U.S. patent application number 12/581553 was filed with the patent office on 2010-06-17 for disposable infusion device with automatically releasable cannula driver.
This patent application is currently assigned to Calibra Medical, Inc.. Invention is credited to Brett J. Carter, Travis Marsot.
Application Number | 20100152666 12/581553 |
Document ID | / |
Family ID | 42241404 |
Filed Date | 2010-06-17 |
United States Patent
Application |
20100152666 |
Kind Code |
A1 |
Carter; Brett J. ; et
al. |
June 17, 2010 |
DISPOSABLE INFUSION DEVICE WITH AUTOMATICALLY RELEASABLE CANNULA
DRIVER
Abstract
An infusion system comprises a disposable wearable infusion
device having a body arranged to be adhered to a patient's skin and
a reservoir for holding a liquid medicament to be infused into the
patient through a cannula extending from the device body to beneath
the patient's skin. The system further includes a cannula driver
arranged to be detachably joined with the infusion device and
including a cannula. The cannula driver is arranged to drive the
cannula into a deployed position extending from the device body to
beneath the patient's skin. The cannula driver includes a release
mechanism that separates the cannula driver from the infusion
device after the cannula is in the deployed position.
Inventors: |
Carter; Brett J.; (Monroe,
WA) ; Marsot; Travis; (Mountain View, CA) |
Correspondence
Address: |
GRAYBEAL JACKSON LLP
400 - 108TH AVENUE NE, SUITE 700
BELLEVUE
WA
98004
US
|
Assignee: |
Calibra Medical, Inc.
Redwood City
CA
|
Family ID: |
42241404 |
Appl. No.: |
12/581553 |
Filed: |
October 19, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12147295 |
Jun 26, 2008 |
|
|
|
12581553 |
|
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|
Current U.S.
Class: |
604/180 |
Current CPC
Class: |
A61M 5/3287 20130101;
A61M 2209/045 20130101; A61M 5/1424 20130101; A61M 2005/1581
20130101; Y10S 128/26 20130101; A61M 5/14248 20130101; A61M 5/14216
20130101; A61M 2005/14252 20130101; A61M 5/16854 20130101; A61M
2005/1426 20130101 |
Class at
Publication: |
604/180 |
International
Class: |
A61M 5/14 20060101
A61M005/14 |
Claims
1. An infusion device comprising: a body arranged to be adhered to
a patient's skin, the body defining a cavity; a reservoir for
holding a liquid medicament to be infused into the patient; and a
cannula assembly including a cannula and a cannula carrier, the
cannula carrier being received within the cavity of the body with
the cannula extending from the cannula carrier and the device body
to beneath the patient's skin to deliver the liquid medicament to
the patient; the cannula carrier being configured to movably mate
with a portion of the infusion device within the cavity.
2. The device of claim 1, wherein the device includes an outlet
structure within the cavity, and wherein the portion of the
infusion device with which the cannula carrier is configured to
movably mate includes the outlet structure.
3. The device of claim 1, wherein the cannula carrier includes a
securing mechanism causing the cannula carrier to be loosely
confined within the infusion device cavity.
4. The device of claim 3, wherein the device includes an outlet
structure within the cavity, and wherein the portion of the
infusion device with which the cannula carrier is configured to
movably mate includes the outlet structure as the cannula carrier
is loosely confined within the infusion device cavity.
5. The device of claim 4, wherein the cannula carrier includes a
flexible seal that movably mates with the outlet structure.
6. The device of claim 4, wherein the outlet structure has a shape
and wherein the cannula carrier has a recess having a shape
generally corresponding to the shape of the outlet structure for
receiving the outlet structure.
7. An infusion device comprising: a body arranged to be adhered to
a patient's skin, the body defining a cavity; a reservoir for
holding a liquid medicament to be infused into the patient; a
cannula assembly including a cannula and a cannula carrier, the
cannula carrier being received within the cavity of the device body
with the cannula extending from the cannula carrier and the device
body to beneath the patient's skin to deliver the liquid medicament
to the patient; wherein the device body and the cannula carrier
together define a self-centering structure that centers the cannula
carrier within the infusion device cavity.
8. The device of claim 7, wherein the device includes an outlet
structure within the cavity, and wherein the self-centering
structure includes the outlet structure.
9. The device of claim 8, wherein the outlet structure has a shape
and wherein the cannula carrier has a recess having a shape
generally corresponding to the shape of the outlet structure for
receiving the outlet structure.
10. The device of claim 8, wherein the cannula carrier includes a
flexible seal that movably mates with the outlet structure.
11. The device of claim 7, wherein the cannula carrier is arranged
to be loosely confined within the infusion device cavity.
12. An infusion system comprising: a disposable wearable infusion
device having a body arranged to be adhered to a patient's skin and
a reservoir for holding a liquid medicament to be infused into the
patient through a cannula extending from the device body to beneath
the patient's skin; and a cannula driver that provides the
disposable wearable infusion device with a cannula, the cannula
driver being arranged to drive the cannula into a deployed position
extending from the device body to beneath the patient's skin, and
wherein, the cannula driver further includes an absorber tab to
remove excess liquid medicament from the cannula during cannula
deployment.
13. An infusion system comprising: a disposable wearable infusion
device having a body arranged to be adhered to a patient's skin and
a reservoir for holding a liquid medicament to be infused into the
patient through a cannula extending from the device body to beneath
the patient's skin; and a cannula driver that provides the
disposable wearable infusion device with a cannula, the cannula
driver being arranged to drive the cannula into a deployed position
extending from the device body to beneath the patient's skin, the
cannula driver comprising an actuator that, when actuated, enables
the driving of the cannula to the deployed position and the
separation of the cannula driver from the infusion device, and
wherein, the actuator includes a snap action mechanism that
accompanies actuation of the cannula driver with a snap action.
14. The system of claim 13, wherein the cannula driver further
comprises a safety control button configured to enable the
actuation of the actuator with a snap action.
15. A cannula deployment apparatus for use with an infusion device,
comprising: a cannula to be deployed; and a cannula driver
including a housing, the cannula driver being arranged to be
detachably joined with the infusion device and to drive the cannula
into a deployed position extending from the infusion device body to
beneath the patient's skin, the cannula driver comprising a plunger
that drives the cannula into a deployed position and a releasable
needle head assembly housed therein, the plunger having a movable
wall portion that when moved, releases the needle head
assembly.
16. A cannula deployment apparatus for use with an infusion device,
comprising: a cannula to be deployed; and a cannula driver
including a housing, the cannula driver being arranged to be
detachably joined with the infusion device and to drive the cannula
into a deployed position extending from the infusion device body to
beneath the patient's skin, the cannula driver comprising a plunger
that drives the cannula into a deployed position and a needle head
assembly housed therein, the needle head assembly being releasable
after cannula deployment, the cannula deployment apparatus further
comprising a translucent portion through which a released needle
head assembly is viewable to confirm cannula deployment.
17. The apparatus of claim 16, wherein the releasable needle head
assembly includes a needle head and wherein the needle head is
colored to assist in the viewability of the needle head assembly
through the translucent portion.
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of application
Ser. No. 12/147,295, filed on Jun. 26, 2008 for DISPOSABLE INFUSION
DEVICE WITH AUTOMATICALLY RELEASABLE CANNULA DRIVER, which is
herein fully incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to infusion devices and more
particularly to such devices that enable liquid medicaments to be
conveniently and safely self-administered by a patient.
[0003] Administration of insulin has traditionally been
accomplished using a syringe. Recently, needle carrying pen-like
devices have also been employed for this purpose. Both forms of
insulin administration require the patients to stick themselves
each time they inject insulin, often many times a day. Thus, these
traditional forms of insulin administration have been a rather
pervasive intrusion in the lives and routines of the patient's who
have had to adopt and employ them.
[0004] More recently, insulin pumps attached by tubing to an
infusion set mounted on the patient's skin have been developed as
an alternative form of insulin administration. Such pumps may be
controlled by a programmable remote electronic system employing
short range radio communication between a control device and
electronics that control the pump. While such devices may involve
fewer needle sticks, they are expensive to manufacture. They are
also complex to operate and cumbersome and awkward to wear.
Further, the cost of such devices can be many times the daily
expense of using a traditional injection means such as a syringe or
an insulin pen.
[0005] Devices of the type mentioned above also require a
significant amount of training to control and thus use the devices.
Great care in programming the devices is required because the pumps
generally carry sufficient insulin to last a few days. Improper
programming or general operation of the pumps can result in
delivery of an excessive amount of insulin which can be very
dangerous and even fatal.
