U.S. patent application number 12/108462 was filed with the patent office on 2008-08-21 for systems and methods for the accurate delivery of flow materials.
Invention is credited to Paul Mario DiPerna, Scott Mallett.
Application Number | 20080196762 12/108462 |
Document ID | / |
Family ID | 30769508 |
Filed Date | 2008-08-21 |
United States Patent
Application |
20080196762 |
Kind Code |
A1 |
Mallett; Scott ; et
al. |
August 21, 2008 |
SYSTEMS AND METHODS FOR THE ACCURATE DELIVERY OF FLOW MATERIALS
Abstract
Pumps and flow regulators provide relatively constant and known
flow volume over time while maintaining isolation of the flow
material. The pumps of the present disclosure provide real time
monitoring of the volume of flow material delivered over time, and
provides for adjustment of the pump or flow regulators to modulate
the flow rate. Thus, flow may be substantially modeled to a desired
flow profile with real time adjustments of the flow rates.
Inventors: |
Mallett; Scott; (Coto de
Caza, CA) ; DiPerna; Paul Mario; (San Clemente,
CA) |
Correspondence
Address: |
GREENBERG TRAURIG LLP (LA)
2450 COLORADO AVENUE, SUITE 400E, INTELLECTUAL PROPERTY DEPARTMENT
SANTA MONICA
CA
90404
US
|
Family ID: |
30769508 |
Appl. No.: |
12/108462 |
Filed: |
April 23, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11343817 |
Jan 31, 2006 |
7374556 |
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12108462 |
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10200109 |
Jul 19, 2002 |
7008403 |
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11343817 |
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Current U.S.
Class: |
137/1 ;
137/565.11 |
Current CPC
Class: |
Y10T 137/0318 20150401;
A61M 5/16809 20130101; Y10T 137/85986 20150401; G01F 11/04
20130101; A61M 5/145 20130101; G01F 1/34 20130101; A61M 5/14593
20130101; A61M 5/142 20130101 |
Class at
Publication: |
137/1 ;
137/565.11 |
International
Class: |
F17D 1/00 20060101
F17D001/00 |
Claims
1. A system comprising: an pump that is configured to measure flow
rate of a flow material in about real time; and at least one flow
regulator for providing substantially constant flow rate; wherein
at least one operating parameter of the pump is adjustable to
change the flow rate in about real time.
2. The system of claim 1, wherein the at least one flow regulator
comprises a variable flow reshapable flow restrictor.
3. The system of claim 1, wherein the at least one flow regulator
comprises an adjustable clamp system.
4. The system of claim 1, wherein the at least one flow regulator
comprises a variable flow reshapable flow restrictor and an
adjustable clamp system.
5. The system of claim 1, wherein the flow material is isolated
from the devices of the pump for pumping the flow material and
measuring the flow material.
6. The system of claim 1, wherein the flow material is contained in
a sterile chamber and the pump preserves the sterility of the flow
material.
7. The system of claim 1, wherein the pump comprises at least two
chambers.
8. The system of claim 7, wherein the pump comprises at least three
chambers.
9. The system of claim 7, wherein the pump comprises at least three
chambers.
10. The system of claim 1, further comprising a microprocessing
unit that is configured to accept and substantially execute a flow
profile.
11. A method comprising providing: a pump capable of measuring flow
rate of a flow material in about real time; a microprocessor for
determining a flow volume over an elapsed time period; and a flow
regulator for modulating a flow rate within a specified range of
flow rates; wherein the flow material is isolated from the devices
used to measure flow rate.
12. The method of claim 11, wherein the at least one flow regulator
comprises a variable flow reshapable flow restrictor.
13. The method of claim 11, wherein the at least one flow regulator
comprises an adjustable clamp system.
14. The method of claim 11, wherein the at least one flow regulator
comprises a variable flow reshapable flow restrictor and an
adjustable clamp system.
15. The method of claim 11, wherein the flow material is isolated
from the devices of the pump for pumping the flow material and
measuring the flow material.
16. The method of claim 11, wherein the flow material is contained
in a sterile chamber and the pump preserves the sterility of the
flow material.
17. The method of claim 11, wherein the pump comprises at least two
chambers.
18. The method of claim 17, wherein the pump comprises at least
three chambers.
