U.S. patent application number 15/299075 was filed with the patent office on 2017-04-27 for transcutaneous analyte sensors, applicators therefor, and associated methods.
The applicant listed for this patent is DexCom, Inc.. Invention is credited to Jillian K. Allen, Leonard Darius Barbod, Jennifer Blackwell, Christopher M. Davis, David DeRenzy, Justen Deering England, Michael J. Estes, Eric Gobrecht, Timothy Joseph Goldsmith, Jason Halac, Jonathan Hughes, Kathleen Suzanne Hurst, Kyle Tinnell Keller, Randall Scott Koplin, Phong Lieu, Stephanie Lynn Mah, Kyle Neuser, Todd Andrew Newhouse, Jack Pryor, Philip Thomas Pupa, Ryan Everett Schoonmaker, Peter C. Simpson, Maria Noel Brown Wells.
Application Number | 20170112533 15/299075 |
Document ID | / |
Family ID | 58557786 |
Filed Date | 2017-04-27 |
United States Patent
Application |
20170112533 |
Kind Code |
A1 |
Schoonmaker; Ryan Everett ;
et al. |
April 27, 2017 |
TRANSCUTANEOUS ANALYTE SENSORS, APPLICATORS THEREFOR, AND
ASSOCIATED METHODS
Abstract
The present embodiments relate generally to systems and methods
for measuring an analyte in a host. More particularly, the present
embodiments provide sensor applicators and methods of use with
activation that implant the sensor, withdraw the insertion needle,
engage the transmitter with the housing, and disengage the
applicator from the housing. Systems and methods according to
present principles allow for such steps to occur without
significant loss of spring force, and without deleterious effects
such as seal slingshotting.
Inventors: |
Schoonmaker; Ryan Everett;
(Oceanside, CA) ; Blackwell; Jennifer; (San Diego,
CA) ; Davis; Christopher M.; (San Diego, CA) ;
DeRenzy; David; (San Diego, CA) ; Gobrecht; Eric;
(Madison, WI) ; Halac; Jason; (Solana Beach,
CA) ; Hughes; Jonathan; (Carlsbad, CA) ;
Hurst; Kathleen Suzanne; (La Mesa, CA) ; Koplin;
Randall Scott; (Middleton, WI) ; Lieu; Phong;
(San Diego, CA) ; Neuser; Kyle; (Madison, WI)
; Newhouse; Todd Andrew; (San Diego, CA) ; Pryor;
Jack; (Ladera Ranch, CA) ; Simpson; Peter C.;
(Cardiff, CA) ; Wells; Maria Noel Brown; (San
Diego, CA) ; England; Justen Deering; (San Francisco,
CA) ; Mah; Stephanie Lynn; (El Cajon, CA) ;
Barbod; Leonard Darius; (San Diego, CA) ; Allen;
Jillian K.; (San Diego, CA) ; Estes; Michael J.;
(Poway, CA) ; Pupa; Philip Thomas; (San Diego,
CA) ; Goldsmith; Timothy Joseph; (San Diego, CA)
; Keller; Kyle Tinnell; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DexCom, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
58557786 |
Appl. No.: |
15/299075 |
Filed: |
October 20, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15298721 |
Oct 20, 2016 |
|
|
|
15299075 |
|
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62244520 |
Oct 21, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/3468 20130101;
A61B 5/0004 20130101; A61B 5/6833 20130101; A61B 2017/00862
20130101; A61B 5/14503 20130101; A61B 2017/00407 20130101; A61B
5/14532 20130101; A61B 2017/0023 20130101 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61B 5/145 20060101 A61B005/145; A61B 5/00 20060101
A61B005/00 |
Claims
1. A wearable portion of a device for monitoring an analyte,
comprising: a disposable housing containing a seal carrier, the
seal carrier configured to support at least one seal and to connect
to at least one implantable sensor; and a transmitter configured to
frictionally or mechanically couple to the disposable housing, the
transmitter configured to conductively couple to a portion of the
sensor; wherein the disposable housing further comprises a
frangible portion, such that once the transmitter frictionally or
mechanically couples to the disposable housing, the transmitter is
held in place at least partially by the frangible portion and the
transmitter cannot be removed without removal of the frangible
portion.
2. The wearable portion of claim 1, wherein the frangible portion
forms an exterior perimeter of the seal carrier, and wherein the
transmitter is inserted adjacent the exterior perimeter.
3. The wearable portion of claim 1, wherein the seal is
frictionally engaged with the insertion assembly.
4. The wearable portion of claim 1, wherein the seal is slidably
coupled with the insertion assembly.
5. The wearable portion of claim 1, wherein the seal comprises an
elastomer.
6. The wearable portion of claim 1, further comprising a carrier
operatively coupled to the disposable housing, the seal being
operatively coupled to the carrier.
7. The wearable portion of claim 6, wherein the carrier is movably
coupled to the disposable housing.
8. The wearable portion of claim 1, wherein the seal comprises a
first portion and a second portion, the first portion having a
first durometer and the second portion having a second durometer,
the second durometer being higher than the first durometer.
9. The wearable portion of claim 8, wherein the first portion
comprises silicone and the second portion comprises TPE.
10. The wearable portion of claim 1, wherein the seal defines a
channel configured to receive a fluid or gel.
11. The wearable portion of claim 1, wherein the insertion assembly
comprises a cannula.
12. The wearable portion of claim 1, further comprising a plurality
of conductive elastomeric contacts disposed within the seal, the
conductive elastomeric contacts defining one or more voids between
the contact surface and the cannula.
13. The wearable portion of claim 12, wherein the seal comprises a
contact surface configured to engage with the cannula, and wherein
the conductive elastomeric contacts define one or more voids
between the contact surface and the cannula.
14. The wearable portion of claim 1, wherein the disposable housing
comprises a first portion coupled to a second portion by a
frangible member.
15. The wearable portion of claim 1, wherein the disposable housing
comprises a receptacle configured to receive a corresponding key of
a compatible electronics unit.
16. The wearable portion of claim 1, wherein the disposable housing
comprises an interference structure configured to prevent
installation of an incompatible electronics unit in the disposable
housing.
17. The wearable portion of claim 1, wherein the disposable housing
defines at least one opening configured to allow passage of the
sensor.
18. The wearable portion of claim 1, wherein the disposable housing
is configured such that the electronics unit, once installed,
cannot be removed from the disposable housing while the housing is
adhered to the skin of the host.
19. The wearable portion of claim 1, wherein the disposable housing
is configured such that the electronics unit, once installed,
cannot be removed from the disposable housing without breaking the
frangible member.
20. The wearable portion of claim 1, wherein the disposable housing
is configured to automatically release from the applicator body
after the separation member is released from the seal.
21. The wearable portion of claim 1, wherein the disposable housing
is configured to automatically release from the applicator body in
response to the separation member being released from the seal.
22. The wearable portion of claim 1, wherein the seal is moveable
relative to the disposable housing, at least after the separation
member is released from the seal.
Description
INCORPORATION BY REFERENCE TO RELATED APPLICATION
[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. 15/298,721, filed Oct. 20, 2016, which
claims the benefit of U.S. Provisional Application No. 62/244,520,
filed Oct. 21, 2015. Each of the aforementioned applications is
incorporated by reference herein in its entirety, and each is
hereby expressly made a part of this specification.
BACKGROUND OF THE INVENTION
[0002] Field of the Invention
[0003] Systems and methods for measuring an analyte in a host are
provided. More particularly, systems and methods are provided for
applying a transcutaneous analyte measurement system to a host.
[0004] Description of the Related Technology
[0005] 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.
[0006] Conventionally, a person with diabetes carries a
self-monitoring blood glucose (SMBG) 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 spread so far 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.
[0007] The process of applying the sensor to the person is
important for such a system to be effective and user friendly. The
application process should result in the sensor assembly being
attached to the person in a state where it is capable of sensing
glucose level information, communicating the sensed data to the
transmitter, and transmitting the glucose level information to the
receiver.
[0008] Exemplary prior art systems are disclosed in, e.g., US PGP
2014/0088389 and US PGP 2013/0267813, owned by the assignee of the
present application and herein incorporated by reference in their
entireties. Such systems tended to rely on particular
configurations of a spring and a seal. These configurations
resulted in certain disadvantages. For example, portions of the
movement occurred when the spring was at its lowest force, e.g., at
the end of its extension or compression, i.e., at its equilibrium
position. In addition, as the spring was maintained in a compressed
or extended or otherwise preloaded condition, between the time of
manufacture and the time of activation, the same could undergo
mechanical fatigue during this time. Such may in addition result in
cause mechanical "creep", particularly in plastic components.
[0009] Other issues include that certain elements, particularly
seals, were subject to "slingshotting" as insertion elements
underwent movements caused by the insertion routine such effects
resulting in inaccurate sensor wire placement, as the amount of
slingshotting is unpredictable. In addition, where a single spring
was suggested in prior implementations, the same would generally
have to be a large spring to accommodate all the motion required in
insertion and retraction, and such a large spring may be expected
to deleteriously cause tissue trauma as the needle and sensor were
forcefully inserted into a host.
[0010] This Background is provided to introduce a brief context for
the Summary and Detailed Description that follow. This Background
is not intended to be an aid in determining the scope of the
claimed subject matter nor be viewed as limiting the claimed
subject matter to implementations that solve any or all of the
disadvantages or problems presented above.
SUMMARY
[0011] The present systems and methods relate to systems and
methods for measuring an analyte in a host, and for applying a
transcutaneous analyte measurement system to a host. The various
embodiments of the present systems and methods for applying the
analyte measurement system have several features, no single one of
which is solely responsible for their desirable attributes. Without
limiting the scope of the present embodiments as expressed by the
claims that follow, their more prominent features now will be
discussed briefly. After considering this discussion, and
particularly after reading the section entitled "Detailed
Description," one will understand how the features of the present
embodiments provide the advantages described herein.
[0012] In a first aspect, an applicator is provided for applying an
on-skin sensor assembly to skin of a host, the device including: an
applicator housing configured to secure a disposable housing, where
the disposable housing is configured to receive an electronics
unit, and where the electronics unit is configured to generate
analyte information based on a signal from a sensor, the sensor
including a sensor wire with an electrode contact portion, the
electrode contact portion configured for use in powering the sensor
and transmitting a signal from the sensor to the electronics unit
when the electronics unit is received in the disposable housing;
and a sensor insertion drive configured to insert an indwelling
portion of the sensor wire into a host and to mount the disposable
housing to a portion of the sensor wire and the electrode portion
that is not indwelling, the indwelling portion of the sensor wire
inserted into skin of a host using a needle configured to provide
support and structure to the sensor wire during insertion, the
sensor insertion drive configured to perform an insertion step
where the needle is inserted into skin of the host to deploy the
sensor wire, and a retraction step where the needle is retracted
from the skin of the host, thereby leaving the sensor wire deployed
in the host, and where the needle insertion step and the needle
retraction step are performed so as to provide a predetermined
force profile during the needle insertion and retraction steps.
[0013] Implementations of the embodiments may include one or more
of the following. The predetermined force profile during the needle
insertion step may be defined by an equation such that F=f(x),
where x is a distance the sensor wire is translated from an initial
position. The function f(x) may be defined to be an envelope
between ax2+bx+c and dx2+gx+h. The function f(x) may be a bimodal
curve. The sensor insertion drive may include a crank slider
component, a rack and pinion component, or a barrel cam. The
applicator may further include a trigger configured to, in response
to being activated, cause the insertion component, e.g., a needle
and/or cannula, to insert the sensor into the host. A needle may be
employed to provide column strength to the sensor, e.g., sensor
wire, and a cannula may be employed to provide column strength to
the needle. The trigger may be an activatable button configured to
be operated by a user, such as one mechanically linked to the
insertion component, such that activation of the button forms a
portion of the insertion step or the retraction step, or a portion
of both.
[0014] A spring may be used to perform the insertion step, and
activation of the button may perform the retraction step. The
spring may be a torsion spring. Activation of the button may
perform the insertion step, and a spring may be used to perform the
retraction step. Activation of the button may include depressing a
plunger. The trigger may be an electromechanical element configured
to be activated by a signal received from a transmitter. The
transmitter may include a smartphone running an insertion
application. The insertion component may further include a cannula
to provide additional column strength and isolation to the needle,
where the cannula is disposed within and through at least one seal
in the housing during the insertion step, and where the cannula is
configured to be removed from the seal and housing as part of the
retraction step.
[0015] The sensor insertion drive may include a primary operating
component and a booster component, such that the booster component
is configured to insert additional stored energy into the primary
operating component to remove the cannula from the seal and housing
during the retraction step. The booster component may be a booster
spring. The housing may define at least one hole for passage of the
sensor wire, and the seal may be configured to substantially
isolate the indwelling portion of the sensor wire from the portion
of the sensor wire that is not indwelling. The applicator may
further include a seal carrier in which the at least one seal is
disposed, where the seal is adhered to the seal carrier, including
by overmolding or gluing. The seal carrier may include sidewall
ribs to reduce seal deformation during cannula removal. The seal
carrier may include a spring couple to the seal to reduce seal
deformation during cannula removal. The seal may be bonded to the
seal carrier to inhibit movement of the seal during removal of the
cannula. The seal or the seal carrier or both may define voids
configured to reduce friction between the seal or seal carrier and
the cannula during removal of the cannula.
[0016] At least two pucks may be disposed within the housing to
electrically couple areas of the electrode contact portion to
respective electrodes on the electronics unit, and the pucks may be
configured to reduce friction between the seal or seal carrier and
the cannula, the configuration to reduce friction defined by shaved
or hollowed out portions of the pucks or by voids within the
pucks.
[0017] The seal may be a hybrid seal included of silicone and TPE.
The seal may be a stack seal, where the stack seal is configured to
decouple movement of the sensor wire from movement of the cannula.
The seal may be a sandwich seal, and the sandwich seal may include
a first seal component and a second seal component, where the
cannula is disposed between the first and second seal components.
The seal may be a flow seal, where the flow seal defines a channel
by a channel wall, the cannula being disposed in the channel, and
may further include a lubricant disposed between the channel wall
and an exterior of the cannula. The seal may be an 0-ring seal.
[0018] The applicator may further include a seal support, where the
seal support is configured to inhibit movement of the seal during
removal of the cannula. The seal support may be a spring. The
applicator may further include a sensor wire support, where the
sensor wire support is configured to inhibit movement of the sensor
wire during removal of the cannula. The sensor wire support may be
a spring. The applicator may further include a motor rotationally
coupled to the cannula, such that the motor is configured to rotate
the cannula prior to and during removal of the cannula. The
applicator may further include a cam rotationally coupled to the
cannula, such that the cam is configured to rotate the cannula
prior to and during removal of the cannula, the cam being coupled
to the insertion component and receiving a linear force therefrom.
The linear force may be received from a spring. The linear force
may be received from user activation of a button. The cam may be
configured to rotate the cannula with a cycle time of less than 500
ms.
[0019] The insertion component may be configured to retract the
cannula prior to retraction of the needle, such that a slingshot
effect of the flexible seal causes the seal to strike the needle
rather than the sensor wire. During the insertion step, the
insertion component may be configured such that the needle is
deployed to a first depth and then the sensor wire is deployed to a
second depth, where the second depth is deeper than the first
depth. The applicator may further include an electronics unit
placement spring configured to snap the electronics unit into the
housing during the retraction step. The electronics unit placement
spring may be configured to draw the electronics unit into the
housing. The housing may be configured to secure the electronics
unit by a mechanical connection to an electronics unit bay, and the
electronics unit and electronics unit bay may be configured such
that the electronics unit cannot be removed from the electronics
unit bay without destruction of a portion of the electronics unit
bay, the destruction also destroying the mechanical connection. The
electronics unit may be configured, in response to the trigger
being activated and/or the electrical connection of the sensor to
the electronics unit, to generate analyte information. The housing
may be configured such that the electronics unit cannot be removed
from the housing while the housing is adhered to the skin of the
host.
[0020] A time between sensor insertion into the host and the
electronics unit securing to the housing may be less than about 1
second. At least one contact on the electronics unit may be more
rigid than the sensor, and the electronics unit may be configured
such that, when fully secured to the housing, the at least one
contact presses the sensor into an elastomeric seal such that the
elastomeric seal is compressed and conforms to the sensor.
[0021] The sensor may be configured, after insertion into the host,
to be surrounded by an elastomeric seal, and the electronics unit
may be configured, in response to the electronics unit being
released from a lock, to compress the elastomeric seal to secure
the sensor and to form a seal around the sensor.
[0022] The device may be configured to disengage from the housing
and from the electronics unit in response to the electronics unit
being released from a lock. The device may be configured to provide
one or more tactile, auditory, or visual indications that the
electronics unit has been inserted into the housing to the extent
permitted by a lock. The applicator may further include a trigger
lock configured to prevent activation of the trigger. The
applicator may further include a protective cover configured to
cover the electronics unit and the housing after sensor insertion
and to secure the electronics unit to the housing.
[0023] In a second aspect, a device is provided for applying an
on-skin sensor assembly to a host, including: a needle containing a
removable sensor, the sensor including a sensor wire with at least
two conductive contact points at an ex vivo portion and a sensing
portion at an in vivo portion, the needle configured to be inserted
into a host to deploy the sensor, including to be inserted into a
host to deploy the sensing portion in vivo in the host, and where
the needle is configured to be retracted out of the host following
deployment; a cannula traversing a seal within a disposable
housing, where the needle is configured to be inserted into the
host after passing at least partially through the cannula in a
first direction when deploying the sensor in the host, and where
the needle is configured to at least partially pass through the
cannula in a direction opposite the first direction when the needle
is being retracted out of the host, and where the cannula is
configured to be retracted out of the seal at least partially
during the time the needle is being retracted out of the host;
where the needle insertion and retraction requires a first portion
of a force profile, and where the cannula retraction requires a
second portion of a force profile; and further including one or
more drive components to provide or enable a force exceeding the
force profile during both the first portion and the second
portion.
[0024] Implementations of the embodiments may include one or more
of the following. The one or more of the drive components may
convert rotational force to a linear force. The drive component may
be a scotch yoke, a crank slider, a barrel cam, or a rack and
pinion. The drive component for the first portion of the force
profile may be a scotch yoke, a crank slider, a barrel cam, or a
rack and pinion, and a drive component for the second portion of
the force profile may be a spring. A source of energy for the
rotational force may be a torsion spring. The spring may be
configured to store energy for the second portion of the force
profile by compression or tension. The needle retraction may cause
the cannula retraction. The second portion may have a maximum
greater than a maximum of the first portion. The first and second
portions may be normal curves.
[0025] The disposable housing further may include a septum, where
the sensor wire passes through the septum, and where the septum
provides the sensor wire with a force against removal from the
host. The first and second portions together may form a bimodal
distribution. The one or more drive components may include a first
helical spring configured to perform the first portion of the force
profile, and a second helical spring configured to perform a second
portion of the force profile. A drive component for the first
portion of the force profile may be a scotch yoke coupled to a
torsion spring, and a drive component for the second portion of the
force profile may be a spring, where the device is configured such
that when motion corresponding to the first portion of the force
profile is completed, the wheel of the scotch yoke is prevented
from rotating any further. The wheel of the scotch yoke may be
prevented from rotating any further, neither forwards nor
backwards. The applicator may further include a ratchet component,
where the wheel of the scotch yoke is prevented from rotating any
further due to the ratchet component.
[0026] The seal carrier may include one or more elements configured
to prevent slingshotting of the seal when the cannula is retracted.
The one or more elements may include ribs mounted to the seal
carrier and penetrating at least a portion of the seal.
[0027] The seal may be a hybrid seal. The hybrid seal may include a
first component having a first durometer and a second component
having a second durometer, the second durometer higher than the
first durometer. The material of the first component may be a
thermoplastic elastomer and a material of the second component may
be silicone. The seal may define an empty volume at least partially
surrounding the cannula before the cannula is retracted, and the
seal may be configured such that the empty volume can be at least
partially filled with a lubricant such as petroleum jelly.
[0028] The seal may be configured to define an injection port for
the lubricant, the injection port in pressure communication with
the empty volume. The empty volume may be substantially the shape
of a rectangular solid. The seal may further define two puck voids,
the puck voids substantially cylindrical in shape, and the device
further may include two pucks, the pucks essentially cylindrical in
shape, each puck occupying one of the puck voids, and the cannula
may be situated so as to traverse each puck prior to cannula
retraction. The puck voids may be defined by cored-out sections of
the pucks.
[0029] In a third aspect, a device is provided for depositing a
sensor within a disposable housing, the sensor not pre-connected to
the disposable housing, including: a needle configured to house an
implantable sensor configured to be deposited into a host, the
sensor constituted by a wire and having a proximal end and a distal
end, the sensor held against movement in one direction when
disposed in the needle by a push rod; an applicator in which the
needle is situated, the applicator including at least one latch; a
drive situated within the applicator to insert the needle into the
host, and to retract the needle following insertion; where at a
distal end of travel of the needle, the push rod engages the latch
such that the push rod is maintained in a stationary position
during needle retraction, such that the distal end of the sensor is
deposited into the host and the proximal end of the sensor is
disposed in the disposable housing.
[0030] Implementations of the embodiments may include one or more
of the following. The applicator may further include a cannula, and
the device may be configured such that the needle travels at least
partially through the cannula at least during a portion of the
insertion and retraction. The cannula may be situated within the
disposable housing. The drive may be configured to remove the
cannula during the retraction of the needle. The drive may include
a torsion spring or a booster spring, for example, e.g., and the
booster spring may be configured to perform the retraction. The
drive further may include a rack and pinion, a crank slider, a
barrel cam, or any other suitable mechanism for converting rotary
motion into linear motion. The sensor may be further held against
movement in the needle, in two directions, by a definition of a
kink in the sensor, where the kink provides a frictional point of
contact between an inner wall of the needle and the sensor, e.g.,
in one implementation one or more wires constituting the
sensor.
[0031] The device may further include a seal in the disposable
housing, such that the proximal end of the sensor is disposed in
the seal in the disposable housing upon insertion and retraction.
The sensor wire may be a coaxial wire having a first exposed
portion and a second exposed portion. The seal may define two
voids, and may further include first and second conductive pucks,
each puck disposed in a respective void, such that the first
conductive puck is in signal communication with the first exposed
portion when the sensor wire is inserted in the seal, and such that
the second conductive puck is in signal communication with the
second exposed portion when the sensor wire is inserted in the
seal. The applicator may further include a seal carrier in which
the seal is disposed. The applicator may further include a pushrod
back spring configured to bias the push rod during movement of the
push rod, whereby ambiguity in movement of the pushrod is
removed.
[0032] In a fourth aspect, a wearable portion of a device for
monitoring an analyte is provided, including: a disposable housing
in which a seal carrier may be located, the seal carrier configured
to support at least one seal and to connect to at least one
implantable sensor wire; and a transmitter configured to
frictionally or mechanically couple to the disposable housing, the
transmitter configured to conductively couple to a proximal portion
of the sensor wire; where the disposable housing further includes a
frangible portion, such that once the transmitter frictionally or
mechanically couples to the disposable housing, the transmitter
cannot be removed without removal of the frangible portion. In
other words, once the frangible portion is removed, the transmitter
can no longer be secured to the disposable housing, and a new
disposable housing must be employed.
[0033] Implementations of the embodiments may include one or more
of the following. The frangible portion may form an exterior
perimeter of the seal carrier, and the transmitter may be inserted
adjacent the exterior perimeter.
[0034] In a fifth aspect, a device is provided for depositing a
sensor within a disposable housing, the sensor not pre-connected to
the disposable housing, including: a needle configured to house an
implantable sensor configured to be deposited into a host, the
needle passing through a seal, the sensor constituted by a wire and
having a proximal end and a distal end, the sensor held against
movement in one direction when disposed in the needle by a push
rod; an applicator in which the needle is situated; a drive
situated within the applicator to insert the needle into the host,
and to retract the needle following insertion; and a spring
configured to engage the sensor wire at least when the needle is
removed, such that, upon removal of the needle and the push rod,
the sensor wire is secured against movement caused by movement of
the needle through the seal.
[0035] A number of advantages may be seen by implementation of
arrangements according to present principles. For example, the
implementations lead to consistency in insertion, retraction, and
speed, leading in turn to a more reproducible sensor environment
and in vivo wound response. This in turn may reduce
sensor-to-sensor performance variability, including due to the
effects of outliers, dip and recover faults, and end-of-life
faults. This further enables reduced factory calibration, including
more predictable signal trends at start up, as well as reduced pain
for the patient.
[0036] As one example, a more rapid insertion and retraction step
reduces the potential for the user to move while the needle and/or
the deployment mechanism are in the body. While the time required
for a user to react to pain has been found to be about 0.40 to 1.0
seconds, systems and methods according to present principles may
insert and retract the needle within, e.g., 0.25 seconds, so that
the needle has exited the skin before a user can begin to react.