[0006] Many patients are also reluctant to wear a pump device
because they can be socially awkward. The devices are generally
quite noticeable and can be as large as a pager. Adding to their
awkwardness is their attachment to the outside of the patients
clothes and the need for a catheter like tubing set running from
the device to an infusion set located on the patient's body.
Besides being obvious and perhaps embarrassing, wearing such a
device can also be a serious impediment to many activities such as
swimming, bathing, athletic activities, and many activities such as
sun bathing where portions of the patient's body are necessarily
uncovered.
[0007] In view of the above, a more cost effective and simple
device has been proposed whereby an injection system is discreetly
attached directly to the skin of the patient. The device may be
attached to the patient under the patient's clothing to deliver
insulin into the patient by the manual pumping of small doses of
insulin out the distal end of a temporarily indwelling cannula that
is made a part of the pump device. The cannula may be made a part
of the drug delivery device before, during or after the attachment
of the drug delivery device to the skin of the patient. The device
may be made quite small and, when worn under the clothes, entirely
unnoticeable in most social situations. It may still carry
sufficient insulin to last a patient several days. It can be
colored to blend naturally with the patient's skin color so as not
to be noticeable when the patient's skin is exposed. As a result,
insulin for several days may be carried by the patient discreetly,
and conveniently applied in small dosages after only a single
needle stick. For a more complete description of devices of this
type, reference may be had to co-pending application Ser. No.
11/906,130, filed on Sep. 28, 2007 for DISPOSABLE INFUSION DEVICE
WITH DUAL VALVE SYSTEM, which application is owned by the assignee
of this application and hereby incorporated herein by reference in
its entirety.
[0008] The present invention provides further improvement to the
devices disclosed in the above referenced co-pending application.
More particularly, the devices disclosed herein provide for
improved patient safety and/or convenience. For example,
embodiments of the invention provide, for example, cannula mobility
for greater patient comfort, needle retraction for improved sharps
handling and disposal, a closable port cover to prevent accidental
misuse by the patient, and a mechanism to secure the cannula in
place within the drug delivery device. These and other advantages
are addressed herein.
SUMMARY OF THE INVENTION
[0009] In one embodiment an infusion device comprises a body
arranged to be adhered to a patient's skin, the body defining a
cavity, and a reservoir for holding a liquid medicament to be
infused into the patient. The device further comprises a cannula
assembly including a cannula and a cannula carrier. The cannula
carrier is received within the cavity of the body with the cannula
extending from the cannula carrier and the device body to beneath
the patient's skin to deliver the liquid medicament to the patient.
The cannula carrier is configured to movably mate with a portion of
the infusion device within the cavity.
[0010] The device may include an outlet structure within the
cavity. The portion of the infusion device with which the cannula
carrier is configured to movably mate may include the outlet
structure.
[0011] The cannula carrier may include a securing mechanism causing
the cannula carrier to be loosely confined within the infusion
device cavity. The device includes an outlet structure within the
cavity. The portion of the infusion device with which the cannula
carrier is configured to movably mate may include the outlet
structure as the cannula carrier is loosely confined within the
infusion device cavity. The cannula carrier may include a flexible
seal that movably mates with the outlet structure. The cannula
carrier has a recess having a shape generally corresponding to the
shape of the outlet structure for receiving the outlet
structure.
[0012] In another embodiment, an infusion device comprises a body
arranged to be adhered to a patient's skin, the body defining a
cavity, and a reservoir for holding a liquid medicament to be
infused into the patient. The device further comprises a cannula
assembly including a cannula and a cannula carrier. The cannula
carrier is received within the cavity of the device body with the
cannula extending from the cannula carrier and the device body to
beneath the patient's skin to deliver the liquid medicament to the
patient. The device body and the cannula carrier together may
define a self-centering structure that centers the cannula carrier
within the infusion device cavity.
[0013] The device may include an outlet structure within the cavity
and the self-centering structure may include the outlet structure.
The outlet structure has a shape and the cannula carrier may have a
recess having a shape generally corresponding to the shape of the
outlet structure for receiving the outlet structure. The cannula
carrier may include a flexible seal that movably mates with the
outlet structure. The cannula carrier may be arranged to be loosely
confined within the infusion device cavity.
[0014] In another embodiment, an infusion system comprises a
disposable wearable infusion device having a body arranged to be
adhered to a patient's skin and a reservoir for holding a liquid
medicament to be infused into the patient through a cannula
extending from the device body to beneath the patient's skin. The
system further comprises a cannula driver that provides the
disposable wearable infusion device with a cannula. The cannula
driver is arranged to drive the cannula into a deployed position
extending from the device body to beneath the patient's skin. The
cannula driver further includes an absorber tab to remove excess
liquid medicament from the cannula during cannula deployment.
[0015] In a still further embodiment, an infusion system comprises
a disposable wearable infusion device having a body arranged to be
adhered to a patient's skin and a reservoir for holding a liquid
medicament to be infused into the patient through a cannula
extending from the device body to beneath the patient's skin. The
system further includes a cannula driver that provides the
disposable wearable infusion device with a cannula. The cannula
driver is arranged to drive the cannula into a deployed position
extending from the device body to beneath the patient's skin. The
cannula driver comprises an actuator that, when actuated, enables
the driving of the cannula to the deployed position and the
separation of the cannula driver from the infusion device. The
actuator includes a snap action mechanism that accompanies
actuation of the cannula driver with a snap action.
[0016] The cannula driver may further comprise a safety control
button configured to enable the actuation of the actuator with a
snap action.
[0017] In a further embodiment, a cannula deployment apparatus for
use with an infusion device comprises a cannula to be deployed; and
a cannula driver. The cannula driver includes a housing. The
cannula driver is arranged to be detachably joined with the
infusion device and to drive the cannula into a deployed position
extending from the infusion device body to beneath the patient's
skin. The cannula driver comprises a plunger that drives the
cannula into a deployed position and a releasable needle head
assembly housed therein. The plunger has a movable wall portion
that, when moved, releases the needle head assembly.
[0018] In a still further embodiment, a cannula deployment
apparatus for use with an infusion device comprises a cannula to be
deployed and a cannula driver including a housing. The cannula
driver is arranged to be detachably joined with the infusion device
and to drive the cannula into a deployed position extending from
the infusion device body to beneath the patient's skin. The cannula
driver comprises a plunger that drives the cannula into a deployed
position and a needle head assembly housed therein. The needle head
assembly is releasable after cannula deployment. The cannula
deployment apparatus further comprises a translucent portion
through which a released needle head assembly is viewable to
confirm cannula deployment.
[0019] The releasable needle head assembly may include a needle
head. The needle head is colored to assist in the viewability of
the needle head assembly through the translucent portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further features and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like reference numerals
identify identical elements, and wherein:
[0021] FIG. 1 is a perspective view of an infusion device embodying
the present invention shown without a deployed cannula;
[0022] FIG. 2 is another perspective view of the infusion device of
FIG. 1 shown with a deployed cannula;
[0023] FIG. 3 is an exploded perspective view of the device of FIG.
