U.S. patent application number 11/589323 was filed with the patent office on 2008-04-24 for infusion pumps and methods and delivery devices and methods with same.
Invention is credited to Paul F. Bente, Colin A. Chong, Ian B. Hanson, R. Paul Mounce.
Application Number | 20080097291 11/589323 |
Document ID | / |
Family ID | 38895676 |
Filed Date | 2008-04-24 |
United States Patent
Application |
20080097291 |
Kind Code |
A1 |
Hanson; Ian B. ; et
al. |
April 24, 2008 |
Infusion pumps and methods and delivery devices and methods with
same
Abstract
A delivery device includes a durable housing portion and a
separable disposable portion that selectively engage and disengage
from each other. The disposable housing portion secures to the
patient-user and may be disposed of after it has been in use for a
prescribed period. Components that normally come into contact with
a patient-user or with an infusion medium, including a pump device,
are supported by the disposable housing portion for disposal after
the prescribed use, while the durable housing portion supports
other components such as electronics for controlling delivery of
the infusion medium from the reservoir and a drive device and drive
linkage.
Inventors: |
Hanson; Ian B.; (Northridge,
CA) ; Bente; Paul F.; (Los Angeles, CA) ;
Mounce; R. Paul; (Burbank, CA) ; Chong; Colin A.;
(Burbank, CA) |
Correspondence
Address: |
FOLEY & LARDNER
2029 CENTURY PARK EAST, SUITE 3500
LOS ANGELES
CA
90067
US
|
Family ID: |
38895676 |
Appl. No.: |
11/589323 |
Filed: |
October 27, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60839741 |
Aug 23, 2006 |
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60839821 |
Aug 23, 2006 |
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60839822 |
Aug 23, 2006 |
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60839832 |
Aug 23, 2006 |
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60839840 |
Aug 23, 2006 |
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Current U.S.
Class: |
604/93.01 ;
29/428; 92/169.1 |
Current CPC
Class: |
G01F 11/029 20130101;
A61M 5/14566 20130101; Y10T 29/49826 20150115; A61M 2005/14268
20130101; A61M 5/14216 20130101; A61M 2209/045 20130101; A61M
2205/8206 20130101; A61M 5/1413 20130101; A61M 5/385 20130101; G01F
11/021 20130101; A61M 2205/0266 20130101; G01F 11/06 20130101; G01F
11/023 20130101; A61M 5/14248 20130101 |
Class at
Publication: |
604/93.01 ;
92/169.1; 29/428 |
International
Class: |
A61M 31/00 20060101
A61M031/00; F01B 11/08 20060101 F01B011/08; B21D 53/00 20060101
B21D053/00 |
Claims
1. A delivery device for delivering an infusion medium to a user,
the device comprising: a first housing portion adapted to be
secured to a user; a second housing portion configured to be
selectively engaged with and disengaged from the first housing
portion, the second housing portion having an enclosed interior
volume; a drive shaft supported by the second housing portion, for
movement in a first direction and in a second direction opposite to
the first direction; a drive device operatively connected to the
drive shaft, to selectively move the drive shaft in the first
direction; and a pump device supported by the first housing
portion, the pump device comprising: a piston chamber having an
interior including a fluid portion having a variable volume for
containing an infusion medium; an inlet port in fluid flow
communication with the interior volume of the piston chamber, the
inlet port configured for connection with a reservoir, for fluid
flow communication with the reservoir; an outlet port in fluid flow
communication with interior volume of the piston chamber; a push
plate supported for back-and-forth movement in a first direction
and in a second direction opposite to the first direction, the push
plate being arranged in a position for operative engagement with
the drive shaft for movement of the push plate in the first
direction as the drive shaft is moved in the first direction, and
for allowing movement of the push plate in the second direction as
the drive shaft is moved in the second direction, when the first
housing portion and the second housing portion are engaged with
each other; a piston head moveable within the piston chamber
between a retracted position and an active position to vary the
volume of the fluid portion of the piston chamber, the piston head
being operatively coupled in a fixed relation to the push plate,
for movement from the retracted position to the active position
with movement of the push plate in the first direction; wherein,
when the piston chamber contains infusion fluid, the volume of the
fluid portion of the piston chamber is reduced as the piston head
is moved from the retracted position to the active position to
provide a pressure within the piston chamber to force the infusion
fluid from the fluid portion of the piston chamber and through the
outlet port; wherein, the volume of the fluid portion of the piston
chamber is increased as the piston head is moved from the retracted
position to the active position to provide a pressure within the
piston chamber to draw infusion fluid into the fluid portion of the
piston chamber, through the inlet port, when the inlet port is
connected in fluid flow communication with a reservoir.
2. A delivery device according to claim 1, further comprising a
bias member operatively coupled to the push plate, for imparting a
bias force on the push plate in the second direction sufficient to
move the push plate in the second direction as the drive shaft is
moved in the second direction, when the first housing portion and
the second housing portion are engaged with each other.
3. A delivery device according to claim 1, further comprising a
reservoir having an interior volume for containing an infusion
medium and a conduit connecting the interior volume of the
reservoir in fluid flow communication with the inlet port of the
pump device.
4. A delivery device according to claim 3, wherein the reservoir is
supported by the first housing portion.
5. A delivery device according to claim 1, wherein the push plate
is coupled to the piston head by a piston rod, the piston chamber
is open to a channel section through which the piston rod extends,
and a seal is provided to inhibit fluid from passing through the
channel section.
6. A delivery device according to claim 1, wherein: the first
housing portion comprises a housing structure having an interior
volume in which the pump device is located, the housing structure
of the first housing portion includes a wall having an opening; the
push plate has a surface that is positioned to be acted upon by the
drive shaft, through the opening in the wall of the housing
structure of the first housing portion, when the first housing
portion and the second housing portion are engaged with each
other.
7. A delivery device according to claim 6, wherein: the second
housing portion comprises a housing structure having an interior
volume in which the drive device is located, the housing structure
of the second housing portion includes a wall having an opening;
the drive shaft extends through the opening in the wall of the
second housing portion.
8. A delivery device according to claim 7, wherein: the drive shaft
has an end that is positioned external to the second housing
portion for engaging the surface of the push plate, when the first
housing portion and the second housing portion are engaged with
each other.
9. A delivery device according to claim 1, wherein one of the
second housing portion and the first housing portion has at least
one flexible pawl and the other of the second housing portion and
the first housing portion has at least one receptacle having a
shape for receiving the at least one flexible pawl, when the first
housing portion and the second housing portion are engaged with
each other.
10. A delivery device according to claim 9, wherein each flexible
pawl includes a first stop surface and each receptacle includes a
second stop surface and wherein the first stop surface engages the
second stop surface, upon the pawl being received within the
receptacle.
11. A delivery device according to claim 1, further comprising
electrical control circuitry contained in the second
housing-portion, wherein the electrical control circuitry controls
the drive device for delivery of the infusion medium from the
reservoir to the user when the second housing portion and the first
housing portion are engaged.
12. A delivery device according to claim 1, wherein the first
housing portion comprises a base portion having a bottom surface
and an adhesive material on the bottom surface for securing the
first housing portion to the skin of the user.
13. A delivery device according to claim 1, wherein the first
housing portion comprises a base portion having a bottom surface
securable to the skin of the user, the delivery device further
comprising an injection site at which a hollow needle or cannula
may be inserted into a user's skin when the bottom surface of the
base portion is secured to the user's skin, and a conduit coupling
the injection site in fluid flow communication with the outlet port
of the pump device.
14. A delivery device according to claim 13, further comprising a
one-way valve within the conduit.
15. A delivery device according to claim 1, further comprising a
conduit coupled to the inlet port of the pump device, and a one-way
valve within the conduit.
16. A pump device for conveying a fluidic medium, the pump device
comprising: a piston chamber having an interior including a fluid
portion having a variable volume for containing a fluidic medium;
an inlet port in fluid flow communication with the interior volume
of the piston chamber, the inlet port configured for connection
with a source of fluidic medium, for receiving fluid medium from
the source into the interior volume of the piston chamber; an
outlet port in fluid flow communication with interior volume of the
piston chamber; a push plate supported for back-and-forth movement
in a first direction and in a second direction opposite to the
first direction, the push plate being arranged in a position for
operative engagement with a drive shaft for movement of the push
plate in the first direction as the drive shaft is moved in the
first direction, and for allowing movement of the push plate in the
second direction as the drive shaft is moved in the second
direction; a piston head moveable within the piston chamber between
a retracted position and an active position to vary the volume of
the fluid portion of the piston chamber, the piston head being
operatively coupled in a fixed relation to the push plate, for
movement from the retracted position to the active position with
movement of the push plate in the first direction; wherein, when
the piston chamber contains infusion fluid, the volume of the fluid
portion of the piston chamber is reduced as the piston head is
moved from the retracted position to the active position to provide
a pressure within the piston chamber to force the infusion fluid
from the fluid portion of the piston chamber and through the outlet
port; wherein, the volume of the fluid portion of the piston
chamber is increased as the piston head is moved from the retracted
position to the active position to provide a pressure within the
piston chamber to draw a fluidic medium into the fluid portion of
the piston chamber, through the inlet port, when the inlet port is
connected in fluid flow communication with the source of fluidic
medium.
17. A pump device according to claim 16, further comprising a bias
member operatively coupled to the push plate, for imparting a bias
force on the push plate in the second direction sufficient to move
the push plate in the second direction as the drive shaft is moved
in the second direction.
18. A pump device according to claim 16, wherein the push plate is
coupled to the piston head by a piston rod, the piston chamber is
open to a channel section through which the piston rod extends, and
a seal is provided to inhibit fluid from passing through the
channel section.
19. A method of making a pump device for conveying a fluidic
medium, the method comprising: providing a piston chamber having an
interior including a fluid portion having a variable volume for
containing a fluidic medium; providing an inlet port in fluid flow
communication with the interior volume of the piston chamber, and
configuring the inlet port for connection with a source of fluidic
medium, for receiving fluid medium from the source into the
interior volume of the piston chamber; providing an outlet port in
fluid flow communication with interior volume of the piston
chamber; supporting a push plate for back-and-forth movement in a
first direction and in a second direction opposite to the first
direction, and arranging the push plate in a position for operative
engagement with a drive shaft for movement of the push plate in the
first direction as the drive shaft is moved in the first direction,
and for allowing movement of the push plate in the second direction
as the drive shaft is moved in the second direction; supporting a
piston head for movement within the piston chamber between a
retracted position and an active position to vary the volume of the
fluid portion of the piston chamber, and operatively coupling the
piston head in a fixed relation to the push plate, for movement
from the retracted position to the active position with movement of
the push plate in the first direction; wherein, when the piston
chamber contains infusion fluid, the volume of the fluid portion of
the piston chamber is reduced as the piston head is moved from the
retracted position to the active position to provide a pressure
within the piston chamber to force the infusion fluid from the
fluid portion of the piston chamber and through the outlet port;
wherein, the volume of the fluid portion of the piston chamber is
increased as the piston head is moved from the retracted position
to the active position to provide a pressure within the piston
chamber to draw a fluidic medium into the fluid portion of the
piston chamber, through the inlet port, when the inlet port is
connected in fluid flow communication with the source of fluidic
medium.
20. A method according to claim 19, further comprising operatively
coupling a bias member to the push plate, for imparting a bias
force on the push plate in the second direction sufficient to move
the push plate in the second direction as the drive shaft is moved
in the second direction.
21. A method according to claim 19, further comprising operatively
coupling the push plate to the piston head by a piston rod, wherein
the piston chamber is open to a channel section through which the
piston rod extends, and a seal is provided to inhibit fluid from
passing through the channel section.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] The present invention relates to U.S. Application
60/839,741, filed Aug. 23, 2006, titled "Infusion Pumps And Methods
And Delivery Devices And Methods With Same," which is incorporated
herein by reference in its entirety and from which a priority
filing date is claimed. The present invention also relates to U.S.
Patent Application No. 60/678,290, filed May 6, 2005 and U.S.
patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled
"Infusion Device And Method With Disposable Portion," each of which
is incorporated herein by reference in its entirety and from which
the priority filing date is claimed. The present invention also
relates to co-pending U.S. patent application No. 60/839,821, filed
Aug. 23, 2006, titled "Infusion Medium Delivery Device And Method
For Driving Plunger In Reservoir" (attorney docket no.
047711.0381); co-pending U.S. patent application No. 60/839,822,
filed Aug. 23, 2006, titled "Infusion Medium Delivery Device And
Method For Driving Plunger In Reservoir" (attorney docket no.
047711.0382); co-pending U.S. patent application No. 60/839,832,
filed Aug. 23, 2006, titled "Infusion Medium Delivery Device With
Compressible Or Curved Reservoir Or Conduit (attorney docket no.
047711.0383); and co-pending U.S. patent application No.
60/839,840, filed 8/23/2.006, titled "Infusion Medium Delivery
Device, System And Method With Needle Inserter And Needle Inserter
Device And Method" (attorney docket no. 047711.0384), the contents
of each of which is incorporated herein by reference, in its
entirety. Embodiments of the present invention also relate to: (i)
U.S. patent application Ser. No. ______, filed Oct. 27, 2006,
entitled "Infusion Medium Delivery Device and Method with Drive
Device for Driving Plunger in Reservoir" (attorney docket no.
047711.0387); (ii) U.S. patent application Ser. No. ______, filed
Oct. 27, 2006, entitled "Infusion Medium Delivery Device and Method
with Compressible or Curved Reservoir or Conduit" (attorney docket
no. 047711.0390); (iii) U.S. Provisional patent application Ser.
No. ______, filed Oct. 27, 2006, entitled "Infusion Medium Delivery
System, Device and Method with Needle Inserter and Needle Inserter
Device and Method" (attorney docket no. 047711.0401); and (iv) U.S.
patent application Ser. No. ______, filed Aug. 23, 2006, entitled
"Systems And Methods Allowing For Reservoir Filling And Infusion
Medium Delivery" (attorney docket no. 047711.0393), the contents of
each of which are incorporated by reference herein, in their
entirety.
FIELD OF THE INVENTION
[0002] Embodiments of the present invention relate to an infusion
medium delivery device for delivering an infusion medium to a
patient-user, wherein the delivery device includes a base portion
and a durable portion connectable to the base portion, and wherein
the base portion can be separated from the durable portion and
disposed of after one or more specified number of uses. The base
portion supports a reservoir, while the durable portion supports a
drive device that is operatively coupled to the reservoir, to
selectively drive fluid out of the reservoir.
BACKGROUND OF THE INVENTION
[0003] Certain chronic diseases may be treated, according to modern
medical techniques, by delivering a medication or other substance
to a patient's body, either in a continuous manner or at particular
times or time intervals within an overall time period. For example,
diabetes is a chronic disease that is commonly treated by
delivering defined amounts of insulin to the patient at appropriate
times. Some common modes of providing an insulin therapy to a
patient include delivery of insulin through manually operated
syringes and insulin pens. Other modern systems employ programmable
pumps to deliver controlled amounts of insulin to a patient.
[0004] Pump type delivery devices have been configured in external
devices (that connect to a patient-user) or implantable devices (to
be implanted inside of a patient-user's body). External pump type
delivery devices include devices designed for use in a generally
stationary location (for example, in a hospital or clinic), and
further devices configured for ambulatory or portable use (to be
carried by a patient-user). Examples of some external pump type
delivery devices are described in U.S. patent application Ser. No.
11/211,095, filed Aug. 23, 2005, titled "Infusion Device And Method
With Disposable Portion" and Published PCT Application WO 01/70307
(PCT/US01/09139) titled "Exchangeable Electronic Cards For Infusion
Devices" (each of which is owned by the assignee of the present
invention), Published PCT Application WO 04/030716
(PCT/US2003/028769) titled "Components And Methods For Patient
Infusion Device," Published PCT Application WO 04/030717
(PCT/US2003/029019) titled "Dispenser Components And Methods For
Infusion Device," U.S. Patent Application Publication No.
2005/0065760 titled "Method For Advising Patients Concerning Doses
Of Insulin," and U.S. Pat. No. 6,589,229 titled "Wearable
Self-Contained Drug Infusion Device," each of which is incorporated
herein by reference in its entirety.
[0005] External pump type delivery devices may be connected in
fluid-flow communication to a patient-user, for example, through a
suitable hollow tubing. The hollow tubing may be connected to a
hollow needle that is designed to pierce the patient-user's skin
and deliver an infusion medium to the patient-user. Alternatively,
the hollow tubing may be connected directly to the patient-user as
or through a cannula.
[0006] In contexts in which the hollow tubing is connected to the
patient-user through a hollow needle that pierces the
patient-user's skin, a manual insertion of the needle into the
patient-user can be somewhat traumatic to the patient-user.
Accordingly, insertion mechanisms have been made to assist the
insertion of a needle into the patient-user, whereby a needle is
forced by a spring to quickly move from a retracted position into
an extended position. Examples of insertion mechanisms that are
built into a delivery device are described in U.S. patent
application Ser. No. 11/211,095, filed Aug. 23, 2005, titled
"Infusion Device And Method With Disposable Portion" (assigned to
the assignee of the present invention), which is incorporated
herein by reference in its entirety. Other examples of insertion
tools are described in U.S. Patent Application Publication No.
2002/0022855, titled "Insertion Device For An Insertion Set And
Method Of Using The Same" (assigned to the assignee of the present
invention), which is incorporated herein by reference in its
entirety. As the needle is moved into the extended position, the
needle is quickly forced through the patient-user's skin in a
single, relatively abrupt motion that can be less traumatic to a
patient-user as compared to a slower, manual insertion of a
needle.
[0007] As compared to syringes and insulin pens, pump type delivery
devices can be significantly more convenient to a patient-user, in
that accurate doses of insulin may be calculated and delivered
automatically to a patient-user at any time during the day or
night. Furthermore, when used in conjunction with glucose sensors
or monitors, insulin pumps may be automatically controlled to
provide appropriate doses of infusion medium at appropriate times
of need, based on sensed or monitored levels of blood glucose.
