
least one of X, at least one of Y, and at least one of Z to be
present.
[0692] The term "and/or" means that "and" applies to some
embodiments and "or" applies to some embodiments. Thus, A, B,
and/or C can be replaced with A, B, and C written in one sentence
and A, B, or C written in another sentence. A, B, and/or C means
that some embodiments can include A and B, some embodiments can
include A and C, some embodiments can include B and C, some
embodiments can only include A, some embodiments can include only
B, some embodiments can include only C, and some embodiments can
include A, B, and C. The term "and/or" is used to avoid unnecessary
redundancy.
[0693] All references cited herein are incorporated herein by
reference in their entirety. To the extent publications and patents
or patent applications incorporated by reference contradict the
disclosure contained in the specification, the specification is
intended to supersede and/or take precedence over any such
contradictory material.
[0694] Unless otherwise defined, all terms (including technical and
scientific terms) are to be given their ordinary and customary
meaning to a person of ordinary skill in the art, and are not to be
limited to a special or customized meaning unless expressly so
defined herein. It should be noted that the use of particular
terminology when describing certain features or aspects of the
disclosure should not be taken to imply that the terminology is
being re-defined herein to be restricted to include any specific
characteristics of the features or aspects of the disclosure with
which that terminology is associated. Terms and phrases used in
this application, and variations thereof, especially in the
appended claims, unless otherwise expressly stated, should be
construed as open ended as opposed to limiting.
[0695] While certain example embodiments have been described, these
embodiments have been presented by way of example only, and are not
intended to limit the scope of the inventions disclosed herein.
Thus, nothing in the foregoing description is intended to imply
that any particular feature, characteristic, step, module, or block
is necessary or indispensable. Indeed, the novel methods and
systems described herein may be embodied in a variety of other
forms; furthermore, various omissions, substitutions, and changes
in the form of the methods and systems described herein may be made
without departing from the spirit of the inventions disclosed
herein.
* * * * *