U.S. patent application number 14/586912 was filed with the patent office on 2015-07-02 for devices and methods for delivering a beneficial agent to a user.
This patent application is currently assigned to ABBVIE INC.. The applicant listed for this patent is ABBVIE INC.. Invention is credited to Gurjinder Dhami.
Application Number | 20150182688 14/586912 |
Document ID | / |
Family ID | 53480599 |
Filed Date | 2015-07-02 |
United States Patent
Application |
20150182688 |
Kind Code |
A1 |
Dhami; Gurjinder |
July 2, 2015 |
DEVICES AND METHODS FOR DELIVERING A BENEFICIAL AGENT TO A USER
Abstract
Drug delivery reservoir cassette for a pump is provided. The
cassette includes a cassette housing having a front surface, a back
surface and lateral sidewalls, the cassette housing defining a
transverse axis extending between the lateral sidewalls and a
longitudinal axis perpendicular to the transverse axis. The
cassette housing includes a cassette body region defining a fluid
reservoir chamber therein, and a cassette base region having a
boundary configured to be received by the pump, the boundary
including a pair of opposing rails disposed on opposite sides of
the longitudinal axis. The cassette base region can also include an
engagement surface, alignment key, and/or support rib to align the
cassette in a receiving region of the pump. A device for delivering
a beneficial agent including a pump and cassette is also
provided.
Inventors: |
Dhami; Gurjinder; (Neenah,
WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBVIE INC. |
NORTH CHICAGO |
IL |
US |
|
|
Assignee: |
ABBVIE INC.
NORTH CHICAGO
IL
|
Family ID: |
53480599 |
Appl. No.: |
14/586912 |
Filed: |
December 30, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62054153 |
Sep 23, 2014 |
|
|
|
61922721 |
Dec 31, 2013 |
|
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Current U.S.
Class: |
604/151 |
Current CPC
Class: |
A61M 2205/8206 20130101;
A61M 2205/12 20130101; A61M 2205/123 20130101; A61M 2205/6027
20130101; A61M 2205/6054 20130101; A61M 5/142 20130101; A61M
5/14228 20130101; A61M 5/14244 20130101 |
International
Class: |
A61M 5/142 20060101
A61M005/142 |
Claims
1. A drug delivery reservoir cassette for a pump, the pump having a
lock member movable between an open position and a closed position,
the cassette comprising: a cassette housing having a front surface,
a back surface and lateral sidewalls, the cassette housing defining
a transverse axis extending between the lateral sidewalls and a
longitudinal axis perpendicular to the transverse axis, the
cassette housing including: a cassette body region defining a fluid
reservoir chamber therein, and a cassette base region having a
boundary configured to be received by the pump, the boundary
including a pair of opposing rails disposed on opposite sides of
the longitudinal axis.
2. The cassette of claim 1, wherein the pair of opposing rails are
substantially symmetrical about the longitudinal axis.
3. The cassette of claim 1, wherein each of the opposing rails is
recessed relative an adjacent portion of the boundary.
4. The cassette of claim 1, wherein the pair of opposing rails are
aligned along a transverse axis relative the longitudinal axis.
5. The cassette of claim 4, wherein each of opposing rails defines
an abutment surface generally parallel with the transverse
axis.
6. The cassette of claim 1, wherein the cassette base region
includes an engagement surface configured to be engaged by the lock
member when in the closed position.
7. The cassette of claim 6, wherein the pair of rails are spaced
from the engagement surface in a direction along the longitudinal
axis.
8. The cassette of claim 6, wherein the boundary includes an
alignment key aligned parallel with the longitudinal axis and
defining a receiving recess to receive an alignment pin from the
pump.
9. The cassette of claim 8, wherein the alignment key is spaced
from the pair of rails and from the engagement surface in a
direction along the longitudinal axis.
10. The cassette of claim 8, wherein the cassette further comprises
a delivery tube assembly extending from the fluid reservoir
chamber, and the cassette base region includes a support rib
projecting from the boundary in engagement with the delivery
tube.
11. The cassette of claim 10, wherein the cassette base region
includes a flat surface proximate an end of the cassette
housing.
12. The cassette of claim 11, wherein the flat surface comprises
two flat surface portions.
13. The cassette of claim 11, wherein the cassette base region
includes a contoured surface configured to mate a corresponding
surface of the pump.
14. The cassette of claim 13, wherein the contoured surface has a
concave shape directed toward the boundary in plan view.
15. The cassette of claim 13, wherein the contoured surface is
substantially symmetrical about the longitudinal axis.
16. The cassette of claim 1, further comprising a beneficial agent
contained in the fluid reservoir.
17. The cassette of claim 16, wherein the beneficial agent
comprises one or more of levodopa and carbidopa.
18. A drug delivery reservoir cassette for a pump, the pump having
a lock member movable between an open position and a closed
position, the cassette comprising: a cassette housing having a
front surface, a back surface and lateral sidewalls, the cassette
housing defining a transverse axis extending between the lateral
sidewalls and a longitudinal axis perpendicular to the transverse
axis, the cassette housing including: a cassette body region
defining a fluid reservoir chamber therein, and a cassette base
region having a boundary configured to be received by the pump, the
cassette base region including an engagement surface configured to
be engaged by the lock member when in the closed position.
19. The cassette of claim 18, wherein the engagement surface is
substantially coplanar with the back surface of the cassette
housing.
20. The cassette of claim 18, wherein the engagement surface
comprises a recessed area recessed relative the back surface of the
cassette base region.
21. The cassette of claim 20, wherein the recessed area is shaped
to receive the lock member when in the closed position.
22. The cassette of claim 20, wherein the recessed area tapers to a
smaller cross dimension toward an end of the cassette housing.
23. The cassette of claim 18, wherein the engagement surface
comprises a pair of engagement surface portions on opposite sides
of the longitudinal axis.
24. The cassette of claim 23, wherein the pair of engagement
surface portions are substantially symmetrical about the
longitudinal axis.
25. The cassette of claim 18, wherein the engagement surface
comprises an elongated strip.
26. The cassette of claim 18, wherein the engagement surface
comprises a unitary bridge across the longitudinal axis.
27. The cassette of claim 18, wherein the boundary includes an
alignment key aligned parallel with the longitudinal axis and
defining a receiving recess to receive an alignment pin from the
pump.
28. The cassette of claim 27, wherein the cassette further
comprises a delivery tube assembly extending from the fluid
reservoir chamber, and the cassette base region includes a support
rib projecting from the boundary in engagement with the delivery
tube.
29. The cassette of claim 28, wherein the support rib is disposed
proximate the engagement surface.
30. The cassette of claim 28, wherein the cassette base region
includes a flat surface proximate an end of the cassette
housing.
31. The cassette of claim 30, wherein the flat surface comprises
two flat surface portions.
32. The cassette of claim 31, wherein the engagement surface
comprises a bridge portion joining the two flat surface
portions.
33. The cassette of claim 28, wherein the cassette base region
includes a contoured surface configured to mate a corresponding
surface of the pump.
34. The cassette of claim 18, further comprising a beneficial agent
contained in the fluid reservoir.
35. The cassette of claim 34, wherein the beneficial agent
comprises one or more of levodopa and carbidopa.
36. A drug delivery reservoir cassette for a pump, the pump having
a lock member movable between an open position and a closed
position, the cassette comprising: a cassette housing having a
front surface, a back surface and lateral sidewalls, the cassette
housing defining a transverse axis extending between the lateral
sidewalls and a longitudinal axis perpendicular to the transverse
axis, the cassette housing including: a cassette body region
defining a fluid reservoir chamber therein, and a cassette base
region having a boundary configured to be received by the pump, the
boundary including an alignment key aligned parallel with the
longitudinal axis and defining a receiving recess to receive an
alignment pin from the pump.
37. The cassette of claim 36, wherein the alignment key is centered
between the lateral side walls.
38. The cassette of claim 36, wherein the alignment key projects
into the boundary.
39. The cassette of claim 36, wherein the alignment key projects
from the cassette body region into the cassette base region.
40. The cassette of claim 36, wherein the alignment key is
channel-shaped.
41. The cassette of claim 36, wherein the receiving recess is
tapered along the longitudinal axis.
42. The cassette of claim 36, wherein the cassette further
comprises a delivery tube assembly extending from the fluid
reservoir chamber, and the cassette base region includes a support
rib projecting from the boundary in engagement with the delivery
tube.