Systems and methods according to present principles further prevent
variability in the needle/sensor angle due to motion of the user.
In addition, systems and methods according to present principles
reduce the potential for tissue damage and pain due to motion
perpendicular to the needle axis, e.g., that could be imparted by
motion of the user.
[0037] In one aspect, an applicator for applying an on-skin sensor
assembly to skin of a host comprises an applicator housing
operatively coupled to a disposable housing, the disposable housing
being configured to receive an electronics unit, the electronics
unit being configured to generate analyte information based on a
signal from a sensor. The applicator further comprises an insertion
assembly comprising an insertion member, the insertion member being
configured to insert the sensor into the skin of the host, a
resistance member releasably coupled to the insertion assembly, a
first drive assembly containing a first amount of stored energy,
the first drive member being configured to drive the insertion
member in a distal direction to an inserted position, and a second
drive assembly containing a second amount of stored energy. The
second drive member is configured to drive the insertion member in
a proximal direction, and the second amount of stored energy is
sufficient to decouple the resistance member from the insertion
assembly. In one embodiment, the first drive assembly is configured
to drive the insertion member in the proximal direction after the
insertion member reaches the inserted position. In another
embodiment, the first drive assembly is configured to activate the
second drive assembly after the first drive assembly begins driving
the insertion member in the proximal direction. In another
embodiment, the first drive assembly is configured to activate the
second drive assembly when the first drive assembly reaches a
trigger position, the trigger position being proximal of the
inserted position. In another embodiment, the second drive assembly
is configured to decouple the resistance member from the insertion
assembly. In another embodiment, the second amount of stored energy
is sufficient to decouple the resistance member from the insertion
assembly. In another embodiment, the second amount of stored energy
is sufficient to decouple the resistance member from the insertion
assembly and drive the insertion member in a proximal direction to
a retracted position. In another embodiment, the proximal direction
and the distal direction extend along an axis of the insertion
member. In another embodiment, the proximal direction and the
distal direction extend at an angle to a plane of the disposable
housing. In another embodiment, the resistance member is
operatively coupled to the disposable housing. In another
embodiment, the resistance member is frictionally engaged with the
insertion assembly. In another embodiment, the resistance member is
slidably coupled with the insertion assembly. In another
embodiment, the resistance member comprises an elastomer. In
another embodiment, the resistance member comprises a seal. In
another embodiment, the applicator further comprises a carrier
operatively coupled to the disposable housing, the resistance
member being operatively coupled to the carrier. In another
embodiment, the carrier is movably coupled to the disposable
housing. In another embodiment, the insertion member comprises a
needle. In another embodiment, the insertion assembly comprises a
cannula. In another embodiment, the insertion member is configured
to travel through the cannula as the insertion member moves
distally. In another embodiment, the resistance member is
releasably coupled to the cannula. In another embodiment, the
cannula is fixed relative to the disposable housing as the
insertion member moves distally. In another embodiment, the seal
comprises a first portion and a second portion, the first portion
having a first durometer and the second portion having a second
durometer, the second durometer being higher than the first
durometer. In another embodiment, the first portion comprises
silicone and the second portion comprises TPE. In another
embodiment, the cannula is disposed between the first and second
seal components. In another embodiment, the resistance member
defines a channel configured to receive a fluid or gel. In another
embodiment, the applicator further comprises a cam configured to
rotate the cannula about an axis of the cannula. In another
embodiment, a distal end of the insertion member extends distal of
the cannula when the resistance member is decoupled from the
insertion assembly. In another embodiment, the resistance member
comprises a contact surface configured to engage with the cannula,
the contact surface defining one or more voids between the contact
surface and the cannula. In another embodiment, the applicator
further comprises a plurality of conductive elastomeric contacts
disposed within the resistance member, the conductive elastomeric
contacts defining one or more voids between the contact surface and
the cannula. In another embodiment, at least a portion of the
insertion assembly extends through the two conductive elastomeric
contacts. In another embodiment, the resistance member comprises a
contact surface configured to engage with the cannula, and wherein
the conductive elastomeric contacts define one or more voids
between the contact surface and the cannula. In another embodiment,
the resistance member is coupled directly to the insertion member.
In another embodiment, the insertion assembly comprises a support
configured to inhibit proximal movement of the sensor, at least
after the insertion assembly reaches the inserted position. In
another embodiment, the support comprises a pushrod. In another
embodiment, the support comprises a spring. In another embodiment,
the disposable housing comprises a first portion coupled to a
second portion by a frangible member. In another embodiment, the
disposable housing comprises a receptacle configured to receive a
corresponding key of a compatible electronics unit. In another
embodiment, the disposable housing comprises an interference
structure configured to prevent installation of an incompatible
electronics unit in the disposable housing. In another embodiment,
the applicator further comprises a trigger configured to activate
the first drive assembly. In another embodiment, the trigger
comprises an electromechanical element configured to be activated
by a signal received from a transmitter. In another embodiment, the
transmitter comprises a smartphone running an insertion
application. In another embodiment, the applicator further
comprises a safety lock configured to prevent operation of the
trigger. In another embodiment, the safety lock comprises a tab
coupled to the trigger by at least one frangible member. In another
embodiment, the first amount of stored energy exceeds about 1/4 lbf
and the second amount of stored energy exceeds about 1/8 lbf. In
another embodiment, at least one of the first drive assembly and
the second drive assembly is configured to convert rotational
motion into linear motion. In another embodiment, at least one of
the first drive assembly and the second drive assembly includes a
scotch yoke, a crank slider, a barrel cam, or a rack and pinion. In
another embodiment, at least one of the first drive assembly and
the second drive assembly includes a spring. In another embodiment,
at least one of the first drive assembly and the second drive
assembly includes a torsion spring. In another embodiment, the
second amount of stored energy is greater than the first amount of
stored energy. In another embodiment, the applicator further
comprises a ratchet member configured to prevent backdriving of the
first drive assembly. In another embodiment, the sensor comprises a
sensor wire. In another embodiment, the resistance member is
configured to substantially isolate a first portion of the sensor
wire from a second portion of the sensor wire. In another
embodiment, the disposable housing defines at least one opening
configured to allow passage of the sensor. In another embodiment,
the carrier comprises a securement member configured to inhibit
proximal movement of the resistance member. In another embodiment,
the securement member comprises glue. In another embodiment, the
securement member comprises one or more inwardly-extending ribs. In
another embodiment, the securement member comprises a spring. In
another embodiment, the disposable housing is configured such that
the electronics unit, once installed, cannot be removed from the
disposable housing while the housing is adhered to the skin of the
host. In another embodiment, the disposable housing is configured
such that the electronics unit, once installed, cannot be removed
from the disposable housing without breaking the frangible member.
In another embodiment, the sensor comprises a bend configured to
frictionally engage with the insertion member. In another
embodiment, the insertion assembly comprises a needle hub, a
cannula, and a cannula hub, and wherein engagement of the needle
hub with the cannula hub causes the cannula to move in a proximal
direction.
[0038] In another aspect, an applicator for applying an on-skin
sensor assembly to skin of a host comprises an applicator housing
operatively coupled to a disposable housing, the disposable housing
being configured to receive an electronics unit, and the
electronics unit being configured to generate analyte information
based on a signal from a sensor. The applicator further comprises
an insertion assembly comprising an insertion member, the insertion
member being configured to insert the sensor into the skin of the
host, a first drive assembly containing a first amount of stored
energy, the first drive member being configured to drive the
insertion member in a distal direction during a first phase and in
a proximal direction during a second phase, and a second drive
assembly containing a second amount of stored energy, the second
drive member being configured to drive the insertion member in the
proximal direction. The first drive assembly is configured to
activate the second drive assembly during the second phase. In one
embodiment, the drive assembly is self-reversing from the first
phase to the second phase. In another embodiment, a distal end of
the insertion member extends distal of the cannula during the
second phase. In another embodiment, the first drive assembly is
configured to drive the insertion member in the proximal direction
after the insertion member reaches an inserted position. In another
embodiment, the first drive assembly is configured to activate the
second drive assembly during the second phase. In another
embodiment, the first drive assembly is configured to activate the
second drive assembly in response to the first drive assembly
reaching a trigger position during the second phase. In another
embodiment, the applicator further comprises a resistance member,
the resistance member being operatively coupled to the insertion
assembly during the first phase, wherein the second drive assembly
is configured to decouple the resistance member from the insertion
assembly during the second phase. In another embodiment, the second
amount of stored energy is sufficient to decouple the resistance
member from the insertion assembly. In another embodiment, the
insertion assembly comprises a cannula. In another embodiment, the
insertion member is configured to travel through the cannula during
the first phase. In another embodiment, the resistance member is
releasably coupled to the cannula. In another embodiment, the
cannula is fixed relative to the disposable housing as the
insertion member moves distally. In another embodiment, at least
one of the first drive assembly and the second drive assembly is
configured to convert rotational motion into linear motion. In
another embodiment, at least one of the first drive assembly and
the second drive assembly includes a scotch yoke, a crank slider, a
barrel cam, or a rack and pinion. In another embodiment, at least
one of the first drive assembly and the second drive assembly
includes a spring. In another embodiment, at least one of the first
drive assembly and the second drive assembly includes a torsion
spring. In another embodiment, the second amount of stored energy
is greater than the first amount of stored energy. In another
embodiment, the applicator further comprising a ratchet member
configured to prevent backdriving of the first drive assembly.
[0039] In another aspect, a sensor inserter assembly for applying
an on-skin device to a skin of a host, the assembly comprises an
applicator body, a disposable housing releasably coupled to the
applicator body, a sharp configured to place a sensor at least
partially into the skin of the host, a resistance member
operatively coupled to the disposable housing, a separation member
releasably coupled to the resistance member, the separation member
being configured to prevent contact of the sharp with the
resistance member, a deployment assembly configured to cause the
sharp to move from a proximal starting position to a distal
insertion position during a first phase and then to a proximal
retracted position during a second phase, the deployment assembly
being further configured to release the separation member from the
resistance member during the second phase, a first stored energy
component storing sufficient energy to drive the first phase and at
least a first part of the second phase, and a second stored energy
component storing sufficient energy to drive at least a second part
of the second phase. In one embodiment, the second stored energy
component stores sufficient energy to drive the second phase. In
another embodiment, the second stored energy component stores more
energy than the first stored energy component. In another
embodiment, the disposable housing is configured to automatically
release from the applicator body after the separation member is
released from the resistance member. In another embodiment, the
disposable housing is configured to automatically release from the
applicator body in response to the separation member being released
from the resistance member. In another embodiment, the resistance
member is moveable relative to the disposable housing, at least
after the separation member is released from the resistance member.
In another embodiment, the deployment assembly is self-reversing
from the first phase to the second phase. In another embodiment,
the deployment assembly is configured to activate the second stored
energy component during the second phase. In another embodiment,
the separation member is frictionally engaged with the resistance
member. In another embodiment, the separation member is slidably
coupled to the resistance member. In another embodiment, at least
one of the first drive assembly and the second drive assembly is
configured to convert rotational motion into linear motion.
[0040] In another aspect, a method of applying an on-skin sensor
assembly to skin of a host comprises providing an assembly
comprising an applicator housing operatively coupled to a
disposable housing, an insertion assembly comprising an insertion
member, a first drive assembly containing a first amount of stored
energy, and a second drive assembly containing a second amount of
stored energy. The method further comprises activating a trigger of
the assembly, wherein activating the trigger causes the first drive
assembly to drive the insertion member in a distal direction during
a first phase, wherein a sensor is inserted into the skin of the
host, the first drive assembly to drive the insertion member in a
proximal direction during a second phase, wherein the first drive
assembly activates the second drive assembly, and the second drive
assembly to drive the insertion member in the proximal direction
during the second phase. In one embodiment, the method further
comprises installing an electronics unit in the disposable housing,
the electronics unit being configured to generate analyte
information based on a signal from the sensor. In another
embodiment, the assembly further comprises a resistance member
coupled to the insertion assembly. In another embodiment,
activating the trigger causes the second drive to decouple the
resistance member from the insertion assembly during the second
phase. In another embodiment, the second amount of stored energy is
sufficient to decouple the resistance member from the insertion
assembly. In another embodiment, the resistance member comprises a
seal. In another embodiment, the insertion assembly comprises a
cannula. In another embodiment, the second amount of stored energy
is greater than the first amount of stored energy. In another
embodiment, at least one of the first drive assembly and the second
drive assembly is configured to convert rotational motion into
linear motion. In another embodiment, the first drive assembly
activates the second drive assembly in response to the first drive
assembly reaching a trigger position during the second phase.
[0041] In further aspects and embodiments, the above method
features of the various aspects are formulated in terms of a system
as in various aspects, having an applicator configured to carry out
the method features. Any of the features of an embodiment of any of
the aspects, including but not limited to any embodiments of any of
the first through fifth aspects referred to above, is applicable to
all other aspects and embodiments identified herein, including but
not limited to any embodiments of any of the first through fifth
aspects referred to above. Moreover, any of the features of an
embodiment of the various aspects, including but not limited to any
embodiments of any of the first through fifth aspects referred to
above, 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 of the various aspects,
including but not limited to any embodiments of any of the first
through fifth aspects referred to above, 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 or apparatus
can be configured to perform a method of another aspect or
embodiment, including but not limited to any embodiments of any of
the first through fifth aspects referred to above.
[0042] This Summary is provided to introduce a selection of
concepts in a simplified form. The concepts are further described
in the Detailed Description section. Elements or steps other than
those described in this Summary are possible, and no element or
step is necessarily required. This Summary is not intended to
identify key features or essential features of the claimed subject
matter, nor is it intended for use as an aid in determining the
scope of the claimed subject matter. The claimed subject matter is
not limited to implementations that solve any or all disadvantages
noted in any part of this disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] 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.
[0044] FIG. 1 is a schematic view of a continuous analyte sensor
system attached to a host and communicating with other devices.
[0045] FIG. 2 illustrates a force profile curve for sensor
insertion.
[0046] FIG. 3 illustrates a partially exploded view of an
applicator configured in accordance with an embodiment.
[0047] FIG. 4 illustrates another force profile curve for sensor
insertion.
[0048] FIG. 5 illustrates a schematic view of components of an
applicator in accordance with an embodiment.
[0049] FIG. 6 illustrates another partially exploded view of the
applicator configured in accordance with an embodiment of FIG.
3.
[0050] FIG. 7 illustrates an exploded perspective view of the
needle hub assembly of the applicator of FIGS. 3 and 6.
[0051] FIG. 8 illustrates a cross-sectional perspective view of the
needle hub assembly of the applicator of FIGS. 3 and 6.
[0052] FIG. 9 illustrates a perspective view of the cannula hub of
the applicator of FIGS. 3 and 6.
[0053] FIG. 10 illustrates a cross-sectional side view of certain
components of the applicator of FIGS. 3 and 6.
[0054] FIG. 11 illustrates a perspective view of the push rod hub
of the applicator of FIGS. 3 and 6.
[0055] FIG. 12 illustrates a perspective view of the applicator of
FIGS. 3 and 6, with the upper housing removed for purposes of
illustration.
[0056] FIG. 13 illustrates a perspective view of the inner needle
hub engaged with the cannula hub of the applicator of FIGS. 3 and
6.
[0057] FIG. 14 illustrates a cutaway perspective view of the push
rod hub engaged with the needle hub assembly of the applicator of
FIGS. 3 and 6.
[0058] FIG. 15 illustrates a top view of the applicator of FIGS. 3
and 6, with the upper housing removed for purposes of illustration,
and with the torsion spring housing in a first configuration.
[0059] FIG. 16 illustrates another top view of the applicator of
FIGS. 3 and 6, with the upper housing removed for purposes of
illustration, and with the torsion spring housing in a second
configuration.
[0060] FIG. 17 illustrates one way of coupling a sensor wire to
contacts, in accordance with one embodiment.
[0061] FIG. 18 illustrates a side view of the coupling of a sensor
wire with the spring of FIG. 17.
[0062] FIG. 19 illustrates another side view of the spring of FIG.
17.
[0063] FIG. 20 illustrates a perspective view of another
arrangement of a sensor insertion drive in accordance with an
embodiment.
[0064] FIG. 21 illustrates a schematic perspective view of another
applicator in accordance with an embodiment, with the upper and
lower housing removed for purposes of illustration.
[0065] FIG. 22 illustrates a force profile curve for sensor
insertion for the applicator of FIG. 21.
[0066] FIG. 23 illustrates another perspective view of the
applicator of FIG. 21.
[0067] FIGS. 24A, 24B, 24C, and 24D illustrate steps of action of
the applicator of FIG. 21.
[0068] FIG. 25 illustrates a schematic perspective view of another
applicator, configured in accordance with an embodiment, with the
upper housing removed for purposes of illustration, and with the
drive in a first configuration.
[0069] FIG. 26 illustrates another schematic perspective view of
the applicator of FIG. 25, with both the upper and lower housing
removed for purposes of illustration, and with the drive in a
second configuration.
[0070] FIG. 27 illustrates a schematic perspective view of another
applicator, configured in accordance with an embodiment.
[0071] FIG. 28 illustrates a cross-sectional perspective view of
another applicator configured in accordance with an embodiment,
with the upper and lower housing removed for purposes of
illustration.
[0072] FIG. 29 illustrates a cross-sectional side view of another
applicator configured in accordance with an embodiment, with the
upper and lower housing removed for purposes of illustration.
[0073] FIG. 30 illustrates a force profile curve for sensor
insertion for a manual insertion applicator.
[0074] FIG. 31 is a flowchart for steps of sensor insertion in
accordance with an embodiment.
[0075] FIG. 32 illustrates a schematic perspective view of a drive
mechanism for an applicator, configured in accordance with an
embodiment.
[0076] FIG. 33 illustrates a schematic perspective view of another
drive mechanism for an applicator, configured in accordance with an
embodiment.
[0077] FIG. 34 illustrates a schematic perspective view of another
drive mechanism for an applicator, configured in accordance with an
embodiment.
[0078] FIG. 35 illustrates one step in a method for deploying a
sensor into the skin of a patient, in accordance with an
embodiment.
[0079] FIG. 36 illustrates another step in a method for deploying a
sensor into the skin of a patient, in accordance with an
embodiment.
[0080] FIG. 37 illustrates a flowchart for steps of sensor
insertion according to another embodiment.
[0081] FIGS. 38A-C illustrate steps of needle deployment through a
cannula, according to one embodiment.
[0082] FIG. 39 illustrates a perspective view of a disposable
housing and seal carrier, configured in accordance with an
embodiment.
[0083] FIG. 40 illustrates a side view of a transmitter being
inserted into a disposable housing, in accordance with an
embodiment.
[0084] FIG. 41 illustrates a perspective view of a transmitter
configured in accordance with an embodiment.
[0085] FIG. 42 illustrates a partial cross-sectional side view of
an applicator configured in accordance with an embodiment, with the
cannula hub in a distal position.
[0086] FIG. 43 illustrates a partial cross-sectional side view of
the applicator of FIG. 42, with the cannula hub in a retracted
position.
[0087] FIG. 44 illustrates a cross-sectional perspective view of
the disposable housing of FIG. 40, with the seal carrier in a first
orientation.
[0088] FIG. 45 illustrates a detail view of a portion of FIG.
44.
[0089] FIG. 46 illustrates a cross-sectional perspective view of
the disposable housing of FIG. 40, with the seal carrier in a
second orientation.
[0090] FIG. 47 illustrates a perspective view of the disposable
housing of FIG. 40, with a breakaway section being removed so as to
facilitate removal of the transmitter.
[0091] FIG. 48 illustrates a cross-sectional perspective view of
the disposable housing and transmitter of FIG. 40, further
illustrating the breakaway feature of the disposable housing.
[0092] FIG. 49A illustrates a cross-sectional perspective view of a
seal configured in accordance with an embodiment.
[0093] FIG. 49B illustrates a cross-sectional side view of the seal
of FIG. 49A.
[0094] FIG. 49C illustrates a perspective view of the seal of FIG.
49A.
[0095] FIG. 50 illustrates a cored-out puck configured in
accordance with an embodiment.
[0096] FIG. 51 illustrates a cross-sectional perspective view of a
hybrid seal configured in accordance with an embodiment.
[0097] FIG. 52 illustrates another perspective view of the hybrid
seal of FIG. 51.
[0098] FIG. 53 illustrates a cross-sectional end view of the hybrid
seal of FIG. 51.
[0099] FIG. 54 illustrates a bottom perspective view of the hybrid
seal of FIG. 51.
[0100] FIG. 55 illustrates an end view of the hybrid seal of FIG.
51.
[0101] FIG. 56 illustrates a cross-sectional side view of the
hybrid seal of FIG. 51.
[0102] FIGS. 57A-C illustrate cross-sectional side views of a flow
seal configured in accordance with an embodiment, at various stages
of needle and grease insertion.
[0103] FIG. 58 illustrates a schematic end view of the flow seal of
FIG. 57, installed within a seal carrier.
[0104] FIG. 59 illustrates a perspective view of the flow seal of
FIG. 57, installed within a seal carrier.
[0105] FIG. 60 illustrates a perspective view of a ringed seal
configured in accordance with an embodiment.
[0106] FIG. 61 illustrates a top view of the ringed seal of FIG.
60.
[0107] FIG. 62 illustrates a cross-sectional side view of the
ringed seal of FIG. 60, taken along line 62-62 of FIG. 61.
[0108] FIG. 63 illustrates a bottom perspective view of a seal
carrier configured in accordance with an embodiment.
[0109] FIG. 64 illustrates a top perspective view of the seal
carrier of FIG. 63, with a sandwich seal being installed in the
seal carrier.
[0110] FIG. 65 illustrates another perspective view of the seal
carrier and sandwich seal of FIG. 64.
[0111] FIG. 66 illustrates a perspective view of a seal carrier and
sandwich seal configured in accordance with another embodiment.
[0112] FIG. 67 illustrates an end view of the seal carrier and
sandwich seal of FIG. 66.
[0113] FIG. 68 illustrates a side view of the seal carrier and
sandwich seal of FIG. 66, with the sandwich seal being installed in
the seal carrier.
[0114] FIG. 69 illustrates another side view of the seal carrier
and sandwich seal of FIG. 66, with the sandwich seal installed in
the seal carrier.
[0115] FIG. 70 illustrates a perspective view of a stack seal
configured in accordance with an embodiment.
[0116] FIG. 71 illustrates a cross-sectional end view of the stack
seal of FIG. 70.
[0117] FIG. 72 illustrates another perspective view of the stack
seal of FIG. 70, shown coupled to a cannula.
[0118] FIG. 73 illustrates one method of performing sensor wire
capture in a seal carrier, in accordance with an embodiment.
[0119] FIG. 74 illustrates another method of performing sensor wire
capture in a seal carrier, in accordance with another
embodiment.
[0120] FIG. 75 illustrates another method of performing sensor wire
capture in a seal carrier, in accordance with another
embodiment.
[0121] FIG. 76 illustrates another method of performing sensor wire
capture in a seal carrier, in accordance with another
embodiment.
[0122] FIG. 77 illustrates another method of performing sensor wire
capture in a seal carrier, in accordance with another
embodiment.
[0123] FIG. 78 illustrates a perspective view of one example of a
seal, configured in accordance with an embodiment.
[0124] FIG. 79 illustrates a cross-sectional side view of the seal
of FIG. 78.
[0125] FIG. 80 illustrates a perspective view of one example of a
seal, configured in accordance with an embodiment.
[0126] FIG. 81 illustrates a cross-sectional perspective view of
the seal of FIG. 80.
[0127] FIG. 82 illustrates a perspective view of one example of a
seal, configured in accordance with an embodiment.
[0128] FIG. 83 illustrates a cross-sectional side view of the seal
of FIG. 82.
[0129] FIG. 84 illustrates one method of triggering a device for
performing automatic insertion in accordance with an
embodiment.
[0130] FIG. 85 illustrates a transmitter within a housing
configured in accordance with an embodiment.
[0131] FIG. 86 illustrates a perspective view of the applicator
system of FIG. 33, in a second configuration.
[0132] FIG. 87 illustrates a perspective view of an applicator
system, configured in accordance with another embodiment.
[0133] FIG. 88 illustrates a cross-sectional perspective view of
the applicator system of FIG. 87, taken along line 88-88 of FIG.
87.
[0134] FIG. 89 illustrates a top perspective view of an assembled
applicator system, configured in accordance with some
embodiments.
[0135] FIG. 90 illustrates a bottom perspective view of the
applicator system of FIG. 89.
[0136] FIG. 91 illustrates a bottom perspective view of a
disposable housing on an adhesive patch with a removable liner, in
accordance with an embodiment.
[0137] FIG. 92 illustrates a bottom perspective view of a
disposable housing on an adhesive patch with a removable liner, in
accordance with another embodiment.
[0138] FIG. 93 illustrates a perspective view of an applicator
system in accordance with another embodiment, and shown in a first
configuration.