[0008] Pump type delivery devices have become an important aspect
of modern medical treatments of various types of medical
conditions, such as diabetes. As pump technologies improve and
doctors and patient-users become more familiar with such devices,
the popularity of external medical infusion pump treatment
increases and is expected to increase substantially over the next
decade.
SUMMARY OF THE DISCLOSURE
[0009] Embodiments of the present invention relate, generally, to
delivery devices, systems and methods for delivering an infusion
medium to a recipient, such as a medical patient. Such delivery
devices may include first and second housing portions (referred to
herein as a durable housing portion and a disposable housing
portion, respectively) that are configured to engage and attach to
each other for operation. The disposable housing portion may
contain an infusion medium reservoir and other components that come
into contact with the infusion medium and/or the patient-user
during operation. The disposable housing portion may also contain a
pump device in accordance with one of the embodiments described
herein. The durable housing portion may contain or otherwise
support components that do not come into contact with the infusion
medium or the patient-user during normal operation of the delivery
device, including, but not limited to, a drive device, drive
linkage, electronic circuits and, in some embodiments, a power
source.
[0010] The disposable housing portion may be disengaged and
separated from the durable housing portion, such that the
disposable housing portion may be readily disposed of after it has
been in use for a period of time, or after one or a prescribed
number of uses. After disengagement and separation from a
disposable housing portion, the durable housing portion may be
engaged and operatively connected to another disposable housing
portion (such as a new, refurbished, user-filled, prefilled,
refilled or re-manufactured disposable housing portion) for further
operation.
[0011] Thus, a delivery device for delivering an infusion medium to
a user according to example embodiments of the invention may
include a disposable housing portion adapted to be secured to a
user and a durable housing portion configured to be selectively
engaged with and disengaged from the disposable housing portion, to
allow disposal of the disposable housing portion without disposing
of the durable housing portion. Delivery device embodiments
described herein may employ any one of various pump embodiments
described herein, to draw the infusion medium from the reservoir
and/or convey the infusion medium to an injection site.
[0012] For example, a delivery device as described herein may
include a pump device supported by the disposable housing portion
and arranged to be operatively driven by a drive device, through a
drive shaft. The drive shaft may be supported by the durable
housing portion, for movement in a first direction and in a second
direction opposite to the first direction. The drive device may
operatively connect to the drive shaft, to selectively move the
drive shaft in the first direction to drive the pump device.
[0013] The pump device according to an embodiment of the invention
is provided with a piston chamber having an interior including a
fluid portion having a variable volume for containing an infusion
medium. An inlet port of the pump device is provided in fluid flow
communication with the interior volume of the piston chamber. The
inlet port is configured for connection with a reservoir, for fluid
flow communication with the reservoir.
[0014] An outlet port of the pump device is provided in fluid flow
communication with interior volume of the piston chamber. A push
plate is supported for back-and-forth movement in a first direction
and in a second direction opposite to the first direction, where
the push plate is arranged in a position for operative engagement
with the drive shaft to move the push plate in the first direction
as the drive shaft is moved in the first direction, and to allow
movement of the push plate in the second direction as the drive
shaft is moved in the second direction, when the disposable housing
portion and the durable housing portion are engaged with each
other.
[0015] A piston head is supported for movement within the piston
chamber between a retracted position and an active position to vary
the volume of the fluid portion of the piston chamber. The piston
head is operatively coupled in a fixed relation to the push plate,
for movement from the retracted position to the active position
with movement of the push plate in the first direction. When the
piston chamber contains infusion fluid, the volume of the fluid
portion of the piston chamber is reduced as the piston head is
moved from the retracted position to the active position to provide
a pressure within the piston chamber to force the infusion fluid
from the fluid portion of the piston chamber and through the outlet
port. Conversely, the volume of the fluid portion of the piston
chamber is increased as the piston head is moved from the retracted
position to the active position to provide a pressure within the
piston chamber to draw infusion fluid into the fluid portion of the
piston chamber, through the inlet port, when the inlet port is
connected in fluid flow communication with a reservoir.
[0016] The delivery device according to an embodiment of the
invention includes a bias member operatively coupled to the push
plate, for imparting a bias force on the push plate in the second
direction sufficient to move the push plate in the second direction
as the drive shaft is moved in the second direction, when the
disposable housing portion and the durable housing portion are
engaged with each other. In the same or further embodiments, the
push plate is coupled to the piston head by a piston rod and the
piston chamber is open to a channel section through which the
piston rod extends. A seal is provided to inhibit fluid from
passing through the channel section.
[0017] In the same or further embodiments, the delivery device
includes a reservoir having an interior volume for containing an
infusion medium and a conduit connecting the interior volume of the
reservoir in fluid flow communication with the inlet port of the
pump device. The reservoir may be supported by the disposable
housing portion.
[0018] According to example embodiments, the disposable housing
portion includes a housing structure that has an interior volume in
which the pump device is located. Also, the housing structure of
the disposable housing portion includes a wall having an opening.
The push plate has a surface that is positioned to be acted upon by
the drive shaft, through the opening in the wall of the housing
structure of the disposable housing portion, when the disposable
housing portion and the durable housing portion are engaged with
each other.
[0019] According to further example embodiments, the durable
housing portion includes a housing structure having an interior
volume in which the drive device is located. Also, the housing
structure of the durable housing portion includes a wall having an
opening through which the drive shaft extends. The drive shaft has
an end that is positioned external to the durable housing portion
for engaging the surface of the push plate, when the disposable
housing portion and the durable housing portion are engaged with
each other.
[0020] According to another aspect of the invention, a pump device
is provided for conveying an fluidic medium. The pump device has a
piston chamber having an interior that includes a fluid portion
having a variable-volume for containing a fluidic medium. An inlet
port is provided in fluid flow communication with the interior
volume of the piston chamber. The inlet port is configured for
connection with a source of fluidic medium, for receiving fluid
medium from the source into the interior volume of the piston
chamber. An outlet port is provided in fluid flow communication
with interior volume of the piston chamber.
[0021] In the above pump embodiment, a push plate is supported for
back-and-forth movement in a first direction and in a second
direction opposite to the first direction. The push plate is
arranged in a position for operative engagement with a drive shaft
for movement of the push plate in the first direction as the drive
shaft is moved in the first direction, and for allowing movement of
the push plate in the second direction as the drive shaft is moved
in the second direction. A piston head is supported for movement
within the piston chamber between a retracted position and an
active position to vary the volume of the fluid portion of the
piston chamber. The piston head is operatively coupled in a fixed
relation to the push plate, for movement from the retracted
position to the active position with movement of the push plate in
the first direction.
[0022] When the piston chamber contains infusion fluid, the volume
of the fluid portion of the piston chamber is reduced as the piston
head is moved from the retracted position to the active position to
provide a pressure within the piston chamber to force the infusion
fluid from the fluid portion of the piston chamber and through the
outlet port. The volume of the fluid portion of the piston chamber
is increased as the piston head is moved from the retracted
position to the active position to provide a pressure within the
piston chamber to draw a fluidic medium into the fluid portion of
the piston chamber, through the inlet port, when the inlet port is
connected in fluid flow communication with the source of fluidic
medium.
[0023] The pump device according to an embodiment of the invention
has a bias member operatively coupled to the push plate, for
imparting a bias force on the push plate in the second direction
sufficient to move the push plate in the second direction as the
drive shaft is moved in the second direction, when the disposable
housing portion and the durable housing portion are engaged with
each other. In the same or further embodiments, the push plate is
coupled to the piston head by a piston rod and the piston chamber
is open to a channel section through which the piston rod extends.
A seal is provided to inhibit fluid from passing through the
channel section.
[0024] Further embodiments of the present invention relate to
methods of making a delivery device for delivering an infusion
medium to a user. A method according to an embodiment of the
invention includes providing a disposable housing portion adapted
to be secured to a user and providing a durable housing portion
configured to be selectively engaged with and disengaged from the
disposable housing portion to allow disposal of the disposable
housing portion without disposing of the durable housing portion.
The method further includes supporting a drive shaft on the durable
housing portion for movement in a first direction and in a second
direction opposite to the first direction, operatively connecting a
drive device to the drive shaft, to selectively move the drive
shaft in the first direction, and supporting a pump device on the
disposable housing portion.
[0025] Supporting the pump device includes providing a piston
chamber having an interior including a fluid portion having a
variable volume for containing an infusion medium, connecting an
inlet port in fluid flow communication with the interior volume of
the piston chamber, the inlet port configured for connection with a
reservoir, for fluid flow communication with the reservoir and
connecting an outlet port in fluid flow communication with interior
volume of the piston chamber. In addition, supporting the pump
device includes supporting a push plate for back-and-forth movement
in a first direction and in a second direction opposite to the
first direction, and arranging the push plate in a position for
operative engagement with the drive shaft for movement of the push
plate in the first direction as the drive shaft is moved in the
first direction, and for allowing movement of the push plate in the
second direction as the drive shaft is moved in the second
direction, when the disposable housing portion and the durable
housing portion are engaged with each other.
[0026] Supporting the pump device further includes arranging a
piston head within the piston chamber for movement between a
retracted position and an active position to vary the volume of the
fluid portion of the piston chamber, and coupling the piston head
in a fixed relation to the push plate, for movement from the
retracted position to the active position with movement of the push
plate in the first direction. In such a method, when the piston
chamber contains infusion fluid, the volume of the fluid portion of
the piston chamber is reduced as the piston head is moved from the
retracted position to the active position to provide a pressure
within the piston chamber to force the infusion fluid from the
fluid portion of the piston chamber and through the outlet port. In
addition, the volume of the fluid portion of the piston chamber is
increased as the piston head is moved from the retracted position
to the active position to provide a pressure within the piston
chamber to draw infusion fluid into the fluid portion of the piston
chamber, through the inlet port, when the inlet port is connected
in fluid flow communication with a reservoir.
[0027] A method according to further embodiments of the invention
includes coupling a bias member to impart a bias force on the push
plate in the second direction sufficient to move the push plate in
the second direction as the drive shaft is moved in the second
direction, when the disposable housing portion and the durable
housing portion are engaged with each other. In the same or further
embodiments, the method includes providing a reservoir having an
interior volume for containing an infusion medium and connecting a
conduit in fluid flow communication with the interior volume of the
reservoir and with the inlet port of the pump device. The reservoir
may be supported on the disposable housing portion.
[0028] Supporting a push plate, according to embodiments of the
invention, includes coupling the push plate to the piston head by a
piston rod, extending the piston rod through an opening in the
piston chamber to a channel section, and providing a seal to
inhibit fluid from passing through the channel section. The method
according to the same or further embodiments includes locating the
pump device in an interior volume of the disposable housing
portion, providing an opening in a wall of the disposable housing
portion and arranging a surface of the push plate in a position to
be acted upon by the drive shaft, through the opening in the wall
of the housing structure of the disposable housing portion, when
the disposable housing portion and the durable housing portion are
engaged with each other.
[0029] The method according to the same or further embodiments
includes locating the drive device in an interior volume of the
durable housing portion, providing an opening in a wall of the
durable housing portion, and extending the drive shaft through the
opening in the wall of the durable housing portion. In such
embodiments, the drive shaft has an end that is positioned external
to the durable housing portion for engaging the surface of the push
plate, when the disposable housing portion and the durable housing
portion are engaged with each other.
[0030] The method according to any of the embodiments described
herein may include providing one of the durable housing portion and
the disposable housing portion with at least one flexible pawl and
the other of the durable housing portion and the disposable housing
portion with at least one receptacle having a shape for receiving
the at least one flexible pawl, when the disposable housing portion
and the durable housing portion are engaged with each other. The
method according to any of the embodiments described herein may
also include containing electrical control circuitry in the durable
housing portion, wherein the electrical control circuitry controls
the drive device for delivery of the infusion medium from the
reservoir to the user when the durable housing portion and the
disposable housing portion are engaged. The method according to any
of the embodiments described herein may include securing the bottom
surface of at least one of the disposable housing portion and the
durable housing portion to the skin of a user, for example, by
applying an adhesive material to a bottom surface of at least one
of the disposable housing portion and the durable housing portion
for securing the disposable housing portion or the durable housing
portion to the skin of the user. The method may further include
providing an injection site at which a hollow needle or cannula may
be inserted into a user's skin when the bottom surface of the base
portion is secured to the user's skin, and connecting a conduit in
fluid flow communication with the hollow needle or cannula and the
outlet port of the pump device. Further embodiments include
connecting a one-way valve within the conduit. Yet further
embodiments include connecting a conduit to the inlet port of the
pump device, and connecting a one-way valve within the conduit.
[0031] A further example of a delivery device described herein
includes a pump device according to an embodiment of the present
invention, supported by the disposable housing portion and arranged
to be operatively driven by a drive shaft, where the drive shaft is
supported by the durable housing portion, for movement in a first
direction and in a second direction opposite to the first
direction. The delivery device may also include a drive device
operatively connected to the drive shaft, to selectively move the
drive shaft in the first direction to drive the pump device.
[0032] A pump device according to an embodiment of the invention
includes a housing provided with a piston channel that has a
generally linear, longitudinal axis. The housing also has an inlet
port in fluid flow communication with the channel and configured
for connection to a reservoir, and an outlet port in fluid flow
communication with the channel and configured for connection in
fluid flow communication with an injection site. A piston is
located in the piston channel and has a first piston section and a
second piston section coupled together for limited movement,
relative to each other. The second piston section has a surface for
operable engagement with the drive shaft when the durable housing
portion and disposable hosing portion are engaged.
[0033] The piston is moveable with movement of the drive shaft
along the longitudinal axis of the piston channel between fill,
pull and dispense positions. In the fill position, the first and
second piston sections are separate to form a chamber having volume
between the first and second piston sections, and the chamber is
aligned in fluid flow communication with the inlet port. In the
pull position, the first and second piston sections are separated
and the chamber formed between the first and second piston sections
is located within the channel, between the inlet port and the
outlet port, out of fluid flow communication with the inlet port
and the outlet port. In the dispense position, the chamber between
the first and second piston sections is aligned in fluid flow
communication with the outlet port.
[0034] The delivery device according to a further embodiment of the
invention also includes a reservoir that has an interior volume for
containing an infusion medium. A conduit connects the interior
volume of the reservoir in fluid flow communication with the inlet
port of the housing of the pump device. The reservoir may be
supported by the disposable housing portion.
[0035] In any of the above-described embodiments, each of the first
and second piston sections may have an end surface that faces the
end surface of the other of the first and second piston sections.
In such embodiments, the second piston section has a hollow
interior portion and an opening on one end, into the hollow
interior portion. The hollow interior portion of the second piston
section has a stop surface. The first piston section includes an
extension portion that extends into the hollow interior portion of
the second piston section and has a stop surface for engaging the
stop surface of the hollow interior portion of the second piston
section when the end surfaces of the first and second piston
sections are fully separated and the piston is in the fill
position. Alternatively, the first piston section may have the
hollow interior portion and an opening on one end, into the hollow
interior portion, where the hollow interior portion has a stop
surface, while the second piston section includes an extension
portion extending into the hollow interior portion of the first
piston section, where the extension portion has a stop surface for
engaging the stop surface of the hollow interior portion of the
first piston section when the end surfaces of the first and second
piston sections are fully separated and the piston is in the fill
position.
[0036] As described above, in any of the above-described
embodiments, each of the first and second piston sections may have
an end surface that faces the end surface of the other of the first
and second piston sections. In addition, the end surfaces of the
first and second piston sections are arranged to abut each other
when the piston is in the dispense position.
[0037] Also in any of the above-described embodiments, the second
piston section may have an end surface facing away from the first
piston section. In such an embodiment, the disposable housing
portion includes a housing structure having an interior volume in
which the pump device is located and also includes a wall with an
opening. The surface of the second piston section that is for
operable engagement with the drive shaft is the end surface of the
second piston section that faces away from the first piston
section, and is positioned to be acted upon by the drive shaft,
through the opening in the wall of the housing structure of the
disposable housing portion when the disposable housing portion and
the durable housing portion are engaged with each other.
[0038] In such an embodiment, the durable housing portion may
include a housing structure having an interior volume in which the
drive device is located and a wall having an opening. The drive
shaft extends through the opening in the wall of the durable
housing portion. Also in such an embodiment, the drive shaft may
have an end that is positioned external to the durable housing
portion for operable connection with the end surface of the second
piston section, when the disposable housing portion and the durable
housing portion are engaged with each other.
[0039] Further embodiments of methods of making a pump device for
conveying a fluidic medium include providing a piston channel in a
housing, where the piston channel has a generally linear,
longitudinal axis, providing an inlet port in fluid flow
communication with the piston channel and configured for connection
to a source of fluidic medium, and providing an outlet port in
fluid flow communication with the piston channel. Such methods
further include providing a piston having a first piston section
and a second piston section coupled together for limited movement,
relative to each other, the second piston section having a surface
for receiving a drive force from a drive shaft, and supporting the
piston within the piston channel for movement along the
longitudinal axis of the piston channel between fill, pull and
dispense positions, when a drive force is received from a drive
shaft. In the fill position, the first and second piston sections
are separate to form a chamber having volume between the first and
second piston sections, and the chamber is aligned in fluid flow
communication with the inlet port. In pull positions, the first and
second piston sections are separated and the chamber formed between
the first and second piston sections is located within the channel,
between the inlet port and the outlet port, out of fluid flow
communication with the inlet port and the outlet port. In the
dispense position, the chamber between the first and second piston
sections is aligned in fluid flow communication with the outlet
port. The end surfaces of the first and second piston sections may
be arranged to abut each other when the piston is in the dispense
position.
[0040] According to further embodiments of such methods, supporting
the piston within the piston channel includes arranging each of the
first and second piston sections end-to-end, with an end surface of
each piston section facing an end surface of the other piston
section. In addition, providing a piston having first and second
piston sections includes providing the second piston section with a
hollow interior portion and an opening on one end, into the hollow
interior portion, the hollow interior portion having a stop surface
and providing the first piston section with an extension portion
extending into the hollow interior portion of the second piston
section, the extension portion having a stop surface for engaging
the stop surface of the hollow interior portion of the second
piston section when the end surfaces of the first and second piston
sections are fully separated and the piston is in the fill
position. Alternatively, providing a piston having first and second
piston sections may include providing the first piston section with
a hollow interior portion and an opening on one end, into the
hollow interior portion, the hollow interior portion having a stop
surface and providing the second piston section with an extension
portion extending into the hollow interior portion of the first
piston section, the extension portion having a stop surface for
engaging the stop surface of the hollow interior portion of the
first piston section when the end surfaces of the first and second
piston sections are fully separated and the piston is in the fill
position.