19. The method of claim 17, wherein the pump comprises at least
three chambers.
20. The method of claim 11, further comprising a microprocessing
unit that is configured to accept and substantially execute a flow
profile.
Description
RELATED APPLICATION
[0001] This application is a continuation of and claims the benefit
of and Paris Convention priority of U.S. Utility application Ser.
Nos. 11/343,817, filed 31 Jan. 2006; 11/462,962, filed 7 Aug. 2006;
11/694,841, filed 30 Mar. 2007; 11/744,819, filed 4 May 2007;
12/020,498, filed 25 Jan. 2008; and 12/039,693, filed 28 Feb. 2008,
the contents of which are each incorporated by reference herein in
its entirety.
BACKGROUND
[0002] This disclosure relates to an apparatus and associated
methods for dispensing flow materials, such as fluids or gasses at
known, measurable, and adjustable rates. Additionally, the present
disclosure relates to flow regulators, flow restrictors having
reshapable lumina which reshape as a function of pressure, which
results in an increase in the flow rate by about a fourth order of
magnitude, as well as clamps that are adjustable based on the
observed flow rate.
SUMMARY
[0003] Pumps and flow regulators provide relatively constant and
known flow volume over time while maintaining isolation of the flow
material. The pumps of the present disclosure provide real time
monitoring of the volume of flow material delivered over time, and
provides for adjustment of the pump or flow regulators to modulate
the flow rate. Thus, flow may be substantially modeled to a desired
flow profile with real time adjustments of the flow rates.
DRAWINGS
[0004] The above-mentioned features and objects of the present
disclosure will become more apparent with reference to the
following description taken in conjunction with the accompanying
drawings wherein like reference numerals denote like elements and
in which:
[0005] FIG. 1 is a block diagram of an embodiment of a sequence of
the devices of the present disclosure in the direction of the flow
of a flow material;
[0006] FIG. 2 is a block diagram of an embodiment of the
interrelationship of the devices of the present disclosure;
[0007] FIG. 3 is a perspective view of an embodiment of a pump of
the present disclosure having three chambers;
[0008] FIG. 4 is a perspective view of an embodiment of a pump of
the present disclosure having two chambers;
[0009] FIG. 5 is a perspective view of an embodiment of a pump of
the present disclosure having two chambers;
[0010] FIG. 6 is a perspective view of an embodiment of a pump of
the present disclosure having two chambers;
[0011] FIGS. 7A to 7C are graphs of an embodiment illustrating the
relationship of volume of the chambers of a three chamber pump as
flow material flows by action of the pump;
[0012] FIGS. 8A and 8B are perspective views of an embodiment of a
flow regulator;
[0013] FIG. 9 is a side view of an embodiment of a flow regulator;
and
[0014] FIG. 10 is a graph illustrating the combined flow potential
of the combination of the flow regulators and pump of the present
disclosure that provide for relatively accurate flow over time of a
flow material based on the flow rate feedback provided from the
pump.
DETAILED DESCRIPTION
[0015] Specific reference is made to the patent applications
incorporated by reference herein, including U.S. Utility
application Ser. Nos. 11/343,817, filed 31 Jan. 2006; 11/462,962,
filed 7 Aug. 2006; 11/694,841, filed 30 Mar. 2007; 11/744,819,
filed 4 May 2007; 12/020,498, filed 25 Jan. 2008; and 12/039,693,
filed 28 Feb. 2008.
[0016] In the following detailed description of embodiments of the
invention, reference is made to the accompanying drawings in which
like references indicate similar elements, and in which is shown by
way of illustration specific embodiments in which the present
disclosure may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the present disclosure, and it is to be understood that other
embodiments may be utilized and that logical, mechanical,
electrical, functional, and other changes may be made without
departing from the scope of the present disclosure. The following
detailed description is, therefore, not to be taken in a limiting
sense, and the scope of the present invention is defined only by
the appended claims. As used in the present disclosure, the term
"or" shall be understood to be defined as a logical disjunction and
shall not indicate an exclusive disjunction unless expressly
indicated as such or notated as "xor."