[0139] FIG. 94 illustrates a perspective view of the applicator
system of FIG. 93, shown in a second configuration.
[0140] FIG. 95 illustrates a perspective view of the applicator
system of FIG. 93, shown in a third configuration.
[0141] FIG. 96 illustrates a partial perspective view the
applicator system of FIG. 93, shown in the first configuration with
certain components removed for purposes of illustration.
[0142] FIG. 97 illustrates a partial perspective view of an
applicator system having a protective tab configured in accordance
with a further embodiment.
[0143] FIG. 98 illustrates another example of a protective tab, in
accordance with a still further embodiment.
[0144] FIG. 99 illustrates a top plan view of a needle configured
in accordance with an embodiment.
[0145] FIG. 100 illustrates a side view of the needle of FIG.
99.
[0146] FIG. 101 illustrates a perspective view of a multi-lumen
needle, configured in accordance with an embodiment.
[0147] FIG. 102 illustrates a bottom perspective view of a
transmitter configured in accordance with an embodiment.
[0148] FIG. 103 illustrates a bottom perspective view of a
transmitter configured in accordance with another embodiment.
[0149] FIG. 104 illustrates a cross-sectional top plan view of the
transmitter of FIG. 102, taken along line 104-104 of FIG. 102, with
the transmitter shown installed in a disposable housing in
accordance with an embodiment.
[0150] FIG. 105 illustrates an exploded perspective view of a lower
housing and a disposable housing of an applicator system configured
in accordance with another embodiment.
[0151] FIG. 106 illustrates a top perspective view of the
disposable housing of FIG. 105, having a transmitter installed
therein, in accordance with another embodiment.
[0152] FIG. 107 shows an elevation view of a needle of one
embodiment;
[0153] FIG. 108 shows a plan view of beveled surfaces of the needle
of FIG. 107;
[0154] FIG. 109 shows an elevation view of tubing being bent to
form a needle of another aspect;
[0155] FIG. 110 shows an elevation view of the tubing of FIG. 109
with a primary bevel formed thereon;
[0156] FIG. 111 shows an elevation view of the tubing of FIG. 110
with a secondary bevel formed thereon;
[0157] FIG. 112 shows an enlarged perspective view of the bevels of
FIG. 111;
[0158] FIG. 113 shows a front elevational view (along a central
axis) of the distal end of the bevels of FIG. 111;
[0159] FIG. 114 is a perspective view of a needle of another
embodiment wherein the needle has a slot;
[0160] FIG. 115 is cross-sectional view of the needle of FIG.
114;
[0161] FIG. 116 is a perspective view of another needle with a slot
extending through the distal end of the needle;
[0162] FIG. 117 is a cross-sectional side view of the needle of
FIG. 116;
[0163] FIG. 118 shows a schematic view of a needle configured in
accordance with another embodiment;
[0164] FIG. 119 shows a schematic view of a needle configured in
accordance with another embodiment;
[0165] FIG. 120 shows a schematic view of a needle configured in
accordance with another embodiment;
[0166] FIG. 121 shows a schematic view of a needle configured in
accordance with another embodiment;
[0167] FIG. 122 shows a schematic view of a needle configured in
accordance with another embodiment;
[0168] FIG. 123 shows a schematic view of a needle configured in
accordance with another embodiment;
[0169] FIG. 124 shows a schematic view of a needle configured in
accordance with another embodiment;
[0170] FIG. 125 shows a schematic view of a needle configured in
accordance with another embodiment;
[0171] FIG. 126 shows a schematic view of a needle configured in
accordance with another embodiment;
[0172] FIG. 127 shows a schematic view of a conventional
needle;
[0173] FIG. 128 shows another needle configured in accordance with
an embodiment;
[0174] FIG. 129 shows another needle configured in accordance with
an embodiment;
[0175] FIG. 130 shows a side view of a single bevel needle
configured in accordance with an embodiment;
[0176] FIG. 131 shows a top view of the needle of FIG. 130;
[0177] FIG. 132 shows a side view of another embodiment of a single
bevel needle with a 13 degree bend angle;
[0178] FIG. 133 shows a side view of another embodiment of a single
bevel needle with a 17 degree bend angle;
[0179] FIG. 134 shows a side view of another embodiment of a needle
including a proximal slot to receive a kink of a sensor.
DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS
[0180] The following description and examples illustrate some
example embodiments of the disclosed invention in detail. Those of
skill in the art will recognize that there are numerous variations
and modifications of this invention that are encompassed by its
scope. Accordingly, the description of a certain example embodiment
should not be deemed to limit the scope of the present
invention.
Sensor System and Applicator
[0181] FIG. 1 is a schematic of a continuous analyte sensor system
100 attached to a host and communicating with a number of other
example devices 110-113. A transcutaneous analyte sensor system
comprising an on-skin sensor assembly 600 is shown which is
fastened to the skin of a host via a disposable housing (not
shown). The system 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. During use, a sensing portion of
the sensor 200 is under the host's skin and a contact portion of
the sensor 200 is electrically connected to the electronics unit
500. The electronics unit 500 is engaged with a housing which is
attached to an adhesive patch fastened to the skin of the host.
[0182] 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 inserting the
sensor 200 through the host's skin. Once the sensor 200 has been
inserted, the applicator detaches from the sensor assembly.
[0183] In general, the continuous analyte sensor system 100
includes any 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 receiver which may be e.g., a smart phone, smart watch,
dedicated device and the like. In one embodiment, the analyte
sensor system 100 includes a transcutaneous glucose sensor, such as
is described in US Patent Publication No. US-2011-0027127-A1, the
contents of which are hereby incorporated by reference in its
entirety. In some embodiments, the sensor system 100 includes a
continuous glucose sensor and comprises a transcutaneous sensor
such as described in U.S. Pat. No. 6,565,509 to Say et al., for
example. In another embodiment, the sensor system 100 includes a
continuous glucose sensor and comprises a subcutaneous sensor such
as described with reference to U.S. Pat. No. 6,579,690 to Bonnecaze
et al. or U.S. Pat. No. 6,484,046 to Say et al., for example. In
another embodiment, the sensor system 100 includes a continuous
glucose sensor and comprises a subcutaneous sensor such as
described with reference to U.S. Pat. No. 6,512,939 to Colvin et
al. In another embodiment, the sensor system 100 includes a
continuous glucose sensor and comprises an intravascular sensor
such as described with reference to U.S. Pat. No. 6,477,395 to
Schulman et al., for example. In another embodiment, the sensor
system 100 includes a continuous glucose sensor and comprises an
intravascular sensor such as described with reference to U.S. Pat.
No. 6,424,847 to Mastrototaro et al. Other 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 entireties. The sensor
extends through a housing, which maintains the sensor on the skin
and provides for electrical connection of the sensor to sensor
electronics, provided in the electronics unit.
[0184] In still further embodiments, the system 100 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.
[0185] In one embodiment, the sensor is formed from a wire or is in
a form of a wire. For example, 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
about 0.1 inches, less than about 0.075 inches, less than about
0.05 inches, less than about 0.025 inches, less than about 0.01
inches, less than about 0.004 inches, or less than about 0.002
inches. 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
one embodiment, a conductive wire electrode is employed as a core.
To such a clad 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 can be desirable
to employ a conductive layer comprising conductive particles (i.e.,
particles of a conductive material) in a polymer or other
binder.
[0186] In certain 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 are
resistant to breakage. For example, in some embodiments, the
ultimate tensile strength of the elongated conductive body is from
about 80 kPsi to about 500 kPsi. In another example, in some
embodiments, the Young's modulus of the elongated conductive body
is from about 160 GPa to about 220 GPa. In still another example,
in some embodiments, the yield strength of the elongated conductive
body is from about 60 kPsi to about 2200 kPsi. In some embodiments,
the sensor's small diameter provides (e.g., imparts, enables)
flexibility to these materials, and therefore to the sensor as a
whole. Thus, the sensor can withstand repeated forces applied to it
by surrounding tissue.
[0187] In addition to providing structural support, resiliency and
flexibility, in some embodiments, the core (or a component thereof)
provides electrical conduction for an electrical signal from the
working electrode to sensor electronics (not shown). In some
embodiments, the core comprises a conductive material, such as
stainless steel, titanium, tantalum, a conductive polymer, and/or
the like. However, in other embodiments, the core is formed from a
non-conductive material, such as a non-conductive polymer. In yet
other embodiments, the core comprises a plurality of layers of
materials. For example, in one embodiment the core includes an
inner core and an outer core. In a further embodiment, the inner
core is formed of a first conductive material and the outer core is
formed of a second conductive material. For example, in some
embodiments, the first conductive material is stainless steel,
titanium, tantalum, a conductive polymer, an alloy, and/or the
like, and the second conductive material is conductive material
selected to provide electrical conduction between the core and the
first layer, and/or to attach the first layer to the core (e.g., if
the first layer is formed of a material that does not attach well
to the core material). In another embodiment, the core is formed of
a non-conductive material (e.g., a non-conductive metal and/or a
non-conductive polymer) and the first layer is a conductive
material, such as stainless steel, titanium, tantalum, a conductive
polymer, and/or the like. The core and the first layer can be of a
single (or same) material, e.g., platinum. One skilled in the art
appreciates that additional configurations are possible.
[0188] In the illustrated embodiments, the electronics unit 500 is
releasably attachable to the sensor 200. The electronics unit 500
includes electronic circuitry associated with measuring and
processing the continuous analyte sensor data, and is 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. 2009-0240120-A1 and
U.S. Patent Publication No. 2012-0078071-A1 the contents of which
are hereby incorporated by reference in their entireties. 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. For example, the
electronics unit 500 can include a potentiostat, a power source for
providing power to the sensor 200, other components useful for
signal processing and data storage, and preferably a telemetry
module for one- 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. For example, 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 herein and in U.S. Pat. No. 7,310,544, U.S. Pat. No.
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
entireties.
[0189] One or more repeaters, receivers and/or display devices,
such as key fob repeater 110, medical device receiver 111 (e.g.,
insulin delivery device and/or dedicated glucose sensor receiver),
smart phone 112, portable computer 113, and the like are
operatively linked to the electronics unit, which receive data from
the electronics unit 500, which is also referred to as the
transmitter and/or sensor electronics body herein, and in some
embodiments transmit data to the electronics unit 500. For example,
the sensor data can be transmitted from the sensor electronics unit
500 to one or more of key fob repeater 110, medical device receiver
111, smart phone 112, portable computer 113, and the like. In one
embodiment, a display device includes an input module with a quartz
crystal operably connected to an RF transceiver (not shown) that
together function to transmit, receive and synchronize data streams
from the electronics unit 500. However, the input module can be
configured in any manner that is capable of receiving data from the
electronics unit 500. Once received, the input module sends the
data stream to a processor that processes the data stream, such as
described in more detail below. The processor is the central
control unit that performs the processing, 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, downloading data, and controlling the
user interface by providing analyte values, prompts, messages,
warnings, alarms, and the like. The processor includes hardware
that performs the processing described herein, for example
read-only memory (ROM) provides permanent or semi-permanent storage
of data, storing data such as sensor ID (sensor identity), receiver
ID (receiver identity), and programming to process data streams
(for example, programming for performing estimation and other
algorithms described elsewhere herein) and random access memory
(RAM) stores the system's cache memory and is helpful in data
processing. An output module, which may be integral with and/or
operatively connected with the processor, includes programming for
generating output based on the sensor data received from the
electronics unit (and any processing that incurred in the
processor).
[0190] In some embodiments, analyte values are displayed on a
display device. In some embodiments, prompts or messages can be
displayed on the display device to convey information to the user,
such as reference outlier values, requests for reference analyte
values, therapy recommendations, deviation of the measured analyte
values from the estimated analyte values, or the like.
Additionally, prompts can be displayed to guide the user through
calibration or trouble-shooting of the calibration.
[0191] Additionally, data output from the output module can provide
wired or wireless, one- or two-way communication between the
receiver and an external device. The external device can be any
device that interfaces or communicates with the receiver. In some
embodiments, the external device is a computer, and the receiver is
able to download current or historical data for retrospective
analysis by a physician, for example. In some embodiments, the
external device is a modem, and the receiver is able to send
alerts, warnings, emergency messages, or the like, via
telecommunication lines to another party, such as a doctor or
family member. In some embodiments, the external device is an
insulin pen, and the receiver is able to communicate therapy
recommendations, such as insulin amount and time, to the insulin
pen. In some embodiments, the external device is an insulin pump,
and the receiver is able to communicate therapy recommendations,
such as insulin amount and time to the insulin pump. The external
device can include other technology or medical devices, for example
pacemakers, implanted analyte sensor patches, other infusion
devices, telemetry devices, or the like. The receiver may
communicate with the external device, and/or any number of
additional devices, via any suitable communication protocol,
including 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, GPRS, ANT, and/or a
proprietary communication protocol.
[0192] Certain aspects of applicators systems are described in U.S.
Patent Publication No. 2013-0267811-A1 and U.S. Pat. No. 7,497,827;
both of which are owned by the assignee of the present application
and herein incorporated by reference in their entireties.
[0193] In particular, the implementations described in the
applications incorporated by reference above depict systems and
methods of applying a transcutaneous sensor into a patient and
situating sensor wires within a housing to which the transmitter is
attached. In some cases a torsion spring provides the force
required for the system to perform the steps, and energy is
similarly stored in the torsion spring, which is preloaded prior to
shipping. However, in other implementations, it may be desirable to
add to the force provided by the torsion spring, or to replace the
torsion spring altogether with another source of force. One reason
for doing so is that in the above implementation the torsion spring
is shipped and stored in the preloaded or constrained
configuration, and is thus subject to loss of spring force over
time. In addition, use of a previously-constrained torsion spring
(or any similar single spring) leads to a reduced spring force at
the end of the spring movement due to Hooke's Law, F=-kx, where x
is the distance from the equilibrium position. That is, at the end
of the spring movement, x is close to zero, and thus so is the
force.
[0194] The below described implementations generally discuss
sensors constituted by one or more sensor wires. However, it will
be understood that the sensors are not limited to such wire shaped
or linear arrangements. Rather, the sensors may be implemented as
planar sensors, volumetric sensors, point sensors, or in other
shapes as will be understood given this description.
[0195] For example, and referring to FIG. 2, the line 12 represents
the spring force given by Hooke's law above, and curve 14
represents the forces required during performance of the insertion
steps above. Where the force required exceeds that available from
the spring, e.g., in section 16, the system is unable to provide
the necessary force. Larger spring forces may be provided by larger
or stiffer spring, e.g., see line 12', but the same are associated
with other difficulties, such as tissue damage when such a large
force is caused to propel a needle into a host, and are moreover
difficult to implement within small housings, as are desired.
[0196] Various other types of applicators may thus be employed, and
are described below. Such applicators endeavor to tailor the
applied force such that the stored force is available and applied
as required. Specific examples will be given below with regard to
specific applicators. In general it will be desired to have more
force available than is required by any given force profile. It is
also noted that a typical force profile has a bimodal distribution,
e.g., has at least two maxima, as may be seen by the bimodal
distribution of FIG. 2. The first maximum, e.g., a first portion of
the force profile, is caused by the force required to have the
needle entering the skin of the host. Once the skin has been
penetrated, the force decreases because the interstitial tissue is
easier to pass through. Thus this force is in the direction of
propagation, e.g., the insertion direction, of the needle. The next
maximum, e.g., a second portion of the force profile, is caused by
retraction, and in particular a retraction of the needle and/or
cannula, which is a force in the opposite direction from that of
the insertion direction. Thus, while for convenience two positive
maxima are shown in the figure, i.e., each indicated by positive
force values, it will be understood that these maxima pertain to
forces acting in opposite directions.
[0197] In one implementation, as shown in FIG. 3, a torsion spring
is used for an insertion step, e.g., a first portion of the force
profile, while another drive mechanism, which can be different from
a torsion spring, is used for a retraction step, e.g., a second
portion of the force profile. In an insertion step, a needle and
sensor are inserted in a host; in a retraction step, the needle is
removed, as well as a cannula, as will be described. In FIG. 3, the
drive mechanism is a helical spring, also termed a "booster"
spring, preloaded so as to be stored in a compressed state. The
preloading provides the energy necessary for the spring to perform
expansion and thus cause retraction of the needle and the
cannula.
[0198] A force profile for the device of FIG. 3 is shown by the
graph 22 of FIG. 4. In the graph 22, the same bimodal force
distribution 14 as in FIG. 2 may still be seen, with the first hump
corresponding to needle insertion, with a majority of the force
needed for skin penetration, and the second hump corresponding to
cannula and needle retraction. In this case, however, at or near
the start of the retraction step, the booster spring is activated,
leading to the rise in force shown from line 12'' to line 18, which
rise then exceeds the force required for the cannula and needle
retraction. As the booster force is provided by a spring, the force
profile (line 18) of the spring follows the form F=-kx. In some
cases, including in the exemplary device shown in FIG. 3, force
from the torsion spring may be arrested, and the retraction force
entirely provided by the booster spring. In other implementations,
both the torsion spring and the booster spring may be involved in
providing retraction forces.
[0199] The applicator of FIG. 3 will be described in detail below,
but initially it is noted that the same includes a number of
interoperating components, and these are diagrammed schematically
in FIG. 5. In particular, an applicator housing is described
generally, but with particular regard to FIGS. 3 and 6. Most of the
operations performed by the applicator pertain to a seal carrier 26
and components thereof. The operations generally relate to sensor
wire insertion performed by a sensor insertion drive mechanism,
which is described in FIGS. 7-16, with variations described in
subsequent figures, e.g., FIGS. 20-38. The drive mechanism
generally but not always includes a primary drive component, e.g.,
a torsion spring, and a booster component, e.g., a booster spring.
While components often perform multiple functions, the same may be
divided very generally into insertion components and retraction
components, with the former being detailed in FIGS. 3, 6, and 7-11.
Exemplary elements pertaining to insertion are listed in FIG. 5.
Elements pertaining generally to retraction are shown in FIGS.
13-16, and exemplary elements therein are also listed in FIG. 5.
The above is intended to be a general and nonlimiting description,
however. For example, in one implementation, a needle and cannula
constitute insertion component that play a key role in insertion of
a sensor, but the same are also key components to be retracted once
a sensor is inserted.
[0200] Referring in more detail now to FIG. 3, the device 20
includes an upper or top applicator housing 30 and a lower or
bottom applicator housing 40. The upper housing 30 and the lower
housing 40 both form a portion of a disposable device, including
all of the components illustrated within and between the upper
housing and the lower housing. In use, the upper housing is mounted
to the lower housing and the same are shipped as a single unit,
with a torsion spring and a booster spring (both in a preloaded
state). Other types of drive mechanisms, which may be preloaded or
not, are also described below. Here the term "preloaded" or
"pre-load" refers to a drive mechanism that, if activated, performs
a desired drive step. For example, a spring that is not in an
equilibrium state may be either compressed or expanded, and each of
the states may be referred to as "preloaded". A torsion spring may
be wound such that, if released, provides a torque on an element
about an axis. Such winding is considered here a form of
preloading.
[0201] The device 20 is intended to perform steps of inserting a
sensor, generally embodied by a sensor wire, into a patient, in
vivo, the sensor wires extending out of the patient and coupled to
an ex vivo disposable housing, the ex vivo disposable housing
adhered to the skin of a patient. A transmitter (not shown in FIG.
3) may then be snapped onto the disposable housing. The transmitter
has electrical contacts which when snapped onto the disposable
housing make contact with respective conductive pucks through which
the sensor wires pass, the sensor wires having respective windows
in their insulation and thus each sensor wire is electrically
coupled to a different puck.
[0202] A seal carrier 26 is illustrated in FIG. 3, and on the seal
carrier 26 is situated a seal 24. The seal 24 performs various
functions, including protecting the sensor wire from moisture,
providing a reliable electrical connection, allowing an accurate
sensor placement during insertion and retraction steps, and
retaining the sensor wire, i.e., providing a secure connection to
the sensor wire in order to prevent cases where a disposable
housing is removed but a sensor wire stays within the body.
[0203] Two holes 34a and 34b are defined within the seal 24, and
within the holes are situated the conductive pucks (not shown in
FIG. 3). The seal carrier 26, seal 24, and a disposable housing 36
are the elements within FIG. 3 which remain with the patient after
use of the applicator (along with sensor/sensor wire, not shown).
The seal carrier 26 and the seal 24 rotate about a hinge 28 which
also serves to couple the seal carrier 26 to the disposable housing
36 which is removably mounted to a lower surface of the lower
housing 40. A detail of the disposable housing 36 and seal carrier
26 may be seen in FIG. 39, which shows the seal 24 and the seal
carrier 26 in the same position as in FIG. 3, i.e., situated at an
approximately 45.degree. angle to the bottom surface of the lower
housing 40. The disposable housing 36, seal carrier 26, and seal 24
are held in this position by a number of features described below.
However, once the sensor wire has been installed in the patient and
the cannula 78 and cannula hub 32 have been retracted, the seal
carrier 26 and seal 24 can rotate about the hinge 28 and rest
within the disposable housing 36 (e.g., generally parallel to or
within the plane of the disposable housing 36). In some
embodiments, the seal carrier 26 can be rotated down manually by
the user. Alternatively, in some embodiments, a spring 38
(described in greater detail below) or other biasing member may be
employed to cause the seal carrier 26 and the seal 24 to transition
from being disposed at an angle to the base of the lower housing 40
to a resting position within (e.g., parallel to or within the plane
of) the disposable housing, either simultaneously with the release
of the disposable housing from the applicator housing, or before or
after release of the disposable housing from the applicator
housing.
[0204] Referring now to FIG. 6 along with FIG. 3, an exemplary
drive component is described with respect to the pictured
components. It will be understood that variations of these
components and steps are encompassed within the scope of the
current specification.
[0205] A user may situate the applicator 20 in a desired location
on their skin, and may remove protective tab 42, allowing access to
button 44. Depression of the button 44 then starts the process of
insertion.
[0206] In particular, depression of the button 44 operates to
disengage the trigger tab 46 from a corresponding stop 49 on a
torsion spring housing 52. With reference to FIG. 15, the trigger
tab 46 becomes disengaged through translation of the button linkage
56 as the button 44 is depressed. The button 44 and/or the button
linkage 56 can be biased upward such that, following the
disengagement of the trigger tab 46 from the stop 49 and activation
of the applicator 20, the button 44 is urged to return to its
original position.
[0207] In embodiments, the protective tab 42 can function as a
safety mechanism or lock, preventing depression of the button 44
(and thus, activation of the system) until after the protective tab
42 is separated and/or removed from the housing 30. In embodiments,
the protective tab can include one or more members which extend
beyond the perimeter of the button 44, over the surface of the
applicator housing 30, so as to prevent depression of the button 44
until after the protective tab (or at least the portions which
extend beyond the perimeter of the button 44) is removed. In
embodiments, the protective tab can be coupled to the applicator
housing 30 by one or more frangible elements which are configured
to break when the tab is pressed up, down, sideways, or when the
protective tab is twisted or pulled. The frangible element(s) can
be configured to break upon application of a force between about
1.0 and 1.8 pounds. In some embodiments, the frangible element(s)
can be configured to break upon application of a force between
about 1.3 and 1.5 pounds. Depending on the desired user
interaction, the protective tab can be configured to be removed via
a twisting motion, a sweeping motion, a bending motion, or a
pulling motion. In some embodiments, for example as illustrated in
FIG. 6, the protective tab 42 can extend straight upward from the
applicator housing 30, for example along a median plane of the
system (e.g., in a plane perpendicular to the plane of the
disposable housing 36).
[0208] In some embodiments, the protective tab and/or the button
can include one or more visual or tactile features configured to
indicate to a user the appropriate method of removal. For example,
the protective tab can include arrows, protrusions, ridges, and/or
tacky grips to indicate the location and direction in which the
user should press on (or pull or twist) the tab to break the
frangible member. FIG. 97 illustrates an applicator system 20a
configured in accordance with one such embodiment, with a
protective tab 42a having ridges 43a, 43b disposed on one side
thereof, so as to indicate to the user that the tab 42a should be
bent to the left side in order to break the protective tab 42a off
of the housing 30. In another example, the protective tab can
extend at an angle from the applicator housing, e.g., tilted
upward, downward, or to the left or right side, so as to indicate
the direction in which the user should press on (or pull or twist)
the tab to break the frangible member. FIG. 98 illustrates a
protective tab 42b configured in accordance with one such
embodiment, in which the protective tab 42 curves to the right as
it extends away from the housing, so as to indicate to the user
that the tab 42a should be bent to the right side in order to break
the protective tab 42b off of the housing.
