U.S. patent application number 16/243662 was filed with the patent office on 2019-05-16 for pump, motor and assembly for beneficial agent delivery.
This patent application is currently assigned to ABBVIE INC.. The applicant listed for this patent is ABBVIE INC.. Invention is credited to Phil D. Anderson, Rajkumar Conjeevaram, Benjamin Greuel, Ted Hanagan, Jim Hoch, Sean Mackey, Kevin Novak, Mark Panzer, Ryan Thompson, Ji Zhou.
Application Number | 20190143034 16/243662 |
Document ID | / |
Family ID | 53480602 |
Filed Date | 2019-05-16 |
View All Diagrams
United States Patent
Application |
20190143034 |
Kind Code |
A1 |
Anderson; Phil D. ; et
al. |
May 16, 2019 |
PUMP, MOTOR AND ASSEMBLY FOR BENEFICIAL AGENT DELIVERY
Abstract
Device for delivering a beneficial agent to a user includes a
cassette including a cassette housing with a fluid reservoir, the
cassette housing having a cassette base region, and a delivery
tube. The device also includes a pump having a pump housing
containing a pump assembly and having a receiving region to receive
the cassette base region. The pump assembly includes a fluid drive
component, a display, a plurality of input buttons. The pump
assembly also includes a first processor coupled to the fluid drive
component and the display and configured to reduce power to the
fluid drive component and the display when the pump is in an
inactive state, and a second processor coupled to the first
processor and the plurality of input buttons, the second processor
configured to provide an activation signal to the first processor
when one or more of the plurality of input buttons is deployed.
Inventors: |
Anderson; Phil D.;
(Libertyville, IL) ; Conjeevaram; Rajkumar; (Lake
Bluff, IL) ; Zhou; Ji; (Lake Villa, IL) ;
Mackey; Sean; (Grayslake, IL) ; Novak; Kevin;
(Park Ridge, IL) ; Hanagan; Ted; (Libertyville,
IL) ; Panzer; Mark; (Appleton, WI) ; Greuel;
Benjamin; (Neenah, WI) ; Hoch; Jim; (Appleton,
WI) ; Thompson; Ryan; (Neenah, WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBVIE INC. |
NORTH CHICAGO |
IL |
US |
|
|
Assignee: |
ABBVIE INC.
NORTH CHICAGO
IL
|
Family ID: |
53480602 |
Appl. No.: |
16/243662 |
Filed: |
January 9, 2019 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14586927 |
Dec 30, 2014 |
|
|
|
16243662 |
|
|
|
|
62054134 |
Sep 23, 2014 |
|
|
|
61922709 |
Dec 31, 2013 |
|
|
|
Current U.S.
Class: |
604/67 ;
604/151 |
Current CPC
Class: |
A61M 2205/6054 20130101;
A61M 2005/16863 20130101; A61M 5/14228 20130101; F04B 43/1223
20130101; A61M 2205/50 20130101; F04B 43/12 20130101; A61M 2205/14
20130101; A61M 2205/16 20130101; A61M 5/14244 20130101; A61M
2205/12 20130101; A61M 5/16831 20130101; F04B 43/082 20130101; A61M
5/142 20130101; A61M 2205/502 20130101 |
International
Class: |
A61M 5/168 20060101
A61M005/168; F04B 43/12 20060101 F04B043/12; F04B 43/08 20060101
F04B043/08; A61M 5/142 20060101 A61M005/142 |
Claims
1-10. (canceled)
11. A device for delivering a beneficial agent to a user,
comprising: a cassette including a cassette housing with a fluid
reservoir defined therein, the cassette housing having a cassette
base region; a delivery tube fluidly coupled with the fluid
reservoir; a pump including a pump housing containing a pump
assembly and having a receiving region to receive the cassette base
region, the pump assembly including: a primary power source, a
secondary power source coupled to the primary power source, a fluid
drive component disposed proximate the receiving region and coupled
to the primary power source and isolated from the secondary power
source, a first processor coupled to the primary power source and
the secondary power source, a second processor coupled to the first
processor, the primary power source and the secondary power source,
one or more memories coupled to the first processor, and at least
one of the first processor and second processor configured, when
the primary power source is removed or disabled, to utilize the
secondary power source and the first processor to complete writing
operations to the one or more memories prior to depletion of the
secondary power source.
12. The device of claim 11, wherein the secondary power source
comprises a 1F capacitor.
13. The device of claim 11, wherein the secondary power source is
coupled to the primary power source via a secondary power source
charger configured to charge the secondary power source when the
primary power source is active.
14. The device of claim 11, wherein the one or more memories
comprises a nonvolatile memory storage.
15. The device of claim 11, wherein the pump assembly further
comprises an RFID transceiver coupled to the secondary power
source.
16. The device of claim 11, wherein the pump assembly further
comprises a speaker coupled to the secondary power source, the
first processor and the second processor each coupled to the
speaker and configured to send an audio signal to the speaker when
a fault is detected.
17. The device of claim 11, wherein the pump assembly further
comprises a display to provide visual feedback to the user, the
display coupled to the primary power source and isolated from the
secondary power source.
18. The device of claim 11, wherein the pump assembly further
comprises an occlusion sensor coupled to the primary power source
and isolated from the secondary power source.
19. The device of claim 11, further comprising a beneficial agent
contained in the fluid reservoir.
20. The device of claim 19, wherein the beneficial agent comprises
one or more of levodopa and carbidopa.
21. A device for delivering a beneficial agent to a user,
comprising: a cassette including a cassette housing with a fluid
reservoir defined therein, the cassette housing having a cassette
base region; a delivery tube fluidly coupled with the fluid
reservoir; a pump including a pump housing containing a pump
assembly having a fluid drive component, the pump housing having a
receiving region to receive the cassette base region, the fluid
drive component disposed proximate the receiving region; a contact
force sensor in communication with the delivery tube and arranged
to measure a force or pressure in the delivery tube; and one or
more processors in communication with the contact force sensor to
receive data representing the measured force or pressure from the
contact force sensor, the one or more processors configured to:
determine a maximum force value detected by the contact force
sensor during an initial pumping cycle, the maximum force value
corresponding to a baseline maximum force value, obtain subsequent
force values from the contact force sensor during each subsequent
pumping cycle, and determine an occlusion is present if one or more
of the subsequent force values exceed the baseline maximum force
value by a threshold amount.
22. The device of claim 21, wherein the one or more processors is
further configured to: determine a subsequent maximum force value
during the subsequent pumping cycle, and adjust the baseline
maximum force value to the subsequent maximum force value if the
subsequent maximum force value is less than the baseline maximum
force value.
23. The device of claim 21, wherein the threshold amount is about
10% of the baseline maximum force value.
24. The device of claim 21, wherein the one or more processors is
further configured to: determine a local maximum force value during
an initial pump revolution of each pump cycle, the local maximum
force corresponding to a baseline local maximum force value, obtain
a subsequent local force maximum during each subsequent pump
revolution of each pump cycle, and determine an occlusion is
present if one or more of the subsequent local force maxima exceeds
the baseline local maximum force value by a local threshold
amount.
25. The device of claim 24, wherein the local threshold amount is
about 13% of the baseline local maximum force value.
26. The device of claim 24, wherein the one or more processors is
further configured to determine the local maximum force value of
each pump cycle when a flow rate of the fluid drive component is
above a threshold flow rate.
27. The device of claim 26, wherein the threshold flow rate is 10
mL/hr.
28. The device of claim 24, wherein the one or more processors is
further configured to: determine a local minimum force value
detected by the contact force sensor during each revolution of each
pumping cycle, and determine an error is present if the local
minimum force value does not exceed the local maximum force value
of a corresponding pump cycle by a local minimum threshold
amount.
29. The device of claim 28, wherein the error comprises a
mechanical failure of the fluid drive component.
30. The device of claim 28, wherein the error comprises an
occlusion signal circuitry failure.
31. The device of claim 21, wherein a duration of each pumping
cycle is determined at least in part by a flow rate of the fluid
drive component.
32. The device of claim 21, further comprising: a motor operatively
coupled to the fluid drive component; and a rotational position
sensor operatively coupled to the motor to determine a rotational
position of the motor; wherein the one or more processors is
further operatively coupled to the rotational position sensor and
further configured to determine each pump revolution from the
rotational position sensor
33. The device of claim 21, wherein the one or more processors is
further configured to stop the fluid drive component when the
occlusion is determined to be present.
34. The device of claim 21, further comprising a display
operatively coupled to the one or more processors, wherein the one
or more processors is further configured to display an error signal
on the display when the occlusion is determined to be present.
35. The device of claim 21, wherein the contact force sensor
consists of a single contact force sensor.
36. The device of claim 21, wherein the one or more processors is
further configured to apply a four-sample moving average filter to
the data representing the measured force or pressure from the
contact force sensor.
37. The device of claim 21, further comprising a beneficial agent
contained in the fluid reservoir.
38. The device of claim 37, wherein the beneficial agent comprises
one or more of levodopa and carbidopa.
39. A device for delivering a beneficial agent to a user,
comprising: a cassette including a cassette housing with a fluid
reservoir defined therein, the cassette housing having a cassette
base region; a delivery tube fluidly coupled with the fluid
reservoir; a pump including a pump housing containing a pump
assembly having a fluid drive component, the pump housing having a
receiving region to receive the cassette base region, the fluid
drive component and a proximity sensor disposed proximate the
receiving region; a lock member coupled to the pump housing and
movable between an open position and a closed position, the
cassette capable of being inserted into and removed from the
receiving region when the lock member is in the open position, and
the cassette being secured to the pump with the cassette base
region within the receiving region and a length of the delivery
tube in operative engagement with the fluid drive component when
the lock member is in the closed position, the lock member
comprising a proximity tag configured to be disposed proximate the
proximity sensor when the lock member is in the closed position; a
contact force sensor in communication with the delivery tube and
arranged to measure a force or pressure in the delivery tube; and
one or more processors in communication with the proximity sensor
and the contact force sensor to receive a proximity signal and
contact force data, respectively, therefrom, the one or more
processors configured to: determine whether the lock member is in
the closed position using the proximity signal, determine whether
the delivery tube is in operative engagement with the fluid drive
component using the contact force data, and enable operation of the
fluid drive component if the lock member is determined to be in the
closed position and the delivery tube is determined to be in
operative engagement with the fluid drive component.
40. The device of claim 39, wherein the proximity sensor comprises
a reed switch.
41. The device of claim 39, wherein the proximity tag comprises a
magnet.
42. The device of claim 39, wherein the one or more processors is
further configured to: compare the contact force data to a
threshold value, and determine the delivery tube is in operative
engagement with the fluid drive component if the contact force data
exceeds the threshold value.
43. The device of claim 39, wherein the one or more processors is
further configured to: determine a local minimum force value
detected by the contact force sensor during each revolution of each
pumping cycle, and determine the delivery tube is in operative
engagement with the fluid drive component if the local minimum
force value exceeds the local maximum force value of a
corresponding pump cycle by a local minimum threshold amount.
44. The device of claim 39, wherein a cassette base region
comprises a radio frequency identification (RFID) tag, and the pump
comprises an RFID reader configured to read the RFID tag when the
cassette is secured to the pump.
45. The device of claim 44, wherein the one or more processors is
further configured to: receive identification information for the
cassette encoded on the RFID tag from the RFID reader, determine
whether the identification information is valid, and enable
operation of the fluid drive component if the identification
information is valid.
46. The device of claim 45, wherein the RFID tag further comprises
an expiration date of the beneficial agent, and the one or more
processors is further configured to: receive the expiration date of
the beneficial agent from the RFID reader, determine whether the
expiration date is exceeded, and enable operation of the fluid
drive component if the expiration date is not exceeded.
47. The device of claim 45, wherein the RFID tag comprises high or
ultra-high radio frequency ID.
48. The device of claim 39, further comprising a beneficial agent
contained in the fluid reservoir.
49. The device of claim 48, wherein the beneficial agent comprises
one or more of levodopa and carbidopa.
50. A device for delivering a beneficial agent to a user,
comprising: a cassette including a cassette housing with a fluid
reservoir defined therein, the cassette housing having a cassette
base region including a RFID tag; a delivery tube fluidly coupled
with the fluid reservoir; a pump including a pump housing
containing a pump assembly including a fluid drive component, a
proximity sensor and a RFID reader, the pump housing having a
receiving region to receive the cassette base region, wherein the
fluid drive component, the proximity sensor and the RFID reader are
disposed proximate the receiving region, and the RFID reader is
configured to read the RFID tag when the cassette is secured to the
pump; a lock member coupled to the pump housing and movable between
an open position and a closed position, the cassette capable of
being inserted into and removed from the receiving region when the
lock member is in the open position, and the cassette being secured
to the pump with the cassette base region within the receiving
region and a length of the delivery tube in operative engagement
with the fluid drive component when the lock member is in the
closed position, the lock member comprising a proximity tag
configured to be disposed proximate the proximity sensor when the
lock member is in the closed position; a contact force sensor in
communication with the delivery tube and arranged to measure a
force or pressure in the delivery tube; and one or more processors
in communication with the proximity sensor, the contact force
sensor and the RFID reader to receive a proximity signal, contact
force data and identification information for the cassette encoded
on the RFID tag, respectively, therefrom, the one or more
processors configured to: determine whether the lock member is in
the closed position using the proximity signal, determine whether
the delivery tube is in operative engagement with the fluid drive
component using the contact force data, determine whether the
identification information is valid, and enable operation of the
fluid drive component if the lock member is determined to be in the
closed position, the delivery tube is determined to be in operative
engagement with the fluid drive component and the identification
information is determined to be valid.
51. The device of claim 50, wherein the RFID tag further comprises
an expiration date of the beneficial agent, and the one or more
processors is further configured to: receive the expiration date of
the beneficial agent from the RFID reader, determine whether the
expiration date is exceeded, and enable operation of the fluid
drive component if the expiration date is not exceeded.
52. The device of claim 50, wherein the RFID tag comprises high or
ultra-high radio frequency ID.
53. The device of claim 50, further comprising a beneficial agent
contained in the fluid reservoir.
54. The device of claim 53, wherein the beneficial agent comprises
one or more of levodopa and carbidopa.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent
Application Nos. 61/922,709, filed Dec. 31, 2013; and 62/054,134,
filed Sep. 23, 2014; each of which is incorporated by reference
herein in its entirety.
BACKGROUND
Field of the Disclosed Subject Matter
[0002] The disclosed subject matter is generally related to
devices, systems and methods for controlling and delivering fluids,
for example for delivery of a beneficial agent to a user.
Description of Related Art
[0003] A variety of fluid transport devices and systems have been
developed for controlling and delivering beneficial agents in fluid
form. Such fluid flow systems can include 1) volumetric-based
aspiration flow systems using positive displacement pumps, and 2)
vacuum-based aspiration systems using a vacuum source. For example,
volumetric aspiration systems include peristaltic pumps for the
delivery of therapeutic agents to a user. Various forms of
peristaltic pumps are known, such as using rotating rollers to
press against a flexible tubing to induce flow therethrough.
Cassette systems or other reservoir configurations can be coupled
with the pump device to provide a source of beneficial agent fluid
via the flexible tubing.
[0004] Such devices and systems are particularly beneficial as
portable infusion pumps capable of being worn or carried by the
user. However, there remains a need for improvement of such devices
and systems. Such improvements include, among other things,
improved energy consumption and battery life, improved pump
efficiency and control, improved comfort and ergonomics, and
improved cassette configuration for more complete access to the
reservoir contents.
SUMMARY
[0005] The purpose and advantages of the disclosed subject matter
will be set forth in and apparent from the description that
follows, as well as will be learned by practice of the disclosed
subject matter. Additional advantages of the disclosed subject
matter will be realized and attained by the methods and systems
particularly pointed out in the written description and claims
hereof, as well as from the appended drawings.
[0006] To achieve these and other advantages and in accordance with
the purpose of the disclosed subject matter, as embodied and
broadly described, the disclosed subject matter includes a
peristaltic pump for delivery of a beneficial agent to a user. The
pump includes a motor, a cam shaft coupled to the motor for
rotation about a longitudinal axis of the cam shaft, the cam shaft
having at least one radially-outward projection defining a helical
engagement portion disposed along a length of the cam shaft, and a
plurality of finger plates disposed along the length of the cam
shaft, each finger plate mounted for movement in a transverse
direction relative to the longitudinal axis of the cam shaft, each
finger plate having an aperture defined therein to receive the cam
shaft therethrough, each aperture having a substantially straight
edge region and an opposing edge region. Engagement of the helical
engagement portion with the substantially flat edge region during
rotation of the cam shaft urges the finger plate transversely
toward an extended position.