43. The cassette of claim 42, wherein the cassette base region
includes a flat surface proximate an end of the cassette
housing.
44. The cassette of claim 43, wherein the cassette base region
includes a contoured surface configured to mate a corresponding
surface of the pump.
45. The cassette of claim 36, further comprising a beneficial agent
contained in the fluid reservoir.
46. The cassette of claim 45, wherein the beneficial agent
comprises one or more of levodopa and carbidopa.
47. A drug delivery reservoir cassette for a pump, the pump having
a lock member movable between an open position and a closed
position, the cassette comprising: a cassette housing having a
front surface, a back surface and lateral sidewalls, the cassette
housing defining a transverse axis extending between the lateral
sidewalls and a longitudinal axis perpendicular to the transverse
axis, the cassette housing including: a cassette body region
defining a fluid reservoir chamber therein, and a cassette base
region having a boundary configured to be received by the pump,
wherein the cassette further comprises a delivery tube assembly
extending from the fluid reservoir chamber, and the cassette base
region includes a support rib projecting from the boundary in
engagement with the delivery tube.
48. The cassette of claim 47, wherein the support rib comprises a
pair of support rib portions.
49. The cassette of claim 47, wherein the delivery tube assembly
includes a pair of end fittings to receive a peristaltic tube, and
further wherein the support rib is substantially aligned between
the pair of end fittings.
50. The cassette of claim 47, wherein the cassette base region
includes a flat surface proximate an end of the cassette
housing.
51. The cassette of claim 50, wherein the cassette base region
includes a contoured surface configured to mate a corresponding
surface of the pump.
52. The cassette of claim 47, further comprising a beneficial agent
contained in the fluid reservoir.
53. The cassette of claim 52, wherein the beneficial agent
comprises one or more of levodopa and carbidopa.
54. A device for delivering a beneficial agent, comprising: a pump
including a pump housing containing a pump assembly having a fluid
drive component, the pump housing having a receiving region
disposed proximate the fluid drive component; and a cassette
including a cassette housing having a front surface, a back surface
and lateral sidewalls, the cassette housing defining a transverse
axis extending between the lateral sidewalls and a longitudinal
axis perpendicular to the transverse axis, the cassette housing
including: a cassette body region defining a fluid reservoir
chamber therein, and a cassette base region having a boundary
configured to be received by the receiving region, the boundary
including a pair of opposing rails disposed on opposite sides of
the longitudinal axis.
55. The device of claim 54, wherein the pair of opposing rails are
substantially symmetrical about the longitudinal axis.
56. The device of claim 54, wherein each of the opposing rails is
recessed relative an adjacent portion of the boundary.
57. The device of claim 54, wherein the pair of opposing rails are
aligned along a transverse axis relative the longitudinal axis.
58. The device of claim 57, wherein each of opposing rails defines
an abutment surface generally parallel with the transverse
axis.
59. The device of claim 54, wherein the cassette base region
includes an engagement surface configured to be engaged by the lock
member when in the closed position.
60. The device of claim 59, wherein the pair of rails are spaced
from the engagement surface in a direction along the longitudinal
axis.
61. The device of claim 59, wherein the boundary includes an
alignment key aligned parallel with the longitudinal axis and
defining a receiving recess to receive an alignment pin from the
pump.
62. The device of claim 61, wherein the alignment key is spaced
from the pair of rails and from the engagement surface in a
direction along the longitudinal axis.
63. The device of claim 61, wherein the device further comprises a
delivery tube assembly extending from the fluid reservoir chamber,
and the cassette base region includes a support rib projecting from
the boundary in engagement with the delivery tube.
64. The device of claim 61, wherein the cassette base region
includes a flat surface proximate an end of the cassette
housing.
65. The device of claim 64, wherein the flat surface comprises two
flat surface portions.
66. The device of claim 64, wherein the cassette base region
includes a contoured surface configured to mate a corresponding
surface of the pump.
67. The device of claim 66, wherein the contoured surface has a
concave shape directed toward the boundary in plan view.
68. The device of claim 66, wherein the contoured surface is
substantially symmetrical about the longitudinal axis.
69. The device of claim 54, further comprising a beneficial agent
contained in the fluid reservoir.
70. The device of claim 69, 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. 61/922,721, filed Dec. 31, 2013; and 62/054,153,
filed Sep. 23, 2014; each of which is incorporated by reference
herein in its entirety.
BACKGROUND
[0002] 1. Field of the Disclosed Subject Matter
[0003] The disclosed subject matter relates to devices, systems and
methods for controlling and delivering fluids, for example for
delivery of a beneficial agent to a user.
[0004] 2. Description of Related Art
[0005] 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 to provide a source of beneficial agent fluid via the
flexible tubing.
[0006] 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
[0007] 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.
[0008] 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 drug
delivery reservoir cassette for a pump, the pump having a lock
member movable between an open position and a closed position. The
cassette generally includes a cassette housing including a cassette
body region and a cassette base region. The cassette housing has a
front surface, a back surface and lateral sidewalls. The cassette
housing defines a transverse axis extending between the lateral
sidewalls and a longitudinal axis perpendicular to the transverse
axis. The cassette body region defines a fluid reservoir chamber
therein. As embodied herein, for purpose of illustration and not
limitation, the cassette base region can be disposed along the
longitudinal axis from the cassette body region. The cassette base
region has a boundary configured to be received by the pump. As
disclosed herein, the cassette base region can include one or more
features, alone or in combination, to align and secure the cassette
when received by the pump.
[0009] In accordance with one aspect of the disclosed cassette base
region, the boundary can include a pair of opposing rails disposed
on opposite sides of the longitudinal axis. As embodied herein, the
pair of opposing rails can be substantially symmetrical about the
longitudinal axis. Each of the opposing rails can be recessed
relative an adjacent portion of the boundary. The pair of opposing
rails can be aligned along a transverse axis relative the
longitudinal axis. Each of opposing rails can define an abutment
surface generally parallel with the transverse axis.
[0010] Furthermore, and as embodied herein, the cassette base
region can include an engagement surface configured to be engaged
by the lock member when in the closed position. The pair of rails
can be spaced from the engagement surface in a direction along the
longitudinal axis. The boundary can also include an alignment key
aligned parallel with the longitudinal axis and can define a
receiving recess to receive an alignment pin from the pump. The
alignment key can be spaced from the pair of rails and from the
engagement surface in a direction along the longitudinal axis. The
cassette can further include a delivery tube assembly extending
from the fluid reservoir chamber, and the cassette base region can
include a support rib projecting from the boundary in engagement
with the delivery tube. The cassette base region can include a flat
surface proximate an end of the cassette housing. The flat surface
can include two flat surface portions. Additionally or
alternatively, the cassette base region can include a contoured
surface configured to mate a corresponding surface of the pump. For
example, the contoured surface can have a concave shape directed
toward the boundary in plan view. The contoured surface can be
substantially symmetrical about the longitudinal axis.
[0011] According to another aspect of the disclosed cassette, the
cassette base region can include an engagement surface configured
to be engaged by the lock member when in the closed position. The
engagement surface can be substantially coplanar with the back
surface of the cassette housing. Alternatively, the engagement
surface can include a recessed area recessed relative the back
surface of the cassette base region. The recessed area can be
shaped to receive the lock member when in the closed position. As
embodied herein, the recessed area can taper to a reduced or
smaller cross dimension in plan view toward an end of the cassette
housing.
[0012] Furthermore, and as embodied herein, the engagement surface
can include a pair of engagement surface portions on opposite sides
of the longitudinal axis. The pair of engagement surface portions
can be substantially symmetrical about the longitudinal axis. The
engagement surface can include an elongated strip. The engagement
surface can include a unitary bridge across the longitudinal axis.
Additional features of the cassette as disclosed herein can be
combined with the engagement surface of this aspect.
[0013] According to another aspect of the disclosed cassette as set
forth above, the cassette base region can include an alignment key
aligned parallel with the longitudinal axis and defining a
receiving recess to receive an alignment pin from the pump. The
alignment key can be centered between the lateral side walls. The
alignment key can project from the cassette body region into the
cassette base region, and particularly, the alignment key can
project into the boundary. The alignment key can be channel-shaped
to define the receiving recess. Additionally or alternatively, the
receiving recess can be tapered along the longitudinal axis.