[0209] With reference again to FIG. 6, once the trigger tab 46
disengages from the torsion spring housing stop 49, the torsion
spring housing 52 is free to rotate under the force provided by the
preloaded torsion spring 54. As the torsion spring housing 52 has a
tab 58 which engages with and moves within the yoke 62 of a scotch
yoke mechanism, rotational movement of the torsion spring housing
52 is translated into longitudinal motion of various components in
the applicator. The yoke 62 of the scotch yoke mechanism is
integral with an outer needle hub 66, and the two are referred to
here as yoke/needle hub assembly 64. An inner needle hub 68 moves
within the outer needle hub 66, and the two are shown in an
expanded configuration in FIG. 7, which also shows a needle 72 and
a booster spring 74. The sensor wire is deployed through a lumen 76
in the needle 72.
[0210] FIGS. 8 and 9 illustrate the assembly 64 with respect to the
inner needle hub 68 and a cannula hub 32 in which a cannula 78 is
mounted. The needle 72 passes through the cannula 78 in the
deployment of the sensor. The cannula 78 passes through the seal
carrier 26, seal 24, and pucks 82 to provide a passage for the
needle 72 during sensor insertion. The cannula 78 is removed from
the seal carrier, seal, and pucks, as part of the insertion
sequence, and in particular is removed by the force of the booster
spring 74. FIG. 10 illustrates a side view of the various
components described.
[0211] The sensor wire may have a kink defined so as to allow a
friction fit within the needle. In this way, the sensor wire is
held within the needle while still able to be translated through
the needle by the force of the push rod. Generally, the kink may be
configured so as to hold the wire within the needle, but in the
case where the wire is external of the needle, and in the cannula,
the kink would not be able to hold the sensor wire within the
cannula, or would only be able to hold it to a minimal degree.
[0212] FIGS. 11 and 12 illustrate a push rod hub 84 in which a push
rod 86 is situated. The push rod hub 84 is situated below the yoke
62 and its arms 88a and 88b extend around the assembly 64 and in
particular around the outer needle hub 66. In an insertion phase,
the push rod hub 84 travels with the yoke/needle hub assembly 64 in
the distal direction because the push rod hub has tabs 124a and
124b (see FIG. 11) at distal ends of its arms 88a and 88b that
engage slots 126a and 126b on the yoke/needle hub assembly 64 (see
FIG. 7).
[0213] The push rod 86 is inserted in the needle proximal of the
sensor, and after sensor insertion, holds the sensor in place
(e.g., in position) while the needle and cannula are retracted. The
push rod 86 can hold the sensor in place, e.g., in vivo, as the
push rod is caused to be stationary at the distal end of its
travel, i.e., the push rod stays in place (e.g., remains fixed or
in the same position) while the needle and cannula move proximally
around it. The push rod hub 84 is described in greater detail
below.
[0214] In use the force of the torsion spring causes the
yoke/needle hub assembly 64 including the outer needle hub 66, to
move downward, i.e., distally, i.e., towards the seal carrier 26.
The inner needle hub moves along with the outer needle hub in this
downstroke because of the engagement of tab 91a and 93a with slot
94a (and a corresponding tab with a corresponding slot on the
opposite side of the assembly 64). By engaging the tab 91a and 93a
of the inner needle hub 68 with the locking features of the slot
94a in the outer needle hub 66 (and engaging a corresponding tab
with a corresponding slot on the opposite side of the assembly 64)
during assembly of the component, the spring 74 becomes compressed
and thus preloaded during assembly. When the inner needle hub is
caused to disengage from the outer needle hub, as will be
described, the force of the spring 74 expanding causes the inner
needle hub to move away from the outer needle hub in a proximal
direction.
[0215] Referring to FIG. 13, the cannula hub 32, which is initially
stationary with respect to the applicator, has two arms 96a and 96b
with a proximal end 98 defining two catches. A distal end 102 of
the inner needle hub 68 is shown engaged in the first catch, which
may be an initial position of the components prior to button
activation. The distal end 102 of the inner needle hub 68
disengages from the first catch and moves into the second catch 104
when the inner needle hub 68 and the cannula hub 32 move towards
each other, and more particularly when the inner needle hub 68
moves towards the cannula hub 32, which occurs when the torsion
spring and the scotch yoke mechanism force the assembly 64 downward
towards the cannula hub 32.
[0216] At or near the lowest point of travel of the scotch yoke
mechanism, two tabs 106 of the push rod hub 84 (only one is shown
in FIG. 11) move past respective stops 108 of the bottom housing 40
(only one is shown in FIG. 6), causing the tabs to initially
compress towards the center of the push rod hub, and to flare out
when the tabs are distally past the stops, restricting the travel
of the push rod hub in a proximal direction. In other words, the
push rod and push rod hub are arrested from traveling in the
proximal direction, as portions of the remainder of the assembly
do, when the scotch yoke mechanism begins its proximal return path,
e.g., the retraction phase.
[0217] In some embodiments, push rod backspring elements 112 (FIG.
11) are disposed at the distal extremity of the arms of the push
rod hub. With the push rod hub 84 in a distal position, the push
rod backspring elements 112 are biased against stops 114 of the
bottom applicator housing 40 (FIG. 6), such that the push rod hub
is substantially arrested from all movement including vibrations.
In particular, it is noted that to move the push rod hub into a
distal position and lock it in place (e.g., to fix it in a distal
position), the tabs 106 (which form hooks that may be deflected)
pass stops 108 (also termed catches) on the bottom applicator
housing 40. The hooks are deflected inward (e.g., toward the push
rod) as they pass the catches during the down or distal travel of
deployment. To ensure that the hooks 106 are set in the catches 108
for the retraction phase of deployment, a minimum amount of over
travel is required. This over travel results in an ambiguity in
push rod location. Since placement accuracy is defined by the push
rod, such ambiguity may be deleterious. A deflected member, e.g.,
the push rod back spring elements 112, are employed which compress
during the down travel of the push rod hub at the distal end. When
the deployment reverses, the push rod back spring provides a
holding force bias for the push rod against the catch. This removes
the ambiguity for push rod location, as well as deleterious effects
such as vibrations. As the push rod hub and push rod are now fixed
at the most distal end of their travel, the sensor is disposed in
the host in its deepest and final position.
[0218] The torsion spring continues to rotate the wheel, causing
the yoke to begin to move in the proximal direction, while the push
rod hub remains fixed. The motion of the yoke in the proximal
direction, in combination with the arrested push rod hub, activates
the booster spring to retract the needle and cannula in the
following fashion. In one implementation the amount of rotation
remaining in the torsion spring after the pin 58 reaches its lowest
point is 5% to 20% of its overall rotation, e.g., 10%.
[0219] First, and referring to FIG. 14, the push rod hub 84
disengages from the yoke/needle hub assembly 64 by the tabs 124a
and 124b being forced outward by the effect of ramps on the surface
of the yoke/needle hub assembly 64 and/or the tabs 124a and 124b
themselves, or both.. While the needle is being pulled out of the
host, the sensor is being deposited into the same, as the push rod
is now fixed in a distal position and backstops or holds the sensor
in place (e.g., resists proximal movement of the sensor).
[0220] Next, two ramps 116 (see FIG. 11, in which only one ramp of
the two is visible) are provided on an internal surface of the push
rod hub 84. As the push rod hub 84 is stationary once it has
reached its lowest (most distal) point of movement, but the outer
needle hub (yoke/needle hub assembly 64) is not, as the yoke/needle
hub assembly 64 begins to move proximally in the retraction phase,
the ramps 116 deflect release tab 92a (as well as corresponding tab
on the opposite side of the assembly 64; see FIG. 13), deflecting
the release tab 92a and the locking tab 91a, 93a inward toward the
needle and disengaging the locking tab 91a and 93a from the slot
94a (and serving the same function on the opposite side of the
assembly 64). This action releases the spring and forces the inner
needle hub upward in the proximal direction by the force of the
booster spring, one end of which being attached to the inner needle
hub and the other end attached to the stationary outer needle hub.
As shown in FIG. 13, the inner needle hub 68 is coupled to the
cannula hub 32, although at this point the distal end 102 is within
the second catch 104. Nevertheless, the distal end 102 cannot
disengage from the cannula hub 32, and thus the cannula hub is
retracted at the same time as the needle. Because the distal end
102 is within the second catch 104, i.e., because two catches are
provided, the needle can be configured to be proud of the cannula
by, e.g., 0 to 150 mils, e.g., 100 mils, or even negative. Benefits
ensue to such systems, as will be described below with respect to
seals and seal slingshotting. In some cases the needle need not be
proud of the cannula in the retraction phase.
[0221] As described above, at this point the scotch yoke mechanism
is now beginning to drive in a proximal direction. However, as the
initial preloading of the torsion spring caused the distal movement
of the yoke, in some cases the force of the booster spring can act
to re-load or "back drive" the torsion spring. Accordingly, in such
implementations a ratchet mechanism can be employed to arrest
movement of the torsion spring. In particular, and referring to
FIG. 15, the torsion spring housing 52 is shown in the initial
configuration where rotation of the same is locked by the trigger
tab 46, and the torsion spring (not shown) is in its fully loaded
state. The torsion spring housing 52 has a ratchet pawl 48 which is
prohibited from rotating (in the counterclockwise direction as
illustrated in FIG. 15) by the trigger tab 46. Once the trigger tab
46 is moved out of the way of the torsion spring housing stop 49
(e.g. by depression of the button 44), the torsion spring housing
52 becomes free to rotate (in the counterclockwise direction as
illustrated in FIG. 15) until the ratchet pawl 48 engages within
the ratchet teeth 136 and/or the torsion spring housing stop 49
hits the hard stop 47. In the configuration shown in FIG. 15, the
pin 58 for the scotch yoke is at its top dead center position,
i.e., at its starting position.
[0222] FIG. 16 shows the configuration as the booster force pushes
on the pin 58 in the direction of the arrow 138. As the direction
of rotation caused by the torsion spring is counterclockwise, i.e.,
the booster force is pushing on the pin in a clockwise direction,
there is a potential for back driving the torsion spring.
Engagement of the ratchet pawl 48 within the ratchet teeth 136 can
serve to inhibit or prevent such back driving. In one
implementation, the device is configured such that the booster
spring is triggered after the ratchet pawl 48 is engaged with the
ratchet teeth 136. In this way, any forces on the pin 58 caused by
the booster force do not result in back driving of the torsion
spring. It is noted that in the position shown in FIG. 16, the
needle has almost been extracted out of the host, but the cannula
has not yet been retracted.
[0223] Engagement of the ratchet pawl 48 is with the ratchet teeth
136 inhibits or prevents clockwise rotation or back driving of the
torsion spring housing 52. Similarly, abutment of the stop 49
against the hard stop 47 inhibits or prevents further
counterclockwise rotation of the torsion spring housing 52. Motion
of the pin 58 is thus also arrested, stopping movement of the
scotch yoke mechanism, including the outer needle hub. The needle,
however, continues to retract, as the same is driven by the booster
spring on the inner needle hub. As described above, movement of the
inner needle hub further causes retraction of the cannula hub. In
this way the cannula and the needle are fully retracted through the
seal by the booster spring. As the cannula hub and cannula are no
longer supporting the seal carrier, the same is free to rotate (by
the effect of gravity) into the disposable housing. In many cases,
it is desirable to include a push spring 38 to assist this motion,
the push spring held up by the cannula hub 32 until the same is
removed and the seal carrier is ready to drop down into the
disposable housing 36, as described in greater detail below. In
some embodiments, one or more retention features 166 of the lower
housing 40 can be employed to prevent the disposable housing 36
from being released from the housing 40 until after the cannula has
been retracted from the seal. In some embodiments, the rotation of
the seal carrier can facilitate the release of the retention
feature(s) 166, allowing the disposable housing to separate from
the device 20. Once the inner needle hub is in a fully retracted
position, the sensor has been placed in the body and the applicator
can be removed leaving the disposable housing assembly.
[0224] Advantages of implementations of the device of FIGS. 3-16
may include one or more of the following. The device has high
usability, a smooth sine wave mechanism motion as caused by the
scotch yoke, and a capability to tune or control the resulting
forces.
[0225] With reference now to FIG. 89, a top perspective view of the
assembled device 20 is illustrated, showing the upper housing 30
coupled to the lower housing 40, with the protective tab 42 intact
over the button 44, prior to deployment of the device 20. FIG. 90
shows a bottom perspective view of the assembled device 20 prior to
deployment. As can be seen in FIG. 90, the upper housing 30 and the
lower housing 40 can be coupled together by mating studs 31 and
holes 41. In the embodiment illustrated in FIGS. 89-91, the studs
31 extend from the upper housing 30 and the holes 41 form part of
the lower housing 40, but other configurations (e.g., the reverse
configuration) are possible. In some embodiments, the upper housing
30 and the lower housing 40 can be coupled together using an
interference fit between the studs 31 and the holes 41. In some
embodiments, the studs 31 and holes 41 can be staked together,
e.g., thermoplastically or heat staked together.
[0226] FIG. 90 also illustrates an adhesive patch 90 disposed on a
lower (distal, or base) surface of the lower housing 40. The
adhesive patch 90 includes a removable liner 80 which covers and
protects the adhesive of the adhesive patch 90 until removed by the
user prior to deployment. In embodiments, the adhesive can comprise
a pressure-sensitive or pressure-activated adhesive. In
embodiments, the base of the lower housing 40 can comprise a rigid
or semi-rigid surface which can be configured to facilitate
activation of the adhesive on the adhesive patch 90, at least in
the region of the patch surrounding the disposable housing, as the
applicator device 20 is placed or pressed against the skin. In some
embodiments, the lower or base surface of the lower housing 40 can
be smooth (either flat or slightly contoured) to as to provide
uniform activation throughout the extent of the adhesive, at least
in the region of the patch surrounding the disposable housing. In
other embodiments, the lower or base surface of the lower housing
40 can include one or more dimples, protrusions, ridges, or other
relief features to ensure activation of the adhesive in certain
regions, e.g. near the outer edge of the patch 90 and/or in the
region immediately surrounding the disposable housing. In some
embodiments, the lower or base surface of the lower housing 40 can
be sized and shaped with a larger footprint than the patch 90
(e.g., such that the base surface of the lower housing 40 extends
beyond the adhesive patch 90 in one or more directions, in the
plane of the disposable housing 40). Such a configuration can help
to prevent undesirable folding or wrinkling of the patch 90.
[0227] With reference now to FIG. 91, a bottom perspective view of
one example of an adhesive patch 90a is shown, having a disposable
housing 36 disposed thereon and having a removable liner 80a
disposed on its opposing surface. The removable liner 80a comprises
a first portion 81a having a release tab 83a which is folded back
away from the patch 90a, and a second portion 85a having a release
tab 87a which is also folded back away from the patch 90a. The
release tabs 83a, 87a are shown separated from one another for
purposes of illustration. The liner 80a includes an opening 89a
through which a needle and sensor can pass during the insertion
process. In the embodiment illustrated in FIG. 91, the first
portion 81a can extend across a roughly equal portion of the
surface area of the patch 90a as the second portion 85a, such that
the first portion 81a and the second portion 85a meet at the center
of the adhesive patch 90a, at or adjacent to the opening 89a.
[0228] With reference now to FIG. 92, a bottom perspective view of
another example of an adhesive patch 90b is shown, having a
disposable housing 36 disposed thereon and having a removable liner
80b disposed on its opposing surface. The removable liner 80b
comprises a first portion 81b having a release tab (not visible in
FIG. 92, but disposed against the opposing surface of the release
tab 87b) which is folded back away from the patch 90b, and a second
portion 85b having a release tab 87b which is also folded back away
from the patch 90b. The liner 80b includes an opening 89b through
which a needle and sensor can pass during the insertion process. In
the embodiment illustrated in FIG. 92, the first portion 81b can
extend a larger portion of the surface area of the patch 90b than
the second portion 85b, such that the first portion 81b and the
second portion 85b meet away from the center of the adhesive patch
90b and away from the opening 89b.
[0229] The sensor wire itself may have one or more contact regions,
e.g., corresponding to an outer silver layer and an inner platinum
layer, separated by a polyurethane layer. It will be understood
that the specific constituents of these conductive and insulator
layers may vary according to implementation. The conductive regions
may be accessed either directly (in the case of contact with the
outer silver layer) or via removal of the silver and polyurethane
layers to obtain access to the platinum layer.
[0230] The wire may include a generally ex vivo portion and a
generally in vivo section, both of which being about and
approximately 1/2 inch in length. The ex vivo portion may include
electrical contact points, and the in vivo portion may include a
sensing portion, which may be at the distal tip of the in vivo
portion or may be proximal of the distal tip of the in vivo
portion. A transmitter may be employed which has electrical
contacts (not shown) which contact first and second pucks. As the
wire also contacts the pucks, the wire is in signal communication
with the transmitter. To ensure that each puck contacts a separate
portion of the wire, the insulated portion of the wire may be
disposed between the pucks. In this way, a first contact, e.g., the
silver portion, makes contact with the first puck, and a second
contact, e.g., the platinum portion, makes contact with the second
puck. In one implementation, the diameter of the pucks is about 80
mils, and the distance between the pucks is about 215 mils.
[0231] FIGS. 17-19 illustrate another arrangement in which robust
connections may be made from a sensor wire to the transmitter. In
particular, a seal carrier 26 is illustrated having spring
connectors 133a and 133b. Each spring 133 includes a compression
section 129 and an extension section 131. The spring 133 is
generally metallic, e.g., stainless steel, copper, and so on, and
may be plated with a coating, such as gold, nickel, etc. In use
within the seal carrier, the springs 133 take the place of the
pucks 123 and 125 described above. In the arrangement shown in FIG.
17, the top portion of the spring is the compression section 129
and functions to provide pressure against the transmitter contact
for a robust connection. The bottom section 131 is an extension
spring and as such is configured to pull the coils together in the
relaxed state. The coils in the extension section are held apart
during insertion (as well is partially during retraction) by the
cannula 78. When the cannula is removed, the coils relax and
contract onto the sensor wire 117, holding the same in place with a
strong frictional connection, connecting the sensor wire to the
spring.
[0232] The implementation of FIGS. 17-19 has advantages in the
reduction of movement-induced noise in the signal for long-duration
sessions, e.g., over 10 days.
[0233] In one alternate implementation of an applicator according
to present principles, a wearable device, such as is embodied in
the disposable housing 36 and transmitter (described below), may be
deployed in a host using systems and methods described in the
applications incorporated by reference above, and in particular as
disclosed in the applications incorporated by reference above. For
example, in the applications incorporated by reference, a sensor
wire is inserted through the cannula into a host, and the wire is
sealed with an elastomeric seal which is compressed by transmitter
insertion.
[0234] In the above implementation of FIGS. 3-16, a supplemental
source of stored energy, i.e., a separate booster spring, was
disclosed to provide a supplemental force to ensure that all steps
of insertion and retraction could be accomplished effectively,
i.e., that the force applied was generally always greater than the
required force profile during both of the insertion and retraction
steps (see FIG. 2). A main source of force, spring 54, provided a
source of energy for an insertion force and even for a portion of a
retraction force, particularly with respect to an insertion
component such as the needle. A secondary source of force, spring
74, provided a source of energy for a retraction force,
particularly for an insertion component such as a cannula. The
additional retraction force was in part necessary because the
insertion component, e.g., the cannula, was being retracted through
a source of resistance, e.g., an elastomeric seal. While a single
large or larger spring may also be employed to accomplish the same
function, the use of such deleteriously increases the size of the
applicator. Thus, to ensure a compact applicator, particularly for
usage by children or small adults, the implementation of FIGS. 3-16
provides a more advantageous alternative.
[0235] In embodiments employing a booster spring, the booster
spring can be fired when the needle is fully inserted, and can be
configured to facilitate the retraction of the needle/cannula
assembly, leaving the sensor behind and installed in the sensor
pod. A considerable amount of force, however, may be released upon
firing of the booster spring. This force can result in a large
acceleration of the inner needle hub against the cannula hub,
possibly creating vibrations or amplifying any existing oscillation
in the mechanism. In embodiments, various design parameters of the
booster spring can be adjusted to change the acceleration curve of
the spring and thereby reduce or avoid any sudden acceleration when
it is fired. Embodiments can thus reduce or avoid any vibration
imparted to the mechanism by the booster spring during retraction
and provide safe and reliable retraction. For example, some
embodiments can employ a variable pitch booster spring, a variable
diameter (e.g., cone-shaped) booster spring, a variable diameter
wire booster spring, or multiple booster springs (e.g., one inside
another, or multiple springs in series) to achieve these goals. In
addition, different materials and/or material processing techniques
can be used to obtain the desired spring constant and thereby
achieve these goals.
[0236] Generally, the implementation of FIGS. 3-16 provides an
alternative in which additional force is provided by a supplemental
source of stored energy, the additional force allowing a more
effective insertion and retraction. Other implementations will also
be understood that supply additional force in a compact design, and
several of these are described below with respect to FIGS. 28 and
34. However, to accomplish the same goal of an effective insertion
and retraction, other alternative methodologies may also be
employed. These include having a user supply a portion of the force
necessary for insertion and retraction, and these are termed manual
or semi-manual alternatives, and several of these are described
below as well, and in particular with respect to FIGS. 21-24. In
yet another alternative methodology, applicator mechanisms may be
made more efficient, or may be configured differently, with the
added efficiency or different configuration negating the need for
an additional force, or otherwise reducing the requirements of the
force profile, such as for easing removal of the cannula. Several
of these alternatives are also described below, with respect to
FIGS. 20, 25-27, 32 and 33. Systems and methods described below
address various of these possibilities. In some cases, a
combination of techniques may be employed to perform the requisite
insertion and retraction steps. For example, FIGS. 29-31 illustrate
an implementation in which additional force may be supplied, where
the system may be made more efficient, and where user force may be
employed.
[0237] As an example of a system configured to obviate any need for
an additional force, and referring in particular to FIG. 20, the
sensor wire may be pre-inserted through a cannula into a seal. In
FIG. 20, for example, the sensor wire is inserted through a cannula
that passes through the seal 24 which is situated on the seal
carrier 26. In this case there is no need to use the transmitter
insertion force to perform the sealing, although the transmitter
insertion force may still be employed to stabilize the seal and the
sensor wire system. Moreover the systems and methods of, e.g., the
application Ser. No. 13/826,372 incorporated by reference above,
and in particular the applicator of FIGS. 3A and 3B therein, may be
employed to insert wires into the seal systems described here.
[0238] One difference between the implementation of FIG. 20 and
that of FIGS. 3-16 is that only one spring 142 is included in the
implementation of FIG. 20. And in the case of FIG. 20, the one
spring is a coiled or helical wire spring, as opposed to the clock
spring 54 of FIG. 6. It is noted in this regard that a clock spring
or power spring generally provides a flatter torque performance
curve in the working range of the spring, and the k factor can be
lower than in a coil wire spring. However, any spring can be used
that provides a torsional force, including both wire springs and
clock springs. Further, any suitable mechanism can be used which is
configured to transform rotational force into linear force. The
solutions described in this specification improve on many of the
devices of the prior art as prior art devices generally do not
perform so many actions with just one or two springs, e.g., needle
and sensor insertion, needle retraction, cannula retraction, and
the like. Advantages of the implementation of FIG. 20 include high
usability and a smooth sine wave mechanism motion as caused by the
scotch yoke.
[0239] As an example of the use of manual or semi-manual or
user-supplied force, and referring in particular to FIG. 21, a
scotch yoke 144 coupled with a torsion spring may be used for
insertion, as in the prior implementation, but a separate manual
force may be provided for one or more individual steps. In FIG. 21,
for example, the retraction step may be performed manually, instead
of with the use of a booster spring. In particular, a button 146 is
coupled to a bar 154 which is configured to arrest rotation of the
wheel 144 until the button 146 is moved in a proximal direction.
For example, movement of the bar may push aside a peg or stop which
had previously prohibited rotation of the wheel. Other techniques
will also be understood.
[0240] Once the button 146 is moved in a proximal direction, the
bar 154 no longer arrests rotation of the wheel 144, and in the
same way as described above, the needle and sensor wire may be
inserted into the host using the force of a torsion spring (not
shown) coaxial with the wheel 144. In particular, a yoke 158 is
illustrated which may be driven downward by rotation of the wheel
144, propelling the needle and sensor into the host. This aspect is
also illustrated in FIG. 24, in which an initial movement of the
button 146 to the right, causing the transition from FIG. 24A to
FIG. 24B, also causes the yoke 158 to move towards the button (to
the left in the figure). The push rod mechanism as described above
or in the applications incorporated by reference may be employed to
maintain the sensor in the host during needle retraction. The
needle may be retracted by the manual retraction button or by
continued rotation of the torsion spring and wheel 144 employing
the yoke 158. As shown in FIG. 24B, the lowest point of the yoke is
illustrated by the yoke 158 in dotted lines, while the initial
retraction of the needle is shown by the yoke in solid lines. To
retract the cannula, the button 146 may be moved so as to engage
the yoke; by continuing movement to the right, as shown in FIGS.
24C and 24D, the cannula may be removed from the seal and seal
carrier. Manual cannula retraction may be particularly useful as it
is generally the step requiring the most force. FIG. 23 illustrates
an applicator 160 employing manual retraction.
