U.S. patent application number 13/831667 was filed with the patent office on 2014-09-18 for intelligent and configurable fluid delivery system and methods for its use.
This patent application is currently assigned to MEDRAD, INC.. The applicant listed for this patent is MEDRAD, INC.. Invention is credited to John A. BROSOVICH, Kevin P. COWAN, David A. MISHLER, Edward J. RHINEHART, Mark TROCKI, Barry L. TUCKER, Arthur E. UBER, III, Martin J. URAM, Michael J. YANNIELLO.
Application Number | 20140276379 13/831667 |
Document ID | / |
Family ID | 51530683 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140276379 |
Kind Code |
A1 |
URAM; Martin J. ; et
al. |
September 18, 2014 |
INTELLIGENT AND CONFIGURABLE FLUID DELIVERY SYSTEM AND METHODS FOR
ITS USE
Abstract
A configurable fluid delivery system and methods for its use are
disclosed. The system may include one or more control units, fluid
delivery units, fluid actuator units, and disposable units. Data
sources and sensors on each of the delivery units, actuator units,
and disposable units may provide data to the control unit, thereby
identifying the components along with the manner in which they may
be configured. The control unit may notify a user regarding the
status of any one or more of the delivery, actuator, and disposable
units to indicate their appropriateness for delivering a fluid
according to one or more selected procedures and protocols. Also
disclosed are methods by which the configurable fluid delivery unit
may provide data to a user to assist the user in assembling and
testing a particular fluid delivery configuration for a specific
use.
Inventors: |
URAM; Martin J.;
(Pittsburgh, PA) ; UBER, III; Arthur E.;
(Pittsburgh, PA) ; COWAN; Kevin P.; (Allison Park,
PA) ; BROSOVICH; John A.; (Pittsburgh, PA) ;
MISHLER; David A.; (Slippery Rock, PA) ; RHINEHART;
Edward J.; (Monroeville, PA) ; YANNIELLO; Michael
J.; (Cheswick, PA) ; TROCKI; Mark; (Cheswick,
PA) ; TUCKER; Barry L.; (Verona, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDRAD, INC. |
Indianola |
PA |
US |
|
|
Assignee: |
MEDRAD, INC.
Indianola
PA
|
Family ID: |
51530683 |
Appl. No.: |
13/831667 |
Filed: |
March 15, 2013 |
Current U.S.
Class: |
604/65 ;
29/428 |
Current CPC
Class: |
A61M 2005/1406 20130101;
A61M 5/16827 20130101; Y10T 29/49826 20150115; A61M 5/172 20130101;
A61M 5/16881 20130101; A61M 5/14212 20130101; A61M 5/1452
20130101 |
Class at
Publication: |
604/65 ;
29/428 |
International
Class: |
A61M 5/172 20060101
A61M005/172 |
Claims
1. A configurable fluid delivery system, the system comprising: a
fluid delivery unit comprising at least one delivery unit data
source; a fluid actuator unit in reversible mechanical
communication with the fluid delivery unit, wherein the fluid
actuator unit comprises an actuator unit data source; and a control
unit comprising: a computing device in reversible data
communication with at least one of the fluid delivery unit and the
fluid actuator unit, and a non-transitory, computer-readable
storage medium in operable communication with the computing device;
and an output device in operable communication with the computing
device; wherein the computer-readable storage medium contains one
or more programming instructions that, when executed, causes the
computing device to: receive delivery unit data from the delivery
unit data source and actuator unit data from the actuator unit data
source, determine a mechanical compatibility status between the
fluid delivery unit and the fluid actuator unit based, at least in
part, on the delivery unit data and the actuator unit data,
transmit, to the output device, an output related to the mechanical
compatibility status, determine a communication integrity status
between two or more of: the fluid delivery unit, the fluid actuator
unit, and the control unit, transmit, to the output device, an
output related to the communication integrity status, and transmit,
to the output device, an output configuration of a graphical
display, wherein the output configuration is dependent, at least in
part, on one or more of the delivery unit data and the actuator
unit data.
2. The configurable fluid delivery system of claim 1, wherein the
fluid delivery unit is configured to be in reversible mechanical
communication with a disposable device.
3. The configurable fluid delivery system of claim 2, wherein the
disposable device comprises one or more of the following: at least
one disposable device identification device, at least one
disposable device sensor, and at least one disposable device data
storage device.
4. The configurable fluid delivery system of claim 2, wherein the
fluid delivery unit is configured to receive disposable unit data
from one or more of the following: a disposable device
identification device, a disposable device sensor, and a disposable
device data storage device.
5. The configurable fluid delivery system of claim 4, wherein the
fluid delivery unit is configured to transmit the disposable unit
data to one or more of the computing device and the fluid actuator
unit.
6. The configurable fluid delivery system of claim 1, wherein the
fluid actuator unit is configured to be in reversible fluid
communication with a fluid source.
7. The configurable fluid delivery system of claim 1, wherein the
fluid actuator unit is configured to receive delivery unit data
from the delivery unit data source.
8. The configurable fluid delivery system of claim 1, wherein the
actuator unit data comprises one or more of the following:
activator unit sensor unit data, actuator unit identifier data, and
actuator unit data from an actuator unit data storage device.
9. A method of assembling a configurable fluid delivery device, the
method comprising: selecting a fluid delivery unit from one or more
fluid delivery units; selecting a fluid actuator unit from one or
more fluid actuator units; placing the fluid actuator unit in
reversible mechanical communication with the fluid delivery unit;
placing a control unit in reversible data communication with one or
more of the fluid delivery unit and the fluid actuator unit;
transmitting, by the control unit to an output device, mechanical
status data related to the reversible mechanical communication
between the fluid actuator unit and the fluid delivery unit; and
transmitting, by the control unit to an output device,
communication status data related to the reversible data
communication between one or more of: the fluid delivery unit and
the control unit; and the fluid actuator unit and the control
unit.
10. The method of claim 9, wherein selecting a fluid delivery unit
comprises selecting the fluid delivery unit based at least in part
on a medical procedure, a veterinary procedure, or a research
procedure.
11. The method of claim 9, wherein transmitting, by the control
unit, mechanical status data comprises transmitting, by the control
unit, the mechanical status data to the output device in a format
determined at least in part on one or more of (i) fluid delivery
unit data received by the control unit and (ii) fluid actuator unit
data received by the control unit
12. The method of claim 9, wherein transmitting, by the control
unit, communication status data comprises transmitting, by the
control unit, the communication status data to the output device in
a format determined at least in part on one or more of (i) fluid
delivery unit data received by the control unit and (ii) fluid
actuator unit data received by the control unit.
13. The method of claim 9, further comprising: selecting a
disposable unit; and placing the disposable unit in reversible
mechanical communication with the fluid delivery unit.
14. The method of claim 13, further comprising placing the
disposable unit in reversible data communication with one or more
of the following: the fluid delivery unit, the actuator unit, and
the control unit
15. The method of claim 13, further comprising transmitting, by the
control unit to an output unit, the mechanical status data related
to the reversible mechanical communication between the disposable
unit and the fluid delivery unit.
16. The method of claim 13, further comprising transmitting, by the
control unit to an output unit, the communication status data
related to a reversible data communication between the disposable
unit and one or more of the fluid delivery unit, the fluid actuator
unit, and the control unit.
17. The method of claim 9, further comprising altering a reversible
mechanical communication between the fluid delivery unit and the
fluid actuator unit based at least in part on the mechanical status
data received by the output unit from the control unit.
