U.S. patent application number 11/787213 was filed with the patent office on 2008-03-06 for heat exchange systems, devices and methods.
This patent application is currently assigned to DEKA Products Limited Partnership. Invention is credited to David E. Altobelli, James D. Dale, Jason A. Demers, Larry B. Gray, Dean Kamen, Kingston Owens, N. Christopher Perry, Brian Tracey, Dirk A. van der Merwe.
Application Number | 20080058697 11/787213 |
Document ID | / |
Family ID | 38323762 |
Filed Date | 2008-03-06 |
United States Patent
Application |
20080058697 |
Kind Code |
A1 |
Kamen; Dean ; et
al. |
March 6, 2008 |
Heat exchange systems, devices and methods
Abstract
Embodiments of the present invention relate generally to
heat-exchanger systems that can be used to heat or cool a fluid
such as blood. Pod pumps that provide low shear and low turbulence
may be used in such systems, particularly for systems that pump
blood. A certain heat-exchanger system used to heat blood or other
fluids may be used to provide whole-body hyperthermic treatments or
regional hyperthermic chemotherapy treatments. A disposable unit
may be used to separate the fluid path from the fluid control
systems. The disposable unit typically includes a heat-exchanger
component that is received by a corresponding heat exchanger in a
base unit. Fluid pumped through the heat-exchanger component is
heated by the heat exchanger.
Inventors: |
Kamen; Dean; (Bedford,
NH) ; Demers; Jason A.; (Manchester, NH) ;
Altobelli; David E.; (Hollis, NH) ; Gray; Larry
B.; (Merrimack, NH) ; Perry; N. Christopher;
(Manchester, NH) ; Tracey; Brian; (Litchfield,
NH) ; Dale; James D.; (Nashua, NH) ; van der
Merwe; Dirk A.; (Manchester, NH) ; Owens;
Kingston; (Bedford, NH) |
Correspondence
Address: |
Michelle Saquet Temple
DEKA Research & Development Corporation
340 Commercial Street
Manchester
NH
03101-1129
US
|
Assignee: |
DEKA Products Limited
Partnership
Manchester
NH
|
Family ID: |
38323762 |
Appl. No.: |
11/787213 |
Filed: |
April 13, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60792073 |
Apr 14, 2006 |
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60835490 |
Aug 4, 2006 |
|
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60904024 |
Feb 27, 2007 |
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60921314 |
Apr 2, 2007 |
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Current U.S.
Class: |
604/6.13 ;
165/122; 165/134.1; 374/E1.011; 374/E1.021; 604/113; 607/106 |
Current CPC
Class: |
A61M 60/43 20210101;
A61F 2007/126 20130101; A61M 60/50 20210101; A61M 2205/127
20130101; G01M 3/188 20130101; F04B 23/06 20130101; G01K 1/16
20130101; A61M 2205/12 20130101; A61M 1/3626 20130101; F04B 43/073
20130101; A61M 60/894 20210101; F04B 43/0081 20130101; F04B 43/0736
20130101; A61M 2205/3653 20130101; A61M 1/369 20130101; A61M 60/205
20210101; A61M 60/113 20210101; A61M 2205/502 20130101; A61M
2205/3368 20130101; A61M 60/892 20210101; G01K 1/08 20130101; A61M
2205/3334 20130101; A61M 60/268 20210101; A61M 2205/3606
20130101 |
Class at
Publication: |
604/006.13 ;
165/122; 165/134.1; 604/113; 607/106 |
International
Class: |
A61M 1/36 20060101
A61M001/36; F28F 13/06 20060101 F28F013/06; F28F 27/00 20060101
F28F027/00 |
Claims
1. A method for heating or cooling a fluid, the method comprising:
providing at least one reciprocating positive-displacement pump,
each pump having: a curved rigid chamber wall; a flexible membrane
attached to the rigid chamber wall, so that the flexible membrane
and rigid chamber wall define a pumping chamber; an inlet for
directing fluid through the rigid chamber wall into the pumping
chamber in at least one of (a) a direction that is substantially
tangential to the rigid chamber wall and (b) a direction that
provides low-shear flow into the pumping chamber; and an outlet for
directing fluid through the rigid chamber wall out of the pumping
chamber in at least one of (a) a direction that is substantially
tangential to the rigid chamber wall and (b) a direction that
provides low-shear flow out of the pumping chamber; providing a
heat exchanger; and pumping the fluid from at least one source
using the at least one reciprocating positive-displacement pump so
as to cause the fluid to pass through the heat exchanger.
2. A method according to claim 1, wherein each pump is provided
with a rigid chamber wall that is hemispheroid.
3. A method according to claim 1, wherein each pump is provided
with a rigid limit structure for limiting movement of the membrane
and limiting the maximum volume of the pumping chamber the flexible
membrane and the rigid limit structure defining an actuation
chamber.
4. A method according to claim 3, wherein each pump is provided
with a rigid chamber wall that is hemispheroid and a rigid limit
structure that is hemispheroid such that the pumping chamber is
spheroid when the membrane is urged against the rigid limit
structure, and the actuation chamber is spheroid when the membrane
is urged against the rigid chamber wall.
5. A method according to claim 1, wherein providing the at least
one reciprocating positive-displacement pump comprising: providing
a pair of reciprocating, positive-displacement pumps as in any of
the preceding claims.
6. A method according to claim 5, wherein pumping the fluid
comprising: operating the pair of pumps out of phase so as to
produce a substantially continuous fluid flow.
7. A method according to claim 5 wherein, pumping the fluid
comprising: providing a disposable unit including a heat-exchanger
component; placing the heat-exchanger component in proximity with
the heat exchanger; and pumping the fluid through the
heat-exchanger component so as to heat or cool the fluid in the
heat-exchanger component.
8. A method according to claim 7, wherein the heat-exchanger
component includes at least one of a heat-exchanger bag, a length
of tubing, and a radiator.
9. A method according to claim 1, wherein the source is a patient
and wherein the fluid is a bodily fluid.
10. A method according to claim 1, further comprising: pumping the
heated fluid to a patient.
11. A method according to claim 10, further comprising: monitoring
the patient's temperature; and controlling operation of at least
one of (a) the at least one pump and (b) the heat exchanger in
order to attain a predetermined patient temperature.
12. (canceled)
13. A method according to claim 3, further comprising: providing a
pneumatic actuation system for intermittently providing either a
positive or a negative pressure to the actuation chamber of each
pump.
14. A method according to claim 13, wherein the pneumatic actuation
system is provided with: a reservoir containing a gas at either a
positive or a negative pressure, and a valving mechanism for
controlling the flow of gas between the gas reservoir and the
actuation chamber of each pump.
15. A method according to claim 14, wherein the pneumatic actuation
system is further provided with at least one actuation-chamber
pressure transducer for measuring the pressure of the actuation
chamber of each plump, and a controller that receives pressure
information from the at least one actuation-chamber pressure
transducer and controls the valving mechanism.
16. A method according to claim 15, wherein the pneumatic actuation
system is further provided with a reservoir pressure transducer for
measuring the pressure of the gas in the reservoir, and wherein the
controller receives pressure information from the reservoir
pressure transducer.
17. A method according to claim 16, wherein the controller compares
the pressure information from the actuation-chamber and reservoir
pressure transducers to determine whether any of the pressure
transducers is malfunctioning.
18. A method according, to claim 3, further comprising: providing a
pneumatic actuation system for alternately providing positive and
negative pressure to the actuation chamber of each pump.
19. A method according to claim 18, wherein the pneumatic actuation
system is provided with: a positive-pressure gas reservoir; a
negative-pressure gas reservoir; and a valving mechanism for
controlling the flow of gas between the gas reservoirs and the
actuation chamber of each pump.
20. A method according to claim 19, wherein the pneumatic actuation
system is further provided with: at least one actuation-chamber
pressure transducer for measuring the pressure of the actuation
chamber of each pump, and a controller that receives pressure
information from the at least one actuation-chamber pressure
transducer and controls the valving mechanism.
21-23. (canceled)
24. A method according to claim 20, wherein the controller controls
the valving mechanism to cause the flexible membrane of each pump
to reach either the rigid chamber wall or the rigid limit structure
at each of stroke's beginning and end, and wherein the controller
determines the amount of flow through each pump based on a number
of strokes.
25. A method according to claim 24, wherein the controller
integrates pressure information an actuation-chamber pressure
transducer over time during a stroke to detect an aberrant flow
condition.
26. A method according to claim 1, wherein the inlet of each pump
is provided with an inlet valve for preventing flow out of the
pumping chamber through the inlet and the outlet of each pump is
provided with an outlet valve for preventing flow into the pumping
chamber through the outlet.
27. A method according to claim 26, wherein the inlet valve and the
outlet valve are passive check valves.
28. A method according to claim 26, wherein the inlet valve and the
outlet valve are actively controlled valves, and wherein pumping
the fluid comprises operating the valves.
29. A disposable unit for use in a heat exchanger system, the
disposable unit comprising: at least one reciprocating
positive-displacement pump, each pump having a curved rigid chamber
wall; a flexible membrane attached to the rigid chamber wall, so
that the flexible membrane and rigid chamber wall define a pumping
chamber; an inlet for directing fluid through the rigid chamber
wall into the pumping chamber in at least one of (a) a direction
that is substantially tangential to the rigid chamber wall and (b)
a direction that provides low-shear flow into the pumping chamber;
and an outlet for directing fluid through the rigid chamber wall
out of the pumping chamber in at least one of (a) a direction that
is substantially tangential to the rigid chamber wall and (b) a
direction that provides low-shear flow out of the pumping chamber;
and a heat-exchanger component, in fluid communication with the at
least one pump and adapted to be received by a heat exchanger.
30. A disposable unit according to claim 29, wherein the
heat-exchanger component includes at least one of a heat-exchanger
bag, a length of tubing, and a radiator.
31. A disposable unit according to claim 29, wherein each pump
includes a rigid chamber wall that is hemispheroid.
32. A disposable unit according to claim 29, wherein each pump
includes a rigid limit structure for limiting movement of the
membrane and limiting the maximum volume of the pumping chamber,
the flexible membrane and the rigid limit structure defining an
actuation chamber.
33-35. (canceled)
36. A disposable unit according to claim 29, wherein the inlet of
each pump includes an inlet valve for preventing flow out of the
pumping chamber through the inlet and the outlet of each pump
includes an outlet valve for preventing flow into the pumping
chamber through the outlet.
37. A disposable unit according to claim 36, wherein the inlet
valve and the outlet valve are passive check valves.
38. A disposable unit according to claim 36, wherein the inlet
valve and the outlet valve are actively controlled valves.
39. A disposable unit according to claim 29, wherein the
heat-exchanger component includes an inlet in fluid communication
with the outlet of the at least one pump for pumping fluid into the
heat-exchanger component for heating or cooling.
40. (canceled)
41. A disposable unit according to claim 29, further comprising a
filter in fluid communication with an outlet of the heat-exchanger
component for filtering heated or cooled fluid flowing out of the
heat-exchanger component.
42. A disposable unit according to claim 29, further comprising: a
manifold including: at least one inlet port for providing fluidic
connection to an inlet of the heat-exchanger component, and an
outlet port for providing fluidic connection to an outlet of the
heat-exchanger component.
43-45. (canceled)
46. A disposable unit according to claim 42, wherein the manifold
further includes at least one sensor component, each sensor
component disposed in a port and capable of transmitting thermal
information regarding fluid passing through the port.
47. (canceled)
48. A disposable unit according to claim 46, wherein each sensor
component includes a thermal well.
49-56. (canceled)
57. A heat-exchanger system comprising: a heat exchanger for
receiving a heat-exchanger component of a disposable unit; a
pneumatic actuation system for operating at least one reciprocating
positive-displacement pump of the disposable unit for pumping fluid
through the heat-exchanger component, each pump including a pumping
chamber defined by a curved rigid chamber wall and a flexible
membrane attached to the rigid chamber wail an further including an
actuation chamber defined at least in part by the flexible
membrane, the actuation chamber in fluid communication with the
pneumatic actuation system; and a controller for controlling the
pneumatic actuation system and the heat exchanger.
58-59. (canceled)
60. A heat exchanger system according to claim 57, wherein the
controller is adapted to compare the temperature readings from the
first and second locations; generate a first alarm signal
indicating faulty temperature readings, if the temperature reading
at the first location is not within a pre-set range from the
temperature reading at the second location; determine if the
temperature reading from the first or second location is above or
below a pre-set temperature range; and if a reading is above or
below the pre-set temperature range, generate a second alarm signal
indicating the temperature is above or below the pre-set
temperature range.