[0007] Additionally, and as embodied herein, the finger plate can
be free of transverse movement as the helical engagement portion
passes along at least a portion of the opposing edge region during
rotation of the cam shaft. The opposing edge region can include an
arcuate edge, and/or can include a gap. Each finger plate can have
a recessed area in a surface proximate the aperture. The recessed
area can be recessed 0.1 mm relative the surface of the finger
plate. Each finger plate can include an end surface at an end
facing the direction of the transverse movement. The recessed area
can be disposed between the aperture and the end surface.
Furthermore, the recessed area can be spaced from the end
surface.
[0008] Additionally, and as embodied herein, with each finger plate
having an end surface at an end facing the direction of the
transverse movement, the end surfaces of the finger plates together
can define a contiguous surface facing the direction of the
transverse movement. Each finger plate can be unbiased, or each
finger plate can be biased away from the extended position. The
plurality of finger plates can be disposed parallel with each other
and arranged for sequential movement toward the extended
position.
[0009] In addition, and as embodied herein, the pump can further
include a gap defined between an end plate of the plurality of
finger plates and an interior wall of the peristaltic pump, wherein
a filler plate can be disposed within the gap. The filler plate can
have a different thickness than each of the plurality of finger
plates. The different thickness can be less than each of the
plurality of finger plates. Alternatively, the different thickness
can be greater than each of the plurality of finger plates. The
substantially straight edge region of the aperture likewise can
have a thickness greater than the opposing edge region. Each finger
plate can include a ceramic material. Additionally or
alternatively, the camshaft can include a ceramic material.
[0010] Additionally, and as embodied herein, the pump can include
one or more bevel gears coupling the motor to the cam shaft. The
cam shaft can include a chamfered portion formed at a radial end of
the helical engagement portion. The helical engagement portion can
extend around the cam shaft greater than one revolution of the
helical engagement portion.
[0011] Additionally, and as embodied herein, the pump can include a
cassette including a cassette housing with a fluid reservoir
defined therein and a delivery tube fluidly coupled with the fluid
reservoir. The cassette housing can have a cassette base region,
and the pump can include a receiving region to receive the cassette
base region with, the plurality of finger plates disposed proximate
the receiving region. Each finger plate thus can be configured to
compress a portion the delivery tube in the extended position. When
the cam shaft rotates out of engagement with the substantially
straight edge region of each finger plate, the delivery tube can be
configured to urge the finger plate away from the extended
position. The plurality of finger plates can be disposed parallel
with each other and arranged for sequential movement toward the
extended position to sequentially compress the delivery tube to
create a vacuum force to draw the beneficial agent from the fluid
reservoir.
[0012] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube and a pump. The cassette
includes a cassette housing with a fluid reservoir defined therein.
The cassette housing has a cassette base region. The delivery tube
is fluidly coupled with the fluid reservoir. The pump includes a
pump housing containing a pump assembly and has a receiving region
to receive the cassette base region. The pump assembly includes a
fluid drive component disposed proximate the receiving region, a
display to provide visual feedback to the user, a plurality of
input buttons disposed on the pump housing, a first processor
coupled to the fluid drive component and the display and configured
to reduce power to or otherwise hibernate the fluid drive component
and the display when the pump is in an inactive state, and a second
processor coupled to the first processor and the plurality of input
buttons. The second processor is configured to provide an
activation signal to the first processor when one or more of the
plurality of input buttons is deployed.
[0013] Additionally or alternatively, the pump assembly can further
include a radio-frequency identification (RFID) transceiver coupled
to the first processor, and the first processor can be is
configured to reduce power to the RFID transceiver when the pump is
in the inactive state. The pump assembly can further include an
occlusion sensor coupled to the first processor, and the first
processor can be configured to reduce power to the occlusion sensor
when the pump is in the inactive state.
[0014] Furthermore, and as embodied herein, the pump assembly can
further include a serial bus coupled to the first processor, and
the first processor can be configured to reduce power to the serial
bus when the pump is in the inactive state. The pump assembly can
further include a power supply voltage monitor coupled to the
second processor, and the second processor can be configured to
maintain the power supply voltage monitor in an active state when
the first processor is powered down. The pump assembly can further
include one or more memories, a primary power supply and a backup
power supply coupled to the second processor, and the second
processor can be configured to utilize the backup power supply to
save present data to the one or more memories when the second
processor detects the primary power supply is removed or
disabled.
[0015] In addition, and as embodied herein, the pump assembly can
further include a battery coulomb counter coupled to the second
processor, and the second processor can be configured to maintain
the battery coulomb counter in an active state when the first
processor is powered down. The pump assembly can further include a
speaker, and the first processor and the second processor each can
be coupled to the speaker and configured to send an audio signal to
the speaker when a fault is detected.
[0016] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube and a pump. The cassette
includes a cassette housing with a fluid reservoir defined therein.
The cassette housing has a cassette base region. The delivery tube
is fluidly coupled with the fluid reservoir. The pump includes a
pump housing containing a pump assembly and has a receiving region
to receive the cassette base region. The pump assembly includes a
primary power source, a secondary power source coupled to the
primary power source, a fluid drive component disposed proximate
the receiving region and coupled to the primary power source
isolated from the secondary power source, a first processor coupled
to the primary power source and the secondary power source, a
second processor coupled to the first processor, the primary power
source and the secondary power source, one or more memories coupled
to the first processor. At least one of the first processor and the
second processor is configured, when the primary power source is
removed or disabled, to utilize the secondary power source and the
first processor to complete writing operations to the one or more
memories prior to depletion of the secondary power source.
[0017] Additionally, and as embodied herein, the secondary power
source can include a 1F capacitor. The secondary power source can
be coupled to the primary power source via a secondary power source
charger configured to charge the secondary power source when the
primary power source is active. The one or more memories can
include a nonvolatile memory storage.
[0018] Furthermore, and as embodied herein, the pump assembly can
further include an RFID transceiver coupled to the secondary power
source. The pump assembly can further include a speaker coupled to
the secondary power source. The first processor and the second
processor each can be coupled to the speaker, directly or via an
audio amplifier, and configured to send an audio signal to the
speaker when a fault is detected. The pump assembly can further
include a display to provide visual feedback to the user. The
display can be coupled to the primary power source and isolated
from or otherwise not connected to the secondary power source. The
pump assembly can further include an occlusion sensor coupled to
the primary power source and isolated from the secondary power
source.
[0019] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube and a pump. The cassette
includes a cassette housing with a fluid reservoir defined therein.
The cassette housing has a cassette base region. The delivery tube
is fluidly coupled with the fluid reservoir. The pump includes a
pump housing containing a pump assembly and has a receiving region
to receive the cassette base region. The pump assembly includes a
fluid drive component disposed proximate the receiving region, a
main controller circuit board coupled to and configured to control
the fluid drive component, and at least one secondary circuit board
foldably joined to the main controller circuit board through a
flexible substrate and disposed within the interior in a stacked
relationship relative the main controller circuit board. A
plurality of such secondary circuit boards can be provided, each
joined to the main controller circuit board by a flexible substrate
either directly or indirectly.
[0020] For example, and as embodied herein, the at least one
secondary circuit board can include a power source controller board
coupled to a power source. The at least one secondary circuit board
can include an occlusion sensor controller board coupled to an
occlusion sensor. The at least one secondary circuit board can
include a serial bus controller board. The serial bus controller
board can include an electromagnetic compatibility component. The
serial bus controller board can include a serial bus port disposed
proximate an exterior wall of the pump housing and aligned with an
aperture in the exterior wall.
[0021] Furthermore, and as embodied herein, the at least one
secondary circuit board can include a motor signal encoder coupled
to the fluid drive component. The fluid drive component can be
coupled to the motor signal encoder in a stacked relationship with
the main controller circuit board. The at least one secondary
circuit board can include a speaker, alone or with an audio
amplifier. The at least one secondary circuit board can include a
haptic actuator.
[0022] In addition, and as embodied herein, the at least one
secondary circuit board can include a display controller coupled to
a display. The display can further include a liquid crystal display
(LCD). The display can further include a flexible light
transmission component in optical communication with the LCD. The
at least one secondary circuit board can include an input
controller. The input controller board can include a plurality of
input buttons disposed proximate an exterior wall of the pump
housing and aligned with corresponding apertures in the exterior
wall. The pump housing can have an interior having a height within
a range of 18.5 mm to 20 mm. The flexible substrate can include
polyimide, copper-clad polyimide, polyether ether ketone,
transparent conductive polyester film, or a combination thereof.
The flexible substrate can have a thickness within a range of 95
.mu.m to 192.5 .mu.m.
[0023] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube, a pump and a contact force
sensor. The cassette includes a cassette housing with a fluid
reservoir defined therein. The cassette housing has a cassette base
region. The delivery tube is fluidly coupled with the fluid
reservoir. The pump includes a pump housing containing a pump
assembly having a fluid drive component, the pump housing having a
receiving region to receive the cassette base region, the fluid
drive component disposed proximate the receiving region. The
contact force sensor is in communication, such as by direct or
indirect contact, with the delivery tube and arranged to measure a
force or pressure in the delivery tube. The device includes one or
more processors in communication with the contact force sensor to
receive data representing the measured force or pressure from the
contact force sensor, the one or more processors configured to
determine a maximum force value detected by the contact force
sensor during an initial pumping cycle, the maximum force value
corresponding to a baseline maximum force value, obtain subsequent
force values from the contact force sensor during each subsequent
pumping cycle, and determine an occlusion is present if one or more
of the subsequent force values exceed the baseline maximum force
value by a threshold amount.
[0024] Additionally, and as embodied herein, the one or more
processors can be further configured to determine a subsequent
maximum force value during the subsequent pumping cycle, and adjust
the baseline maximum force value to the subsequent maximum force
value if the subsequent maximum force value is less than the
baseline maximum force value. The threshold amount can be about 10%
of the baseline maximum force value.
[0025] Furthermore, and as embodied herein, the one or more
processors can be further configured to determine a local maximum
force value during an initial pump revolution of each pump cycle,
the local maximum force corresponding to a baseline local maximum
force value, obtain a subsequent local force maximum during each
subsequent pump revolution of each pump cycle, and determine an
occlusion is present if one or more of the subsequent local force
maxima exceeds the baseline local maximum force value by a local
threshold amount. The local threshold amount can be about 13% of
the baseline local maximum force value. The one or more processors
can be further configured to determine the local maximum force
value of each pump cycle when a flow rate of the fluid drive
component is above a threshold flow rate. The threshold flow rate
can be 10 mL/hr.
[0026] Furthermore, and as embodied herein, the one or more
processors can be further configured to determine a local minimum
force value detected by the contact force sensor during each
revolution of each pumping cycle, and determine an error is present
if the local minimum force value does not exceed the local maximum
force value of a corresponding pump cycle by a local minimum
threshold amount. The error can include a mechanical failure of the
fluid drive component. The error can include an occlusion signal
circuitry failure. A duration of each pumping cycle can be
determined at least in part by a flow rate of the fluid drive
component.
[0027] In addition, and as embodied herein, the device can further
include a motor operatively coupled to the fluid drive component,
and a rotational position sensor operatively coupled to the motor
to determine a rotational position of the motor. The one or more
processors can be further operatively coupled to the rotational
position sensor, and the one or more processors can be further
configured to determine each pump revolution from the rotational
position sensor. The one or more processors can be further
configured to stop the fluid drive component when the occlusion is
determined to be present. The device can further include a display
operatively coupled to the one or more processors, and the one or
more processors can be further configured to display an error
signal on the display when the occlusion is determined to be
present. The contact force sensor can include a single contact
force sensor. The one or more processors can be further configured
to apply a four-sample moving average filter to the data
representing the measured force or pressure from the contact force
sensor.
[0028] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivery of a beneficial
agent to a user generally includes a cassette, a delivery tube, a
pump, a lock member, and a contact force sensor. The cassette
includes a cassette housing with a fluid reservoir defined therein.
The cassette housing has a cassette base region. The delivery tube
is fluidly coupled with the fluid reservoir. The pump includes a
pump housing containing a pump assembly having a fluid drive
component, the pump housing having a receiving region to receive
the cassette base region, the fluid drive component disposed
proximate the receiving region. The lock member is coupled to the
pump housing and movable between an open position and a closed
position, the cassette capable of being inserted into and removed
from the receiving region when the lock member is in the open
position, and the cassette being secured to the pump with the
cassette base region within the receiving region and a length of
the delivery tube in operative engagement with the fluid drive
component when the lock member is in the closed position. The lock
member includes a proximity tag configured to be disposed proximate
the proximity sensor when the lock member is in the closed
position. The contact force sensor is in communication with the
delivery tube and arranged to measure a force or pressure in the
delivery tube. The device further includes one or more processors
in communication with the proximity sensor and the contact force
sensor to receive a proximity signal and contact force data,
respectively, therefrom, the one or more processors configured to
determine whether the lock member is in the closed position using
the proximity signal, determine whether the delivery tube is in
operative engagement with the fluid drive component using the
contact force data; and enable operation of the fluid drive
component if the lock member is determined to be in the closed
position and the delivery tube is determined to be in operative
engagement with the fluid drive component.
[0029] Additionally, and as embodied herein, the proximity sensor
can include a reed switch. The proximity tag can include a magnet.
The one or more processors can be further configured to compare the
contact force data to a threshold value, and determine the delivery
tube is in operative engagement with the fluid drive component if
the contact force data exceeds the threshold value. The one or more
processors can be further configured to determine a local minimum
force value detected by the contact force sensor during each
revolution of each pumping cycle, and determine the delivery tube
is in operative engagement with the fluid drive component if the
local minimum force value exceeds the local maximum force value of
a corresponding pump cycle by a local minimum threshold amount.
[0030] Furthermore, and as embodied herein, a cassette base region
can include a RFID tag. The receiving region can include a RFID
reader configured to read the RFID tag when the cassette is secured
to the pump. The one or more processors can be further configured
to receive identification information for the cassette encoded on
the RFID tag from the RFID reader, determine whether the
identification information is valid, and enable operation of the
fluid drive component if the identification information is valid.
The RFID tag can further include an expiration date of the
beneficial agent, and the one or more processors can be further
configured to receive the expiration date of the beneficial agent
from the RFID reader, determine whether the expiration date is
exceeded, and enable operation of the fluid drive component if the
expiration date is not exceeded. The RFID tag can include high or
ultra-high radio frequency ID.
[0031] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube, a pump, a lock member, and a
contact force sensor. The cassette includes a cassette housing with
a fluid reservoir defined therein. The cassette housing has a
cassette base region including a RFID tag. The delivery tube is
fluidly coupled with the fluid reservoir. The pump includes a pump
housing containing a pump assembly having a fluid drive component,
a proximity sensor and a RFID reader, the pump housing having a
receiving region to receive the cassette base region, the fluid
drive component, proximity sensor and RFID reader disposed
proximate the receiving region. The lock member is coupled to the
pump housing and movable between an open position and a closed
position, the cassette capable of being inserted into and removed
from the receiving region when the lock member is in the open
position, and the cassette being secured to the pump with the
cassette base region within the receiving region and a length of
the delivery tube in operative engagement with the fluid drive
component when the lock member is in the closed position. The lock
member includes a proximity tag configured to be disposed proximate
the proximity sensor when the lock member is in the closed
position. The contact force sensor is in communication with the
delivery tube and arranged to measure a force or pressure in the
delivery tube. The device further includes one or more processors
in communication with the proximity sensor, the contact force
sensor and the RFID reader to receive a proximity signal, contact
force data and identification information for the cassette encoded
on the RFID tag, respectively, therefrom, the one or more
processors configured to determine whether the lock member is in
the closed position using the proximity signal, determine whether
the delivery tube is in operative engagement with the fluid drive
component using the contact force data, determine whether the
identification information is valid, and enable operation of the
fluid drive component if the lock member is determined to be in the
closed position, the delivery tube is determined to be in operative
engagement with the fluid drive component, and the identification
information is determined to be valid.
[0032] Furthermore, and as embodied herein, the one or more
processors can be further configured to receive identification
information for the cassette encoded on the RFID tag from the RFID
reader, determine whether the identification information is valid,
and enable operation of the fluid drive component if the
identification information is valid. The RFID tag can further
include an expiration date of the beneficial agent, and the one or
more processors can be further configured to receive the expiration
date of the beneficial agent from the RFID reader, determine
whether the expiration date is exceeded, and enable operation of
the fluid drive component if the expiration date is not exceeded.
The RFID tag can include high or ultra-high radio frequency ID.