Additional features of the cassette as disclosed herein can be
combined with the alignment key of this aspect.
[0014] According to another aspect of the disclosed cassette as set
forth above, a delivery tube assembly can be provided extending
from the fluid reservoir chamber. The cassette base region can
include a support rib projecting from the boundary in engagement
with the delivery tube. The support rib can include a pair of
support rib portions. The delivery tube assembly can include a pair
of end fittings to receive a peristaltic tube, and the support rib
can be substantially aligned between the pair of end fittings.
Additional features of the cassette as disclosed herein can be
combined with the support rib of this aspect.
[0015] According to another aspect of the disclosed subject matter,
a device for delivering a beneficial agent is provided. The device
generally includes a pump and a cassette. The pump includes a pump
housing containing a pump assembly having a fluid drive component.
The pump housing has a receiving region disposed proximate the
fluid drive component. The cassette can include any combination of
features described herein.
[0016] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivering a beneficial
agent is provided. The device generally includes a cassette, a
pump, a delivery tube and a lock member. 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 has a receiving region to receive the cassette
base region. The fluid drive component is disposed proximate the
receiving region. The lock member is coupled to the pump housing
and is movable between an open position and a closed position. The
cassette is capable of being inserted into and removed from the
receiving region when the lock member is in the open position. The
cassette is 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.
[0017] Additionally, and as embodied herein, an alignment pin can
be operatively coupled to the lock member. Movement of the lock
member between the open position and the closed position can extend
at least a portion of the alignment pin into engagement with the
cassette housing. The cassette housing can define a receiving
recess proximate the cassette base region to receive the alignment
pin when the lock member is moved toward the closed position. The
receiving recess can be tapered toward a closed end. The receiving
recess can be defined by an alignment projection projecting from
the cassette body region into the cassette base region. For
example, the cassette base region can include an alignment key
having a receiving recess to receive the alignment pin. The
alignment pin can include a tapered end. The lock member can
include a protrusion, and the alignment pin can include a notch to
receive the protrusion to engage the lock member to operatively
couple the alignment pin to the lock member.
[0018] Furthermore, and as embodied herein, the lock member can
include a latch, which can be configured as a cam lever. The
receiving region can further include a torsion spring mechanically
coupled to the latch to bias the latch toward the open
position.
[0019] In addition, and as embodied herein, the latch can further
include a latch cam surface, and the pump can further include an
occlusion block disposed proximate the receiving region and having
an occlusion block cam surface. The occlusion block can be biased
to urge the occlusion block cam surface against the latch cam
surface. The latch cam surface and the occlusion block cam surface
can be configured to urge the occlusion block toward an operative
position to hold the peristaltic tube in functional relationship to
the fluid drive component when the latch is moved from the open
position toward the closed position. The latch cam surface and the
occlusion block cam surface can be configured to define a dead zone
where the occlusion block remains in the operative position during
continued movement of the latch continues from the open position to
the closed position. For example, the dead zone can be defined by
10 degrees of final movement of the latch from the open position to
the closed position with no corresponding movement of the occlusion
block. The latch can include a pivotal latch mounted on a hinge.
Alternatively, the latch can include a draw latch mounted for
sliding movement.
[0020] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivering a beneficial
agent is provided. The device generally includes a cassette, a
pump, a delivery tube and a lock member. The cassette includes a
cassette housing with a fluid reservoir defined therein. The
cassette housing has a cassette base region, and the cassette base
region includes a radio frequency identification (RFID) shell
housing a RFID tag. The delivery tube is fluidly coupled with the
fluid reservoir. The pump includes a pump housing containing a RFID
reader and a pump assembly having a fluid drive component. The pump
housing has a receiving region to receive the cassette base region.
The RFID reader and the fluid drive component are disposed
proximate the receiving region. The lock member is coupled to the
pump housing and is movable between an open position and a closed
position. The cassette is capable of being inserted into and
removed from the receiving region when the lock member is in the
open position. The cassette is secured to the pump with the
cassette base region within the receiving region with the RFID tag
disposed proximate the RFID reader and a length of the delivery
tube in operative engagement with the fluid drive component when
the lock member is in the closed position.
[0021] Additionally, and as embodied herein, the RFID shell can
include a raised surface relative an adjacent surface of the
cassette base region. The raised surface can have a height of about
2 mm relative the adjacent surface. The receiving region can
include a dimple having a bottom radius of 2.5 mm and a top radius
of 6.25 mm, each as measured from an exterior of the pump housing.
The RFID tag can be molded in the RFID shell. Additionally or
alternatively, the RFID tag can be bonded to the RFID shell. The
RFID tag can include identification information for the cassette
encoded thereon. The RFID tag can include attribute information of
a beneficial agent contained in the fluid reservoir encoded
thereon. The attribute information can include one or more of a
concentration, a formation date, and an expiration date of the
beneficial agent.
[0022] Furthermore, and as embodied herein, the receiving region
can further include a RFID receiving region with the RFID reader
housed therein. The RFID receiving region can be configured to
engage the RFID shell when the cassette is secured to the pump with
the cassette base region within the receiving region of the pump
housing. The RFID receiving region can have a shape configured to
mate with the RFID shell. For example, the RFID shell can include a
raised surface relative an adjacent surface of the cassette base
region, and the RFID receiving region can include a dimple
configured to receive the raised surface when the cassette is
secured to the pump with the cassette base region within the
receiving region of the pump housing. The RFID shell and RFID
receiving region can be configured to dispose the RFID tag within
about 5 mm of the RFID reader when the cassette is secured to the
pump with the cassette base region within the receiving region of
the pump housing. The RFID reader can have a range of detection
configured to read the RFID tag only when the RFID receiving region
is in engagement with the RFID shell. The device can further
include a processor coupled to the RFID reader and configured to
verify identification information for the cassette encoded on the
RFID tag. Additionally or alternatively, the processor can be
coupled to the RFID reader and configured to enable operation of
the pump if an expiration date of the beneficial agent encoded on
the RFID tag is not exceeded. In addition or as a further
alternative, the processor can be coupled to the RFID reader and
configured to determine one or more dosing options based at least
in part on a concentration of the beneficial agent encoded on the
RFID tag. The RFID tag can include high or ultra-high radio
frequency ID.
[0023] According to another aspect of the disclosed subject matter,
and further to the above, a drug delivery reservoir cassette for a
pump having an RFID reader, a receiving region configured to
receive the cassette, and a lock member movable between an open
position and a closed position is provided. The cassette includes a
cassette housing with a fluid reservoir defined therein. The
cassette housing has a cassette base region. The cassette base
region includes a radio frequency identification (RFID) shell
housing a RFID tag configured to be read by the RFID reader. The
cassette is capable of being inserted into and removed from the
receiving region when the lock member is in the open position, and
the cassette is secured to the pump with the cassette base region
within the receiving region with the RFID tag disposed proximate
the RFID reader when the lock member is in the closed position.
[0024] The cassette can include any combination of features
described herein. For example, and as embodied herein, the RFID
shell comprises a raised surface relative an adjacent surface of
the cassette base region the RFID shell can include a raised
surface relative an adjacent surface of the cassette base region.
The raised surface can have a height of about 2 mm relative the
adjacent surface. The receiving region can include a dimple having
a bottom radius of 2.5 mm and a top radius of 6.25 mm, each as
measured from an exterior of the pump housing. The RFID tag can be
molded in the RFID shell. Additionally or alternatively, the RFID
tag can be bonded to the RFID shell. The RFID tag can include
identification information for the cassette encoded thereon. The
RFID tag can include attribute information of a beneficial agent
contained in the fluid reservoir encoded thereon. The attribute
information can include one or more of a concentration, a formation
date, and an expiration date of the beneficial agent.
[0025] As embodied herein, any of the various devices and cassette
can include a beneficial agent contained in the fluid reservoir.
The beneficial agent can include one or more of levodopa and
carbidopa.
[0026] 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.
[0027] 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
[0028] FIG. 1 is an exploded perspective view of an exemplary
device for delivering a beneficial agent according to the disclosed
subject matter.
[0029] FIG. 2 is a perspective view of the device of FIG. 1, with
the cassette received by the pump and the lock member in an open
position.
[0030] FIG. 3 is a perspective view of the device of FIG. 2, with
the lock member in a closed position.