61-85. (canceled)
86. A radiator for use in a heat-exchanger system, the radiator
comprising: a body including a thermally conductive material; and a
channel disposed in the body for receiving a length of tubing.
87. A radiator according to claim 86, wherein the channel
comprises: an inner loop; an outer loop; and a serpentine portion
connecting the inner and outer loops, such that fluid flowing
through portions of tubing disposed in the inner and outer loops of
the channel flow in opposite directions.
88. A method of moving blood between a patient-access device and a
heat exchanger for heating the blood the method comprising:
providing a reciprocating positive-displacement pump; providing a
flow line having a first portion between the patient-access device
and the pump and having a second portion between the pump and the
heat exchanger; providing for each of the first and second portions
of the flow line a valve for permitting flow in only one direction
of the flow line; and actuating the pump to cause the flow of blood
between the patient-access device and the heat exchanger.
89. A method according to claim 88, wherein the pump is provided
with a flexible membrane as a reciprocating member.
90. A method according to claim 89, wherein the pump is provided
with a pneumatic actuation system for alternately providing
positive and negative pressure to the membrane.
91-92. (canceled)
93. A system for extracorporeal thermal therapy, the system
comprising: a heat exchanger for heating the blood, a reciprocating
positive-displacement pump for moving blood between a
patient-access device and the heat exchanger, the pump having an
inlet line and an outlet line; a first valve, located in the inlet
line, for preventing flow of blood out of the pump; and a second
valve, located in the outlet line, for preventing flow of blood
into the pump.
94-95. (canceled)
96. A heat exchanger for heating extracorporeal blood, the heat
exchanger comprising a pump, the heat exchanger comprising: a
heat-exchange flow path having an inlet and an outlet; an
electricity-to-heat converter that turns electrical power into heat
for absorption by the blood; a first temperature sensor located at
the inlet for measuring the temperature of the blood entering the
heat exchanger; a second temperature sensor located at the outlet
for measuring the temperature of the blood exiting the heat
exchanger; a metering system that determines at least one of the
volume or flow rate of blood passing through the heat exchanger;
and a controller in communication with the converter, the first and
second temperature sensors, and the metering system, the controller
receiving information regarding at least one of: the amount of
power being used by the converter, temperature information from the
first and second temperature sensors, flow-rate information from
the metering system, and volume information from the metering
system, the controller analyzing the received information in order
to determine whether a fault condition exists, and generating a
signal if a fault condition is detected.
97. A heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising: an inlet for
unheated blood; an outlet for heated blood; a flow path from the
inlet to the outlet; a set of heating elements overlapping the flow
path, including at least first and second heating elements the
second heating element being located adjacent the flow path near
the outlet, and the first heating element being located adjacent
the flow path at a point upstream of the second heating element; a
first temperature sensor located adjacent the flow path upstream of
the first heating element; a second temperature sensor located
adjacent the flow path between the first and second heating
elements; and a controller for receiving temperature information
from the first and second temperature sensors and for generating a
signal if a temperature difference being measured by the first and
second sensors exceeds a limit.
98-121. (canceled)
122. A method of heating a patient's blood, the method comprising;
providing a heat-exchanger system for heating blood from the
patient and pumping heated blood to the patient; connecting a first
temperature probe from the patient to the heat-exchanger system,
the heat-exchanger system controlling the blood heating and pumping
based on temperature information received from the first
temperature probe and displaying the temperature information
received from the first temperature probe to an operator;
monitoring patient temperature by the operator using an independent
second temperature probe, and terminating the treatment if either
of the temperature probes conveys an unacceptable temperature
reading.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority from the following United
States Provisional Patent Applications, all of which are hereby
incorporated herein by reference in their entireties:
[0002] U.S. Provisional Patent Application No. 60/792,073 entitled
Extracorporeal Thermal Therapy Systems and Methods filed on Apr.
14, 2006;
[0003] U.S. Provisional Patent Application No. 60/835,490 entitled
Extracorporeal Thermal Therapy Systems and Methods filed on Aug. 4,
2006;
[0004] U.S. Provisional Patent Application No. 60/904,024 entitled
Hemodialysis System and Methods filed on Feb. 27, 2007; and
[0005] U.S. Provisional Patent Application No. 60/921,314 entitled
Sensor Apparatus filed on Apr. 2, 2007.
[0006] This application is also related to the following United
States patent applications, all of which are being filed on even
date herewith and are hereby incorporated herein by reference in
their entireties:
[0007] U.S. patent application entitled LIQUID PUMPING SYSTEM,
DEVICE AND METHOD (Attorney Docket No. 1062/E78); and
[0008] U.S. patent application entitled THERMAL AND CONDUCTIVITY
SENSING SYSTEMS, DEVICES, AND METHODS (Attorney Docket No.
1062/E79).
[0009] This application is also related to U.S. patent application
Ser. No. 10/697,450 entitled BEZEL ASSEMBLY FOR PNEUMATIC CONTROL
filed on Oct. 30, 2003 and published as Publication No. US
2005/0095154 (Attorney Docket No. 1062/D75) and related PCT
Application No. PCT/US2004/035952 entitled BEZEL ASSEMBLY FOR
PNEUMATIC CONTROL filed on Oct. 29, 2004 and published as
Publication No. WO 2005/044435 (Attorney Docket No. 1062/D71 WO),
both of which are hereby incorporated herein by reference in their
entireties.
TECHNICAL FIELD
[0010] The present invention relates heat exchange systems
BACKGROUND ART
[0011] It is known in the prior art that altering the body
temperature of a patient by means of extracorporeal heating can
treat a variety of diseases, such as Hepatitis C and possibly some
types of cancer, HIV/AIDS, rheumatoid arthritis and psoriasis. In
order to heat the blood in a reasonable amount of time, high flow
rates are necessary from the patient's body to a heater and back to
the patient.
[0012] Centrifugal pumps have been used in prior art systems in
order to achieve relatively large flow rates of blood to and from
the patient's body. Although the centrifugal pumps can achieve the
necessary high flow rates, the centrifugal pumps create relatively
large shear forces on the blood resulting in an undesirable amount
of hemolysis. Heated blood is even more prone to hemolysis.
[0013] Because of the large flow rates of blood to and from the
patient, a leak in the system could quickly result in the death of
the patient.
[0014] The prior art systems also typically involve bulky equipment
and are relatively clumsy, resulting in time lags when switching
the system from one patient to the next, and increasing the risk of
the system being improperly set up.
SUMMARY OF THE INVENTION
[0015] In accordance with one aspect of the invention there is
provided a method for heating or cooling a fluid, the method
comprising:
[0016] providing at least one reciprocating positive-displacement
pump, each pump having: [0017] a curved rigid chamber wall; [0018]
a flexible membrane attached to the rigid chamber wall, so that the
flexible membrane and rigid chamber wall define a pumping chamber;
[0019] an inlet for directing fluid through the rigid chamber wall
into the pumping chamber in at least one of (a) a direction that is
substantially tangential to the rigid chamber wall and (b) a
direction that provides low-shear flow into the pumping chamber;
and [0020] an outlet for directing fluid through the rigid chamber
wall out of the pumping chamber in at least one of (a) a direction
that is substantially tangential to the rigid chamber wall and (b)
a direction that provides low-shear flow out of the pumping
chamber;
[0021] providing a heat exchanger; and
[0022] pumping the fluid from a source using the at least one
reciprocating positive-displacement pump so as to cause the fluid
to pass through the heat exchanger.
[0023] In accordance with another aspect of the invention there is
provided a disposable unit for use in a heat exchanger system, the
disposable unit comprising:
[0024] at least one reciprocating positive-displacement pump, each
pump having [0025] a curved rigid chamber wall; [0026] a flexible
membrane attached to the rigid chamber wall, so that the flexible
membrane and rigid chamber wall define a pumping chamber; [0027] an
inlet for directing fluid through the rigid chamber wall into the
pumping chamber in at least one of (a) a direction that is
substantially tangential to the rigid chamber wall and (b) a
direction that provides low-shear flow into the pumping chamber;
and [0028] an outlet for directing fluid through the rigid chamber
wall out of the pumping chamber in at least one of (a) a direction
that is substantially tangential to the rigid chamber wall and (b)
a direction that provides low-shear flow out of the pumping
chamber; and
[0029] a heat-exchanger component, in fluid communication with the
at least one pump and adapted to be received by a heat
exchanger.
[0030] In accordance with another aspect of the invention there is
provided a heat-exchanger system comprising:
[0031] a heat exchanger for receiving a heat-exchanger component of
a disposable unit;
[0032] a pneumatic actuation system for operating at least one pump
of the disposable unit for pumping fluid through the heat-exchanger
component; and
[0033] a controller for controlling the pneumatic actuation
system.
[0034] In some embodiments, the disposable unit may be considered
to be part of the heat-exchanger system.
[0035] In accordance with another aspect of the invention there is
provided a method of moving blood between a patient-access device
and a heat exchanger for heating the blood, the method
comprising:
[0036] providing a reciprocating positive-displacement pump;
[0037] providing a flow line having a first portion between the
patient-access device and the pump and having a second portion
between the pump and the heat exchanger;
[0038] providing for each of the first and second portions of the
flow line a valve for permitting flow in only one direction of the
flow line; and
[0039] actuating the pump to cause the flow of blood between the
patient-access device and the heat exchanger.
[0040] In accordance with another aspect of the invention there is
provided a system for extracorporeal thermal therapy, the system
comprising:
[0041] a heat exchanger for heating the blood;
[0042] a reciprocating positive-displacement pump for moving blood
between a patient-access device and the heat exchanger, the pump
having an inlet line and an outlet line;
[0043] a first valve, located in the inlet line, for preventing
flow of blood out of the pump; and
[0044] a second valve, located in the outlet line, for preventing
flow of blood into the pump.
[0045] In accordance with another aspect of the invention there is
provided a heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising a pump
according to one of above claims, and further including a
heat-exchange flow path having an inlet for unheated blood an
outlet for heated blood;
[0046] an electricity-to-heat converter that turns electrical power
into heat for absorption by the blood;
[0047] a first temperature sensor located at the inlet for
measuring the temperature of the blood entering the heat
exchanger;
[0048] a second temperature sensor located at the outlet for
measuring the temperature of the blood exiting the heat
exchanger;
[0049] a metering system that measures the flow rate of blood
passing through the heat exchanger; and
[0050] a controller in communication with the converter, the first
and second temperature sensors, and the metering system, the
controller receiving information regarding the amount of power
being used by the converter, receiving temperature information from
the first and second temperature sensors, receiving flow-rate
information from the metering system, analyzing the received
information in order to determine whether a fault condition exists,
and generating a signal if a fault condition is detected.
[0051] In accordance with another aspect of the invention there is
provided a heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising:
[0052] an inlet for unheated blood;
[0053] an outlet for heated blood;
[0054] a flow path from the inlet to the outlet;
[0055] a set of heating elements overlapping the flow path,
including at least first and second heating elements, the second
heating element being located adjacent the flow path near the
outlet, and the first heating element being located adjacent the
flow path at a point upstream of the second heating element;
[0056] a first temperature sensor located adjacent the flow path
upstream of the first heating element;
[0057] a second temperature sensor located adjacent the flow path
between the first and second heating elements; and
[0058] a controller for receiving temperature information from the
first and second temperature sensors and for generating a signal if
a temperature difference being measured by the first and second
sensors exceeds a limit.
[0059] In accordance with another aspect of the invention there is
provided a heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising:
[0060] an inlet for unheated blood;
[0061] an outlet for heated blood;
[0062] a flow path from the inlet to the outlet;
[0063] a set of heating elements overlapping the flow path,
including at least first, second and third heating elements, the
third heating element being located adjacent the flow path near the
outlet, the second heating element being located adjacent the flow
path at a point prior to the third heating element, and the first
heating element being located adjacent the flow path at a point
prior to the second heating element;
[0064] a first temperature sensor located adjacent the flow path
between the first and second heating elements;
[0065] a second temperature sensor located adjacent the flow path
between the second and third heating elements; and
[0066] a controller for receiving temperature information from the
first and second temperature sensors and for generating a signal if
a temperature difference being measured by the first and second
sensors exceeds a limit.