[0033] For each of the aspects described above, the device and/or
cassette can include a beneficial agent contained in the fluid
reservoir. The beneficial agent can include one or more of levodopa
and carbidopa. Furthermore, the various aspects above can be
combined to provide a device, pump and/or cassette with selected
features and combinations of features as desired.
[0034] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and are intended to provide further explanation of the disclosed
subject matter claimed.
[0035] The accompanying drawings, which are incorporated in and
constitute part of this specification, are included to illustrate
and provide a further understanding of the disclosed subject
matter. Together with the description, the drawings serve to
explain the principles of the disclosed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] FIG. 1A is an exploded perspective view of an exemplary
device for delivering a beneficial agent according to the disclosed
subject matter.
[0037] FIG. 1B is an exploded schematic view of an exemplary
embodiment of a pump assembly according to the disclosed subject
matter.
[0038] FIG. 2A is a perspective view of an exemplary occlusion
block of the pump assembly of FIG. 1B.
[0039] FIG. 2B is a perspective view of the occlusion block of FIG.
2A joined to an exemplary base block of the pump assembly of FIG.
1B.
[0040] FIG. 2C is a perspective view of exemplary finger plates
joined to the base block of FIG. 2B.
[0041] FIG. 2D is a perspective view of an exemplary cam shaft
joined to the base block of FIG. 2C.
[0042] FIG. 2E is a perspective view of an exemplary motor assembly
joined to the base block and cam shaft of FIG. 2D, with portions
cut away for purpose of illustration.
[0043] FIG. 2F is a detail view of a portion of FIG. 2E.
[0044] FIG. 2G is a detail perspective view of an exemplary lock
member joined to the base block of FIG. 2F.
[0045] FIG. 2H is a bottom plan view of the pump assembly of FIG.
2G.
[0046] FIG. 3A is a front view of an exemplary embodiment of a
finger plate for use with the pump assembly of FIG. 1B, the rear
view being substantially similar.
[0047] FIG. 3B is a left side view of the finger plate of FIG. 3A,
the right side view being substantially similar.
[0048] FIG. 3C is a bottom view of the finger plate of FIG. 3A.
[0049] FIG. 3D is a top right perspective view of the finger plate
of FIG. 3A.
[0050] FIG. 4A is a front view of an alternative embodiment of a
finger plate for use with the pump assembly of FIG. 1B, the rear
view being substantially similar.
[0051] FIG. 4B is a left side view of the finger plate of FIG. 4A,
the right side view being substantially similar.
[0052] FIG. 4C is a bottom view of the finger plate of FIG. 4A.
[0053] FIG. 4D is a top right perspective view of the finger plate
of FIG. 4A.
[0054] FIG. 5A is a front view of another alternative embodiment of
a finger plate for use with the pump assembly of FIG. 1B, the rear
view being substantially similar.
[0055] FIG. 5B is a left side view of the finger plate of FIG. 5A,
the right side view being substantially similar.
[0056] FIG. 5C is a bottom view of the finger plate of FIG. 5A.
[0057] FIG. 5D is a top right perspective view of the finger plate
of FIG. 5A.
[0058] FIG. 6A is a plan view of an exemplary cam shaft joined with
an exemplary bevel gear for use with the pump assembly of FIG.
1B.
[0059] FIG. 6B is a plan view of the exemplary cam shaft of FIG.
6A.
[0060] FIG. 6C is a cross-sectional view of the exemplary cam shaft
taken along line 6C-6C of FIG. 6B.
[0061] FIG. 6D is a cross-sectional view of the exemplary cam shaft
taken along line 6D-6D of FIG. 6B.
[0062] FIG. 6E is a front view of the exemplary bevel gear of FIG.
6A.
[0063] FIG. 6F is a right side view of the exemplary bevel gear of
FIG. 6E, the left side view being substantially similar.
[0064] FIG. 6G is a side view of the exemplary bearing of FIG.
6A.
[0065] FIG. 6H is a cross-sectional view of the exemplary bearing
of FIG. 6G taken along line 6H-6H of FIG. 6G.
[0066] FIGS. 7A-7C each is an alternative embodiment of a cam shaft
protrusion according to the disclosed subject matter, each
illustrating an alternative cam shaft contacting surface.
[0067] FIG. 8A is a partial cross-sectional view taken along a
longitudinal axis of the exemplary cam shaft, illustrating the cam
shaft interacting with exemplary finger plates of the pump assembly
of FIG. 1B.
[0068] FIG. 8B is a partial cross-sectional view taken along an
axis transverse to the longitudinal axis of the cam shaft of FIG.
8A, illustrating the cam shaft interacting with exemplary finger
plates of the pump assembly of FIG. 1B.
[0069] FIG. 8C is a partial cross-sectional view taken parallel to
a longitudinal axis of the exemplary cam shaft and through a
portion of the projection of the cam shaft, illustrating the
portion of the projection interacting with exemplary finger plates
of the pump assembly of FIG. 1B
[0070] FIG. 9 is a schematic diagram illustrating an exemplary
circuit board assembly for a beneficial agent delivery device
according to the disclosed subject matter.
[0071] FIG. 10A is a perspective view of a physical layout of an
exemplary circuit board assembly for a beneficial agent delivery
device according to the disclosed subject matter.
[0072] FIG. 10B is a side view of the exemplary circuit board
assembly of FIG. 10A.
[0073] FIG. 10C is a top plan view of the exemplary circuit board
assembly of FIG. 10A.
[0074] FIG. 10D is a bottom plan view of the exemplary circuit
board assembly of FIG. 10A.
[0075] FIGS. 11A-11B together are a schematic diagram illustrating
an exemplary delivery system for a beneficial agent delivery device
according to the disclosed subject matter.
[0076] FIGS. 12A-12B together are a schematic diagram illustrating
exemplary power distribution for the delivery system of FIGS.
11A-11B.
[0077] FIG. 13 is a schematic diagram illustrating exemplary fluid
drive component controller portion of the delivery system of FIGS.
11A-11B.
[0078] FIG. 14 is a schematic diagram illustrating exemplary
techniques to control a fluid drive component for a beneficial
agent delivery device according to the disclosed subject
matter.
[0079] FIG. 15 is a flow chart illustrating an exemplary technique
for delivering a beneficial agent to a patient according to the
disclosed subject matter.
[0080] FIGS. 16A-16B each is a flow chart illustrating an exemplary
technique for operating a beneficial agent delivery device
according to the disclosed subject matter.
[0081] FIGS. 17A-17M are diagrams illustrating exemplary techniques
for occlusion detection and/or fault detection for a beneficial
agent delivery device according to the disclosed subject
matter.
[0082] FIGS. 18A-1 to 18A-4 together are a schematic diagram
illustrating exemplary techniques for providing a graphical user
interface for a beneficial agent delivery device according to the
disclosed subject matter.
[0083] FIG. 18B is a flow chart illustrating exemplary techniques
for providing a graphical user interface for a beneficial agent
delivery device according to the disclosed subject matter.
[0084] FIG. 18C-1 and 18-C-2 together are a schematic diagram
illustrating an exemplary technique for providing a graphical user
interface for a beneficial agent delivery device according to the
disclosed subject matter.
[0085] FIGS. 18D-1 to 18D-4 together are a schematic diagram
illustrating exemplary techniques for providing a graphical user
interface for a beneficial agent delivery device according to the
disclosed subject matter.
DESCRIPTION
[0086] Reference will now be made in detail to the various
exemplary embodiments of the disclosed subject matter, exemplary
embodiments of which are illustrated in the accompanying drawings.
The structure and corresponding method of operation of and method
of using the disclosed subject matter will be described in
conjunction with the detailed description of the system.
[0087] The apparatus and methods presented herein can be used for
administering any of a variety of suitable therapeutic agents or
substances, such as a drug or biologic agent, to a patient. For
example, and as embodied herein, the device can include a pump
joined to a cassette, which can include a fluid reservoir
containing a fluid substance and can be joined to a delivery tube
system. In operation, the pump can operate on the cassette to
deliver the fluid substance through the tubing system. In this
manner, the device is capable of administering a dosage of the
fluid substance, such as a therapeutic agent, including a
formulation in a liquid or gel form, through the delivery tube
system and to a patient. In some embodiments, the fluid therapeutic
agent can include one or more pharmaceutical or biologic agents.
For example and without limitation, one such fluid therapeutic
agent can be a central nervous system agent, such as levodopa. The
central nervous system agent can be administered alone or in
combination with, for example and without limitation, a
decarboxylase inhibitor, such as carbidopa.
[0088] In accordance with one aspect of the disclosed subject
matter, a peristaltic pump for delivery of a beneficial agent to a
user includes a motor, a cam shaft coupled to the motor for
rotation about a longitudinal axis of the cam shaft, the cam shaft
having at least one radially-outward projection defining a helical
engagement portion disposed along a length of the cam shaft, and a
plurality of finger plates disposed along the length of the cam
shaft, each finger plate mounted for movement in a transverse
direction relative to the longitudinal axis of the cam shaft, each
finger plate having an aperture defined therein to receive the cam
shaft therethrough, each aperture having a substantially straight
edge region and an opposing edge region. Engagement of the helical
engagement portion with the substantially flat edge region during
rotation of the cam shaft urges the finger plate transversely
toward an extended position.
[0089] Additionally, and as embodied herein, the finger plate can
be free of transverse movement as the helical engagement portion
passes along at least a portion of the opposing edge region during
rotation of the cam shaft. The opposing edge region can include an
arcuate edge, and/or can include a gap. Each finger plate can have
a recessed area in a surface proximate the aperture. The recessed
area can be recessed 0.1 mm relative the surface of the finger
plate. Each finger plate can include an end surface at an end
facing the direction of the transverse movement. The recessed area
can be disposed between the aperture and the end surface.
Furthermore, the recessed area can be spaced from the end
surface.
[0090] Additionally, and as embodied herein, with each finger plate
having an end surface at an end facing the direction of the
transverse movement, the end surfaces of the finger plates together
can define a contiguous surface facing the direction of the
transverse movement. Each finger plate can be unbiased, or each
finger plate can be biased away from the extended position. The
plurality of finger plates can be disposed parallel with each other
and arranged for sequential movement toward the extended
position.
[0091] In addition, and as embodied herein, the pump can further
include a gap defined between an end plate of the plurality of
finger plates and an interior wall of the peristaltic pump, wherein
a filler plate can be disposed within the gap. The filler plate can
have a different thickness than each of the plurality of finger
plates. The different thickness can be less than each of the
plurality of finger plates. Alternatively, the different thickness
can be greater than each of the plurality of finger plates. The
substantially straight edge region of the aperture likewise can
have a thickness greater than the opposing edge region. Each finger
plate can include a ceramic material. Additionally or
alternatively, the camshaft can include a ceramic material.
[0092] Additionally, and as embodied herein, the pump can include
one or more bevel gears coupling the motor to the cam shaft. The
cam shaft can include a chamfered portion formed at a radial end of
the helical engagement portion. The helical engagement portion can
extend around the cam shaft greater than one revolution of the
helical engagement portion.
[0093] Additionally, and as embodied herein, the pump can include a
cassette including a cassette housing with a fluid reservoir
defined therein and a delivery tube fluidly coupled with the fluid
reservoir. The cassette housing can have a cassette base region,
and the pump can include a receiving region to receive the cassette
base region with, the plurality of finger plates disposed proximate
the receiving region. Each finger plate thus can be configured to
compress a portion the delivery tube in the extended position. When
the cam shaft rotates out of engagement with the substantially
straight edge region of each finger plate, the delivery tube can be
configured to urge the finger plate away from the extended
position. The plurality of finger plates can be disposed parallel
with each other and arranged for sequential movement toward the
extended position to sequentially compress the delivery tube to
create a vacuum force to draw the beneficial agent from the fluid
reservoir.
[0094] Furthermore, and as embodied herein, the pump can further
include a beneficial agent contained in the fluid reservoir. The
beneficial agent can include one or more of levodopa and
carbidopa.
[0095] The accompanying figures, where like reference numerals
refer to identical or functionally similar elements throughout the
separate views, serve to further illustrate various embodiments and
to explain various principles and advantages all in accordance with
the disclosed subject matter. For purpose of explanation and
illustration, and not limitation, exemplary embodiments of the pump
assembly of the disclosed subject matter and components thereof are
shown in the accompanying FIGS. 1-8C. Furthermore, FIGS. 9 to 18D-4
each depicts techniques and corresponding systems for delivery of a
beneficial agent to a user. Additionally, for example and without
limitation, further details of exemplary cassettes and lock members
for use with the pump assembly for delivery of a beneficial agent
to a user, as discussed further below, are described in
concurrently filed applications by Applicant, each entitled
"DEVICES AND METHODS FOR DELIVERING A BENEFICIAL AGENT TO A USER,"
Ser. Nos. ______ and ______, each of which is incorporated by
reference in its entirety.
[0096] While the disclosed subject matter is described with respect
to a delivery device to administer a dose of therapeutic agent, one
skilled in the art will recognize that the disclosed subject matter
is not limited to the illustrative embodiment, and that the devices
disclosed herein can be configured for delivering any suitable
substance therethrough. In addition, the components and the method
of using the delivery device are not limited to the illustrative
embodiments described or depicted herein. For example, the delivery
device embodied herein can be used with other tubing assemblies and
components thereof for similar benefits and advantages, and are not
limited for use with the delivery tubing herein.
[0097] Referring to an illustrative embodiment of FIG. 1A, a
delivery device 1000 includes a cassette 1010 and a pump 1030.
Cassette 1010 includes a cassette housing 1011 with a fluid
reservoir defined therein and a cassette base region 1012. A
delivery tube 1020 is fluidly coupled with the fluid reservoir.
Pump 1030 or pump device can include a pump housing 1031 with a
pump assembly 100 disposed therein. Pump housing 1031 can include a
receiving region 1032 configured to receive cassette base region
1012. As described further below, pump assembly 100 includes a lock
member 11 coupled to pump housing 1031 and movable between an open
position and a closed position. Cassette 1010 is capable of being
inserted into and removed from the receiving region 1032 when the
lock member 11 is in the open position, and the cassette 1010 is
secured to the pump 1030 with the cassette base region 1012 within
the receiving region 1032 and a length of the delivery tube 1020 in
operative engagement with the pump 1030 when the lock member 11 is
in the closed position.
[0098] Referring to an illustrative embodiment of FIG. 1B, pump
assembly 100 can include a pump mechanism base block 1 and a cam
shaft 2 joined thereto. A motor assembly 3 can be joined to the cam
shaft 2, for example and as embodied herein, using bevel gears 6
disposed at a 90 degree angle from each other to transmit
rotational force from the motor assembly 3 to the cam shaft 2. A
plurality of finger plates 4 can be disposed along the longitudinal
axis of the cam shaft 2. As embodied herein, each of the finger
plates 4 can have the same dimensions. Additionally or
alternatively, finger plates can be included that have different
dimensions than other finger plates. For example and not
limitation, finger plate 4a can have a thickness less than the
thickness of the finger plates 4, and/or finger plate 4b can have a
thickness greater than the thickness of the finger plates 4. For
purpose of illustration and not limitation, as embodied herein,
finger plate 4a can have a thickness of 0.60 mm, finger plates 4
can have a thickness of 0.74 mm, and finger plate 4b can have a
thickness of 0.90 mm. For purpose of illustration and not
limitation, and as embodied herein, the tolerance of the finger
thickness can be +/-0.025 mm.
[0099] With reference to FIG. 1B, base block 1 can be provided to
mount an occlusion sensor on the base block 1, as discussed further
herein. For example and not limitation, such mounting can reduce
the space occupied by the occlusion sensor and improve its accuracy
compared to mounting the occlusion sensor on the pump housing. As
embodied herein, motor 3 can be cylindrical. For example and not
limitation, the motor 3 can have a length-to-width ratio of about
3.5:1 or greater, and as embodied herein can have a length-to-width
ratio of about 5.1:1. Furthermore, and as embodied herein, motor 3
can be a coreless DC motor.
[0100] For purpose of illustration and not limitation, base block 1
can be formed by any suitable material (e.g., plastic, composites,
metal, etc.), such as by machining, molding or the like. For
example and not limitation, the material can be a metal such as
6061-T6 aluminum alloy. Additionally or alternatively, the base
block 1 can include a finish, such as hard anodized per MIL-A-8625,
TYPE III, class 2. The finish can be any desired or suitable color
(e.g. black), and can have any suitable thickness, for example a
thickness of at least 0.015 mm. Anodization can be applied
selectively to pump components, such as base block 1, including for
example pump components in electrical communication to provide
suitable equipment grounding. For purpose of illustration and not
limitation, a label including a part number can be included, for
example, on the bottom side of the base block 1.