[0031] FIGS. 4A-4G are perspective, front, rear, left side, right
side, top and bottom views, respectively, of an exemplary cassette
of the device of FIG. 1.
[0032] FIGS. 5A-5G are perspective, front, rear, left side, right
side, top and bottom views, respectively, of an exemplary pump of
the device of FIG. 1.
[0033] FIG. 6 is an exploded perspective view of an exemplary
embodiment of a pump assembly in accordance with the disclosed
subject matter.
[0034] FIG. 7A a bottom view of an exemplary lock member of the
pump of FIG. 1.
[0035] FIG. 7B is a cross-sectional view of the exemplary lock
member taken along line B-B of FIG. 7A.
[0036] FIG. 7C is a detailed view of region 7C of the cross section
of the exemplary lock member of FIG. 7B.
[0037] FIG. 7D is a cross-sectional view of the exemplary lock
member taken along line D-D of FIG. 7A.
[0038] FIG. 7E is a partial rear view of the exemplary lock member
of FIG. 7A.
[0039] FIG. 7F is a top view of the exemplary lock member of FIG.
7A.
[0040] FIG. 7G is a bottom perspective view of the exemplary lock
member of FIG. 7A.
[0041] FIG. 8A is a cross-sectional view of the exemplary device
taken along line 8A-8A of FIG. 2.
[0042] FIG. 8B is a cross-sectional view of the exemplary device
taken along line 8B-8B of FIG. 3.
[0043] FIG. 9A is a cross-sectional view of the exemplary device
taken along line 9A-9A of FIG. 2.
[0044] FIG. 9B is a cross-sectional view of the exemplary device of
FIG. 9A, with the lock member urged from the open position toward
the closed position.
[0045] FIG. 9C is a cross-sectional view of the exemplary device of
FIG. 9A, with the lock member urged further from the open position
toward the closed position.
[0046] FIG. 9D is a cross-sectional view of the exemplary device
taken along line 9D-9D of FIG. 3, with the lock member fully
engaged.
[0047] FIG. 10 is a cross-sectional view of the exemplary device
taken along line 10-10 of FIG. 3.
[0048] FIG. 11A is an enlarged perspective view of an alternative
embodiment of a membrane for a pump housing in accordance with the
disclosed subject matter.
[0049] FIG. 11B is an enlarged perspective view of another
alternative embodiment of a membrane for a pump housing in
accordance with the disclosed subject matter.
[0050] FIG. 11C is an enlarged perspective view of yet another
alternative embodiment of a membrane for a pump housing in
accordance with the disclosed subject matter.
[0051] FIG. 12A is a top perspective view of an exemplary battery
cover door of the pump of FIG. 1, with the battery cover door in a
closed position, and selected portions cut away for purpose of
illustration.
[0052] FIG. 12B is a top view of the exemplary battery cover door
of FIG. 12A, with the battery cover door in an open position, and
selected portions cut away for purpose of illustration.
[0053] FIG. 13 is a plan view of an exemplary delivery tube
assembly and fluid reservoir for use with the disclosed subject
matter.
DESCRIPTION
[0054] 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.
[0055] 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.
[0056] In accordance with one aspect of the disclosed subject
matter, a drug delivery reservoir cassette for a pump is provided.
The pump has a lock member movable between an open position and a
closed position, such as described further below. The cassette
generally includes a cassette housing including a cassette body
region and a cassette base region. The cassette housing has a front
surface, a back surface and lateral sidewalls. The cassette housing
defines a transverse axis extending between the lateral sidewalls
and a longitudinal axis perpendicular to the transverse axis. The
cassette body region defines a fluid reservoir chamber therein. As
embodied herein, for purpose of illustration and not limitation,
the cassette base region can be disposed along the longitudinal
axis from the cassette body region. The cassette base region has a
boundary configured to be received by the pump. The cassette base
region can include one or more features as described herein for
alignment and securement of the cassette when received by the
pump.
[0057] As embodied herein, the boundary can include a pair of
opposing rails disposed on opposite sides of the longitudinal axis.
For example, the pair of opposing rails can be substantially
symmetrical about the longitudinal axis. Each of the opposing rails
can be recessed relative an adjacent portion of the boundary. The
pair of opposing rails can be aligned along a transverse axis
relative the longitudinal axis. Each of opposing rails can define
an abutment surface generally parallel with the transverse
axis.
[0058] Additionally or alternatively, or in combination with any of
the features of the cassette base region described herein, the
cassette base region can include an engagement surface configured
to be engaged by the lock member when in the closed position. For
example, the pair of rails can be spaced from the engagement
surface in a direction along the longitudinal axis, if combined
together. As embodied herein, the engagement surface can be
substantially coplanar with the back surface of the cassette
housing. Alternatively, the engagement surface can include a
recessed area recessed relative the back surface of the cassette
base region. The recessed area can be shaped to receive the lock
member when in the closed position. As embodied herein, the
recessed area can taper to a reduced or smaller dimension in plan
view toward an end of the cassette housing.
[0059] Additionally or alternatively, or in combination with any of
the features of the cassette base region described herein, the
boundary can include an alignment key aligned parallel with the
longitudinal axis and defining a receiving recess to receive an
alignment pin from the pump. As embodied herein, the alignment key
can be centered between the lateral side walls. The alignment key
can project into the boundary. The alignment key can project from
the cassette body region into the cassette base region. The
alignment key can be channel-shaped. Additionally or alternatively,
the receiving recess can be tapered along the longitudinal
axis.
[0060] Additionally or alternatively, or in combination with any of
the features of the cassette base region described herein, the
cassette can include a delivery tube assembly extending from the
fluid reservoir chamber, and the cassette base region can include a
support rib projecting from the boundary in engagement with the
delivery tube. As embodied herein, the support rib can include a
pair of support rib portions. The delivery tube assembly can
include a pair of end fittings to receive a peristaltic tube, and
the support rib can be substantially aligned between the pair of
end fittings.
[0061] Additionally or alternatively, or in combination with any of
the features of the cassette base region described herein, the
cassette base region can include a flat surface proximate an end of
the cassette housing. The flat surface can include two flat surface
portions.
[0062] Additionally or alternatively, or in combination with any of
the features of the cassette base region described herein, the
cassette base region can include a contoured surface configured to
mate with a corresponding surface of the pump. The contoured
surface can have a concave shape directed toward the boundary in
plan view. The contoured surface can be substantially symmetrical
about the longitudinal axis.
[0063] According to another aspect of the disclosed subject matter,
and further to the above, a device for delivering a beneficial
agent is provided. The device generally includes a pump and a
cassette. The pump includes a pump housing containing a pump
assembly having a fluid drive component. The pump housing has a
receiving region disposed proximate the fluid drive component, the
receiving region configured to receive at least a portion of the
cassette. The cassette can include any combination of features of
the cassette base region described herein.
[0064] 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
device for delivering a beneficial agent, including a drug delivery
reservoir cassette, in accordance with the disclosed subject matter
are shown in FIGS. 1-13.
[0065] 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.
[0066] Referring to an illustrative embodiment of FIGS. 1-3,
delivery device 100 includes a cassette 10 including a cassette
housing 11. Cassette housing 11 can have a cassette body region 14.
Cassette body region 14 can define an interior to contain a fluid
reservoir 12 (shown for example in FIG. 13) within the cassette
housing 11, as discussed further herein. Cassette body region 14
can be any suitable shape to accommodate a fluid reservoir 12. For
example, and as embodied herein, cassette body region 14 can have a
bulbous shape defining a curved surface proximate a back surface of
the cassette housing 11, which can accommodate a fluid reservoir 12
having a similar size and shape. As embodied herein, cassette body
region 14 can have a generally flat surface proximate front surface
of cassette housing 11, opposite the back surface, which can allow
cassette housing 11 to lay flat on a planar surface, such as a
table, to facilitate a user to insert or remove cassette 10 from
engagement with a pump 30, as discussed herein.
[0067] Furthermore, and as embodied herein, the cassette housing 11
can have a cassette base region 13 to join with the pump mechanism
30, as discussed further herein. As shown, for purpose of
illustration and not limitation, cassette base region 13 can be
disposed along a longitudinal axis, such as disposed along the
longitudinal axis a from the cassette body region 14 defined along
cassette 10.