[0067] In accordance with another aspect of the invention there is
provided a heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising:
[0068] an inlet for unheated blood;
[0069] an outlet for heated blood;
[0070] an electricity-to-heat converter that turns electrical power
into heat for absorption by the blood;
[0071] a first temperature sensor located at the inlet for
measuring the temperature of the blood entering the heat
exchanger;
[0072] a second temperature sensor located at the outlet for
measuring the temperature of the blood exiting the heat
exchanger;
[0073] a metering system that measures the flow rate of blood
passing through the heat exchanger; and
[0074] a controller in communication with the converter, the first
and second temperature sensors, and the metering system, the
controller receiving information regarding the amount of power
being used by the converter, receiving temperature information from
the first and second temperature sensors, receiving flow-rate
information from the metering system, analyzing the received
information in order to determine whether a fault condition exists,
and generating a signal if a fault condition is detected.
[0075] In accordance with another aspect of the invention there is
provided a heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising:
[0076] an inlet for unheated blood;
[0077] an outlet for heated blood;
[0078] an electricity-to-heat converter that turns electrical power
into heat for absorption by the blood;
[0079] a disposable unit containing a flow path of the blood from
the inlet to the outlet, the disposable unit being made primarily
of a thermoplastic material;
[0080] an electrical-conductivity sensor for measuring the
resistance between the blood in the flow path a thermowell and the
converter; and
[0081] a controller in communication with the
electrical-conductivity sensor and generating a signal if the
measured resistance does not satisfy a safety parameter.
[0082] In accordance with another aspect of the invention there is
provided a heat exchanger for heating extracorporeal blood for
hyperthermia treatment, the heat exchanger comprising:
[0083] a disposable unit having [0084] an inlet for unheated blood,
[0085] an outlet for heated blood, and [0086] a flow path of the
blood from the inlet to the outlet; and
[0087] a base unit having
[0088] a heater for heating blood in the flow path, the heater
including a first thermally conductive plate for conducting heat to
a first side of the disposable unit, and a second thermally
conductive plate for conducting heat to a second side of the
disposable unit opposite the first plate, the first and second
plates being adapted to squeeze together, upon actuation by a
controller, in order to urge blood out of the disposable.
[0089] In accordance with another aspect of the invention there is
provided a method of locating temperature probes for monitoring a
patient's temperature, the method comprising:
[0090] taking temperature readings from a first temperature probe
to be located at a first location in the patient's body;
[0091] taking temperature readings from a second temperature probe
to be located at a second location in the patient's body;
[0092] comparing the temperature readings from the first and second
probes;
[0093] positioning the first and second temperature probes in the
patient's body;
[0094] determining if the temperature reading from the first or
second location is above a pre-set limit; and
[0095] generating a placement signal, if the temperature reading
from the first probe is within a pre-set range from the temperature
reading from the second probe, and if the reading from the first or
second location is above a pre-set limit.
[0096] In accordance with another aspect of the invention there is
provided a method of providing a hyperthermic treatment to a
patient, the method comprising:
[0097] providing a heat-exchanger system for heating blood from the
patient and pumping heated blood to the patient;
[0098] connecting a first temperature probe from the patient to the
heat-exchanger system, the heat-exchanger system controlling the
blood heating and pumping based on temperature information received
from the first temperature probe and displaying the temperature
information received from the first temperature probe to an
operator;
[0099] monitoring patient temperature by the operator using an
independent second temperature probe; and [0100] terminating the
treatment if either of the temperature probes conveys an
unacceptable temperature reading.
[0101] In some embodiments of the invention there is provided a
pump-pod geometry that reduces shear on the fluid being pumped and,
when used to pump blood (especially heated blood), reduces
hemolysis.
[0102] In one embodiment of the invention, a reciprocating
positive-displacement pump is provided with a hemispherical rigid
chamber wall; a flexible membrane attached to the rigid chamber
wall, so that the flexible membrane and rigid chamber wall define a
pumping chamber; an inlet for directing flow through the rigid
chamber wall into the pumping chamber in a direction that provides
low-shear flow into the pumping chamber; and an outlet for
directing flow through the rigid chamber wall out of the pumping
chamber in a direction that provides low-shear flow out of the
pumping chamber.
[0103] In one embodiment of the invention, a reciprocating
positive-displacement pump is provided comprising a rigid
hemispherical chamber wall; a flexible membrane attached to the
rigid chamber wall, so that the flexible membrane and rigid chamber
wall define a pumping chamber; an inlet for directing flow through
the rigid chamber wall into the pumping chamber in a direction that
is substantially tangential to the rigid chamber wall; and an
outlet for directing flow through the rigid chamber wall out of the
pumping chamber in a direction that is substantially tangential to
the rigid chamber wall. In some embodiments, the reciprocating
positive-displacement pump also includes a rigid limit structure
for limiting movement of the membrane and limiting the maximum
volume of the pumping chamber, the flexible membrane and the rigid
limit structure defining an actuation chamber. The rigid limit
structure may be adapted to limit movement of the flexible membrane
such that, when the pumping chamber is at maximum volume, the rigid
chamber and the flexible membrane (which will be urged against the
rigid limit structure) define the pumping chamber as a spherical
volume. The rigid limit structure may be a hemispherical limit wall
that, together with the flexible membrane, defines a spherical
actuation chamber when the pumping chamber is at minimum
volume.
[0104] In certain embodiments, the reciprocating
positive-displacement pump is provided with a pneumatic actuation
system that intermittently provides either a positive or a negative
pressure to the actuation chamber. The pneumatic actuation system
in some embodiments include a reservoir containing a gas at either
a positive or a negative pressure, and a valving mechanism for
controlling the flow of gas between the actuation chamber and the
gas reservoir. The reciprocating positive-displacement pump may be
provided with an actuation-chamber pressure transducer for
measuring the pressure of the actuation chamber, and a controller
that receives pressure information from the actuation-chamber
pressure transducer and controls the valving mechanism. In certain
embodiments, a reservoir pressure transducer for measuring the
pressure of the pressure of gas in the reservoir is provided, and
the controller receives pressure information from the reservoir
pressure transducer. The controller in some embodiments compares
the pressure information from the actuation-chamber and reservoir
pressure transducers to determine whether either of the pressure
transducers is malfunctioning.
[0105] In certain embodiments, the pneumatic actuation system
alternately provides positive and negative pressure to the
actuation chamber. In one arrangement, the pneumatic actuation
system includes a positive-pressure gas reservoir, a
negative-pressure gas reservoir, and a valving mechanism for
controlling the flow of gas between the actuation chamber and each
of the gas reservoirs. In such embodiments, an actuation-chamber
pressure transducer is also provided for measuring the pressure of
the actuation chamber, and a controller that receives pressure
information from the actuation-chamber pressure transducer and
controls the valving mechanism. In addition, such embodiments may
include a positive-pressure-reservoir pressure transducer for
measuring the pressure of the positive-pressure gas reservoir, and
a negative-pressure-reservoir pressure transducer for measuring the
pressure of the negative-pressure gas reservoir. The controller
receives pressure information from these transducers and analyzes
the pressure information to determine whether any of the pressure
transducers are malfunctioning. The controller also controls the
pressure of the reservoir or reservoirs to ensure it does not
exceed a pre-set limit.
[0106] In certain embodiments, the controller causes dithering of
the valving mechanism and determines when a stroke ends from
pressure information from the actuation-chamber pressure
transducer. In further embodiments, the controller controls the
valving mechanism to cause the flexible membrane to reach either
the rigid chamber wall or the rigid limit structure at each of a
stroke's beginning and end. In this embodiment, the controller can
determine the amount of flow through the pump based on a number of
strokes. In addition, the controller may integrate pressure
information from the actuation-chamber pressure transducer over
time during a stroke (or otherwise determines the work done during
a stroke) as a way of detecting an aberrant flow condition.
[0107] In some embodiments of the invention, the reciprocating
positive-displacement pump includes an inlet valve for preventing
flow out of the pump and an outlet valve for preventing flow into
the pump. In some embodiments, these valves are simply passive
check valves, and in other embodiments, these valves are active
valves that are controlled to cause fluid to flow in the desired
direction. In certain embodiments, the pump is adapted for pumping
a liquid, and in further embodiments, the pump is adapted for
pumping a biological liquid, such as blood. As noted above, some
embodiments of the inventions are well adapted for pumping heated
blood.
[0108] In certain embodiments, the pumps are paired--or otherwise
ganged--together so that an inlet line leads to both pumps' inlets
and wherein an outlet line leads from both pumps' outlets. In such
embodiments, the pumps may be operated out of phase such that when
one pump's pumping chamber is substantially full the other pump's
pumping chamber is substantially empty.
[0109] Embodiments of the invention also provide methods for
heating blood extracorporeally. One method includes the steps of
providing a reciprocating positive-displacement pump; providing a
flow line having a first portion between the patient-access device
and the pump and having a second portion between the pump and a
heat exchanger; providing for each of the first and second portions
of the flow line a valve for permitting flow in only one direction
of the flow line; and actuating the pump to cause the flow of blood
between the patient-access device and the heat exchanger. The pump
may be provided with a flexible membrane as a reciprocating member.
A pneumatic actuation system may be provided for alternately
providing positive and negative pressure to the membrane. A pump
having one of the various structures described herein may be used
in such methods.
[0110] Certain methods for heating blood extracorporeally include
the steps of providing a reciprocating positive-displacement pump
having a curved rigid chamber wall, a flexible membrane attached to
the rigid chamber wall so that the flexible membrane and rigid
chamber wall define a pumping chamber, an inlet for directing flow
through the rigid chamber wall into the pumping chamber in a
direction that is substantially tangential to the rigid chamber
wall, and an outlet for directing flow through the rigid chamber
wall out of the pumping chamber in a direction that is
substantially tangential to the rigid chamber wall; providing a
heater; providing blood from a source; and pumping the blood using
the reciprocating positive-displacement pump so as to cause the
blood to flow through the heater and be heated. The reciprocating
positive-displacement pump is, in certain embodiments, provided
with the structural features discussed herein.
[0111] Certain embodiments of these methods include the step of
monitoring the patient's temperature. Monitoring the patient's
temperature may include the steps of taking a temperature reading
from a first location in the patient's body; taking a temperature
reading from a second location in the patient's body; comparing the
temperature readings from the first and second locations;
generating a first alarm signal indicating faulty temperature
readings, if the temperature reading at the first location is not
within a pre-set range from the temperature reading at the second
location; determining if the temperature reading from the first
location is above a pre-set upper limit; and generating a second
alarm signal indicating an overheated condition, if a reading is
above the pre-set upper limit.
[0112] The methods described herein may use a disposable unit for
use in a system for heating blood extracorporeally. Such disposable
units may include a reciprocating positive-displacement pump having
a curved rigid chamber wall, a flexible membrane attached to the
rigid chamber wall so that the flexible membrane and rigid chamber
wall define a pumping chamber, an inlet for directing flow through
the rigid chamber wall into the pumping chamber in a direction that
is substantially tangential to the rigid chamber wall, and an
outlet for directing flow through the rigid chamber wall out of the
pumping chamber in a direction that is substantially tangential to
the rigid chamber wall; and a heat-exchanger component, in fluid
communication with the pump, and adapted to be received by a
heater. The heat-exchanger component may include a flexible bag
that defines a flow path therethrough. The reciprocating
positive-displacement pump may have a structure as described
herein.
[0113] The disposable unit preferably attaches, in an easily
removable manner, to a base unit, which preferably includes means
for attaching to a pneumatic actuation system that intermittently
provides either a positive or a negative pressure to the pump's
actuation chamber, and preferably includes the controller for
controlling the pneumatic actuation system. The controller
preferably controls the system so as to perform methods described
herein. The base unit is preferably capable of receiving and
holding disposable units having pod pumps with different stroke
volumes
[0114] In one embodiment of a system for extracorporeal thermal
therapy, a heat exchanger is provided for heating the blood; a
reciprocating positive-displacement pump is provided for moving
blood between a patient-access device (e.g., a cannula, needle or
shunt) and the heat exchanger, the pump having an inlet line and an
outlet line; a first valve, located in the inlet line, is provided
for preventing flow of blood out of the pump; and a second valve,
located in the outlet line, is provided for preventing flow of
blood into the pump. The pump may have a structure as described
herein.
[0115] In a particular embodiment, the reciprocating
positive-displacement pump uses a flexible membrane made from a
material that reduces hard snapping of the membrane as the membrane
reciprocates. The central portion may include bumps that space the
central portion away from the rigid chamber wall when the membrane
is in a minimum-pumping-chamber-volume position. Such bumps prevent
liquid from being trapped between the membrane and the wall.