18. The method of claim 9, further comprising replacing the fluid
delivery unit based at least in part on the mechanical status data
received by the output unit from the control unit.
19. The method of claim 18, wherein replacing the fluid delivery
unit comprises replacing the fluid delivery unit with a second
fluid delivery unit, wherein each of the fluid delivery unit and
the second fluid delivery unit are of a first type.
20. The method of claim 18, wherein replacing the fluid delivery
unit comprises replacing the fluid delivery unit with a second
fluid delivery unit, wherein the fluid delivery unit is of a first
type and the second fluid delivery unit is of a second type.
21. The method of claim 9, further comprising replacing the fluid
actuator unit based at least in part on the mechanical status data
received by the output unit from the control unit.
22. The method of claim 21, wherein replacing the fluid actuator
unit comprises replacing the fluid actuator unit with a second
fluid actuator unit, wherein each of the fluid actuator unit and
the second fluid actuator unit are of a first type.
23. The method of claim 21, wherein replacing the fluid actuator
unit comprises replacing the fluid actuator unit with a second
fluid actuator unit, wherein the fluid actuator unit is of a first
type and the second fluid actuator unit is of a second type.
Description
BACKGROUND
[0001] Automated fluid delivery systems find many applications in
medicine, veterinary practice, and animal research. The number of
possible procedures, fluids, recipients, and conditions for fluid
delivery may vary markedly. Procedures may include fluid delivery
of antibiotics, saline, radiological contrast fluid, radioactive
tracers, bone cement, gels, and gene therapy. The fluids may also
include small molecules, macromolecules, gels, particles, cells,
and viruses in any number of combinations. Recipients may include
small rodents such as mice and rats, medium sized animals such as
pigs and dogs, and humans. Volumes of injectate may range from
about 1000 ml or more to less than about 1 nl, and delivery times
may range from over about 1000 seconds (about 20 minutes) or more
to less than 1 msec.
[0002] It is apparent that the variety of uses for fluid delivery
systems suggests a variety of different systems, each optimized for
the procedure, recipient, fluid, and/or condition for its intended
use. It may be appreciated, both from the user's perspective as
well as from the manufacturer's perspective, that the large number
of possible fluid delivery systems may prove inconvenient. As one
example, a small hospital may not be able to afford separate fluid
delivery devices for antibiotic administration and the delivery of
radiological contrast solutions for CT imaging. As another example,
a medical researcher using animal models for human diseases may not
wish to devote needed laboratory space to the number of injectors
necessary to cover the wide variety of test animals including mice,
dogs, and pigs. From the perspective of a manufacturer, it may be
inefficient to develop one fluid delivery system to inject genetic
material into a dog liver and then develop from scratch a second
system to deliver radiological contrast material to a patient,
since both systems are merely specific examples of a general system
for introducing a fluid into a recipient.
[0003] It may, therefore, be appreciated that an intelligent and
configurable fluid delivery system may reduce excess cost, space,
and development time for both users and manufacturers, and provide
flexibility to researchers to allow the development of new
procedures that are not presently available with current
equipment.
SUMMARY
[0004] In an embodiment, a configurable fluid delivery system may
include a fluid delivery unit having at least one delivery unit
data source, a fluid actuator unit in reversible mechanical
communication with the fluid delivery unit, in which the fluid
actuator unit has an actuator unit data source, and a control unit.
The control unit may include a computing device having a
non-transitory, computer-readable storage medium in operable
communication with the computing device, the computing device
further being in reversible or two way data communication with the
fluid delivery unit and the fluid actuator unit, and an output
device in operable communication with the computing device.
Additionally, the computer-readable storage medium may contain one
or more programming instructions that, when executed, may cause the
computing device to receive delivery unit data from the delivery
unit data source and actuator unit data from the actuator unit data
source, determine a mechanical compatibility status between the
fluid delivery unit and the fluid actuator unit based, at least in
part, on the delivery unit data and the actuator unit data,
transmit, to the output device, an output related to the mechanical
compatibility status, determine a communication integrity status
between two or more of the fluid delivery unit, the fluid actuator
unit, and the control unit, transmit, to the output device, an
output related to the communication integrity status, and transmit,
to the output device, an output configuration of a graphical
display, wherein the output configuration is dependent, at least in
part, on one or more of the delivery unit data and the actuator
unit data.
[0005] In an embodiment, a method of assembling a configurable
fluid delivery device includes selecting a fluid delivery unit from
one or more fluid delivery units, selecting a fluid actuator unit
from one or more fluid actuator units, placing the fluid actuator
unit in reversible mechanical communication with the fluid delivery
unit, placing a control unit in reversible data communication with
one or more of the fluid delivery unit and the actuator unit,
transmitting, by the control unit to an output device, mechanical
status data related to the reversible mechanical communication
between the fluid actuator unit and the fluid delivery unit, and
transmitting, by the control unit to an output device,
communication status data related to the reversible data
communication between one or more of the fluid delivery unit and
the control unit, and the fluid actuator unit and the control
unit.
[0006] In an embodiment, a fluid delivery device or system may
incorporate a high crack pressure valve between a fluid
pressurizing device and one or more fluid path elements conducting
fluid to the patient or fluid recipient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 illustrates an example of a configurable fluid
delivery system in accordance with the present disclosure.
[0008] FIG. 2 illustrates examples of a fluid delivery unit that
may be part of a configurable fluid delivery system in accordance
with the present disclosure.
[0009] FIGS. 3A-D illustrate examples of disposable units that may
be used with fluid delivery units that may be part of a
configurable fluid delivery system in accordance with the present
disclosure.
[0010] FIG. 4 is a flow diagram of an illustrative method of
assembling a configurable fluid delivery system in accordance with
the present disclosure.
[0011] FIG. 5 is a flow diagram of an illustrative method by which
a configurable fluid delivery system may assist a user in
assembling the configurable fluid delivery system in accordance
with the present disclosure.
[0012] FIGS. 6A,B illustrate examples of a spool-type high crack
pressure valve in accordance with the present disclosure.
[0013] FIG. 7 illustrates an example of a compression-type high
crack pressure valve in accordance with the present disclosure.
DETAILED DESCRIPTION
[0014] In a broad sense, a fluid delivery device may include a
fluid delivery unit, such as a cradle element to hold a syringe, a
disposable unit, such as a syringe, a fluid actuator unit, such as
a linear driven piston and drive elements, which together are
operated and controlled by a control unit to provide an injection.
The control unit may present a user with information regarding
setting up an injection protocol, ongoing status during the
injection, and additional information regarding the injection
procedure. In one example, the information may be presented as a
graphical interface specific to the type of injection protocol
being used. Additionally, the control unit may receive information
from the user via an input device regarding parameters necessary
for setting up the injection protocol.
[0015] A typical design cycle for such a fluid delivery device may
have separate portions dedicated to the development of the actuator
unit, the fluid delivery unit, the disposable unit, and the control
unit. The design of the control unit, in particular, may require
detailed knowledge of the fluid delivery unit, the fluid actuator
unit, and the disposable unit. The control unit may include
programming to incorporate safety features to prevent any one of
the components from being damaged or operated outside its design
specifications. Such safety features, such as maximum fluid
delivery rate, total fluid delivery volume, and maximum fluid
delivery pressure, may depend on the capabilities of the fluid
delivery device's components. Additionally, the control unit may
present a graphical interface to the user specific to the type of
procedure for which the fluid delivery device may be used and may
be designed to provide the optimum information regarding that
procedure. The graphical interface may also be designed to receive
only the information relevant to that injection procedure and
include safeguards to prevent a user from entering information
outside the appropriate bounds for operating the fluid delivery
unit during that protocol.