[0101] As embodied herein, an occlusion block 9 can be provided.
Extension springs 8 can be secured to occlusion block 9, for
example by inserting each spring 8 through clearance holes in
occlusion block 9, inserting spring retention pins (not shown)
through the holes and urging the pins into the occlusion block 9.
The assembled occlusion block 9 can be inserted into the pump
mechanism base block 1.
[0102] Additionally, a lock member 11 can be assembled onto the
pump base 1. For example, a rear pin 10 can be inserted into the
pump base 1 to secure a pin driver 13, which can be configured with
an upward-facing notch. The lock member 11, pin driver 13 and
torsion springs 12, 20 can be aligned and a latch hinge pin 15 can
be inserted into lock member 11 and through the pin driver 13 and
torsion springs 12, 20. One or more set screws 23 can be inserted
into pump base 1 to adjust the occlusion block 9 position, as
discussed herein. Spring retainer pins 17 can be inserted into pump
mechanism base 1, and a free end of extension springs 8 can be
urged over spring the retainer pins 17, which can be press fit into
pump mechanism base 1 to secure the extension springs 8.
[0103] For example and not limitation, the occlusion block 9 can be
moved into place by the lock member 11. The occlusion block 9 can
be positioned to correspond to a desired occlusion percentage, for
example within a range of 20% to 30% occlusion. Occlusion
percentage O can be calculated based on the tubing wall thickness W
and the occlusion distance D (e.g. the distance between the
occlusion block 9 and the finger plates 4) using the equation
O=100%*(1 -(D/(2*W))). For purpose of illustration and not
limitation, 100% occlusion can occur when D=0, which can correspond
to the finger plates 4 in engagement with the occlusion block 9,
that is without any space for a tube therebetween. Similarly, 0%
occlusion can occur when D=2*W, which can correspond to the tubing
being compressed by the finger plates 4 and occlusion block 9 such
that inner walls of the tubing are proximate to or engaging each
other. Accordingly, a 25% occlusion can correspond to the thickness
of the walls of the tubing being compressed by 25% by the finger
plates 4 and occlusion bock 9. Occlusion percentage can refer to
the peak occlusion caused by the finger plates 4 during the overall
stroke of the finger plates 4. Suitable occlusion, which can be
within a range of about 24% to about 29%, and as embodied herein at
about 27.5%, can prevent backflow and increase repeatability.
Additionally, the lock member 11 configured to move the occlusion
block 9 into place can affect the occlusion percentage tolerance,
as discussed further herein.
[0104] For purpose of illustration and not limitation, an alignment
pin 10 can be included and configured to move with the lock member
11 to insert into a drug cartridge brought into alignment with the
pump and secured with the lock member 11. Insertion of the
alignment pin 10 into the cartridge can reduce rocking of the drug
cartridge and ensure proper alignment of the cartridge with the
pump. Additionally or alternatively, the base block 1 can be
adjusted to support greater pin stroke. For purpose of illustration
and not limitation, mounting for torsion springs 12, 20 can be
mounted to or integral with the base block 1.
[0105] A plurality of finger plates 4 can be placed in the cavity
of the pump mechanism base block 1, as discussed herein. A gap can
be defined between an end finger plate 4 and the inside wall of the
base block 1, and as such, a non-standard thickness finger plate(s)
4a, 4b can be selected with a suitable thickness(es) and inserted
to fill any such gap remaining between the end finger plate 4 and
the inside wall of the base block 1. As discussed herein, the cam
shaft 2 can be threaded through the apertures of the finger plates
4 and rotatably mounted at either end by mounting holes in the pump
mechanism base block 1 for cam shaft bearings 19. Cam shaft
bearings 19 can be inserted into pump mechanism base block 1 and
press fit to secure the cam shaft 2 to the base block 1. Bevel gear
6 can be disposed at an exposed end of cam shaft 2, as discussed
herein.
[0106] The distance or gap between the occlusion block 9 and the
peristaltic finger plates 4 can be adjusted using set screws 23 to
adjust the location of the hinge pin 15. For purpose of
illustration and not limitation, the hinge pin 15 can determined
the position of the lock member 11 and the location of the
occlusion block 9. Set screws 23 can be tightened to urge the latch
hinge pin 15 to an initial position. The bevel gears 6 can be
rotated to position the finger plates 4, as shown for purpose of
illustration and not limitation. The outer finger plates 4 can
initially be closest to the occlusion block 9. The rear pin 10 can
be inserted and the lock member 11 can be closed. To calibrate the
distance or gap between the finger plates 4 and the occlusion block
9, an object of a known thickness can be inserted into the gap
formed between the finger plates 4 and the occlusion block 9. For
example and not limitation, as embodied herein, the object can be a
pin with a known thickness, such as a 0.112'' gauge pin. For
purpose of illustration and not limitation, the object can be
inserted into the gap formed between the finger plates 4 and the
occlusion block 9 on the inlet side. If the object drops passes
through the gap, the set screws 23 on that side can be adjusted to
decrease the gap. The inserting of the object through the gap can
be repeated on the inlet side until the object does not pass
through. Additionally, another object of a slightly less thickness
can be passed through the gap to confirm that the gap has the
desired size. For example and not limitation, as embodied herein,
the other object can be a pin of a smaller gauge such as a 0.111''
gauge pin. If the other object passes through the gap, the gap is
appropriately sized. If the other object does not pass through the
gap, the set screws can be adjusted to increase the gap. This
process can be repeated at the outlet side.
[0107] The lock member 11 can be configured as a cam lever and
actuated to move the occlusion block 9 into place when loading a
new tube. The rear pin 10 can operate to stabilize the tubing
cartridge in the housing, and can be actuated when lock member 11
is actuated.
[0108] Torsion springs 12, 20 can lift the lock member 11, for
example, when the lock member 11 is not fully seated. Extension
spring(s) 8 can urge the occlusion block away from the finger
plates 4 when the lock member 11 is lifted.
[0109] For purpose of illustration and not limitation, a top cover
14 can be provided. The top cover 14 can be secured with screws 18.
Additionally or alternatively, a magnet 22 can be included. For
example and not limitation, the magnet 22 can be included in the
lock member 11. A sensor (not pictured) can be added to the base
block 1 to sense the magnet 22. For example, the sensor can be a
reed switch, which can be operated by the magnetic field of the
magnet 22 when lock member 11 is in the closed position. As such
the magnet 22 and sensor can help to ensure proper and safe
operation of the pump assembly 100.
[0110] As embodied herein, the motor assembly 3 can be mounted to
the base block. For example and not limitation, such mounting can
reduce the space occupied by the pump assembly 1700 compared to
mounting the motor assembly 3 to the pump housing.
[0111] With reference to views of the various components as
depicted in FIGS. 2A-2H, the pump assembly 100 can be configured as
follows. An occlusion block 9 can be provided, for example as shown
in FIG. 2A. Extension springs 8 can be secured to occlusion block
9, for example by inserting each spring 8 through clearance holes
in occlusion block 9 and insert spring retention pins 8a through
the holes and pressing the pins into the occlusion block 9. The
assembled occlusion block 9 can be inserted into the pump mechanism
base block 1, as shown for example in FIG. 2B. Spring retainer pins
17 can be inserted into pump mechanism base 1, and a free end of
extension springs 8 can be urged over spring retainer pin, which
can be press fit into pump mechanism base 1 to secure the extension
springs 8.
[0112] A plurality of finger plates 4 can be placed in the cavity
of the pump mechanism base block 1, as shown for example in FIG.
2C. As embodied herein, for purpose of illustration, twenty-seven
finger plates 4 are depicted, and are slidably disposed between end
walls of the base block 1. A gap can be defined between an end
finger plate 4 and the inside wall of the base block 1, and as
such, a non-standard thickness finger plate 4a, 4b can be selected
with a suitable thickness and inserted to fill any such gap
remaining between the end finger plate 4 and the inside wall of the
base block 1. Each finger plate 4 has an aperture 41 defined
therethrough, as described further below, which is aligned with
mounting holes 1a shown in FIG. 2C.
[0113] The cam shaft 2 is provided with a radially-outward
projection 21 as described further below, and threaded through the
apertures 41 of the finger plates 4 and mounting holes la of base
block 1, as shown for example in FIG. 2D. In this manner, cam shaft
2 is rotatably mounted at either end by mounting holes 1a in the
pump mechanism base block 1 with cam shaft bearings 19, as
described further below. That is, cam shaft bearings 19 can be
inserted into pump mechanism base block 1 and press fit to secure
the cam shaft 2 to the base block 1. A bevel gear 6 can be disposed
at an exposed end of cam shaft 2. As embodied herein, a pin hole on
bevel gear 6 and cam shaft 2 can be aligned, and a bevel gear
retaining pin (not shown) can be inserted therein and press fit
into the gear/shaft assembly.
[0114] With reference to FIG. 2E, the motor assembly can include a
motor, gearbox and encoder. A side mount bracket 33 can be
installed over a face of the motor 3, as shown, and can be secured
to the motor 3, for example using screws 33a. Alternatively, a
mount bracket for the motor assembly can be integral with base
block 1. A bevel gear 6 can be inserted onto an end of a shaft of
motor 3, and a pin hole in bevel gear 6 can be aligned with a pin
hole on the shaft. A gear pin can be inserted into the pin hole and
press fit to secure the bevel gear 6 to the motor 3. In this
manner, the motor assembly is adjustable relative the bevel gear 6
and cam shaft 2 for proper alignment. Motor assembly can include an
encoder 3a configured to provide position and/or speed control of
motor 3, as described further herein.
[0115] Mount bracket to mount motor assembly 3 can be aligned with
mounting holes provided in the pump mechanism base block 1 and
secured, for example using mounting screws. A gap between the
occlusion block face 9 and the surface of the finger plates 4 can
be formed, and can be adjusted using the occlusion block set
screws, as discussed herein, to a predetermined dimension. The
dimension can be suitable to allow the finger plates to contact and
compress a liquid or gel-containing peristaltic tube therein.
[0116] As shown for example in FIGS. 2F-2H, a lock member 11 can be
assembled onto the pump base 1. For example, a rear pin 10 can be
inserted into the pump base 1 to secure a pin driver 13 having an
upward-facing notch, as shown for example in FIG. 2F. The lock
member 11, pin driver 13 and torsion spring 12 can be aligned and a
latch hinge pin 15 can be inserted into the lock member 11 and
through the pin driver 13 and torsion spring 12. One or more set
screws 18 can be inserted into pump base 1 to adjust the occlusion
block 9 position, as discussed further herein.
[0117] Referring now to FIGS. 3A-3D, an exemplary embodiment of a
finger plate 4 is shown. Finger plates 4 each have recessed areas
42 in at least one side surface thereof, proximate opening 41. As
depicted herein, the recessed areas 42 reduce surface friction
between adjacent finger plates 4 during movement relative one
another. For example, and as embodied herein, each recess 42 can
have a depth of about 0.1 mm relative to the corresponding surface
of the finger plate 4. As further depicted herein, the recessed
area of each finger plate 4 does not extend to the surface of the
finger plate disposed adjacent the peristaltic tube. In this
manner, the tube interaction surface 43 of each finger plate 4 is
generally planar and together the finger plates 4 can define a
contiguous surface for improved pumping performance and
accuracy.
[0118] As embodied herein, the finger plates 4 can be symmetrical.
For purpose of illustration and not limitation, the finger plate 4
can have a D-shaped opening 41. The shape of opening 41 can improve
moldability, for example by allowing material to flow into each
part of a mold more easily compared to other opening shapes, e.g.,
rectangular. To strengthen the flat portion of the D-shape opening
41, the amount of material proximate the area of contact with
camshaft 2 can be increased. For purpose of illustration and not
limitation, the finger plates 4 can be made of any suitable
material (e.g., plastic, ceramic, composites, metal, etc.). For
example, the finger plates can be made out of a plastic, such as
commercially available Delrin 520MP or RTP 1399, or ceramic
material.
[0119] With reference to FIGS. 4A-4D, an alternative embodiment of
a finger plate 4' is shown, having alternative dimensions compared
to finger plate 4. Referring now to FIGS. 5A-5D, an alternative
embodiment of a finger plate 4'' is shown, having alternative
dimensions compared to finger plate 4. For purpose of illustration
and not limitation, optional smaller finger plate(s) 4a and larger
finger plate(s) 4b can be included. For example and not limitation,
during assembly the overall dimensions of the combined finger
plates 4 can be evaluated, and certain finger plates 4, for example
one or more end finger plates 4 can be replaced with a smaller
finger plate 4a or a larger finger plate 4b to achieve a desired
fit.
[0120] FIG. 6A illustrates an exemplary camshaft 2, bearing 19, and
bevel gear 6. FIGS. 6B-6D illustrate further features of exemplary
camshaft 2. Additionally FIGS. 6E-6F illustrate further features of
exemplary bearing 19. FIGS. 6G-6H illustrate further features of
exemplary bevel gear 6. With reference to FIGS. 6A-6H, for purpose
of illustration and not limitation, camshaft 2 can have increased
load capacity compared to certain cam shafts for similar
applications. For example and not limitation, the journal diameter
can be 50% greater than certain camshafts for similar applications.
Additionally, the camshaft 2 can be made of any suitable material
(e.g., plastic, ceramic, composites, metal, etc.). For example, and
as embodied herein, the material can be a ceramic material, such as
and without limitation, zirconium oxide ceramic. Camshaft 2 can be
lubricated with any suitable lubricant to reduce frictional forces,
such as, without limitation, DuPont.TM. Krytox.RTM. GPL205,
TURMOGREASE Highspeed L 182 (LUBCON Turmo.RTM. Lubrication),
TURMOPOL GREASE LC 2201 (LUBCON Turmo.RTM. Lubrication) and
Turmopol Oil 68 HT (LUBCON Turmo.RTM. Lubrication). Furthermore,
and as embodied herein, the cam shaft 2 can include a chamfered
portion formed at the end of the helical portion to prevent contact
with the outer bearing 19. Additionally, and as embodied herein,
the tolerances of the attachment of the camshaft 2 to the bevel
gear 6 can be improved by using an over molded bevel gear 6, as
compared to, e.g., a pin. Using an over molded bevel gear 6 can
also reduce manufacturing steps of the pump assembly 1700.
[0121] FIGS. 7A-7C show the profile for the contacting surfaces of
exemplary camshafts. For purpose of illustration and not
limitation, certain other camshafts for similar applications can be
configured with a generally flat surface to contact the finger
plates. For purpose of comparison, as shown for example in FIG. 7A,
a rounded profile for contacting can create a point contact that
can wear down the flat section of the opening in the finger plates
4 and distort the shape of the opening. As embodied herein. the
exemplary camshaft 2 can have a flattened egg shape for the profile
of the helical camshaft, as shown for example in FIG. 7C. The egg
shape can distribute the force from the camshaft 2 to the finger
plates 4 over a larger surface. As such, the overall wear of the
camshaft 2 on the finger plates 4 can be reduced.
[0122] Referring now to FIGS. 8A-8C, exemplary features of the
interaction of camshaft 2 with finger plates 4 are illustrated. In
operation, the pump assembly 100 can operate as a fluid drive
component. As embodied herein, the motor 3 turns bevel gears 6,
which turns cam shaft 2. As shown for example in FIGS. 6A-6D, cam
shaft 2 has a radially-outward projection 21 defining a helical
engagement portion disposed along a length of the cam shaft 2.
FIGS. 8A-8C each is a cross-sectional schematic diagram
illustrating the finger plates 4 interacting with the cam shaft 2
and the occlusion block 9. As shown in FIG. 8A, projection 21
engages finger plates 4 to urge each finger plate 4 transversely in
sequence toward occlusion block 9 to compress an adjacent portion
of a peristaltic tube (not shown) disposed proximate occlusion
block 9. The compression of the peristaltic tube urges a liquid or
gel within the peristaltic tube in a direction out of the
peristaltic tube. Further rotation of the cam shaft 2 urges each
finger 4 plate away from occlusion block 9 to release the
peristaltic tube. The release of the compressed peristaltic tube
thus can create a vacuum force within the peristaltic tube to draw
additional fluid from the fluid source into the peristaltic tube.
In this manner, and as discussed further herein, the position of
the finger plates 4 with respect to the peristaltic tube is
controlled by the angular position of the rotatable cam shaft 2
within the aperture 41. Additionally or alternatively, the finger
plates 4 can be biased, for example toward the return position away
from occlusion block 9.