1;
[0024] FIG. 4 is a sectional view, in perspective, to an enlarged
scale, taken along lines 4-4 of FIG. 1, showing the actuation
linkages of the device of FIG. 1 prior to medicament dosage
delivery;
[0025] FIG. 5 is another sectional view, in perspective, to an
enlarged scale, taken along lines 5-5 of FIG. 2, showing the
actuation linkage operation of the device of FIG. 1 during
medicament dosage delivery;
[0026] FIG. 6 is another sectional view similar to that of FIG. 5,
in perspective, to an enlarged scale, showing the actuation linkage
operation of the device of FIG. 1 immediately after dosage
delivery;
[0027] FIG. 7 is a schematic representation of the valves and pump
of the device of FIG. 1 between medicament dosage deliveries and
during the filling of the pump with the medicament;
[0028] FIG. 8 is another schematic representation of the valves and
pump of the device of FIG. 1 during medicament dosage delivery;
[0029] FIG. 9 is a sectional view, in perspective, to an enlarged
scale, showing the configuration of the valves of the device of
FIG. 1 during pump filling and prior to medicament dosage
delivery;
[0030] FIG. 10 is another sectional view, in perspective, to an
enlarged scale, showing the configuration of the valves of the
device of FIG. 1 during dosage delivery;
[0031] FIG. 11 is a top perspective view of the base of the device
of FIG. 1 illustrating various fluid paths within the device;
[0032] FIG. 12 is a partial bottom plan view of the base of the
device of FIG. 1 to illustrate the interior of a prime indicator
according to one embodiment thereof;
[0033] FIG. 13 is a bottom plan view of the base of the device of
FIG. 1 illustrating the prime indicator interior covered by a
translucent cover according to the above mentioned prime indicator
embodiment;
[0034] FIG. 13A is a bottom view of the device 110 illustrating a
removable non-adhesive layer overlying an adhesive layer on the
device base;
[0035] FIG. 14 is a sectional view in perspective of an occlusion
detector and lock-out according to an embodiment of the device of
FIG. 1 shown prior to an intended dosage delivery;
[0036] FIG. 15 is another sectional view in perspective of the
occlusion detector and lock-out shown during an intended dosage
delivery;
[0037] FIG. 16 is another sectional view in perspective of the
occlusion detector and lock-out shown during occlusion detection
and just prior to lock-out;
[0038] FIG. 17 is a perspective view of the device of FIG. 1 and a
cannula placement assembly attached thereto ready to provide the
device with a cannula according to a still another embodiment;
[0039] FIG. 18 is a sectional view, in perspective, to an enlarged
scale, of the device and cannula placement assembly before the
cannula is deployed;
[0040] FIG. 19A is a sectional view like that of FIG. 18, showing
the device and cannula placement assembly during cannula
deployment;
[0041] FIG. 19B is a sectional view of a securing mechanism that
attaches the cannula assembly to the drug delivery device;
[0042] FIG. 19C is another sectional view showing additional
details of the securing mechanism;
[0043] FIG. 19D is a sectional view of a securing mechanism
securing the cannula driver to the plunger;
[0044] FIG. 20 is a sectional view like that of FIG. 18, showing
the device and cannula placement assembly after cannula
deployment;
[0045] FIG. 21A is a sectional view, in perspective, of the cannula
placement assembly of FIG. 17, showing the driver prior to cannula
deployment;
[0046] FIG. 21B is a sectional view of the driver actuator
illustrating the actuator button snap action mechanism, prior to
actuation.
[0047] FIG. 21C is a sectional view of the driver actuator
illustrating the actuator snap action mechanism, after
actuation.
[0048] FIG. 22 is a sectional view, in perspective, and to an
enlarged scale, of the cannula placement assembly of FIG. 17,
showing the driver through a plane perpendicular to the sectional
plane of FIG. 21 and prior to cannula deployment;
[0049] FIG. 23 is another sectional view similar to FIG. 22 showing
the cannula placement assembly in an enabled configuration;
[0050] FIG. 24 is a sectional view, in perspective, and to an
enlarged scale, showing the cannula placement assembly being
released for deploying a cannula;
[0051] FIG. 25 is a sectional view, similar to that of FIG. 21,
showing the cannula placement assembly during cannula
deployment;
[0052] FIG. 26 is another sectional view, similar to that of FIG.
21, showing the cannula placement assembly after cannula
deployment;
[0053] FIG. 27 is a perspective view of the device and cannula
placement assembly after cannula deployment and separation of the
cannula driver from the device;
[0054] FIG. 28 is another sectional view of the cannula placement
assembly and device to an enlarged scale showing the device and
driver including details of a cannula needle port cover during
cannula delivery;
[0055] FIG. 29A is a sectional view similar to that of FIG. 28
showing the device and the cannula placement assembly including
further details of the cannula needle port cover after cannula
deployment;
[0056] FIGS. 29B and 29C are sectional views of the cannula
assembly which, when taken together, show lateral movement
permitted to the cannula assembly by the device assembly;
[0057] FIG. 30A is a sectional view, to an enlarged scale, showing
a drive needle assembly including a drive needle and drive needle
head according to a further embodiment of the invention;
[0058] FIG. 30B is a perspective view of the needle head assembly
as seen through a translucent cap of the drive cylinder;
[0059] FIG. 30C is a sectional view of the cannula inserter showing
the final position of the cannula drive needle within the drive
cylinder;
[0060] FIG. 31 is a sectional view, to an enlarged scale,
illustrating an alternative embodiment of a cannula port cover
after cannula deployment;
[0061] FIG. 32A is a perspective view of another embodiment of the
cannula assembly with its cannula access port in an open
position;
[0062] FIG. 32B shows, in perspective view, the cannula assembly of
FIG. 32A with its cannula access port in closed position;
[0063] FIG. 33A is a sectional perspective view of a cannula driver
embodying further aspects of the invention having an absorber tab
shown prior to needle deployment; and
[0064] FIG. 33B is a partial sectional perspective view of the
absorber tab illustrating its bent condition after cannula
deployment.
DETAILED DESCRIPTION OF THE INVENTION
[0065] Referring now to FIGS. 1 and 2, they are perspective views
of an infusion device 110 embodying various aspects of the present
invention. FIG. 1 shows the device prior to receiving and thus
without a cannula while FIG. 2 illustrates the device after having
received a cannula 130 that has a distal end 131. As may be seen in
both FIGS. 1 and 2, the device 110 generally includes an enclosure
112, a base 114, a first actuator control button 116, and a second
actuator control button 118.
[0066] The enclosure 112, as will be seen subsequently, is formed
by virtue of multiple device layers being brought together. Each
layer defines various components of the device such as, for
example, a reservoir, fluid conduits, pump chambers, and valve
chambers, for example. This form of device construction results in
a compact design and enables manufacturing economy to an extent
that the device is disposable after use.
[0067] The base 114 preferably includes a pad 115 attached to the
base 114. The pad 115 has an adhesive coating 117 on the side
thereof opposite the base 114 to permit the device to be adhered to
a patient's skin. The adhesive coating may originally be covered
with a releasable cover 292 (FIG. 13A) that may be pealed off of
the adhesive layer 117 when the patient endeavors to adhere the
device 110 to their skin.
[0068] The device 110, as will be seen herein after is first
adhered to the patient's skin followed by the deployment of the
cannula 130 thereafter. However, it is contemplated herein that
various aspects of the present invention may be realized within a
device that may alternatively be mated with a previously deployed
cannula assembly.
[0069] The actuator buttons 116 and 118 are placed on opposites
sides of the device 110 and directly across from each other. This
renders more convenient the concurrent depression of the buttons
when the patient wishes to receive a dose of the liquid medicament
contained within the device 110. This arrangement also imposes
substantially equal and opposite forces on the device during dosage
delivery to prevent the device from being displaced and possibly
stripped from the patient. As will be further seen hereinafter, the
concurrent depression of the buttons is used to particular
advantage. More specifically, the actuator button 116 may serve as
a valve control which, when in a first position as shown,
establishes a first fluid path between the device reservoir and the
device pump to support pump filling, and then, when in a second or
depressed position, establishes a second fluid path between the
device pump and the device outlet or distal end of the cannula to
permit dosage delivery to the patient. As will be further seen, a
linkage between the control actuator buttons 116 and 118 permits
actuation of the device pump with the actuator control button 118
only when the second fluid path has been established by the first
actuator control button 116. Hence, the first actuator control
button 116 may be considered a safety control.
[0070] The actuator buttons 116 and 118 are preferably arranged to
require a complete follow-through of their travel to achieve
activation of the device pump and thus dosage delivery. This,
together with the sudden release of resistance to actuator
advancement creates a snap action that provides an advantage in
positively knowing that dosage delivery has occurred and that no
less than a full dose has been delivered. For more description
regarding this feature, reference may be had to co-pending
application Ser. No. 11/906,102, titled DISPOSABLE INFUSION DEVICE
WITH SNAP ACTION ACTUATION, which application is owned by the
assignee of this application and is incorporated herein by
reference in its entirety.
[0071] As may be noted in FIG. 1, the device 110 includes a cavity
120 that is arranged to receive a cannula assembly 122 (FIG. 2)
from which the cannula 130 extends. When the cannula is deployed,
the outlet 124 of the device 110 is placed in fluid communication
with the cannula 130 by a cannula carrier 128 of the cannula
assembly 122 that carries the cannula. When thus deployed, the
cannula 130 extends from the base 114 of the device 110 to beneath
the skin of the user.
[0072] As may further be noted in FIGS. 1 and 2, the enclosure 112
of the device 110 includes a pair of pockets 140 and 142 on
opposite sides of the second actuator button 118. A similar pair of
pockets, not seen in the figure, are also provided on opposite
sides of the first actuator button 116. These pockets are used to
receive corresponding projections of a cannula placement assembly
for releasably joining the cannula placement assembly to the device
110 to support cannula deployment as will be described
subsequently. As will also be seen, upon cannula deployment, the
cannula placement assembly is automatically released from the
device by the driver projections being forced from the pockets.