[0116] The controller, in a particular embodiment, receives
temperature information from a first temperature sensor located at
the inlet for measuring the temperature of the blood entering the
heat exchanger and from a second temperature sensor located at the
outlet for measuring the temperature of the blood exiting the heat
exchanger, while also receiving flow-rate information from a
metering system that measures the flow rate of blood passing
through the heat exchanger. These temperature sensors may be
located in a base unit of the system, while thermally conductive
thermowells in the disposable unit provide thermal communication
between the flow path and the base unit's sensors. The controller
is also in communication with an electricity-to-heat converter and
receives information regarding the amount of power being used by
the converter. The controller, in this embodiment, analyzes the
received information from the temperature probes, the metering
system and the converter in order to determine whether a fault
condition exists, and generates a signal if a fault condition is
detected.
[0117] The controller may also receive temperature information from
temperature sensors mounted near heating elements adjacent the heat
exchanger's heating plates, wherein electrical current causes the
heating elements to heat the heating plates, which in turn heat the
blood passing through the heat exchanger. A set of heating elements
may overlap the flow path through the heat exchanger. The set of
heating elements includes at least first and second heating
elements, the second heating element being located adjacent the
flow path near the outlet, and the first heating element being
located adjacent the flow path at a point upstream of the second
heating element. A first temperature sensor is located adjacent the
flow path upstream of the first heating element, and a second
temperature sensor is located adjacent the flow path between the
first and second heating elements. In this embodiment, the
controller receives temperature information from the first and
second temperature sensors, and generates a signal if a temperature
difference being measured by the first and second sensors exceeds a
limit. Of course, the heat exchanger may use additional heating
elements beyond the two referred to here. The flow path may course
through a substantially planar disposable unit. This disposable
unit, as noted above, may be a flexible bag.
[0118] A first heating plate, which in one embodiment is simply a
thermally conductive plate, may be located between the heating
elements and the disposable unit. A second heating plate may be
located adjacent the disposable unit opposite the first heating
plate, and a second set of heating elements may be located on a
side of the second plate opposite the disposable unit and
overlapping the flow path, including at least fourth, fifth and
sixth heating elements, the sixth heating element being located
adjacent the flow path near the outlet, the fifth heating element
being located adjacent the flow path at a point prior to the sixth
heating element, and the fourth heating element being located
adjacent the flow path at a point prior to the fifth heating
element. In this embodiment, a third temperature sensor may be
located adjacent the flow path between the fourth and fifth heating
elements, and a fourth temperature sensor is located adjacent the
flow path between the fifth and sixth heating elements. The
controller also receives temperature information from the third and
fourth temperature sensors and generates a signal if a temperature
difference being measured by the third and fourth sensors exceeds a
limit. In one embodiment, the first and second plates may be
adapted to squeeze together, upon actuation by the controller, in
order to urge blood out of the disposable.
[0119] In a certain embodiment, the thermowells referred to
previously may also be electrically conductive and be used to
detect leaks or air in the system. The disposable unit adapted to
be received by the heat exchanger and containing a flow path of the
blood may be made primarily of a thermoplastic material. The
thermowells located at each of the inlet and outlet are preferably
metal to improve thermal and electrical conductivity between the
first temperature sensor and the blood in the inlet and between the
second temperature sensor and the blood in the outlet. The heating
plates each typically include an electrical-conductivity sensor for
measuring the resistance between a thermowell and a plate. The
controller is in communication with the electrical-conductivity
sensor and generates a signal if the measured resistance is too low
(indicating a leak in the disposable unit) and/or too high
(indicating air in the disposable unit).
[0120] In a certain embodiment, a valving system is provided. The
valving system includes a valve cassette and a control cassette.
The valve cassette contains a plurality of valves, each valve
including a valving chamber and an actuation chamber, each valve
being actuatable by a control fluid in the actuation chamber. The
control cassette has a plurality of fluid-interface ports for
providing fluid communication with a control fluid from a base
unit. A plurality of tubes extends between the valve cassette and
the control cassette. Each tube provides fluid communication
between a fluid-interface port and at least one actuation chamber,
such that the base unit can actuate a valve by pressurizing control
fluid in a fluid interface port.
[0121] These aspects of the invention are not meant to be exclusive
or comprehensive and other features, aspects, and advantages of the
present invention are possible and will be readily apparent to
those of ordinary skill in the art when read in conjunction with
the following description, the appended claims, and the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0122] The foregoing features of the invention will be more readily
understood by reference to the following detailed description,
taken with reference to the accompanying drawings, wherein:
[0123] FIG. 1 is a perspective view of an
extracorporeal-blood-heating system having a base unit with a
disposable unit according to one embodiment of the invention;
[0124] FIG. 2 is a perspective view of components of the disposable
unit shown in FIG. 1;
[0125] FIG. 3 is a perspective view of a pump pod of the disposable
unit shown in FIG. 2;
[0126] FIG. 4 is a schematic showing a pressure actuation system
that may be used to actuate the pump pod shown in FIG. 3;
[0127] FIGS. 5A and 5B are respectively upper and lower perspective
views of an alternative embodiment of a pump pod arrangement;
[0128] FIG. 6 is a schematic of an embodiment of the extracorporeal
blood heating system;
[0129] FIGS. 7 and 8 are graphs showing how pressure measurements
can be used detect the end of a stroke, in one embodiment;
[0130] FIGS. 9 and 10 show how the pressure-measurement signals are
filtered by the system's controller;
[0131] FIG. 11 is a graph showing pressure readings in each of the
pump pods in the disposable unit, and the results of filtering
these readings;
[0132] FIG. 12 is a graph showing how pressure measurements are
used to determine average pressure;
[0133] FIG. 13A is a perspective view of the components from the
system of FIG. 1 used for transferring heating to the blood;
[0134] FIG. 13B is a perspective, back-side cross-sectional view of
the manifold of FIGS. 2 and 49, in accordance with an exemplary
embodiment of the present invention;
[0135] FIG. 13C shows a thermowell that may be used in the manifold
of FIGS. 2, 49, and 13B in the heat-exchanger figure of FIG. 1, in
accordance with an exemplary embodiment of the present
invention;
[0136] FIG. 14 is an exploded view showing the basic components of
a heat exchanger in an alternative embodiment;
[0137] FIGS. 15, 16 and 17 show respectively top perspective, end
perspective and top plan views of the disposable unit's
heat-exchanger bag used in the heat exchanger shown in FIG. 14;
[0138] FIG. 18 shows a preferred placement of temperature
transducers in a heat exchanger;
[0139] FIG. 19 is a flow chart showing a method for checking a
patient's temperature;
[0140] FIG. 20 is a sectional view of a pod-pump that may be
incorporated into embodiments of fluid-control cassettes;
[0141] FIG. 21 is a sectional view of a valve that may be
incorporated into embodiments of fluid-control cassettes;
[0142] FIGS. 22A and 22B shows a pump cassette incorporating two
pump pods of the type shown in FIG. 20 and a number of valves of
the type shown in FIG. 21 along with various fluid paths and other
components, in accordance with an exemplary embodiment of the
present invention;
[0143] FIG. 23 is a schematic representation of dual-housing
cassette arrangement according to one embodiment;
[0144] FIG. 24 is a schematic view of a whole-body hyperthermic
treatment system in accordance with an exemplary embodiment of the
present invention;
[0145] FIG. 25 shows the base unit of FIG. 1, in accordance with an
exemplary embodiment of the present invention;
[0146] FIG. 26 shows a close-up view of the manifold interface of
FIG. 25, in accordance with an exemplary embodiment of the present
invention;
[0147] FIG. 27 shows an exemplary user interface screen in
accordance with an exemplary embodiment of the present
invention;
[0148] FIG. 28 is a graph showing how pressures applied to a pod
pump may be controlled in order to facilitate end-of-stroke
detection, in accordance with an exemplary embodiment of the
present invention;
[0149] FIG. 29 is a schematic representation of circulatory fluid
flow in the pump pod shown in FIG. 3, in accordance with an
exemplary embodiment of the present invention;
[0150] FIGS. 30A and 30B are top and section views of a modular pod
pump;
[0151] FIGS. 31A and 31B are top and section views of a pod pump
with separate inlet and outlet ports, FIG. 31A showing a section
line to indicate the view in FIG. 31B;
[0152] FIGS. 32A and 32B are top and section views of a pod pump
with an insert in the actuation chamber;
[0153] FIGS. 33A and 33B are top and section views of a pod pump
with a laminated construction;
[0154] FIGS. 34A and 34B are top and section views of a pod pump
with a laminated construction;
[0155] FIG. 35A is an exploded pictorial view of a pod pump with a
multi part housing; FIGS. 35B-E are pictorial views of various
embodiments of diaphragms;
[0156] FIGS. 36A and 36B are side and end views of an assembled pod
pump with a multi part housing;
[0157] FIG. 36C is a close up view of a port on a pod pump with a
multi part housing;
[0158] FIG. 37 is an exploded pictorial view of a multi part pod
pump housing;
[0159] FIGS. 38A and 38B are top and section views of a pod pump
assembly with integral valves;
[0160] FIG. 39 is an exploded pictorial view of a pod pump
assembly;
[0161] FIG. 40A is a pictorial view of two parts of a multi part
pod pump housing;
[0162] FIG. 40B is a pictorial closeup view of aligning features on
parts of a multi part pump housing;
[0163] FIG. 41A is a pictorial section view of a pod pump assembly
with some portions removed;
[0164] FIG. 41B is a close up pictorial view of aligning and
joining features on a pod pump housing;
[0165] FIG. 42A is a pictorial view of a pod pump;
[0166] FIG. 42B is a sectional view of the pod pump shown in FIG.
42A;
[0167] FIG. 42C is a pictorial view of a pod pump;
[0168] FIG. 42D is a sectional view of the pod pump shown in FIG.
42C;
[0169] FIGS. 43A-43C are exploded and section views of one
embodiment of a pod pump cassette;
[0170] FIGS. 44A-44B are pictorial views of one embodiment of a pod
pump cassette;
[0171] FIG. 45 shows a representation of a regional hyperthermic
chemotherapy treatment system in accordance with an exemplary
embodiment of the present invention;
[0172] FIGS. 46A and 46B respectively show upper and lower
perspective views of a flexible membrane having a configuration of
raised bumps, such as may be used in pump pods such as the in the
pump pod of FIG. 4, in accordance with an exemplary embodiment of
the present invention;
[0173] FIG. 47A shows some of the interior components of the base
unit of FIGS. 1 and 25, in accordance with an exemplary embodiment
of the present invention;
[0174] FIG. 47B shows a rear perspective view of the base unit of
FIGS. 1 and 25 showing patient interfaces, in accordance with an
exemplary embodiment of the present invention;
[0175] FIG. 48 shows an exemplary disposable unit in accordance
with an exemplary embodiment of the present invention;
[0176] FIGS. 49A and 49B respectively show a perspective back-side
view and a perspective bottom view of the manifold from FIG. 2, in
accordance with an exemplary embodiment of the present
invention;
[0177] FIGS. 50A and 50B are embodiments of the sensing apparatus
where the thermal well is a continuous part of the fluid line;
[0178] FIGS. 51A and 51B are embodiments of the sensing apparatus
where the thermal well is a separate part from the fluid line;
[0179] FIGS. 52A and 52B are embodiments of the sensing apparatus
showing various lengths and widths of the thermal well;
[0180] FIG. 53 is a pictorial view of a thermal well according to
one embodiment of the sensing apparatus;
[0181] FIG. 54 is a cross sectional view of an exemplary embodiment
of the thermal well;
[0182] FIGS. 55A and 55B show section views of embodiments of
thermal wells having variable wall thickness;
[0183] FIGS. 56A-56S are sectional views of various embodiments of
the thermal well embedded in a fluid line;
[0184] FIG. 57 is a section side view of one embodiment of the
sensing probe;
[0185] FIG. 58 is an exploded view of the embodiment shown in FIG.