[0041] Further method embodiments also include providing a
disposable housing portion with a surface adapted to be secured to
a user and providing the disposable housing portion and a durable
housing portion with connection structure to allow the disposable
housing portion and the durable housing portion to be selectively
engaged with each other for operation and disengaged from each
other to allow disposal of the disposable housing portion without
disposing of the durable housing portion. Such methods further
include supporting a drive shaft with the durable housing portion,
for movement in a generally linear dimension and operatively
connecting a drive device to the drive shaft, to selectively move
the drive shaft in the generally linear dimension. Such methods
further include supporting a pump housing with the disposable
housing portion, where the pump housing has a piston channel with a
generally linear, longitudinal axis.
[0042] Also, such further methods include providing an inlet port
extending to the piston channel and configured for connection to a
source of fluidic medium and providing an outlet port in fluid flow
communication with the piston channel. In addition, such methods
include providing a piston having a surface for receiving a drive
force from the drive shaft when the disposable housing portion and
the durable housing portion are engaged for operation, and
supporting the piston in the piston channel for movement along the
longitudinal axis of the piston channel between fill and dispense
positions upon receiving a force from a drive shaft. In the fill
position, the piston is moved to a position to allow fluid flow
communication through the inlet port and into the piston channel
and piston chamber. In the dispense position, the piston is moved
to a position to obstruct fluid flow communication through the
inlet port and to reduce the volume of the piston chamber to force
fluid in the piston chamber out of the outlet port.
[0043] In yet further embodiments, a method includes providing the
housing of the pump device with an outlet chamber in fluid flow
communication with the piston chamber and the outlet port. Such
embodiments further include arranging a one-way valve between the
piston chamber and the outlet chamber and arranged to allow fluid
flow from the piston chamber to the outlet chamber and inhibit
fluid flow from the outlet chamber to the piston chamber. In
further embodiments, the one-way valve is a duckbill valve
structure.
[0044] A pump device according to another embodiment of the
invention also includes a housing provided with a piston channel
that has a generally linear, longitudinal axis. An inlet port,
extends to the piston channel and is configured for connection to a
reservoir. A piston chamber is in fluid flow communication with the
channel. An outlet port is also in fluid flow communication with
the piston channel and is configured for connection in fluid flow
communication with an injection site.
[0045] A piston is located in the piston channel and has a surface
for receiving a drive force from the drive shaft when the durable
housing portion and disposable hosing portion are engaged. The
piston is moveable with movement of the drive shaft along the
longitudinal axis of the piston channel between fill and dispense
positions. In the fill position, the piston is moved to a position
to allow fluid flow communication through the inlet port and into
the piston channel and piston chamber. In the dispense position,
the piston is moved to a position to obstruct fluid flow
communication through the inlet port and to reduce the volume of
the piston chamber to force fluid in the piston chamber out of the
outlet port.
[0046] In further embodiments, the housing of the pump device
includes an outlet chamber in fluid flow communication with the
piston chamber and the outlet port. In such embodiments, the pump
device includes a one-way valve between the piston chamber and the
outlet chamber, arranged to allow fluid flow from the piston
chamber to the outlet chamber and inhibit fluid flow from the
outlet chamber to the piston chamber. In one embodiment, the
one-way valve is a duckbill valve structure.
[0047] Any of the above-described embodiments may include a
reservoir having an interior volume for containing an infusion
medium and a conduit connecting the interior volume of the
reservoir in fluid flow communication with the inlet port of the
housing of the pump device. The reservoir may be supported by the
disposable housing portion.
[0048] Also in any of the above-described embodiments, the durable
housing portion may include a housing structure that has an
interior volume in which the drive device is located and a wall
having an opening. In such embodiments, the drive shaft extends
through the opening in the wall of the durable housing portion. In
further embodiments, the drive shaft has an end that is positioned
external to the durable housing portion for operable connection
with the surface of the piston, when the disposable housing portion
and the durable housing portion are engaged with each other.
[0049] Also in any of the above-described embodiments, one of the
durable housing portion and the disposable housing portion may have
at least one flexible pawl and the other of the durable housing
portion and the disposable housing portion may have at least one
receptacle with a shape for receiving the at least one flexible
pawl, when the disposable housing portion and the durable housing
portion are engaged with each other. In such embodiments, each
flexible pawl may include a first stop surface and each receptacle
may include a second stop surface arranged such that the first stop
surface engages the second stop surface, upon the pawl being
received within the receptacle.
[0050] Also in any of the above-described embodiments, electrical
control circuitry may be contained in the durable housing portion.
The electrical control circuitry controls the drive device for
delivery of the infusion medium from the reservoir to the user when
the durable housing portion and the disposable housing portion are
engaged.
[0051] Also in any of the above-described embodiments, the base
portion has a bottom surface and an adhesive material may be
provided on the bottom surface for securing the disposable housing
portion to the skin of the user. Further embodiments may include an
injection site at which a hollow needle or cannula may be inserted
into a user's skin when the bottom surface of the base portion is
secured to the user's skin, and a conduit that couples the
injection site in fluid flow communication with the outlet port of
the pump device. In yet further embodiments, a one-way valve is
provided within the conduit. In yet further embodiments, a conduit
is coupled to the inlet port of the pump device, and a one-way
valve within the conduit.
[0052] In any of the above-described embodiments, a conduit may be
coupled to the inlet port of the pump device, and a one-way valve
may be provided within the conduit. These and other embodiments of
the invention are described herein with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0053] FIG. 1 is a generalized diagram of a delivery system in
relation to a human patient-user.
[0054] FIG. 2 is a perspective view of a delivery device according
to an embodiment of the invention.
[0055] FIG. 3 is a perspective view of a durable portion and a
disposable portion of the delivery device of FIG. 2, with the
durable portion separated from the disposable portion.
[0056] FIG. 4 is a schematic, cross-sectional view of a disposable
housing portion of a delivery device according to an embodiment of
the invention.
[0057] FIG. 5 is a side view of the disposable housing portion of
the embodiment of FIG. 4.
[0058] FIG. 6 is a schematic, cross-sectional view of a durable
housing portion of a delivery device according to an embodiment of
the invention.
[0059] FIG. 7 is a side, schematic, cross-sectional view of the
durable housing portion of FIG. 6.
[0060] FIG. 8 shows a schematic view of a pump device and reservoir
according to a further embodiment of the invention.
[0061] FIG. 9 shows a schematic view of a pump device and reservoir
according to yet a further embodiment of the invention.
[0062] FIG. 10 shows a schematic view of a pump device and
reservoir according to yet a further embodiment of the
invention.
[0063] FIG. 11 shows a side, partial cross-section view of a piston
of the pump device of FIG. 8, according to an embodiment of the
invention.
[0064] FIG. 12 shows a perspective view of a shuttle housing of the
pump device of FIG. 8, according to an embodiment of the
invention.
[0065] FIGS. 13a-15b show side cross-section views of the pump
device of FIG. 10, in a fill, shuttle and dispense position,
respectively.
[0066] FIGS. 16 and 17 each show a side cross section view of pump
device according to another embodiment of the invention, with the
piston in the extended and retracted positions, respectively.
[0067] FIG. 18 shows a perspective view of a linear motion motor
that may be employed in a further embodiment of the invention.
[0068] FIG. 19 shows a schematic, cross-section view of a pump
device and reservoir according to a further embodiment of the
invention that employs a motor of FIG. 18.
[0069] FIG. 20 is a perspective view of a piston plunger for the
embodiment of FIG. 19.
[0070] FIG. 21 shows a schematic, cross-section view of a pump
device and reservoir according to yet a further embodiment of the
invention that employs a motor of FIG. 18.
[0071] FIG. 22 shows a schematic side view of an arrangement of a
durable housing portion and a disposable housing portion of a
delivery system according to an embodiment of the invention
consistent with the embodiment of FIG. 3.
[0072] FIG. 23 shows a schematic side view of an arrangement of a
durable housing portion and a disposable housing portion of a
delivery system according to another embodiment of the
invention.
[0073] FIG. 24 shows a partially exploded view of a delivery device
according to an embodiment of the invention.
[0074] FIG. 25 shows a schematic top view of an arrangement of a
durable housing portion and a disposable housing portion of a
delivery system according to an embodiment of the invention.
[0075] FIG. 26 shows a schematic top view of an arrangement of a
durable housing portion and a disposable housing portion of a
delivery system according to another embodiment of the
invention.
[0076] FIGS. 27-29 each show a perspective view of a connection
arrangement for a disposable housing portion and an injection site
module.
[0077] FIGS. 30 and 31 each show a perspective view of another
connection arrangement for a disposable housing portion and an
injection site module.
[0078] FIGS. 32-34 each show a perspective view of yet another
connection arrangement for a disposable housing portion and an
injection site module.
DETAILED DESCRIPTION
[0079] The present invention relates, generally, to delivery
devices, systems and methods for delivering an infusion medium,
such as a drug, to a recipient, such as a medical patient. In
particular embodiments, a delivery device includes first and second
housing portions (referred to herein as a durable housing portion
and a disposable housing portion, respectively) that are configured
to engage and attach to each other for operation. The disposable
housing portion may contain or otherwise support an infusion medium
reservoir and other components that come into contact with the
infusion medium and/or the patient-user during operation. The
disposable housing portion may also contain or otherwise support a
pump device in accordance with one of the embodiments described
herein. The pump device is connected or connectable in fluid flow
communication with the reservoir, to draw fluid from the reservoir
and/or convey the fluid to an injection site.
[0080] The disposable housing portion may be disengaged and
separated from the durable housing portion, such that the
disposable housing portion may be readily disposed of after it has
been in use for a period of time, or after one or a prescribed
number of uses. After disengagement and separation from a
disposable housing portion, the durable housing portion may be
engaged and operatively connected to another disposable housing
portion (such as a new, refurbished, user-filled, pre-filled,
refilled or re-manufactured disposable housing portion) for further
operation. The durable housing portion may contain or otherwise
support components that do not come into contact with the infusion
medium or the patient-user during normal operation of the delivery
device, including, but not limited to, a drive device, drive
linkage, electronic circuits and, in some embodiments, a power
source.
[0081] Delivery device embodiments described herein may employ any
one of various pump embodiments described herein, to draw the
infusion medium from the reservoir and/or convey the infusion
medium to an injection site. Particular pump embodiments may be
configured to provide a pump configuration that is operable in the
manner described herein, yet is capable of being manufactured with
sufficient economical economy to be included in a disposable
housing portion.
[0082] While embodiments of the present invention are described
herein with reference to an insulin delivery example for treating
diabetes, other embodiments of the invention may be employed for
delivering other infusion media to a patient-user for other
purposes. For example, further embodiments of the invention may be
employed for delivering other types of drugs to treat diseases or
medical conditions other than diabetes, including, but not limited
to drugs for treating pain or certain types of cancers, pulmonary
disorders or HIV. Further embodiments may be employed for
delivering media other than drugs, including, but not limited to,
nutritional media including nutritional supplements, dyes or other
tracing media, saline or other hydration media, or the like. Also,
while embodiments of the present invention are described herein for
delivering or infusing an infusion medium to a patient-user, other
embodiments may be configured to draw a medium from a
patient-user.
[0083] Furthermore, while embodiments of the present invention
refer to the housing portions of disclosed delivery devices as
disposable or durable, and may be configured to allow the
disposable housing portion to be disposed of and replaced in an
economically efficient manner, it will be understood that, in
further embodiments, the disposable housing portion embodiments
described herein may be re-used and need not be disposed of.
Similarly, the durable housing portion embodiments described herein
may be disposed of after one or more uses, if desired. However,
embodiments are configured to allow certain components (for
example, those that contact the infusion medium or the patient-user
during operation) to be housed in a first housing portion that may
be readily disposable, while other components (for example, those
that do not contact the infusion medium or the patient-user during
operation and that have a replacement cost that is of a relatively
significant level) may be housed in a second housing portion that
may be re-used with one or more new, user-filled, pre-filled,
refilled, refurbished or remanufactured disposable first housing
portions.
[0084] A generalized representation of an infusion medium delivery
system 10 is shown in FIG. 1, wherein the system includes a
delivery device 12 configured according to an embodiment of the
invention described herein. The system 10 may also include other
components coupled for communication with the delivery device 12,
including, but not limited to, a sensor or monitor 14, a command
control device (CCD) 16 and a computer 18. Each of the CCD 16, the
sensor or monitor 14, the computer 18 and the delivery device 12
may include receiver, transmitter or transceiver electronics that
allow communication with other components of the system. The
delivery device 12 may include electronics and software for
analyzing sensor data and for delivering the infusion medium
according to sensed data and/or pre-programmed delivery routines.
Some of the processing, delivery routine storage and control
functions may be carried out by the CCD 16 and/or the computer 18,
to allow the delivery device 12 to be made with more simplified
electronics. However, in other embodiments, the system 10 may
include a delivery device 12 that operates without any one or more
of the other components of the system 10 shown in FIG. 1. Examples
of the types of communications and/or control capabilities, as well
as device feature sets and/or program options may be found in U.S.
patent application Ser. No. 10/445,477 filed May 27, 2003, and
entitled "External Infusion Device with Remote Programming, Bolus
Estimator and/or Vibration Alarm Capabilities," and U.S. patent
application Ser. No. 10/429,385 filed May 5, 2003, and entitled
"Handheld Personal Data Assistant (PDA) with a Medical Device and
Method of Using the Same," U.S. patent application Ser. No.
09/813,660 filed Mar. 21, 2001, and entitled "Control Tabs For
Infusion Devices And Methods Of Using The Same," all of which are
incorporated herein by reference in their entirety.
[0085] In the generalized system diagram of FIG. 1, the delivery
device 12 and sensor or monitor 14 are secured to a patient-user 1.
The locations at which those components are secured to the
patient-user 1 in FIG. 1 are provided only as a representative,
non-limiting example. The delivery device 12 and sensor or monitor
14 may be secured at other locations on the patient-user 1, and
such locations may depend upon the type of treatment to be
administered by the system 10. Such other locations may include,
but are not limited to, other locations on the patient-user's body,
locations on the patient-user's clothing, belt, suspenders, straps,
purse, tote or other structure that may be carried by the
patient-user.
[0086] As described in further detail below, the delivery device 12
contains a reservoir of an infusion medium and a pump, for
delivering the infusion medium, such as, but not limited to an
insulin formulation, into the patient-user's body in a controlled
manner. Control instructions and/or data may be communicated
between the delivery device 12, the sensor or monitor 14, the CCD
16 and the computer 18. The delivery device 12 may be configured to
secure to the skin of a patient-user 1, in the manner of a patch,
at a desired location on the patient-user. In such embodiments, it
is desirable that the delivery device 12 have relatively small
dimensions for comfort and ability to conceal the device, for
example, under a garment.
[0087] Examples of patch-like delivery devices are described in
U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005,
which is incorporated herein, in its entirety. Delivery devices
described in U.S. patent application Ser. No. 11/211,095 employ a
reservoir structure having a moveable plunger for selectively
driving fluid from the reservoir. An example of a patch-like
delivery device 12 is shown in FIGS. 2-3 herein which, according to
one embodiment of the present invention, employs a peristaltic
pumping arrangement as shown in FIGS. 4-7. The delivery device 12
in FIG. 2 includes a base housing portion 20 that, in some
embodiments, may be disposable after one or a number of specified
uses, and a further housing portion 22. For convenience, but
without limitation, the base portion 20 is referred to herein as a
disposable housing portion or disposable portion, while the further
housing portion 22 is referred to herein as a durable housing
portion or durable portion. However, as noted above, in operation,
either or both housing portions 20 or 22 may be disposed of or
re-used, depending upon the context of use.
[0088] The disposable housing portion 20 may support structural
elements that ordinarily contact the patient-user's skin or the
infusion medium, during operation of the delivery device 12. On the
other hand, the durable housing portion 22 may support elements
(including electronics, motor components, linkage components, and
the like) that do not ordinarily contact the patient-user or the
infusion medium during operation of the delivery device 12. Thus,
elements in the durable housing portion 22 of the delivery device
12 are typically not contaminated from contact with the
patient-user or the infusion medium during normal operation of the
delivery device 12.
[0089] In the illustrated embodiment, the disposable housing
portion 20 of the delivery device 12 includes a base 21 that
includes or otherwise supports a reservoir retaining portion 24
that houses a reservoir and a pump device. The durable housing
portion 22 may include a housing that secures onto the base 21
adjacent the reservoir retaining portion 24. The durable housing
portion 22 may house a suitable drive device, such as an
electrically operated motor (not shown in FIG. 2), and drive
linkage components (not shown in FIG. 2) for operatively coupling
the drive device to the pump to drive fluid out of the reservoir,
when the durable housing portion 22 is coupled to the disposable
housing portion 20. The durable housing portion 22 also may house
suitable control electronics (not shown in FIG. 2) for controlling
the operation of the drive device to drive fluid from the reservoir
in a controlled manner. Further embodiments may include other
electronics within the durable housing portion 22, such as, but not
limited to communication electronics (not shown in FIG. 2) for
communicating with the sensor or monitor 14, the CCD 16, the
computer 18 and/or other components of the system 10 shown in FIG.
1.
[0090] The base 21 of the disposable housing portion 20 has a
bottom surface (facing downward and into the page in FIGS. 2 and 3)
that is configured to secure to a patient-user's skin at a desired
location on the patient-user. A suitable adhesive may be employed
at the interface between the bottom surface of the base 21 and the
patient-user's skin, to adhere the base 21 to the patient-user's
skin. The adhesive may be provided on the bottom surface of the
base 21, with a peelable cover layer 23 covering the adhesive
material. In this manner, a patient-user may peel off the cover
layer 23 to expose the adhesive material and then place the
adhesive side of the base 21 against the patient-user's skin. In
further embodiments described below, multiple layers of adhesive
material, alternating with multiple layers of cover layer material
may be provided on the base 21, to allow the base to be secured to,
removed from and then, again, secured to a patient-user's skin for
multiple re-uses or re-applications.