[0241] The button 146 may be provided with indentations biased in a
way to assist the user in moving the button in the direction
indicated by arrow 152 (see FIG. 21), e.g., so as to remove the
needle and cannula from the seal system, seal carrier, and
housing.
[0242] FIG. 22 illustrates the resulting force profile. In an
initial portion of movement, indicated by the segment 12'', the
force profile is the same as that of the spring 12 because the same
type of spring is causing the movement. In the retraction phase,
however, the force available rises to line 154, exceeding that
necessary to perform the remainder of the motions called for by the
steps. While a constant level of force is indicated by the line 154
in FIG. 22, it will be understood that, being caused by a manual
mechanism, the same is essentially arbitrary and is limited only to
the force with which a user can bring to bear on the button
146.
[0243] Other ways may also be employed of converting rotational
energy stored in a torsion spring (and thus resulting in a
rotational force) into the more linear translation required in a
sensor deposition system. Put another way, one basic requirement of
an applicator system is that the same be configured to perform an
insertion of a sensor transcutaneously, such that a portion of the
sensor is in vivo in the interstitial space in a host (the distal
portion) and a portion of the sensor (the proximal portion) is ex
vivo. In some cases the sensor may have sufficient column strength
and a sharpened end so as to be able to penetrate the skin itself
using systems and methods disclosed here or in applications
incorporated by reference. In other cases, including in most
implementations disclosed here, a needle is used for insertion of
the sensor, and the sensor travels with the needle during insertion
and is maintained in vivo while the needle retracts, i.e., leaving
the sensor in place. In other cases as will be described the needle
is used to perform insertion but the sensor wire has sufficient
column strength to penetrate even deeper than the needle, through
the patient's interstitial area.
[0244] Thus a general required motion applicable to most
embodiments is that of insertion and retraction, i.e., insertion to
insert the needle and sensor assembly, and retraction to remove the
needle. In some cases, greater column strength is provided to the
needle, and the needle motion itself is significantly eased, by
incorporation of a cannula, which is generally a hypotube. For
example, and as in FIGS. 3-16, rather than having the needle
penetrate a seal, the cannula may be stationary within the seal
during insertion, such that the needle can easily move through the
cannula to perform the sensor insertion step. However, to effect
the seal, the cannula is to be removed, and the same often
encounters a significant removal force as the cannula is to be
removed from an elastomer seal. To reduce the number of motions
required, in many implementations the cannula is removed at the
same time as the needle. For example, with respect to the
implementation of FIGS. 3-16, the cannula hub latches onto the
inner needle hub which is propelled in a proximal direction by the
booster spring. In this way the cannula is removed. In all of these
implementations, however, a back-and-forth linear motion is
required. If energy is stored via a torsional spring, then
conversion from rotational force to linear force is also required.
In the above implementations a scotch yoke was conveniently used.
However, other devices and techniques may also be employed. So long
as the back-and-forth motion can be performed, the remainder of the
system may be as described above with respect to the applications
incorporated by reference above or with respect to the
implementations of FIGS. 3-16. For example, in any implementation,
on the downward (distal) or initial stroke, a push rod hub may be
included to maintain a sensor in place by latching onto a portion
of the housing at a distal end of its travel. In the same way, a
needle hub may latch onto a cannula hub to allow removal of the
cannula where such is included. In embodiments incorporating a
cannula hub, the bond force between the cannula hub and the cannula
itself can be greater than about 5 pounds, greater than about 10
pounds, or greater than about 20 pounds, to avoid separation of the
cannula from the cannula hub as the cannula is retracted from the
seal. Extrapolations to other implementations will also be
understood.
[0245] As an example of an implementation in which overall
efficiency is increased, thus negating the need for an additional
force or driving mechanism or source of stored energy, and
referring to FIG. 25, an applicator 224 may include a crank slider
mechanism 222 which translates rotational force to linear force in
the same way as a crank slider on a sewing machine translates
linear motion to rotational motion. In FIG. 25 the crank slider is
driven from the bottom. In FIG. 26, the crank slider is driven from
the top, and in particular the crank slider 228 is driven by
rotation of the wheel 226. The crank slider 228 may be coupled to a
point location on the needle/hub assembly 232 or may be coupled
within a yoke 234 thereof.
[0246] Without wishing to be bound by theory, it is believed that
crank slider mechanisms are generally more efficient than scotch
yoke mechanisms, and subsequently result in a reduction of energy
losses during the deployment cycle. In some implementations, crank
slider mechanisms may be employed without a booster spring, because
of the reduction of energy losses. As in FIGS. 3-16, a similar
button latch system may be employed to arrest rotational movement
until such time as a user has activated the button, at which time
the crank slider mechanism can be employed to insert and retract
the needle and/or cannula in a similar fashion as described
above.
[0247] In the same way, and for the same purpose of increasing
efficiency of the device, and referring to the device 242 in FIG.
27, a rack and pinion mechanism may be employed to provide the
reciprocating or back-and-forth motion. In particular, a rack 244
is coupled to the outer needle hub, indicated by the yoke 248 in
the figure. Of course, the attachment for coupling between the rack
244 and the outer needle hub need not be a yoke, but can be any
sort of attachment. A pinion 246 is shown, having teeth 252 on only
one portion. Rotation of the pinion 246 caused by, e.g., a torsion
spring, thus causes movement of the rack 244. As shown, if the
pinion 246 were to rotate clockwise under the influence of the
torsion spring, the teeth 252 of the pinion 246 would engage teeth
254 on the rack, driving the rack downward. As the pinion 246
continues to rotate, the teeth 252 eventually engage teeth 256 on
the rack, driving the rack (and that which it is attached to)
upward in a proximal direction, completing the motions required to
perform sensor and needle insertion and needle retraction. The
remainder of the configuration may be as described above in FIGS.
3-16.
[0248] One exemplary benefit to the rack and pinion mechanism is
that the same may in some implementations have benefits over the
scotch yoke mechanism. For example, scotch yoke mechanisms
typically have points in their cycles of low torque and high
torque, which can make them susceptible to stalling in places where
a large amount of torque is required. A rack and pinion mechanism
generally provides a more constant torque and may overall be more
efficient in transferring the torsional spring energy to linear
motion.
[0249] As another example of an implementation in which additional
force is supplied, FIG. 28 illustrates another mechanism which may
be employed to perform a reciprocating back and forth motion for
purposes of insertion and retraction. In particular, the applicator
262 includes an outer needle hub 266 containing a first compression
spring 272, and an inner needle hub 268 containing a second
compression spring 274. In one implementation, the spring 272 is
maintained until use in a compressed state, and the spring 274 is
also maintained until use in a compressed state. The spring 272 may
be coupled to the outer needle hub at a proximal point, and the
spring 268 may be coupled to the inner needle hub at a distal
point.
[0250] Activation of the trigger may then cause the release and
subsequent extension of the spring 272, driving the needle with
sensor into the host. In the same way as described above, with
regard to activation of the booster spring e.g., using a push rod
hub which latches into a portion of the applicator housing, the
spring 274 may be activated, causing retraction of the needle out
of the host, while leaving a portion of the sensor within.
[0251] FIG. 29 illustrates another implementation 264 of a drive
mechanism, this implementation employing just a single compression
spring 278 within the applicator 276. In this implementation, the
spring 278 provides both a down insertion force (distally, into the
body) and an upward retraction force, (proximally, away from the
body), and has the manufacturing benefit of eliminating a part as
compared to the implementation of FIG. 28. In this case the spring
278 is held in a preloaded fully compressed state. A distal wall
277 holding the spring against expanding in a distal direction is
then removed, or moved distally, and the spring thus expands by
driving off a proximal wall 279, which holds the spring against
expanding in the proximal direction. The spring releases
approximately half its stored energy to drive the needle into the
body in this insertion step. The spring is now still half loaded
with the distal wall in the bottom position. The proximal wall is
then released to use the second half of the spring energy to drive
the needle (and cannula, if used in a given implementation) in a
proximal direction away from the distal wall.
[0252] Besides manual retraction, another implementation includes a
step of user preload. This implementation may be a variant of the
single compression spring. However, for manual insertion, the
spring may be placed on the shelf in the half loaded state. The
initial input of the force by the user pressing the plunger fully
loads the spring. Then the release is identical to the single
spring implementation described above with respect to FIG. 29.
[0253] One benefit to the implementation of manual insertion is
that only a single coaxial spring is required, thus significantly
reducing costs. In use, a user would depress the plunger against
the resistance of the spring, in the same way as a button on a
ballpoint pen is compressed against a spring. No activation of a
needle occurs until the bottom of travel is reached by the plunger.
When at the bottom of travel, the spring releases, and the needle
and push rod are pushed forward under the skin. This position is
maintained until the user releases the plunger at which time the
plunger retracts, pulling the needle and cannula back and
depositing the sensor. As in the other implementations, the push
rod may stay in the distal or bottom position, causing the sensor
to be deposited into the host. The user may then remove the
applicator and install a transmitter.
[0254] Advantages to the implementation of user preload insertion
include lower-cost and fewer components, as well as the avoidance
of partial deployments, as no activation occurs until the user
fully depresses the plunger. Another significant advantage to
manual insertion is that the spring is not fully preloaded, but
rather half-loaded by the user right before activation. In this
way, problems with sizing components for sustained loads in plastic
components, such as creep, are avoided.
[0255] An exemplary force profile is illustrated by the graph 210
in FIG. 30, in which it is seen that only half-force is exerted
until the plunger is at the bottom extent of travel, as shown by
segment 202, but at that point (point 212) the force increases to a
maximum, caused by the spring being compressed to a maximum
displacement (F=-kx.sub.max). The spring then relaxes as it
expands, shown by segment 204, and the resulting force decreases
linearly. At point 208 the user releases the plunger, causing
additional spring force to enter into the system, indicated by the
rise of force in graph 210. The force continues to decay, as shown
by segment 206, as the spring expands towards equilibrium. The
force is then employed to retract the cannula as well as the
needle. As may be seen, the available force exceeds that required
through all points of the insertion and retraction.
[0256] A method of use is illustrated by the flowchart 214 of FIG.
31, in which a first step is that a user depresses a button plunger
(step 216). No action occurs until the button reaches its bottom of
travel. At the bottom of travel, the spring releases, which inserts
the needle, sensor, and push rod (step 218). Upon removal of the
user pressure on the plunger, the same begins moving in the
opposite direction, causing retraction of the needle, as well as a
cannula (step 222), in embodiments where a cannula is included. In
some cases the user depression of the plunger may provide the force
required to insert the needle and sensor. The sensor deploys as the
pushrod inhibits sensor movement during needle retraction.
[0257] The implementations of FIGS. 28 and 29, as well as manual
insertion, in some cases provide certain benefits over the scotch
yoke mechanisms described above. In particular, the torsional
spring in the scotch yoke mechanism sometimes cannot provide enough
energy to perform all deployment functions. In FIGS. 28 and 29 and
manual insertion, the use of compression springs provides a
unidirectional assembly process which is convenient for automation.
In the implementation of FIG. 28, dedicated springs for "needle in"
and "needle/cannula out" functions allow the springs to be custom
designed and tuned according to the system requirements. In
addition, the same may be associated with certain assembly and
manufacturing advantages.
[0258] FIG. 32 illustrates another implementation of a drive
mechanism, this implementation allowing an even wider range of
movements and motions of component parts. In particular, the drive
mechanism 302 includes a barrel cam 306 having an axle 304 which
may be driven by, e.g., a torsion spring or by user motion. The
implementation of FIG. 32 may be particularly advantageous in
addressing the problem of moving multiple components, which
depending on implementation, are required to change direction to
perform sensor insertion. A barrel cam may be employed which
contains multiple tracks which control the movement of each
component independently of each other, and as such may be more
reliable and controlled. In this way, the implementation of FIG. 32
may be made particularly efficient.
[0259] The barrel cam 306 performs the conversion of rotational
force to linear or translational or longitudinal force. The barrel
cam 306 includes one or more channels, shown as channels 308, 312,
and 314. Parts such as the outer needle hub, inner needle hub, a
cannula hub, push rod hub, and the like, are driven by
corresponding nubs which a ride within the channels or tracks of
the barrel 306. In particular, nub 316 is driven by rotation of the
channel 308. Nub 318 is driven by rotation of the channel 312. Nub
322 is driven by rotation of the channel 314. The linear positions
of the needle hub, push rod hub, and cannula hub, can be controlled
by the shapes of the tracks in the barrel cylinder. In this way,
component parts may be inserted and retracted as needed, without
the need for hub drop offs. As the cylinder rotates, each of the
hubs move linearly independently from one another.
[0260] FIG. 33 illustrates yet another implementation of a high
efficiency drive mechanism, this drive mechanism 324 including a
wheel 326 configured to cooperate with a first yoke 328 and a
second yoke 332 to facilitate the insertion and retraction
processes in a similar way to that described in FIGS. 3-16. The
first yoke 328 is operatively coupled to a needle hub 340 and a
push rod hub 338, and the second yoke 332 is operatively coupled to
a cannula hub 342. The rotation of the wheel 326 may be driven by,
e.g., a torsion spring, for example as described herein in
connection with FIG. 6. However, in this implementation, the wheel
326 has a first pin 334 extending therefrom which is configured to
engage with the first yoke 328 during at least a portion of the
rotation of the wheel 326, and a second pin 336 extending therefrom
which is configured to engage with the second yoke 332 during at
least another portion of the rotation of the wheel 326. . In the
embodiment illustrated in FIG. 33, the first pin 334 and the second
pin 336 are disposed at different radii about the center of the
wheel 326. In the configuration illustrated in FIG. 33, the push
rod hub 338 is fixed with respect to (e.g., locked to) the first
yoke 328 and the needle hub 340, for example as described above in
connection with the embodiment illustrated in FIGS. 7 and 11. As
the wheel 326 rotates in a clockwise direction, under influence of
the torsion spring, the pin 334 pushes the first yoke 328 and the
needle hub 340 in a distal direction as it travels within first
yoke 328. As illustrated in FIG. 86, as (or after) the first pin
334 begins moving in a distal direction, continued rotation of the
wheel 326 causes the second pin 336 to engage with (e.g., enter)
the second yoke 332. At this stage the push rod hub 338 is
disengaged from the needle hub 340 such that the needle hub 340 can
move in a proximal direction as the push rod hub 338 remains in a
distal position. As the second pin 336 travels within the second
yoke 332, it pulls the second yoke 332 in a proximal direction,
away from the seal carrier 26 and disposable housing 36, thus
performing retraction steps. In other words, in this
implementation, the wheel 326 causes the first yoke 328 to perform
insertion and the second yoke 332 to perform retraction. Such a
configuration can provide the ability to precisely set different
insertion and retraction forces as desired, using a single torsion
spring. The mechanical advantage of the cam wheel can thus be tuned
to the available spring force.
[0261] In the embodiment illustrated in FIGS. 33 and 86, the first
pin 334 remains engaged with the first yoke 328 as the second pin
336 engages the second yoke 332 and throughout the insertion and
retraction processes. Other configurations are possible, however,
in which the first pin disengages from the first yoke before or
after the second pin engages with the second yoke. In embodiments,
one or both ends of the first yoke 328 can be open, allowing the
pin 334 to engage with (e.g., enter) and/or release from (e.g.,
exit) the first yoke 328 at the desired rotational position(s) of
the wheel 326. Similarly, one or both ends of the second yoke 332
can be open, allowing the pin 336 to engage with (e.g., enter)
and/or release from (e.g., exit) the second yoke 332 at the desired
rotational position(s) of the wheel 326. In the embodiment
illustrated in FIGS. 33 and 86, the second pin 336 is disposed at a
larger radius of the wheel 326 than the first pin 334, and extends
from the underside of a radially-extending arm of the wheel 326. In
other embodiments, the second pin can be disposed at the same or
smaller radius than the first pin. In still other embodiments, the
same pin can be configured to engage with the first yoke and the
second yoke during separate portions of the wheel's rotation.
[0262] FIGS. 87 and 88 illustrate a drive mechanism 350 according
to a further embodiment. The drive mechanism 350 includes a wheel
352 configured to cooperate with a yoke 358 to facilitate the
insertion and retraction processes in a similar way to that
described in FIGS. 3-16. The yoke 358 is operatively coupled to a
needle hub 356 and a push rod hub 354, as well as to a cannula hub
362. The rotation of the wheel 352 may be driven by, e.g., a
torsion spring, for example as described herein in connection with
FIG. 6. However, in this implementation, as illustrated in FIG. 88,
the drive mechanism 350 also includes a booster spring 364
configured to facilitate the cannula retraction process. In the
configuration illustrated in FIGS. 87 and 88, the push rod hub 354
is fixed with respect to (e.g., locked to) the needle hub 356, for
example in a similar fashion as described above in connection with
the embodiment illustrated in FIGS. 7 and 11. As the wheel 352
rotates in a clockwise direction, under influence of the torsion
spring, the pin 360 travels within yoke 358 and pushes the needle
hub 356 in a distal direction, while the cannula hub 362 remains
stationary (e.g., fixed in place or position). After the pin 360
reaches its most distal position, continued rotation of the wheel
352 causes the pin 360 to travel in the opposite direction in the
yoke 358 and pull the yoke 358 and the needle hub 356 in a proximal
direction. At this stage the push rod hub 354 is disengaged from
the needle hub 356 such that the needle hub 356 can move in a
proximal direction as the push rod hub 354 remains fixed or locked
in a distal position. At the same time or shortly thereafter, a
release member is activated which releases the cannula hub 362 from
engagement with the base of the lower housing 40, thereby actuating
the booster spring 364. As the booster spring 364 expands, it
pushes the cannula hub 362 away from the seal carrier 26 and
disposable housing 36, thus facilitating the retraction process in
conjunction with the torsion spring. Such a configuration can also
provide the ability to precisely set different insertion and
retraction forces as desired. Variations of booster springs may
also be employed, which implementations use similar mechanisms as
those shown in FIGS. 3-16. As noted above in some cases the wheel
cam can be made larger and the needle may be fully inserted and
retracted by the torsion spring. The booster spring may be linked
independently to the cannula hub and may fire while the needle is
still in motion and being driven by the wheel. The wheel cam may be
smaller in this implementation because it does not fully retract
the needle from the seal. The booster is fired when the torsion
spring has finished its travel. The booster spring is attached to
the needle hub and drives the needle (which picks up the cannula
and cannula hub) on the way out of the seal.
[0263] Referring now to FIGS. 93-96, an applicator device 20c (with
its upper housing and other components removed for purposes of
illustration) is illustrated which is configured in accordance with
an alternative embodiment. FIG. 93 illustrates the device 20c in a
resting state, prior to deployment. The device 20c includes an
outer needle hub 66c, an inner needle hub 68c, and a push rod 86c.
The device 20c further includes a disposable housing 36c and a seal
carrier 26c having a two-part configuration. The seal carrier 26c
includes a first portion 27 which is operatively coupled to the
disposable housing 36c at a hinge 28, at least prior to deployment
of the device 20c. The seal carrier 26c also includes a second
portion 29 which is coupled to both the push rod 86c and a needle
72 and which, prior to deployment, is disposed separate from and
proximal of the first portion 27. The second portion 29 includes at
least one seal 24. The first portion 27 and the second portion 29
are both disposed at the same angle with respect to the plane of
the disposable housing 36c.
[0264] During the insertion process, the outer needle hub 66c, the
inner needle hub 68c, and the push rod 86c move together in a
distal direction, along with the second portion 29 of the two-part
seal carrier 26c. The second portion 29 slidingly engages with the
first portion 27 and ultimately snaps into engagement with the
first portion 27. At this stage, the needle 72 and the sensor wire
are deployed into the patient's skin.
[0265] In configurations with a two part seal carrier negative
interactions affecting force required or sensor positioning (e.g.
friction or seal recoil) are prevented. This is accomplished by
negating relative movement between the sealing member and needle
during the insertion phase of the cycle. This also has the
additional benefit of lowering component count (e.g. deleting the
cannula) and holding a smaller lumen in the seal which may have
sealing benefits.
[0266] FIG. 94 illustrates the device 20c just after deployment,
with the outer needle hub 66c, the inner needle hub 68c, and the
push rod 86c having been driven in a distal direction, for example
by a drive mechanism including a torsion spring, a scotch yoke
mechanism, a booster spring, and/or any other suitable drive
mechanism, for example as described herein. Under the continued
influence of the torsion spring (or other drive mechanism), the
inner needle hub 68c begins to retract and pull the needle 72 in
the distal direction, while the outer needle hub 66c and the push
rod 86c remain fixed in a distal position. As illustrated in FIG.
95, a booster spring 74 can be activated at this stage to
facilitate the retraction process, in conjunction with the torsion
spring. Once the needle 72 is retracted from the seal 24, the seal
carrier 26c is rendered free to rotate downward (e.g., under the
force of gravity or spring force) into a deployed position, ready
to receive a transmitter.
[0267] FIG. 34 illustrates another implementation according to
present principles, in which additional energy is supplied, and in
which a dual spring variant is used. In this case, dual constant
force springs 192 and 194 are employed instead of compression or
tension springs. Use of constant force springs generally provides a
different output force curve.
[0268] In all of the implementations noted, when the cannula 78 is
removed from the seal 24, a deleterious phenomenon termed
"slingshotting" may occur, and many of the efforts of systems and
methods according to present principles are directed towards
reduction or elimination of slingshotting. In particular, when the
cannula is removed, the seal, which is generally made of an
elastomer, is pulled by the cannula due to friction at the point of
contact (actually a cylinder of contact). Thus, a cylindrical
portion of the seal, generally in the interior of the seal and
adjacent the cannula, is temporarily pulled by the cannula during
cannula removal.
[0269] As the cannula emerges from the seal, the lack of frictional
"pull" of the cannula on the seal causes the seal to rebound in the
distal direction. Depending on configuration, the rebounding
("slingshotting") seal may frictionally contact the sensor wire
and/or needle and force the same forward, having a deleterious
effect on placement of the contact points on the sensor wire
vis-a-vis the contact pucks. For example, the slingshotting can
result in a change of position of over 100 mils, and to this is
compared the diameter of the pucks, which may be, e.g., 80 mils,
and the distance between the pucks, which may be, e.g., 215
mils.
[0270] Some ways to combat seal slingshotting include modification
of the seal to reduce its frictional contact with the cannula.
These ways are discussed below. Another way to combat seal
slingshotting is to perform an action with the cannula to ease its
removal from the seal, or at least to perform an action that causes
the seal to slingshot less. Referring to FIGS. 35 and 36, one such
method is to rotate the cannula during removal. In both figures,
the cannula 78 is caused to rotate by the torsion spring 406, but
it should be noted that the rotational force on the cannula may be
caused by a number of different components, including by use of a
cam rotationally coupled to the cannula. In FIG. 35, a cannula
drive 402 is disposed at an end of the cannula, and the same is
shown as being driven by the torsion spring 406 through a linkage
408. In FIG. 36, the cannula 78 is caused to rotate by the cannula
drive 404 disposed on a side of the cannula, and the same is driven
by a linkage 412 from the torsion spring 406. In one
implementation, the cannula is rotated prior to and during removal
of the cannula, e.g., with a cycle time of less than 500 ms.
[0271] The amount of rotation required may be small, and the same
need only rotate during the time immediately before cannula removal
up to the time most or all of the cannula is removed. In one
implementation, and without wishing to be bound by theory, it is
believed that, in the absence of rotation, the static friction and
adhesion between the cannula and the seal must be overcome for the
seal to not be pulled by the cannula. If the cannula is caused to
rotate, the static friction and adhesion has already been overcome,
and the only force required is that caused by the kinetic friction.
Assuming the normal force is the same, as the kinetic friction is
generally less than static friction, the cannula force is much less
on the seal during removal. Relative motion between the seal and
the cannula about the rotational axis does not cause deformation of
the seal elastomer about the longitudinal axis. Therefore
slingshotting effects can be minimized by breaking static friction
and adhesion in the rotational axis.
[0272] It will be understood that the cannula drive may be
constituted by a number of devices, including those driven by the
same sources of energy performing the insertion and/or retraction,
devices specifically dedicated for this purpose, or the like. Such
devices may include cams, motors, and so on.
[0273] Besides rotating the cannula (or causing the cannula to
perform another like motion, e.g., vibrating the cannula) to
accomplish the goal of lessening seal slingshotting, another way to
specifically reduce the effect of seal slingshotting on the sensor
wire is to retract the cannula prior to retraction of the needle.
In this way, the seal slingshotting or "snapback" contacts the
needle and not the sensor wire itself. The needle shields the
sensor wire from the slingshotting effect.
[0274] Referring to the flowchart 414 of FIG. 37, steps of this
implementation of the retraction sequence are shown. A first step
is that the needle retracts but remains within the body of the
patient (step 416). A next step is that the cannula is picked up by
the moving needle in the fashion described above, but the needle
remains proud of the cannula by a certain length, e.g., 1 mm (step
418). A final step is that the cannula exits the seal, followed
shortly by the needle. This implementation may be similar to that
described in FIGS. 3-16, but where the needle is made slightly
longer.