[0016] It may, therefore, be appreciated that significant
programming may be involved in the design of a control unit.
Although any one type of fluid delivery device may differ from
another type of fluid delivery device, nevertheless, there may be
control components that are similar across a number of devices. One
method for streamlining the control unit design may be for
developers to have a library of routines (re-usable code) from
which specific control routines may be incorporated into the
control unit software during development. A difficulty with this
method of software development may lie with potential upgrades and
changes to hardware components of the fluid delivery device. If
hardware is replaced on a fluid delivery device that is already in
operation or available for sale, novel features in the upgraded
hardware may not be reflected in the original control software, and
thus may go unused. Alternatively, an upgrade in the device
hardware may then require an equivalent upgrade in the control unit
software to take advantage of the new features.
[0017] One method of addressing possible unequal development cycles
of control unit software and delivery unit hardware may include the
addition of intelligence within the separate hardware components
associated with the fluid delivery device. In one embodiment, each
fluid delivery unit, each actuator unit, and each disposable unit
may have identification information included in the hardware
itself. Such identification information may then be read by the
control unit as a means to identify each of the components included
in the fluid delivery device. The control unit software may then
use the identification information to determine which of a variety
of pre-programmed steps to take. In another embodiment, some or all
of the fluid delivery unit components may include not only
identification information, but executable software code (for
example in small flash memory units) that may be downloaded by the
control unit for execution. In this manner, the original control
unit programming may not be restricted to the original programming,
but may be able to incorporate updated programming associated with
the individual hardware components necessary. Alternatively, each
of the fluid delivery unit components may include a unit specific
control unit that may present a standardized interface to the
system control unit.
[0018] Disclosed below are a general outline of generic components
that may be used in such an intelligent and configurable fluid
delivery device and system, as well as a few specific examples of
the types of fluid delivery devices that may be developed from it.
It may be appreciated that a wide variety of individual devices may
be produced from such a system, and that the examples disclosed
below include merely a small number of possible devices. It may be
further appreciated that where a singular component--such as a
fluid delivery unit, a fluid actuator unit, a disposable unit or,
an interface device--is disclosed, multiple components may also be
considered incorporated within the scope of the disclosure.
[0019] FIG. 1 illustrates a general intelligent and configurable
fluid delivery system. The system 100 may include a fluid delivery
unit 110 and a fluid actuator unit 120 that are placed in
reversible mechanical communication 115 so that the fluid actuator
unit may cause the fluid delivery unit to express a fluid for use
during a procedure. The fluid delivery unit 110 may also be in
reversible communication with a controller unit 130 over a fluid
delivery unit communication link 127. Similarly, the fluid actuator
unit 120 may also be in reversible communication with the
controller unit 130 over a fluid actuator unit communication link
125.
[0020] As illustrated in FIG. 2, non-limiting examples of a fluid
delivery unit 210 may include one or more of the following: a
single syringe delivery unit 260a, a micro-syringe delivery unit
260b, a catheter 260c, a multiple syringe delivery unit 260d, and a
needle. Additional non-limiting fluid delivery units may include
one or more of the following: a gear pump unit, a peristaltic pump
unit, a multiple inline syringe pump unit, a diaphragm pump unit,
and other pumping mechanisms known in the medical fluid delivery
art.
[0021] The fluid delivery unit 110 may include at least one
delivery unit data source. In some non-limiting embodiments, the
delivery unit data source may include one or more of the following:
a delivery unit sensor, a delivery unit ID device, and a delivery
unit data storage device. In some other non-limiting embodiments,
the delivery unit data source may include one or more of the
following: a delivery unit temperature sensor, a delivery unit
pressure sensor, a motor current sensor, a force sensor, a delivery
unit fluid flow sensor, a delivery unit fluid flow acceleration
sensor, a delivery unit fluid flow deceleration sensor, a delivery
unit particle-counting sensor, a delivery unit fluid viscosity
sensor, and a delivery unit fluid leak sensor. In other
non-limiting embodiments, the delivery unit data source may include
one or more of the following: a linear bar code, a matrix bar code,
and an RFID device. Additional non-limiting embodiments of the
delivery unit data source may include one or more of the following:
a flash drive device, a readable solid state memory device, a
magnetic memory strip, a disk drive, and a programmable/readable
solid state memory device.
[0022] Delivery unit data, associated with any one or more of the
delivery unit data sources, may include without limitation any one
or more of the following: delivery unit sensor unit data, delivery
unit identifier data, and delivery unit data from a delivery unit
data storage device. In some embodiments, the delivery unit data
may include one or more of the following: a delivery unit product
ID code, a delivery unit model number, a delivery unit serial
number, a delivery unit date of manufacture, a time of fluid
injection, a software version identifier, a firmware version
identifier, calibration data, operational capability data, and a
delivery unit place of manufacture. Additional non-limiting
examples of delivery unit data may further include one or more of
the following: delivery unit configuration data, delivery unit use
data, actuator unit compatibility data, a time of fluid injection,
and delivery unit function instructional code. Descriptions of
exemplary data associated with one or more fluid path elements may
be found in U.S. Pat. No. 5,739,508 to Uber which is hereby
incorporated by reference in its entirety.
[0023] The fluid delivery unit 110 may also be configured to be in
reversible mechanical communication with a disposable device. The
disposable device may include, as non-limiting examples, one or
more of the following: a cannula that may include a needle, a
contrast-containing syringe, a pharmaceutical-containing syringe, a
cell fluid containing syringe, a gene therapy containing syringe, a
flushing-fluid containing syringe, an empty syringe, a
high-pressure fluid syringe, a micro-syringe, a transfer tube, a
one-way valve, a manually controllable multi-port valve, an
automatically controllable multi-port valve, and one or more pieces
of tubing or conduit that together may form a fluid path.
[0024] The disposable device may also include, as non-limiting
examples, one or more of the following: at least one disposable
device identification device, at least one disposable device
sensor, and at least one disposable device data storage device. The
fluid delivery unit 110 may be configured to receive disposable
unit data from one or more of the following: a disposable device
identification device, a disposable device sensor, and a disposable
device data storage device. Non-limiting examples of disposable
unit data may further include one or more of the following:
disposable identification data, disposable temperature data,
disposable pressure data, disposable fluid leak data, and
disposable multiple use data.
[0025] FIGS. 3A-D further illustrate non-limiting configurations of
disposable units with associated fluid delivery units.
[0026] FIG. 3A illustrates a fluid delivery unit 310a that may be
of a type capable of forming a reversible mechanical communication
with a disposable tubing set 360 having a needle. The tubing set
360 may include a data source 363, such as a sensor or a device
containing identification data. The data source 363 may further
include a data source output 365 that may be in communication with
any of the components of the fluid delivery system. Supply fluid
for the fluid delivery unit 310a may be sourced from any of a
number of fluid sources 366 over a fluid delivery line 361. Sources
may include bags or vials among others such sources. The fluid
source 366 may also include a data source 367, such as a sensor or
a device containing identification data.