8;
[0186] FIG. 59 is a sectional view of an alternate embodiment of
the tip of the sensing probe;
[0187] FIG. 60A is an alternate embodiment of the sensing
probe;
[0188] FIG. 60B is an alternate embodiment of the sensing
probe;
[0189] FIG. 61 is a side view of an alternate embodiment of the
sensing probe;
[0190] FIG. 62A is a section view of a sensing probe coupled to a
thermal well;
[0191] FIG. 62B is an alternate embodiment of the sensing probe
shown in FIG. 13A;
[0192] FIG. 63A is a section view of a sensing probe as shown in
FIG. 8 coupled to a thermal well;
[0193] FIG. 63B is an alternate embodiment of the sensing probe
shown in FIG. 14A;
[0194] FIG. 64 is a sectional view of one exemplary embodiment of
the sensor apparatus;
[0195] FIG. 65 shows an alternate embodiment of a sensing probe
coupled to a thermal well;
[0196] FIG. 66 is a section view of one embodiment of a sensing
probe coupled to a thermal well and suspended by a spring;
[0197] FIG. 67 is a section view of one embodiment of a sensing
probe in a housing;
[0198] FIG. 68 is a section view of one embodiment of a sensing
probe in a housing;
[0199] FIG. 69 is a section view of one embodiment of a sensing
probe in a housing;
[0200] FIG. 70 is a side view of a fluid line including two
sensors;
[0201] FIG. 71 is a section view of a fluid line with a sensor
apparatus;
[0202] FIG. 72 shows one way in which the various components of the
disposable unit of FIG. 2 can be interconnected;
[0203] FIGS. 73A-73B are graphical representations of occlusion
detection in accordance with an exemplary embodiment of the present
invention;
[0204] FIGS. 74A-74C show plots for volume flow, pod volumes, and
total hold up flow for two pump pods operating in a zero degree
phase relationship, a 180 degree phase relationship, and a 90
degree phase relationship, respectively, in accordance with
exemplary embodiments of the present invention
[0205] FIG. 75 shows a radiator for use with a length of tubing, in
accordance with an exemplary embodiment of the present
invention;
[0206] FIG. 76 shows a length of flexible tubing install in the
radiator of FIG. 75 in accordance with an exemplary embodiment of
the present invention;
[0207] FIG. 77 shows a heat exchanger plate having guides for
receiving the radiator of FIG. 75, in accordance with an exemplary
embodiment of the present invention;
[0208] FIG. 78 shows a heat exchanger plate having a cylindrical
wall for receiving the radiator of FIG. 75, in accordance with an
exemplary embodiment of the present invention;
[0209] FIG. 79 shows a heat exchanger plate having an integral
radiator of the type shown in FIG. 75, in accordance with an
exemplary embodiment of the present invention;
[0210] FIG. 80 shows an enclosed radiator having fluid inlet and
outlet ports, in accordance with an alternate embodiment of the
present invention;
[0211] FIG. 81 shows a variation of the disposable unit of FIG. 48
including a patient connection circuit having a sterile protective
covering, in accordance with an exemplary embodiment of the present
invention;
[0212] FIG. 82 shows a representation of the patient connection
circuit from FIG. 81 with a portion of tubing exposed through the
sterile protective covering, in accordance with an exemplary
embodiment of the present invention; and
[0213] FIG. 83 shows a variation of the disposable unit of FIG. 81
including an additional fluid delivery line, in accordance with an
exemplary embodiment of the present invention;
[0214] FIG. 84 shows a fluid circuit that may be used for providing
regional hyperthermic chemotherapy treatment, in accordance with an
exemplary embodiment of the present invention;
[0215] FIG. 85 shows another fluid circuit including a balancing
chamber that may be used for providing regional hyperthermic
chemotherapy treatment, in accordance with an exemplary embodiment
of the present invention;
[0216] FIG. 86 shows another fluid circuit including a balancing
chamber and a second pump that may be used for providing regional
hyperthermic chemotherapy treatment, in accordance with an
exemplary embodiment of the present invention; and
[0217] FIG. 87 shows a fluid circuit including a drain valve that
may be used for providing regional hyperthermic chemotherapy
treatment, in accordance with an exemplary embodiment of the
present invention.
[0218] It should be noted that the foregoing figures and the
elements depicted therein are not necessarily drawn to consistent
scale or to any scale. Unless the context otherwise suggests, like
elements are indicated by like numerals.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0219] Definitions. As used in this description and the
accompanying claims, the following terms shall have the meanings
indicated, unless the context otherwise requires:
[0220] "Spheroid" means any three-dimensional shape that generally
corresponds to a oval rotated about one of its principal axes,
major or minor, and includes three-dimensional egg shapes, oblate
and prolate spheroids, spheres, and substantially equivalent
shapes.
[0221] "Hemispheroid" means any three-dimensional shape that
generally corresponds to approximately half a spheroid.
[0222] "Spherical" means generally spherical.
[0223] "Hemispherical" means generally hemispherical.
[0224] "Dithering" a valve means rapidly opening and closing the
valve.
[0225] "Pneumatic" means using air or other gas to move a flexible
membrane or other member.
[0226] "Substantially tangential" means at an angle less than
75.degree. to a tangent, or in the case of a flat wall, at an angle
of less than 75.degree. to the wall.
[0227] "Fluid" shall mean a substance, a liquid for example, that
is capable of being pumped through a flow line. Blood is a specific
example of a fluid.
[0228] "Impedance" shall mean the opposition to the flow of
fluid.
[0229] A "patient" includes a person or animal from whom, or to
whom, fluid is pumped, whether as part of a medical treatment or
otherwise.
[0230] "Subject media" is any material, including any fluid, solid,
liquid or gas, that is in contact with either a sensing probe or a
thermal well.
[0231] Various aspects of the present invention are described below
with reference to various exemplary embodiments. It should be noted
that headings are included for convenience and do not limit the
present invention in any way.
1. Exemplary Reciprocating Positive-Displacement Pumps
[0232] Embodiments of the present invention relate generally to
certain types of reciprocating positive-displacement pumps (which
may be referred to hereinafter as "pods," "pump pods," or "pod
pumps") used to pump fluids, such as a biological fluid (e.g.,
blood or peritoneal fluid), a therapeutic fluid (e.g., a medication
solution), or a surfactant fluid. Certain embodiments are
configured specifically to impart low shear forces and low
turbulence on the fluid as the fluid is pumped from an inlet to an
outlet. Such embodiments may be particularly useful in pumping
fluids that may be damaged by such shear forces (e.g., blood, and
particularly heated blood, which is prone to hemolysis) or
turbulence (e.g., surfectants or other fluids that may foam or
otherwise be damaged or become unstable in the presence of
turbulence).
[0233] Generally speaking, the pod pump is a modular pump
apparatus. The pod pump can be connected to any subject fluid
(i.e., liquid, gas or variations thereof) source, which includes
but is not limited to a path, line or fluid container, in order to
provide movement of said subject fluid. In some embodiments,
multiple pod pumps are used, however, in other embodiments, one pod
pump is used. The pod pump can additionally be connected to at
least one actuation source, which in some embodiments, is at least
one air chamber. In some embodiments, the pod pump is modularly
connected to any device or machine. However, in other embodiments,
the pod pump is part of a device, machine or container that is
attached to another device, machine or container. Although the pod
pump is modular, the pod pump may also be part of another modular
structure that interacts with any machine, device, container or
otherwise.
[0234] In one embodiment, the pod pump includes a housing having a
diaphragm or movable impermeable membrane attached to the interior
of the housing. The diaphragm creates two chambers. One chamber
does not come into contact with subject fluid; this chamber is
referred to as the actuation chamber. The second chamber comes into
contact with the subject fluid. This chamber is referred to as the
pump or pumping chamber.
[0235] The pod pump, in some embodiments, includes an inlet fluid
path and an outlet fluid path. Thus, in these embodiments, a
subject fluid is pumped into the pump chamber, then out of the pump
chamber. In some embodiments, valving mechanisms are used to ensure
that the fluid moves in the intended direction. In other
embodiments, the inlet fluid path and the outlet fluid path are one
in the same.
[0236] The actuation of the diaphragm is provided for by a change
in pressure. This change in pressure can be created through use of
positive and negative air pressures. In one embodiment, a pneumatic
mechanism is used to fill the actuation chamber with air (creating
a positive pressure) and then to suck the air out of the actuation
chamber (creating a negative pressure). In some embodiments, the
air flows through a port in the actuation chamber. The port can be,
but is not limited to, an opening or aperture in the actuation
chamber. In other embodiments, any fluid (i.e., liquid, gas or
variations thereof) can be used as an actuation fluid.
[0237] For purposes of this description, exemplary embodiments are
shown and described. However, other embodiments are contemplated,
thus, the description provided are meant to bring an understanding
of the pod pump embodiments, other variations will be apparent.
1.1. Exemplary Pump Pod Configurations
[0238] FIG. 3 shows a reciprocating positive-displacement pump 25
in accordance with an exemplary embodiment of the present
invention. In this embodiment, the reciprocating
positive-displacement pump 25 is essentially a self-contained unit
(which may be referred to hereinafter as a "pod") that may be used
as a component of a larger pumping system. The reciprocating
positive-displacement pump 25 includes a "top" portion (also
referred to as the "pumping chamber wall") 31 and a "bottom"
portion (also referred to as the "actuation chamber wall") 32 that
are coupled together at pod wall 30, for example, by ultrasonic
welding or other technique. It should be noted that the terms "top"
and "bottom" are relative and are used here for convenience with
reference to the orientation shown in FIG. 3. Each of the portions
31 and 32 has a rigid interior surface that is preferably (although
not necessarily) hemispherical, such that the pod has an interior
cavity that is preferably (although not necessarily) spherical.
[0239] In the embodiment shown in FIG. 3, the actuation chamber
wall 32 is a unitary structure while the pumping chamber wall 31 is
formed from two halves that are coupled together along perimeter
2052, for example, by ultrasonic welding or other technique (which
facilitates assembly of the integral valves, discussed below). FIG.
37 shows an exploded view of the three pump pod wall sections in
accordance with an exemplary embodiment of the present invention.
FIG. 38A shows a top view of the assembled three-piece pump pod.
FIG. 38B shows a side cross-sectional view of the assembled
three-piece pump pod. FIG. 39 shows an exploded view of the pump
pod components. FIGS. 37-39 are discussed in greater detail below.
Of course, the present invention is in no way limited to the way in
which the pumping chamber wall 31 and the actuation chamber wall 32
are constructed or assembled, although ultrasonic welding of the
pumping chamber wall 31 and the actuation chamber wall 32 is
considered a preferred embodiment.
[0240] Within the reciprocating positive-displacement pump 25, a
flexible membrane 33 (also referred to as the "pump diaphragm") is
mounted where the pumping-chamber wall 31 and the actuation-chamber
wall 32 meet (i.e., at the pod wall 30). The pump diaphragm 33
effectively divides that interior cavity into a variable-volume
pumping chamber (defined by the rigid interior surface of the
pumping chamber wall 31 and a top surface of the membrane 33) and a
complementary variable-volume actuation chamber (defined by the
rigid interior surface of the actuation chamber wall 32 and a
bottom side of the membrane 33). The top portion 31 includes a
fluid inlet 34 and a fluid outlet 37, both of which are in fluid
communication with the pumping chamber. The bottom portion 32
includes a pneumatic interface 38 in fluid communication with the
actuation chamber. As discussed in greater detail below, the
membrane 33 can be urged to move back and forth within the cavity
by alternately applying negative and positive pneumatic pressure at
the pneumatic interface 38. As the membrane 33 reciprocates back
and forth in the embodiment shown in FIG. 3, the sum of the volumes
of the pumping and actuation chambers remains constant.
[0241] During typical fluid pumping operations, the application of
negative pneumatic pressure to the pneumatic interface 38 tends to
withdraw the membrane 33 toward the actuation chamber wall 32 so as
to expand the pumping chamber and draw fluid into the pumping
chamber through the inlet 34, while the application of positive
pneumatic pressure tends to push the membrane 33 toward the pumping
chamber wall 31 so as to collapse the pumping chamber and expel
fluid in the pumping chamber through the outlet 37. During such
pumping operations, the interior surfaces of the pumping chamber
wall 31 and the actuation chamber wall 32 limit movement of the
membrane 33 as it reciprocates back and forth. In the embodiment
shown in FIG. 3, the interior surfaces of the pumping chamber wall
31 and the actuation chamber wall 32 are rigid, smooth, and
hemispherical. In lieu of a rigid actuation-chamber wall 32, an
alternative rigid limit structure--for example, a portion of a
bezel used for providing pneumatic pressure and/or a set of
ribs--may be used to limit the movement of the membrane as the
pumping chamber approaches maximum value. Bezels and rib structures
are described generally in U.S. patent application Ser. No.
10/697,450 entitled BEZEL ASSEMBLY FOR PNEUMATIC CONTROL filed on
Oct. 30, 2003 and published as Publication No. US 2005/0095154
(Attorney Docket No. 1062/D75) and related PCT Application No.