[0073] Referring now to FIG. 3, it is an exploded perspective view
of the device 110 of FIG. 1. It shows the various component parts
of the device. The main component parts include the aforementioned
device layers including the base layer 160, a reservoir membrane
162, an intermediate layer 164 and a top body layer 166. As may
also be seen in FIG. 3, the base layer 160 is a substantially rigid
unitary structure that defines a first reservoir portion 168, a
pump chamber 170, and a valve chamber 190 that receives a shuttle
bar 200 of a shuttle valve 210. A reservoir membrane layer 162 is
received over the reservoir portion 168 to form an
expandable/deflatable reservoir of the device 110. The base layer
160 may be formed of plastic, for example. The base and the top
body layer may be joined together, trapping the intermediate layer
there between by any means such as with screws, ultrasonic welding
or laser welding.
[0074] The valve chamber 190 is arranged to receive a valve shuttle
bar 200 carried by and extending from the first actuator button
116. A series of O-rings, to be described subsequently, are seated
on the shuttle bar 200 to form first, second, and third valves. The
actuator button 116 also carries a first linkage portion 240 of the
linkage that permits actuation of the device pump with the actuator
control button 118 only when the second fluid path has been
established by the first actuator control button 116. The first
linkage portion 240 is received within a suitably configured bore
270 formed in the base layer 160 and will be described
subsequently.
[0075] The pump actuator button 118 is arranged to be linked to a
pump piston 300 and a second linkage portion 340 to interact with
the first linkage portion 240. The pump piston 300 is arranged to
be received within the pump chamber 170 and the second linkage
portion 340 is arranged to be received within the bore 270 for
interacting with the first linkage portion 240. O-rings are seated
on the piston 300 to provide a seal against leakage and to prevent
external contaminants from entering the piston chamber.
[0076] The intermediate layer 164 may be a generally resilient
member and received on the base layer 160 to cover channels scribed
in the base layer as a type of gasket to form fluid channels 380
that serve to conduct the medicament from the reservoir to the
device outlet and to the distal end 131 (FIG. 2) of the cannula
130. Springs 410 are arranged to spring load the actuator buttons
116 and 118 away from each other.
[0077] The reservoir membrane 162 is formed of flexible membrane
material and is received over the reservoir portion 168 to form the
reservoir of the device 110. A rigid plate 420 is arranged to be
adhered to the reservoir membrane 162 of the reservoir. Because the
membrane 162 is flexible, it will move as the reservoir is filled
and emptied. The rigid plate 420 will then move with it. The plate
420 includes an eyelet 422 dimensioned to receive an elongated web
424 that forms a part of a medicament level indicator. The web 424
carries an indicator line or feature 426 that may be read through a
window 428 of the device top most panel 440.
[0078] Another component of the device 110 is a translucent window
450 that is received on the underside of the base 160. As will be
seen hereinafter, the window forms a part of a prime indicator. It
is formed of a transparent material such as glass or transparent
plastic and has a roughened surface rendering it translucent.
However, when it is covered with or at least wetted by liquid
medicament, it is rendered essentially transparent creating a
visually obvious condition and, for example, permitting indicia to
be seen beneath it indicating that the conduit to the device outlet
is primed and ready to deliver fixed doses of medicament when
desired.
[0079] FIGS. 4-6 show details of the operation of the linkage that
permits actuation of the device pump with the actuator control
button 118 only when the second fluid path from the reservoir to
the outlet has been established by the first actuator control
button 116. The linkage has been given the general reference
character 150.
[0080] As may be seen FIG. 4, the first actuator button 116 has an
extension 152 that terminates in a block 154. The block 154 has a
first ramp surface 156 and a second ramp surface 158. When the
device 110 is actuated, the button 116 is concurrently depressed
with pump button 118. It and its extension 152 and block 154 are
free to move to the right. As seen in FIGS. 4 and 5, the pump
actuator button 118 has parallel extensions 250 and 252 which are
joined and separated be a rod member 254. The extensions 250 and
252 are pivotally mounted to pivot about a pivot point 256. Another
extension 260 of the pump actuator button 118 spring biases the
extensions 250 and 252 as shown in FIG. 4. As seen in FIG. 4, the
extensions 250 and 252 abut an abutment 262 which they must clear
to enable the actuator 118 to be moved to the left. As shown in
FIG. 5, as the button 116 is depressed, its extension 152 moves to
the right causing the first ramp surface 156 to engage the rod
member 254. Continued movement of the button causes the rod member
254 to ride up the first ramp surface 156 which in turn causes the
extensions 250 and 252 to begin to move slightly to the left and
bend upward against the loading of extension 260. Eventually, the
rod member 254 rides up the length of the first ramp 156 and down
the second ramp 158 causing the extensions 250 and 252 to clear the
abutment 262 and continue their travel to the left until the
extensions are received on the opposite side of the abutment as
shown in FIG. 6. The pump button 116 has now been fully depressed
to deliver a dose of measured medicament. When the ends of
extensions 250 and 252 totally clear the abutment 262, they will
snap behind the abutment 262 as shown in FIG. 6 and become
temporarily locked. Meanwhile, the rod member 254 has traversed all
the way down the second ramp surface 158. The buttons 116 and 118
are now fully depressed.
[0081] Hence, from the above, it may be seen that the pump button
118 could not at first move freely while the first actuator button
116 which operates the valves could. As a result, the pump
actuation lags behind the valve actuation. This enables the device
outlet to be sealed from the reservoir and the pump connected to
the outlet before the pump is permitted to pump any medicament to
the outlet. Hence, the device establishes a medicament delivery
flow path to the cannula before the pump is able to begin pumping
the medicament to the patient. Thus, it is assured that there is
never an open unobstructed pathway between the reservoir and the
fluid outlet. Also, by assuring that the pump only draws fluid from
the reservoir when the pathway to the outlet is sealed off, it is
also assured that a precise amount of fluid is moved with each pump
cycle. This operation is completely timed by the linkage just
described and occurs quickly, appearing to the patient that both
actuator buttons are moving at the same rate.
[0082] When the extensions 250 and 252 of the pump button clear the
abutment 262, they become locked in a snap action. This provides
positive feedback to the patient that a dosage of medicament was
delivered as desired. It also causes a full dose to be delivered.
By virtue of the snap action of the pump actuator, only full doses
may be administered.
[0083] When the medicament has been delivered, the spring loading
of the actuator buttons returns the buttons to their first or
initial position. During this time, the same timing provided by the
block 154 is used for recharging the pump. More specifically, ramp
158 unlatches the ends of extensions 250 and 252 by lifting rod
member 254. While the extensions 250 and 252 are being lifted by
the ramp 158, the valve control button 116 is returning to the left
to cause the outlet to be disconnected from the pump before the
reservoir is reconnected to the pump for charging, thus sealing the
outlet from both the pump and the reservoir before the reservoir is
connected to the pump for recharging. This assures that the pump
does not pull medicament from the patient but only from the
reservoir. As the pump returns, a full dose of the medicament is
drawn up into the piston chamber 170 to ready the device for the
next dosage delivery.
[0084] Referring now to FIGS. 7 and 8, they are schematic
representations of the valves and pump of the device of FIG. 1
between medicament dosage filling (FIG. 7) and medicament dosage
delivery (FIG. 8). As may be seen in FIGS. 7 and 8, the device 110
further includes a reservoir 222, a pump 224, and the cannula 130.
The reservoir 222 may be formed as shown in FIG. 3 by the
combination of the device base 160 and the flexible membrane 162.
The device further includes the shuttle valve 210 including shuttle
bar 200. The shuttle bar 200 is shown within the valve chamber 190.
The shuttle bar 200 and O-rings 214 and 216 form a first valve 212,
shuttle bar 200 and O-rings 220 and 222 form a second valve 234 and
shuttle bar 200, O-ring 226 and a bypass channel 186 form a third
valve 224. Although O-rings are used herein to form seals, other
types of valve construction may employ forms of seals other than
O-rings without departing from the invention.
[0085] The pump piston 300 is within the piston chamber 170 to form
a piston pump 172. The actuator control button 218 is directly
coupled to and is an extension of the pump piston 226. It may also
be noted that the actuator buttons 116 and 118 are spring loaded by
springs 117 and 119, respectively. The springs are provided for
returning the actuator buttons to a first or start position after a
dosage is administered.