[0027] FIG. 3B illustrates a fluid delivery unit 310b that may
receive different fluids from multiple fluid sources. One fluid for
the fluid delivery unit 310b may be sourced from a first fluid
source 370 over a first fluid delivery line 371. The first fluid
source 370 may be a vial containing a small amount of fluid, such
as a radiopharmaceutical fluid. The second fluid source 373 may be
a bag containing a large amount of fluid, such as a fluid to purge
the fluid delivery unit 310b of the radiopharmaceutical fluid. The
second fluid source 373 may also include a data source 376, such as
a sensor or a device containing identification data. Although not
illustrated in FIG. 3B, the first fluid source 370 may also include
a data source.
[0028] FIG. 3C illustrates a fluid delivery unit 310c that may be
in reversible physical communication with a catheter 380, such as a
balloon catheter. The fluid delivery unit 310c may be configured to
supply fluid to the catheter 380 over an inlet line 384 and receive
fluid from a return line 386. Fluid introduced into the catheter
380 may be used to inflate or deflate an angioplasty balloon 382.
The catheter 380 may also include a data source 387, such as a
sensor or a device containing identification data. The data source
387 may further include a data source output 389 that may be in
communication with any of the components of the fluid delivery
system.
[0029] FIG. 3D illustrates a fluid delivery unit 310d that may be
used to supply multiple fluids. Although FIG. 3D illustrates a
single fluid delivery unit 310d that may be used to supply multiple
fluids, it may be recognized that multiple fluids may be delivered
by two separate fluid delivery units, such as 260a, coordinated
through the communication of one or more fluid actuator units 120
and/or controller units 130. Each fluid may be supplied from a
separate device, such as a syringe. An example of such a device may
include a fluid delivery system designed to inject a radiological
contrast fluid and a separate flushing solution, such as neutral
saline. In addition to the syringes supplying the fluids,
disposable units may include a manifold 390 configured to receive
fluid from each of the syringes. The manifold may be in fluid
communication with a first syringe over a transfer line containing
a first fluid control device 396, such as a first valve. The first
fluid control device 396 may be manually controlled or under
automated control by a control unit (130, see FIG. 1). One example
of a manual valve may be a one-way fluid valve to prevent fluid
from entering the first syringe. Automated control may be
accomplished by transmission of control signals over a first valve
control line 397. The manifold 390 may also be in fluid
communication with a second syringe over a transfer line containing
a second fluid control device 398, such as a second valve. The
second fluid control device 398 may be manually controlled or under
automated control by a control unit (130, see FIG. 1). One example
of a manual valve may be a one-way fluid valve to prevent fluid
from entering the second syringe. Automated control may be
accomplished by transmission of control signals over a second valve
control line 399. The first fluid control device 396 and the second
fluid control device 398 may be operated to allow only one fluid to
flow at time, or may permit both fluids to flow into the manifold
390 effectively simultaneously, allowing fluid mixture. The
manifold 390 may also include a selection valve 393 to select the
flow of only one of the two fluids at a time, or may be configured
to act as a mixing valve of the two fluids. The selection valve 393
may be manually controlled or under automated control by a control
unit (130, see FIG. 1). Automated control may be accomplished by
transmission of control signals over a selection valve control line
392.
[0030] It may be appreciated that control and/or sensor data
transmitted by any of the sensors or function control devices
associated with the disposable unit as disclosed above may be
received by any one or more of the fluid delivery system
components, including without limitation, the fluid delivery unit
110, the fluid actuator unit 120, and/or the control unit 130.
Similarly, control and/or sensor data received by any of the
sensors or function control devices associated with the disposable
unit as disclosed above may be transmitted by any one or more of
the fluid delivery system components, including without limitation,
the fluid delivery unit 110, fluid actuator unit 120, and/or
control unit 130. Similarly, control and/or sensor data received by
the fluid delivery unit 110 from any of the sensors or function
control devices associated with the disposable unit as disclosed
above may be transmitted to any one or more of the remaining fluid
delivery system components, including without limitation, the fluid
actuator unit 120 and/or control unit 130.
[0031] Returning to FIG. 1, non-limiting examples of a fluid
actuator unit 120 may include one or more of the following: a pump,
a single-piston actuator, a multi-piston actuator, a multi-cylinder
actuator, a rotary actuator, a reciprocal plunger actuator, and a
peristaltic actuator. The fluid activator unit 120 may also include
at least one activator unit data source. The actuator unit data
source may include, as non-limiting examples, one or more of the
following: an actuator unit sensor, an actuator unit ID device, and
an actuator unit data storage device. The actuator unit data source
may further include, as non-limiting examples, one or more of the
following: an actuator unit temperature sensor, an actuator unit
pressure sensor, an actuator unit mechanical motion sensor, an
actuator unit fluid delivery rate sensor, an actuator unit fluid
delivery acceleration sensor, a force sensor, a motor current
sensor, a syringe identification sensor, an actuator unit fluid
delivery particle-counting sensor, an actuator unit fluid viscosity
sensor, and an actuator unit fluid delivery deceleration sensor.
Additionally, the actuator unit data source may incorporate one or
more of the following: a linear bar code, a matrix bar code, and an
RFID device. Further, the actuator unit data source may include one
or more of the following: a disk drive, a flash drive device, a
readable solid state memory device, and a programmable/readable
solid state memory device.
[0032] The actuator unit data source may provide actuator unit data
that may be available to one or more of the fluid delivery unit 110
and the control unit 130. The actuator unit data may include, as
non-limiting examples, one or more of the following: activator unit
sensor unit data, actuator unit identifier data, and actuator unit
data from an actuator unit data storage device. Additionally, the
actuator unit data may further include one or more of the
following: an actuation unit product ID code, an actuation unit
model number, an actuation unit serial number, an actuation unit
date of manufacture, a software version identifier, a firmware
version identifier, and an actuation unit place of manufacture. The
actuator unit data may also include one or more of the following:
actuation unit configuration data, actuation unit use data,
delivery unit compatibility data, calibration data, operational
capability data, and actuation unit function instructional
code.
[0033] The fluid actuator unit 120 may further be configured to
receive delivery unit data from one or more delivery unit data
sources. Additionally, the fluid actuator unit 120 may be
configured to be in reversible fluid communication with a fluid
source.
[0034] Although mechanical communication 115 may refer solely to
the arrangement of the physical components, it may be understood
that the communication may also incorporate data communication
between the fluid delivery unit 110 and the fluid actuator unit
120. Such data communication between the fluid delivery unit 110
and the fluid actuator unit 120 may be embodied in the same
physical connector as the mechanical communication connector (such
as a "plug and play" connection), or the data communication between
the two units may be accomplished using one or more separate
electrical connectors. In one non-limiting embodiment, the actuator
unit 120 and the delivery unit 110 may simply "snap together". In
an alternative non-limiting embodiment, the actuator unit 120 and
the delivery unit 110 may additionally be affixed onto a mechanical
or electro-mechanical base 105 that may assist in stabilizing the
actuator unit and the delivery unit in their functional
relationship. It may be appreciated that fluid delivery units 110
and fluid actuator units 120 may be designed specifically for use
as part of the fluid delivery system. Alternatively, one or more
"translation pods" may permit a commercially available fluid
delivery unit 110 or fluid actuator unit 120 to be incorporated
into the fluid delivery system. Such "translation pods" may include
simple electronic pass-through components to permit data exchange
with the control unit 130. Alternatively, the "translation pods"
may include microprocessors, non-volatile and volatile storage
media and other intelligent electronics along with program
instructions to translate instructions issued by the control unit
130 into commands and data native to the commercial fluid delivery
units 110 or fluid actuator units 120. The "translation pods" may
similarly convert data from the commercial components into data and
information readily usable by the control unit 130. Alternatively,
a commercially available fluid delivery unit 110 or fluid actuator
unit 120 may include the data and interface connections
pre-configured to exchange data with control unit 130 without the
need for a "translation pod".