PCT/US2004/035952 entitled BEZEL ASSEMBLY FOR PNEUMATIC CONTROL
filed on Oct. 29, 2004 and published as Publication No. WO
2005/044435 (Attorney Docket No. 1062/D71 WO), both of which are
hereby incorporated herein by reference in their entireties. Thus,
the rigid limit structure--such as the rigid actuation chamber wall
32, a bezel, or a set of ribs--defines the shape of the membrane 33
when the pumping chamber is at its maximum value. In a preferred
embodiment, the membrane 33 (when urged against the rigid limit
structure) and the rigid interior surface of the pumping chamber
wall 31 define a spherical pumping-chamber volume when the pumping
chamber volume is at a maximum.
[0242] Thus, in the embodiment shown in FIG. 3, movement of the
membrane 33 is limited by the pumping-chamber wall 31 and the
actuation-chamber wall 32. As long as the positive and negative
pressurizations provided through the pneumatic port 38 are strong
enough, the membrane 33 will move from a position limited by the
actuation-chamber wall 32 to a position limited by the
pumping-chamber wall 31. When the membrane is forced against the
actuation-chamber wall 32, the membrane and the pumping-chamber
wall 31 define the maximum volume of the pumping chamber. When the
membrane is forced against the pumping-chamber wall 31, the pumping
chamber is at its minimum volume.
[0243] In a preferred embodiment, the pumping-chamber wall 31 and
the actuation-chamber wall 32 both have a hemispheroid shape so
that the pumping chamber will have a spheroid shape when it is at
its maximum volume. More preferably, the pumping-chamber wall 31
and the actuation-chamber wall 32 both have a hemispherical shape
so that the pumping chamber will have a spherical shape when it is
at its maximum volume. By using a pumping chamber that attains a
spheroid shape--and particularly a spherical shape--at maximum
volume, circulating flow may be attained throughout the pumping
chamber. Such shapes accordingly tend to avoid stagnant pockets of
fluid in the pumping chamber. As discussed further below, the
orientations of the inlet 34 and outlet 37--with each being
substantially tangential to the interior surface of the pumping
chamber wall 31--also tend to improve circulation of fluid through
the pumping chamber and reduce the likelihood of stagnant pockets
of fluid forming. Additionally, compared to other volumetric
shapes, the spherical shape (and spheroid shapes in general) tends
to create less shear and turbulence as the fluid circulates into,
through, and out of the pumping chamber.
1.2. Exemplary Inlet/Outlet Valves
[0244] Generally speaking, reciprocating positive-displacement
pumps of the types just described may include, or may be used in
conjunction with, various valves to control fluid flow through the
pump. Thus, for example, the reciprocating positive-displacement
pump may include, or be used in conjunction with, an inlet valve
and/or an outlet valve. The valves may be passive or active. In the
exemplary embodiment shown in FIG. 3, the reciprocating
positive-displacement pump 25 includes a passive one-way inlet
check valve 35 and a passive one-way outlet check valve 36. The
inlet check valve 35 allows fluid to be drawn into the pumping
chamber through the inlet 34 but substantially prevents backflow
through the inlet 34. The outlet check valve 36 allows fluid to be
pumped out of the pumping chamber through the outlet 37 but
substantially prevents backflow through the outlet 37.
[0245] Thus, in an exemplary embodiment using the reciprocating
positive-displacement pump 25, the membrane 33 is urged back and
forth by positive and negative pressurizations of a gas provided
through the pneumatic port 38, which connects the actuation chamber
to a pressure-actuation system. The resulting reciprocating action
of the membrane 33 pulls liquid into the pumping chamber from the
inlet 34 (the outlet check valve 36 prevents liquid from being
sucked back into the pumping chamber from the outlet 37) and then
pushes the liquid out of pumping chamber through the outlet 37 (the
inlet check valve 35 prevents liquid being forced back into the
inlet 34).
[0246] In alternative embodiments, active valves may be used in
lieu of the passive check valves 35 and 36. The active valves may
be actuated by a controller in such a manner as to direct flow in a
desired direction. Such an arrangement would generally permit the
controller to cause flow in either direction through the pump pod
25. In a typical system, the flow would normally be in a first
direction, e.g., from the inlet to the outlet. At certain other
times, the flow may be directed in the opposite direction, e.g.,
from the outlet to the inlet. Such reversal of flow may be
employed, for example, during priming of the pump, to check for an
aberrant line condition (e.g., a line occlusion, blockage,
disconnect, or leak), or to clear an aberrant line condition (e.g.,
to try to dislodge a blockage).
1.3. Exemplary Pump Inlet/Outlet Orientations
[0247] In the embodiment shown in FIG. 3, the inlet 34 and the
outlet 37 are oriented so as to direct fluid into and out of the
pumping chamber at angles that are substantially tangential to the
interior surface of the pumping chamber wall 31. Thus, the fluid
flow through the inlet 34 into the pumping chamber avoids being
perpendicular to the membrane 33, even as the membrane approaches a
position where the pumping chamber is at its minimum volume. This
orientation of the inlet 34 and the outlet 37 tends to reduce the
shear forces on the liquid being pumped, particularly when compared
to centrifugal pumps, which generally apply a great deal of stress
on the fluid being pumped.
[0248] The orientation of the inlet 34 and outlet 37 with respect
to each other also tends to reduce shear flow and turbulence. When
the pumping chamber reaches its maximum volume, the fluid continues
circulating through the pumping chamber even as fluid stops flowing
through the inlet 34. The direction of this circulating flow is a
result of the direction of the inlet 34 and the internal flow
geometry. Generally speaking, after a very short pause, the
membrane 33 will be actuated to start moving to reduce the volume
of the pumping chamber and fluid will start flowing through the
outlet 37. When the fluid enters the pumping chamber, it moves in a
rotating current and stays rotating until exiting the pumping
chamber. The exiting fluid peels off from the outer layer of the
rotating current in the same direction in which it was rotating.
The spherical shape of the pump pods is particularly advantageous
to achieve the desired flow circulation. The orientation of the
outlet 37 with respect to circulating flow within the pumping
chamber at the moment of maximum pumping chamber volume is such
that flow does not have to change direction sharply when it begins
to be urged through the outlet 37. By avoiding sharp changes in
flow direction, shear and turbulence is reduced. Thus, the
orientation of the inlet 34 and outlet 37 with respect to each
other and the internal flow geometry reduces shear and turbulence
on the liquid being pumped. For example, in FIG. 3, there is only a
small change in direction in a path extending from the inlet 34
directly to the outlet 37, but other arrangements will also reduce
sharp changes in direction as the pump pod transitions from a fill
stroke to an expel stroke.
[0249] Thus, when the fluid being pumped is whole blood,
centrifugal pumps (which apply a great deal of stress on the red
blood cells) can cause a large amount of hemolysis and therefore
can reduce a patient's hematocrit to the detriment of the patient,
whereas pump pods of the types described above (which apply low
shear forces and turbulence) tend to produce substantially lower
hemolysis. Similarly, when the fluid being pumped is a surfactant
or other fluid prone to foaming, the reduced shear forces and
reduced turbulence of the pod pumps tends to reduce foaming.
[0250] FIG. 29 is a schematic representation of circulatory fluid
flow in the pump pod 25 shown in FIG. 3, in accordance with an
exemplary embodiment of the present invention. As fluid enters the
pumping chamber through the inlet, the orientation of the inlet
directs fluid tangentially to the inside surface of the pumping
chamber wall so as to create a circulatory flow. As fluid
approaches the outlet, the fluid is already flowing substantially
in the direction of the outlet so that the fluid is not required to
make any drastic changes in direction when being pumped from the
outlet. The fluid therefore tends to peel off of the circulatory
flow in a laminar fashion to provide reduced shear forces on the
fluid.
[0251] Generally speaking, for low shear and/or low turbulence
applications, it is desirable for the inlet and outlet to be
configured so as to avoid sharp or abrupt changes of fluid
direction. It is also generally desirable for the inlet and outlet
(and the pump chamber itself) to be free of flash or burrs. The
inlet and/or outlet may include rounded edges to help smooth out
fluid flow.
1.4. Alternative Pump Configurations
[0252] FIG. 20 is a sectional view of an alternative pump pod 2025
such as may be incorporated into a larger fluid-control cassette,
in accordance with an alternative embodiment of the present
invention. In this embodiment, the pump pod is formed from three
rigid pieces, namely a "top" plate 2091, a middle plate 2092, and a
"bottom" plate 2093 (it should be noted that the terms "top" and
"bottom" are relative and are used here for convenience with
reference to the orientation shown in FIG. 20). The top and bottom
plates 2091 and 2093 may be flat on both sides, while the middle
plate 2092 is provided with channels, indentations and holes to
define the various fluid paths, chambers, and ports. To form the
pump pod 2025, the top and bottom plates 2091 and 2093 may include
generally hemispheroid portions that together define a hemispheroid
chamber.
[0253] A membrane 2109 separates the central cavity of the pump pod
into a chamber (the pumping chamber) that receives the fluid to be
pumped and another chamber (the actuation chamber) for receiving
the control gas that pneumatically actuates the pump. An inlet 2094
allows fluid to enter the pumping chamber, and an outlet 2095
allows fluid to exit the pumping chamber. The inlet 2094 and the
outlet 2095 may be formed between middle plate 2092 and the bottom
plate 2093. Pneumatic pressure is provided through a pneumatic port
2106 to either force, with positive gas pressure, the membrane 2109
against one wall of pump pod's cavity to minimize the pumping
chamber's volume (as shown in FIG. 20), or to draw, with negative
gas pressure, the membrane towards the other wall of the pump pod's
cavity to maximize the pumping chamber's volume.
[0254] The membrane 2109 is provided with a thickened rim 2088,
which is held tightly in a groove 2089 in the middle plate 2092.
Thus, the membrane 2109 can be placed in and held by the groove
2089 before the top plate 2091 is ultrasonically welded to the
middle plate 2092, so the membrane will not interfere with the
ultrasonic welding of the two plates together, and so that the
membrane does not depend on the two plates being ultrasonically
welded together in just the right way to be held in place. Thus,
this pump pod should be able to be manufactured easily without
relying on ultrasonic welding to be done to very tight
tolerances.
[0255] One or more pump pods 2025 may be incorporated into a single
cassette, which may also include one or more valves 2000. FIG. 21
is a sectional view of a pneumatically controlled valve 2000 that
may be used in embodiments of the above-mentioned cassette. A
membrane 2090, along with the middle plate 2092, defines a valving
chamber 2097. Pneumatic pressure is provided through a pneumatic
port 2096 to either force, with positive gas pressure, the membrane
2090 against a valve seat 2099 to close the valve, or to draw, with
negative gas pressure, the membrane away from the valve seat to
open the valve. A control gas chamber 2098 is defined by the
membrane 2090, the top plate 2091, and the middle plate 2092. The
middle plate 2092 has an indentation formed on it, into which the
membrane 2090 is placed so as to form the control gas chamber 2098
on one side of the membrane and the valving chamber 2097 on the
other side.
[0256] The pneumatic port 2096 is defined by a channel formed on
the "top" surface of the middle plate 2092, along with the top
plate 2091. By providing fluid communication between several
valving chambers in a cassette, valves can be ganged together so
that all the valves ganged together can be opened or closed at the
same time by a single source of pneumatic pressure. Channels formed
on the "bottom" surface of the middle plate 2092, along with the
bottom plate, define the valve inlet 2094 and the valve outlet
2095. Holes formed through the middle plate 2092 provide
communication between the inlet 2094 and the valving chamber 2097
(through the valve seat 2099) and between the valving chamber and
the outlet 2095.
[0257] The membrane 2090 is provided with a thickened rim 2088,
which fits tightly in a groove 2089 in the middle plate 2092. Thus,
the membrane 2090 can be placed in and held by the groove 2088
before the top plate 2091 is ultrasonically welded to the middle
plate 2092, so the membrane will not interfere with the ultrasonic
welding of the two plates together, and so that the membrane does
not depend on the two plates being ultrasonically welded together
in just the right way to be held in place. Thus, this valve should
be easy to manufacture without relying on ultrasonic welding to be
done to very tight tolerances. As shown in FIG. 21, the top plate
2091 may include additional material extending into control gas
chamber 2098 so as to prevent the membrane 2090 from being urged
too much in a direction away from the groove 2089, so as to prevent
the membrane's thickened rim 2088 from popping out of the groove
2089.
[0258] Referring now to FIGS. 30A and 30B, one embodiment of the
pod pump 3000 is shown. In this embodiment, the pod pump 3000
includes a housing. Referring now to FIG. 30B, the housing includes
two portions 3002, 3004. The portions 3002, 3004 are joined and
retain a diaphragm 3006. Referring to FIG. 30A, as shown in this
embodiment, the housing portions 3002, 3004 are joined by screws.