[0068] The delivery device 100 also includes a pump 30, which can
include a pump housing 31. With reference to FIGS. 1-3 and 5A-5G,
the pump housing 31 can include a receiving region 32 to receive
the cassette base region 13. For example, and as embodied herein,
the receiving region can be disposed at one end of the pump 30.
Referring now to FIGS. 1-3, the cassette base region 13 can be
inserted into the receiving region 32 and secured to the pump 30 by
closing lock member 40 into engagement with the cassette 10. As
embodied herein, for illustration and not limitation, the lock
member 40 is in the form of a lever, which closes over the cassette
10. In this manner, and as shown for example in FIGS. 9A-9D, the
lock member 40 can also be configured to engage and secure
peristaltic tube 23 to the pumping mechanism 30, as discussed
further herein. The cassette 10 can be inserted into and removed
from the receiving region 32 when the lock member 40 is in the open
position. When the lock member 40 is in the closed position, the
cassette 10 can be secured to the pump 30 with the cassette base
region 13 disposed within the receiving region 32 and inhibited or
prevented from disengagement from the pump 30.
[0069] Additionally, with reference to FIGS. 5A-5B, pump housing 31
can include one or more inputs and outputs for interaction with a
user. For example, and as embodied herein, pump housing 31 can
include input buttons 85 disposed thereon, to provide, for example
and without limitation, dosage settings and other device settings.
Input buttons 85 can be formed using any suitable techniques. For
example, and as embodied herein, input buttons 85 can be overmolded
onto pump housing 31. Input buttons 85 can be formed of a material
having a coefficient of static friction greater than that of the
remainder of the pump housing 31, such as and without limitation,
OM 3060-1 (GLS Corporation Versaflex.RTM.) and TM5ADT, TM6ADT and
TM7ADT (each from Kraiburg TPE Corporation THERMOLAST.RTM.) which
can, for example and without limitation, prevent sliding of pump
housing 31 when disposed face down on a planar surface, such as a
table, to facilitate a user to insert or remove cassette 10 from
engagement with a pump 30, as discussed herein. Pump housing 31 can
also include an output display 86. Output display 86 can be any
suitable display to provide visual information to a user, for
example and without limitation, an LCD or LED display or any other
suitable display.
[0070] Referring now to FIGS. 4A-4G and 5A-5G, for the purpose of
illustration and not limitation, the cassette 10 can be configured
to be aligned and/or secured with the pump 30 via one or more
features within the receiving region 32. For example, and as
embodied herein, cassette base region 13 can define a boundary 28
to be received by receiving region 32 of the pump. As embodied
herein, cassette base region 13 can include one or more rails 29
(as shown for example in FIG. 4B) configured to receive protrusions
33 of receiving region 32. As shown for example in FIG. 4B,
cassette base region 13 can include a pair of opposing rails 29,
which can be disposed on opposite sides of a longitudinal axis a
defined by cassette 10, and can be substantially symmetrical about
the longitudinal axis a. Additionally, and as embodied herein, each
rail 29 can be recessed relative an adjacent portion of the
boundary 28. As shown for purpose of illustration, rails 29 can be
aligned along a transverse axis b defined across cassette 10. As
embodied herein, each rail 29 can thus define an abutment surface
generally parallel with the transverse axis b.
[0071] Additionally, and as embodied herein, protrusions 33 to
receive rails 29 can be formed in pump base block 1 (as shown for
example in FIG. 6). For purpose of illustration, and as embodied
herein, pump housing 31 can include one or more slots 39 (as shown
for example in FIGS. 11A-11C) configured to receive protrusions 33
of the pump base block 1. Alternatively, the configuration of the
rails and protrusions can be reversed, such that rails 29 are
disposed on the cassette 10 and slots 39 are disposed on the pump
30.
[0072] Additionally or alternatively, and as embodied herein, the
cassette 10 can be secured and aligned via an engagement surface
17, which can be received and captured by lock member 40 when in
the closed position, as discussed further herein. Engagement
surface 17 can be substantially coplanar with the back surface of
the cassette housing 11. Alternatively, engagement surface 17 can
include a recessed area 92 recessed relative the back surface of
the cassette housing 17. For purpose of illustration, and as
embodied herein, recessed area 92 can be shaped to receive and/or
mate with at least a portion of lock member 40 when in the closed
position, as shown for example in FIGS. 2-3. As such, and as
embodied herein, recessed area 92 can taper to a smaller cross
dimension toward an end 82 of the cassette housing 11, as shown for
example in FIG. 4C. With reference to FIG. 4B, as embodied herein,
the engagement surface 17 can be configured as an elongated strip
of material to be engaged by lock member 40 when closed about
engagement feature 17. In this manner, engagement surface 17 can
form a unitary bridge across the longitudinal axis a.
Alternatively, engagement surface 17 can include a pair of
engagement surface portions on opposite sides of the longitudinal
axis a, and in some embodiments, the pair of engagement surface
portions can be substantially symmetrical about the longitudinal
axis a.
[0073] Additionally or alternatively, and as embodied herein, the
cassette 10 can be secured and aligned with the pump 30 via
alignment pin 41 in the locking mechanism. As such, and as embodied
herein, cassette base region 13 can include an alignment key 44
defining a receiving recess to receive alignment pin 41. For
purpose of illustration and not limitation, and as embodied herein,
alignment key 44 can be centered between the lateral side walls of
cassette housing 11. As embodied herein, alignment key 44 can
project into the boundary 28, and in some embodiments, alignment
key 44 can project from the cassette body region 14 into the
cassette base region 13. Alignment key 44 can have any suitable
shape to receive alignment pin 41. For example and not limitation,
alignment key 44 can be cylindrical, channel-shaped or any other
suitable shape. Additionally or alternatively, as shown for example
in FIG. 8B, the receiving recess formed by alignment key 44 can be
tapered along the longitudinal axis a to assist with receipt and
alignment of alignment pin 41 therein.
[0074] For purpose of illustration and not limitation, as shown for
example in FIGS. 5C and 8A-8B, lock member 40 can be biased, such
as by a torsion spring 42, to urge lock member 40 toward the open
position. Additionally, and embodied herein, lock member 40 can
include a pin driver 43, which can have a projection 43a received
in notch 41a of alignment pin 41. As embodied herein, pin driver 43
can be urged upon movement of lock member 40 toward the open
position to drive the alignment pin 41 away from retention feature
44 in the disposable cassette housing 11 (as shown for example in
FIG. 8A). With reference to FIG. 8B, when the lock member 40 is
moved to the closed position, the lock member 40 urges the pin
driver 43 to drive the alignment pin 41 into the retention feature
44 of the cassette housing 11. For purpose of illustration and not
limitation, as embodied herein, the alignment pin 41 can be
tapered. The material for the alignment pin 41 can be stainless
steel.
[0075] Additionally or alternatively, as further embodied herein,
cassette 10 can include support rib 54 as shown in FIG. 4B. In this
manner, and as embodied herein, pump 30 can include a tubing guide
ridge 52 (as shown for example in FIG. 5C), which can engage or
restrict movement of the peristaltic tube 23 when the cassette 10
is received within the receiving region 32. When the cassette 10 is
received within the receiving region 32, tubing guide ridge 52 can
align with support rib 54 (as shown for example in FIG. 4B) on the
cassette base region 11, for example and as embodied herein to
guide peristaltic tube 23 into engagement with an occlusion sensor.
For purpose of illustration, and as embodied herein, support rib 54
can project from boundary 28. Additionally, and as embodied herein,
support rib 54 can include a pair of support rib portions.
Alternatively, support rib 54 can be configured as a single,
unitary rib. As shown in FIG. 4B, for purpose of illustration and
not limitation, cassette housing 11 can include a pair of end
fittings 24a, 24b to support peristaltic tube 23, and if provided,
support rib 54 can be substantially aligned with end fittings 24a,
24b.
[0076] Additionally or alternatively, and as further embodied
herein, cassette base region 13 can include a contoured surface 80
configured to mate with a corresponding contoured end 81 of pump
30, as shown in FIG. 1. For purpose of illustration, and not
limitation, contoured surface 80 can include contoured end portions
80a, 80b having a concave contour relative cassette base region 13
proximate opposing sides of cassette base region 13. Additionally
or alternatively, cassette base region 13 can include a selected
flat surface 82 proximate an end of cassette housing 11. As
embodied herein, flat surface 82 can include flat surface portion
82a, 82b proximate lateral side walls of cassette housing 11. Flat
surface 82 of cassette base region 13 can be sized and shaped to
engage corresponding flat surface 83 of receiving region 32 of pump
30.