[0091] The disposable portion 20 may include a button or other
operator 25 for operating a needle insertion mechanism located
within the reservoir retaining portion 24. Alternatively, or in
addition, reference number 25 may represent an opening, through
which an external needle insertion mechanism may operate. Examples
of suitable needle insertion mechanisms are described in U.S.
patent application Ser. No. 11/211,095, filed Aug. 23, 2005, and
U.S. Provisional Patent Application No. 60/839,840, filed Aug. 23,
2006, titled "Infusion Medium Delivery Device, System And Method
With Needle Inserter And Needle Inserter Device And Method"
(attorney docket no. 047711.0384), each of which is incorporated
herein by reference in its entirety. Other needle/cannula insertion
tools may be used (or modified for use) to insert a needle and/or
cannula, such as for example U.S. patent application Ser. No.
10/389,132 filed Mar. 14, 2003, and entitled "Auto Insertion Device
For Silhouette Or Similar Products," and/or U.S. patent application
Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled "Insertion
Device For Insertion Set and Method of Using the Same," both of
which are incorporated herein by reference in their entirety.
Alternatively, the reservoir retaining portion may include a
suitable opening or port for connecting one end of a hollow tube to
the reservoir, while the other end of the hollow tube is connected
to a hollow needle for piercing the patient-user's skin and
conveying the infusion medium from the reservoir into the
patient-user, for example, as described with reference to FIG. 2 of
U.S. patent application Ser. No. 11/211,095, filed Aug. 23,
2005.
[0092] The durable housing portion 22 of the delivery device 12
includes a housing shell configured to mate with and secure to the
disposable housing portion 20. The durable housing portion 22 and
disposable housing portion 20 may be provided with correspondingly
shaped grooves, notches, tabs or other suitable features that allow
the two parts to easily connect and disconnect from each other (for
example, by a friction connection, snap connection, or other
suitable connection arrangement), by manually pressing the two
portions together in a manner well known in the mechanical arts. In
a similar manner, the durable housing portion 22 and disposable
portion 20 may be separated from each other by manually applying
sufficient force to unsnap the two parts from each other. In
further embodiments, a suitable seal, such as an annular seal, may
be placed along the peripheral edge of the disposable housing
portion 20 and/or the durable housing portion 22, so as to provide
a liquid, hermetic, or air-tight seal between the durable portion
20 and the durable portion 22.
[0093] The durable housing portion 22 and disposable housing
portion 20 may be made of suitably rigid materials that maintain
their shape, yet provide sufficient flexibility and resilience to
effectively snap together and apart, as described above. The base
21 material may be selected for suitable compatibility with the
patient-user's skin. For example, the disposable housing portion 20
and the durable housing portion 22 of the delivery device 12 may be
made of any suitable plastic, metal, composite material or the
like. The disposable housing portion 20 may be made of the same
type of material or a different material relative to the durable
housing portion 22. The disposable and durable housing portions may
be manufactured by injection molding or other molding processes,
machining processes or combinations thereof.
[0094] The base 21 may be made of a relatively flexible material,
such as a flexible silicone, plastic, rubber, synthetic rubber or
the like. By forming the base 21 of a material capable of flexing
with the patient-user's skin, a greater level of patient-user
comfort may be achieved when the base is secured to the
patient-user's skin. Also, a flexible base 21 can result in an
increase in the site options on the patient-user's body at which
the base 21 may be secured.
[0095] The disposable housing portion 20 and/or the durable housing
portion 22 may include an internal sensor (not shown in FIGS. 2 and
3) for connection to a patient-user, for example, through a needle
(not shown in FIGS. 2 and 3) for piercing a patient-user's skin
when the disposable housing portion 20 is secured to a
patient-user's skin. In such embodiments, a suitable aperture (not
shown in FIGS. 2 and 3) may be formed in the base 21, to allow the
passage of the sensor needle to pierce a patient-user's skin.
Alternatively, the durable housing portion 20 of the delivery
device 12 may be connected to an external sensor 14, through a
sensor lead, as described with respect to FIG. 2 of U.S. patent
application Ser. No. 11/211,095, filed Aug. 23, 2005, titled
"Infusion Device And Method With Disposable Portion." The sensor
may include any suitable biological sensing device, depending upon
the nature of the treatment to be administered by the delivery
device 12. For example, in the context of delivering insulin to a
diabetes patient, the sensor 14 may include a blood glucose sensor.
Alternatively, or in addition, one or more environmental sensing
devices may be included in or on the delivery device 12, for
sensing one or more environmental conditions. In further
alternatives, the sensor may be included with as a part or along
side the infusion cannula and/or needle, such as for example as
shown in U.S. patent Ser. No. 11/149,119 filed Jun. 8, 2005, and
entitled "Dual Insertion Set," which is incorporated herein by
reference in its entirety.
[0096] As described above, by separating disposable elements of the
delivery device 12 from durable elements, the disposable elements
may be arranged on the disposable portion 20, while durable
elements may be arranged within a separable durable portion 22. In
this regard, after one (or a prescribed number) of uses of the
delivery device 12, the disposable portion 20 may be separated from
the durable portion 22, so that the disposable portion 20 may be
disposed of in a proper manner. The durable portion 22 may, then,
be mated with a new (un-used, user-filled, pre-filled, refilled,
refurbished or re-manufactured) disposable portion 20 for further
delivery operation with a patient-user. This also provides the user
with the option to change medication delivery, by changing out and
replacing reservoirs 26 with different ones containing either
different medications, such as Amilyn, GLP-1, Byetta, Peptide C,
insulin sensitizers, combinations of medications (with or without
insulin) or the like. Alternatively, the user my change out
different types of insulin (e.g., long acting, fast acting, or the
like) or utilize different concentrations (U50, U100, U200, U400 or
the like).
[0097] An example of a disposable housing portion 20 and a durable
housing portion 22 of a delivery device 12 according to an
embodiment of the invention is shown in FIGS. 4-7, wherein FIGS. 4
and 5 show a top and side view, respectively, of a disposable
housing portion 20, while FIGS. 6 and 7 show a top and side
cross-sectional view of a durable housing portion 22. With
reference to FIG. 4, the disposable housing portion 20 includes a
base portion 21 and a reservoir retaining portion 24, as described
above. With reference to FIGS. 4-7, the durable housing portion 22
is configured to be manually positioned on the base portion 21,
adjacent the reservoir retaining portion 24 of the disposable
housing portion 20 and to be engaged with and connected to the
disposable housing portion 20, yet be selectively separable from
the disposable housing portion 20, by manual force. When the
durable housing portion 22 is engaged and connected with the
disposable housing portion 20, a drive device within the durable
housing portion 22 is arranged to make an operative connection with
a pump device located within the disposable housing portion 20, as
described below.
[0098] A reservoir 26 is located in the reservoir retaining portion
24. The reservoir 26 may include a container having an internal
volume for containing a fluidic infusion medium, such as, but not
limited to an insulin formulation. The reservoir 26 may be made of
any material suitably compatible with the infusion medium,
including, but not limited to suitable metal, plastic, ceramic,
glass, composite material or the like. For example, the reservoir
26 may be formed of a plastic material referred to as TOPAS
(trademark of Ticona, a subsidiary of Celanese Corporation), such
as described in U.S. patent application Ser. No. 11/100,188, filed
Apr. 5, 2005 (Publication No. 2005/0197626), the entire contents of
which are incorporated herein by reference.
[0099] The reservoir 26 may be supported by the reservoir retaining
portion 24 of the disposable housing portion 20 in any suitable
manner. For example, the reservoir 26 may be supported on a surface
of the base 21 and held in place by one or more projections, walls
or other surfaces. In some embodiments, the reservoir 26 may be
configured to be removable and replaceable with respect to the
disposable housing portion 20. In other embodiments, the reservoir
26 may be secured to the disposable housing portion 20 in a manner
intended to inhibit removal of the reservoir 26 from the disposable
housing portion 20. For example, an adhesive material may be
employed to adhere a surface of the reservoir 26 to the base 21 or
other structure of the disposable housing portion 20. In further
embodiments, multiple layers of adhesive material, alternating with
multiple layers of cover layer material may be provided on the
reservoir 26 or the base 21, to allow the reservoir to be secured
to, removed from and then, again, secured to the base or replaced
with another reservoir to secure to the base, for reservoir
replacement, refilling, or other service.
[0100] In yet other embodiments, the reservoir 26 may be formed
unitarily with the reservoir retaining portion 24, for example, as
a hollow chamber provided within an otherwise solid portion of the
reservoir retaining portion 24. In such embodiments, the hollow
interior of the reservoir retaining portion 24 may be coated or
lined in another manner with a suitable metal, plastic, plastic
TOPAS (trademark of Ticona, a subsidiary of Celanese Corporation),
ceramic, glass, composite material or the like. Alternatively, or
in addition, the retaining portion 24, itself, may be made of a
suitable metal, plastic, plastic, TOPAS (trademark of Ticona, a
subsidiary of Celanese Corporation), ceramic, glass, composite
material or the like.
[0101] The reservoir 26 has an outlet port 30, through which the
infusion medium contained within the interior of the reservoir 26
may be communicated out of the reservoir. The outlet port 30 is
open to the interior of the reservoir 26 and may include suitable
tube-connection structure for connecting a fluid conduit 32 in
fluid flow communication with the outlet port. The connection
structure may include any suitable connection structure that may be
selectively (or, in some embodiments, permanently) connected to a
reservoir 26 to provide fluid flow communication with the interior
of the reservoir 26. For example, the connection structure may
function with a pierceable septum located within the outlet port of
the reservoir. In such embodiments, the connection structure may
include a typical Luer-type connector having a cap structure for
receiving an outlet port of the reservoir and a hollow needle for
piercing the septum in the outlet port of the reservoir 26 (such
as, but not limited to, the reservoir connector 86 described in
U.S. Patent Application Ser. No. 60/839,840, filed Aug. 23, 2006,
titled "Infusion Medium Delivery Device, System And Method With
Needle Inserter And Needle Inserter Device And Method" (attorney
docket no. 047711.0384), which is incorporated herein by reference,
in its entirety. Further examples of needle/septum connectors can
be found in U.S. patent application Ser. No. 10/328,393 filed Dec.
22, 2003, and entitled "Reservoir Connector," which is incorporated
herein by reference in its entirety. In other alternatives,
non-septum connectors such as Luer locks, or the like may be used.
The conduit 32 may include any suitable structure that provides a
fluid flow path, such as, but not limited to a tube-shaped conduit
made of any suitable material, including, but not limited to
silicone or other plastic, metal, ceramic or composite
material.
[0102] A first end of the conduit 32 is connected or connectable to
the reservoir, through a reservoir connection structure as
described above. A second end of the conduit 32 is connected in
fluid flow communication with an inlet port 33 of a pump device 34.
The pump device 34 has an outlet port 35 connected in fluid flow
communication with a second conduit 36, for conveying fluid to a
delivery or injection site 38 located on the disposable housing
portion 20. The injection site 38 may include an insertion
mechanism to assist the insertion of a needle or cannula into the
patient-user and connection of the needle or cannula in flow
communication with the second conduit 36. Examples of such
insertion mechanisms that are built into a delivery device are
described in U.S. patent application Ser. No. 11/211,095, filed
Aug. 23, 2005, titled "Infusion Device And Method With Disposable
Portion" and U.S. Patent Application Ser. No. 60/839,840, filed
Aug. 23, 2006, titled "Infusion Medium Delivery Device, System And
Method With Needle Inserter And Needle Inserter Device And Method"
(attorney docket no. 047711.0384)(each assigned to the assignee of
the present invention), each of which is incorporated herein by
reference in its entirety. Other needle/cannula insertion tools may
be used (or modified for use) to insert a needle and/or cannula,
such as for example U.S. patent application Ser. No. 10/389,132
filed Mar. 14, 2003, and entitled "Auto Insertion Device For
Silhouette Or Similar Products," and/or U.S. patent application
Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled "Insertion
Device For Insertion Set and Method of Using the Same," both of
which are incorporated herein by reference in their entirety.
[0103] A first valve 40 may be provided within the first conduit 32
(or between the first conduit 32 and the reservoir 26 or the
inlet-port 33 of the pump device 34) for restricting fluid flow to
one direction from the reservoir 26 to the inlet port 33 of the
pump device 34. A second valve 42 may be provided within the second
conduit 36 (or between the second conduit 36 and the injection site
38 or the outlet port 35 of the pump device 34) for restricting
fluid flow to one direction from the outlet port 35 of the pump
device 34 to the injection site 38. Any suitable one-way valve
structure may be employed for valves 40 and 42.
[0104] The example embodiment of a pump device 34 in FIG. 4
includes a pump chamber 44 having an internal volume 45 and
moveable piston having a piston head 46 located within the pump
chamber 44 and a piston shaft 50 extending from the piston head.
The piston head 46 is selectively moveable from a retracted
position (as shown in FIG. 4) in the direction of arrow 48, to an
active position, to reduce the volume of the portion of the chamber
44 on the outlet port side of the piston head 46. The piston head
46 is also moveable from the active position toward the direction
opposite of the arrow 48, to the retracted position (as shown in
FIG. 4), to increase the volume of the portion of the chamber 44 on
the outlet port side of the piston head 46.
[0105] The piston head 46 is fixedly connected to the piston shaft
50. The piston shaft 50 defines a longitudinal axis A that extends
along the linear direction of movement of piston 46 (the linear
direction of and opposite of the arrow 48) and has a first end that
is connected to the piston head. The piston head 46 and the piston
shaft 50 may include a unitary body. Alternatively, the piston head
46 and the piston shaft 50 may include two members that are coupled
together in a fixed relation to each other. The second end of the
piston shaft 50 is fixedly connected to a push plate 52. The push
plate 52 and the piston shaft 50 may include a unitary body.
Alternatively, the push plate 52 and the piston shaft 50 may
include two members that are coupled together in a fixed relation
to each other. The piston head 46, piston shaft 50 and push plate
52 may be made of any suitably rigid material or materials,
including, but not limited to metal, plastic, ceramic, composite
material or the like.
[0106] The push plate 52 may be located within a second chamber 54
that is spaced from the piston chamber 44, but connected to the
piston chamber 44 by a channel section 56. The channel section 56
may include a hollow, tubular structure having an internal passage
through which the piston shaft 50 extends. One or more seals 58 may
be located within or adjacent to the internal passage of the
channel section 56, such as, but not limited to one or more o-ring
seals or the like, for inhibiting fluid from passing through the
channel section 56. The seal(s) 58 may be made of any suitable seal
material, including, but not limited to, plastic, rubber, silicone,
metal, ceramic or composite material.
[0107] A bias member 60 is operatively connected to the piston, for
example, by operative connection with the push plate 52, to provide
a bias force on the piston for urging the piston along the linear
dimension of the axis A, opposite to the direction of arrow 48. In
the embodiment of FIG. 4, the bias member 60 includes a coil spring
arranged within the second chamber 54, around and coaxial with the
longitudinal axis A of the piston shaft 50. The coil spring bias
member 60 of FIG. 4 has one end that abuts an internal wall of the
second chamber 54 and a second end that abuts a first surface of
the push plate 52. The coil spring bias member 60 is configured to
be in a partially compressed state, to impart a force on the push
plate 52 in the direction opposite to the direction of arrow 48.
The first surface of the push plate 52 may include an annular
groove in which one end of the coil spring bias member 60 may
reside, to help retain the coil spring bias member 60 in place. A
similar annular groove may be provided in the surface of the
interior wall of the second chamber 54 that is abutted by the coil
spring bias member, in which the other end of the coil spring bias
member may reside.
[0108] In one embodiment, each of the pump chamber 44 and the
second chamber 54 include a generally cylindrical body, having a
hollow interior. In such an embodiment, the channel section 56 may
include a generally hollow, cylindrical section extending between
the pump chamber 44 and the second chamber 54 and having a
generally cylindrical interior volume. Also in such embodiments,
each of the piston head 46 and the push plate 52 may include
disk-shaped members and the piston shaft 50 may include a
cylindrical member, each having a generally circular cross-section
(taken perpendicular to the axis A). However, in other embodiments,
such structural elements having other suitable shapes may be
employed. The pump chamber 44, second chamber 54 and channel
section 56 may include a single, unitary structure. In alternative
embodiments, the pump chamber 44, second chamber 54 and channel
section 56 may be composed of one or more separate parts that are
connected together in a fixed relation to each other. The pump
chamber 44, second chamber 54 and channel section 56 may be made of
any suitably rigid material or materials, including, but not
limited to metal, plastic, ceramic, composite material or the like.
In one embodiment, the second chamber 54 may be configured
unitarily with the housing structure that forms the reservoir
retaining portion 24 of the disposable housing portion 20. The
housing structure of the reservoir retaining portion 24 may define
an interior volume (for containing the reservoir 26, conduits 32
and 36, components of the injection site 38 and components of the
pump device 34) that is sealed from the external environment by the
walls of the housing structure, the seal 58 and a septum or other
seal structure in the delivery site 38, prior to operation of a
needle injector at the injection site.
[0109] The reservoir retaining portion 24 of the disposable housing
portion 20 has a side or wall 66 that has an opening (which may be
a recess) 68 through which the push plate 52 may be acted upon. For
example, a second surface of the push plate 52 (facing in an
opposite direction relative to the facing direction of the first
surface against which the coil spring bias member 60 abuts) may be
exposed through the opening 68 and faces in a direction outward
from the opening 68. The push plate is arranged to be engaged by
(or otherwise acted upon) a portion of a drive linkage supported on
the durable housing portion 22, upon the durable housing portion 22
and disposable housing portion 20 being engaged and connected
together for operation, as described below.
[0110] The durable housing portion 22 has a side or wall 70 (FIG.