However, in alternate embodiments, any fasteners or fastening
method can be used, which include, but are not limited to: snap
together tabs, ultrasonic welding, laser welding or other assembly
means known in the art.
[0259] Although as shown in the embodiments in FIGS. 30A and 30B,
the housing is formed by two portions 3002, 3004, in other
embodiments (some described below) the housing is formed from more
than two portions. In still other embodiments, the housing is a
single portion.
[0260] In various embodiments, the size of the housing may vary.
The size may vary depending on the volume of subject fluid intended
to be pumped by each stroke of the pod pump. Another factor that
may influence the size is the desired aspect ratio of the pod
pump.
[0261] Also, in various embodiments, the shape of the housing
chamber may vary. Thus, although FIGS. 30A and 30B, as well as many
of the additional figures in this description describe and show
substantially spherical pod pump housing, the pod pump housing is
by no means limited to a spherical shape. Referring now to FIGS.
42A and 42B, an alternate pod pump 4200 shape is shown. Thus,
although only two shapes are shown herein, in alternate
embodiments, the pod pump housing can be any shape desired.
[0262] Referring now to FIGS. 42A and 42B, an alternate embodiment
of the pod pump is shown. Although in this embodiment, the pod pump
is oval shaped, in still other embodiments, the pod pump can be any
shape desired. Many of the embodiments of the pod pumps will
include a pump chamber, an actuation chamber, a diaphragm (or
movable member), at least one actuation port and at least one
inlet/outlet port. In some embodiments, the pod pump includes an
inlet and an outlet port. Various embodiments are described herein
and features described with respect to one embodiment should be
understood to be available for any embodiment, thus the embodiment
features can be mixed and matched, and any embodiment can include
one or more of the features described herein.
[0263] Referring again to FIGS. 30A and 30B the pod pump shown in
this embodiment, is substantially spherical. As shown in this
embodiment, the pump housing (which includes the pump chamber and
the actuation chamber) is substantially spherical; however, the lip
or facade around the pump housing is not entirely spherical. Thus,
the exterior of the housing can be any shape, and in some
embodiments, the exterior of the housing is a different shape from
the pump housing. However, in some embodiments, the exterior
housing is the same shape or substantially the same shape as the
pump housing.
[0264] The housing portions 3002, 3004, when joined, form a hollow
chamber. In embodiments where the housing is a single portion, the
interior of the housing is a hollow chamber. Where a diaphragm 3006
is connected or attached to the interior of the housing, the
diaphragm 3006 divides the interior of the housing into two
chambers, an actuation chamber 3010 and a pump chamber 3012. In
some embodiments, the interior of the housing is divided into equal
volume chambers, however, in other embodiments, the chambers are
varying volume chambers.
[0265] The diaphragm 3006 may be made of any flexible material
having a desired durability and compatibility with the subject
fluid. The diaphragm 3006 can be made from any material that may
flex in response to liquid or gas pressure or vacuum applied to the
actuation chamber 3010. The diaphragm material may also be chosen
for particular bio-compatibility, temperature compatibility or
compatibility with various subject fluids that may be pumped by the
diaphragm 3006 or introduced to the chambers to facilitate movement
of the diaphragm 3006. In the exemplary embodiment, the diaphragm
3006 is made from high elongation silicone. However, in other
embodiments, the diaphragm 3006 is made from any elastomer or
rubber, including, but not limited to, silicone, urethane, nitrite,
EPDM or any other rubber or elastomer.
[0266] The shape of the diaphragm 3006 is dependent on multiple
variables. These variables include, but are not limited to: the
shape of the chamber; the size of the chamber; the subject fluid
characteristics; the volume of subject fluid pumped per stroke; and
the means or mode of attachment of the diaphragm 3006 to the
housing. The size of the diaphragm 3006 is dependent on multiple
variables. These variables include, but are not limited to: the
shape of the chamber; the size of the chamber; the subject fluid
characteristics; the volume of subject fluid pumped per stroke; and
the means or mode of attachment of the diaphragm 3006 to the
housing. Thus, depending on these or other variables, the shape and
size of the diaphragm 3006 may vary in various embodiments. The
diaphragm 3006 can have any thickness. However, in some
embodiments, the range of thickness is between 0.002 inches to
0.125 inches. Depending on the material used for the diaphragm, the
desired thickness may vary. In one embodiment, high elongation
silicone is used in a thickness ranging from 0.015 inches to 0.050
inches.
[0267] In the exemplary embodiment, the diaphragm 3006 is
pre-formed to include a substantially dome-shape in at least part
of the area of the diaphragm 3006. One embodiment of the
dome-shaped diaphragm 3006 is shown in FIG. 35A as 3514. Again, the
dimensions of the dome may vary based on some or more of the
variables described above. However, in other embodiments, the
diaphragm 3006 may not include a pre-formed dome shape.
[0268] In the exemplary embodiment, the diaphragm 3006 dome is
formed using compression molding. However, in other embodiments,
the dome may be formed by using injection molding.
[0269] In alternate embodiments, the diaphragm 3006 is
substantially flat until actuated. In other embodiments, the dome
size, width or height may vary.
[0270] In various embodiments, the diaphragm 3006 may be held in
place by various means and methods. In one embodiment, the
diaphragm 3006 is clamped between the portions of the housing, and
in some of these embodiments, the rim of the housing may include
features to grab the diaphragm 3006. In others of this embodiment,
the diaphragm 3006 is clamped to the housing using at least one
bolt or another device. In another embodiment, the diaphragm 3006
is over-molded with a piece of plastic and then the plastic is
welded or otherwise attached to the housing. In another embodiment,
the diaphragm 3006 is bonded to a mid-body portion (not shown,
described below with respect to FIGS. 33A-34B) and the actuation
housing portion. Although some embodiments for attachment of the
diaphragm 3006 to the housing are described, any method or means
for attaching the diaphragm 3006 to the housing can be used. The
diaphragm 3006, in one alternate embodiment, is attached directly
to one portion of the housing at the attachment points 3018.
[0271] In the embodiment shown in FIG. 30B, the diaphragm 3006 is
held in place in the interior of the housing at attachment points
3018 using one of the above described embodiments or another method
for attachment. The attachment points 3018 are areas where the
diaphragm 3006 is held between the two portions 3002, 3004 of the
housing at the two portions' 3002, 3004 meeting point. In some
embodiments, the diaphragm 3006 is thicker at the attachment points
3018 than in other areas of the diaphragm 3006. In some
embodiments, this thicker area is a gasket, in some embodiments an
O-ring, ring or any other shaped gasket. Referring now to FIG. 35A,
an embodiment of the diaphragm 3514 is shown with a gasket 3520. In
these embodiments, the gasket 3520 is the point that connects to
the housing.
[0272] In some embodiments of the gasket 3520, the gasket 3520 is
contiguous with the diaphragm 3514. However, in other embodiments,
the gasket 3520 is a separate part of the diaphragm 3514. In some
embodiments, the gasket 3520 is made from the same material as the
diaphragm 3514. However, in other embodiments, the gasket 3520 is
made of a material different from the diaphragm 3514. In some
embodiments, the gasket 3520 is formed by over-molding a ring
around the diaphragm 3514. The gasket 3520 can be any shape ring or
seal desired so as to complement the pod pump housing embodiment.
In some embodiments, the gasket 3520 is a compression type
gasket.
[0273] The interior of the housing includes at least one port for
subject fluid (pump port) and at least one port for actuation fluid
(actuation port). Referring to FIG. 30B, the actuation port 3008
and pump port 3014 are shown. Although the embodiment shown in FIG.
30B includes one pump port 3014 and one actuation port 3008, in
other embodiments (some of which are described below) the pod pump
includes more than one pump port and/or more than one actuation
port.
[0274] Still referring to FIG. 30B, the location of the pump port
3014 and the actuation port 3008 may also vary in the different
embodiments. In the embodiment shown, the pump port 3014 and the
actuation port 3008 are located on one side of the pod pump 3000.
In other embodiments, some which are shown and described herein,
the pump port and the actuation port may be in various locations on
the pod pump, sometimes the same side, sometimes different side,
and in embodiments having more than one pump port and/or more than
one actuation port, the locations of all of these ports can vary.
In most embodiments, however, the actuation port (or, in some
embodiments, at least one actuation port) 3008 is in fluid
communication with the actuation chamber 3010 and the pump port
(or, in some embodiments, at least one actuation port) 3014 is in
fluid communication with the pump chamber 3012.
[0275] The actuation port 3008 communicates liquid or gas pressure
with a liquid or gas source to add or remove liquid or gas from the
actuation chamber 3010. Upon addition or removal of liquid or gas
from the actuation chamber 3010 the diaphragm 3006 flexes to
increase or decrease the volume of the pumping chamber 3012. The
action of the diaphragm 3006 flexing causes the movement of the
subject fluid either into or out of a pump port 3014. In the
embodiments shown in FIG. 30B, both the actuation port 3008 and
pumping port 3014 are aligned for attachment to or removal from
other equipment. However, as discussed above, the ports may be
oriented in any manner desired.
[0276] Still referring to FIG. 30B, in the embodiment shown,
O-rings 3020 are located at the actuation port 3008 and pumping
port 3014. However, in other embodiments, other means for
connecting the pod pump 3000 to other equipment such as barbed
connectors, quick connects, glue, clamps and other fastening means
may be used. Referring to FIG. 30A, in one embodiment, flex tabs
3016 are provided to facilitate the fastening of the pod pump 3000
to other equipment, however, in alternate embodiments, additional
or alternative locating and fastening features or means may be
used. In still other embodiments, fastening features may not be
present on the pod pump 3000.
[0277] Movement of the diaphragm 3006 causes the volume of the pump
chamber 3012 and the volume of the actuation chamber 3010 to
change. When the volume of the actuation chamber 3010 decreases,
the volume of the pump chamber 3012 increases. This in turn creates
a negative pressure in the pump chamber 3012. The negative pressure
causes the subject fluid to enter the pump chamber 3012.
[0278] When a positive pressure is present in the actuation chamber
3010, either through air or liquid entering the actuation chamber
3010 through one or more actuation ports 3008, the volume of the
pump chamber 3012 decreases, creating a positive pressure in the
pump chamber 3012. The positive pressure urges the subject fluid
out of the pump chamber 3012 through one or more pump ports 3014.
Although one pump port 3014 is shown, in other embodiments, more
than one pump port is included. In some of these embodiments, one
pump port is an inlet port and one pump port is an outlet port. The
location, position and configurations of the pump ports vary and in
may vary accordingly to a particular intended purpose.
[0279] Referring now to FIGS. 31A and 31B, another embodiment of
the pod pump 3100 is shown. In this embodiment, the housing
includes two portions 3102, 3104. Referring now to FIG. 31B, a
diaphragm 3106 is connected to the interior chamber of the housing
at points 3116. In this embodiment, the diaphragm 3106 is connected
to the housing at a position where the two portions 3102, 3104
meet. This sandwiches the diaphragm 3106 holding the diaphragm
3106.
[0280] The diaphragm 3106 divides the interior of the pod pump 3100
housing into two chambers; an actuation chamber 3108 and a pump
chamber 3110. In this embodiment the pump chamber 3110 includes
with two pump ports 3114, either of which may be an inlet or outlet
port when the pump is actuated. Referring again to both FIGS. 31A
and 31B, the pod pump 3100 includes barbed connectors 3112, which
may be used for the attachment of tubing to the pump ports 3114 and
actuation port 3118. The duty of each port is determined by the
configuration of other equipment the port is attached to. In this
embodiment barbed connectors 3112 are provided for the attachment
of tubing but other attachment methods are possible.