[0077] These various features of the cassette base region can be
combined in various combinations and arrangements as desired. For
example and not limitation, the cassette can be provided with the
rails and engagement surface, without an alignment key if desired.
Likewise, and without limitation, the cassette can be provided with
a pair of alignment keys each offset from the longitudinal axis
a.
[0078] According to another aspect of the disclosed subject matter,
a device for delivering a beneficial agent is provided. The device
generally includes a cassette, a pump, a delivery tube and a lock
member. 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 has a
receiving region to receive the cassette base region. The fluid
drive component is disposed proximate the receiving region. The
lock member is coupled to the pump housing and is movable between
an open position and a closed position. The cassette is capable of
being inserted into and removed from the receiving region when the
lock member is in the open position. The cassette is 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.
[0079] Additionally, and as embodied herein, an alignment pin can
be operatively coupled to the lock member. Movement of the lock
member between the open position and the closed position can extend
at least a portion of the alignment pin into engagement with the
cassette housing. The cassette housing can define a receiving
recess proximate the cassette base region to receive the alignment
pin when the lock member is moved toward the closed position. The
receiving recess can be tapered toward a closed end. For example,
the receiving recess can be defined by an alignment projection,
such as an alignment key, projecting from the cassette body region
into the cassette base region. The alignment pin can include a
tapered end. To move the alignment pin into an extended position,
the lock member can include a protrusion, and the alignment pin can
include a notch to receive the protrusion to engage the lock member
to operatively couple the alignment pin to the lock member.
Furthermore, and as embodied herein, the lock member can include a
latch, and receiving region can further include a torsion spring
mechanically coupled to the lock member to urge the latch toward
the open position.
[0080] In addition, and as embodied herein, the latch can further
include a latch cam surface, and the pump can further include an
occlusion block disposed proximate the receiving region and having
an occlusion block cam surface. The occlusion block can be biased
to urge the occlusion block cam surface against the latch cam
surface. The latch cam surface and the occlusion block cam surface
thus can be configured to urge the occlusion block toward an
operative position to hold the peristaltic tube in functional
relationship to the fluid drive component when the latch is moved
from the open position toward the closed position. The latch cam
surface and the occlusion block cam surface can be configured to
define a dead zone where the occlusion block remains in the
operative position during continued movement of the latch continues
from the open position to the closed position. The dead zone can be
defined by 10 degrees of final movement of the latch from the open
position to the closed position. The latch comprises a pivotal
latch mounted on a hinge. Alternatively, the latch can include a
draw latch mounted for sliding movement. The features of this
aspect can be combined with one or more feature of the apparatus
and methods set forth above.
[0081] With reference to FIG. 6, the pump housing 31 can include a
pump assembly 200 having a fluid drive component. The pump assembly
200 can be configured, for example, as a peristaltic pump. For
example, a peristaltic pump can include a motor 3, a cam shaft 2,
and a plurality of finger plates 34 disposed along the length of
the cam shaft 2. The cam shaft 2 is coupled to the motor 3 for
rotation about a longitudinal axis a of the cam shaft 2, and has at
least one radially-outward projection 5 defining a helical
engagement portion disposed along a length of the cam shaft 2. The
plurality of finger plates 34 are disposed along the length of the
cam shaft 2. Each finger plate 34 is mounted for movement in a
transverse direction relative to the longitudinal axis a of the cam
shaft 2, and has an aperture defined therein to receive the cam
shaft 2 therethrough. Additional details of suitable fluid drive
components and related features of the pump suitable for use
herewith are described in concurrently filed applications by
Applicant, each entitled "PUMP, MOTOR AND ASSEMBLY FOR BENEFICIAL
AGENT DELIVERY," Ser. Nos. ______, ______ and ______, each of which
is incorporated by reference in its entirety.
[0082] For purpose of illustration and not limitation, as embodied
herein, lock member 40 can be configured as a latch or cam lever,
such as a pivotal latch, a draw latch, or any other suitable
latching mechanism. As shown for example in FIGS. 6 and 7A-7G, lock
member 40 can be configured as a pivotal latch. Lock member 40 can
include a latch cam surface 48 to engage an occlusion block, as
discussed further herein. Additionally, and as embodied herein,
lock member 40 can include a hinge receptacle 75 to receive a hinge
pin 45 to allow pivotal movement of lock member 40. As embodied
herein, hinge pin 45 can also engage pin driver 43 to lock member
40 to allow pivotal movement of pin driver 43 with lock member 40,
as discussed further herein. Additionally, lock member 40 can be
biased toward an open position, such as by torsion spring 42.
Furthermore, and as embodied herein, lock member 40 can include a
closure sensor receptacle 55 to receive a closure sensor, such as
for purpose of illustration and not limitation, as embodied herein,
a magnet to trigger a reed sensor, as discussed further herein. As
shown in FIG. 7A, and as embodied herein, lock member 40 includes a
tapered end 76 sized and shaped to engage a corresponding recess in
cassette base region 13, as discussed further herein. As shown in
FIG. 7F, for purpose of illustration and not limitation, lock
member 40 can include one or more raised surface features 79 to
assist with engagement of lock member 40, for example by a user, to
move lock member 40 between the open position and closed
position.
[0083] Referring now to FIGS. 9A-9D, when the lock member 40 is
moved into the closed position, the lock member 40, urged by
torsion spring 42, pivots about the lever hinge 45. Tension springs
46 urge the occlusion block cam surface 47 of occlusion block 9
against the latch cam surface 48 of lock member 40. As such, and
with reference to FIGS. 9A-9D, the occlusion block 9 can be
positioned, by the stroke of the lock member 40, an appropriate
distance to dispose the peristaltic tube 23 operatively against the
peristaltic fingers 34 when closed, as shown for example in FIG.
9D.
[0084] As illustrated for example in FIG. 9C, with the lock member
40 within a certain angle of rotation .alpha., for example and
without limitation, within a range of approximately
0.degree.-10.degree. relative to the pump 30, the lock member lever
cam surface 48 as embodied herein enters a so-called "dead zone."
That is, within the "dead zone," the lock member 40 can continue to
be closed and latch against the pump housing 31, while the
occlusion block 9 remains positioned in a fully latched state. In
this manner, the occlusion block 9 is properly positioned relative
to the peristaltic fingers 34 even if the lock member 40 is not
fully closed, and thus the effect of mechanical tolerances in the
locking assembly on the position of the occlusion block 9 can be
reduced. A closure indicator, embodied herein as a magnet disposed
in closure sensor receptacle 55 of lock member 40, or other
suitable closure elements, can be detected by a closure sensor,
embodied herein as a magnetic field detector disposed in the pump
housing 31 proximate the lock member 40 to allow the pump assembly
to detect when the lock member 40 is fully closed.
[0085] As illustrated for example in FIG. 9D, with lock member 40
further urged into the closed position, distal projection 72 of
lock member 40 moves along cam surface of lock member release 70 to
urge lock member release 70 away from lock member 40 and allow
distal projection 72 to move beyond and engage corresponding
projection 73 of release 70. In this manner, lock member 40 is
secured in the closed position by projection 73 of release 70,
which is biased into engagement with lock member 40 by spring 74.
To release lock member 40, lock member release 70 can be urged away
from lock member 40 to move projection 73 out of alignment with
distal projection 72 to allow lock member 40, which as described
herein can be biased in the open position, to be urged into the
open position, as embodied herein by torsion spring 42.
[0086] As illustrated for example in FIG. 6, in some embodiments,
set screws 49 can be provided to the lever hinge pin 45 to allow
for adjustment during assembly to account for mechanical tolerances
and provide a suitable occlusion distance. Polishing the surface of
lock member 40 can reduce friction between the occlusion block
surface 47 and the lock member 40. The roughness average of the cam
lever can be about 0.4 .mu.m. This can be accomplished by one or
more of tumbling, anodizing, and polishing the lock member 40.
Additionally, providing an occlusion block cam surface 47 with a
slope of 30 degrees can increase the vertical component of the
force of the lock member 40.