[0086] A fluid conduit 182 extends between the reservoir 180 and
the valve 212. An annular conduit 192 extends between the O-rings
216 and 226, and an annular conduit 194 extends between the O-rings
226 and 220. A fluid conduit 184 provides a fluid connection
between the reservoir 180 and the annular conduits 192 and 194
depending upon the position of the shuttle valve 210. Also
illustrated in FIG. 7 is the linkage 150 that assures that the
shuttle valve 210 is actuated before the piston pump 172 is
actuated to provide a dose of medicament.
[0087] In FIG. 7, the valves are shown in a first configuration
immediately after having returned to their first position following
a dosage delivery. After the return of the valves, the linkage 150
permits the pump actuator 118 and piston 300 to return for
refilling the pump chamber 300 in ready for the next medicament
dosage delivery. During their return, the medicament flows as
indicated by arrows 202 from the reservoir 180, through the conduit
182, through the annular channel 192, through conduit 184, and into
the pump chamber 170.
[0088] As may be noted, when in the first position, the valves 218
and 224 isolate the outlet 124 from both the reservoir 180 and the
piston pump 118. Having two such valves isolate the outlet 124 when
the valves are in the first configuration provides an added degree
of safety from medicament being inadvertently delivered to the
patient between dosage deliveries. For example, this provides
additional safety that the liquid medicament is not accidentally
administered to the patient notwithstanding the inadvertent
application of pressure to the reservoir. In applications such as
this, it is not uncommon for the reservoir to be formed of flexible
material. While this has its advantages, it does present the risk
that the reservoir may be accidentally squeezed as it is worn.
Because the valves 118 and 124 isolate the outlet 124 when the
valves are in their first configuration, this redundant protection
assures that pressure, accidentally applied to the reservoir, will
not cause the fluid medicament to flow to the cannula.
[0089] In addition to the linkage 150 preventing return of the
piston 300 until after the valves return to their first and start
positions, the O-rings on the shuttle bar 200 are also spaced apart
to insure that the valves 218 and 224 isolate the outlet 124 from
the pump 172 and reservoir 180 before the pump is again connected
to the reservoir. The O-ring spacing thus effectively forms a
second linkage to assure that the cannula 130 is connected to the
pump 172 only when a dosage is to be delivered and that it is never
connected to the reservoir 180.
[0090] In operation, the pump chamber 170 is first filled as the
actuator button 118 returns to the first position after having just
delivered a medicament dosage. In this state, the shuttle valve 210
is set so that the first valve 212 will be open and the second and
third valves 218 and 224 will be closed. This establishes a first
fluid path indicated by arrows 202 from the reservoir 180 to the
pump chamber 170 to fill the piston pump 172. When the patient
wishes to receive another dose of medicament, the actuator buttons
are concurrently pressed. The aforementioned linkages, including
linkage 150, cause the first valve 212 to close and the second and
third valves 218 and 224 to thereafter open. Meanwhile, actuation
of the pump 172 is precluded until the first valve 212 is closed
and the second and third valves 118 and 224 are opened. At this
point a second fluid path indicated by arrows 204 is established
from the pump chamber 170 to the cannula 130. The medicament is
then administered to the patient through the distal end 131 of
cannula 130.
[0091] Once the medication dosage is administered, the piston 330,
and thus the actuator button 118, is returned under the spring
pressure of spring 119 to its initial position. During the travel
of the piston back to its first position, a given volume of the
liquid medicament for the next dosage delivery is drawn from the
reservoir into the pump chamber 170 as described above to ready the
device for its next dosage delivery.
[0092] Referring now to FIG. 9, it is a sectional view in
perspective showing the valve configuration of the device 110 of
FIG. 1 during medicament filling of the pump chamber 170
immediately after a dosage delivery. Here, it may be clearly seen
that the first actuator button 116 is directly coupled to the
shuttle bar 200 of the valves 212, 218, and 224. Above the valves
are the conduits from the reservoir, from the pump, and to the
cannula. More particularly, the conduit 182 is in fluid
communication with the reservoir, the conduit 184 is in fluid
communication with the pump, and the conduit 124 is in fluid
communication with the cannula. The valves are shown with the first
valve 212 opened, communicating reservoir conduit 182 with the pump
conduit 184 through channel 192, the second valve 218 closed and
blocking the conduit 124 to the cannula, and the third valve 224
closed and blocking both the reservoir conduit 182 and the pump
conduit 184 from the cannula conduit 124. This permits medicament
to flow from the reservoir through conduit 182, through channel
192, and to the pump chamber 170 through conduit 184 as the
actuator button 116 returns to its first position. Hence, the pump
chamber is filled and ready for the next dosage delivery.
[0093] Referring now to FIG. 10, it is a sectional view in
perspective similar to that of FIG. 9 but showing the valve
configuration of the device 110 of FIG. 1 during medicament
delivery. Here, the valves are shown with the first valve 212
closed and blocking the reservoir conduit 182, the second valve 218
opened permitting the outlet conduit 124 to communicate with the
annular conduit 194, and the third valve 224 opened permitting
medicament to flow from the annular conduit 192, through bypass
186, and to annular conduit 194. Thus, medicament is permitted to
flow from the pump conduit 184, through annular conduit 192,
through the bypass 186, through annular conduit 194, and into the
outlet conduit 124 to administer the fixed volume dosage. As
previously mentioned, the O-rings defining the first valve 212, the
third valve 224, and the second valve 218 are spaced apart so that
conduit 182 is blocked before conduits 184 and 124 are connected
together through the valves 224 and 218.
[0094] FIG. 11 is a top perspective view of the base 160 of the
device 110 of FIG. 1. Carried on the base 160 is the intermediate
layer 164. Together, the base 160 and intermediate layer 164 define
numerous fluid conduits within the device 110. One such fluid
conduit is designated with reference character 270 in FIG. 11. The
conduit 270 is within the fluid path that leads to the outlet 124.
It is in the downstream portion of that path and takes a bend at
272 towards the bottom side of the base 160 where it, through an
opening 274, enters a chamber 276 (FIG. 12). The chamber 276
communicates with the device outlet 124 that projects into the
aforementioned cavity 120. When the cannula 130 (FIG. 29A) is
placed, it extends through an opening 123 in the cavity to beneath
the patient's skin and communicates with the outlet 124 as
described herein after.
[0095] The chamber 276 is partly defined by a seal rim 278 which
receives a translucent cover 280 (FIG. 13). The top wall of the
chamber 276 has an inverted cone shaped surface 282 portion and a
tapered portion 284 to the outlet 124.
[0096] The translucent cover may be formed of transparent plastic
wherein the surface that faces the chamber is roughed in a manner
that renders the plastic cover translucent. The upper surface of
the chamber is preferably coated with indicia which may, for
example, be a color, such as blue. When the chamber is empty, the
blue indicia will not be readily seen because the rough surface of
the cover has rendered the cover translucent. However, when the
chamber 276 is filled with a liquid, such as the liquid medicament,
the cover 280 will become more transparent allowing the blue
indicia to be readily seen. The chamber 276 and cover 280 thus form
a prime indicator 286 adjacent the outlet 124. More particularly,
the prime indicator 286 is immediately adjacent the outlet 124
since when the chamber is filled and the indicia readily seen, it
will be known that the conduits and cannula are sufficiently prime
with medicament to permit a full dosage to be delivered upon the
next activation of the device 110.
[0097] In use, it is contemplated that the reservoir be filled
through a fill port 290 on the bottom of the device 110 before the
device is deployed on the patient's skin. After the device is
filled, the translucent cover or window 280 may be viewed during
device priming. During the priming process, the actuators 116 and
118 may be depressed a number of times until the blue indicia on
the top surface portions 282 and 284 of the chamber are seen
through the window 280. This provides an indication to the user
that the chamber 276, and more importantly, the conduits are
sufficiently primed and full with medicament to enable actual
dosage delivery upon the next actuation of the device 110. Hence, a
prime indicator 286 is provided immediately adjacent the outlet
124.
[0098] In FIG. 13A, it may be seen that the removable non-adhesive
layer 292, in accordance with this embodiment, includes two
portions, a first portion 293 and a second portion 294. Each of the
first and second layer portions 293 and 294, respectively, includes
a tab 298 and 297 respectively that extend beyond the margins of
the device base. This permits the tabs 297 and 298 to be grasped
for effortless removal of the removable non-adhesive layer portion
294 and 293. The layer portion 293 includes cutouts. The cutouts
295 and 296 extend through the pad 115 (FIG. 2) to provide access
to the device fill port 290 and the prime indicator window 280.