[0035] It may be appreciated further that the mechanical
communication 115 between the fluid actuator unit 120 and the fluid
delivery unit 110 may be reversible. Such a feature may be useful
if the fluid actuator unit 120 and/or the fluid delivery unit 110
suffer a failure during use requiring a replacement part to be
substituted for the failed unit. A failure condition of the fluid
actuator unit 120 and/or the fluid the delivery unit 110 may be
communicated to the user by the control unit 130 via any of a
number of possible output devices. The failure notification may be
based at least in part on mechanical status data received by the
control unit 130 from the fluid delivery unit 110 and/or the fluid
actuator unit 120. The replacement part for either the fluid
deliver unit 110 or fluid actuator unit 120 may be of the same type
as the original (failed) unit, or may be of a different type such
as an upgraded part.
[0036] The fluid delivery unit 110 and the fluid actuator unit 120
may further be in data communication with the controller unit 130.
The fluid delivery unit 110 may have a fluid delivery unit
communication link 127 with the control unit 130, while the fluid
actuator unit 120 may have a separate fluid actuator unit
communication link 125 with the control unit. Alternatively, the
fluid delivery unit 110 and the fluid actuator unit 120 may
communicate with the control unit 130 over the same data
communication link. The communication links may be reversible, so
that the control unit 130 may both receive data from and transmit
data to the fluid delivery unit 110 and/or the fluid actuator unit
120. It may be appreciated that more than a single fluid delivery
unit 110 and fluid actuator unit 120 may be associated with the
fluid delivery system. As one non-limiting example, a control unit
130 may be in data communication with a plurality of fluid delivery
units 110 and associated fluid actuator units 120. Such a
configuration may be useful for a veterinary research application
in which a number of experimental animals are each infused with one
or more medications according to a protocol specifically designed
for each animal. The control unit 130 may permit a user to control
and monitor each fluid delivery unit 110 separately, and provide
information from each combination of a fluid delivery unit 110 and
a fluid actuator unit 120.
[0037] As disclosed above, the fluid delivery unit 110 may be in
reversible communication with a controller unit 130 over a fluid
delivery unit communication link 127. Non-limiting examples of data
to be communicated may include fluid delivery unit data and/or
disposable device data. Similarly, the fluid actuator unit 120 may
be in reversible communication with the controller unit 130 over a
fluid actuator unit communication link 125. Non-limiting examples
of data to be communicated may include actuator and/or control
signals to activate the fluid actuator. Some non-limiting examples
of such control signals may include one or more of the following: a
fluid delivery unit rate signal, a fluid delivery unit volume
signal, a fluid delivery unit pressure signal, a fluid delivery
unit particle-counting signal, and a fluid delivery unit
acceleration/deceleration signal. In addition, the controller unit
130 may receive input data over an input communication link 137
from an input device 140, and provide output data over an output
communication link 135 to an output device 150. It may be
appreciated that the input device 140 and the output device 150 may
be the same physical device. Consequently, the input communication
link 137 and the output communication link 135 may be the same
physical device.
[0038] Control unit 130 may include any number of components. In
some non-limiting embodiments, the control unit may include a
non-transitory, computer-readable storage medium in operable
communication with a computing device. In some embodiments, the
control unit 130 may also include the output device 150 in operable
communication 135 with the computing device as well as the input
device 140 in operable communication 137 with the computing device.
Alternatively, one or both of the output device 150 and the input
device 140 may be separate devices from the control unit 130.
Additionally, the control unit 130 may include any one or more of
the following: an internet communication interface, a serial
communication interface, a parallel communication interface, a
local network interface, a wide range network interface, an optical
interface, a wireless communications interface, a gesture-driven
interface, a voice-activated interface, and an RF interface. Such
communication interfaces may be in communication with, as
non-limiting examples, hospital information systems, radiology
information systems, imaging systems, workstations, PACS systems,
and service or monitoring systems. Non-limiting examples of output
devices 150 may include: a computer, a work station, a laptop
computer, an iPad, a tablet, a phablet, a Blackberry device, a PDA,
and a cellular telephone. Non-limiting examples of input devices
140 may include: a keyboard, a mouse, a joystick, an optical
character reader, an RF device interface, a voice recognition
interface, a touch screen, and a motion tracking device.
[0039] The non-transitory, computer-readable storage medium, in
operable communication with a computing device as part of the
control unit 130, may contain one or more programming instructions
that, when executed, cause the computing device to: receive
delivery unit data from the delivery unit data source and actuator
unit data from the actuator unit data source; determine a
mechanical compatibility status between the fluid delivery unit 110
and the fluid actuator unit 120 based, at least in part, on the
delivery unit data and the actuator unit data; transmit, to the
output device 150, an output related to the mechanical
compatibility status; determine a communication integrity status
between two or more of the fluid delivery unit 110, the fluid
actuator unit 120, and the control unit 130; and transmit, to the
output device 150, an output related to the communication integrity
status. In addition, the one or more programming instructions may
cause the computing device to transmit, to the output device 150,
an output configuration of a graphical display that depends on the
output configuration, at least in part, on one or more of the
delivery unit data and the actuator unit data. The output display
information may be chosen by the control unit 130 from among
display data preloaded in the non-transitory memory. In one
non-limiting embodiment, the specific display may be based at least
in part on the fluid delivery unit data, the disposable data,
and/or the fluid actuator data. In another non-limiting embodiment,
the specific display may be based at least in part on a procedure
entered by the user via the input device 140. Alternatively, a user
may choose a specific display from a library of displays. In
another embodiment, a user may create a custom display from
graphical primitives provided by the control unit 130.
[0040] It may be appreciated that the control unit 130 may also
receive programming instructions specific to the fluid delivery
unit 110 from one or more delivery unit data sources. Similarly,
the control unit 130 may receive programming instructions specific
to the fluid actuator unit 120 from one or more actuator unit data
sources. In yet another alternative, the control unit 130 may
receive programming instructions over a communications link from
another device including, but not limited to, a computer, a laptop,
a tablet, a cell phone, or any other source of electronic data.
Additional data related to the fluid delivery unit 110, disposable
devices, the fluid actuator unit 120, or any other component of the
fluid delivery system may be received by the control unit 130 over
a communications link from another device including, but not
limited to, a computer, a laptop, a tablet, a cell phone, or any
other source of electronic data. Such additional data may include
without limitation software or firmware upgrades for any of the
fluid delivery system components or information related to user
displays.
[0041] The computing device, along with its associated volatile and
non-volatile storage media, may additionally serve to retain,
track, organize, analyze, and log performance and/or activity data
from any of the fluid delivery system components. Such performance
and/or activity data may be downloaded by a user at the fluid
delivery system or remotely. Locally downloaded performance and/or
activity data may be presented to the user as part of a user
display on the output device 150 or as hard copy. In some
embodiments, a user may further enter instructions over the input
device 140 or remotely cause the computing device to analyze the
performance and/or activity data according to a user directed
method. In some non-limiting examples, the computing device may
include a library of possible analysis or reporting routines from
which the user may choose.