[0087] According to another aspect of the disclosed subject matter,
and further to the above a device for delivering a beneficial agent
is provided. The device generally includes a cassette, a pump, a
delivery tube and a lock member. The cassette includes a cassette
housing with a fluid reservoir defined therein. The cassette
housing has a cassette base region, and the cassette base region
includes a radio frequency identification (RFID) shell housing a
RFID tag. The delivery tube is fluidly coupled with the fluid
reservoir. The pump includes a pump housing containing a RFID
reader and a pump assembly having a fluid drive component. The pump
housing has a receiving region to receive the cassette base region.
The RFID reader and the fluid drive component are disposed
proximate the receiving region. The lock member is coupled to the
pump housing and is movable between an open position and a closed
position. The cassette is capable of being inserted into and
removed from the receiving region when the lock member is in the
open position. The cassette is secured to the pump with the
cassette base region within the receiving region with the RFID tag
disposed proximate the RFID reader and a length of the delivery
tube in operative engagement with the fluid drive component when
the lock member is in the closed position.
[0088] Additionally, and as embodied herein, the RFID shell can
include a raised surface relative an adjacent surface of the
cassette base region. The raised surface can have a height of about
2 mm relative the adjacent surface. The receiving region can
include a dimple having a bottom radius of 2.5 mm and a top radius
of 6.25 mm, each as measured from an exterior of the pump housing.
The RFID tag can be molded in the RFID shell. Additionally or
alternatively, the RFID tag can be bonded to the RFID shell. The
RFID tag can include identification information for the cassette
encoded thereon. The RFID tag can include attribute information of
a beneficial agent contained in the fluid reservoir encoded
thereon. The attribute information can include one or more of a
concentration, a formation date, and an expiration date of the
beneficial agent.
[0089] Furthermore, and as embodied herein, the receiving region
can further include a RFID receiving region with the RFID reader
housed therein. The RFID receiving region can be configured to
engage the RFID shell when the cassette is secured to the pump with
the cassette base region within the receiving region of the pump
housing. The RFID receiving region can have a shape configured to
mate with the RFID shell. For example, the RFID shell can include a
raised surface relative an adjacent surface of the cassette base
region, and the RFID receiving region can include a dimple
configured to receive the raised surface when the cassette is
secured to the pump with the cassette base region within the
receiving region of the pump housing. The RFID shell and RFID
receiving region can be configured to dispose the RFID tag within
about 5 mm of the RFID reader when the cassette is secured to the
pump with the cassette base region within the receiving region of
the pump housing. The RFID reader can have a range of detection
configured to read the RFID tag only when the RFID receiving region
is in engagement with the RFID shell. The device can further
include a processor coupled to the RFID reader and configured to
verify identification information for the cassette encoded on the
RFID tag. Additionally or alternatively, the processor can be
coupled to the RFID reader and configured to enable operation of
the pump if an expiration date of the beneficial agent encoded on
the RFID tag is not exceeded. In addition or as a further
alternative, the processor can be coupled to the RFID reader and
configured to determine one or more dosing options based at least
in part on a concentration of the beneficial agent encoded on the
RFID tag. The RFID tag can include high or ultra-high radio
frequency ID.
[0090] According to another aspect of the disclosed subject matter,
and further to the above, a drug delivery reservoir cassette for a
pump having an RFID reader, a receiving region configured to
receive the cassette, and a lock member movable between an open
position and a closed position is provided. The cassette includes a
cassette housing with a fluid reservoir defined therein. The
cassette housing has a cassette base region. The cassette base
region includes a radio frequency identification (RFID) shell
housing a RFID tag configured to be read by the RFID reader. The
cassette is capable of being inserted into and removed from the
receiving region when the lock member is in the open position, and
the cassette is secured to the pump with the cassette base region
within the receiving region with the RFID tag disposed proximate
the RFID reader when the lock member is in the closed position.
[0091] The cassette can include any combination of features
described herein. For example, and as embodied herein, the RFID
shell comprises a raised surface relative an adjacent surface of
the cassette base region. the RFID shell can include a raised
surface relative an adjacent surface of the cassette base region.
The raised surface can have a height of about 2 mm relative the
adjacent surface. The receiving region can include a dimple having
a bottom radius of 2.5 mm and a top radius of 6.25 mm, each as
measured from an exterior of the pump housing. The RFID tag can be
molded in the RFID shell. Additionally or alternatively, the RFID
tag can be bonded to the RFID shell. The RFID tag can include
identification information for the cassette encoded thereon. The
RFID tag can include attribute information of a beneficial agent
contained in the fluid reservoir encoded thereon. The attribute
information can include one or more of a concentration, a formation
date, and an expiration date of the beneficial agent. The features
of these aspects can be combined with one or more features of the
apparatus and methods set forth above.
[0092] For example and as embodied herein, cassette 10 can include
an RFID enclosure shell to house an RFID tag. RFID enclosure shell
can be configured to engage RFID tag with a corresponding RFID
reader in pump 30. With reference to FIGS. 4B and 10, for purpose
of illustration and not limitation, the RFID enclosure shell 19 can
be shaped as a raised surface projecting into cassette base region
13. As shown for example in FIG. 10, RFID tag 18 be disposed within
RFID enclosure shell 19 by any suitable technique. For example and
without limitation, RFID tag 18 can be injection molded into the
RFID enclosure shell 19. Alternatively, the RFID tag 18 can bonded
to the RFID enclosure shell 19, for example by a potting technique,
such as epoxy potting.
[0093] Referring now to FIGS. 5C and 10, as embodied herein, the
pump housing 31 can have a RFID receiving region 38 to house an
RFID reader 37 and can engage with the RFID enclosure shell 19 of
the cassette housing 11. The RFID receiving region 38 can be
configured as a dimple disposed in the receiving region 32 of the
pump housing 31. For example, and as embodied herein, the dimple
can be 1.9 mm deep, and can include a 2.5 mm bottom radius and a
6.25 mm top radius measured from the exterior of the pump housing
31. The RFID enclosure shell 19 and the RFID receiving region 38
can be configured to allow the RFID tag 18 to be disposed within 5
mm of an RFID reader 37 when the cassette housing 11 and the pump
housing 31 are joined together, as described in further detail
below. For purpose of illustration, and not limitation, as embodied
herein, RFID reader 37 can be embedded in a circuit board disposed
in pump housing 31. RFID reader 37 can be "box-shaped," such as a
square or rectangular spiral, and formed by a number of wire
windings, embodied herein as 14 coil windings, with 7 windings in
each of two layers of the PCB. As such, RFID reader 37 can have
outer cross-dimensions of 0.360''.times.0.372'' and can have a
central aperture having inner cross-dimensions of
0.204''.times.0.228''. In this manner, RFID reader 37 can be
configured with a range of detection to only detect RFID tag 18
when the cassette housing 11 is joined to the pump housing 31, such
that another RFID tag further away from the RFID reader 37 would be
outside the range of detection. Additionally or alternatively, the
RFID reader 37 can be configured to determine which one of a
plurality of RFID tags is closer to the RFID reader 37, and thus
can determine which one of a plurality of cassette housings is
joined to the pump housing 31. RFID reader 37 can utilize any
suitable RFID techniques, including and without limitation, low,
high, or ultra-high radio frequency ID.
[0094] RFID reader 37 also can be configured to identify drug
cassettes and read information encoded in RFID tag 18. In this
manner, the system can be used to detect cassettes that are not
compatible or warrantied for use with the pump or otherwise to
deter counterfeiting of drug cassettes. For purpose of illustration
and not limitation, RFID tag 18 can include identification
information for cassette 10 encoded thereon. Additionally or
alternatively, RFID tag 18 can include attribute information of a
beneficial agent contained in the fluid reservoir encoded thereon,
which can include, without limitation, a concentration, a formation
date, and/or an expiration date of the beneficial agent. RFID
reader 37 can be coupled to a processor, which can be configured to
receive and verify the identification information for cassette 10
encoded on the RFID tag, and can be further configured to enable
operation of pump 30 only if the identification information for
cassette 10 can be verified. Additionally or alternatively, the
processor can be configured to enable operation of pump 30 only if
an expiration date of the beneficial agent, if encoded on the RFID
tag 18, is not exceeded. Additionally or as a further alternative,
processor coupled to RFID reader 37 can be configured to determine
one or more dosing options based at least in part on a
concentration of the beneficial agent contained within cassette 10,
if encoded on the RFID tag 18.