6) that faces the wall 66 of the reservoir retaining portion 24 of
the disposable housing portion 20, when the durable housing portion
22 is engaged with the disposable housing portion 20 as shown in
FIG. 2. The side or wall 70 defines an opening 72 through which a
portion of a linkage structure may extend, to contact and act upon
the push plate 52, when the durable housing portion 22 is engaged
with the disposable housing portion 20.
[0111] As described above, the durable housing portion 22 is
configured to engage and connect to the disposable housing portion
20, yet be disconnected and separated from the disposable housing
portion 20 by application of sufficient manual force. Any suitable
connection structure, including, but not limited to, engageable
snap fitted members, friction fitted members, flexible or moveable
interlocking members or the like may be employed on the disposable
housing portion and durable housing portion. In the embodiment
shown in FIGS. 4-6, the connection structure includes a pair of
engagement pawls 74 extending from the wall 66 of the reservoir
retaining portion 24 of the disposable housing portion 20 and a
pair of correspondingly shaped receptacles 76 on the wall 70 of the
durable housing portion 22. Each engagement pawl 74 is configured
to fit within an associated one of the receptacles 76, when the
durable housing portion 22 is aligned with the disposable housing
portion 20 in an engagement position, to connect the durable
housing portion 22 and the disposable housing portion 20
together.
[0112] Each engagement pawl 74 may include a structure extending
from the wall 66 and having a stop surface 78 for engaging a
corresponding stop surface 79 of a receptacle 76, when the
engagement pawl 74 is inserted into its associated receptacle 76.
The stop surfaces 78 and 79, when engaged, inhibit separation of
the durable housing portion 22 and the disposable housing portion
20, unless a sufficient separation force is applied. Preferably,
the relative flexibility and resiliency of the pawls 74 and/or
receptacles 76 allow the durable housing portion 22 and the
disposable housing portion 20 to remain connected to each other
unless a sufficient manual force is applied in the separation
directions (for example the disposable housing portion is forced in
a direction of arrow 48 relative to the durable housing portion
and/or the durable housing portion is forced in a direction
opposite to arrow 48 relative to the disposable housing portion). A
sufficient force would cause the pawls 74 and/or receptacles 76 to
resiliently flex enough to allow the stop surface 78 of each pawl
74 to ride over the stop surface 79 of its associated receptacle
and, thus, allow the pawls 74 to be withdrawn from the receptacles
76, as the disposable portion 20 is separated from the durable
portion 22.
[0113] Each pawl 74 may include an angled or curved surface
(surface at an angle or having a tangent that is not parallel or
perpendicular to external surface of the wall 66) to facilitate
insertion of the pawls 74 into the receptacles 76. The pawls 74 may
be made of a material having sufficient rigidity and flexibility to
function as described herein, including, but not limited to, metal,
plastic, composite material or the like. The pawls 74 may be made
of the same material as and may be formed unitary with the wall 66
of the disposable housing portion 22. In other embodiments, the
pawls 74 may be formed separately from the disposable housing
portion and then connected to the wall 66. While the illustrated
embodiment shows a pair of pawls 74 and a corresponding pair of
receptacles 76, other embodiments may employ a single pawl and
associated receptacle or more than two pawls and associated
receptacles. Also, while the illustrated embodiment shows pawls 74
on the wall 66 of the disposable housing portion 20 and receptacles
76 on the wall 70 of the durable housing portion 22, other
embodiments may employ one more pawls on the wall 70 of the durable
housing portion 22 and one or more associated receptacles on the
wall 66 of the disposable housing portion 20. Yet other embodiments
may employ various combinations of one or more pawls and associated
receptacles on each of the walls 66 and 70.
[0114] The durable housing portion 22 includes a housing structure
having an interior volume 80. A drive device 82 is supported in
interior volume of the durable housing portion 22 and is
operatively connected to a drive shaft 84, through a linkage
structure 86. The drive device 82 may include, for example, but is
not limited to a motor or other device for converting electrical
power into rotational motion. Such drive devices may include, but
are not limited to, a DC motor, a flat or pancake DC motor, a servo
motor, a stepper motor, an electronically commutated motor, a
rotary piezo-electrically actuated motor, a piezo-electrically
actuated or thermally actuated bender with or without an escapement
wheel, an electronically actuated solenoid with or without an
escapement wheel or a shaped memory alloy wire with or without an
escapement wheel. Various examples of escapement wheel arrangements
with benders, solenoids, shaped memory alloy wires or the like are
described in U.S. Patent Application Ser. No. 60/839,822, filed
Aug. 23, 2006, titled "Infusion Medium Delivery Device And Method
For Driving Plunger In Reservoir" (attorney docket no.
047711.0382), which is incorporated herein by reference in its
entirety. Further examples of shape memory alloy wire drive systems
may be found in U.S. Pat. No. 6,375,638 issued Apr. 23, 2002, and
entitled "Incremental Motion Pump Mechanisms Driven by Shape Memory
Alloy Wire or the Like," and U.S. patent application Ser. No.
11/230,142 filed Sep. 19, 2005, and entitled "SMA Wire Driven
Positive Displacement MicroPump With Pulsatile Output," both of
which are incorporated herein by reference in their entirety.
[0115] The linkage structure 86 may include any suitable gear, gear
train, belt, shaft or other linkage arrangement that communicates
rotational motion of the motor or other rotational motion producing
device to linear motion of the drive shaft 84. In the embodiment of
FIG. 6, the linkage structure includes a drive cam 90 that is
coupled for rotation with a drive gear 92, about a rotational axis
94. The drive shaft 84 has one end coupled to the drive cam, at a
location offset from the rotational axis 94, such that rotation of
the drive cam results in linear motion of the drive shaft 84. The
drive gear 92 is arranged to be rotationally driven about the axis
94 by the motor or other rotational drive device, for example, by
direct connection to the motor or other rotational drive device or
by indirect connection through other portions of the linkage
structure 86, such as, but not limited to gears, shafts, belts or
the like. Further examples of linkage structures may be found in
U.S. patent application Ser. No. 09/813,660 filed Mar. 21, 2001,
and entitled "Control Tabs For Infusion Devices And Methods Of
Using The Same," which is incorporated herein by reference in its
entirety.
[0116] In other embodiments, the drive device 82 may include a
device that converts electrical power to linear motion, including,
but not limited to piezo-electrically actuated solenoid or bender,
thermally actuated solenoid or bender and electrically actuated
solenoid devices. In such linear motion drive device embodiments,
the linkage structure 86 may include any suitable gear, gear train,
belt, shaft or other linkage arrangement that communicates linear
motion of the drive device to linear motion of the drive shaft 84.
In further linear motion drive device embodiments, the linear
motion drive device may be directly connected to the drive shaft 84
(or the drive shaft 84 may be part of the linear motion drive
device, such as the drive shaft of a solenoid).
[0117] The drive device 82 is connected to a control circuit that
is supported within the durable housing portion 22 of the delivery
device, for controlling the operation of the drive device according
to a desired infusion delivery program or profile. A delivery
program or profile may be stored within a suitable electronic
storage medium (not shown) located within the durable housing
portion 22 and/or may be communicated to the delivery device 12
from other sources, such as a CCD 16 or a computer 18 (as shown in
FIG. 1). In such embodiments, the delivery program or profile may
be employed by the control circuit to control the operation of the
drive device 82 in accordance with the delivery program or profile.
Alternatively or in addition, the control circuit may control the
drive device 82 to deliver one or more discrete volumes of the
infusion medium in response to delivery demand control signals
generated within the device 12 or communicated to the device 12
from other sources, such as a CCD 16 or a computer 18 (as shown in
FIG. 1).
[0118] The durable housing portion 22 may contain additional
electronic circuitry (not shown) for communication with external
devices such as the CCD 16 or computer 18, for storage of sensor
data or other data, for processing and control functions, or for
other functions. The durable housing portion 22 may have a user
interface (not shown) including one or more buttons, electronic
display, or the like, and associated electronic interface circuitry
to allow a user to access data and/or input data or instructions to
control electronic circuitry within the durable housing portion 22.
Examples of the types of communications and/or control
capabilities, as well as device feature sets and/or program options
may be found in U.S. patent application Ser. No. 10/445,477 filed
May 27, 2003, and entitled "External Infusion Device with Remote
Programming, Bolus Estimator and/or Vibration Alarm Capabilities,"
and U.S. patent application Ser. No. 10/429,385 filed May 5, 2003,
and entitled "Handheld Personal Data Assistant (PDA) with a Medical
Device and Method of Using the Same," both of which are
incorporated herein by reference in their entirety.
[0119] The durable housing portion 22 may contain a battery, high
energy capacitor or other electronic power source for providing
electrical power to the drive device 82, control circuit
electronics and other electronic circuitry contained in the durable
housing portion 22. The control circuit electronics, other
electronic circuitry and the power source are represented in FIGS.
6 and 7 by reference number 98. In such embodiments, the battery,
high energy capacitor or other electronic power source may be
rechargeable through a recharge connector (not shown) provided on
the durable housing portion 22. Alternatively, or in addition, the
power source may be removeable and replaceable with respect to the
durable housing portion 22. In other embodiments, a battery,
capacitor or other electronic power source (not shown) may be
supported on the disposable housing portion 20 and connectable to
the drive device 82, control circuit and other electronic circuitry
in the durable housing portion, through electrical connectors (not
shown in FIGS. 4-7) that make an electrical connection upon the
durable housing portion 22 being coupled to the disposable housing
portion 20, without additional manual manipulation. Such electrical
connectors may include one or more pairs of conductive pads, where
each pair of pads is connected to opposite poles of the power
source and located on any suitable surface of the disposable
housing portion 20 that engages a corresponding surface on the
durable housing portion 22, when the durable housing portion 22 is
engaged with the disposable housing portion 20. In such
embodiments, the corresponding surface of the durable housing
portion 22 includes one or more corresponding pairs of conductive
pads that are electrically connected to the drive device 82,
control circuit and other electronic circuitry in the durable
housing portion and are arranged to engage the conductive pads on
the disposable housing portion, when the durable housing portion 22
is coupled to the disposable housing portion 20.
[0120] The drive device 82, linkage structure 86, control circuit,
other electronic circuitry and power source 98 described above, are
located within the interior volume 80 of the durable housing
portion 22. As described above, the drive shaft 84 extends through
an opening in the wall 70 of the durable housing portion 22. To
protect those electrical and mechanical components from certain
environmental conditions (such as, but not limited to, moisture,
air, biological or medical fluids), the interior volume 80 of the
durable portion 22 may be suitably sealed from the external
environment by the housing structure that forms the durable portion
22 and by one or more seals 99 provided around the drive shaft 84,
within or adjacent the opening in the wall 70. The seal(s) 99 may
include, but are not limited to, one or more o-ring seals or the
like. The seal(s) 99 may be made of any suitable seal material,
including, but not limited to, plastic, rubber, silicone, metal,
ceramic or composite material.
[0121] Accordingly, the delivery device 12 of FIGS. 4-6 includes a
disposable housing portion 20 supporting a reservoir 26, a pump
device 34 and other components described above, and a durable
housing portion 22 for supporting a drive device 82, a drive shaft
84, linkage structure 86, and electronics (which may also include a
power source) 98. To operate the delivery device 12, the reservoir
in the disposable housing portion 20 may be filled with a suitable
infusion medium. The disposable housing portion 20 may be secured
to a patient-user's skin (either before or after filling the
reservoir), in the manner described above. A needle injector may be
operated to place a hollow needle or cannula through the
patient-user's skin and connect the hollow needle or cannula in
fluid flow communication with the conduit 36.
[0122] The durable housing portion 22 may be manually aligned with
the disposable housing portion 20, and engaged with and connected
to the disposable housing portion 20 (either before or after the
disposable housing portion is secured to a patient-user's skin and
either before or after the needle injector is activated), in the
manner described above. By engaging and connecting the durable
housing portion 22 with the disposable housing portion 20, an end
of the drive shaft 84 (opposite to the end connected to the drive
cam 90) abuts or is positioned adjacent to the push plate 52. For
example, when the durable housing portion 22 is aligned to be
engaged and connected with the disposable housing portion 20, the
drive shaft 84 may extend into the opening in the wall 66 of the
reservoir retaining portion 24 of the disposable housing portion 20
and contact or reside adjacent the outward-facing surface of the
push plate 52.
[0123] Once the disposable housing portion 20 and the durable
housing portion 22 are engaged and connected together, the drive
device 82 may be selectively activated, with the electrical control
and power provided by the control circuit electronics and power
source 98, to selectively move the drive shaft 84 in a
back-and-forth motion along two generally linear directions
(corresponding to the direction of arrow 48 and the direction
opposite to the direction of arrow 48), as described above. For
example, the drive device 82 may be controlled to selectively
rotate the drive gear 92 and drive cam 90 in a first direction
about the rotation axis 94. As the drive cam 90 rotates, the drive
shaft is moved in one direction and then the opposite direction,
along the linear dimension of the arrow 48. Alternatively, the
drive shaft 82 may be driven in a linear back-and-forth motion by
rotating the drive gear 92 and drive cam 90 in one direction and
then the opposite direction, for example, by controlling the drive
device to drive in one direction and then the opposite
direction.
[0124] As the drive shaft 84 is driven in the direction of arrow
48, the extended end of the drive shaft 84 engages the push plate
52 and imparts a force on the push plate 52 in the direction of
arrow 48 sufficient to move the push plate 52 in the direction of
arrow 48, against the force of the coil spring bias member 60. As
the push plate 52 is moved in the direction of arrow 48, the piston
shaft 50 and piston head 46 are moved in the direction of arrow 48,
from the retracted position (as shown in FIG. 4), to an active
position. As the piston head 46 moves toward the active position,
the volume of the portion of the piston chamber 44 located on one
side of the piston head 46 (the side to the left of the piston head
46 in the orientation shown in FIG. 4) is reduced. As that portion
of the piston chamber 44 volume reduces, the pressure within that
volume increases to force fluid through the outlet port 35, conduit
36 and one-way valve 42, to the injection site 38.
[0125] The amount of motion of the drive shaft 84 in the direction
of arrow 48 is selected to move the piston head from the retracted
position (shown in FIG. 4). Once the piston head 46 reaches its
active position, the drive shaft 84 also reaches its farthest point
of motion in the direction of arrow 48. Thereafter, the drive shaft
84 is moved in the direction opposite to the direction of arrow 48
as the drive device 82 continues to impart a drive force. As the
drive shaft 84 moves in the direction opposite to the direction of
arrow 48, the push plate 52, piston, piston shaft 50 and piston
head 46 also move in the direction opposite to the direction of
arrow 48 to the retracted position (shown in FIG. 4), by the force
of the coil spring bias member 60.
[0126] As the piston head 46 moves in the direction opposite of the
direction of arrow 48, from its active position toward its
retracted position, the volume of the portion of the piston chamber
44 located on one side of the piston head 46 (the side to the left
of the piston head 46 in the orientation shown in FIG. 4)
increases. As that portion of the piston chamber 44 volume
increases, the pressure within that volume decreases sufficiently
to draw fluid from the reservoir 26, through the conduit 32, the
one-way valve 40 and the inlet port 33, and into that portion of
the volume of the piston chamber 44. In this manner, the portion of
the volume of the piston chamber on one side of the piston head 46
(the side to the left of the piston head 46 in the orientation
shown in FIG. 4) fills with infusion medium, for another stroke of
the piston head 46 in the direction of arrow 48. Accordingly, the
pump device 34 may be driven by the motion of the drive shaft 84,
to effectively force infusion medium from the piston chamber 44 to
the injection site 38, and by the return force of the bias member
60, to draw infusion medium from the reservoir 26, into the piston
chamber 44. The drive device 82 may be controlled by the control
circuit, in accordance with a pre-defined delivery profile, to
selectively deliver a suitable amount of infusion medium to the
patient-user, through the injection site. The delivery profile may
be designed in accordance with a pre-known volume of the piston
chamber 44 and the pre-known volume of infusion medium delivered
through the outlet port 35 and conduit 36 to the injection site 38,
for each stroke of the piston head 46 from the retracted position
to the active position.
[0127] Before starting a pumping process, the piston chamber 44 may
be primed, for example, by pre-filling the piston chamber 44 with
infusion medium during manufacture, assembly or at another time
period prior to securing the disposable portion of the delivery
device to a patient-user's skin, by filling the piston chamber 44
either before or after securing to the patient-user through a
filling port (not shown), or by operating the drive device to cause
the piston head 36 to make one or more strokes to lower the
pressure within the piston chamber sufficient to draw fluid from
the reservoir through the inlet port 33 before activation of a
needle injector at the injection site 38. In yet other embodiments,
a priming port may be provided in the piston chamber 44, where the
priming port may include a one-way air valve (not shown) that
allows air to escape, but inhibits infusion fluid from escaping the
piston chamber 44 and inhibits air from entering the piston chamber
44. In such embodiments, the priming port may be covered with a
material that allows the passage of air, but inhibits the passage
of water or other liquids. Examples of structures that permit
air-flow, but that inhibit fluids can be found in U.S. patent
application Ser. No. 10/328,393 filed Dec. 22, 2003, and entitled
"Reservoir Connector," and U.S. patent application Ser. No.
10/699,429 filed Oct. 31, 2003, and entitled "External Infusion
Device with a Vented Housing," both of which are incorporated
herein by reference in their entirety.
[0128] The embodiment shown in FIGS. 4-6 employs a bias member 60
for imparting a force on the push plate 52, to return the push
plate 52 to the retracted position (shown in FIG. 4). In such an
embodiment, the drive shaft 84 may be arranged to engage and abut
the push plate 52 to push the push plate 52 in the direction of
arrow 48, while the bias member 60 urges the push plate 52 back
toward the retracted position (in the direction opposite to the
direction of arrow 48), when the drive shaft 84 is driven to the
return position. Other embodiments may employ the return motion of
the drive shaft 84 (in the direction opposite to the direction of
arrow 48) to return the push plate 52 to the retracted position.