[0275] The implementation of FIG. 37 may provide several benefits.
Without wishing to be bound by theory, it is noted that a kink in
the needle (described below with respect to FIG. 38) prevents
forward motion during most of the seal recoil during the retraction
step. In addition, the seal is allowed to recoil while the sensor
wire is still protected by the needle.
[0276] In yet another implementation, and referring to FIG. 38A-C,
the length of the needle may be reduced so that the needle does not
penetrate as deep as the sensor. Generally the strength of the
needle is required to penetrate the skin of the host, but once past
the skin, the column strength of even the sensor wire is generally
sufficient to allow further penetration into this interstitial
area, e.g., at least 2 to 3 mm beyond the needle tip. Referring to
FIG. 38A, a needle 422 is shown penetrating the skin of a host. The
needle contains within it a sensor wire 424, and in FIG. 38, the
kink 426 as well as push rod 428 can also be seen.
[0277] In FIG. 38B, the sensor wire 424 has been pushed out to a
further distance (more distal) than the needle 422. Retraction of
the needle is shown in FIG. 38C, resulting in deposition of the
sensor wire 424 into the host.
[0278] This implementation may be implemented by modifying the
implementation of FIGS. 3-16 by, e.g., lengthening the push rod
and/or shortening the needle. Various other mechanisms may be
employed to push the sensor to the second depth. Various advantages
inure to the implementation of FIG. 38, including that the sensor
extends past the location where trauma from the needle is produced,
reducing sensor artifacts and other deleterious signal effects,
e.g., "first-day noise". In addition, this implementation allows a
reduction in the height of the applicator, which is driven at least
in part by the length of the needle. In this regard it is noted
that the needle is driven approximately 1-6 mm below the skin,
which the sensor is driven approximately 4-15 mm.
[0279] In embodiments, the needle can be a single-lumen needle with
a single bevel at its point, such as the needle 450 illustrated in
FIGS. 99 and 100. In some embodiments, the trailing edge or heel of
the needle tip (i.e., the portion of the needle tip to the right of
line A-A in FIG. 99) can be subjected to special processing during
manufacturing, e.g., an extra bead blast at either or both of the
inside and outside edges, so as to remove any fine burrs and avoid
coring or other trauma to the patient's skin. Embodiments can thus
avoid inaccurate glucose readings that might otherwise result from
cellular damage to the patient's tissue during sensor
deployment.
[0280] In some embodiments, the needle can be a multi-lumen needle,
such as the needle 456 illustrated in FIG. 101. The needle 456
comprises a metal outer lumen 458 and a polymer inner lumen 460.
Embodiments incorporating an inner lumen comprising a compliant
material such as a polymer can serve to limit or minimize tissue
trauma.
[0281] In some embodiments, the needle can be a curved, C-shaped,
or Tuohy needle. For example, as shown in FIG. 107, a needle 1010
includes a wall structure 1012, a cutting edge 1014 and a blunt
contour 1016. The needle 1010 advantageously can be used to deliver
a sensor 1018 (such as an analyte sensor, for example, a glucose
sensor) through an outer skin layer and into a sensor depth in a
less invasive way than when performed by prior art needles. In the
needle design, the size of the cutting edge 1014 is balanced
against a portion of the distal wall structure 1012 that has blunt
contours 1016. Thus, the needle 1010 is capable of cutting the more
durable outer skin layer (first phase) and then progressively
widening open the cut for further advancement into the subcutaneous
layer (second phase) with minimal tissue trauma. When the needle is
sufficiently advanced with the sensor therein, the needle and the
sensor are then detached, and the needle is retracted leaving the
sensor 1018 in a desired position. Early testing has shown a
reduction of "dip and recover" incidents (and reduction in average
duration of an incident) with glucose sensors delivered using the
needles described herein.
[0282] The term "needle" as used herein should be construed to
cover any delivery device that can contain the sensor 1018 for
delivery to the appropriate depth. The "needle" can have any of a
variety of shapes with regard to its wall structure 1012. For
example, the wall shape can be cylindrical with a circular
cross-section or can have a V-shaped, square or rectangular, or
even some irregular, cross-section. The wall shape also need not be
an extruded shape with the same cross-section along its axis. For
example, the wall shape may start as a cylindrical tube with a
circular cross-section at a proximal end and then change to a
V-shape (in cross section) as it approaches the distal end. The
wall shape may also have defined along its length slots or various
openings--such as a slot that gives it a C-shape in cross-section.
(The open cross-section of the C or V-shapes affords clearance for
attachment of wiring, for example.)
[0283] Generally, however, the wall structure 1012 defines some
inner (relative to some outer surface of the wall) dimension (width
or diameter for example) that supports or contains the sensor 1018
for subcutaneous delivery. For example, in a V-shaped
cross-section, the inner part of the V near its base has a diameter
that is occupied by the sensor lodged between the two inner wall
surfaces. Thus, the "dimension" is defined by the position that the
sensor occupies (or would occupy) during delivery in or on the
needle wall structure 1012. The term "needle" also covers other
devices (with different names) that share similar wall structures
and functions (e.g., delivery of an implantable device), such as,
for example, a tube, channel, cannula, catheter or blunt dilator
with a recess or opening for deployment of an implantable device
(e.g., a sensor).
[0284] The wall structure 1012 of the needle 1010 has, in the
embodiment of FIG. 107, a tubular shape defining a central opening
1022 with a central axis 1020. The wall structure 1012 is formed
from a tube by bending, machining and polishing as shown generally
by FIGS. 109-111. The proximal end of the wall structure 1012
retains its stock tubular shape and has, for example, an outside
diameter of 0.018 plus 0.001 or minus 0.0005 inches. Preferably,
the inside diameter is an inner dimension sized to contain a
cross-section of the sensor 1018 for its delivery. The sensor 1018
has a smaller cross sectional diameter than the diameter of the
central opening 1022. The size and shape of the central opening
1022 may vary though according to the size and shape of the sensor
1018 being delivered. As noted above, the needle 1010 may have a
wall structure 1012 with a shape that varies axially and in
cross-section. For example, the wall structure cross-section could
have a rectangular, C-shape or V-shape, as will be discussed in
more detail below.
[0285] In some embodiments, the outer diameter of the wall
structure 1012 at the proximal end, for example, may be about
0.0135 plus 0.001 or minus 0.0002 inches. The outer diameter and
thickness of the wall structure 1012 reflects a balance of columnar
stiffness and minimization of the wound size for clearance of the
needle through the patient's skin. In certain embodiments, the
diameter of the wall structure 1012 is minimized, but not to the
point where the needle 1010 is susceptible to buckling under the
expected axial load from needle insertion.
[0286] In one aspect, the wall structure 1012 has a length
configured to retain and protect the sensor 1016. In the case of
one type of subcutaneously delivered glucose sensor, for example,
the wall structure 1012 has a length of about 2.31.+-.0.02
inches.
[0287] The strength of the wall structure 1012 (e.g., column
strength) is determined in part by its material composition. A
range of materials can be used, for example, steel (e.g., stainless
steel), ceramics, titanium, tantalum, nickel, nickel-titanium,
iridium, silver, palladium, platinum-iridium, iridium, ceramics,
composites, and combinations or alloys thereof, and/or the like.
Polymers that may be used include, but are not limited to,
polycarbonate, polymethacrylic acid, ethylene vinyl acetate,
polyesters, fluoropolymers including polytetrafluorethylene
(TEFLON.RTM.), polyethylene, polypropylene, high density
polyethylene, nylons, polyethylene terephthalate, and polyesters,
combinations thereof, and the like. Stiffer materials like
stainless steel (SS304 with a full hard temper) can store more
deformation energy and have a higher modulus (190-203 GPa Young's
modulus) and elastic limit (205-310 MPa) than many other materials
and thus have good stiffness and resistance to buckling and
permanent (plastic) deformation. This helps to keep the shape of
the needle (and its ability to deliver the sensor) through
penetration of the skin to the sensor depth. Also, steel has the
advantage that it can be machined (formed, filed, ground, etc.) to
create a sharper edge than many other materials. Further, steel
tends to hold its edge well--the aforementioned modulus and energy
storage capability keep the edge sharp through its use.
[0288] The insertion force and buckling strength of the needle 1010
has been determined. The needle 1010 is inserted at 45 degrees into
10N Syndaver at 1 in/min. Peak insertion force was measured using a
lON load cell. Insertion forces were measured for 8 attempts at an
average of 0.22 b lbf with a minimum of 0.156 lbf and a maximum of
0.298 lbf and a standard deviation of 0.0505. Insertion forces were
also measured for conventional needles and averaged 0.191 lbf with
a range of 0.163 lbf and 0.237 lbf and a standard deviation of
0.0239.
[0289] Buckling strength was tested by compressing the needle 1010
against a non-pierceable (metal plate) and measuring the axial
force required to buckle the needle using the 10N load cell. The
buckling strength of the needle 1010 was (for 8 samples) 2.505 lbf
on average with a minimum of 2.185 lbf and a maximum of 2.280 lbf
and a standard deviation of 0.2189. For conventional needles, 2.458
lbf on average with a minimum of 2.158 lbf and a maximum of 2.755
lbf was measured.
[0290] The ratios of buckling strength as a ratio to insertion
force ranged from about 7.3 to 14.6 times the insertion force.
Thus, the needle 1010 is capable of withstanding buckling even with
presentation of some relatively high percentage of blunt contour
for dilation of the skin opening.
[0291] The "central axis" is a reference point for an amount and
positioning of the cutting edge 1014 and blunt contours relative to
the proximal portion of the sensor 1016 (or where the sensor would
be if it were within the needle 1010). For example, the central
axis of the wall structure 1012 in the implementation of FIG. 107
is defined by the unbent proximal end of the wall structure.
Namely, the center, elongate axis of the proximal unbent tube of
the wall structure--shown by the intermittently dashed line--is the
central axis 1020.
[0292] The central axis 1020 is not limited to a linear shape.
Generally, the central axis will be defined by a line through a
series of points wherein the points are the centroids of a series
of cross-sectional slices of the proximal end of the sensor 1018.
Thus, as the path of the sensor 1018 bends or curves, the central
axis 1020 will follow. (The "centroid" is an average position of
all of the points in a shape. For a cylindrical sensor it is the
center of the circular cross-section. However, the sensor need not
have any particular cross-sectional shape to define a central
axis--even an irregular cross-sectional shape has a centroid.)
Generally, then, the central axis defines a central location of the
composite pathway of the sensor 1018 proximal the edges and blunt
contours as a reference point for the positioning of the edges and
blunt contours 1014, 1016.
[0293] The central opening 1022 is an opening in the center defined
by a closed boundary wall structure--such as the one defined by the
tubular portion of the needle 1010 wall structure 1012 in FIG. 107.
The central opening 1022 is an opening that is configured to
receive (through sizing, finishing, etc.) the major dimensions
(e.g., diameter or width) of the sensor 1018 to be delivered.
[0294] Referring back to FIGS. 107, 108 and 112, the distal end of
the wall structure 1012 has formed thereon the cutting edge 1014
and blunt contours 1016. The blunt contours 1016 may include a bend
1030 in the wall structure 1012 of the needle 1010. The bend 1030
is formed in the tubing used to create the wall structure 1012, as
shown in FIG. 109, prior to application of the bevels and cutting
edge 1014. The bend angle can range from about 5 degrees, in
increments of one degree, to about 30 degrees for the cutting edge
1014 configurations with primary bevel angles ranging from 3 to 12
degrees and (optionally) secondary bevel angles of 8 to 24
degrees.
[0295] The bend may be any of a variety of angles depending on the
desired angle of entry of the tip of the cutting edge. Preferably,
the bevel angle of the cutting edge 1014 is balanced to the amount
of blunt contour 1016 seen by the skin as it is penetrated. The
amount of blunt contour and cutting edge "seen" by the skin for
example is the projected area occupied by the blunt contour and
cutting edge when viewed along the central axis 1020. (This
captures a measure of what proportion of the blunt and cutting
edges impacts the skin as the needle is advanced along the central
axis line.) The blunt surface area is the amount of area occupied
by the blunt contours of the needle from this view and the cutting
surface area is the amount of surface area positioned opposite the
blunt contours starting with the cutting edge, again as viewed
along the central axis 1020.
[0296] Generally, a design with a greater bend (and a larger blunt
contour area seen at the insertion site) is more advantageous for
reducing wound size. However, the extent of the bend (and size of
the blunt contour seen at the insertion site) is limited by the
need for some aspect of the cutting edge 1014 to be positioned to
penetrate the skin surface and form a hole large enough for
expansion of the hole without further tearing. Thus the bevel angle
or other angle of the cutting edge 1014 relative to the central
axis balances the amount of bend 1030's angle.
[0297] Lubricants or other materials may be added into the lumen of
the needle 1010 to facilitate sensor withdrawal. For example,
silane, silicone, parylene or other material with a low coefficient
of friction may be added to the luminal surface of the needle.
Coating the lumen walls with lubricious fluid improves the ease of
release of the sensor without damaging the sensor membrane or
otherwise inhibiting sensor operation.
[0298] The cutting edge 1014 may include several sharpened edges or
portions thereof in composite or a single planar facet forming a
single sharpened edge. In any case, the cutting edge 1014 in the
embodiment of FIGS. 107 and 108 is formed on a set of beveled
surfaces.
[0299] The beveled surfaces may include a primary or proximal bevel
1024 and a pair of secondary or distal bevels 1026, as shown in
FIG. 108. The primary bevel, as shown in FIG. 107, may extend at
about a 7 degree angle relative to a line paralleling the central
axis and extending from the outer surface of the wall structure
1012 on the proximal, unbent end of the wall structure. The primary
bevel could be at any of a variety of angles depending upon the
desired proportion and orientation of forward facing cutting edge
1014 and blunt contours 1016. For example, the primary bevel 1024
could be within a range of about 3 degrees to about 12 degrees,
depending upon the amount of upstream bend in the wall structure
1012.
[0300] In one implementation, the cutting edge 1014 could be
defined on a single, primary bevel 1024 having an angle in the
angle ranges described above, such as the angle shown in FIG. 110.
(FIG. 110 is an intermediate stage in the process of manufacturing
the needle 1010 in FIG. 111, but represents where a single-bevel
embodiment would stop for sharpening.) The distal edges of this
primary bevel 1024 could then be sharpened to form the cutting edge
1014 sized in some desired proportion to polished edges and blunt
contours to create the desired two-phase cutting and dilation that
reduces invasiveness and dip and recover. (A more detailed
description of how the blunt dissection and cutting surfaces are
balanced in their proportions is described above and below in more
detail.)
[0301] In certain embodiments, such as the one illustrated FIGS.
107, 108, and 111-114, two additional secondary or distal bevels
1026 are formed on the distal tip of the wall structure 1012 on the
opposite side of the wall structure from the bend 1030. (FIGS. 109
and 110 show the embodiment of FIG. 5 being formed from stock
tubing.) Relative to the same reference point, the bevels 1026 are
angled at about 12.4 degrees, as shown in FIG. 107. The two distal
bevels 1026 may also define an angle between their proximal edges,
as shown in FIGS. 128 and 129. FIG. 128 shows an angle between the
proximal bevel edges of 120 degrees. FIG. 129 shows an angle
between the proximal bevel edges of 20 degrees.
[0302] The secondary bevels 1026 may be varied in their angle from
the outer surface line. However, a range of about 8 to 24 degrees
balances the proportion of cutting edges 1014 and blunt contours
1016 for wound reduction. In some embodiments, the needle may have
a 17 degree bend 30, 7 degree primary bevel 1024 and 16 degree
secondary bevel 1026.
[0303] In FIG. 108, the distance between the proximal most-tip of
the beveled surfaces (along the central axis 1020) to the
distal-most tip of the beveled surfaces is 0.05.+-.0.01 inches. The
distance between the proximal most point of the secondary bevels
1016 and the distal-most tip of the secondary bevels 1016 is
0.03.+-.0.006 inches.
[0304] Although the set of bevels 1024, 1026 form several axially
oriented edges on the distal end of the wall structure 1012, not
all of those edges are necessarily sharpened. Instead, the cutting
edge 1014 is formed only on more distal portions of the secondary
bevels 1026. In particular, for example, on FIG. 113 a circle
centered on the central axis is shown circumscribed about a bottom
edge of the proximal wall structure 1012 and extending over the
bevels. In this implementation, only the portion of the bevels
within the circle are sharpened. Those bevels outside the circle
are rounded.
[0305] In the illustrated embodiment of FIG. 113, the circle has a
diameter of 0.018 inches--the same diameter of the tube used to
form the wall structure 1012. The sharpened portion of the bevels
1026 extends only to the edge of that circle as it maps onto the
secondary bevels 1026. Although having the advantage of matching up
with the proximal cross-section of the wall structure 1012, the
sharpened portions can be expanded or reduced based on desired
wound size, sensor characteristics, patient variation, etc.
[0306] The remainder of the edges of the bevels 1024, 1026 may be
rounded into smoothed, non-cutting edges having about 2 to 3
thousandths of an inch radius or greater. For example, the heel and
other edges of the primary bevel 1024 may be blasted with media to
smooth them. Blasting the heel of the bevel (the proximal, inner
edge defining the central opening 1022) may smooth it to reduce or
eliminate coring, which occurs when the skin is picked up during
needle 1010 insertion (also sometimes referred to as "coring").
[0307] As shown in FIG. 113, in some embodiments, the needle design
1010 balances the cutting edge 1014 and blunt contours 1016 to
promote the two-phase cutting and dilation process of sensor 1018
insertion. Various metrics can be used to define and describe the
balance in the needle design between cutting edge 1014 and blunt
contour 1015. For example, as shown in FIG. 113, in one embodiment,
the cutting edge 1014 only occupies about 60 degrees (33%) of the
180 degrees of the outer peripheral edge of the bevels 1024, 1026.
Generally, the smaller the proportion of the edges of the bevels
1024, 1026 that are sharpened to the edges that are unsharpened,
the smaller the initial wound before dilation. Variations are
possible from 50% of the total edge being sharpened down to 20% in
increments of 5%.
[0308] In one embodiment, the bend 1030 advantageously repositions
or offsets the leading point (and initial contacting cutting
feature) of a conventional needle to the opposite side of the
circular cross-section by 0.0112 inches, as shown by comparison of
FIGS. 114 and 115. Thus, the offset of the point pushes it over
(0.002 inches, as shown in FIG. 113) the central axis 1020. For
example, the point is about 62% of the way across the diameter to
the opposite side of the circumscribed circle. In this manner, the
central axis 1020 (as it would for any offset of greater than 50%
of the diameter or other relevant dimension associated with the
position of the sensor) passes through the blunt contour 1016
rather than above the cutting edge 1014.
[0309] It should be noted, however, that an advantage of presenting
a blunt contour 1016 starts with any sized bend 1030 (or other
structure or modification) that moves the point and other cutting
edges 1014 within the outermost periphery of the circumscribed wall
structure 1012. Offsetting the cutting edge away from the outermost
periphery and closer to (or past) the central axis than the
adjacent outer edge by even 1% therefore results in some benefit of
reduced invasiveness. Such positioning presents a blunt contour to
the skin during insertion of the needle. Generally, the further the
positioning across the dimension of the needle 1010, the larger the
proportion of the area presented to the skin that is made up by a
blunt contour (versus cutting edge). For example, in some
embodiments, the cutting edge can be repositioned across the
dimension from about 5% to about 65% of the dimension in intervals
of 5%. At the same time, some amount of cutting edge must be
presented or no initial opening in the skin will be formed large
enough to be dilated without tearing by the blunt dissection--hence
the concept of "balance" between cutting and blunt dissection
described above.
[0310] Although sometimes referred to as a diameter for the
purposes of the round tubing used for wall structure 1012 in the
illustrated embodiments, the relevant "dimension" is any major
dimension across the portion of the wall structure 1012--or "cross
dimension"--configured to hold the sensor. Another metric that can
be used to characterize the proportion of cutting edge 1014 to
blunt contour 1016 is the projected area dedicated to blunt
contours 1016 projected along from a perspective viewed along the
central axis 1020. For example, as shown in a view along the
central axis in FIG. 113, about 2/3 of the area of the circle
circumscribing the outer edge of the rounded wall structure 1012 is
dedicated to blunt contour 1016.
[0311] The various degrees of bend and bevel angles disclosed
herein are not arbitrary. Rather, they impact wound size (and
consequently dip-and-recover and other foreign body responses) and
sensor deployment amongst other things. For example, FIGS. 118-126
and Table 1 below show variations in the bend angle and bevel
angles and the impact on the ratio of blunt area (in grey) to
cutting area (cross-hatched). Ratios run from as low as 0.85 for
FIG. 120--where the blunt area is smaller than the cutting area--to
as high as 2.74 times as much blunt area as cutting area for FIG.
124. Notably, there is an interplay between the bend angle and the
bevel angles that determines the ultimate proportion. If a lower
bend angle is used, then it restricts the amount of primary bevel
angle before the blunt area drops dramatically and may not reduce
wound formation. Eventually, the blunt area is so small as to
approach that of the conventional needle shown in FIG. 127.
Similarly, if a high bend angle is used, the cutting edge may not
be sufficient to pierce the dermis layer during the initial cutting
phase. The bend in the needle can also be limited by other
constraints. If the bend is too severe, then the sensor could get
stuck in the lumen of the needle and may not deploy. Or, the sensor
may be damaged when it is deployed.
TABLE-US-00001 TABLE 1 Cutting Blunt Ratio Bend Primary Secondary
Surface Surface (Blunt SA/ Angle Bevel Bevel Area Area Cutting FIG.
(.degree.) (.degree.) (.degree.) (In{circumflex over ( )}2)
(In{circumflex over ( )}2) SA) 118 10 5 12 0.000096 0.000188 1.96
119 10 7 12 0.000122 0.000151 1.24 120 10 9 12 0.000143 0.000121
0.85 121 17 5 12 0.000079 0.000206 2.61 122 17 7 12 0.000104
0.000168 1.62 123 17 9 12 0.000126 0.000136 1.08 124 20 5 12
0.000076 0.000208 2.74 125 20 7 12 0.000101 0.000171 1.69 126 20 9
12 0.000124 0.000138 1.11
[0312] The relationship of the ratio (blunt surface area / cutting
surface area) versus needle bend and primary bevel angle can be
defined by an equation: Ratio (BSA/CSA)=0.1895+0.2266*(Bend
Angle)-0.004952*(Bend Angle).sup.2 for a primary bevel angle of 5
degrees. The constants change with each of the primary bevel angle
changes. Ratio=0.171+0.1379*Bend Angle)-0.003095*(Bend Angle).sup.2
for a primary bevel angle of 7 degrees. Ratio=0.1329+0.09457*Bend
Angle)-0.002286*(Bend Angle).sup.2 for a primary bevel angle of 9
degrees. The changing constants can be determined via curve fit to
the data above in Table 1 for different bevel angles.
[0313] FIGS. 109-111 illustrate in part how the needle 1010 is
manufactured. Stock tubing is first bent to a predetermined angle
(e.g., about 10 or 17 degrees) to form the bend 1030 in wall
structure 1012. The primary bevel 1024 is then ground or machined
to the first desired angle. Then, the secondary bevels 1026 are
ground to the second desired angle. Non-cutting edges are blasted
with material to round them out and remove burrs. The cutting edges
1014, if necessary, are either present from the grinding or
generated by further sharpening on the axially directed bevel
edges.
[0314] Referring now to FIGS. 114 and 115, the needle 1010 may be
designed with slot 1034 (or slots). These slots may facilitate
delivery or removal of the sensor 1018, or aid in reducing wound
trauma. FIGS. 114 and 115, for example, illustrate slot 1034 formed
as a window near the distal end of the wall structure 1012 of the
needle 1010. The slot 1034 is formed by cutting a portion (e.g.,
about half of the circumference of the tubular wall structure) away
and having ramped or rounded (radius about 0.5 to about 1 inches)
walls near the proximal and distal ends for a smooth transition. In
the particular embodiment shown, the distal edge of the slot 1034
is about 0.8 mm from the end of the wall structure 1012 beginning
at the primary bevel 1024. The slot 1034 is about 3 mm long.
Advantageously, the sensor (shown in dashed lines) can be inserted
through the slot 1034 into the distal-most, closed section of the
wall structure 1012, allowing it to be more easily freed for
delivery. It is contemplated that the dimensions corresponding to
the embodiment illustrated in FIGS. 114 and 115 can be different
depending at least in part on the dimensions of the sensor to be
inserted.
[0315] FIGS. 116 and 117 illustrate a needle with a slot 1034 that
extends to the distal end of the needle 1010. In one embodiment,
the proximal closed portion of the needle wall structure 1012 is
about 8 mm and the slot extends along 6 mm of the end of the wall
structure. Viewed along the central axis, the slot 1034 forms a
C-shape at the distal end of the needle.