[0123] As embodied herein, the camshaft 2 can have a round lobe or
projection 21 that wraps around the shaft in a helical shape. The
helical shape of the projection 21 can wrap around the camshaft 2
slightly greater than one revolution. As such, in operation, as the
camshaft 2 rotates, at least a portion of the camshaft 2 can be
acting on a sufficient number of finger plates 4 to ensure the
tubing interfacing with the finger plates 4 remains occluded
throughout each rotation. In this manner, fluid can be urged to
flow in a single direction.
[0124] The interaction of the camshaft 2 with the D-shaped opening
41 of a series finger plates 4 can produce a peristaltic pumping
motion. The helical lobe 21 can exert a force on the finger plates
4 as it rotates, which can result in motion of the finger plates 4
perpendicular to the camshaft 2, as shown for example in FIG. 8C.
Additionally, as shown for example in FIG. 8B, as the camshaft 2
rotates, the portion of the camshaft 2 projection 21 engaging the
finger plate 4 can urge the finger plate 4 at different locations
within the D-shaped opening 41. For example and not limitation, the
camshaft 2 and the opening 41 can be configured such that contact
can be made with a central portion of the flat and curved portions
of the D-shaped opening 41 and no contact can be made with outer
corner portions of the opening 41, for example as illustrated in
FIG. 8B. As no contact can be made with the outer corner portions
of the D-shaped opening 41, the finger plates 4 can be urged to
move in a single axis. The camshaft 2 can also include an over
molded bevel gear 6 formed at an end thereof for coupling with the
motor 3 and mounting features of the base block 1 to hold the
camshaft 2 in the pump assembly 100, as described herein.
[0125] Referring now to FIG. 8B, each finger plate 4 has an
aperture 41 to receive the cam shaft 2 proximate a segment of
engagement portion 21. Each aperture 41 depicted herein has a
substantially flat edge 44 at a first end proximate the occlusion
block 9, and a substantially arcuate edge 45 at a second end
opposite the first end. With reference to FIG. 8B, rotation of the
cam shaft 2 and engagement portion 21 rotates engagement portion 21
into engagement with the substantially flat edge 44, and urges
finger plate 4 toward occlusion block 9 a distance to urge the
peristaltic tube engagement surface 43 into engagement with a
peristaltic tube disposed therein. Further rotation of the cam
shaft 2 maintains engagement portion 21 in engagement with flat
edge 44 and maintains finger plate 4 in engagement with the
peristaltic tube. Rotation of cam shaft 2 and engagement portion 21
beyond flat edge 44 moves engagement portion 21 along a side of the
aperture 41 and into engagement with arcuate edge 45, which urges
finger plate 4 away from occlusion block 9 and out of engagement
with the peristaltic tube. Alternatively, for purpose of
illustration and not limitation, finger plates 4 can be biased away
from occlusion block 9 along the single axis. For example, finger
plates 4 can be biased away from occlusion block 9 by force exerted
from peristaltic tube 223 to urge finger plates 4 away from
peristaltic tube 223 when not engaged by camshaft 2. As such,
camshaft 2 can be configured to engage flat edge 44 to engage
peristaltic tube 223 and not engage arcuate edge 45.
[0126] The cam shaft 2 is coupled to the motor 3 for rotation about
a longitudinal axis of the cam shaft 2, and has at least one
radially-outward projection 21 defining a helical engagement
portion disposed along a length of the cam shaft. The plurality of
finger plates 4 are disposed along the length of the cam shaft.
Each finger plate 4 is mounted for movement in a transverse
direction relative to the longitudinal axis of the cam shaft, and
is in operative engagement with the helical engagement portion to
move transversely between an extended position and a return
position. The processor is in operative communication with the
encoder 3b to receive rotation data to determine an amount of
rotation of motor 3.
[0127] As discussed further herein, one or more processors can
determine an amount of rotation of motor 3 and/or cam shaft 2. The
processor can be in communication with one or more memories to
store the rotation data from encoder 3b over time. Using the
rotation data from encoder 3b, the processor can determine an
amount of rotation of the motor 3 or cam shaft 2 over a certain
period of time, for example to determine a motor velocity. A
predetermined relationship between the rotation of the motor 3 or
cam shaft 2 and a sequential movement of finger plates 4 resulting
in an amount of beneficial agent dispensed can be utilized to
determine an amount of beneficial agent dispensed using the amount
of rotation of the motor 3 or cam shaft 2. Additionally or
alternatively, the processor can be operative to activate the motor
3 for a certain period of time, for example by operating the motor
3 until a desired amount of beneficial agent has been
dispensed.
[0128] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivery of a beneficial
agent to a user generally includes a cassette, a delivery tube and
a pump. The cassette includes a cassette housing with a fluid
reservoir defined therein. The cassette housing has a cassette base
region. The delivery tube is fluidly coupled with the fluid
reservoir. The pump includes a pump housing containing a pump
assembly and has a receiving region to receive the cassette base
region. The pump assembly includes a fluid drive component disposed
proximate the receiving region, a main controller circuit board
coupled to and configured to control the fluid drive component, and
at least one secondary circuit board foldably joined to the main
controller circuit board through a flexible substrate and disposed
within the interior in a stacked relationship relative the main
controller circuit board. A plurality of such secondary circuit
boards can be provided, each joined to the main controller circuit
board by a flexible substrate either directly or indirectly.
[0129] For example, and as embodied herein, the at least one
secondary circuit board can include a power source controller board
coupled to a power source. The at least one secondary circuit board
can include an occlusion sensor controller board coupled to an
occlusion sensor. The at least one secondary circuit board can
include a serial bus controller board. The serial bus controller
board can include an electromagnetic compatibility component. The
serial bus controller board can include a serial bus port disposed
proximate an exterior wall of the pump housing and aligned with an
aperture in the exterior wall.
[0130] Furthermore, and as embodied herein, the at least one
secondary circuit board can include a motor signal encoder coupled
to the fluid drive component. The fluid drive component can be
coupled to the motor signal encoder in a stacked relationship with
the main controller circuit board. The at least one secondary
circuit board can include a speaker, alone or with an audio
amplifier. The at least one secondary circuit board can include a
haptic actuator.
[0131] In addition, and as embodied herein, the at least one
secondary circuit board can include a display controller coupled to
a display. The display can further include a liquid crystal display
(LCD). The display can further include a flexible light
transmission component in optical communication with the LCD. The
at least one secondary circuit board can include an input
controller. The input controller board can include a plurality of
input buttons disposed proximate an exterior wall of the pump
housing and aligned with corresponding apertures in the exterior
wall. The pump housing can have an interior having a height within
a range of 18.5 mm to 20 mm. The flexible substrate can include
polyimide, copper-clad polyimide, polyether ether ketone,
transparent conductive polyester film, or a combination thereof.
The flexible substrate can have a thickness within a range of 95
.mu.m to 192.5 .mu.m.
[0132] In accordance with this aspect of the disclosed subject
matter, the apparatus and methods herein can include one or more of
the features described above. For purpose of illustration and not
limitation, with reference to FIG. 9, the pump assembly includes a
pump printed circuit board (PCB) assembly 200 joined to pump
components. The pump PCB assembly 200 can include a main controller
circuit board 202, which, for purpose of illustration and not
limitation, can be configured as a rigid flex PCB assembly using
known construction techniques as illustrated for example in FIG. 9.
A remainder of the PCB assembly 200 can articulate around main
controller circuit board 202 at several flex sections 204 to allow
the PCB to conform and fold to fit the enclosure. In this manner,
several secondary or satellite boards can provide functionality for
certain functions proximate their point of use.
[0133] For purpose of illustration and not limitation, and as
embodied herein, a secondary circuit board can include battery PCB
assembly 206, which can provide reverse battery protection, fusing,
and proper creepage or clearance to meet regulatory requirements as
well as including a battery connection 208, e.g., springs, to join
a power source 210, embodied herein as batteries 210, to pump PCB
assembly 200. Occlusion sensing can be performed in the pump
mechanism, as described further herein, and a secondary circuit
board can include a dedicated occlusion sensing PCB assembly 212,
which can provide, for purpose of illustration and not limitation,
latch detection. Additionally or alternatively, and as embodied
herein, a secondary board can include a serial bus PCB assembly
214, which can include EMC components and can provide a suitable
mounting location for a serial bus connector 216, which can be any
suitable connector for data bus communication, including but not
limited to a USB connector. Furthermore, and as embodied herein, a
secondary circuit board can include a button PCB assembly 224,
which can have buttons joined thereto and disposed on an exterior
face of the pump housing to provide input from a user to the pump
assembly 100.
[0134] Referring still to FIG. 9, pump PCB assembly 200 can have
various off-board components joined thereto. For purpose of
illustration, and not limitation, pump PCB assembly 200 can have a
motor 3 with an encoder 3a joined to main controller board 202.
Additionally or alternatively, pump PCB assembly 200 can have a
display 218, embodied herein as a liquid crystal display (LCD) with
flexlight joined to main controller board 202. As a further
alternative, pump PCB assembly 200 can have a haptic actuator 220
and/or a speaker 222 joined to main controller circuit board 202,
for example to provide tactile or audible feedback to a user. The
off-board components can be joined to pump PCB assembly by any
suitable connection, including but not limited to rigid flex
connection and/or discrete wire connections of suitable
construction as known.
[0135] Referring now to FIGS. 10A-10D, an exemplary physical layout
of pump PCB assembly 200 is shown, for purpose of illustration and
not limitation. As shown for example in FIGS. 10A-10D, occlusion
sensing PCB assembly 212, serial bus PCB assembly 214, haptic
actuator 220 and button PCB assembly 224 each are joined to main
controller circuit board 202 via rigid flex portions 204. For
purpose of illustration, and not limitation, the exemplary physical
layout of pump PCB assembly 200 can allow pump PCB assembly to be
utilized in a relatively low-profile enclosure having a reduced
footprint and thickness. For example, and as embodied herein, pump
PCB assembly 200 can be assembled in an enclosure having a length
within a range of 110 mm to 115 mm, a width within a range of 63 mm
to 65.7 mm and a thickness within a range of 18.45 mm to 20 mm.
[0136] According to another aspect of the disclosed subject matter,
and further to the aspects above, a device for delivery of a
beneficial agent to a user generally includes a cassette, a
delivery tube and a pump. The cassette includes a cassette housing
with a fluid reservoir defined therein. The cassette housing has a
cassette base region. The delivery tube is fluidly coupled with the
fluid reservoir. The pump includes a pump housing containing a pump
assembly and has a receiving region to receive the cassette base
region. The pump assembly includes a fluid drive component disposed
proximate the receiving region, a display to provide visual
feedback to the user, a plurality of input buttons disposed on the
pump housing, a first processor coupled to the fluid drive
component and the display and configured to reduce power to or
otherwise hibernate the fluid drive component and the display when
the pump is in an inactive state, and a second processor coupled to
the first processor and the plurality of input buttons. The second
processor is configured to provide an activation signal to the
first processor when one or more of the plurality of input buttons
is deployed.
[0137] Additionally or alternatively, the pump assembly can further
include a radio-frequency identification (RFID) transceiver coupled
to the first processor, and the first processor can be is
configured to reduce power to the RFID transceiver when the pump is
in the inactive state. The pump assembly can further include an
occlusion sensor coupled to the first processor, and the first
processor can be configured to reduce power to the occlusion sensor
when the pump is in the inactive state.
[0138] Furthermore, and as embodied herein, the pump assembly can
further include a serial bus coupled to the first processor, and
the first processor can be configured to reduce power to the serial
bus when the pump is in the inactive state. The pump assembly can
further include a power supply voltage monitor coupled to the
second processor, and the second processor can be configured to
maintain the power supply voltage monitor in an active state when
the first processor is powered down. The pump assembly can further
include one or more memories, a primary power supply and a backup
power supply coupled to the second processor, and the second
processor can be configured to utilize the backup power supply to
save present data to the one or more memories when the second
processor detects the primary power supply is removed or
disabled.
[0139] In addition, and as embodied herein, the pump assembly can
further include a battery coulomb counter coupled to the second
processor, and the second processor can be configured to maintain
the battery coulomb counter in an active state when the first
processor is powered down. The pump assembly can further include a
speaker, and the first processor and the second processor each can
be coupled to the speaker and configured to send an audio signal to
the speaker when a fault is detected.
[0140] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube and a pump. The cassette
includes a cassette housing with a fluid reservoir defined therein.
The cassette housing has a cassette base region. The delivery tube
is fluidly coupled with the fluid reservoir. The pump includes a
pump housing containing a pump assembly and has a receiving region
to receive the cassette base region. The pump assembly includes a
primary power source, a secondary power source coupled to the
primary power source, a fluid drive component disposed proximate
the receiving region and coupled to the primary power source
isolated from the secondary power source, a first processor coupled
to the primary power source and the secondary power source, a
second processor coupled to the first processor, the primary power
source and the secondary power source, one or more memories coupled
to the first processor. At least one of the first processor and the
second processor is configured, when the primary power source is
removed or disabled, to utilize the secondary power source and the
first processor to complete writing operations to the one or more
memories prior to depletion of the secondary power source.
[0141] Additionally, and as embodied herein, the secondary power
source can include a 1F capacitor. The secondary power source can
be coupled to the primary power source via a secondary power source
charger configured to charge the secondary power source when the
primary power source is active. The one or more memories can
include a nonvolatile memory storage.
[0142] Furthermore, and as embodied herein, the pump assembly can
further include an RFID transceiver coupled to the secondary power
source. The pump assembly can further include a speaker coupled to
the secondary power source. The first processor and the second
processor each can be coupled to the speaker, directly or via an
audio amplifier, and configured to send an audio signal to the
speaker when a fault is detected. The pump assembly can further
include a display to provide visual feedback to the user. The
display can be coupled to the primary power source and isolated
from or otherwise not connected to the secondary power source. The
pump assembly can further include an occlusion sensor coupled to
the primary power source and isolated from the secondary power
source.
[0143] In accordance with these aspects, the pump assembly and
related features as described above can be included individually or
in combination. Referring now to FIGS. 11A-11B, a block diagram of
an exemplary delivery system 300 is illustrated. For purpose of
illustration and not limitation, a primary power source 302
provides power to the pump assembly 100. Primary power source 302
can be any suitable power source, and as embodied herein is a pair
of series connected AA batteries. A power supply system 304
provides appropriate voltages for the digital and analog functions
of the pump assembly 100. The power supply system 302 can include
mitigations for electromagnetic compatibility (EMC) events and
circuitry to allow for segmentation of the power supply system 304,
which can improve battery life performance.
[0144] With reference to FIGS. 11A-11B, a system of processor
components can provide overall control of the system. One of
ordinary skill in the art will appreciate that any of the system
can be implemented using one or more processors configured to
perform the techniques described herein. For example, a software
application can be stored on a non-transitory computer readable
medium, such as a CD-ROM, DVD, Magnetic disk, ROM, RAM, or the
like, the instructions of which can be read into a memory coupled
to the one or more processors of the system. When executed, the
software can instruct the processor to perform a particular
function. As described herein below, for purposes of clarity,
functionality of the system may be described generally, without
recitation that one or more processor of the system is configured
to perform the functionality. Alternatively, the system can be
implemented in hard-wired circuitry in place of, or in combination
with, software instructions for implementation of the presently
disclosed subject matter. Thus, embodiments of the presently
disclosed subject matter are not limited to any specific
combination of hardware and software, provided such hardware and
software are configured to perform the method as disclosed
herein.
[0145] For purpose of illustration and not limitation, with
reference to FIGS. 11A-11B, a first processor 306 can be configured
to provide motor control and UI functions. For example, and as
embodied herein, first processor 306 can be configured as an
ARM-based processor, such as a Texas Instruments Tiva processor, or
any other suitable processor. The first processor 306 can be
configured to hibernate, i.e., to enter an inactive state for
example to utilize less power when certain pump functions are not
necessary or desired, and a second processor 308 can be configured
to perform certain background tasks while first processor 306
hibernates. For example, and as embodied herein, second processor
308 can be configured as a mixed-signal microcontroller, such as a
Texas Instruments MSP430, or any other suitable processor.
Additionally, and as embodied herein, a number of sensing
components can be operably coupled to first processor 306 and/or
second processor 308, for example and without limitation, to sense
occlusion, battery voltage and current, and communicate with an
RFID tag in a beneficial agent container, as discussed further
herein.