Such embodiments may employ suitable connection structure for
allowing the drive shaft 84 to be selectively engaged and connected
to the push plate 52, when the durable housing portion 22 is
engaged and connected to the disposable housing portion 20. Such
connection structure may include, but not limited to, engageable
snap fitted members, friction fitted members, flexible or moveable
interlocking members or the like. In one embodiment, the connection
structure for connecting the drive shaft 84 to the push plate 52
may include a pawl and associated receptacle arrangement (similar
to the pawl 74 and receptacle 76 described above), wherein one of
the pawl and receptacle is provided on the push plate and the other
of the pawl and receptacle is provided on the end of the drive
shaft 84.
[0129] As described above, the embodiment shown in FIGS. 4-6 may
employ any one of various types of suitable drive devices
including, but are not limited to, a DC motor, a flat or pancake DC
motor, a servo motor, a stepper motor, an electronically commutated
motor, a rotary piezo-electrically actuated motor, a
piezo-electrically actuated or thermally actuated bender with or
without an escapement wheel, an electronically actuated solenoid
with or without an escapement wheel or a Shape Memory Alloy (SMA)
wire with or without an escapement wheel. For example, the linear
motion of the push plate 52 may be provided by an SMA wire, such
as, but not limited to, Nitinol (Nickel-Titanium/Naval Ordinance
Laboratory). A Nitinol driver may be provided in the durable
housing portion 22 or the disposable housing portion 20.
[0130] For example, in the embodiment of FIG. 8, an SMA wire 91 is
located in the disposable housing portion 20, and has one end 91a
connected to the push plate 52 (or directly to the piston shaft 50
by omitting the push plate 52) and a second end 91b connected in a
fixed position relative to the disposable housing portion. The SMA
wire 91 is configured to expand in the linear direction (the
direction of the wire, to push the piston shaft 50 in the direction
of arrow 48, upon application of a suitable electrical potential
across the SMA wire. The two ends 91a and 91b of the SMA wire 91
are connected, through suitable electrical leads 95 and 97, to an
electrical connector element 93 on the disposable housing portion
20.
[0131] The connector element 93 is configured to electrically
connect with a corresponding connector element 99 on the durable
housing portion 22, when the disposable housing portion 20 and the
durable housing portion 22 are engaged. The connector element 99 is
electrically connected to a battery (or other suitable source of
electrical power) and control electronics 98, to selectively
provide an electrical potential across the leads 95 and 97, to
selectively energize the SMA wire, when the disposable housing
portion 20 and the durable housing portion 22 are engaged. Because
the power source in the durable housing portion 22 and the SMA wire
drive device in the disposable housing portion 20 need only an
electrical connection for operation, the respective housing
portions 20 and 22 may be enclosed and sealed, and need not include
any openings to the external environment. In further embodiments,
such sealed housing portions may include a vent opening for
equalizing pressure between the interior of the housing portion and
the exterior environment.
[0132] In the embodiment of FIG. 8, when the durable housing
portion 22 is engaged with the disposable housing portion 20, an
electrical connection is made between the connector elements 93 and
99, to connect the battery and control electronics 98 to the leads
95 and 97 for the SMA wire. Application of a controlled electrical
power signal to the leads 95 and 97, from the battery and control
electronics 98 causes the SMA wire to expand in the linear
direction. Because the end 91b of the SMA wire is connected in a
fixed relation to the disposable housing portion 20, the controlled
linear expansion of the SMA wire causes the second end of the SMA
wire to selectively move in the direction of arrow 48, to move the
push plate 52 in the direction of arrow 48. In this manner, the
battery and control electronics 98 may operate the pump 34, to
selectively drive fluid from the pump, to an injection site.
[0133] Another drive example that employs an SMA wire is shown in
FIG. 9, wherein an SMA wire is located in the durable housing
portion 22. In FIG. 9, the SMA wire 91' has one end 91a' coupled to
a push rod 100 and a second end 91b' coupled in a fixed relation
with the durable housing portion 22. The push rod 100 is supported
for movement in a linear direction (the directions of arrow 48 and
opposite to arrow 48), for example, by a suitable support structure
102 that includes a slide bearing surface abutting the push rod
100. The support structure 102 may be part of or affixed to the
durable housing portion 22. The push rod 100 is connected to a
mating member 104 that has a mating surface accessible from outside
of the durable housing portion 22. A bias member provides a return
force on the mating member 104 and may comprise a coil spring
connected between the mating member 104 and the support structure
102.
[0134] The mating member 104 may be located external to the durable
housing portion 22 and/or may extend through an opening in the
durable housing portion 22, such that the mating surface of the
mating member 104 is arranged to engage a corresponding mating
surface on the pump device 34, when the durable housing portion 22
and the disposable housing portion 20 are engaged. In the
embodiment of FIG. 9, a connection shaft 50' extends from the pump
device 34 and has a mating surface on one end that is shaped to
engage and mate with the mating surface of the mating member 104.
In the embodiment in FIG. 9, the connection shaft 50' extends from
the push plate 52. In other embodiments, the push plate 52 may be
omitted, such that the connection shaft 50' comprises a portion of
the piston shaft 50.
[0135] In the embodiment of FIG. 9, when the durable housing
portion 22 is engaged with the disposable housing portion 20, a
mechanical connection is made between the mating member 104 and the
connection shaft 50. Application of a controlled electrical power
signal across the SMA wire causes the SMA wire to expand in the
linear direction. Because the end 91b' of the SMA wire is connected
in a fixed relation to the durable housing portion 22, the
controlled linear expansion of the SMA wire causes the second end
of the SMA wire to selectively move in the direction of arrow 48,
to move the push rod 100 and the mating member 104 in the direction
of arrow 48. In this manner, the battery and control electronics 98
may operate the pump 34, to selectively drive fluid from the pump,
to an injection site.
[0136] A linear-motion pump device 134 according to a further
embodiment of the invention is shown in FIGS. 10-15. The pump
device 134 may be employed in a delivery device 12 as described
above with respect to FIGS. 4-7, in place of the linear motion pump
device 34 described above. The pump device 134 includes a shuttle
mechanism that is operated by imparting a linear force for
providing a linear motion of a piston shuttle.
[0137] With reference to FIG. 10, the pump device 134 operates to
dispense fluid from a reservoir 126. The reservoir 126 may be
located in a disposable housing portion, similar to the disposable
housing portion 20 described above. The reservoir 126 may include a
reservoir structure as described above with respect to reservoir 26
in FIGS. 4-7. Alternatively, the reservoir 126 may include a
flexible bag or a container having flexible walls that collapse, as
fluid is withdrawn from the reservoir interior.
[0138] The reservoir 126 may include a septum 128, such as a
self-sealing septum that may be pierced by a needle (for example a
syringe needle) for filling or refilling of the reservoir. The
septum 128 may be positioned at a location where it is exposed
through an opening in the housing structure that forms the
disposable housing portion 20, to allow access for filling or
refilling operations from outside of the disposable housing portion
20. The reservoir 126 may be filled or refilled, for example, by
inserting a needle of a syringe through the septum 128 and
operating the syringe to dispense infusion fluid from the needle,
into the interior of the reservoir.
[0139] The pump device 134 includes a shuttle housing 136 and a
shuttle piston 138. The shuttle housing 136 includes a structural
body made of any suitably rigid material, including, but not
limited to, metal, plastic, ceramic, glass or composite materials.
The shuttle housing 136 includes an interior channel 140 having a
longitudinal axis A1. The shuttle housing 136 may include a
cylindrical-shaped body having an outer peripheral wall surface 137
and the channel 140 may be cylindrical shaped channel generally
centrally located within the cylindrical shaped body. However,
other embodiments may employ other suitable shapes for the shuttle
housing 136 and channel 140. The shuttle housing 136 includes an
inlet port 142, comprising an opening through the outer wall of the
shuttle housing 136, to the channel 140. The shuttle housing 136
also includes an outlet port 144, comprising a second opening
through the outer wall of the shuttle housing 136, to the channel
140. The outlet port 144 is located at a spaced relation relative
to the inlet port 142, along the longitudinal axis A.sub.1 of the
channel 140.
[0140] In the embodiment of FIGS. 10-15, the inlet port 142 and the
outlet port 144 are offset from each other by 180 degrees around
the longitudinal axis A.sub.1 of the channel 140, with the inlet
port 142 directed upward and the outlet port directed downward
relative to the orientation of FIGS. 10-15. However, in other
embodiments, the inlet port 142 and the outlet port 144 may be
offset from each other by less than or greater than 180 degrees, or
may be in line (not offset) with respect to the longitudinal axis
A.sub.1 of the channel 140. The outlet port 144 may be connected to
a conduit in fluid flow communication with an injection site, such
as conduit 36 and injection site 38 as shown in FIG. 4.
[0141] The piston 138 includes first and second piston sections 146
and 148, respectively. Each piston section 146, 148 includes a
structural body having a longitudinal axis and a shape
corresponding to the shape of the channel 140. Accordingly, in
embodiments in which the channel 140 has a cylindrical shape, the
structural body of the piston sections 146 and 148 each include a
cylindrical shaped body having an outer diameter slightly less than
the diameter of the channel 140. The diameters of the piston
sections 146, 148 and the channel 140 are selected to allow the
piston sections 146, 148 to fit within and move axially within the
channel 140, yet inhibit leakage of infusion fluid between the
piston sections 146, 148 and the interior wall of the channel 140.
The piston sections 146, 148 may be made of any suitably rigid
material, including, but not limited to, metal, plastic, ceramic,
glass or composite materials.
[0142] The piston sections 146, 148 are arranged, end-to-end, at
least partially within the channel 140, such that one end 147 of
piston section 146 faces an opposite-facing end 149 of piston
section 148. The piston sections 146, 148 are separate structural
bodies that are coupled together, yet moveable relative to each
other in the axial dimension of the channel 140. A coupling
structure suitable for allowing axial movement of the piston
sections 146 and 148 relative to each other is provided to couple
the piston sections 146, 148 together. One embodiment of such a
suitable coupling structure is shown in FIG. 11 and includes a
hollow interior channel 150 extending axially within the interior
of one of the piston sections, such as the piston section 148. The
end of the piston section 148 that faces the piston section 146 is
provided with an opening 152 into the interior channel 150 of the
piston section 148. The channel 150 of the piston section 148 has a
stepped interior surface, that has a first diameter D.sub.1
adjacent the opening 152 and a second diameter D.sub.2 further
spaced from the opening 152 along the axial dimension A.sub.1. A
step, forming a stop surface 154, is provided at the transition
between the two diameters D.sub.1 and D.sub.2 of the channel
150.
[0143] The coupling structure further includes an extension portion
156, extending axially from the end of the piston section 146 that
faces the piston section 148. The extension portion 156 is rigidly
fixed relative to the piston section 146. The extension portion 156
may be formed integral with the piston section 146 as a single,
unitary body, or may be formed separate from the piston section 146
and fixedly secured to the piston section 146. The extension
portion 156 extends toward the piston section 148 and through the
opening 152 in the end of the piston section 148 and into the
channel 150. The extension portion 156 has a free end on which a
head 158 is located. The head 158 provides a stop surface 160 for
engaging the stop surface 154, as described below.
[0144] One or more seals 159, including, but not limited to o-ring
seals, may be provided around the opening 152 and/or around the
extension portion 156, to inhibit fluid flow communication through
the opening 152 and into the channel 150. Such seal(s) 159 may be
made of any suitable seal material, including, but not limited to,
metal, plastic, silicone, ceramic, composite material or the like.
While the coupling structure in the embodiment of FIG. 9 employs a
channel 150 in the piston section 148 and an extension portion 156
on the piston section 146, other embodiments may employ a channel
150 in the piston section 146 and an extension portion on the
piston section 148, to function in a manner as described
herein.
[0145] The coupling structure allows the piston sections 146, 148
to move axially relative to each other to separate from each other
for a limited distance, while remaining connected to each other. As
one or both of the piston sections 146, 148 moves axially to
separate the piston sections 146, 148, a gap or chamber 162 is
formed between the two facing ends 147 and 149 of the piston
sections 146 and 148, respectively. The width of the gap or chamber
162 (in the axial dimension) increases, as one or both of the
piston sections 146, 148 move to separate, until the stop surface
160 of the head 158 engages the stop surface 154 of the stepped
interior surface of the channel 150. Upon engagement of the stop
surfaces 160 and 154, further relative movement of the piston
sections 146, 148 in a separation direction (axially away from each
other) is inhibited. On the other hand, as one of the piston
sections 146, 148 is moved toward the other piston section from a
separated position, the gap or chamber 162 decreases in width (in
the axial dimension) until the facing ends 147, 149 of the piston
sections 146, 148 contact each other.
[0146] In operation, the piston 138 (including both piston sections
146, 148) is moved in a linear manner, along the axial dimension
A1, by selective operation of a drive device, similar to the
operation of the drive device described above with respect to FIGS.
4-7. In one embodiment, the end 151 of the piston section 148
opposite to the end 149 is arranged to be acted upon by a drive
shaft, such as drive shaft 84 described above with respect to FIGS.
4-7, to impart a force on the piston section 148 sufficient to
provide axial motion of the piston 138 within the channel 140. For
example, the shuttle housing 136 and piston 138 of the pump device
134 of FIG. 10 may be supported within the reservoir retaining
portion 24 of the disposable housing portion 20 (of FIGS. 4 and 5),
in place of the pump device 34 described above, and with the end
151 of the piston 138 arranged to be exposed or otherwise arranged
to be acted upon through the opening 68 in the wall 66 of the
disposable housing portion 20 (similar to the manner in which the
end of the push plate 52 is exposed or otherwise acted upon by the
drive shaft 84, through the opening 68, as described above). When
the durable housing portion 22 is engaged and connected to the
disposable housing portion 20, the drive shaft 84 is arranged to
abut or otherwise impart a force onto the end 151 of the piston
section 148.
[0147] The drive shaft 84 and the end 151 of the piston section 148
may be provided with a suitable connection structure for allowing
the drive shaft 84 to be selectively engaged and connected to the
end 151 of the piston section 148, when the durable housing portion
22 is engaged and connected to the disposable housing portion 20.
Such connection structure may include, but is not limited to,
engageable snap fitted members, friction fitted members, flexible
or moveable interlocking members or the like. In one embodiment,
the connection structure for connecting the drive shaft 84 to the
end 151 of the piston section 148 may include a pawl and associated
receptacle arrangement (similar to the pawl 74 and receptacle 76
described above), wherein one of the pawl and receptacle is
provided on the push plate and the other of the pawl and receptacle
is provided on the end of the drive shaft 84.
[0148] By connecting the drive shaft 84 to the end 151 of the
piston section 148, the drive shaft 84 may impart forces on the
piston section 148 in the direction of arrow 164 and, then in the
direction of arrow 166, to provide a back-and-forth motion of the
piston section 148 in the axial dimension A.sub.1. The length of
motion of the drive shaft 84 and the dimensions of the piston
sections 146, 148 and the extensions portion 156 are selected to
allow the piston sections to move (with the motion of the drive
shaft 84), as described with reference to FIGS. 13-15.
[0149] The piston 138 (including piston sections 146, 148 shown in
FIGS. 13-15) are moveable along the axial dimension A.sub.1,
between at least three general positional locations along the axial
dimension A.sub.1. The three general positional locations are
referred to herein as the fill position (FIGS. 13a-c), the shuttle
position (FIG. 14) and the dispense position (FIGS. 15a-b).
[0150] The piston 138 may be placed in a start portion of the fill
position (FIG. 13a) prior to the beginning of operation (for
example, during manufacture, assembly or installation).
Alternatively, the piston 138 may be in another initial position
(for example the position shown in FIG. 14) prior to operation, and
the drive device 82 may be initially operated to move the drive
shaft 84 and, thus the piston 138 from that initial position, in
the direction of arrow 164, to a start portion of the fill position
(as shown in FIG. 13a).
[0151] The drive force on the piston 138 is applied by the drive
shaft 84 onto the end 151 of the piston section 148. Accordingly,
if the piston sections 146, 148 are initially separated, the drive
force imparted by the drive shaft 84 on the piston end 151 in the
direction of arrow 164, will first cause the piston section 148 to
move toward the piston section 146 and close the gap or chamber
162, until the end surfaces 147 and 149 of the piston sections 146
and 148, respectively, come into contact.
[0152] In a starting (or ending) portion of the fill position, as
shown in FIG. 13a, the piston 138 is arranged with the end faces
147 and 149 of the piston sections 146 and 148 adjacent the inlet
port 144 and with no (or a minimal) gap between the end faces 147
and 149 of the piston sections 146 and 148. From the starting
portion of the fill position of FIG. 13a, the piston section 148
may be moved in the direction of arrow 166 to open the gap or
chamber 162 between the end faces 147 and 149 of the piston
section.
[0153] The opening of the gap or chamber 162, while the gap or
chamber 162 is sealed from the external environment, creates a low
pressure volume (relative to the pressure within the reservoir 126)
within the gap or chamber 162. In one embodiment, the low pressure
volume within the gap or chamber 162 provides a sufficient pressure
differential relative to the pressure within the reservoir 126, to
cause fluid to flow into the gap or chamber 162, from the reservoir
126, through the inlet port 142. By opening the gap or chamber 162,
fluid is drawn from the reservoir, through the inlet port 142 and
into the gap or chamber 162. As the piston section 148 continues to
move in the direction of arrow 166, the gap or chamber 162
continues to widen to the complete fill portion of the fill
position, shown in FIG. 13c, at which the piston sections 146 and
148 are in a fully separated state (wherein the stop surfaces 154
and 160 of FIG. 11 are abutted together).
[0154] In the fill position of FIGS. 13a-c, the piston sections 146
and 148 are positioned relative to the shuttle housing 136, such
that the gap or chamber 162 is located in fluid flow communication
with the inlet port 144 of the shuttle housing 136. In that
position, fluid flow communication is provided between the interior
of the reservoir 126 and the gap or chamber 162, through the inlet
port 144, to allow infusion fluid to flow from the reservoir, into
the gap or chamber 162. Fluid may flow from the reservoir 126 and
into the gap or chamber 162, for example, by the force of a
pressure differential created when piston sections 146, 148
separate to form the gap or chamber 162 and/or by gravitational
force (wherein the gap or chamber 162 is located below the
reservoir 126, during operation, as shown in FIGS. 13-15).