Hence, as described above, the device 110 may be filled and primed
for use before the removable layer portions 293 and 294 are removed
for adhering the device to a patient's skin.
[0099] FIGS. 14-16 are sectional views in perspective of an
occlusion detector and lock-out 350 according to an embodiment of
the device of FIG. 1. FIG. 14 shows the occlusion detector and
lock-out 350 prior to an intended dosage delivery, FIG. 15 shows
the occlusion detector and lock-out 350 during to an intended
dosage delivery, and FIG. 16 shows the occlusion detector and
lock-out 350 during occlusion detection and just prior to
lock-out.
[0100] The occlusion detector and lock-out 350 serves to detect,
during each dosage delivery, blockages between the shuttle valve
and the distal end 131 of the cannula 130 (FIG. 8). Such blockages
are most likely to occur within the cannula and may result in an
improper amount of medicament being delivered during an attempted
dosage delivery. For example, the user might have an erroneous
belief that a full dosage had been delivered when, in fact, a
dosage of insufficient quantity had been delivered. As will be seen
subsequently, the occlusion detector is responsive to pressure
within the pathway from the shuttle valve to the outlet and cannula
that occurs during an attempted dosage delivery when a blockage
exists.
[0101] The occlusion detector 350 has an inlet 132 that
communicates with the outlet 124 (FIG. 10) of the shuttle valve 210
and an outlet 134 that communicates with the prime indicator 286
(FIG. 12). Between the inlet 132 and the outlet 134 is a channel
136. Hence, the channel 136 is within the fluid path from the valve
to the outlet 125 of the device that may be coupled to the cannula
130 (FIGS. 7 and 8). The occlusion detector 350 also includes a
resilient diaphragm 352 over which the channel 136 extends.
Adjacent the diaphragm 352 is a deflectable stop 354. As will be
seen subsequently, when there is an occlusion within the fluid
path, an attempted dosage delivery results in an increased back
pressure against the diaphragm 352 and the deflectable stop 354.
This causes the deflectable stop 354 to engage a projection 157 of
the linkage 150. This disables the linkage 150 that controls the
interaction of the actuator buttons 116 and 118 and that causes the
actuator buttons 116 and 118 to become locked.
[0102] More particularly, as may be further seen in FIG. 14, the
linkage 150 is adjacent the occlusion detector 350. When the
actuator buttons are depressed, the projection 157, carried by the
extension 152 of the valve actuator button 116, slides across block
255 carried on pivot 256.
[0103] As may be seen in FIG. 15, upon further depression of
buttons 116 and 118, the projection 157 slides past the distal end
of the deflectable stop 354. It may also be seen that, as
previously described, the rod member 254 has ridden up the first
ramp 156 and down the second ramp 158 of block 154. This causes the
first ramp 156 to engage a ramp surface 257 of block 255.
[0104] If no occlusion exists within the fluid path to the cannula,
the blocks 154 and 255 and the actuator buttons 116 and 118 will
return as previously described under spring pressure. However, if
an occlusion does exist within the fluid path to the cannula, back
pressure will quickly build in the channel 136 to cause the
deflectable stop 354 to be deflected downwardly. This is shown in
FIG. 16. The deflectable stop 354 is now aligned with the
projection 157. When, under spring pressure, the actuator buttons
116 and 118 are urged to their starting positions, the projection
157 will be caught by the deflectable stop 354 to lock the device
and preclude its further use. Still further, the deflectable stop
354 or the projection 157 may be breakable or permanently
deformable upon their engagement. This would render the linkage 150
jammed and irreversibly locked to permanently preclude further use
of the device.
[0105] Referring now to FIG. 17, it is a perspective view of the
device 110 of FIG. 1 with a cannula placement assembly 500
releasably attached thereto ready to provide the device with a
cannula according to a still another embodiment. It is contemplated
that the device 110 and cannula placement assembly 500 be
pre-attached to each other upon delivery to a patient and that upon
placement of the cannula, the cannula placement assembly 500 be
automatically separated from the device 110.
[0106] The cannula placement assembly 500 generally includes a
cannula driver portion 510 and an actuation portion 512. The
cannula driver portion 510 is generally cylindrical in shape
including a drive cylinder 514. The actuation portion includes an
actuator button 516 and a safety control button 518. As will be
seen subsequently, the safety control button 518 must first be
depressed into a locked depressed position before the actuator
button 516 may be depressed to set the cannula placement sequence
into motion.
[0107] FIG. 18 is a sectional view, in perspective, to an enlarged
scale, of the device 110 and cannula placement assembly 500 before
the cannula is deployed. As may be noted in FIG. 18, the interior
components of the cannula driver portion 510 include a plunger 524,
a needle assembly 520, and the cannula assembly 122.
[0108] The cannula assembly, as previously described, includes the
cannula 130, of the type known in the art, and a cannula carrier
128. The cannula carrier 128 is arranged to be received within the
cavity 120 into which the device outlet 124 projects. Once the
cannula carrier 128 is received into the cavity 120, the cannula
carrier 128 establishes a fluid path from the outlet 124 to the
cannula 130.
[0109] The needle assembly 520 includes a drive needle 522. The
drive needle 522 includes a needle head assembly 526 and a needle
shaft 527. Before the cannula 130 is placed, the cannula assembly
122 is carried by the needle assembly 520 and more specifically, by
the cannula 130 being received on the drive needle 522 with the
cannula carrier 128 being immediately adjacent the drive plunger
524 as shown.
[0110] The needle head assembly 526 is initially seated within the
drive plunger 524. To that end, the needle head assembly 526 is
within the plunger 524 and has an exterior surface 530 that
conforms to the interior surface 532 of a springable wall portion
531 of the plunger 524. Specifically, wall portion 531 comprises
one or more ridges on the interior surface 532 that catch a portion
of the needle head assembly 526. The needle shaft 527 extends from
the needle head assembly 526, through an opening of the plunger
524, through the cannula carrier 128, and finally through the
cannula 130 to terminate at a tip 521. During cannula placement,
the cannula 130 and drive needle 522 extend through the opening 123
of the device 110.
[0111] The cannula driver 510 further includes a first drive spring
534 and a second drive spring 536. The first drive spring is
originally compressed between an inner end wall 538 of the drive
cylinder 514 and a top surface 540 of the plunger 524. The first
drive spring 534 serves to drive the plunger 524 downwardly to in
turn drive the cannula 130 and the drive needle 522 through the
opening 123.
[0112] The plunger 524 is released by the actuator button 516 being
depressed. As will be seen subsequently, the actuator button 516
includes a portion that interferes with a shoulder of the plunger
524. When the actuator button is depressed, that interference is
resolved and the drive carrier 524 is free to move downwardly under
the influence of the first drive spring 534. The needle tip 521
pierces the patient's skin and the lower portion of the needle
shaft 527 and cannula 130 are placed beneath the patient's skin.
The cannula 130 and needle 522 quickly reach the fully driven,
temporary, configuration shown in FIG. 19A.
[0113] In FIG. 19A, it may be seen that the cannula 130 and needle
shaft 527 upon which the cannula 130 is carried have been driven
through the opening 123 of the device 110. The first drive spring
534 is now in an extended condition.
[0114] When the cannula driver 510 reaches the configuration shown
in FIG. 19A, the wall portion 531 of the plunger 524 clears a
shoulder 542 of a short wall portion 544 of the drive cylinder 514.
The wall portion 531 springs outwardly. This separates the
conformal surfaces 530 and 532 of the wall portion 531 from the
needle head 526. This frees the needle head 526 from the plunger
524. The needle head 526 is now free to move upwardly out of and
away from the plunger 524 under the influence of the second drive
spring 536. Simultaneously, since the new position of the wall
portion 531 is directly underneath the surface 542, the plunger 524
is prevented from moving upward with the needle head 526. This
ensures that there can be no reactivation of the inserter
device.
[0115] Additionally and optionally, the cannula carrier 128
comprises a securing mechanism configured to secure it into the
cavity 120, thereby ensuring the cannula itself does not move and
dislodge from the skin. An exemplary securing mechanism 750 is
shown in FIGS. 19B, and 19C which show the cannula carrier 128 to
an enlarged scale. Mechanism 750 comprises tabs 751 and 752, which
are oriented at a sufficient angle to enable them to enter into the
cavity 120 with carrier 128. During their entry, shown in FIG. 19B,
the tabs 751 and 752 are forced against wall 753 of the drug
delivery device 110 and are pushed inwardly towards each other.
Upon their entry into cavity 120, as shown in FIG. 19C, the tabs,
which have been pushed together, spring back to their natural
state. The natural state of the tabs 751 and 752 prevent the tabs,
and therefore the cannula carrier 128, from exiting the cavity 120.