[0146] For purpose of illustration and not limitation, as embodied
herein, motor control system 300 includes a motor drive 310
configured to provide amplification of motor control output 312
from first processor 306 to drive motor 3, embodied herein as a
brush DC motor coupled through a gearbox to the remainder of pump
assembly 100. Feedback from encoder 3a can be conditioned, for
purpose of illustration and not limitation in the motor drive
block, to allow for closed loop control of motor velocity and
position, as shown for example in FIGS. 11A-11B.
[0147] Additionally, as embodied herein, motor control system 300
can include a number of user interface (UI) components in
communication with first processor 306 and/or second processor 308.
UI components can include, for purpose of illustration and not
limitation, display 218, embodied herein as an LCD display, speaker
222, embodied herein as a piezo ceramic speaker, and/or a haptic
actuator 220, configured to provide visual, audible and tactile
feedback to a user, as discussed further herein.
[0148] Referring now to FIGS. 12A-12B, an exemplary block diagram
of a power supply system 304 is illustrated. For purpose of
illustration and not limitation, as embodied herein, power supply
system 304 includes a secondary power source 314. Secondary power
source 314 can be any suitable power source, and as embodied herein
is a pair of 1F capacitors. Power supply system 304 can be divided
into two subsets of power supplies, for example and without
limitation as illustrated by the dashed line of FIGS. 12A-12B,
including a first power subset 316 (e.g., right of dashed line)
configured to receive backup power from secondary power source 314
when primary power source 302 is removed or disabled, e.g., upon
failure or depletion thereof, and a second power subset 318 (e.g.,
left of the dashed line) configured to lose power upon removal or
disabling of primary power source 302.
[0149] For purpose of illustration and not limitation, as embodied
herein, power supply system 304 can provide backup of digital
hardware power supplies, for example and without limitation to
allow for cleanup and user notification activities to complete upon
removal or disabling of primary power source 302. A supercapacitor
manager 320 can provide charging control, balancing, and protection
to the secondary power source 314. For purpose of illustration,
upon removal or disabling of primary power source 302, the
supercapacitor manager can switch first power subset 316 to receive
power from secondary power source 314. For example, can provide
backup power to certain digital circuitry operating in a mid/high
power state for a period of time until depletion of secondary power
source 314, and as embodied herein, the period of time can be
approximately 4 seconds. For example, and as embodied herein, power
supply system 304 can provide backup power to a removable
non-volatile memory storage 322, such as a secure digital memory
card, to allow for storage of files on memory storage 322. As such,
if primary power source 302 is removed or becomes disabled during a
writing process to memory storage 322, sufficient time can be
provided by secondary power source 314 to ensure internal processes
of the memory storage 322 complete before secondary power source
314 fails. Additionally or alternatively, and as embodied herein, a
Swissbit power fault tolerant SD card can be utilized in memory
storage 322 to reduce or prevent hard failures of the filesystem in
the event of removal or disabling of primary power source 302.
[0150] Additionally, and as embodied herein, power supply system
304 includes a number of power supplies to provide, for purpose of
illustration and not limitation, appropriate voltage levels,
references, and division of noisy and clean power. A first power
path for the system can be derived from a first power supply
3V3_FG. As embodied herein, first power supply 3V3_FG can be
implemented with a buck/boost low standby current supply to allow
for primary power supply 302 input voltages between 1.8 and
.about.3.5V, which can represent a suitable range of input voltages
provided by AA batteries, including without limitation, alkaline
and Lithium Iron Disulfide cell batteries. First power supply
3V3_FG can supply power to, for example and without limitation,
supercapacitor manager 320 and fuel gauging circuits, including a
coulomb counter 324. Supercap manager 320 can provide a second
power supply 3V3_DIG, which can represent a main power supply for
all digital circuitry.
[0151] Power supply system 304 can include a third power supply
3V3_M, which can be a 3.3V power supply configured to provide noise
isolation to motor drive 310. Third power supply 3V3_M can utilize
a similar regulator as first power supply 3V3_FG, and as embodied
herein, can be controlled by second processor 306 to allow
independent shutdown of power supply to motor 3, for example and
without limitation to prevent or mitigate uncommanded motor
operation.
[0152] Additionally or alternatively, and as embodied herein, a
fourth power supply 5V0 can be derived from first power supply
3V3_FG, and can be configured to provide power to, for purpose of
illustration and not limitation, analog sensors and display 218, as
discussed further herein.
[0153] Furthermore, and as embodied herein, a plurality of power
segments can be included in one or more of the power supplies
described herein. For example and without limitation, as embodied
herein, the second power supply 3V3_DIG and fourth power supply 5V0
domains can each include a plurality of power segments to reduce or
inhibit power used by individual peripherals. That is, certain
peripherals of pump assembly 100 do not allow for appropriately low
power consumption when disabled. Thus, such high loss peripherals
can be segmented behind, for example and without limitation, load
switches. Other peripherals, for example and without limitation
peripherals having an acceptably low loss, can be attached to their
"parent" power supply rail, e.g., first power supply 3V3_FG or
fourth power supply 5V0, as appropriate, and controlled by an
appropriate enable signal.
[0154] For example and not limitation, as embodied herein, power
segments can include a first supply segment 3V3_SD for the memory
storage 322 and second supply segment 3V3_USB for the serial bus
214 (shown for example in FIG. 11A), each implemented from second
power supply 3V3_DIG. Additionally or alternatively, as embodied
herein, a third supply segment 5V0_HUNGRY can be provided to power
the encoder 3a and occlusion sensor 212, and can be implemented
from fourth power supply 5V0, as shown for example in FIGS.
12A-12B.
[0155] In addition, and as embodied herein, motor 3 can be powered
by motor drive 310, configured for example and as embodied herein
as a single switch buck style motor drive. As embodied herein,
motor inductance and back EMF can maintain supply currents to motor
3 within an acceptable level. As such, motor 3 can be prevented or
inhibited from receiving a reversed supply voltage, for example and
without limitation due to certain failures (e.g., short or open) of
any parts of motor drive 310, thus preventing motor 3 from
operating in reverse.
[0156] Referring now to FIG. 13, an exemplary fluid drive control
system 400 for pump assembly 100 is illustrated. As described
further herein, as embodied herein, pump assembly 100 can be
implemented as a linear peristaltic pump. Pump assembly 100 can
include, as described herein, a motor 3 with encoder 3a and gearbox
mated to the components interface with the peristaltic tube 223,
including cam shaft 2 and finger plates 4. In operation, pump
assembly 100 can urge fluid through a tubing system joined to
peristaltic tube 223 by engaging peristaltic tube 223 in a linear
fashion from inlet to outlet, which can provide an inherent pinch
valve function preventing the fluid moving from outlet to
inlet.
[0157] For purpose of illustration and not limitation, motor 3 can
be any suitable motor 3, for example and embodied herein as a
cordless DC brushed motor. The windings of motor 3 can be selected
having a size suitable to provide a torque and speed profile to
drive the linear peristaltic pump with the voltage provided by the
two AA batteries. For example and without limitation, as embodied
herein, motor 3 can include suitable windings to provide a nominal
terminal inductance of about 0.0354 mH. In operation, motor 3
provides rotational energy suitable to move the cam shaft 2 and
finger plates 4 to act upon the fluid in fluid communication with
peristaltic tube 223.
[0158] Additionally, and as embodied herein, gearbox 3b can be
disposed at the output of motor 3 and configured to translate
torque provided from motor 3 to provide higher torque to cam shaft
2 at the expense of lower output speed. For purpose of
illustration, and as embodied herein, gearbox 3b can have a gear
ratio within a range between 67:1 and 131:1. Furthermore, and as
embodied herein, bevel gears 6 can provide a 1:1 translation of
torque and speed from the output of gearbox 3b to cam shaft 2. As
such, motor 3 and gearbox 3b can be oriented 90 degrees relative to
cam shaft 2 to allow these components to fit within the desired
enclosure.
[0159] With continued reference to FIG. 13, as embodied herein, a
motor control loop and motor drive signal can be implemented to
utilize one or more processors. For purpose of illustration, and
not limitation, as embodied herein, the motor control loop and
motor drive signal each can be implemented to utilize first
processor 306.
[0160] For example, and as embodied herein, an exemplary technique
for a motor control loop 500 is illustrated in FIG. 14. Referring
now to FIG. 14, in operation, motor control loop 500 can receive
electrical pulses from encoder 3a as motor 3 rotates. The
electrical pulses from encoder 3a can be analyzed by first
processor 306 to determine a change of position, at 501, of motor 3
by counting a total number of pulses and to determine a velocity,
at 502, by measuring an amount of time between pulses. The
calculated position and velocity information can thus provide
inputs to the motor control loop 500.
[0161] With continued reference to FIG. 14, for purpose of
illustration and not limitation, as embodied herein, two
proportional integration (PI) controllers can be utilized: a
position PI controller 503 and a velocity PI controller 504. The
calculated velocity can be input thereto. For example and not
limitation, the input can be a trapezoid velocity profile, as
illustrated herein. The present run duration and the present
current position and velocity information can be updated based on
the position feedback 501 and the velocity feedback 502 at regular
intervals. For example and not limitation, as embodied herein, the
regular intervals can be chosen as 1 millisecond. The present run
duration can be compared to the determined run duration to
determine whether the present run duration has exceeded the
determined run duration. If the present run duration is exceeded,
motor 3 can be stopped. A present position error can be calculated,
which can be represented as a difference between the present run
duration and the determined run duration. To continue driving the
ramp up of the trapezoid profile, position PI controller can adjust
for the position error to include the present position error, e.g.,
by decreasing the duration of the driving signal corresponding to
the amount of the present run duration exceeding the determined run
duration or by increasing the duration of the driving signal
corresponding to the amount of the determined run duration that is
less than the present run duration. Next the velocity error can be
calculated, and the velocity PI controller can correct for the
velocity error in a similar manner as the position error. The
output from the velocity PI controller can be checked for
saturation. The updated driving voltage can be outputted to the
motor 3.
[0162] The inset of FIG. 14 shows an exemplary trapezoidal velocity
profile. For purpose of illustration and not limitation, an
exemplary calculation for the trapezoidal velocity profile for a
volume setpoint VSP of 25 .mu.L can be performed as follows. The
volume per revolution RPUMP of the camshaft 2 of the pump assembly
100 can be a known constant based on camshaft design, for example
and without limitation, as embodied herein 18 .mu.L/rev. The gear
ratio G between motor 3 and cam shaft 2 can also be a known
constant based on the motor and pump design, for example and
without limitation, embodied herein as chosen within a range of
67:1 to 131:1. The volume per revolution of the motor RMOTOR can be
represented as RPUMP/G=0.280597015 .mu.L/rev. The number of
revolutions of the motor TSP to deliver the volume set point can be
represented as VSP/RMOTOR. A maximum velocity TDMAX can be selected
based on the motor specification, for example and without
limitation, embodied herein as 55.8 rev/s. The ramp up time tRU and
ramp down time tRD each can be chosen based on the motor, and can
be the same or different, for example and as embodied herein, each
can be 0.1 s. The time tSS during which the motor is supplied with
normal operating voltage corresponding to the max velocity can be
represented as tSS=(TSP/TDMAX)-0.5*(tRU+tRD). Accordingly, a
smaller volume setpoint can correspond to a smaller tSS. For
example and not limitation, a volume setpoint of 1 .mu.L can have a
smaller tSS than described above.
[0163] Furthermore, and as embodied herein, the output of the motor
control loop 500, at 505, can provide a signal used to generate a
pulse-width-modulation (PWM) signal for the motor drive 310. The
PWM can provide a lower resultant voltage to motor 3 as a function
of the PWM duty cycle. The motor speed can be proportional to
voltage, so the motor speed (and as a result, position) can be
changed based on PWM duty cycle. The duty cycle can be determined
by the output of the motor control loop 500. In this manner, the
PWM can provide a signal for the motor drive 310 to control the
voltage being applied to the motor.
[0164] For purpose of illustration and not limitation, as embodied
herein, motor drive 310 can be operated to apply an initial
operating signal (e.g., a voltage or current) to motor 3. The
initial operating signal can start the operation of the motor at a
relatively low level, which can reduce or prevent strain on the
motor 3 during activation. Motor drive 310 can be operated to
increase a magnitude of the operating signal to the motor 3 up to a
normal operating signal, which is greater than the initial
operating signal. The magnitude of the operating signal can be
increased, for example and without limitation, in a linear manner,
a stepped manner with any number of steps between the initial
operating signal and the normal operating signal, a gradual manner,
an exponential manner, or any other suitable manner of increasing
the operating signal from the initial operating signal to the
normal operating signal.
[0165] In addition, and as embodied herein, motor drive 310 can
receive the PWM signal provided from first processor 306 to control
the operating signal applied to the motor 3. Motor drive 310, for
purpose of illustration and not limitation, can be implemented as a
power MOSFET, which can be controlled by the PWM signal and switch
on/off the operating signal applied to motor 3. In this manner,
motor drive 310 can convert battery energy to the desired operating
signal for motor 3 to maintain suitable control of velocity and
position of motor 3.
[0166] Motor 3 can be driven to operate the pump assembly 100 in a
manner to improve battery life. For purpose of illustration and not
limitation, as embodied herein, motor 3 can be operated in bursts
at higher speed, compared to continuous operation at low speeds. As
such, the motor 3 can operated at a cadence, e.g., by performing a
pumping event at a selected time interval. A processor can control
the motor assembly 3, as described herein. For example and not
limitation, processor 306 can cause motor drive 310 to apply an
increasing magnitude of operating signal (e.g., voltage or current)
to motor 3 from an initial operating signal magnitude up to a
normal operating signal magnitude, as described herein.
Additionally, the processor can cause motor drive 310 to apply a
decreasing magnitude of operating signal to motor 3 from the normal
operating signal magnitude back down to the initial operating
signal magnitude. The operating signal magnitude can be increased
or decreased, for example and without limitation, in a linear
manner, a stepped manner with any number of steps between the
initial magnitude and the normal operating magnitude, a gradual
manner, an exponential manner, or any other suitable manner, as
described herein. For purpose of illustration and not limitation,
as embodied herein, the applied signal magnitude can correspond to
a trapezoidal velocity profile of the motor 3. Additionally, as
described herein, processor 306 can control the motor assembly 3
based on various input and/or feedback signals. For example, the
input and/or feedback signals can include the position, velocity,
and/or current of the motor assembly 3, as described herein.
[0167] For example and not limitation, the selected time interval
for the cadence can be any suitable time period, for example and
without limitation, selected between 1-15 minutes. Any suitable
technique can be utilized to determine the appropriate operating
time for each time interval to achieve a desired flow rate. For
example, and as embodied herein, a lookup table can be used to
determine an operating time for each time interval to achieve a
selected flow rate. Alternatively, the cadence or operating time
can be calculated based on a formula or other suitable technique.
For purpose of illustration and not limitation, a base packet size
can be selected to correspond to a base amount of fluid to be
dispensed. For example, the base packet size can be any suitable
volume, such as 1 .mu.L, 12.5 .mu.L, or 25 .mu.L. A lookup table
can provide fluid amounts, which can correspond to integer
multiples of the base packet size being delivered at a selected
time interval, embodied herein as a 1-minute time interval. For
illustration and not limitation, a flow rate of 0.1 ml/h
corresponds to one 25 .mu.L packet every 15 minutes during the
hour, 0.2 ml/h corresponds to one packet every eight minutes plus
one extra packet during the hour (e.g. at the last minute 0), 0.3
ml/h corresponds to one packet every five minutes, etc. For example
and not limitation, a pumping cadence for a flow rate of 0.6 mL/hr
can be calculated as follows. 0.6 mlhr can be equivalent to 600
.mu.L/hr. Assuming an exemplary packet size of 25 .mu.L, 600/25=24
packets to be delivered to achieve the flow rate. 24 packets
divided over 60 minutes yields 2.5 minutes per packet. Rounding to
the nearest whole number results in 3 minutes per packet, which
yields 20 packets over the hour. The remaining 4 packets divided
over 60 minutes results in 15 minutes per packet. The resulting
cadence therefore can be one packet every 3 minutes and one
additional packet every 15 minutes.
[0168] FIG. 15 is a diagram illustrating exemplary techniques for
delivery of a beneficial agent to a user. At 2401, a flow rate is
selected. Next, at 2402, a pumping cadence is determined based on
flow rate. For example and not limitation, the pumping cadence can
be calculated or can be determined from a lookup table accessible,
as embodied herein by first processor 306, and additionally or
alternatively by second processor 308. At 2403, a volume setpoint
for a pumping event is determined for each time interval. For
example, the volume setpoint can be calculated or looked up e.g.,
in a database or lookup table. At 2404, a number of motor
revolutions corresponding to the volume setpoint can be calculated.