[0042] It may be appreciated that control unit 130 may represent a
single device or may represent multiple devices among which the
various functions of the control unit as previous disclosed may be
dispersed. For example, if a standalone fluid delivery system is
used as fluid delivery unit 110 and/or a fluid actuating unit 120,
the standalone fluid delivery system may already include some
internal control functions as well as some user interface and data
communication capability. Thus, control unit 130 may include higher
level control functions capable of controlling and communicating
with such independent units. The functions of control unit 130 may
include coordinating the actions of such independent units by
receiving from or transmitting to them the data and/or other
information to coordinate their activities.
[0043] In addition, if the fluid delivery unit 110 and/or fluid
actuating unit 120 lack real time or sufficient or continuous
safety checks to confirm proper and safe delivery of the fluid to
the patient, such safety checks may be included among the functions
of the control unit 130 or of the "translation pods." If the fluid
delivery unit 110 and/or fluid actuating unit 120 are incorporated
into a base 105, the base may also include one or more safety
checking functions. Such safety checking may be performed, for
example. by an independent computer system incorporated in the base
105. The base 105 may be adapted to communicate with fluid delivery
unit 110, fluid actuating unit 120, and/or the control unit 130.
Alternatively, for configurations lacking a base 105, the control
unit 130, on detecting unsafe operation during an injection, may
instruct the fluid delivery unit 110 and/or fluid actuating unit
120 to stop delivery via electronic or software commands. In one
alternative non-limiting example, the control unit 130 may remove
power from the one or more failing units so that their operations
cease.
[0044] FIG. 4 is a flow diagram of a non-limiting method in which a
configurable fluid delivery system may be assembled. A user of the
system may select 400 one or more of a plurality of fluid delivery
units and select 405 one or more of a plurality of fluid actuator
units. The user or assembler may choose either the delivery unit or
the actuator unit first depending on the user criteria, such as the
type of procedure for which the fluid delivery system may be used
including, without limitation, a medical procedure, a veterinary
procedure, or a research procedure. The user may mechanically
connect the fluid actuator unit to the fluid delivery unit 410. In
the spirit of the system being disclosed, it may be appreciated
that the mechanical connection may be reversible. Such a reversible
mechanical connection may permit the assembled units to be
disassembled to replace incorrect, inoperable, or faulty units or
to be reassembled in an alternate configuration for use in
alternative procedures.
[0045] The user may place 415 a control unit in reversible data
communication with the one or more fluid delivery units and/or
actuator units. Again, it may be appreciated that the method and
components associated with the communication of data among the
fluid delivery unit, the fluid activator unit, and the control unit
may allow the data communication to be initiated, maintained, and
dissociated. It may be understood that the order of the assembly
process is not limiting. In one non-limiting alternative order of
steps, the control unit may initially be connected to the delivery
unit first, and then the actuator unit may be connected to the
delivery unit and the control unit.
[0046] Once the three units are connected together, both
mechanically and electronically, the control unit may transmit 420
mechanical status data related to the reversible mechanical
communication between the fluid actuator unit and the fluid
delivery unit to an output device. The control unit may also
transmit 425 communication status data to the output device. The
communication status data may be related to the reversible data
communication between the fluid delivery unit and the control unit,
and/or the fluid actuator unit and the control unit.
[0047] Given the configurable nature of the fluid delivery system,
it may be appreciated that the output transmitted by the control
unit related to the mechanical status data may be in a format
determined at least in part on (i) fluid delivery unit data
received by the control unit and/or (ii) fluid actuator unit data
received by the control unit. Thus, as a non-limiting example, a
GUI presented by the output device may be determined by the type of
fluid delivery unit and/or the actuator unit, indicating status
information specific to one or more of the units. Similarly, the
output transmitted by the control unit related to communication
status data may be in a format determined at least in part on (i)
fluid delivery unit data received by the control unit and/or (ii)
fluid actuator unit data received by the control unit.
[0048] The method may also include a user selecting a disposable
unit and placing the disposable unit in reversible mechanical
communication and data communication with the fluid delivery unit.
Alternatively, the user may place the disposable unit in reversible
data communication with the actuator unit or with the control unit.
It may further be appreciated that the control unit may transmit to
an output unit the mechanical status data related to the reversible
mechanical communication between the disposable unit and the fluid
delivery unit. In addition, the control unit may transmit to an
output unit communication status data related to a reversible data
communication between the disposable unit and one or more of the
fluid delivery unit, the fluid actuator unit, and the control unit,
depending on the unit receiving the communication data from the
disposable unit. As one example of the use of the output status
data by a user, the mechanical status data displayed on the output
unit may indicate a fault in the connectivity between the fluid
delivery unit and the actuator unit. As a result, the user may
attempt to repair a faulty mechanical connection by altering the
connection between the fluid delivery unit and the fluid actuator
unit.
[0049] FIG. 5 presents a flow chart of one embodiment of how a
configurable fluid delivery system may assist a user in configuring
a specific fluid delivery configuration. The control unit may
display 500 to the user a list of possible procedures. The user may
select 505 one of the procedures representing the type of procedure
the user wishes to pursue. The control unit may display 510 a list
of fluid delivery units appropriate for the procedure on the output
unit. If the configurable system includes a mechanical or
electro-mechanical base, the user may attach a fluid delivery unit
to the base. The control unit, in data connection with the
installed fluid delivery unit, may receive the fluid delivery unit
data, to determine if the unit is acceptable for the procedure. If
not, the control may notify 515 the user that the unit is
unacceptable.
[0050] The control unit may display 520 a list of possible fluid
actuator units to the user according to the chosen procedure. The
user may choose an actuator unit and couple it to the fluid
delivery unit. The control unit, in data connection with both the
installed fluid delivery unit and fluid actuator unit, may receive
the fluid delivery unit data and fluid actuator data, to determine
if the actuator is appropriate for the delivery unit and is
correctly mechanically attached to it. Again, the control may
notify 525 the user if the actuator unit is improper or if the
mechanical connection between the two units is faulty. It may be
understood that the order of attachment of the fluid delivery unit
and fluid actuator unit to the base and/or the control unit may be
arbitrary.
[0051] Once the delivery unit, actuator unit, and control unit are
assembled, the system may use the data from the user (type of
procedure) and the delivery and actuator units, to display 530 one
or more possible pre-programmed fluid delivery protocols. In one
embodiment, the user may respond to the protocol prompts generated
by the controller and enter 535 one selected from the list. In one
alternative embodiment, the user may wish to program a new protocol
based on the procedure and assembled components. Such a protocol
may be entered by the user into the control unit by means of any of
the above disclosed input methods. The control unit may display 540
on the output unit a list of possible disposable units consistent
with the procedure, delivery unit, actuator, and protocol
information previously provided. The user may attach a disposable
unit to the delivery unit. Data from the delivery unit, available
to the control unit, may be checked by the control unit for
applicability. As previously described, the control unit may notify
545 the user if the disposable unit is inappropriate for the
application or if the disposable unit is not in proper mechanical
contact with the fluid delivery unit.
[0052] At the end of the mechanical and data connection sequence,
the control unit may provide a final system-wide check to assure
that an appropriate delivery unit, actuator unit, and disposable
unit have been chosen by the user and have been correctly
assembled. The control unit may notify 550 the user of any
mechanical or electronic faults in the completed assembly. After
the fluid delivery system has been assembled and tested, the
control unit may display 555 an output, such as a GUI, to the user
that may be specific to the procedure, components, and protocol as
assembled by the user.