[0017] As used herein, the term "real time" shall be understood to
mean the instantaneous moment of an event/condition or the
instantaneous moment of an event/condition plus short period of
elapsed time used to make relevant measurements, optional
computations, and communicate the measurement or computation,
wherein the state of an event/condition being measured is
substantially the same as that of the instantaneous moment
irrespective of the elapsed time interval. Used in this context
"substantially the same" shall be understood to mean that the data
for the event/condition remains useful for the purpose for which it
is being gathered after the elapsed time period.
[0018] Incorporated by reference are pumps, including infusion
pumps, that measure flow rate in real time or about real time.
Incorporated by reference are flow regulators, including flow
restrictors and clamps that are useful for modulating flow rate.
The present disclosure is directed to systems and methods for the
substantially accurate delivery of flow material over time. For
example, insulin dosages must be accurately delivered to patients
over time. The present disclosure provides devices and methods that
allow for accurate delivery of flow materials at relatively
constant, yet adjustable, flow rates.
[0019] The inventors of the present disclosure have discovered
novel systems and methods for the delivery of flow materials
controllably and predictably. Specifically, the systems and methods
of the present disclosure accomplish the substantially accurate
delivery of flow materials while isolating the flow material. The
lack of contact (isolation) between control and measurement devices
and the flow material is useful in many applications, including the
delivery of sterile flow materials or flow materials that cannot be
contacted for safety reasons.
[0020] According to embodiments illustrated by FIG. 1, there is
shown a system for dispensing a flow material. The system comprises
pump 100, flow regulator 200, and delivery device 300. According to
embodiments, pump 100 comprises an infusion pump that (1) provides
feedback as to the flow rate in about real time, and (2) maintains
isolation of the flow material from the devices for effecting
delivery and measuring flow rate.
[0021] Flow regulator 200 comprises one or more devices disposed
downstream from pump 100 designed to regulate flow rate and provide
relatively constant flow, including adjustably constant flow
(substantially constant flow rate that may be adjusted as needed in
real time).
[0022] According to the embodiments, flow regulator 200 may be
omitted from the devices of the present disclosure, according to
various embodiments. Flow regulators include, among other devices,
flow restrictors, clamps, etc., disclosed in the incorporated
references, as well as those well known and understood by
artisans.
[0023] Delivery device 300 comprises those devices and implements
that facilitate delivery from the pump to a specific target. In
medical applications, for example, delivery device 300 includes
tubing, needles, luer connectors, etc., which are readily
identifiable by artisans on a case-by-case basis.
[0024] According to embodiments, and as disclosed herein and in the
incorporated references, pumps 100 and flow regulators 200 may by
regulated via a microprocessor to provide control or adjustability
to flow rate, as illustrated by an embodiment of the
interrelationship in FIG. 2. As illustrated in FIG. 2 and disclosed
more fully in the incorporated applications, microprocessor 500
monitors the state of the devices of the present disclosure at time
intervals. Accordingly, flow rate from pump 100 is determined using
pressure sensor(s) 504 and temperature sensor(s) 506. Clock 502
provides a time interval measurement device, whereby flow rate data
508 from pump 100 may be determined in about real time.
[0025] Using flow rate data 508, adjustments may be made to the
devices disclosed herein to adjust flow rate 510. According to
embodiments, adjustments to flow rate are effected by modulating
pump 100 to increase or decrease flow rate, as disclosed in the
incorporated applications. Similarly, flow regulators 200 may be
adjusted 512 to provide relatively constant flow rate. Flow
regulators 200 may either be passive or self adjustable, that is
they are adjusted based on the inherent flow characteristics of the
flow materials (e.g., the pressure of flow material, the volume of
flow material, etc.) or are controlled actively by microprocessor
500. According to embodiments, microprocessor 500 controls output
devices 514 responsible for adjustments to pump 100 or flow
regulator 200.
[0026] FIG. 3 illustrates an embodiment of pump 100 that may be
used in accordance with the present disclosure. Incorporated by
reference U.S. Utility patent application Ser. Nos. 11/343,817
(filed Jan. 31, 2006), 11/744,819 (filed May 4, 2007), and
12/020,498 (filed Jan. 25, 2008) disclose pumps 100 suitable for
use in the present disclosure, for example. As shown in the
embodiment in FIG. 3, pump 100 comprises first chamber 110, second
chamber 120, and third chamber 125. First chamber 110 and second
chamber 120 hold gas 112. The gas is pressurized in first chamber
110 and released into second chamber 120 to drive the device
separating second chamber 120 from third chamber 130. Artisans will
recognize that flow material 113 in third chamber 125 is isolated
from gas 112 and the devices to measure flow rate or flow volume,
namely pressure sensors 115, 117. Optionally, temperature sensors
may also be disposed within first and second chamber to improve the
accuracy to the flow volume measurements.