For example, the number of motor revolutions can be determined from
on a known ratio of revolutions to volume delivered. At 2405, a
duration to activate the motor 3 to achieve motor revolutions can
be calculated. For example, the duration for activating the motor 3
can be determined from a known motor velocity to achieve the number
of determined motor revolutions. At 2406, the control loop, timers,
and interrupts can be primed with results from the determined
velocity and duration. Then at 2406, the control loop, timers, and
interrupts can be enabled to activate the motor 3 at the determined
velocity and duration. For each time interval, any suitable
combination of the aforementioned events can be repeated to update
the determined values for the time interval and to produce or
adjust the motor control loop.
[0169] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivery of a beneficial
agent to a user generally includes a cassette, a delivery tube, a
pump, a lock member, and a contact force sensor. The cassette
includes a cassette housing with a fluid reservoir defined therein.
The cassette housing has a cassette base region. The delivery tube
is fluidly coupled with the fluid reservoir. The pump includes a
pump housing containing a pump assembly having a fluid drive
component, the pump housing having a receiving region to receive
the cassette base region, the fluid drive component disposed
proximate the receiving region. The lock member is coupled to the
pump housing and movable between an open position and a closed
position, the cassette capable of being inserted into and removed
from the receiving region when the lock member is in the open
position, and the cassette being secured to the pump with the
cassette base region within the receiving region and a length of
the delivery tube in operative engagement with the fluid drive
component when the lock member is in the closed position. The lock
member includes a proximity tag configured to be disposed proximate
the proximity sensor when the lock member is in the closed
position. The contact force sensor is in communication with the
delivery tube and arranged to measure a force or pressure in the
delivery tube. The device further includes one or more processors
in communication with the proximity sensor and the contact force
sensor to receive a proximity signal and contact force data,
respectively, therefrom, the one or more processors configured to
determine whether the lock member is in the closed position using
the proximity signal, determine whether the delivery tube is in
operative engagement with the fluid drive component using the
contact force data; and enable operation of the fluid drive
component if the lock member is determined to be in the closed
position and the delivery tube is determined to be in operative
engagement with the fluid drive component.
[0170] Additionally, and as embodied herein, the proximity sensor
can include a reed switch. The proximity tag can include a magnet.
The one or more processors can be further configured to compare the
contact force data to a threshold value, and determine the delivery
tube is in operative engagement with the fluid drive component if
the contact force data exceeds the threshold value. The one or more
processors can be further configured to determine a local minimum
force value detected by the contact force sensor during each
revolution of each pumping cycle, and determine the delivery tube
is in operative engagement with the fluid drive component if the
local minimum force value exceeds the local maximum force value of
a corresponding pump cycle by a local minimum threshold amount.
[0171] Furthermore, and as embodied herein, a cassette base region
can include a RFID tag. The receiving region can include a RFID
reader configured to read the RFID tag when the cassette is secured
to the pump. The one or more processors can be further configured
to receive identification information for the cassette encoded on
the RFID tag from the RFID reader, determine whether the
identification information is valid, and enable operation of the
fluid drive component if the identification information is valid.
The RFID tag can further include an expiration date of the
beneficial agent, and the one or more processors can be further
configured to receive the expiration date of the beneficial agent
from the RFID reader, determine whether the expiration date is
exceeded, and enable operation of the fluid drive component if the
expiration date is not exceeded. The RFID tag can include high or
ultra-high radio frequency ID.
[0172] According to another aspect of the disclosed subject matter,
a device for delivery of a beneficial agent to a user generally
includes a cassette, a delivery tube, a pump, a lock member, and a
contact force sensor. The cassette includes a cassette housing with
a fluid reservoir defined therein. The cassette housing has a
cassette base region including a RFID tag. The delivery tube is
fluidly coupled with the fluid reservoir. The pump includes a pump
housing containing a pump assembly having a fluid drive component,
a proximity sensor and a RFID reader, the pump housing having a
receiving region to receive the cassette base region, the fluid
drive component, proximity sensor and RFID reader disposed
proximate the receiving region. The lock member is coupled to the
pump housing and movable between an open position and a closed
position, the cassette capable of being inserted into and removed
from the receiving region when the lock member is in the open
position, and the cassette being secured to the pump with the
cassette base region within the receiving region and a length of
the delivery tube in operative engagement with the fluid drive
component when the lock member is in the closed position. The lock
member includes a proximity tag configured to be disposed proximate
the proximity sensor when the lock member is in the closed
position. The contact force sensor is in communication with the
delivery tube and arranged to measure a force or pressure in the
delivery tube. The device further includes one or more processors
in communication with the proximity sensor, the contact force
sensor and the RFID reader to receive a proximity signal, contact
force data and identification information for the cassette encoded
on the RFID tag, respectively, therefrom, the one or more
processors configured to determine whether the lock member is in
the closed position using the proximity signal, determine whether
the delivery tube is in operative engagement with the fluid drive
component using the contact force data, determine whether the
identification information is valid, and enable operation of the
fluid drive component if the lock member is determined to be in the
closed position, the delivery tube is determined to be in operative
engagement with the fluid drive component, and the identification
information is determined to be valid.
[0173] Furthermore, and as embodied herein, the one or more
processors can be further configured to receive identification
information for the cassette encoded on the RFID tag from the RFID
reader, determine whether the identification information is valid,
and enable operation of the fluid drive component if the
identification information is valid. The RFID tag can further
include an expiration date of the beneficial agent, and the one or
more processors can be further configured to receive the expiration
date of the beneficial agent from the RFID reader, determine
whether the expiration date is exceeded, and enable operation of
the fluid drive component if the expiration date is not exceeded.
The RFID tag can include high or ultra-high radio frequency ID.
[0174] Each of these aspects can be combined with one or more of
the various features of the apparatus and method described above.
For purpose of illustration and not limitation, as embodied herein,
pump assembly 100 can include one or more sensors to provide
information regarding the operation of the pump. For example and
without limitation, pump assembly 100 can include an occlusion
sensor 90 (shown in FIG. 1B). As embodied herein, occlusion sensor
90 can include a Honeywell silicon strain gauge configured to
measure a force of peristaltic tube 223 against occlusion block 9.
Occlusion sensor 90 can be coupled to occlusion board 212 to
provide force data received by occlusion sensor 90 to first
processor 306, as shown for example in FIGS. 11A-11B. For purpose
of illustration and not limitation, as embodied herein, occlusion
board 212 can include an amplifier in line with occlusion sensor 90
to converts the output of occlusion sensor 90 to a single ended
signal suitable for processing by first processor 306. As discussed
further herein, first processor 306 can perform calculations using
the output of occlusion board 212 during operation of the fluid
drive component to determine whether an occlusion is present in a
tubing system in communication with peristaltic tube 223, as
discussed further herein.
[0175] Additionally or alternatively, referring now to FIGS. 1, 2G
and 2H, and as embodied herein, pump assembly 100 can include a
proximity tag 22 disposed in recess 91 of lock member 11 to
activate a proximity sensor 92 disposed proximate top cover 14. For
purpose of illustration and not limitation, as embodied herein, the
proximity sensor 92 can include a reed switch, and proximity tag 22
can include a magnet. As such, when the lock member 11 is in the
closed position, proximity tag 22 can activate the proximity sensor
92 to send a signal to first processor 306 and/or second processor
308 that the lock member 11 is in the closed position indicating
that occlusion block 9 is in operative engagement with peristaltic
tube 223.
[0176] Additionally or alternatively, with reference to FIGS. 9 and
11A-11B, as embodied herein, pump assembly 100 can include an RFID
reader 320 coupled to an RFID antenna 322 configured to read an
RFID tag from a cassette joined to pump assembly 100. RFID reader
320 can be configured to identify drug cartridges and read
information encoded in an RFID tag in a cassette joined to pump
assembly 100. In this manner, the system can be used to deter
counterfeiting drug cartridges. As embodied herein, RFID reader 320
can be coupled to first processor 306 to process data read by RFID
reader 320.
[0177] For purpose of illustration and not limitation, the RFID tag
can include identification information encoded thereon for a
cassette joined to pump assembly 100. As embodied herein,
identification information can include a serial number or other
identification number. As such, and as embodied herein, first
processor 306 can determine that the serial number or other
identification number is a valid, for example using a checksum
formula or any other suitable technique to validate an
identification number. Additionally or alternatively, the RFID tag
can include attribute information of a beneficial agent contained
in the fluid reservoir encoded thereon, which can include, without
limitation, a formation date and/or an expiration date of the
beneficial agent. First processor 306 can thus compare the
formation date and/or the expiration date of the beneficial agent
to the present date to determine whether the beneficial agent is
expired. First processor 306 can further validate the entire set of
data from the RFID tag, which can include the identification
information, if provided, attribute information, if provided, and
any other information encoded on the RFID tag, and validation for
the entire set of data can be formed, for example and without
limitation, using a single checksum.
[0178] Referring now to FIGS. 16A-16B, one or more of the occlusion
sensor 90, proximity tag 22 and RFID reader 320, if provided, can
provide notification and confirmation of attachment of the cassette
to the pump assembly 100. For purpose of illustration, and not
limitation, as shown for example in FIG. 16A, an exemplary
technique 1500 for activating a device to deliver a beneficial
agent for a user is provided. At 1501, pump assembly 100 can
determine whether lock member 11 is in the closed position, for
example and as embodied herein using proximity tag 22 and the
proximity sensor 92 as described herein. At 1502, pump assembly 100
can determine whether peristaltic tube 223 is in operative
engagement with occlusion block 9 of the pump assembly 100, for
example and as embodied herein using occlusion sensor 90. That is,
for purpose of illustration and not limitation, first processor 306
can compare force data received from occlusion sensor 90, as
described above, to a threshold. For purpose of illustration and
not limitation, and as embodied herein, force data can be received
from occlusion sensor 90 in units referred to herein as "counts,"
which can be a magnitude of a discrete or continuous signal over
time corresponding to a magnitude of force against occlusion sensor
90. As embodied herein, the threshold can be within a range of 150
counts to 2500 counts, which can represent a force greater than 0
and less than or equal to the force applied by the peristaltic tube
223 to the occlusion block 9 when in operative engagement
therewith. At 1504, if the lock member is determined to be in the
closed position and the peristaltic tube 223 is determined to be in
operative engagement with occlusion block 9, pump assembly 100 can
activate motor drive 310 to drive motor 3, as described herein.
[0179] For purpose of illustration, and not limitation, as shown
for example in FIG. 16B, another exemplary technique 1550 for
activating a device to deliver a beneficial agent for a user is
provided. At 1551, pump assembly 100 can determine whether lock
member 11 is in the closed position, for example and as embodied
herein using proximity tag 22 and the proximity sensor 92 as
described herein. At 1552, pump assembly 100 can determine whether
peristaltic tube 223 is in operative engagement with occlusion
block 9 of the pump assembly 100, for example and as embodied
herein using occlusion sensor 90, as described herein. At 1553,
cassette identification information can be read by RFID sensor 320,
if provided, and first processor 306 can determine whether the
cassette identification information is valid, as described herein.
At 1554, if the lock member is determined to be in the closed
position, the peristaltic tube 223 is determined to be in operative
engagement with occlusion block 9, and the cassette identification
information is determined to be valid, pump assembly 100 can
activate motor drive 310 to drive motor 3, as described herein.
[0180] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivery of a beneficial
agent to a user generally includes a cassette, a delivery tube, a
pump and a contact force sensor. The cassette includes a cassette
housing with a fluid reservoir defined therein. The cassette
housing has a cassette base region. The delivery tube is fluidly
coupled with the fluid reservoir. The pump includes a pump housing
containing a pump assembly having a fluid drive component, the pump
housing having a receiving region to receive the cassette base
region, the fluid drive component disposed proximate the receiving
region. The contact force sensor is in communication, such as by
direct or indirect contact, with the delivery tube and arranged to
measure a force or pressure in the delivery tube. The device
includes one or more processors in communication with the contact
force sensor to receive data representing the measured force or
pressure from the contact force sensor, the one or more processors
configured to determine a maximum force value detected by the
contact force sensor during an initial pumping cycle, the maximum
force value corresponding to a baseline maximum force value, obtain
subsequent force values from the contact force sensor during each
subsequent pumping cycle, and determine an occlusion is present if
one or more of the subsequent force values exceed the baseline
maximum force value by a threshold amount.
[0181] Additionally, and as embodied herein, the one or more
processors can be further configured to determine a subsequent
maximum force value during the subsequent pumping cycle, and adjust
the baseline maximum force value to the subsequent maximum force
value if the subsequent maximum force value is less than the
baseline maximum force value. The threshold amount can be about 10%
of the baseline maximum force value.
[0182] Furthermore, and as embodied herein, the one or more
processors can be further configured to determine a local maximum
force value during an initial pump revolution of each pump cycle,
the local maximum force corresponding to a baseline local maximum
force value, obtain a subsequent local force maximum during each
subsequent pump revolution of each pump cycle, and determine an
occlusion is present if one or more of the subsequent local force
maxima exceeds the baseline local maximum force value by a local
threshold amount. The local threshold amount can be about 13% of
the baseline local maximum force value. The one or more processors
can be further configured to determine the local maximum force
value of each pump cycle when a flow rate of the fluid drive
component is above a threshold flow rate. The threshold flow rate
can be 10 mL/hr.
[0183] Furthermore, and as embodied herein, the one or more
processors can be further configured to determine a local minimum
force value detected by the contact force sensor during each
revolution of each pumping cycle, and determine an error is present
if the local minimum force value does not exceed the local maximum
force value of a corresponding pump cycle by a local minimum
threshold amount. The error can include a mechanical failure of the
fluid drive component. The error can include an occlusion signal
circuitry failure. A duration of each pumping cycle can be
determined at least in part by a flow rate of the fluid drive
component.
[0184] In addition, and as embodied herein, the device can further
include a motor operatively coupled to the fluid drive component,
and a rotational position sensor operatively coupled to the motor
to determine a rotational position of the motor. The one or more
processors can be further operatively coupled to the rotational
position sensor, and the one or more processors can be further
configured to determine each pump revolution from the rotational
position sensor. The one or more processors can be further
configured to stop the fluid drive component when the occlusion is
determined to be present. The device can further include a display
operatively coupled to the one or more processors, and the one or
more processors can be further configured to display an error
signal on the display when the occlusion is determined to be
present. The contact force sensor can include a single contact
force sensor. The one or more processors can be further configured
to apply a four-sample moving average filter to the data
representing the measured force or pressure from the contact force
sensor.
[0185] These aspects can be combined with one or more features of
the apparatus and method described above. Furthermore, and for
purpose of illustration and not limitation, as described herein,
techniques for occlusion sensing can use occlusion sensor 90 to
measure a force of peristaltic tube 223 against occlusion block 9.
Occlusion sensor 90 can be coupled to occlusion board 212 to
provide force data received by occlusion sensor 90 to first
processor 306, as shown for example in FIGS. 11A-11B. For purpose
of illustration and not limitation, occlusion sensor 90 can include
a contact force sensor, for example and embodied herein as a strain
gauge, mounted directly onto pump base block 1 to contact the
peristaltic tubing proximate the outlet side of the tubing at or
near occlusion block 9. Such a location can allow the sensor to
monitor occlusions in a tubing system disposed between pump
assembly 100 and the patient. Furthermore, and as embodied herein,
first processor 306 can perform averaging on data received from
occlusion sensor 90, for example and without limitation to reduce
data spikes or other anomalies due to noise. As embodied herein,
four-sample moving average filtering can be performed on the
data.
[0186] For purpose of illustration and not limitation, and as
embodied herein, exemplary techniques for occlusion sensing can
include a one or more threshold checks. A difference between a
nominal pumping pressure and the occlusion pressure can be affected
by loading variability, the viscosity of the drug, and the pump
cadence (e g running at higher pump speeds for shorter durations),
which can contribute to increases in the peak pressures of the pump
pulses. Occlusion sensing techniques can also be utilized to detect
and prevent or inhibit pressure in the tubing system from exceeding
a threshold pressure for an extended period of time. Additionally,
and as embodied herein, a plurality of sensing techniques can be
performed in parallel using the same data from a single occlusion
sensor, which can be referred to as a "layered" approach.
Alternatively, a single technique for occlusion sensing can be
performed. As a further alternative, a plurality of sensing
techniques using a plurality of occlusion sensors can be performed,
either sequentially or in parallel.