EXAMPLES
[0053] As one non-limiting example, the configurable system may be
used to assemble a dual-injection device, composed of two syringes,
each associated with a syringe drive actuator. Such a dual-syringe
system is schematically presented in FIG. 3D.
[0054] A challenge associated with fluid delivery using a flexible
injection system of this invention that delivers multiple fluids is
that when the system and fluid path is being pressurized during the
delivery of a first fluid, that first fluid may drive other fluids
in a reverse flow direction, even if their pressurizing means are
designed to resist or prevent movement. This reverse flow may be
caused by mechanical capacitance, defined as C=V/P. As the
capacitance, C, increases, a volume change, V, for a given
pressure, P, also increases. Metal components tend to have
significantly less capacitance than plastic components. However,
many disposable fluid path elements are plastic because of other
benefits that plastics may provide. In addition, tubing, syringe
barrels, and rubber covers may also have significant
capacitance.
[0055] In FIG. 3D if the fluid path 390 does not contain valves 396
and 398, when a first syringe moves forward to develop pressure to
drive the fluid from the first syringe, the pressure may cause the
fluid to pressurize the outflow end of the second syringe.
[0056] One embodiment to reduce or essentially eliminate this
reverse flow is to include valves 396 and 398. In this embodiment,
valves 396 and 398 may be check valves that allow flow in one
direction with a relatively low pressure drop. However, when only a
partial volume of the syringe or fluid is to be delivered,
undesirable behavior may result even with check valves. When the
first syringe moves to pressurize the first fluid, a pressure is
developed along the fluid path. With check valve 396 in place, the
pressure drives little or no fluid into the second line. When the
first syringe stops moving, the second syringe may begin to move.
When the pressure in the second line becomes greater than the
pressure in the first line, fluid may flow through check valve 396.
At this point in the delivery, both syringes may be pressurized,
but only the second fluid may flow. When fluid delivery is complete
and the syringes stop their motion, the pressure may decrease as
the fluid exits the disposable unit into the patient. As long as a
pressure difference exists, fluid may continue to flow or dribble
out of the two syringes into the fluid path and possibly the
patient. This additional flow may result from the capacitance of
the fluid path elements. Disposable syringes have particularly high
capacitance due to the rubber covers. Long lengths of flexible
disposable tubing may also have a relatively high capacitance. One
solution is to incorporate valves 396 and 398 having a high opening
or cracking pressure that may be above or near the maximum
operating pressure of the system. One embodiment of such a high
cracking pressure valve may include a spool valve having an
internal sliding element that can block fluid flow. The valve may
include a resistive force element, such as a spring or a
pressurized bladder, to resist the movement of the sliding
element.
[0057] In operation, when the fluid pressure against the sliding
element is greater than the force from the force element, the
sliding element may move to open an exit segment of the valve,
thereby permitting fluid flow. When the pressure against the
sliding element drops below the pressure required to counter the
force element, the sliding element may return to its original
position, thereby preventing fluid flow through the valve. In
non-limiting examples, the sliding element may be made of rubber or
a thermoplastic elastomer. The force element may be a metal spring
or also be an elastomer, which may be manufactured as an integral
part of the sliding element.
[0058] A second non-limiting embodiment may be composed of a
compressible tube and an asymmetric pressure element to compress
the tube. The asymmetric pressure element may be designed to
compress the tube completely at one segment, compress the tube
partially at a second segment, and not compress the tube at a third
segment. The force of compression can be created by a variety of
methods including, for example, a spring, a bladder, an
electromechanical actuator, or a magnetic actuator. As the pressure
in the third segment increases, the downward force of the pressure
element may be counteracted by the fluid pressure in the second
segment. An increase in fluid pressure may result in the force of
the pressure element at the first segment being overcome, and fluid
may flow through the valve.
[0059] In yet another embodiment, valves 396 and 398 may be
actively controlled by the control unit by means of control data
transmitted by the control unit over lines 397 and 399,
respectively. The control unit may adjust the state of either or
both of valves 396 and 398 based on data received from one or more
pressure sensors associated with the disposable unit. In one
non-limiting embodiment, such pressure sensors may be disposed with
one upstream of each valve and optionally one downstream of each
valve. It may be appreciated that the cracking pressure to open
automated control of valves 396 and 398 may be configured by the
control unit, and may be adjusted according to the procedure and
protocol for which the device may be used. It may be recognized
that an actively controlled valve may be controllably opened to
relieve the pressure in the syringes when the procedure is
completed. Alternatively, pressure can be relieved mechanically if
the syringe piston or actuator is moved in the reverse (i.e.
non-dispensing) direction. In yet another alternative example, a
stopcock or other manually controlled valve may be used to bleed
off the pressure. In still another alternative example, the valve
396 may incorporate a mechanical lever, rod, or handle to allow for
manual actuation to release the pressure.
[0060] In a non-limiting example, a high crack pressure valve may
be placed in the fluid path from the fluid delivery unit 110, which
may include a bellows or collapsible syringe or container.
Descriptions of exemplary collapsible syringes and/or bladders may
be found in U.S. Provisional Patent Ser. No. 61/636,049 to Uber et
al., U.S. Published Patent Application No. 2012/0209111 to Cowan et
al., and PCT Patent Application Serial No. PCT/US2011/57701 to
Cowan et al., each of which is hereby incorporated by reference in
its entirety. In syringes of this type, the syringe capacitance may
be increased as a result of the folds of the bellows or flexibility
of the collapsing member or rolling diaphragm. When the bellows
syringe is operated at low pressure, the relationship between
piston position and output of fluid may have one functional
relationship. When the bellows is being maximally compressed by
operating with a pressure at or near its maximum capability, the
folds may significantly distend or distort before a significant
amount of fluid is dispensed. Thus, the relationship between piston
position and output of fluid may have a very different functional
relationship. For discharge pressures that are intermediate between
these two, the amount of collapse may be intermediate and the
functional relationship between piston position and output of fluid
will have a different functional relationship as well. It may be
difficult to accurately or reproducibly determine the relationship
between the amount of motion of the syringe plunger and the amount
of fluid delivered. Accurate and consistent control of fluid
delivery may require a consistent relationship between piston or
pump motion and fluid volume delivery. If the syringe discharges
the fluid through a high crack pressure check valve, the pressure
on the fluid container may be repeatable and known. Thus, a known
relationship between piston or pump motion and fluid volume may be
used by the controller unit 130 to accurately and consistently
provide the desired fluid delivery.
[0061] A first embodiment of a high crack pressure check valve,
such as valve 396 in FIG. 3D is illustrated in FIGS. 6A,B. The
fluid path segments 611 and 612 serve to conduct fluid to and from
the valve, respectively. The valve further comprises a sliding
element 613 which may block fluid flow between segment 611 and 612.
Pressure in segment 612 cannot move the sliding element 613 because
the force created by the pressure acts symmetrically. The seals
613a and 613b may prevent the leakage of fluid into or out of
segment 612. Pressure in segment 611 may generate a force which
pushes the sliding element 613 to the left as illustrated in FIG.
6B, allowing fluid to flow from segment 611 into segment 612. The
force from pressure in segment 611 may be resisted by a force
element 615, such as a spring, a pressurized bladder, or an
electromechanical or magnetic force actuator. Force element 615 may
push sliding element 613 to the right. The motion of the sliding
element 613 may be constrained to move between the closed position
shown in FIG. 6A and the open position shown in FIG. 6B. Movement
may be constrained by detents on the inside of the valve (not
shown) or by constraints imposed by rod 614.