Additionally and optionally, one or more indentations 754 are
provided in wall 753 to correspond to and secure the tabs 751 and
752.
[0116] Additionally and optionally, plunger 524 comprises
releasable holder tabs configured to secure the plunger to the
cannula carrier during the downward motion of the plunger.
Exemplary holder tabs are shown at 761 and 762 in FIG. 19D, which
is a view of the plunger 524 shown in FIG. 19A to an enlarged
scale. Tabs 761 and 762 are configured to grasp the cannula carrier
128 until the carrier has descended into the cavity 120. After it
has descended, the tabs 751 and 752 prevent the cannula carrier
from moving upward with the plunger 524 as it ascends.
[0117] As the needle head 526 moves upwardly, it of course takes
the needle shaft 527 with it. When the needle head 526 reaches the
extent of its travel (FIG. 20) by the extension of the second drive
spring 536 (the first drive spring 534 has been omitted from the
figure for clarity), the needle shaft 527 is fully extracted from
the cannula 130 leaving only the cannula 130 beneath the patient's
skin. The cannula carrier 128 has also been received within the
cavity 120 of the device 110. As the cannula carrier 128 is
received within the cavity 120, the device outlet 124 is placed
into fluid communication with the cannula 130 through the cannula
carrier 128.
[0118] Turning now to the actuation mechanism that drives the
insertion device, FIG. 21A is a sectional view, in perspective,
showing details of the actuator portion 512 of the cannula
placement assembly 500 of FIG. 17. FIG. 21A shows the assembly as
configured prior to cannula deployment. As previously described,
the actuator portion 512 includes the safety control button 518 and
the actuator 516.
[0119] The safety control button includes a recess 550 and the
actuator button 516 includes an extension 560. Before actuation,
the extension 560 of the actuator 516 abuts the safety control
button to preclude the depressing of the actuator 516. However,
when the safety control button is depressed, as will be seen
subsequently, the recess 550 is brought into alignment with the
extension 560 to permit the actuator 516 to be depressed for
setting into motion the placement of the cannula 130 as previously
described.
[0120] As may also be noted in FIG. 21A, the cannula placement
assembly 500 further includes a plurality of projections 562 and
564. It is also contemplated that the cannula placement assembly
500 includes two additional such projections. The projections are
arranged to be received within corresponding pockets of the
wearable infusion device to permit the cannula placement assembly
500 to be releasably carried on the device 110 as shown, for
example, in FIG. 17. For example, projection 562 is intended to be
received by pocket 140 of the device 110 of FIGS. 1 and 2. The
distance between the projections 562 and 564 is maintained by a
latch 566 that includes a bendable arm 568 and a catch 572. The
bendable arm includes a hook 570 at its distal end that is held by
the catch 572. At least one urging member in the form of springs
573 and 575 (FIG. 20) serve to provide a continuous force for
separating the projections 562 and 564. That force also maintains
the hook 570 locked onto the catch 572, and the hook 570 being
locked onto the catch 572 maintains the projections within their
respective pockets to releasably maintain the cannula placement
assembly 500 on the device 110.
[0121] The actuator 516 still further includes a latch release
projection 580. The latch release projection 580 includes a ramped
surface 582 arranged to engage and bend the bendable arm 568 as the
actuator 516 is depressed. Eventually, sufficient depression of the
actuator 516 bends the arm 568 sufficiently to cause the hook 570
to clear the catch 572. The actuator is shaped in such a manner
that, as it is depressed in a single motion, it causes release and
placement of the cannula before the hook 570 clears the catch 572.
When the hook 570 clears the catch 572, the latch 566 is released
and the projections, including projections 562 and 564 are forced
apart under spring pressure to cause the cannula placement assembly
500 to be separated from the device 110.
[0122] In accordance with a further embodiment, the actuation
mechanism provides a positive indication or feedback to the user
signaling that the insertion of the cannula has taken place. This
same mechanism may also serve to ensure that the user only actuates
the device once, rendering the needle inaccessible after use of the
cannula driver. According to this embodiment the actuator is
provided with a snap action feature as is illustrated in FIG. 21B
and FIG. 21C. These figures show sectional views of the actuator
button 516 that has tab 583 to create a snap action when forced
against a projection 567 provided within the body of the cannula
insertion device. In FIG. 21B, the actuator button and tab 583 are
shown prior to actuation, while FIG. 21C shows the tab 583 relative
to the projection 567 after the actuation. Actuation of the
actuator button moves the tab 583 between the position seen in FIG.
21B and that seen in FIG. 21C. This causes flexing and immediate
release of the tab 583 to produce a snap feel. This also produces
an audible click to signal actuation to the user. Projection 567 is
further configured such that tab 583 is allowed to slide over
projection 567 only in the direction of actuation. This prevents
the tab 583 from reverting (and thereby reverting the actuator
button) to the pre-actuation position.
[0123] FIG. 22 is a sectional view, in perspective, and to an
enlarged scale, of the cannula placement assembly of FIG. 17,
showing the assembly through a plane perpendicular to the sectional
plane of FIG. 21 and prior to cannula deployment. Here it may be
seen that the control button 518 includes a pair of chordal
recesses 580 and 582 that defined bendable legs 584 and 586
respectively. Each of the legs 584 and 586 includes a projecting
foot 588 and 590 respectively. When the safety control button 518
is in a raised initial position as shown in FIG. 22, the foot 588
is confined within a slot 592 of an extension 598 of the actuator
button 516 and the foot 590 is confined within a slot 594 of
another extension 598 of the actuator button 516.
[0124] When the control button 518 is depressed, the legs 580 and
586 permit the feet 588 and 590 to slide out of their respective
slots 592 and 594, respectively. They then progress downwardly
until the legs 584 and 586 and feet 588 and 590 wrap about the
extensions 596 and 598 of the actuator 516. The feet 588 and 590
become confined beneath bottom surfaces 600 and 602, respectively,
of the actuator button extensions 596 and 598, respectively to lock
the safety control 518 in the enable configuration of FIG. 23.
[0125] In FIG. 23 it may be clearly seen that the feet 588 and 590
are beneath and confined by the bottom surfaces 600 and 602,
respectively, of the actuator button extensions 596 and 598. The
bendable legs 584 and 586 cause the control button 518 to enter
this configuration with a snap action. This provides positive
feedback to the user that the control button has been successfully
depressed and that the cannula placement assembly is now ready for
the depression of the actuator button 516. The confinement by the
actuator extensions 596 and 598 of the feet 588 and 590 causes the
control button 518 to be locked in the depressed enable state. This
conveys to a user after use that the cannula placement assembly is
not to be reused and even assists in making such reuse impossible
or at least difficult.
[0126] With the control button now depressed and engaged in the
enable configuration, the extension 560 of the actuator button 516
(FIG. 21) will now be aligned with the slot 550 of the control
button 518. This permits the actuator to be depressed and
actuated.
[0127] FIGS. 24 and 25 are sectional views showing the cannula
placement assembly 500 as the actuator button 516 is being
depressed. In FIG. 25 it may be seen that the extension 560 of the
actuator button 516 is aligned with and entering into the slot 550
of the control button 518. As this occurs, the extension 598 slides
in the chordal recess 582 of the control button 518 and the
extension 596 slides in the chordal recess 580 of the control
button.
[0128] The extension 598 further includes a wing 610 having an
upper surface 612 that normally engages a lower surface 523 of the
plunger 524 to interfere with the movement of the plunger 524 as
previously described. As the actuator button 516 is depressed, the
upper surface 612 of the extension 598 clears the lower surface 523
of the plunger 524. When this occurs, the drive carrier is released
to be driven by spring 534 for placing the cannula 130 into a
deployed position beneath the patient's skin.
[0129] FIG. 25 further shows that the latch 566 includes a second
catch 573. The second catch 573 serves to catch the hook after it
is lifted over the first catch 772. The second catch 573 is also
positioned so that even though it catches the hook 570, the
projections are still separated sufficiently to release the cannula
placement assembly 500 from the device 110. The cannula placement
assembly will not fall apart because it is held together in part by
the second catch 572 catching the hook 570.
[0130] FIG. 26 is a sectional view showing the cannula placement
assembly 500 after cannula deployment. The assembly is separated
from the device. The projection 560 is fully within the slot 550 of
the control button 518. This serves to further preclude reuse of
the assembly 500 after cannula placement.