[0187] Additionally, and as embodied herein, exemplary techniques
for occlusion sensing can analyze an occlusion sensor 90 force
magnitude, referred to herein as "counts," at various points in a
given pumping cycle and/or can analyze occlusion sensor force data
prior to the pump assembly 100 activating for starts for a
subsequent pumping cycle. Exemplary techniques for occlusion can
examine a difference between occlusion pump counts, and determine
whether an occlusion is present, as described herein. For example
and without limitation, if the difference between two counts is
outside of a predetermined window or threshold, the pump assembly
100 can determine an occlusion to be present. For purpose of
illustration and not limitation, as embodied herein, the
predetermined window or threshold can be within a range of 81
counts to 138 counts, which can vary based at least in part on the
present flow rate of the pump.
[0188] Furthermore, and as embodied herein, pressure peaks can be
sensed, an initial variability can be adjusted for, and other
non-occlusion events can be accounted for. Force against the wall
of peristaltic tube 223 or pressure within the peristaltic tube 223
can be measured after the pump assembly 100 turns off and a force
delta can be calculated after measuring the force when the pump
assembly 100 turns back on for the next cadence. For purpose of
illustration and not limitation, the delta can be large during
normal pump operation at least in part because the internal
pressure of the tubing can decay when the pump is off. During an
occlusion, the delta can be measurably smaller, at least in part
because there can be little or no pressure decay. When an occlusion
is detected, the pump assembly 100 can be shut off (e.g. by
terminating voltage supply to the motor 3). Additionally, the user
can be notified, for example, by a screen prompt or an audio
alarm.
[0189] As embodied herein, a pumping cycle can refer to a portion
of time during which pump assembly 100 is delivering a beneficial
agent. Referring now to FIGS. 17A-17M, exemplary techniques for
occlusion sensing are illustrated. FIG. 17A is a diagram
illustrating exemplary occlusion sensor counts over time for pump
assembly 100 operating at a 1 mL/hr flow rate, with an occlusion
introduced into the system at about 1500 seconds. FIG. 17B
illustrates a zoomed-in portion of the time scale of the diagram of
FIG. 17A. As shown for example in FIG. 17B, an exemplary pumping
cycle is illustrated between about 322 seconds and 323 seconds on
the time scale. For purpose of illustration and comparison, FIG.
17C is a diagram illustrating exemplary occlusion sensor counts
over time at a 40 mL/hr flow rate, with an occlusion introduced
into the system at about 250 seconds. FIG. 17D illustrates a
detailed portion of the time scale of the diagram of FIG. 17C. As
shown for example in FIG. 17D, an exemplary pumping cycle is
illustrated between about 62 seconds and 92 seconds on the time
scale. As such, the duration of a pumping cycle can increase as
flow rate increases.
[0190] Additionally or alternatively, and as embodied herein, the
occlusion sensor can determine a maximum force value detected
during an initial pumping cycle, which can be used to establish a
baseline maximum. For purpose of illustration and not limitation,
FIG. 17E is a diagram illustrating exemplary occlusion sensor
counts over time for pump assembly 100 operating at a 5 mL/hr flow
rate, with an occlusion introduced into the system at about 900
seconds. FIG. 17F illustrates a detailed portion of the time scale
of the diagram of FIG. 17E. For example and without limitation, as
shown in FIG. 17F, a maximum counts value of about 2330 is
identified at about 5 seconds, and can be established as the
baseline maximum counts value. Force values detected during
subsequent pumping cycles can be compared to the established
baseline maximum. For purpose of illustration and not limitation,
when the detected force values during subsequent pumping cycles
exceed the baseline maximum by a certain percentage, embodied
herein as 10%, the occlusion sensor can determine an occlusion to
be present. The percentage threshold can be adjusted to detect
occlusions with suitable accuracy while reducing or eliminating
false positives.
[0191] For purpose of illustration and not limitation, as embodied
herein, the baseline maximum can be adjusted at during subsequent
pumping cycles. Adjustment of the baseline maximum can account for
certain amounts of relaxation of the cassette components that can
occur during use or variations between different cassettes. For
purpose of illustration and comparison, FIG. 17G illustrates
exemplary counts values over time of four different cassettes,
illustrating variation of force counts over time within each
cassette and overall among the different cassettes. To adjust the
baseline maximum, the maximum force value detected during the
subsequent pumping cycle can be compared to the baseline maximum.
If the maximum force value detected during the subsequent pumping
cycle is less than the baseline maximum, the lower maximum force
value can become the new baseline maximum, and the detection of
force values can be repeated for a subsequent pumping cycle. The
adjustment to the baseline maximum can account for a variety of
factors, including drift of the tubing. If the maximum force value
detected during the subsequent pumping cycle is greater than the
baseline maximum, but less than the threshold to detect an
occlusion, the current baseline maximum can be maintained, and
detection of force values can be repeated for a subsequent pumping
cycle. Additionally or alternatively, the baseline maximum can be
adjusted to account for changes in flow rate. For purpose of
illustration, if the flow rate increase is detected, for example
due to a change of flow rate setting or due to delivery of a higher
flow rate dose, such as a morning dose or extra dose, a subsequent
pumping cycle can be used to establish a new baseline maximum to
avoid a false occlusion from being detected. As a further
alternative, if a flow rate decrease is detected, for example due
to a change of flow rate setting or due to delivery of a lower flow
rate dose, such as a normal dose occurring after a morning dose or
extra dose, the new baseline maximum can be adjusted as described
above in a manner similar to accounting for tubing drift.
[0192] Furthermore or as a further alternative, detection of
occlusions existing prior to pumping can be performed. Such
occlusions can cause pump to exceed suitable pressure for an
extended amount of time, and the time to detect an occlusion before
suitable pressure is exceeded can be less than that for occlusions
developing during pumping. As such, detection of occlusions
existing prior to pumping can involve examining force data per pump
revolution, that is, for example and not limitation, by detecting
local maxima for each pump revolution within a given pumping
cycle.
[0193] For example and not limitation, FIG. 17H is a diagram
illustrating exemplary occlusion sensor counts over time for pump
assembly 100 operating at a 40 mL/hr flow rate, with an occlusion
introduced into the system at about 250 seconds. For purpose of
illustration and comparison, FIG. 17I is a diagram illustrating
exemplary pressure data from independent pressure sensor data
corresponding to the pump assembly 100 operation of FIG. 17H. As
shown in FIG. 17I, a first pressure sensor 439058 is disposed on
the cassette housing, and a second pressure sensor 439776 is
disposed at a connection between the tubing system joined to the
cassette and a patient administration set tubing.
[0194] Additionally, for purpose of illustration, and not
limitation, FIG. 17J illustrates a detailed portion of the time
scale of the diagram of FIG. 17H. As shown in FIG. 17J, for example
and without limitation, a single pump revolution can be detected
within a pumping cycle. Additionally or alternatively, a single
pump revolution can be detected, for example and as embodied herein
using motor rotation data from encoder 3b. As embodied herein, a
maximum force during the single pump revolution can be detected and
established as a reference maximum. For purpose of illustration, as
embodied herein, a pump revolution after the initial pump
revolution can be the single pump revolution to establish the
reference maximum, for example and without limitation the third
pump revolution after an initial pump revolution can be used to
avoid initial pumping behavior, which can mimic a preexisting
occlusion, affecting the established reference. For each subsequent
pump revolution after the established reference, a maximum force
can be detected and compared to the reference maximum. For purpose
of illustration, and not limitation, FIG. 17K is a diagram
illustrating exemplary occlusion sensor counts over time for pump
assembly 100 operating at a 40 mL/hr flow rate. As shown in FIG.
17K, maximum and minimum forces for each pump revolution are
identified with dots on the exemplary waveform. For purpose of
illustration, and not limitation, FIG. 17L is a diagram
illustrating further exemplary occlusion sensor counts over time
for pump assembly 100 operating at a 40 mL/hr flow rate. As shown
in FIG. 17L, a reference maximum (referred to as a reference counts
value) is identified and compared to maximum force counts values
for subsequent pump revolutions. For purpose of illustration and
not limitation, when the detected maximum force exceeds the
reference maximum by a certain percentage, which can be chosen for
example and without limitation within a range of 13% to 55%, and as
embodied herein can be 55%, the occlusion sensor can determine an
occlusion to be present. The percentage threshold can be adjusted
to detect occlusions with suitable accuracy while reducing or
eliminating false positives. The occlusion sensor can be configured
to examine local force maxima for detection of occlusions only when
the flow rate is above a certain flow rate, for example and without
limitation, embodied herein at 10 mL/hr. Lower flow rates can
provide additional time to detect an occlusion using other
techniques without examining the local force maxima during each
pump revolution. Additionally or alternatively, for purpose of
illustration, the occlusion sensor can be configured to examine
local force maxima for detection of occlusions only for a
predetermined number of pump revolutions, for example and embodied
herein as nine pump revolutions, after an initial pump revolution
during fluid delivery. As a further alternative, the local force
minima and maxima can be adjusted as described above with respect
to the baseline maximum for a pumping cycle, for example and
without limitation to account for changes in flow rate, as
described above.
[0195] In addition or as an additional alternative, detection of
other failures can be performed by the occlusion sensor. For
example and without limitation, as illustrated in FIG. 17M, pump
drivetrain failure (e.g., due to a broken camshaft or other drive
train component) or occlusion sensor signal conditioning circuitry
failure can produce a relatively flat force sensor waveform over
time. As such, both minimum and maximum force can be determined for
each pump revolution in a pumping cycle. As shown for example in
FIG. 17M, if the maximum force does not exceed the minimum force by
a certain threshold, the occlusion sensor can indicate an
error.
[0196] According to another aspect of the disclosed subject matter,
and further to the above, exemplary techniques for graphical user
interfaces for a device for delivering a beneficial agent to a user
are provided. For purpose of illustration and not limitation, FIGS.
18A-1 to 18A-4 together are a schematic diagram illustrating
exemplary techniques 1700 and associated graphical user interface
screens for delivering a beneficial agent to a user. For example
and without limitation, at 1701, a blank screen can be displayed on
display 218, indicating that the pump is not operational and first
processor 306 is in a hibernation state. A user can press any input
button in communication with button PCB assembly 224, as shown for
example in FIGS. 11A-11B, to signal second processor 308 to awaken
first processor 306 from a hibernation state to an active state and
activate display 218. At 1702, a splash screen on display 218 can
provide an indication to the user that first processor 306 and
display 218 are active. At 1710, if a morning dose has not yet been
delivered within a certain time period, the display 218 can prompt
a user to initiate a morning dose, as discussed further below. At
1703, if the morning dose has already been delivered within a
certain time period, the display 218 can prompt a user to initiate
a normal dose. If the user selects to start normal delivery of a
dose, at 1704, pump assembly 100 can be activated to deliver a dose
for a predetermined flow rate, as described herein, and display 218
can provide a visual indication that the normal dose is being
delivered. The display 218 can indicate, for purpose of
illustration and not limitation, a remaining drug life time, a time
until drug cartridge depletion, a flow rate, and an indication of
the progress of the normal dose. At 1705, during delivery of the
normal dose, a user can press an extra dose button to request an
extra dose and can press a cancel button to cancel a dose. At 1706,
if the user presses the extra dose button, and a number of extra
doses exceeds a predetermined limit for a time period, display 218
can indicate that the extra dose option is locked out, and can
further indicate when the option for an extra dose will become
available. At 1707, display 218 indicates that the extra dose
option is available. At 1708, if the user presses the extra dose
button while it is available, pump assembly 100 can be activated to
deliver a dose for a predetermined flow rate, as described herein,
and display 218 can provide a visual indication that the normal
dose is being delivered.
[0197] For purpose of illustration and not limitation, FIG. 18B is
a flow chart illustrating additional details of exemplary
techniques to deliver a morning dose. For example and without
limitation, as described above with respect to 1710, if a morning
dose has not yet been delivered within a certain time period, the
display 218 can prompt a user to initiate a morning dose. To
determine if a morning dose has been delivered, a morning dose
lockout check can be performed. For example and without limitation,
as embodied herein, when a morning dose is delivered at 1710, a
morning dose lockout timer is set for a predetermined period of
time, embodied herein as 18 hours. Additionally, as embodied
herein, when a new cassette is detected, at 1712, a morning dose
lockout check is performed. That is, at 1713, the morning dose
lockout timer is checked to see if the lockout timer has expired
and/or if a new cassette has been installed. If the lockout timer
has not expired, or a new cassette has not been installed, the
lockout check exits at 1717 and the user is prompted at screen 1703
to start a normal dose. If the lockout timer has expired and a new
cassette has been installed, at 1714, a morning dose icon is
cleared from display 218. At 1715, an extra dose counter is reset
to 0. At 1716, an existing event log file is closed and a new event
log file is opened. The lockout check exits at 1717 and proceeds to
1710 to prompt the user to initiate a morning dose.
[0198] For purpose of illustration and not limitation, FIGS. 18C-1
to 18C-2 and 18D-1 to 18D-4 are schematic diagrams illustrating
additional details of exemplary techniques to allow a clinician to
access settings for pump assembly 100. For example and without
limitation, at 1721, a blank screen can be displayed on display
218, indicating that the pump is not operational and first
processor 306 is in a hibernation state, e.g., powered down. A
clinician can press any input button in communication with button
PCB assembly 224, as shown for example in FIGS. 11A-11B, to signal
second processor 308 to awaken, e.g. activate, first processor 306
from a hibernation state to an active state and activate display
218. At 1722, a splash screen on display 218 can provide an
indication to the clinician that first processor 306 and display
218 are active. Further at 1722, the clinician can press and hold a
button, embodied herein as a bolus button, for a predetermined
period of time to enter a code entry screen. At 1723, the clinician
can be prompted to enter a clinician code to access menu options
available to a clinician having the clinician code. At 1724, the
clinician can select a clinician settings option to view and change
a number of clinician settings. For purpose of illustration and not
limitation, as embodied herein, clinician settings can include
settings for high, medium and low flow rates that can be chosen by
a patient, an extra dose flow rate, and a morning dose flow rate.
At 1725, the clinician can select a patient settings option to view
and change a number of settings for a patient. For purpose of
illustration and not limitation, at 1726, patient settings can
include a flow rate minimum, a flow rate maximum, and extra dose
flow rate limit, and extra dose lockout period, a morning dose flow
rate limit, and a morning dose lockout period. Additionally or
alternatively, patient settings can include a morning dose
enable/disable setting and/or an extra dose enable/disable. As
embodied herein, if morning dose is disabled, the morning dose
confirmation screens can be skipped. Additionally or alternatively,
if extra dose is disabled, a notification screen can be displayed
indicating the extra dose is disabled.
[0199] Each of the components described herein can be made of any
suitable material (e.g., plastic, composites, metal, etc.) and
technique for its intended purpose. In addition to the specific
embodiments claimed below, the disclosed subject matter is also
directed to other embodiments having any other possible combination
of the dependent features claimed below and those disclosed above.
As such, the particular features disclosed herein can be combined
with each other in other manners within the scope of the disclosed
subject matter such that the disclosed subject matter should be
recognized as also specifically directed to other embodiments
having any other possible combinations. Thus, the foregoing
description of specific embodiments of the disclosed subject matter
has been presented for purposes of illustration and description. It
is not intended to be exhaustive or to limit the disclosed subject
matter to those embodiments disclosed.
[0200] The devices and techniques of the disclosed subject matter
can be used for delivery of any of a variety of suitable fluid
substances of corresponding volume or dose.
[0201] While the disclosed subject matter is described herein in
terms of certain preferred embodiments, those skilled in the art
will recognize that various modifications and improvements can be
made to the disclosed subject matter without departing from the
scope thereof. Moreover, although individual features of one
embodiment of the disclosed subject matter can be discussed herein
or shown in the drawings of the one embodiment and not in other
embodiments, it should be apparent that individual features of one
embodiment can be combined with one or more features of another
embodiment or features from a plurality of embodiments.
[0202] In addition to the specific embodiments claimed below, the
disclosed subject matter is also directed to other embodiments
having any other possible combination of the dependent features
claimed below and those disclosed above. As such, the particular
features presented in the dependent claims and disclosed above can
be combined with each other in other manners within the scope of
the disclosed subject matter such that the disclosed subject matter
should be recognized as also specifically directed to other
embodiments having any other possible combinations. Thus, the
foregoing description of specific embodiments of the disclosed
subject matter has been presented for purposes of illustration and
description. It is not intended to be exhaustive or to limit the
disclosed subject matter to those embodiments disclosed.
[0203] It will be apparent to those skilled in the art that various
modifications and variations can be made in the method and system
of the disclosed subject matter without departing from the spirit
or scope of the disclosed subject matter. Thus, it is intended that
the disclosed subject matter include modifications and variations
that are within the scope of the appended claims and their
equivalents.
* * * * *