[0062] In operation, when the pressure in segment 611 reaches a
value of P-open, the force on the slide 613, due to the fluid
pressure being greater than the force from the force element 615,
may cause the slider to move to the left, opening the exit segment
612 and allowing fluid to flow through the valve. When the pressure
in segment 611 drops below P-open, the slider may move to the right
and fluid flow out of or into segment 611 may be prevented.
[0063] In the case where this valve is used in a medical device,
the fluid path elements may be made from plastic, such as
polycarbonate or PVC. The slider 613 may be made of rubber or a
thermoplastic elastomer. The force element 615 may include a metal
spring or an elastomer, or optionally made as an integral part of
the slider 613. For use in sterile situations, this design may
require that all the elements that contact the fluid be sterilized
or be disposable.
[0064] A second embodiment of a high crack pressure check valve,
such as valve 396 in FIG. 3D is illustrated in FIG. 7, in which
only a compressible tube 701 may be in contact with the fluid and
thus may be disposable. The other components of the valve can be
used multiple times. Pressure element 703 may compress tube 701,
closing it off at segment 701a. Pressure element 703 may be
designed so that as it closes off segment 701a, it partially
compresses segment 701b and does not compress segment 701c. The
force of compression can be created by a variety of methods,
including, for example, a spring, bladder, electromechanical, or
magnetic actuator. As the pressure increases in inflow segment 711,
the downward force on pressure element 703 may be counteracted by
the fluid pressure in segment 701b. When the net force is such that
the pressure element 703 cannot hold the tubing in segment 701a in
a closed position, the tubing opens and fluid begins to flow from
inflow segment 711 to outflow segment 712. This may occur at
pressure P-open. When the pressure in inflow segment 711 drops
below P-open, the net force on pressure element 703 may be such
that it will again close off tube 701 and fluid flow will stop.
[0065] In this second embodiment, there may be a segment 701d,
which may be on the outflow side and may also be partially
compressed by pressure element 703, due to the stiffness and shape
of the tube. Thus there may be a small force on pressure element
703 produced by pressure in tube segment 701d. If the area of
segment 701d is much less than the area of segment 701b, the effect
of this non-ideal situation can be minimized or made
insignificant.
[0066] In another non-limiting example, an inline high crack
pressure valve may be used with a pulsatile pump such as a
diaphragm or peristaltic pump. Accumulators, for example, a spring
or pressure biased reservoir, can be placed on the output of such
pumps to attempt to smooth the flow, but accumulators may operate
effectively only within a limited pressure range. By placing a high
crack pressure valve downstream of the accumulator, the accumulator
may consistently operate at a pressure in the same range as the
high crack pressure valve, independent of the downstream pressure
fluctuations. As a result, potential oscillations in fluid flow due
to the operation of the pump may be damped. The respective pressure
ranges of the accumulator and the high crack pressure valve, in
addition to the accumulator volume, may depend at least in part on
the operating pressure of the pump, the specifics of the fluid
path, the fluid volumes and flow rates for delivery, and the pump
output pulsatility. Additionally, a high crack pressure valve may
be as useful with single fluid delivery devices as with multiple
fluid delivery devices.
[0067] In some situations, such as CT contrast delivery, the
pressure developed by the pumps during normal injections can
approach or exceed 300 psi. In such cases, an opening or crack
pressure may be about 350 psi or more. In angiography, an opening
or crack pressure may be over 1000 psi. In alternative procedures,
such as a fluid injection into a mouse, the injected volume may be
small, on the order of 50 microliters, and the injection pressures
involved may be on the order of 10's of psi. Therefore, for
procedures using small animals, a crack pressure of 50 psi or even
20 psi may be sufficient. In one non-limiting example, each
application may have associated with it a specific high pressure
crack valve having a set and procedure specific P-open. In an
alternative non-limiting example, a single high pressure crack
valve having an adjustable P-open pressure may be used among a
variety of procedures. One embodiment of an adjustable high
pressure crack valve may include a user-adjustable screw to
compress a spring. In another embodiment of an adjustable high
pressure crack valve, an adjustable electromechanical actuator may
be used to apply the variable clamping force. Such automated
adjustable high pressure crack valves may be useful for real time
modification by the system controller. In one non-limiting example,
the control unit may alter the variable clamping force based at
least in part upon data received by the control unit from one or
more pressure sensors in the system.
[0068] The present disclosure is not to be limited in terms of the
particular embodiments described in this application, which are
intended as illustrations of various aspects. Many modifications
and variations can be made without departing from its spirit and
scope, as will be apparent to those skilled in the art.
Functionally equivalent methods and apparatuses within the scope of
the disclosure, in addition to those enumerated in this disclosure,
will be apparent to those skilled in the art from the foregoing
descriptions. Such modifications and variations are intended to
fall within the scope of the appended claims. The present
disclosure is to be limited only by the terms of the appended
claims, along with the full scope of equivalents to which such
claims are entitled. It is also to be understood that the
terminology used in this disclosure is for the purpose of
describing particular embodiments only, and is not intended to be
limiting.
[0069] With respect to the use of substantially any plural and/or
singular terms in this disclosure, those having skill in the art
can translate from the plural to the singular and/or from the
singular to the plural as is appropriate to the context and/or
application. The various singular/plural permutations may be
expressly set forth in this disclosure for sake of clarity.
[0070] It will be understood by those within the art that, in
general, terms used in this disclosure, and especially in the
appended claims (e.g., bodies of the appended claims) are generally
intended as "open" terms (e.g., the term "including" should be
interpreted as "including but not limited to," the term "having"
should be interpreted as "having at least," the term "includes"
should be interpreted as "includes but is not limited to," etc.).
While various compositions, methods, and devices are described in
terms of "comprising" various components or steps (interpreted as
meaning "including, but not limited to"), the compositions,
methods, and devices can also "consist essentially of" or "consist
of" the various components and steps, and such terminology should
be interpreted as defining essentially closed-member groups.
[0071] It will be further understood by those within the art that
if a specific number of an introduced claim recitation is intended,
such an intent will be explicitly recited in the claim, and in the
absence of such recitation no such intent is present. For example,
as an aid to understanding, the following appended claims may
contain usage of the introductory phrases "at least one" and "one
or more" to introduce claim recitations. However, the use of such
phrases should not be construed to imply that the introduction of a
claim recitation by the indefinite articles "a" or "an" limits any
particular claim containing such introduced claim recitation to
embodiments containing only one such recitation, even when the same
claim includes the introductory phrases "one or more" or "at least
one" and indefinite articles such as "a" or "an" (e.g., "a" and/or
"an" should be interpreted to mean "at least one" or "one or
more"); the same holds true for the use of definite articles used
to introduce claim recitations. It will be further understood by
those within the art that virtually any disjunctive word and/or
phrase presenting two or more alternative terms, whether in the
description, claims, or drawings, should be understood to
contemplate the possibilities of including one of the terms, either
of the terms, or both terms. For example, the phrase "A or B" will
be understood to include the possibilities of "A" or "B" or "A and
B."
[0072] From the foregoing, it will be appreciated that various
embodiments of the present disclosure have been described for
purposes of illustration, and that various modifications may be
made without departing from the scope and spirit of the present
disclosure. Accordingly, the various embodiments disclosed are not
intended to be limiting, with the true scope and spirit being
indicated by the following claims.
* * * * *