[0316] Sensor delivery systems that employ a needle without a slot
are typically unable to deliver a pre-connected sensor (i.e., a
sensor connected to sensor electronics prior to sensor insertion).
With these systems, electrical connection between the sensor and
the sensor electronics occurs after the sensor has been inserted
and often after the needle has been retracted. In some embodiments,
such as the embodiment illustrated in FIGS. 116 and 117, a slot
1034 facilitates removal of the needle from a pre-connected sensor
which may be designed to connect to sensor electronics through an
electrical wire that extends through the slot prior to and during
sensor insertion. After sensor insertion, the slot 1034 allows for
removal of the needle from the sensor 1018 without disturbing the
electrical connection which was already established prior to
insertion.
[0317] In short, the C-shape or V-shape or other shape formed by a
slot 1034 extending through the distal end of the needle 1010 may
provide for delivery of pre-connected sensors 1018. The wires from
the sensor can extend through the slot 1034 while the rest of the
sensor is held within the opening 1022. More than one slot could be
used, such as for several electrical connectors. In addition, the
slots may vary in size, shape and positioning depending upon the
desired use and/or reduction of invasiveness.
[0318] The windows and slots may be combined with the bend and
other characteristics of the needles illustrated in FIGS.
107-113.
[0319] FIGS. 130 and 131 show another embodiment of the needle
1010. The needle 1010 includes a single primary bevel 1024 having a
13 degree angle for the bend 1030 from the lower horizontal wall
line of the wall structure 1012. The point is elevated 0.152
(plus/minus 0.051) mm from the bottom wall line of the wall
structure. The needle 1010 has an inner diameter of 0.343 (plus
0.025/minus 0.013) mm and an outer diameter of 0.457 (plus
0.025/minus 0.013) mm. The primary bevel has a gentle curvature
extending from its tip to the proximal edge. FIG. 131 shows a bevel
length of 1.270 (plus/minus 0.152) mm. Shown in cross-hatch is a
bead blasted (for burr removal and anti-coring) proximal length of
0.762 (plus/minus 0.152) mm. Advantageously, reducing the bend
angle from 17 to 13 degrees reduced the chances of sensor damage
during deployment.
[0320] FIG. 132 shows another embodiment of the single-bevel needle
1010 with a 13 degree bend 1030, but with no gentle curve in its
bevel 1024. Instead, the primary bevel is straight and at about a
13.5 degree angle with respect to the top outer edge of the wall
structure 1012.
[0321] FIG. 133 shows another embodiment of the needle 1010 with a
single bevel 1024, including a 17 degree bend angle and a 7 degree
bevel angle. The point is elevated 0.012 inches from the bottom
edge of the wall structure 1012.
[0322] FIG. 134 shows another embodiment of the needle 1010 wherein
the wall structure defines a proximal slot 1040. The proximal slot
is scalloped into a portion of the needle on the side of the needle
1010 having the point. The sensor 1018 includes a kink 1042
configured to seat into the proximal slot 1040 so as to maintain
the orientation of the sensor. In particular, the proximal portion
of the sensor dips down into--and optionally somewhat extending out
of--the proximal slot 1040, reverses direction and continues
distally into alignment with the needle central opening 1022,
opposite the proximal slot. Advantages of the proximal slot 1040
include holding the sensor 1018 in a specified position until a
pushrod moves it out of position. Also, needle assembly would be
facilitated by holding the sensor 1018 in a desired or predictable
positon. Another advantage is the bend 1030 of the needle 1010 can
be cleared by biasing the sensor 1018's distal end to the opposite
side of the wall structure 1012. The sensor 1018 would be less
likely to run into the bend in the central opening 1022 during
deployment.
[0323] Embodiments can incorporate various additional or
alternative features to avoid or limit tissue trauma. For example,
some embodiments can be configured to reduce vibration and/or
lateral motion of the needle tip during the insertion and
retraction phases of sensor deployment by de-coupling at least a
portion of the device from the needle. For example, some
embodiments can include additional bearing features operatively
coupled to the inner needle hub, so as to decouple the inner needle
hub from the outer needle hub or other portions of the device and
minimize transfer of any vibrational forces to the needle.
Additionally or in the alternative, some embodiments can include
features configured to counteract any moments placed on the needle
during the insertion or retraction phases, or to otherwise limit or
constrain the path of the needle during the insertion and
retraction phases to a straight line and thereby avoid or reduce
the likelihood of tissue trauma. In some embodiments, the needle
hub itself can comprise a semi-rigid or somewhat compliant
material, to provide damping of high frequency vibrations and/or
lateral movement during actuation and ensure that the needle
follows the prescribed path. In some embodiments, the needle itself
can comprise a relatively low temper (e.g. less than full hard
stainless steel), to allow the needle shaft to flex during the
insertion and retraction phases.
[0324] Other aspects of systems and methods according to present
principles are now described. FIGS. 39-48 illustrates steps of
transmitter insertion into a sensor housing according to variations
of present principles. Referring to FIG. 39, a disposable housing
36 is illustrated with various components as described above,
including a seal carrier 26 and a seal 24. In the figure, the seal
carrier 26 is illustrated in the position in which it would be just
subsequent to removal of the cannula hub as part of the retraction
step. In particular, the seal carrier 26 is at an approximately
45.degree. angle to the plane of the disposable housing 36. In many
cases, the influence of gravity would overcome the frictional
resistance of the hinge axis, causing the seal carrier 26 to rotate
generally towards the disposable housing 36. However, in some cases
it fails to do so, and as a consequence the seal carrier is left at
the 45.degree. angle. This is generally a minor inconvenience as
the user can easily push the seal carrier down into the disposable
housing prior to attachment of a transmitter. See, e.g., FIG. 40
for a depiction of a transmitter 500 being inserted into the
disposable housing 36, and in particular where a tab 501 (FIG. 41)
is inserted into a corresponding slot 442 (FIG. 40) in the
disposable housing 36. The transmitter 500 is then snapped into
place by user depression of the transmitter thumb pad 502 (FIG.
41). In some embodiments, the snap fit between the transmitter 500
and the disposable housing 36 can be configured such that a force
of greater than about 2 pounds, greater than about 5 pounds,
greater than about 10 pounds, or greater than about 20 pounds is
required to remove the transmitter from the disposable housing 36,
so as to prevent unwanted (or premature, in the case of reusable
transmitters) separation of the transmitter from the disposable
housing.
[0325] If the seal carrier 26 falls into place in the disposable
housing 36 upon removal of the cannula hub, it is generally
apparent to users how the transmitter 500 is to be snapped into the
disposable housing. However, when the seal carrier 26 is left at a
significant angle with respect to the disposable housing 36, it may
not be apparent to all users how the transmitter is to be snapped
into the disposable housing, particularly where the angled position
of the seal carrier obscures the user view of the slot 442.
Accordingly, it is desirable to have a component that serves to
exert a force to rotate (or otherwise push) the seal carrier 26
down into place in the disposable housing 36.
[0326] In some embodiments, as illustrated in FIGS. 102 and 104, a
transmitter 500a can include one or more keys 522a configured to
engage with corresponding seats 524a in a corresponding disposable
housing 36a. FIG. 103 illustrates another transmitter 500b having
keys 522b having a different configuration than keys 522a. The
configuration of the keys 522b prevents seating of the transmitter
500b in the disposable housing 36a, such that the transmitter 500b
cannot be pressed in, snapped in, or otherwise installed in the
disposable housing 36a (for example as illustrated in FIG. 40).
Similarly, the seats in a disposable housing (not shown) which is
configured to receive the transmitter 500b can be configured to
prevent seating of the transmitter 500a in that disposable housing.
FIG. 104a shows a cross-sectional view of the transmitter 500a
installed in a compatible disposable housing 36a, the cross section
being taken along the surface A of the transmitter 500a (see FIG.
102). By providing corresponding transmitter/disposable housing
combinations with corresponding keys and seats which are
incompatible with the keys and seats of other combinations, users
can be prevented from installing the wrong transmitter (e.g., an
incompatible transmitter) in a disposable housing. As shown in FIG.
102, the keys 522a comprise a pair of protrusions extending from a
lower surface B of the transmitter 500a. In other embodiments, a
single protrusion or more than two protrusions are possible.
Further, although the keys 522a have a tapering configuration as
they extend in the direction of surface A, other configurations of
keys are also possible; e.g. the keys can taper in the opposite
direction, or can have any other regular or irregular shape. In
embodiments, one or more keys can extend from the surface A in a
direction normal to the surface A.
[0327] Referring now to FIGS. 44 and 45, a spring 38 may be coupled
to the upper applicator housing 30 which is preloaded and biased
against a tab 504 on the seal carrier 26. It will be understood
that in alternative implementations, the spring 38 may be replaced
with other types of drive components, and the same may be coupled
to other features of the applicator, so long as the feature remains
stationary relative to the seal carrier 26. Moreover, the spring 38
may be biased against other portions of the seal carrier, or even
biased against the seals. FIG. 42 indicates the arrangement of the
components when the cannula hub 32 is in place, and FIG. 43
indicates the arrangement of the components upon retraction of the
cannula hub 32. In the latter figure, the spring 38 is exerting a
force in the direction of arrow 506, and as there is no longer a
cannula hub situated to oppose this force, the seal carrier 26 is
about to be forced down by the spring 38 into the disposable
housing 36.
[0328] Referring to FIGS. 44 and 45, the seal carrier 26 may
further be provided with a tab 508 which engages and locks into a
corresponding slot 512 in the disposable housing 36 via a snap fit
connection, disallowing the seal carrier from moving from the
desired down/flat position. FIG. 45 shows a more detailed view of
how this connection is made.
[0329] Referring back to FIG. 40, the disposable housing 36 is
further configured to provide a one-time-use feature. This
one-time-use feature prevents multiple re-insertions of the
transmitter to protect the integrity of the seal, seal grease, and
conductive pucks, as well as sensor location. It further prevents
sensor restart sessions, i.e., reuse of a sensor in a second
session, such being generally deleterious and inconsistent with
labeling. In addition, the one-time-use feature may ensure that a
transmitter 500 remains in place in the disposable housing 36
during removal of the combination transmitter/disposable
housing/sensor (the "wearable") from the body of the patient.
[0330] In more detail, the disposable housing 36 includes a
breakaway section 432 which is attached to a remainder of the
disposable housing 36 via frangible portions 436 and 438. An access
strip 434 may be employed in some implementations to further ease
the removal of the breakaway section 432 from the remainder of the
disposable housing 36. For example, a user may grab, push, or pull
on the access strip 434 and twist or pull so as to remove the
breakaway section 432 from the remainder. That is, the breakaway
section 432 can be used to bend or break out of the way in order to
remove the transmitter from the disposable housing once the same
has been removed from the body. In some embodiments, a breakaway
section can be configured to break away from the remainder of the
disposable housing 36 under a force of between about 2-4 pounds.
Also in some embodiments, a breakaway section can be configured to
break away from the remainder of the disposable housing 36 at a
break angle of between about 30-60 degrees.
[0331] FIG. 47 illustrates a system in which the breakaway section
is being twisted as part of the removal process of the same,
subsequent to which the transmitter 500 can be removed and reused.
FIG. 47 also illustrates an adhesive portion 516 which adheres the
wearable to the skin of the user.
[0332] Additional advantages ensue to the disposable housing 36
including a breakaway section 432. The same allows a minimization
of insertion forces required to latch the transmitter onto the
disposable housing. This system minimizes deflection of the
disposable housing due to compression of the seal. The system
maintains compression of the seal over time and temperature, acting
against deleterious consequences including creep. The same provides
a user-friendly removal process to separate the transmitter from
the disposable housing after the wearable has been removed from the
body.
[0333] Referring back to FIGS. 39 and 41, the system may include a
one-way double snap feature configured such that it is generally
impossible to remove the transmitter while on the body. (This
aspect is also detailed in FIG. 48 in which the flush nature of the
transmitter 500 with respect to the disposable housing 36 is made
evident.) The double snaps may be located on the sidewalls of the
disposable housing and in part are embodied by voids 516 defined in
the disposable housing 36 and cooperating tabs 514 on the
transmitter 500. In particular, the tabs 514 snap into voids 516
during transmitter insertion. The sidewall snaps also help to
minimize deflection and maintain seal compression.
[0334] As noted above, many of the implementations described
provide ways to make available additional power and force to
perform the steps of insertion or retraction. In some cases, the
additional force does not result in an increase of overall force,
but a better distribution of force, so that force is available when
needed to perform the desired steps. In some cases, and as
described below, systems and methods according to present
principles relate to ways to decrease the force required, e.g., to
lower the force required in a given force profile. Many systems and
methods as described below achieve this effect by modification of
the seal component 24 discussed generally above, as well as
modifications to its associated seal carrier 26. In addition,
besides easing force requirements on insertion and retraction
components, systems and methods according to present principles
also relate to reducing the effect of seal slingshotting as
described above, again by modification of the seal 24 and/or by
other means of arresting movement of the sensor wire.
[0335] In particular, FIGS. 49 and 51-56 describe ways to reduce
slingshotting, FIGS. 73-77 describe ways to hold sensors, e.g.,
sensor wires, more stably or in a stronger fashion, which also
combats slingshotting, and FIGS. 50, 57-72, and 78-83 describe ways
of separating the seal from an insertion component, e.g., from the
cannula, so as to reduce the force required to remove the
cannula.
[0336] In more detail, FIGS. 49A-C describe one way of modifying
the seal so as to reduce or eliminate seal slingshotting. In this
figure, a seal 624, e.g., an elastomer seal such as a silicone
seal, is overmolded onto a seal carrier 626, where the overmold
includes adhesion between the elastomeric seal 624 and the seal
carrier 626, which may be constituted of, e.g., a hard rigid poly
carbonate material. While overmolding is discussed here, it will be
understood that other means of adhering may also be employed,
including by the use of glue.
[0337] In this implementation, various ribs may be provided to
reduce seal deformation during cannula removal. The ribs may be
adhered to the seal during the overmolding process to even more
fully situate the seal in place. One or more pillar ribs 602 at
least partially surround the conductive pucks (not shown). The
pillar ribs 602 may completely surround the pucks or may only
partially surround the pucks. Sidewall ribs may also be provided in
some configurations to reduce seal deformation during cannula
removal. A continuous wall rib 604 is illustrated which extends
from one side of the seal carrier to the other, e.g., along the
distal/proximal axis. The ribs as described may be formed of
materials similar or the same as the seal carrier 626, and may
moreover be integral therewith. The ribs may also be formed of a
different material, but in general the material should be of higher
durometer than that of the seal 624. An additional rib 606 is
illustrated, and the same may either be a "floating" rib, situated
within the seal 624 but not directly connected to the seal carrier
626, or the additional rib 606 may be directly connected to the
seal carrier 626.
[0338] Variations of these configurations of ribs will also be
understood to help reduce seal slingshotting, e.g., by prohibiting
motion of the seal in and along the distal/proximal axis. Certain
of these configurations are described below. For example, to even
further lessen the effect or possibility of seal slingshotting,
voids 608 may be defined in the seal 624 to reduce the amount of
seal material in contact with the cannula, thus reducing the effect
of seal slingshotting.
[0339] Another way of easing force requirements on insertion and
retraction is described with respect to FIG. 50, in which a system
is illustrated which is intended to reduce the force required to
remove an insertion component such as a cannula. In the figure, a
conductive puck 123' is illustrated with a cored-out section 518,
cored out in the same fashion as a pineapple is cored out before
slicing. A cannula 78 is also illustrated, but the remainder of the
seal and seal carrier components, which surround the conductive
puck 123', are omitted for clarity. By coring out the conductive
pucks, frictional resistance is reduced when the cannula is
retracted out of the pucks. Resistance may still be present from
the seals, but the same may also be reduced in ways as described
below. The coring may be such that a minimum wall thickness still
remains in the cylinder wall, e.g., at least about 0.030'', so as
to allow compression on the puck and prevent buckling. The shape
may generally be a cylinder to prevent the need to key the puck
during assembly, but other shapes are also possible. For example,
square, hexagonal, or hourglass, but these may be less preferable
due to added difficulty in assembly.
[0340] FIGS. 51-56 illustrate another implementation 628 of a seal
for use in a seal carrier, this implementation termed a hybrid
seal. Hybrid seal implementations may employ different materials
having different durometers. A rigid or high durometer material may
be employed for sensor placement, thus reducing slingshotting, and
a softer or lower durometer seal material may be employed for
increased sealing ability. In the implementation of FIGS. 51-56,
the hybrid dual material design is employed which provides the
properties of a high durometer material such as silicone, desired
for sensor placement, but with a different softer material placed
in strategic locations for sensor wire sealing. This implementation
addresses certain problems that arise when a seal material is of a
single unitary type, particularly a material like silicone.
Silicone has properties which are advantageous and which result in
accurate sensor placement relative to pucks in an applicator
device. As noted, however, the same properties which help place the
sensor accurately sometimes makes sealing around the sensor wire
more difficult.
[0341] In more detail, a first material 634, which may be a high
durometer material such as an elastomer, e.g., silicone, may be
disposed in locations in which significant contact is made with a
cannula, needle, and sensor wire. A second lower durometer material
632 may then be placed to constitute the rest of the seal 628, and
in particular in locations where a sealing function is desired. The
second material 632 may be, e.g., a thermoplastic elastomer (TPE).
As noted the second material 632 typically has a lower durometer
than that of the silicone, allowing the same to achieve a better
seal.
[0342] The implementation of FIGS. 51-56 provides a unique solution
for at least the reason of sterilization. TPE is typically more
robust to sterilization effects than silicone (e.g., for gamma and
e-beam), and thus the hybrid seal 628 provides significant
advantages over nonhybrid seals.
[0343] FIGS. 57-59 illustrate another implementation of the seal
636 according to present principles, such termed a flow seal 636.
In particular, as noted above during application deployment the
force required to remove the cannula from the seal causes stress
within the components and adds risk because of preloaded and
stressed components, particularly in situations of long shelf life.
The implementation of FIGS. 57-59 solves this problem by
significantly reducing the force required to remove the cannula
from the seal. It does so by removing a significant portion of the
seal from the seal carrier, and replacing the same with a flowable
material.
[0344] In particular, the cannula 78 passes through a channel 646
formed between a seal portion 638 and the seal carrier 644. During
manufacture, a fluid such as grease, e.g., petroleum jelly, is
injected into the channel 646. Following injection, it need not
occupy the entirety of the channel. However, when the transmitter
is placed on top of the seal and forced onto the seal and seal
carrier, making contact with the pucks 123 and 125, the seal
portion 638 will be significantly compressed, forcing the grease
throughout the channel. The grease provides a moisture barrier and
significantly reduces the retraction force required for the
cannula, consequently reducing slingshotting.
[0345] The grease may be inserted through a septum 642, e.g., with
a needle. A front septum 648 may be provided, and the same may
advantageously be employed to help retain the sensor wire in place
via friction. The septum 648 (and septum 642) may be made of seal
material, e.g., an elastomer, and the same generally is
pre-stressed to "close up" when the cannula or needle is removed.
In some implementations, the septum may be made of a more rigid
elastomer, to allow a more rigid hold on the wire. Because of this
there may still be an increase in force required when the cannula
begins to be retracted from the septum, but in many of the
applicator implementations, the beginning of cannula retraction is
at a point when the retraction drive, e.g., spring, has
considerable energy with which to exert a force, e.g., the spring
is not at the end of its movement, and thus such retraction is
easily performed.
[0346] The pucks 123 and 125 may be "floating", in the sense that
they are held by the seal 638 and are not penetrated by the cannula
(nor is the seal 638), except at the septum 648. However, the pucks
123 and 125 may be held within the seal 638 by the use of annular
tabs 652 moving within cylindrical channels 654.
[0347] FIGS. 57A-57C illustrate the seal 638 before needle and
grease insertion (FIG. 57A), with needle insertion but before
grease is injected (FIG. 57B), and finally after grease injection
(FIG. 57C). FIG. 59 indicates a perspective view of the flow seal
636 in place within a seal carrier 644.
[0348] Various advantages inure to the implementation of FIGS.
57-59. For example, when the transmitter is forced onto the
disposable housing and seal/seal carrier, the grease flows
throughout the interior of the seal carrier, significantly
protecting the wire from moisture. Another significant advantage
results in the implementation of FIGS. 57-59 particularly as
compared to where an entire solid seal is employed. In particular,
elastomer seals can become "set" during the process of
sterilization. Thus, when the seal is manufactured and is
sterilized with the cannula in place, removal of the cannula
sometimes may leave a void. In the present system, the grease or
petroleum jelly could provide a gap filling function. Another
significant advantage inures in the effect of the flow seal on
applicator mechanisms. For example, the flow seal may reduce the
force of seal retraction such that a booster spring or other
"extra" retraction force mechanism is not required.
[0349] Alternatives of the system of FIGS. 57-59 will also be
understood. For example, while just a single wire-holding septum is
shown in FIG. 57, septum 648, another septum may be placed on the
other side of the seal, creating a dual septum system, which would
serve to trap the grease between the two septa. In addition, the
septa serve an additional purpose of removing grease from the
cannula, so that the same stays within a sealed zone.
[0350] In another alternative, rather than piercing the septum, the
cannula could be held just proximal to it. During deployment, i.e.,
needle insertion, the needle pierces the septum and performs sensor
insertion. The cannula still serves the purpose of preventing
needle contact with the grease inside the flow seal. This
implementation has the benefit that the septum remains in an
unstressed state during sterilization and storage. This aspect
eliminates the compression set that would otherwise reduce sensor
retention by the septum post sterilization and after storage.
[0351] In yet another implementation, as shown in FIGS. 60-62, a
seal 662 may be constructed with a number of annular or ringed
seals 664, e.g., a face seal with one or more concentric annular
ringed protrusions or ridges on the sealing face. Embodiments
employing multiple rings can provide multiple sealing barriers to
ingress, and can also concentrate the sealing force to the more
critical areas of the seal. In some embodiments, one or more
0-rings can be disposed near one or more of the annular protrusions
(e.g., in the groove between two of the ridges) to create an
additional seal. As with prior implementations, the top of the
ringed seals contacts the transmitter and the bottom contacts the
seal carrier.
[0352] This implementation may reduce the amount of force needed to
remove the cannula from the seal. In addition, the same allow for
seal breaches to occur, e.g., in one ring, without affecting the
seal integrity of the other ring(s). (Seal breaches may occur due
to surface defects, tolerances, and the like.) In variations of the
implementation of FIGS. 60-62, the number of rings can be varied,
their cross-sectional shape can be varied, and the shape of the
ring itself can vary, e.g., in some implementations noncircular
rings may be employed.
[0353] Another implementation which may be employed to reduce the
normal force on the cannula by the seal, and thus to make the
cannula easier to remove, is by use of the sandwich seal. Such a
sandwich seal is illustrated by FIGS. 63-69.
[0354] In particular, as noted the force required to remove the
cannula from the seal typically stresses the components of the seal
and applicator system. Efforts have been attempted at reducing the
required force to remove the cannula by slitting the seals, but
such seal slitting operations are typically undesirable and
deleterious.
[0355] A sandwich seal employs a two-part design in which the
cannula is sandwiched between the two parts. This results in a
generally much lower cannula pull force requirement because along
the length of the cannula the frictional force of the seal thereon
is less. Other advantages include that no grease is required for
sealing, and sensor retention is decoupled from the seal and can be
made much more robust. Ideal sealing materials, such as low
durometer elastomers, can be employed because the sealing function
is decoupled from other functions such as sensor placement.
[0356] In more detail, a sandwich seal may be employed which
increases the gap spacing between the seal and the cannula. Instead
of a single block of elastomeric material, two blocks may be
employed and the cannula can pass through in-between the blocks.
The cannula thus has a larger opening through which to pass,
minimizing resistance and slingshotting.
[0357] Referring first to FIG. 63, a seal carrier 668 is
illustrated with a bottom sandwich seal component 672. A passage
674 is seen with a general "U"-shape through pillar columns 676.
Between each set of pillar columns a puck may be placed (not
shown). The seal carrier 668 may be made of a rigid material such
as a polycarbonate, and the bottom sandwich seal component 672 may
be made of, e.g., an elastomer or other material such as silicone,
or any material allowing for sensor retention.
[0358] A top sandwich component 678 is illustrated, having a top
frame 682 and a top seal 684. The top sandwich component 678 may be
hinged to the bottom component 672 (see hinge 692 in FIG. 64), and
the top sandwich component may then be held fast to the bottom
component 672 by a latch tab 686 which may pass and hold fast to a
tab 688 in the bottom component.
[0359] In use, and during insertion, the system may be in the
unlatched position, as illustrated in FIG. 64. Any of the
applicators described above may be employed to deploy the sensor
wire between the top seal 684 and the bottom seal 672. The top seal
and bottom seal (and top frame and seal carrier) may then be
snapped together using the latch 686 and the tabs 688. The top seal
and bottom seal may be snapped together when the transmitter is
inserted, providing the seal and sensor retention needed. The pucks
may be contained in the top seal, and may snap down on top of the
sensor wire, again when the transmitter is inserted.