[0027] FIG. 4 illustrates embodiments of pump 100 that may be used
in accordance with the present disclosure. Pump 100 comprises first
chamber 110 and second chamber 120, together with pressure sensor
115. A temperature sensor may be optionally installed to improve
accuracy for flow rate or flow volume determination. As with the
previous embodiments, flow material contained in second chamber 120
is isolated from the gas and the devices to measure flow rate or
flow volume. Flow material travels through flow conduit 130, and
may flow through flow regulator 200, according to embodiments. The
embodiment illustrated in FIG. 4 provides fill conduit 150 for
refilling second chamber with flow material.
[0028] In two chamber versions of pump 100, an initial calibration
is performed and after first chamber 110, is pressurized whereby
the volume in second chamber 120 may be determined at any point
during flow of the flow material.
[0029] FIG. 5 illustrates embodiments of a variation of FIG. 4,
where first chamber 110 comprises a collapsible or flexible
container. For example, first chamber 110 is a container that is
hangable from intravenous hanging devices standard in most
hospitals.
[0030] Likewise, FIG. 6 illustrates embodiments of a variation of
FIGS. 4 and 5, where first chamber 110 and second chamber 120 are
separated by a movable barrier 122.
[0031] According to embodiments, FIG. 7A-7C illustrates the volume
characteristics of each chamber of pump 100, illustrated by a pump
has three chambers (for example, the embodiment illustrated in FIG.
3) by the solid lines and a pump that has 2 chambers for the dashed
line. Accordingly, the volume of first chamber 110 remains constant
throughout operation. Because the pressure of first chamber 110 is
much greater than the pressure of second chamber 120, according to
embodiments, first chamber 110 maintains sufficient pressure to
deliver flow material from third chamber 125.
[0032] Because a movable barrier is disposed between second chamber
120 and third chamber 125 in the exemplary example of FIG. 3 (or
due to the movable or collapsible nature of the second chamber 120
in FIGS. 4-6), these volumes of each of second chamber 120 and
third chamber 125 are variable. As observed in FIG. 7B, over the
time interval from time (t) zero to time 11, the volume of second
chamber 120 rises as flow material is dispensed from pump 100 due
to operation of the movable barrier and pressure that is
transferred from first chamber 110 to second chamber 120, wherein
the pressure in second chamber 120 exceeds the pressure in third
chamber 125, thereby advancing movable barrier in the direction of
third chamber 125. Because discrete aliquots of pressure are
delivered from first chamber 110 to second chamber 120 at various
time intervals, the change in volume is greatest when the pressure
differential between second chamber 120 and third chamber 125 is
greatest.
[0033] As the movable barrier advances, the volume in second
chamber 120 increases thereby decreasing the pressure in second
chamber 120. Thus, with less pressure exerted on the movable
barrier, the change in volume slows until it reaches equilibrium
with the pressure (plus other physical factors that impede flow of
the flow material) in third chamber 125. The change in volume in
third chamber 125 mirrors that of second chamber 120, whereby the
volume of second chamber 120 and third chamber 125 together is
constant.
[0034] According to the embodiments in FIGS. 4-6, there would be no
parabolic, stepwise appearance. Rather the entire line for both
chambers would represent a parabolic change in volume profile shown
by the dashed lines for FIGS. 7A and 7B. Where flow regulators are
disposed downstream, these lines maybe modified to be substantially
linear.
[0035] Based on the measurements of the temperature sensor(s) 115,
117, the dispensed volume of flow material 113 from pump 100 may be
determined. Because the time interval is also known, flow rate may
also be calculated, according to embodiments. Thus, according to
embodiments, knowledge of flow volume or flow rate allows the
parameters driving pump 100 to be adjusted to dispense flow
material in a known, substantially controlled manner. For example,
according to embodiment illustrated in FIG. 3, if the flow rate is
determined to be too rapid, microprocessor 500 may delay effecting
the delivery of the next aliquot of pressurized gas from first
chamber 110 to second chamber 120 for a prescribed time period. If
the flow rate is determined to be too slow, more rapid delivery of
aliquots of pressurized gas from first chamber 100 to second
chamber 120 may be effected, thereby causing the flow rate to be
more rapid for a longer period of time (see FIG. 7B and FIG. 7C).