Alternatively, or in addition, fluid flow from the reservoir 126,
to the gap or chamber 162 may be provided or enhanced by providing
the interior of the reservoir 126 with a pressure higher than the
pressure in the gap or chamber 162 (for example, by imparting a
force on a flexible wall of the reservoir and/or filling the
reservoir with pressurized fluid).
[0155] From the complete fill portion of the fill position of FIG.
13c, further motion of the drive shaft 84 in the direction of arrow
166 causes the piston 138 (including the piston sections 146, 148)
to move in the direction of arrow 166, while the gap or chamber 162
is maintained. As the piston 138 moves in the direction of arrow
166, the gap or chamber 162 moves in the direction of arrow 166,
through locations between the inlet port 144 and the outlet port
145 to a transport or shuttle position shown in FIG. 14, at which
the gap or chamber 162 is aligned with the outlet port 144. The
full stroke of motion of the drive shaft 84 in the direction of
arrow 166 may be selected such that the end of the stroke of motion
of the drive shaft 84 in the direction of arrow 166 corresponds to
the position of the piston sections 146 and 148 in FIG. 14.
Similarly, the full stroke of motion of the drive shaft 84 in the
direction of arrow 164 may be selected such that the end of the
stroke of motion of the drive shaft 84 in the direction of arrow
164 corresponds to the position of the piston sections 146 and 148
in FIG. 13a.
[0156] At the end of the full stroke of motion of the drive shaft
84 in the direction of arrow 166, the drive shaft 84 begins to move
back, in the direction of arrow 164 (opposite to the direction of
arrow 166). By allowing the drive shaft 84 to move a relatively
small distance in the direction of arrow 164, the piston section
148 is moved in the direction of arrow 164 relative to the piston
section 146 and the shuttle housing 136, as shown in FIG. 15a, to
begin dispensing fluid from the gap or chamber 162, into the outlet
port 144. Further motion of the drive shaft in the direction of
arrow 164 causes the piston section 148 to move in the direction of
arrow 166 until the end faces 147 and 149 of the piston sections
146 and 148 abut each other, as shown in FIG. 15b.
[0157] In the complete dispense portion of the dispense position
(FIG. 15b), the pressure in the gap or chamber 162 is increased by
driving the piston sections 146 and 148 further together, to force
the infusion medium out of the gap or chamber 162 and into the
conduit 36. For example, once the piston 138 has reached position
at which the gap or chamber 162 is aligned with and in fluid-flow
communication with the outlet port 144, (FIG. 14) the drive shaft
84 may impart a force on the end surface 151 of the piston portion
148, in the direction of arrow 164 (FIGS. 15a-b). That force causes
the piston section 148 to move axially in the direction of arrow
164, relative to the piston section 146 and shuttle housing 136,
until the end walls 147 and 149 (FIG. 1I) of the piston sections
146, 148 abut each other. As the piston section 148 moves toward
the piston section 146, the volume of the gap or chamber 162
decreases, causing the infusion medium within the gap or chamber to
be forced out of the gap or chamber and be dispensed into the
conduit 36, through the outlet port 144.
[0158] The piston section 146 may be configured to provide a
bi-directional friction with the interior surface of the piston
channel 140 of the cylinder 136 that is greater than that of the
piston member 148 in the cylinder 136. In the fill stroke direction
166, the piston section 146 is held back relative to the motion of
the piston member 148, to open the chamber 162. In the dispense
stroke direction 164, the piston section 146 resists motion
relative to the motion of the piston section 148 to fully force the
fluid from the chamber into the outlet port 144. This
bi-directional friction for the piston section 146 may be provided
by selecting the shape and/or size of the outer diameter of the
piston section 146 to provide suitable friction engagement with the
inside surface of the piston channel 140 and/or by providing one or
more O-ring seals around the piston section 146.
[0159] A reservoir 126, piston 138 and shuttle housing 136
configuration, as shown in FIGS. 10-15 may be employed in a
disposable housing portion 20, as described above, in place of the
pump device 34 and reservoir 26 described above with respect to
FIGS. 4-7). The piston 138 may be operatively coupled to a drive
shaft 84, as described above, when a durable housing portion 22 is
coupled to the disposable housing portion 2, to control movement of
the piston 138 in a back-and-forth motion along the axial dimension
A1 (in the directions of arrows 164 and 166).
[0160] With the configuration of FIGS. 10-15, such movement of the
piston 138 causes the piston sections 146, 148 to move between the
fill position (FIG. 11), the shuttle position (FIG. 12) and the
dispense position (FIG. 13) and back, within the shuttle housing
136. Such motion of the piston sections 146, 148 causes a volume of
infusion medium to be dispensed from the outlet port 144 and into
the conduit 136, with each back-and-forth motion of the piston 138.
The volume of infusion medium dispensed with each back-and-forth
motion of the piston 138 is dependent on the volume of the gap or
chamber 162 and may be pre-determined for providing a suitable
delivery profile to control the operation of the drive device 84.
Accordingly, the pump device embodiment of FIGS. 10-15 may be
operatively coupled to a linearly driven drive shaft, to allow for
a controlled dispensing of infusion medium, with relatively few
moving parts and relatively uncomplicated structural
components.
[0161] A linear-motion pump device 234 according to a further
embodiment of the invention is shown in FIGS. 16 and 17. The pump
device 234 may be located in the reservoir containing portion 24 of
a disposable housing portion 20 as described above with respect to
FIGS. 2 and 3. For example, the pump device 234 may be employed in
a delivery device 12 as described above with respect to FIGS. 4-7,
in place of the linear motion pump device 34 described above.
[0162] In FIGS. 16 and 17, the pump device 234 is operably
connected to communicate fluid between a reservoir 226 in the
reservoir containing portion 24 and an injection site 238. For
example, the pump device 234 may be operated to communicate a
fluidic infusion medium from the reservoir 226, to a patient,
through a hollow needle or cannula inserted into the patient's skin
at the injection site 238. A needle insertion mechanism (not shown
in FIGS. 16 and 17) may be located within the injection site 238
and/or may be operated through an opening 25 (or other suitable
operator) in the reservoir containing portion 24, as described
above with respect to FIGS. 2 and 3. The reservoir 226 and
injection site 238 in FIGS. 16 and 17 may be similar to the
reservoir 26 and injection site 38 described above with respect to
the embodiment of FIGS. 4-7.
[0163] The pump device 234 includes a piston 240 that is moveable
in a longitudinal axial dimension A.sub.2 of a piston channel 241.
The piston 240 has a head portion 242 that may be arranged to be
engaged by a drive shaft (such as drive shaft 84 of FIGS. 6 and 7)
and/or connected to the drive shaft (for example, with a connection
structure as described above with respect to the structure for
connecting the drive shaft 84 to the piston section 148 of FIGS.
10-15), when the disposable housing portion 20 is engaged with and
connected to the durable housing portion 22, as described above. By
engagement and/or connection of the drive shaft 84 to the piston
head 242, a drive device 82 in the durable housing portion 22 may
be operated to control selective motion of the drive shaft 84 and,
thus, the piston 240 in the axial dimension A.sub.2, in the
direction of arrows 243 and 244.
[0164] The piston 240 may be made of any suitably rigid material,
including, but not limited to metal, plastic, ceramic, composite
material or the like. In the embodiment of FIGS. 16 and 17, the
disposable housing portion 20 includes a housing section 236 that
defines a longitudinal channel in which the piston channel 241 and
piston 240 are located. An inlet port 246, for example, an opening
through the housing section 236, is provided in fluid flow
communication with the reservoir 226 through a septum member 247.
The septum member 247 may be made of a pierceable material, such
as, but not limited to, a silicone, or other soft plastic material
that may be pierced by a needle, and reseal itself after removal of
the needle. The septum member 247 may be exposed through an opening
in the disposable housing portion 20, for example, to allow
refilling of the reservoir by piercing the septum with a syringe
needle and expelling fluid from the syringe needle.
[0165] In FIGS. 16 and 17, a piston channel member 249 is located
within the housing section 236 and has a central channel that
defines the piston channel 241 and a piston chamber 250. A gap
provided between a portion of the piston channel member 249 and a
portion of the housing section 236 forms an outlet chamber 248. A
one-way valve 252 is provided between the piston chamber 250 and
the outlet chamber 248, to allow fluid flow from the piston chamber
250 to the outlet chamber 248 when fluid pressure within the piston
chamber 250 is sufficient to open the one-way valve 252.
[0166] The piston channel member 249 has an annular channel 254
around its outer peripheral surface, in alignment and fluid flow
communication with the inlet port 246. A further flow passage 256
in the piston channel member 249 connects the annular channel 254
in fluid flow communication with an piston chamber 250. The piston
channel member 246 may be made of any suitably rigid material,
including, but not limited to metal, plastic, ceramic, composite
material or the like. For ease of manufacture, the piston channel
member 246 may be formed as a separate member relative to the
disposable housing portion 20 and may be secured to the disposable
housing portion 20, within the central channel of the housing
section 236, by any suitable connection mechanism including, but
not limited to, a friction fit, adhesive, thermal bonding, or the
like. In further embodiments, the piston channel member 246 may be
formed unitarily with the housing section 236 of the disposable
housing portion 20.
[0167] The piston 240 is moveable within the piston channel 241
along the axial dimension A.sub.2, between an extended position
(FIG. 16) and a retracted position (FIG. 17). A bias member, such
as, but not limited to, a coil spring 256 may be provided to urge
the piston in the direction of arrow 243, toward a retracted
position. In the extended position (shown in FIG. 16), the piston
abuts a piston valve seat 258 to inhibit fluid back-flow from the
piston chamber 250, toward the passage 256 and annular channel 241.
When the piston is in the retracted position (shown in FIG. 17),
the piston is separated from the piston valve seat 258 and allows
fluid to flow from the passage 256, into the piston chamber 250.
The piston valve seat 258 may be formed as a unitary portion of the
piston channel member 249 as shown in FIGS. 16 and 17, or may be
formed separate from and connected to the piston channel member 249
during manufacture.
[0168] In operation, the piston 240 is moved axially, in the
direction of arrow 243 to create a low pressure volume in the
piston chamber 250 sufficient to draw fluid into the piston chamber
250, from the reservoir 226, through the inlet port 246, channel
241 and passage 256. Infusion medium from the reservoir may,
thereby, enter and be contained in the piston chamber 250, until
the piston 240 is moved in the direction of arrow 244. Once the
piston chamber 250 is sufficiently filled with infusion medium, the
piston 240 is moved in the direction of arrow 244, to increase the
fluid pressure within the piston chamber 250. Once the fluid in the
piston chamber 250 reaches a sufficient pressure, the one-way valve
252 opens and fluid in the chamber 250 passes from the chamber 250,
to a conduit 236 that is connected in fluid flow communication with
the injection site 238. The conduit 236 and injection site 238 may
be similar to the conduit 36 and injection site 38 described above
with respect to FIG. 4. The one-way valve 252 allows fluid to flow
from the piston chamber 250 and out through the outlet chamber 248,
but inhibits fluid flow from the outlet chamber 248 into the piston
chamber 250.
[0169] In the embodiment of FIGS. 16 and 17, the one-way valve 252
includes a duckbill valve structure formed on the piston channel
member. However, other embodiments may employ other suitable
one-way valve configurations. Accordingly, as a result of the
piston stroke in the direction of arrow 243 and then in the
direction of arrow 244, a volume of infusion medium is drawn into
the pump device 234 from a reservoir 226 and is then dispensed
through the one-way valve 252, to an injection site 238, under the
controlled motion of a drive device (such as, but not limited to,
the drive shaft 84 and drive device 82 described above). Upon
completion of the piston stroke in the direction of arrow 243 and
then in the direction of arrow 244, the piston motion may be
repeated, to cause further delivery of infusion medium to the
injection site.
[0170] Accordingly, the pump device 234 of FIGS. 16 and 17 may be
operated with the generally linearly moveable drive shaft 84,
similar to the operation of the drive shaft 84 on the pump device
34 and 134, described above. Also, the pump device 234 of FIGS. 16
and 17 may be supported by a first housing portion (such as the
disposable housing portion 20), while the drive shaft 84 and drive
device 82 are supported by a second housing portion (such as the
durable housing portion 22), where the first and second housing
portions are configured to be selectively engaged for operation and
disengaged from each other, as described above.
[0171] A linear-motion pump device 334 according to a further
embodiment of the invention is shown in FIGS. 18-20. The pump
device 334 of FIGS. 18-20 may be located in the reservoir
containing portion 24 of a disposable housing portion 20 as
described above with respect to FIGS. 2 and 3. For example, the
pump device 334 may be employed in a delivery device 12 as
described above with respect to FIGS. 4-7, in place of the linear
motion pump device 34 and reservoir 26 described above.
[0172] The pump device 334 employs a miniature piezoelectric
actuator or motor, for example, but not limited to the type
referred to as a Squiggle moter (SQUIGGLE is a Trademark of New
Scale Technologies), produced by New Scale Technologies, Inc. of
Victor, N.Y. A representation of a miniature piezoelectric motor
344, such as a Squiggle motor, is shown in FIG. 18. With reference
to FIG. 18, the motor 344 includes a support structure 345, such as
a plate made of a suitably rigid material, such as, but not limited
to, metal, plastic, ceramic, glass, composite material or the like.
A piezoelectric patch or stack 346 is supported on one side of the
support plate 345. A screw housing 347 is located on the opposite
side of the piezoelectric patch or stack 346, relative to the
support plate 345. The screw housing 347 may include, but is not
limited to, a nut or plate having an opening through which a drive
screw 348 extends. The screw housing 347 may be made of a suitably
rigid material, such as, but not limited to, metal, plastic,
ceramic, glass, composite material or the like. The threaded drive
screw 348 extends through the screw housing 347, piezoelectric
patch or stack 346 and motor support 345, and is arranged to move
in a linear direction (of the arrow 349) and rotate relative to the
screw housing 347 and motor support 345, upon actuation of the
piezoelectric patch or stack 346. The piezoelectric patch or stack
346 is connected to a suitable power source and control electronics
(not shown in FIG. 18), for selective energization of the
piezoelectric patch or stack 346. The motor 344 may be supported in
a durable housing portion 22, as described above. As the main body
of the motor 344 vibrates, a screw is turned, resulting in linear
motion that can be precisely controlled to a nanometer resolution.
In one embodiment, the motor 344 is arranged as a linear actuator,
where the screw is held stationary and the vibration generating
portion is used to provide a force to push against a piston plunger
in a reservoir to drive a fluid from the reservoir.
[0173] When the durable housing portion 22 is engaged with a
disposable housing portion 20, the pump device 334 is operably
connected to communicate fluid between a reservoir 0.326 in the
reservoir containing portion 24 of the disposable housing portion
and an injection site 338 (similar to the injection site 38
described above). The reservoir 326 may comprise a canister-style
container or other suitable container that has an interior volume
with a longitudinal dimension A.sub.2 along which a piston plunger
may move. The pump device 334 includes a piston plunger 336 that is
located within the reservoir 326 and moveable in the longitudinal
dimension A.sub.2 of the reservoir 326. The piston plunger 336
includes a piston head 338 and a piston shaft 339. The piston head
338 has a shape and size suitable for sealing against the interior
surface of the reservoir 336, to inhibit fluid flow between the
piston head 338 and the interior surface of the reservoir 336.
Alternatively, or in addition, one or more seals may be provided
around the peripheral surface of the piston head 338, to inhibit
fluid flow between the piston head 338 and the interior surface of
the reservoir 336. Movement of the piston 336 in the direction of
arrow 350 causes a fluid-containing portion 352 of the reservoir
336 to decrease in volume and drive fluid from the reservoir 336,
to the injection site 338.
[0174] In the embodiment of FIGS. 19 and 20, the piston shaft 339
has a semi-cylindrical shape and an open, semi-cylindrical hollow
interior section that is arranged to fit over and receive at least
a portion of the motor 344 and to engage the motor support 345 of
the motor 344, when the durable housing portion and the disposable
housing portion are engaged. The semi-cylindrical piston shaft 339
may include suitably shaped indentations, cut-outs, openings or the
like, to accommodate a portion of the motor 344, up to the screw
housing 347. Further indentations, cut-outs or openings may be
provided on the end surface of the semi-cylindrical piston shaft
339 to snugly mate with the screw housing 347 of the motor 344,
Once the motor 344 is engaged with the piston shaft 339, the motor
may be activated to prime the fluid path and to seat the motor on
the piston shaft 339.
[0175] In the embodiment of FIG. 19, actuation of the motor 344 (by
selective application of a controlled electrical power signal to
the piezoelectric patch or stack 346) causes a relative motion
between the drive screw 348 and the screw housing 347. By
supporting one end of the drive screw 348 in engagement with a
stationary surface 358 (stationary with respect to the durable
housing portion), the relative motion of between the drive screw
348 and the screw housing 347 translates to a motion of the screw
housing 347 in the direction of arrow 350. Because the screw
housing 347 is engaged with the semi-cylindrical piston shaft 339,
the motion of the screw housing 347 in the direction of arrow 350
causes the piston 336 to move in the direction of arrow 350. In
this manner, a controlled activation of the piezoelectric patch or
stack 346 provides a controlled motion of the piston 336 to
selectively drive fluid from the reservoir interior 352, to the
injection site 338. A frictionless bearing may be provided at the
engagement location of the screw 348 and the surface 358. The
hollow interior of the semi-cylindrical piston shaft 339 may be
made sufficiently large to provide clearance to avoid obstructing
any rotational motion of the drive screw 348.
[0176] Another embodiment as shown in FIG. 21 includes a reservoir
326 and a piston head 338 as described above with respect to FIG.
19. However, instead of employing a semi-cylindrical piston shaft
(as described above with respect to FIG. 19), the embodiment in
FIG. 21 employs the drive screw 348 of the motor 344 as the piston
shaft, wherein one end of the drive screw 348 is connectable
directly to the piston head 338, when the durable housing portion
22 is engaged with the disposable housing portion 20.