[0131] FIG. 27 is a perspective view of the device 110 and cannula
placement assembly 500 after cannula deployment and separation of
the cannula placement assembly from the device. Clearly seen in
FIG. 27 are the remaining projections 563 and 565 and remaining
pockets 141 and 143 for releasably retaining the assembly 500 on
the device 110. After cannula placement, the separated cannula
placement assembly 500 may be discarded.
[0132] FIG. 28 is a sectional view of the cannula placement
assembly 500 and the device 110 to an enlarged scale showing
details of a cannula needle port cover 125 during delivery of the
cannula 130. The cannula 130 is carried on the cannula carrier 128.
The cannula carrier includes a port 127 through which the needle
522 passes when it is retracted back into the driver 510 by the
spring 536. To preclude access into the device and especially
direct access to the cannula through the port 127 after the cannula
130 has been deployed, the cannula carrier 128 includes the port
cover 125. In accordance with this embodiment, the port cover is
made of relatively impenetrable material such as hard plastic or
steel or the like and is substantially U-shaped and is confined
within a slot 129. One leg of the port cover 125 is displaced and
held away from the port 127 by the needle 522. It is a resilient
material, such as spring steel and is held in place in, for
example, a slightly compressed state, by the needle shaft 527 which
is loaded through the hole in the port cover as shown at 125 in
FIG. 28. Responsive to the cannula 130 being placed and the needle
shaft 527 removed from the device 110, the one leg of the port
cover is freed and permitted to spring to its natural shape such
that the one leg overlies the port 127 as shown at 125 in FIG. 29A
and in greater detail at 727 in FIG. 31. This results in the port
127 being blocked to preclude access to the interior of the device
110 once the cannula has been placed. Once the cannula 130 is
deployed, the device 110 will appear as shown in FIG. 2. As
previously mentioned, when the cannula 130 is placed, a fluid
connection is established between the outlet 124 and the cannula
130 through the cannula carrier 128. After priming, the device 110
is ready to deliver its first dose of medicament.
[0133] In one embodiment of the device, the cannula carrier 128 is
configured for movement or play in the deployed condition, which is
shown in the enlarged views of FIGS. 29B and 29C. The movement of
the cannula carrier is provided to minimize the forces acting on
the cannula during and after insertion. This makes the presence of
the cannula more comfortable to the user and thus, the device more
wearable to the user. In FIGS. 29B and 29C, the cannula assembly
128 is shown positioned within cavity 120 formed within the top
portion 112 and bottom portion 114 of the inserter body. Outlet 124
extends through an outlet structure 741 which is received by a
generally correspondingly shaped recess 742 in the cannula
assembly. A flexible seal 743 is provided at the base of the
recess, surrounding the perimeter of the recess opening. As shown,
the outlet structure 741 is conically shaped, but it may be any
suitable shape. Similarly, the recess 742 is configured to receive
a conical shape, but it may have any shape that suitably
corresponds to outlet structure 741. When the cannula is deployed,
outlet structure 741 of conduit 124 mates with recess 742 provided
in the cannula assembly. The recess 742 is configured to correspond
in shape and to accommodate the outlet structure 741. Flexible seal
743 at the base of the recess 742 serves to cushion the entry of
the outlet structure into the recess 742, so that the former does
not fully enter the latter. Thus, the outlet structure 741 has some
ability to move within the recess 742. The space in the recess 742
created by the cushioning, as well as the recess itself, allows the
cannula assembly limited freedom to move around the outlet
structure 741. In FIG. 29B, for example, the cannula carrier 128 is
oriented to the right of the tip portion 741. In FIG. 29C, the
cannula carrier 128 is oriented to the left of the outlet structure
741. Notwithstanding the cannula carrier 128 being confined within
the cavity 120 by the securing mechanism previously described, it
will be loosely confined therein allowing the cannula carrier
movement. This ability for the cannula carrier to moveably mate
with the outlet structure serves to reduce shear forces bearing on
the cannula during normal activity and to reduce discomfort to the
user otherwise due to cannula displacement. Simultaneously, the
receipt of the cannula carrier 128 onto the outlet structure 741
acts to self-center the cannula carrier 128 within cavity 120.
[0134] Additionally, once the cannula carrier of the cannula
assembly receives the outlet structure 741, a fluid communication
path is opened, as shown in FIGS. 29B and 29C. For example, as seen
in FIG. 29C, fluid from the reservoir (not shown) is now free to
pass through outlet 124, via space 744, into deployed cannula 130,
and into the patient. The flexible seal 743 aids to maintain a
fluid-tight junction between outlet structure 741 and recess
742.
[0135] FIG. 30A is a sectional view, to an enlarged scale, showing
another driver needle assembly 620 including a drive needle shaft
622 and drive needle head 626 according to a further embodiment of
the invention. Here it may be seen that the drive needle shaft 622
and the drive needle head 626 are two separate parts. The drive
needle shaft 622 has a turned section 623 and an elongated section
627. The turned section 623 rides in a slot 630 of the drive needle
head 626. The elongated section 627 passes through and is free to
slide on a through bore 628 of the drive needle head 626. The
needle assembly 620 may be used to assist in cannula placement and
returned by spring 536 after cannula deployment in the same manner
as previously described.
[0136] One embodiment is configured to ensure that the needle 527
will not harm the user after cannula deployment. In this
embodiment, as shown in FIGS. 30B and 30C, after the cannula is
deployed, the needle 527 is withdrawn completely into the body of
the drive cylinder 514 so that the sharp point of the needle is
rendered inaccessible during subsequent handling by a user. This is
accomplished when the needle head 526 is acted upon by spring 536,
which pushes the needle head 526 against the top cap 537 of the
drive cylinder 514. In this embodiment, top cap 537 is made of
translucent material so that the needle head 526, which is
optionally colored a vibrant color such as green, is visible when
it reaches the top cap 537. This visibility indicates successful
deployment of the cannula and full retraction of the needle
point.
[0137] FIG. 31 is a sectional view, to an enlarged scale,
illustrating an alternative embodiment of a cannula port cover 725.
The port cover is shown covering a needle port 727 after cannula
deployment. The port 727, as in the previous embodiment, is defined
by the cannula carrier 728. The port cover 725 is generally
U-shaped and confined in a cut-out 730. The cut-out 730 has a width
that is greater than the diameter of the needle slot 727 to permit
a cannula driver needle (not shown) to pass there through upon
return after cannula placement. The port cover 725 has an end 729
that is confined by the cut-out 730 and a slot 732 formed in a side
wall of the cannula carrier 728. The port cover 725 is therefore
free to pivot to the position shown after the cannula driver needle
(not shown) passes there through upon its return. As may be noted
in FIG. 31A, the port cover 725 has a width, adjacent the port 727,
that is smaller than the diameter of the port 727. While the port
cover 725 does not completely cover the port 727, it is still of
sufficient dimension to preclude access to the cannula through the
port 727 by, for example, an external syringe needle.
[0138] An alternative embodiment of a cannula port cover is shown
in FIGS. 32A and 32B. Cannula carrier 728' is provided with studs
734 that partly serve to anchor spring member 733. Though four
studs 734 are shown in the present embodiment, any number may be
used for the functions described herein. FIG. 32A shows the cannula
driver port 727' in its open position. Prior to insertion of the
cannula, the needle (not shown) displaces the portion of spring
member 733 from its natural state to maintain an open cannula
driver port 727'. After the cannula has been inserted, and as the
needle retracts into the drive cylinder (not shown), the spring
member 733 is allowed to return to its natural state and closes
port 727', as shown in FIG. 32B.
[0139] In one embodiment, the device is provided with an absorber
tab for removing fluid from the cavity 120 (FIGS. 29B, 29C) during
cannula deployment, thereby preventing fluid from escaping the
device and promoting neatness. As shown in FIGS. 33A and 33B,
absorber tab 533 is provided below the actuator mechanism and below
the needle head 526 prior to deployment, as shown in FIG. 33A. The
tab 533 is configured such that when the plunger 524 is deployed
and descends, absorber tab 533 is bent away, as shown in FIG. 33B.
The tab 533 is made of an absorbent material, for example cotton,
overlain at least in part by a non-absorbent material, for example
polyester. In the present embodiment, the polyester is provided as
a mesh that is bondable to the insert button and facilitates the
movement of fluid therethrough. It captures any extraneous liquid
leaked from the conduit 124 during priming of the device. This
prevents leakage of insulin outwardly from the conduit and to the
surface of the device.
[0140] While particular embodiments of the present invention have
been shown and described, modifications may be made. It is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention as defined by those claims.
* * * * *