Flow regulators 200 may also be used to provide adjustments to
achieve substantially constant flow rate.
[0036] According to embodiments, such as those illustrated in FIGS.
4-6, control of flow rate may be effected through the use of flow
regulators 200. For example and according to embodiments, flow
regulator 200 comprises a flow restrictor as illustrated in FIGS.
8A and 8B. Accordingly, flow regulator 200 comprises a predictably
flexible member having lumen 222. Increased pressure of flow
material causes the aperture of lumen 222 to increase in a
predictable fashion as described in greater detail in incorporated
by reference U.S. Utility application Ser. Nos. 11/462,962 (filed
Aug. 7, 2006) and 11/694,841 (filed Mar. 30, 2007). According to
embodiments, these flow regulators are controlled indirectly by
pump 100, because either the pressure of flow material or volume of
flow material is outcome determinative of the flow rate.
[0037] According to embodiments, flow regulator 200 may also
comprise pump 214 and expandable member 210 system as shown in an
embodiment illustrated in FIG. 9. Expandable member 210 expands and
contracts within lumen 222 of vessel for transporting flow material
220. Thus, when a slow flow rate is needed, the pressure within
expandable member 210 is increased by pump 214 to cause expandable
member 210 to occupy additional cross sectional area of lumen 222,
as described in greater detail in incorporated by reference U.S.
Utility application Ser. No. 12/039,693 (filed Feb. 28, 2008). Such
flow regulators 200 may be coupled to microprocessor 500 to effect
a known, substantially controlled flow rate or delivered flow
volume. Moreover, because microprocessor 500 controls flow
regulator 200, according to embodiments, the flow rate or delivered
flow volume over time is adjustable in real time.
[0038] Artisans will recognize that other flow regulators that have
the characteristics of providing a predictable flow rate either via
a feedback mechanism or by the pump are expressly and inherently
contemplated as being within the range of equivalents of the flow
regulators applicable to the present disclosure.
[0039] The combination of at least pump 100 or pump 100 and at
least one flow regulator 200 provide a predicable flow rate profile
that may be adjusted to some predetermined flow profile, while
preserving isolation of the flow material. For example, as
illustrated in FIG. 10, a predetermined flow profile is illustrated
by the line representing "Desired Flow Rate." Because of the many
variables at play in pumping a flow material, however, the "Actual
Flow Rate" does not exactly model the desired flow rate. However,
using microprocessor to modulate flow rate based on real time flow
rate feedback from pump 100, pump 100 or flow regulator 200 may be
adjusted (illustrated by the solid line in FIG. 10) as disclosed
herein and in the incorporated by reference patent applications to
substantially model the predetermined flow profile. Artisans will
readily observe that the predetermined flow profile is both linear
and constant in FIG. 10; according to embodiments, however, the
predetermined flow profile need be neither linear nor constant. The
real time feedback provided by pump 100 will allow nearly any
conceivable predetermined flow profile, provided the line
representing the course is continuous.
[0040] Also disclosed herein are methods for accomplishing the same
as disclosed in detail in the incorporated by reference patent
applications. Generally, the pump will both dispense flow material
and measure flow rate. One or more flow regulators will be disposed
downstream of the pump, according to embodiments. Other embodiments
will omit the flow regulator. Microprocessor will obtain readings
from the sensors and clock and calculate volume dispense or flow
rate, which data will them be used by microprocessor to output
adjustments to at least one of the pump or flow regulator (s) to
substantially effect a desired flow profile by modulating the flow
rate using the devices and methods disclosed herein and within the
incorporated by reference applications.
[0041] While the apparatus and method have been described in terms
of what are presently considered to be the most practical and
preferred embodiments, it is to be understood that the disclosure
need not to be limited to the disclosed embodiments. It is intended
to cover various modifications and similar arrangements included
within the spirit and scope of the claims, the scope of which
should be accorded the broadest interpretation so as to encompass
all such modifications and similar structures. The present
disclosure includes any and all embodiments of the following
claims.
* * * * *