Alternatively, an extension member may extend from the drive screw
348 and connect to the piston head 338, when the durable housing
portion 22 is engaged with the disposable housing portion 20. In
the embodiment in FIG. 21, the motor support 345 and/or the screw
housing 347 of the motor 344 is (are) secured in a fixed relation
to the durable housing portion 22, for example, by coupling one or
both of those structures to a wall 360 of or in the durable housing
portion 22. In operation, upon selective application of a suitable
power signal to the motor 344, the drive screw 348 is caused to
selectively move in the linear direction of arrow 350, to
selectively move the piston head 338 relative to the reservoir 326.
In this manner, the piston head 338 in FIG. 21 may be selectively
moved to reduce the volume 352 of the interior of the reservoir 326
and drive fluid from the reservoir 326 to the injection site
338.
[0177] In embodiments described above, the disposable housing
portion (e.g., 20 in FIG. 3) is provided with a base portion 21
that may be secured to the patient-user's skin by, for example, but
not limited to, an adhesive material provided on the bottom surface
of the base portion 21. That arrangement is generally represented,
in side view, in FIG. 18, wherein an adhesive material 101 is
provided on the bottom surface (skin-facing surface) of the base 21
of the disposable housing portion 20. As shown in FIGS. 2, 3 and
18, the durable housing portion 22 may be configure to be arranged
on the base 21 of the disposable housing portion 20 to engage and
connect to the disposable housing portion 20. In such an
arrangement, the base 21 may be disposed between the durable
housing portion 22 and the patient-user's skin, during operation,
such that only the base 21 of the disposable housing portion
remains in contact with the patient-user's skin, during
operation.
[0178] However, in other embodiments, the durable housing portion
22 and the disposable housing portion 20 may be configured to
engage each other in a side-by-side arrangement, for example, as
represented in FIG. 19. In the side-by-side arrangement in FIG. 19,
either one or both of the durable housing portion 22 and the
disposable housing portion 20 may be provided with a base having an
adhesive material 101 (and a peelable cover layer 23 as shown in
FIG. 3).
[0179] In yet further embodiments, as represented by FIG. 20, one
or both of the durable housing portion 22 and the disposable
housing portion 20 may be attachable and detachable from a separate
base member 21'. Suitable connecting structure, such as described
above for connecting the durable housing portion and the disposable
housing portion together, may be employed for connecting the
durable housing portion and the disposable housing portion to the
base member 21'. The separate base member 21' may include a
generally flat, plate-like structure made of any suitably rigid
material including, but not limited to, plastic, metal, ceramic,
composite material or the like. The base member 21' has a surface
(the upper-facing surface in FIG. 20) to which the disposable
housing portion 20 and the durable housing portion 22 may be
attached. The base member 21' has a second surface (the
lower-facing surface in FIG. 20) to which an adhesive material and
a peelable cover film may be applied, as described above, to allow
the base member 21' to be secured to a patient-user's skin.
[0180] The base member 21' may include a needle inserter device 25,
as described above. Examples of suitable needle inserter devices
are described in U.S. patent application Ser. No. 11/211,095, filed
Aug. 23, 2005, and U.S. Patent Application No. 60/839,840, titled
INFUSION MEDIUM DELIVERY SYSTEM, DEVICE AND METHOD WITH NEEDLE
INSERTER AND NEEDLE INSERT DEVICE AND METHOD, filed Aug. 23, 2006,
(attorney docket no. 047711-0384), each of which is incorporated
herein by reference in its entirety. In such embodiments, the base
member 21' may be secured to a patient-user's skin. Then, the
needle inserter 25 may be activated to insert a hollow needle or
cannula into the patient-user's skin. Then, after the hollow needle
or cannula is inserted, the durable housing portion 22 and the
disposable housing portion 20 may be attached to the base member
21', to connect the reservoir within the disposable housing portion
20 in fluid flow communication with the hollow needle or cannula.
In one embodiment, the durable housing portion 22 and the
disposable housing portion 20 may be connected together (for
example, in the manner described above) before attaching those
housing portions to the base member 21'. In a further embodiment,
one of the durable and disposable housing portion is attached to
the base member 21' before the durable and disposable housing
portions are connected together. In such further embodiment, the
needle inserter device may be activated to insert a hollow needle
or cannula into the patient-user's skin after the disposable
housing portion is attached to the base member 21' (either before
or after the durable and disposable housing portions are connected
together). Other needle/cannula insertion tools may be used (or
modified for use) to insert a needle and/or cannula, such as for
example U.S. patent application Ser. No. 10/389,132 filed Mar. 14,
2003, and entitled "Auto Insertion Device For Silhouette Or Similar
Products," and/or U.S. patent application Ser. No. 10/314,653 filed
Dec. 9, 2002, and entitled "Insertion Device For Insertion Set and
Method of Using the Same," both of which are incorporated herein by
reference in their entirety.
[0181] Alternatively, reference number 25 may represent an opening
in the base member 21' that aligns with a needle inserter device
(or aligns with a further opening) located in the disposable
housing portion 20, when the disposable housing portion 20 is
attached to the base member 21'. In such embodiments, the base
member 21' may be secured to the patient-user's skin. Then the
disposable housing portion 20 is attached to the base member 21'
(either before or after the durable and disposable housing portions
are connected together). Once the disposable housing portion 20 is
attached to the base member 21', the needle inserter device 25 may
be activated to insert a hollow needle or cannula into a
patient-user's skin (either before or after the durable and
disposable housing portions are connected together).
[0182] Also, while embodiments described above may include an
on-board needle or cannula injector device that may be activated
through the operator or opening 25, other embodiments may employ an
injection site module 103 that is external to the disposable
housing portion 20, but connected to the disposable housing portion
20, through a suitable conduit 102, as shown in FIG. 21. The
external injection site module 103 may include a needle or cannula
injector device structure and an operator or opening (similar to
the operator or opening 25 described above) through which the
injector device may be activated. Alternatively or in addition, the
external injection site module 103 may include an infusion set such
as, but not limited to an infusion set as described or referenced
in U.S. patent application Ser. No. 10/705,686, filed Nov. 10,
2003, titled "Subcutaneous Infusion Set" (Publication No.
2005/0101910) and/or U.S. patent application Ser. No. 11/004,594,
filed Dec. 3, 2004, titled "Multi-Position Infusion Set Device And
Process" (Publication No. 2006/0129090), each of which is assigned
to the assignee of the present invention and each of which is
incorporated herein by reference, in its entirety.
[0183] The conduit 102 that connects the module 103 with the
disposable housing portion 20 may be any suitable tubing structure
having a fluid flow passage, such as, but not limited to, a
flexible tube made of plastic, silicone or the like. An adhesive
material may be provided on the tubing structure (or between the
tubing structure and the patient-user's skin) to secure the tubing
to the patient-user's skin. By locating the injection site module
103 external to the disposable housing portion 20, the disposable
housing portion 20 and the durable housing portion 22 may be
clipped to a patient-user's clothing, belt, suspender or other
article of apparel or may be held in a pocket of an article of
apparel or carried in a purse or the like.
[0184] In one embodiment, the conduit 102 may be fixed at one end
to the disposable housing portion 20, in fluid-flow communication
with the reservoir within the disposable housing portion 20, and
fixed at a second end to an external injection site module 103, for
connection in fluid-flow communication with a hollow needle or
cannula, as described above. In further embodiments, one or both of
the ends of the conduit 102 may include suitable connection
structures that allow the conduit ends to be selectively connected
in fluid-flow communication with, and selectively disconnected from
the disposable housing portion 20 and/or the injection site module
103. Such connectors may comprise a hollow needle and septum, a
Luer connector, or other suitable fluid-communication connectors.
In such embodiments, the disposable housing portion 20 and the
durable housing portion 22 may be disconnected from the module 103,
for example, by disconnecting one of the ends of the conduit 102
from the module 103 or the disposable housing portion 20, while
leaving the module 103 in place (without requiring the patient-user
to withdraw the needle or cannula and, later, insert a needle or
cannula to resume operation). In this manner, a patient-user may
readily disconnect and remove the disposable housing portion 20 and
durable housing portion 22, for example, to allow the patient-user
to shower, bath, swim or conduct other activities, yet also allow
the patient-user to readily re-connect the disposable housing
portion 20 to the module 103, for example, upon completion of such
activities. Examples of connectors can be found in U.S. patent
application Ser. No. 10/328,393 filed Dec. 22, 2003, and entitled
"Reservoir Connector," and U.S. Pat. No. 5,545,152 issued Aug. 13,
1996, and entitled "Quick-Connect Coupling For A Medication
Infusion System," both of which are incorporated herein by
reference in their entirety. In other alternatives, different
connectors such as Luer locks, or the like may be used.
[0185] In yet further embodiments, the conduit 102 may be
eliminated and an injection site module 103 may be directly
connected with the disposable housing portion 20, as shown in FIG.
22. In such an embodiment, one or more suitable fluid flow passages
are provided through the disposable housing portion 20 and into the
injection site module 103, for fluid-flow communication between the
reservoir in the disposable housing portion 20 and a hollow needle
or cannula, as described above. Also, in such embodiments, the
injection site module 103 and the disposable housing portion 20 may
include mating connection structures to allow the injection site
module 103 and the disposable housing portion 20 to be selectively
connected and disconnected from each other.
[0186] Various examples of mating arrangements, for directly
connecting an injection site module 103 to a disposable housing
portion are described with reference to FIGS. 23-30. FIGS. 23-30
show an example arrangement, in which an injection site module 103
includes at least one (two in FIG. 23) protruding engagement pawl
174 that are configured to be received in a corresponding number of
receptacles on the disposable housing portion 20 (similar to the
pawls 74 and receptacles 76 described above). In other embodiments,
the pawl(s) 174 may be located on the disposable housing portion
20, while the corresponding receptacles may be located on the
module 103. In yet other embodiments, each of the disposable
housing portion 20 and the module 103 may include one or more pawls
and one or more receptacles.
[0187] The pawls 174 and receptacles may be configured to allow a
patient-user to manually slide the pawls into the receptacles as
the disposable housing portion 20 and the module 103 are brought
together. When the pawls 174 are received in the corresponding
receptacles, the module 103 is secured to the disposable housing
portion 20. The pawls 174 may include a shaped portion or head to
provide a snap-fit with the receptacles, when the pawls 174 are
fully received within the receptacles. The pawls 174 may be
configured with sufficient flexibility to allow the patient-user to
separate the disposable housing portion 20 from the module 103, by
applying a sufficient force to full those two parts away from each
other and unsnap the pawls 174 from the receptacles. In the
embodiment of FIGS. 23-25, the module 103 may be attached to or may
include a base portion 450 that may be secured to a patient-user's
skin during operation, in lieu of the extended base 21 of the
disposable housing portion 20 described above. The base portion 450
may include an adhesive material as described herein with respect
to the base 21 of the disposable housing portion 20.
[0188] As shown in FIG. 25, the embodiment of FIGS. 23-25 may be
formed in three general parts, including the disposable housing
portion 20, the durable housing portion 22 and the module 103 on
the base portion 450. The durable housing portion 22 and the
disposable housing portion 20 may be secured together (as shown in
FIG. 23), and the combined, connected disposable and durable
housing portions may be secured to the module 103 and base portion
450. In one embodiment, the base portion 450 may be secured to a
patient-user's skin, before the combined, connected disposable and
durable housing portions are secured to the module 103 and base
portion 450. In a further embodiment, the combined, connected
disposable and durable housing portions are secured to the module
103 and base portion 450, before the base portion 450 is secured to
the patient-user's skin.
[0189] Another example of a connection structure is described with
reference to FIGS. 26 and 27, wherein the module 103 includes a
shaped head 452 configured to be received within a correspondingly
shaped opening or receptacle in the disposable housing portion 20.
The shaped head 452 may be configured with a shape that allows the
head to be received in the receptacle when the disposable housing
portion 20 is aligned relative to the module 103 in a first
alignment position, as shown in FIG. 26, and further allows the
disposable housing portion 20 to be rotated relative to the module
103 while the head 452 is received within the receptacle to a
second alignment position as shown in FIG. 27. The receptacle in
the disposable housing portion 20 may be shaped to allow the head
452 to be freely received or removed from the receptacle, when the
disposable housing portion 20 is in the first alignment position
(FIG. 26), yet abut the head 452 and inhibit separation of the head
452 from the receptacle (and, thus, inhibit separation of the
disposable housing portion 20 from the module 103), when the
disposable housing portion is in the second alignment position
(FIG. 27).
[0190] A further example of a connection structure is described
with reference to FIGS. 28-30, wherein the module 103 includes a
shaped receptacle 454 configured to receive a correspondingly
shaped connector member in the disposable housing portion 20. In
FIGS. 28-30, the module 103 is formed, integral with the disposable
housing portion 20. The shaped receptacle 454 may be configured
with a shape that allows the connector member of the disposable
housing portion to be engaged with the receptacle 454 when the
disposable housing portion 20 is aligned relative to the module 103
in a first alignment position, as shown in FIG. 28, and further
allows the disposable housing portion 20 to be rotated relative to
the module 103, while the receptacle 454 is engaged within the
connector member, to a second alignment position as shown in FIG.
29. The receptacle 454 and the connector member in the disposable
housing portion 20 may be shaped to allow the connector member to
be freely engage the receptacle 454, when the disposable housing
portion 20 is in the first alignment position (FIG. 28), yet lock
with the receptacle 454 and inhibit separation of the connector
member from the receptacle (and, thus, inhibit separation of the
disposable housing portion 20 from the module 103), when the
disposable housing portion is in the second alignment position
(FIG. 29). The receptacle 454 and connection member may include any
suitable known rotary connection structures for connecting two
structures together upon engagement and relative rotation of the
two structures in one direction, yet allow the two structures to be
disengaged and separated from an engaged arrangement, by relative
rotation of the two structures in the second, opposite
direction.
[0191] As shown in FIG. 30, the embodiment of FIGS. 28-30 may be
formed in three general parts, including the disposable housing
portion 20, the durable housing portion 22 and the module 103 on
the base portion 456. The durable housing portion 22 and the
disposable housing portion 20 may be secured together (as shown in
FIG. 28), and the combined, connected disposable and durable
housing portions may be secured to the base portion 456. In one
embodiment, the base portion 456 may be secured to a patient-user's
skin, before the combined, connected disposable and durable housing
portions are secured to the base portion 456. In a further
embodiment, the combined, connected disposable and durable housing
portions are secured to the base portion 456, before the base
portion 456 is secured to the patient-user's skin.
[0192] In yet further embodiments, the injection site module may be
formed as a unitary structure with the disposable housing portion
20. Also, in any of the embodiments described above, one or more
sensors may be located in the disposable housing portion 20, the
injection site module 103 or the durable housing portion 22, for
sensing a biological condition, including, but not limited to,
blood glucose level, level of infusion medium in the patient-user's
blood and/or other conditions. Such sensor(s) may include a hollow
needle or cannula and/or a set of micro-needles, as described
above, for piercing the patient-user's skin to convey fluid from
the patient to the sensor.
[0193] Also, while embodiments described above may include an
adhesive material and a cover film 23 (FIGS. 2 and 3), further
embodiments may include a plurality of adhesive material layers
alternating with a corresponding plurality of cover film layers 23,
to allow the delivery device to be secured, removed and re-secured
to the patient-user's skin one or more times. In such embodiments,
a first cover film layer located at the end of the stack of
alternating layers of adhesive material and cover film, may be
removed to expose a first layer of adhesive material. With the
first layer of adhesive material exposed, the delivery device (or
component thereof) may be adhered to a patient-user's skin, as
described above. After a suitable period of usage, the delivery
device (or component having the adhesive) may be removed from the
patient-user's skin, for example, for servicing, re-filling,
replacement of one or more components, or the like. After removal
of the delivery device (or component) from the patient-user's skin,
a second cover film layer on the delivery device (or component) may
be removed to expose a second layer of adhesive material. With the
second layer of adhesive material exposed, the delivery device (or
component) may be secured to the same patient-user or, in certain
contexts, to a different patient-user, for further operation. The
process may be repeated a number of times up to the number of
adhesive material and cover film layer pairs are included in the
plural alternating layers of adhesive material and cover film.
[0194] In addition, while embodiments described above include an
injection site located on the disposable housing portion 20 or in
an external injection site module 103, other embodiments may employ
an injection site located in the durable housing portion 22 and
connected, through suitable fluid-flow passages, to the reservoir
in the disposable housing portion 20, when the durable housing
portion and disposable housing portion are engaged. Also, while
embodiments are described above in the context of delivery devices
for delivering an infusion medium from a reservoir to a
patient-user, other embodiments may be operated to withdraw a
fluidic medium from a patient-user (or other source) and transfer
the fluidic medium to the reservoir. Such other embodiments may be
operated by operating the drive device to selectively move the
piston plunger away from the septum-end of the reservoir (to
increase the fluid-retaining volume of the reservoir) to create a
negative pressure sufficient to draw fluid from the patient-user
(or other source) to which the hollow needle or cannula is
secured.
[0195] Various aspects of the multiple embodiments described above
may be employed independently or in combinations thereof.
Significant advantages can be obtained from various embodiments and
combinations described herein, wherein an at site delivery system
may be made of two parts, including a disposable portion and a
non-disposable portion. The disposable portion may contain
components that are in direct contact with the infusion medium,
such as reservoir body, reservoir piston, septum systems and
injection needle. The non-disposable portion could contain
components that are not in contact with the medication including
the drive system, pressure or force sensing system, battery,
electronics, display, and non-disposable housing. By simplifying
the manner in which the disposable portion of the delivery device
can be replaced and by simplifying the manner in which the delivery
device can be re-activated after replacing a disposable portion, a
greater number of patients will be able to use and benefit from
such delivery devices.
[0196] While particular embodiments of the present invention have
been shown and described, it will be obvious to those skilled in
the art that the invention is not limited to the particular
embodiments shown and described and that changes and modifications
may be made without departing from the spirit and scope of the
claimed invention. For example, while embodiments are described
above in the context of delivery devices for delivering an infusion
medium from a reservoir to a patient-user, other embodiments may be
operated to withdraw a fluidic medium from a patient-user (or other
source) and transfer the fluidic medium to the reservoir. Such
other embodiments may be operated to move fluid toward the
reservoir, for example, by reversing the direction of the one-way
valves 40 and 42.
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