[0095] The housing provided herein can be made of a variety of
constructions and configurations. For example, and not limitation,
with reference to FIGS. 1-3 and 5C, the pump housing 31 can include
a rear closure portion 35 and a front closure portion 36. One of
the closure portions, such as the rear closure portion 35 as
embodied herein, can include a membrane 37 disposed between the
receiving region 32 and the fluid drive component, as embodied
herein, to cover the finger plates of the peristaltic pump. In such
a configuration, the finger plates of the peristaltic pump will
push on the peristaltic tube 23 with the membrane 37 disposed
in-between the fingers and the peristaltic tube 23. The membrane 37
can prevent debris and fluid from contacting and interfering with
the pumping mechanism. The membrane 37 can be a thermoformed or
injection molded membrane, which can be over-molded onto the rear
closure portion 35. As embodied herein, the membrane 37 can define
a rectangular-shaped protrusion extending from an end of the rear
closure portion 35. Membrane 37 can define vertical sides extending
from the rear closure portion 35 and forming slightly rounded
corners at an outer face of the membrane 37. Additionally or
alternatively, membrane 37 can have a first side extending from the
rear closure portion 35 to the outer face of the membrane 37 at a
gradual slope, and can have an opposing side extending vertically
from the rear closure portion 35 and forming rounded corners
proximate the outer face of the membrane 37. In this manner, the
gradual slope formed proximate the inlet side of the peristaltic
tube 23 can allow for a more gradual compression of the peristaltic
tube 23.
[0096] Furthermore, and as embodied herein, the membrane 37 can be
formed having dimensions and using materials to reduce rigidity,
and thus utilize less force from the pump to move the membrane 37
and engage the peristaltic tube 23. For example, increased
thickness of the membrane 37 can cause increased force applied by
the pump during operation, and thus, increased power utilized and
decreased battery performance. As such, the membrane 37 can have a
thickness between 0.009 inches and 0.019 inches, and in some
embodiments can have a thickness between 0.009 inches and 0.015
inches, which can provide suitable protection from debris and fluid
ingress with suitable battery consumption. The material properties
of the membrane 37, including flexibility, can similarly affect
battery performance. In some embodiments, the membrane can be
formed from Elastollan C80A, Estane 2103-90A, Elastollan S85A,
Elastollan S95A or other suitable materials.
[0097] Referring now to FIGS. 11A-11C, alternative embodiments of a
membrane 37 are illustrated. As shown for example in FIG. 11A,
membrane 37a can include rounded corners on each end of membrane
37a, and each rounded corner can be tapered inward toward a center
of membrane 37a. Alternatively, as shown for example in FIG. 11B,
membrane 37b can include rounded corners on each end of membrane
37b, and each rounded corner can be tapered outward away from a
center of membrane 37b. As a further alternative, as shown for
example in FIG. 11C, membrane 37c can include rounded corners on
each end of membrane 37c, one of the rounded corners being tapered
inward toward a center of membrane 37c and one of the rounded
corners being tapered outward away from a center of membrane 37c.
In each configuration, the curvature formed proximate the inlet
side and outlet side of the peristaltic tube 23 can allow for
peristaltic tube 23 to expand more easily after compression. For
example and without limitation, as embodied herein, the curvature
proximate the inlet side can reduce or prevent contact with one or
more end fittings or joints proximate inlet side of peristaltic
tube 23. Additionally or alternatively, the curvature formed
proximate the outlet side can prevent or inhibit the membrane from
being urged away from the occlusion sensor. Membrane 37, 37a, 37b
and 37c can be formed having any suitable thickness to prevent
debris or liquid from entering pump housing 31 and to avoid
interference with peristaltic tube 23 and/or engagement of finger
plates 4 therewith. For purpose of illustration and not limitation,
as embodied herein, membrane 37, 37a, 37b and 37c can have a
thickness of 0.33 mm.
[0098] Referring now to FIGS. 12A-12B, for the purpose of
illustration and not limitation, in some embodiments, the pump
housing 31 can include a battery cover 611. The battery cover 61
can have a rectangular shape defining a length and width. In some
embodiments, the battery cover 61 can be hingedly connected to the
pump housing 31 along the width (referred to as a "barn door
arrangement"). In alternative embodiments battery cover 61 can be
hingedly connected to the pump housing 31 along the length
(referred to as a "tailgate arrangement"). FIGS. 12A-12B show the
battery cover 61 in the barn door arrangement. As embodied herein,
the pump housing 31 can include a rod 63. The battery cover 61 can
include a hinge 62 having a `C` shape. The C-shaped hinge 62 can
allow the battery cover 61 to snap off of the pump housing 31 if
urged too far away from the pump housing 31 without damaging the
hinge and allowing the battery cover 61 to be reinstalled. In this
manner, preventing damage to the battery cover 61 from over
extension of the battery cover can provide a benefit for a user
with poor dexterity. Battery cover 61 can include a release button
64 coupled to a latch projection 65. Actuation of release button
64, for example by sliding release button away from latch
projection 65, can release latch projection from a latch receptacle
66 in pump housing 31 to allow hinged movement of battery cover 61
away from pump housing 31. The battery compartment can also include
a gasket to insulate the battery compartment and protect the
battery compartment from fluid ingress.
[0099] Referring now to FIG. 13, as embodied herein, cassette
housing 11 can contain a fluid reservoir therein. For example, the
housing itself can define the fluid reservoir, or an additional
component to define the reservoir can be contained therein. If
provided separately, the fluid reservoir 12 can be disposed in the
cassette housing 11. For example, and as embodied herein, the
cassette housing 11 can be configured with two enclosure clamshell
portions 17 and 18 (as shown for example in FIGS. 1-3), which can
receive and contain the fluid reservoir 12. The two clamshell
portions 17 and 18 can be adhered or otherwise joined together, for
example by ultrasonic welding.
[0100] As embodied herein, fluid reservoir 12 can include a
flexible pouch, which can have any of a variety of suitable shapes.
Opposing sides of the pouch can be secured about a perimeter to
form the fluid reservoir 12, for example by thermal or radio
frequency (RF) welding or the like. The fluid reservoir 12 can have
a dip tube 14. The dip tube 14 can be configured, for example and
without limitation, from SUNLITE VYSUN 102-80-26 (Non-DEHP PVC),
DuPont Elvax 3182-2 EVA, or any suitable tubing material. As
embodied herein, the dip tube 14 can have a length within a range
of approximately 108-111 mm, with a plurality of approximately 2 mm
diameter apertures disposed therein. The dip tube 14 can extend
from the fluid reservoir 12 to serve as a delivery tube if desired
or appropriate. Alternatively, and as embodied herein, an adaptor
disposed external to the cassette housing 11 can be provided and
coupled to a proximal end of the dip tube 14. In this manner, a
separate delivery tube can be coupled to the adaptor for delivery
of the beneficial agent from the fluid reservoir 12 to the user by
operation of the pump 30. Additionally, a peristaltic tube can be
provided between or as a part of the dip tube 14 and/or the
delivery tube for interaction with the pump 30.
[0101] For the purpose of illustration and not limitation, an
exemplary embodiment of such an adaptor is depicted in FIG. 13. As
shown, the fluid reservoir 12 includes an adaptor 15 disposed
external to the cassette housing 11. Adaptor 15 can be coupled to a
proximal end of the dip tube 14. As embodied herein, a
polypropylene-barbed elbow fitting 16 is provided at the proximal
end of the dip tube 14. The elbow fitting 16 can be adhered to the
exterior end of the dip tube 14 and oriented in plane with the
fluid reservoir 12. A peristaltic tube 23 can be installed or
coupled to an opposing end of the elbow fitting 16. For example,
and as embodied herein, the peristaltic tube 23 can be formed from
a section of Saint Gobain Biosil Precision tubing material. The
peristaltic tube 23 can have an inside diameter of 1.6 mm and an
outside diameter of 4.8 mm. A junction fitting 24 is joined to the
peristaltic tube 23, and a delivery tube 20 can be adhered into the
junction fitting 24. As such, the delivery tube 20 can be fluidly
coupled with the fluid reservoir 12.
[0102] 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.
[0103] 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.
[0104] 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.
[0105] 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.
[0106] 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.
* * * * *