[0360] In one implementation, the bottom seal material 672 may have
a higher durometer than the seal material 684. In another
implementation, the opposite may be true. Having a higher durometer
bottom seal material 672 allows support of the sensor wire in a way
so as to produce a reliable connection to the pucks but which also
allows good sealing when sandwiched to the lower durometer material
snapping down from above it. In some cases, the frame 682 and the
top seal 684 may both be made of an overmolded low durometer seal
material.
[0361] Variations of the implementation of FIGS. 63-65 may include
one or more of the following. A septum may be placed at the distal
end of the seal, e.g., within the top frame 682, and the same may
be pre-pierced by the needle. Upon deployment, the sensor wire may
be held by the septum. In another variation, the bottom housing may
include puck retaining features which keep the wire from moving out
of the path of puck conduction, as well as providing added
stability to the pucks.
[0362] In yet another variation, the top portion of the seal (frame
682 and seal 684) may be held above the needle, and the septum
(described above) is not pierced in its manufactured state. Rather,
the needle pierces the septum upon activation of the applicator. In
this variation, the cannula can be eliminated, reducing parts and
increasing manufacturability. The septum beneficially remains in an
unstressed state during sterilization and storage. This aspect has
the advantage of a limited compression set that would otherwise
reduce sensor retention by the septum post sterilization and after
storage. In this variation, the top portion of the seal may be held
out of the way of the needle before and during deployment as well
as during storage, which may be accomplished by putting snaps on
the top seal component or incorporating features into the carrier
that hold the seal in the applicator and prevent the top seal from
compressing on the needle.
[0363] FIG. 66 shows a particular implementation of a sandwich seal
694, showing a low durometer seal material 684' held in the top
frame 682, which is hingedly attached to the seal carrier 668. In
this implementation, a septum 696 is disposed, where the septum
material has a relatively high durometer, e.g., silicone with a
durometer of 50-70 shore A, e.g., with an exemplary thickness of,
e.g., 0.062''. Unlike the implementations of FIGS. 63-65, in the
implementation of FIG. 66, there is no lower durometer seal
material from the top seal 684 in the path of the cannula. Rather,
the high durometer silicone of the septum provides the retention
force for the sensor wire to keep the same from being removed
before the seal is completely snapped down. As before, the seal may
be snapped down to a final configuration upon the insertion of the
transmitter. Even before this final configuration is attained, the
sensor wire is still held firmly in place by the septum, to reduce
the chance of accidental removal of the sensor wire prior to the
transmitter being snapped down.
[0364] FIGS. 67-69 illustrate progressive steps of the use of a
sandwich seal with septum 694. FIG. 67 illustrates a profile view
of the sandwich seal in an open position, and FIG. 68 illustrates a
side view. FIG. 67 illustrates a side view in a closed
position.
[0365] Advantages of the implementation of FIGS. 63-69 may include
one or more of the following. In some implementations, the cannula
may be removable from the design. The implementation may
significantly reduce or eliminate slingshotting effects of
retraction. Either the top or the bottom portions of the seal
design, or both, may be overmolded. The implementations allow
improved product manufacturability and reliability. For example,
slitting and exchange processes required in single piece seals may
be eliminated in these implementations. In some implementations,
additional force devices such as booster springs may be eliminated,
because the cannula or needle has force for retraction has been
reduced.
[0366] FIGS. 70-72 illustrate another implementation 702 of a seal
design, in particular showing a "stack" seal. This implementation,
like the sandwich seal, places less normal force on the cannula,
resulting in a lower cannula retraction force requirement. Sensor
retention is decoupled and can be much more robust, as the same can
be accomplished by a septum. The implementation of FIG. 70 requires
no grease for sealing, and ideal sealing materials, e.g., low
durometer TPE, can be employed, as the sealing function is
decoupled from other functions, e.g., sensor placement. In
addition, seal slitting process, which is undesired, is no longer
required.
[0367] In implementations according to these principles, a seal
housing 704 includes a septum 705 for use in holding a sensor wire
as described above, the septum 705 located at a distal portion of
the seal subassembly. A material 706 is illustrated, which is
overmolded onto a rigid plastic component 703. The material 706 may
be a low durometer component, e.g., TPE or silicone or other
sealing material. The material 706 also contacts a bottom portion
of the rigid plastic component 703, as shown in FIG. 71. The pucks
708 and 710 are shown in the figures, along with the cannula 712.
The implementation of FIG. 70 bears certain similarities with the
sandwich seal of FIG. 63, one difference being that the
implementation of FIG. 70 includes an overmolded top sealing
material, rather than one which is mechanically inserted into a
frame.
[0368] FIGS. 73-77 illustrate other ways to combat slingshotting
and to ensure accurate sensor placement. In particular, and
referring to FIGS. 73 and 74, a seal carrier 732 may have a base
734 and a top portion 736, which base and top portions may be
according to any of the implementations described. Either or both
(the base portion is shown in the figures) may incorporate a spring
element 738 which, e.g., abuts and is held in place by an element
742 integral with the base 734. The spring element 738 includes a
contact element 744 which abuts and provides pressure against a
cannula 746 prior to removal of the cannula. FIG. 73 illustrates a
seal carrier with one spring element 738. FIG. 74 illustrates a
seal carrier 732' incorporating two spring elements. The operations
are the same whether one or two spring elements are used.
[0369] When the cannula is removed during retraction, the spring
element 738, and in particular the contact element 744, no longer
abuts the cannula but rather it abuts the sensor wire, providing
additional force against sensor wire movement. In one variation,
spring element 738 may be configured to provide a greater force
when contacting the sensor wire then when contacting the cannula.
In another variation, the spring element 738 may be arrested from
movements such that the contact element 744 does not even abut the
cannula until such time as the cannula is removed, and then the
arresting of movement may be removed and the spring element caused
to contact and provide a force against the sensor wire.
[0370] FIG. 75 illustrates another implementation of a spring
element system, in which a spring element 736 has a first portion
738 and a second portion 742, and the same are configured on
opposite sides of the seal carrier 737. By being on opposite sides
of the seal carrier 737, the spring element 736 may be both
frictionally and by virtue of a spring force in solid engagement
with the seal carrier 737. The spring element 742 may include,
e.g., two fingers 741 and 743, which are kept apart by the cannula,
or by an element the cannula passes through. Upon removal of the
cannula, or upon removal of the element the cannula passes through,
the two fingers 741 and 743 closed down upon the sensor wire, and
hold the same in a secure fashion.
[0371] FIG. 76 illustrates an alternative implementation, in which
instead of the cannula or sensor wire being held securely by the
spring element, the seal is held by a spring element against
slingshotting. In particular, a seal carrier 754 is illustrated
having a seal 756, shown in cross-section in FIG. 76. A cannula 762
is illustrated, through which a needle and sensor wire may be
delivered as described above. A spring element 754 is employed to
hold the seal 756 securely, and in particular against movement such
as slingshotting. In this way, the seal is prohibited from
movements during cannula removal, reducing the effects of
slingshotting on the sensor wire.
[0372] FIG. 77 illustrates an assembly 772 that operates in a way
similar to a mouse trap. In this implementation, a spring element
773 provides a force generally perpendicular to the cannula
retraction direction on the distal side of the seal.
[0373] FIGS. 78-83 further illustrate ways according to present
principles to withdraw the cannula and deposit a sensor wire within
an elastomeric seal. As noted, friction between the seal and the
cannula can cause the elastomeric seal to move, and such movement
may cause unwanted side effects such as sensor placement error due
to slingshotting.
[0374] The implementations of FIG. 78 et seq. provide ways to
reduce the amount of seal interaction with the sensor wire by
creating voids along the sensor path. In addition, anchoring
features are provided to limit the amount the seal can move. For
example, physical walls may be employed within the sensor housing
to limit the amount the sensor can move, and/or a glue may be
employed to further limit seal movement. In addition, certain of
the implementations described provide a reduction in force required
to remove the cannula.
[0375] In more detail, and referring first to FIG. 78-79, a design
is shown for a seal assembly 802 having a seal housing 804 in which
undercuts are created through the puck holes to create voids in the
cannula / wire pathway. A void 804 is illustrated adjacent puck
hole 808a (which is the distal puck hole) and a void 806 is
illustrated adjacent puck hole 808b (which is the proximal puck
hole). In both cases undercuts below the top of the puck hole are
disposed to create the void. In the implementation shown, material
is removed around both sides of the distal puck, while for the
proximal puck, material is removed only up to the puck support
walls. An inset 810 is illustrated for the distal portion of the
seal, such that the same is inset from the front of the seal
carrier. The inset 810 serves the purpose of exposing the tip of
the cannula (such that there is no seal piercing by the moving
needle) and limiting the wall thickness of the seal material
between void 804 and 810.
[0376] FIG. 80-81 illustrate another implementation, in which glue
wells are added in the front and back. Adding glue through an
opening serves to adhere the elastomer to the rigid seal carrier.
This embodiment further illustrates the same voids and inset as
shown in FIGS. 78-79.
[0377] In more detail, the seal housing 812 includes one or more
glue wells 814. In FIG. 80, four glue wells 814 are illustrated,
two in the front of the seal assembly and two in the back. A seal
816 is also shown, and referring further to FIG. 81 it may be seen
how the glue wells 814 are formed in the seal 816. The glue wells
may be chamfered and rounded. The glue wells may run to the floor
of the seal carrier, and once glue has been disposed in the glue
wells, the seal is adhesively coupled to the seal housing, reducing
seal movement and subsequent slingshotting.
[0378] FIG. 82-83 illustrate another implementation, in which again
material is removed along the sensor wire and cannula path by
creating shaped voids formed from the top surface. In the
implementation 818, a front seal void 820 is formed or defined
which may have, e.g., an oval shape of seal material removed. Puck
support is still maintained. This void has no undercut, and thus
simplifies the corresponding manufacturing tool. A mid-seal void
822 is also shown, which again may have an oval shape of material
removed, although in this and the front seal void, non-oval shapes
may also be removed. Again puck support is maintained, and the
mid-seal void, like the front seal void, has no undercut,
simplifying the manufacturing tool. As with the implementation of
FIGS. 78-79, the distal seal may be inset from the front of the
seal carrier.
[0379] It will be understood that in any of the implementations of
FIG. 78 et seq., variations in the placement and shape of voids and
glue wells are possible, and depend on the particular seal assembly
design, as well as on the sensor wire and/or cannula placement and
removal force profile required.
[0380] Variations of the above will also be understood. For
example, in some cases users may find it difficult or inconvenient
to hold the applicator flat on their skin and push the activation
button at the same time. Such may be particularly true if the user
is inserting the sensor on their side or back. For these reasons,
and referring to FIG. 84, an applicator 902 may be automatically
triggered by a remote device 906 by having an electromechanical
device 904 activate the trigger. While the receiver 904 is shown in
the figure as occupying the location of the button, it will be
understood that the same may be entirely internal to the applicator
902.
[0381] The activating device 906 and the activated device 902,
i.e., the applicator, may be communicatively coupled in a number of
ways, including wirelessly or via a wired link. Wireless
communication schemes may include RF links such as may be enabled
by Bluetooth protocols, WiFi, or the like. Other communication
schemes will also be understood. Advantages of such systems and
methods according to present principles are described above, but
also include that the user may situate the applicator on their body
in a more stable fashion, rather than having to use one of their
fingers to also push the activation button (or manipulate another
activator, such as a slider or the like disclosed here).
[0382] The activating device 906 may be, e.g., a smart phone, a
smart watch, a computing device, a dedicated receiver or
transmitter, e.g., similar to a garage door opener or other remote
control, or the like. The same may incorporate timers or other time
delay devices, as well. In alternative implementations, a button on
the applicator may be employed, as in FIGS. 3-16, but the same may
employ a time delay.
[0383] In another variation, and referring to FIG. 85, an
implementation is shown in which a transition region is provided at
the intersection of the adhesive 516 and the disposable housing 36.
In particular, a transition region comprising a volumetric solid
910 is provided to ease the transition between the adhesive 516 and
the disposable 36. The transition region may include a material
such as silicone which can be formed and which can provide a
profile transition between the adhesive patch and the transmitter
housing on the wearable. The transition region limits the
occurrence of features on the wearable that can snag on elements,
e.g., the user's clothes, and tear the wearable off. The material
may be flexible for patient comfort.
[0384] In another embodiment, and referring to FIGS. 105 and 106,
an applicator device (only a lower housing 40d is illustrated in
FIG. 105) can be adapted for use in applying a disposable housing
36d to the skin of a patient. The disposable housing 36d can be
disposed on an adhesive patch 90d. The disposable housing 36d can
be configured to receive a transmitter 500d (see FIG. 106) which is
adapted for one time use. The disposable housing 36d can include a
slot 442d configured to receive a corresponding tab (not shown in
FIG. 106, but similar to the tab 501 illustrated in FIG. 41) on the
transmitter 500d, so as to help position the transmitter 500d as it
is installed in the disposable housing 36d, in a similar fashion as
the transmitter 500 and disposable housing 36
[0385] -A1; U.S. illustrated in FIG. 40. In contrast to the
transmitter 500 and disposable housing 36 illustrated in FIG. 40,
however, the disposable housing 36d and the transmitter 500d can be
configured without any breakaway features, release tabs or snaps,
or other release features designed to facilitate removal of the
transmitter 500d after installation in the disposable housing 36d.
Thus, some embodiments can include single-use disposable housings
which are configured for use with single-use transmitters. In some
embodiments, such a disposable housing can be configured with a
smaller footprint than a disposable housing configured with a
breakaway portion or other release features designed to facilitate
the removal of a reusable transmitter.
[0386] In embodiments, a sensor insertion device can generally
include an upper housing, a lower housing, a protective tab (e.g.,
a safety frangible), a trigger button, a torsion spring housing or
wheel cam, a torsion spring, an outer needle hub, an inner needle
hub, a needle, a sensor, a push rod hub, a push rod, a cannula hub,
a cannula, a compression spring, a seal carrier, a seal, a
disposable housing, and an adhesive patch, for example as described
herein. In some embodiments, a sensor insertion device can be
configured to deploy generally as follows. In an initial
configuration, for example as manufactured and provided to the
consumer, the upper housing and lower housing are coupled together
to house the inner components of the device. The torsion spring and
the compression spring are pre-energized or pre-loaded. The outer
needle hub, inner needle hub, cannula hub, and push rod hub are
fixedly coupled to one another in an initial, pre-deployed
configuration, with the needle and push rod in an initial proximal
position. The cannula is in an initial distal position, and is
operatively coupled to the disposable housing via the seal. In some
embodiments, the cannula extends through the elastomeric seal in
frictional engagement with the elastomeric seal. The seal carrier
is hingedly coupled to the disposable housing, but disposed at an
angle with respect to the disposable housing, in line with an angle
of insertion. In the initial configuration, the cannula hub
cooperates with ribs of the lower housing to secure the seal
carrier in this angled position. Also in the initial configuration,
a tab or other protrusion of the trigger is disposed so as to block
or prevent rotation of the torsion spring housing, and thereby
prevent activation of the torsion spring. The sensor is disposed
fully within the lumen of the needle, distal of the push rod. The
push rod, needle, and cannula are arranged telescopically along the
axis of insertion of the sensor.
[0387] In order to enable deployment of the device, the user first
decouples or otherwise removes the protective tab, which is
initially coupled to the trigger to prevent unintentional
deployment of the device. The user then presses down on the
trigger. The trigger slides through a track in the upper housing,
and the tab is displaced from its blocking engagement with the
torsion spring housing, thereby releasing or activating the torsion
spring and causing the torsion spring housing to rotate about its
center axis.
[0388] The torsion spring housing includes a pin configured to
engage with a slot or yoke in the outer needle hub. As the torsion
spring housing begins to rotate (under the force of the activated
torsion spring), the pin pushes the slot and, thus, the outer
needle hub, in a distal direction. Since the inner needle hub and
push rod hub are both fixed to the outer needle hub at this stage,
but the cannula hub is fixed in the distal direction (e.g.,
prevented from moving distally by the positioning of the seal
carrier and disposable housing), the inner needle hub and push rod
hub both move distally with respect to the cannula hub. With this
movement, the inner needle hub moves from a first engagement
position with the cannula hub, travelling to a second engagement
position with the cannula hub. The needle, sensor, and push rod
travel together to their most distal positions, and the needle and
sensor are inserted into the skin.
[0389] After (or at the same time as) the outer needle hub, the
inner needle hub, and the push rod hub reach their most distal
position, arms or other features of the push rod hub engage with
corresponding tabs or other positional engagement features of the
lower housing to lock the push rod hub in its distal position (e.g.
to prevent proximal movement of the push rod hub). Backspring
features forming part of (or coupled to) the push rod hub deform as
the push rod hub reaches its distal position to bias the push rod
hub against the positional engagement features of the lower
housing, thereby fixing the position of the push rod hub (and the
push rod) in the axial direction.
[0390] As the torsion spring housing continues to rotate (still
under the force of the activated torsion spring), the drive
mechanism self-reverses, and the engagement of the pin with the
slot begins to move the outer needle hub back in a proximal
direction, initiating retraction of the needle. Since the push rod
hub is fixed in a distal position at this stage (e.g., prevented
from moving proximally by its engagement with the lower housing),
the push rod provides a backstop to the sensor in the distal
position and prevents proximal movement of the sensor as the needle
moves in the proximal direction.
[0391] The movement of the outer needle hub in the proximal
direction causes the outer needle hub to decouple from the push rod
hub (e.g., by causing the disengagement or interengaging features
of the outer needle hub and the push rod hub). As the outer needle
hub continues to move proximally with respect to the push rod hub,
tabs or protrusions of the push rod hub engage with tabs or
protrusions of the inner needle hub, to release the inner needle
hub from engagement with the outer needle hub. At or about the same
time, the torsion spring housing rotates into a section of the
upper housing containing one or more ratchet engagement teeth and a
hard stop. This structure engages the ratchet arm of the torsion
spring housing and arrests rotational movement of the torsion
spring housing, as well as and linear movement of the outer needle
hub. The decoupling of the inner needle hub from the outer needle
hub serves to release or otherwise activate the compression spring,
which drives the inner needle hub further in the proximal
direction. As the inner needle hub is driven proximally, it couples
with second engagement feature of the cannula hub. The movement of
the inner needle hub pulls the needle, the cannula hub, and the
cannula in the proximal direction. This drives the cannula out of
the seal and the cannula and needle to the fully retracted proximal
position.
[0392] Once the cannula hub is moved out from under the seal
carrier to a proximal position, the seal carrier is free to rotate
about its hinged coupling with the disposable housing, from its
initial angled orientation to a flat or other final orientation
within the disposable housing, in which the disposable housing can
receive a transmitter. In some embodiments, this rotation is
assisted with the addition of, for example, a spring-like arm
biased against the seal carrier. At this stage, the disposable
housing is also decoupled from the remainder of the device, such
that the device need only be lifted away by the user to leave the
disposable housing applied to the skin and ready to receive the
transmitter.
[0393] It should be appreciated that all methods and processes
disclosed herein may be used in any glucose monitoring system,
continuous or intermittent. It should further be appreciated that
the implementation and/or execution of all methods and processes
may be performed by any suitable devices or systems, whether local
or remote. Further, any combination of devices or systems may be
used to implement the present methods and processes.
[0394] Methods and devices that are suitable for use in conjunction
with aspects of the preferred embodiments are disclosed in U.S.
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[0396] The above description presents the best mode contemplated
for carrying out the present invention, and of the manner and
process of making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art to which it
pertains to make and use this invention. This invention is,
however, susceptible to modifications and alternate constructions
from that discussed above that are fully equivalent. Consequently,
this invention is not limited to the particular embodiments
disclosed. On the contrary, this invention covers all modifications
and alternate constructions coming within the spirit and scope of
the invention as generally expressed by the following claims, which
particularly point out and distinctly claim the subject matter of
the invention. While the disclosure has been illustrated and
described in detail in the drawings and foregoing description, such
illustration and description are to be considered illustrative or
exemplary and not restrictive.
[0397] 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.
[0398] 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. As examples of the
foregoing, the term `including` should be read to mean `including,
without limitation,` including but not limited to,' or the like;
the term `comprising` as used herein is synonymous with
`including,` `containing,` or `characterized by,` and is inclusive
or open-ended and does not exclude additional, unrecited elements
or method steps; the term `having` should be interpreted as `having
at least;` the term `includes` should be interpreted as `includes
but is not limited to;` the term `example` is used to provide
exemplary instances of the item in discussion, not an exhaustive or
limiting list thereof; adjectives such as `known`, `normal`,
`standard`, and terms of similar meaning should not be construed as
limiting the item described to a given time period or to an item
available as of a given time, but instead should be read to
encompass known, normal, or standard technologies that may be
available or known now or at any time in the future; and use of
terms like `preferably,` `preferred,` `desired,` or `desirable,`
and words of similar meaning should not be understood as implying
that certain features are critical, essential, or even important to
the structure or function of the invention, but instead as merely
intended to highlight alternative or additional features that may
or may not be utilized in a particular embodiment of the invention.
Likewise, a group of items linked with the conjunction `and` should
not be read as requiring that each and every one of those items be
present in the grouping, but rather should be read as `and/or`
unless expressly stated otherwise. Similarly, a group of items
linked with the conjunction `or` should not be read as requiring
mutual exclusivity among that group, but rather should be read as
`and/or` unless expressly stated otherwise.
[0399] Where a range of values is provided, it is understood that
the upper and lower limit, and each intervening value between the
upper and lower limit of the range is encompassed within the
embodiments.
[0400] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations may be expressly set forth
herein for sake of clarity. The indefinite article `a` or `an` does
not exclude a plurality. A single processor or other unit may
fulfill the functions of several items recited in the claims. The
mere fact that certain measures are recited in mutually different
dependent claims does not indicate that a combination of these
measures cannot be used to advantage. Any reference signs in the
claims should not be construed as limiting the scope.
[0401] It will be further understood by those within the art that
if a specific number of an introduced claim recitation is intended,
such an intent will be explicitly recited in the claim, and in the
absence of such recitation no such intent is present. For example,
as an aid to understanding, the following appended claims may
contain usage of the introductory phrases `at least one` and `one
or more` to introduce claim recitations. However, the use of such
phrases should not be construed to imply that the introduction of a
claim recitation by the indefinite articles `a` or `an` limits any
particular claim containing such introduced claim recitation to
embodiments containing only one such recitation, even when the same
claim includes the introductory phrases `one or more` or `at least
one` and indefinite articles such as `a` or `an` (e.g., `a` and/or
`an` should typically be interpreted to mean `at least one` or `one
or more`); the same holds true for the use of definite articles
used to introduce claim recitations. In addition, even if a
specific number of an introduced claim recitation is explicitly
recited, those skilled in the art will recognize that such
recitation should typically be interpreted to mean at least the
recited number (e.g., the bare recitation of `two recitations,`
without other modifiers, typically means at least two recitations,
or two or more recitations). Furthermore, in those instances where
a convention analogous to `at least one of A, B, and C, etc.` is
used, in general such a construction is intended in the sense one
having skill in the art would understand the convention (e.g., `a
system having at least one of A, B, and C` would include but not be
limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). In those instances where a convention analogous to
`at least one of A, B, or C, etc.` is used, in general such a
construction is intended in the sense one having skill in the art
would understand the convention (e.g., `a system having at least
one of A, B, or C` would include but not be limited to systems that
have A alone, B alone, C alone, A and B together, A and C together,
B and C together, and/or A, B, and C together, etc.). It will be
further understood by those within the art that virtually any
disjunctive word and/or phrase presenting two or more alternative
terms, whether in the description, claims, or drawings, should be
understood to contemplate the possibilities of including one of the
terms, either of the terms, or both terms. For example, the phrase
`A or B` will be understood to include the possibilities of `A` or
`B` or `A and B.`
[0402] All numbers expressing quantities of ingredients, reaction
conditions, and so forth used in the specification are to be
understood as being modified in all instances by the term `about.`
Accordingly, unless indicated to the contrary, the numerical
parameters set forth herein are approximations that may vary
depending upon the desired properties sought to be obtained. At the
very least, and not as an attempt to limit the application of the
doctrine of equivalents to the scope of any claims in any
application claiming priority to the present application, each
numerical parameter should be construed in light of the number of
significant digits and ordinary rounding approaches.
[0403] Furthermore, although the foregoing has been described in
some detail by way of illustrations and examples for purposes of
clarity and understanding, it is apparent to those skilled in the
art that certain changes and modifications may be practiced.
Therefore, the description and examples should not be construed as
limiting the scope of the invention to the specific embodiments and
examples described herein, but rather to also cover all
modification and alternatives coming with the true scope and spirit
of the invention.
* * * * *