[0281] Referring now to FIGS. 32A and 32B, an alternate embodiment
of the pod pump 3000 similar to the pod pump shown in FIGS. 30A and
30B is shown. However, in this embodiment, an additional component
3202 is included in the actuating chamber 3108. In some
embodiments, an additional component 3202 can also be included in
the pump chamber 3110, and in other embodiments, an additional
component 3202 can be included in just the pump chamber. The
additional component 3202 may serve to limit the motion of the
diaphragm 3006, dampen the diaphragm's 3006 travel, filter air or
gas entering or leaving the actuation chamber 3108 or dampen sound
or vibration in the pod pump 3000. In some embodiments, e.g., where
the pod pump 3000 is used in a fluid management system, an
additional component 3202 may be present in both chambers to
quicken the time for equalizing temperature within the chambers. In
some of these embodiments, the additional component(s) 3202 may
include a mesh plastic, a woven type material, a copper wool, a
foam material, or other material, and may create a greater surface
area to equilibrate air or other gas. In some embodiments, the
additional component(s) 3202 may be part of a fluid management
system (FMS) and may be used to perform certain fluid management
system measurements, such as, for example, measuring the volume of
subject fluid pumped through the pump chamber during a stroke of
the diaphragm 3006 or detecting air in the pumping chamber, e.g.,
using techniques described in U.S. Pat. Nos. 4,808,161; 4,826,482;
4,976,162; 5,088,515; and 5,350,357, which are hereby incorporated
herein by reference in their entireties. The additional component
3202 may completely or partially cover the actuation chamber port
or may be completely free of the actuation chamber port.
[0282] In the preceding figures, various embodiments,
characteristics and features of the pod pump are described and
shown. The various characteristics can be "mixed-and-matched",
i.e., any one characteristic can be added to any embodiment of the
pod pump. The configurations shown are for example only, and the
location of the ports, number of ports, attachment means, size of
the housing, sizes of the chamber, etc., may vary in the different
embodiments. The figures and embodiments described below
additionally include various embodiments, characteristics and
features, all of which also can be "mixed-and-matched" with any of
the characteristics and features described in any of the
embodiments in this description.
[0283] Referring to FIGS. 33A and 33B, an alternate embodiment of a
pod pump 3300 is shown with a pump chamber cover 3302, an actuation
chamber cover 3304 and a mid plate portion 3306. In this embodiment
the mid plate 3306 and the actuation chamber cover 3304 retain the
diaphragm 3308 and one or more secondary diaphragms 3310 or 3312.
The secondary diaphragms may act passively or may be actuated by
gas, liquid or mechanical forces to serve as active valves to
control the flow of fluid through the pump chamber cover fluid path
3314. In this embodiment of the pod pump 3300, a fluid path 3314 is
formed in the pump chamber cover 3302 such that fluid may flow
through the flow path 3314 regardless of the position of the
diaphragm 3308. In this embodiment as in other embodiments the pump
chamber cover 3302, actuation chamber cover 3304 and mid plate
3306, in one embodiment, are made of plastic but in other
embodiments, may be made from other materials including but not
limited to metal or glass. In this embodiment the pump chamber
cover 3302, actuation chamber cover 3304 and mid plate 3306 may be
joined by laser welding or may be joined by various other methods
as deemed appropriate for the chosen component materials and the
desired pod pump use. Other joining possibilities include but are
not limited to snap together tabs, press fit, snap fit, solvent
bonding, heat welding, electromagnetic welding, resistance welding,
RF welding, screws, bolts, ultrasonic welding, adhesive, clamping
by components that neighbor the pump when in use or other joining
methods commonly used in the art.
[0284] Referring now to FIGS. 34A and 34B one embodiment of a pod
pump 3400 is shown. In this embodiment inlet and outlet ports are
located at opposite ends of the pump chamber 3406 and are
interchangeable depending on the configuration of the pump or its
intended use. The diaphragm 3408 is shown nearly fully extended
into the pump chamber 3406. In this embodiment the inlet and outlet
ports 3402 and 3404 may be partially or fully obscured by the
diaphragm 3408 when fully actuated by fluid pressure in the
actuation chamber 3410. Blocking of the inlet or outlet ports may
serve to limit or switch the flow of subject fluid through the pump
chamber 3406 as may be desired in certain applications. In this
embodiment the pumping side of the diaphragm 3408, i.e., the side
of the diaphragm 3408 that contacts the subject fluid, is smooth,
which may provide different flow characteristics with some subject
fluids or provide different contact between the diaphragm 3408 and
pump chamber 3406 when reduction of flow through the inlet or
outlet ports 3402 and 3404 is desired when the diaphragm is fully
extended into the pump chamber 3406.
[0285] In some embodiments, the diaphragm has a variable
cross-sectional thickness, as shown in FIG. 34B. Thinner, thicker
or variable thickness diaphragms may be used to accommodate the
strength, flexural and other properties of the chosen diaphragm
materials. Thinner, thicker or variable diaphragm wall thickness
may also be used to manage the diaphragm thereby encouraging it to
flex more easily in some areas than in other areas, thereby aiding
in the management of pumping action and flow of subject fluid in
the pump chamber 3406. This embodiment the diaphragm 3408 is shown
having its thickest cross-sectional area closest to its center.
However in other embodiments having a diaphragm 3408 with a varying
cross-sectional, the thickest and thinnest areas may be in any
location on the diaphragm 3408. Thus, for example, the thinner
cross-section may be located near the center and the thicker
cross-sections located closer to the perimeter of the diaphragm
3408. Still other configurations are possible. Referring to FIGS.
35B-E, one embodiment of a diaphragm is shown having various
surface embodiments, these include smooth (FIG. 35 ), rings (FIG.
35E), ribs (FIG. 35D), dimples or dots (FIG. 35C) of variable
thickness and or geometry located at various locations on the
actuation and or pumping side of the diaphragm 3408. In one
embodiment of the diaphragm, the diaphragm has a tangential slope
in at least one section, but in other embodiments, the diaphragm is
completely smooth or substantially smooth.
[0286] Referring now to FIG. 35A a pictorial exploded view of an
exemplary embodiment of a pod pump 3500 is shown. This figure shows
one embodiment of the ports, however, an exemplary embodiment is
described below with respect to FIG. 37. In this embodiment the
housing is made of three sections. Two of the portions 3502, 3504
may be joined to form a pump chamber 3506 (portions 3502, 3504
referred to as "pump chamber portions") and the third portion 3508
(referred to as the actuation chamber portion) includes an
actuation chamber 3512 and an actuation port 3510 to communicate
fluid pressure to the actuation chamber 3512. The pump chamber
portions 3502, 3504 may be joined together to form a pump chamber
assembly. This assembly may then be joined with the actuation
chamber portion 3508 to form the housing.
[0287] The diaphragm 3514 is connected to the interior of the
housing. In the exemplary embodiment, the diaphragm 3514 is
sandwiched between the pump chamber 3506 and the actuation chamber
3512. The diaphragm 3514 segregates the actuation chamber 3512 from
the pump chamber 3506.
[0288] In this exemplary embodiment, where the pump chamber 3506 is
composed of two portions 3502, 3504, where the portions are molded,
this design may allow for minimum flash or burrs. Thus, in this
embodiment, the pump chamber will not have flash in the fluid path
thus, presents a gentle pumping environment. This embodiment may be
advantageous for use with those subject fluids vulnerable to
shearing, and/or where delicate subject fluids are pumped, thus
flash or burrs should be avoided.
[0289] In the exemplary embodiment shown in FIG. 35A, the pump 3500
is shown having two ports 3518, 3516. For ease of description,
these ports 3518, 3516 are called "inlet" and "outlet" ports.
However, either port 3518, 3516 can serve as an inlet port,
likewise, either port can serve as an outlet port. The pump inlet
and outlet ports 3516, 3518 connect to the pump chamber 3506 at
edges 3520 and 3522. In one embodiment, the edges 3520, 3522 are
left sharp and are subject to flash when they are molded with
retractable cores. However, in the exemplary embodiment, the pump
may be manufactured without retractable cores and therefore may
have radii on the edges 3520, 3522 thereby eliminating flash or
burrs from the flow path that may damage delicate or sensitive
subject fluids.
[0290] Still referring to FIG. 35A, as shown in this exemplary
embodiment, the pod pump 3500 includes three housing portions 3502,
3504, 3508 and a diaphragm 3514. Two housing portions 3502, 3504
form a pump chamber 3506 portion as well as two ports 3516, 3518. A
third portion 3508 forms the actuation chamber 3512. The diaphragm
3514 is attached between the pump chamber 3506 and actuation
chamber 3512 by sandwiching the diaphragm lip 3520, which in one
embodiment, is an integral O-ring, however, in other embodiments,
can be any other shaped gasket, between the rims 3524 of the
housing portions. In the embodiment shown in FIG. 35A, the
diaphragm 3514 includes tangent edges. The tangent edges are
present where the shape of the diaphragm 3514 is not a continuous
dome, thus, in one section; the diaphragm is conical shaped as
indicated by the tangent edges. Although tangent edges are depicted
in this embodiment, in alternate embodiments, the diaphragm can
include various surfaces, which may include, but are not limited to
one or more of the following: dimples, rings, ridges, ribs, smooth,
or another variable surface.
[0291] As discussed above, the pump chamber 3506 and the ports
3516, 3518 are formed by two housing portions 3502, 3504. These
portions 3502, 3504 fit together as described below with respect to
FIGS. 36A-36C.
[0292] Referring now to FIGS. 36A and 36B, assembled side and end
views of the pump 3500 of FIG. 35 are shown. Here the pump chamber
portions 3502 and 3504 and the actuation chamber portion 3508 have
been joined to conceal the diaphragm 3514, not shown. The
components of the pod pump housing may be joined by various methods
including but not limited to snap together tabs, press fit, snap
fit, solvent bonding, heat welding, electromagnetic welding,
resistance welding, RF welding, screws, bolts, ultrasonic welding,
adhesive, clamping by components that neighbor the pump when in use
or other joining methods commonly used in the art.
[0293] In the exemplary embodiment as shown in FIGS. 35A-41B, the
pod pump 3500 housing includes three portions having features, some
specific for the portions to be ultrasonically welded. The design
of these three portions includes features that allows for the
portions to be joined by ultrasonic welding, but the resultant pod
pump is can pump delicate subject fluids with minimal, if any,
resultant damage to the subject fluid following ultrasonic welding.
A description of the three portions of the housing and the features
for assembly is below. Although these embodiments are described
with respect to ultrasonic welding, it should be understood that
these embodiments alternatively may be laser welded or joined using
snap together tabs, press fit, snap fit, solvent bonding, heat
welding, electromagnetic welding, resistance welding, RF welding,
screws, bolts, adhesive, clamping by components that neighbor the
pump when in use or other joining methods commonly used in the
art.
[0294] Referring now to FIG. 36C an enlarged view of one port is
shown. This can be either the inlet or outlet port as shown in FIG.
35A. In this embodiment the inlet and outlet ports are
interchangeable and both have similar interior and exterior
geometry. However, their locations may vary.
[0295] In this embodiment, portions of the housing 3502, 3504 are
joined to form a port 3604. In this embodiment the pump chamber
portions 3502, 3504 are depicted as being joined by ultrasonic
welds at the energy director 3602. However, in alternate
embodiments, other joining methods, as described above, can be
used. The zone 3606 where housing portions 3502, 3504 are joined is
at least partially isolated from the fluid path of the port 3604 by
an area 3608. The area 3608 is formed after joining the housing
portions 3502, 3504 together. The area 3608, in one embodiment,
increases resistance to flow, thus, the area 3608 creates a path of
more resistance than the main flow through the chamber. Thus, the
area 3608 is a flow inhibiting area. Thus, the flow of fluid to the
zone 3606 where the housing portions meet is decreased. This flow
inhibiting area 3608 can be any size desired, however, in the
embodiment shown, the flow inhibiting area 3608 is created where
the distance between the two portions may range from 0.001
inch-0.005 inch and in some embodiments a range of 0.015 inch-0.020
inch. However, the area 3608 can be any size desired and may vary
depending on a number of variables including but not limited to:
fluid volume, chamber volume and pumping rate. In many embodiments,
the distance between the two portions 3502, 3504 creating the area
3608 is a fraction of the size or volume of the main flow path. In
other embodiments, the area 3608 is any size or volume desired to
present desired resistance to the flow of fluid to the area
3606.
[0296] In alternate embodiments, and in some of these embodiments,
depending on the overall volume of the pod pump, the area 3608 may
have a larger or smaller range. The flow inhibiting area 3608
provides a means where if fluid does flow across the flow
inhibiting area 3608 it will experience much greater resistance
than fluid flowing through the larger area of the port 3604. By
virtue of less fluid flowing in the flow inhibiting area 3608 and
reaching the zone 3606 where the housing components are joined,
less fluid will tend to contact any burrs, flash, surface
irregularities or impurities that may be present in area 3606 where
the housing components are joined. This isolation from flash,
burrs, surface irregularities or other effects of various joining
methods may provide for more gentle and safer transport of delicate
of sensitive subject fluids as may be desired for certain
applications.
[0297] Rounded edges 3612 on the pump housing portions 3502, 3504
provide, amongst other things, a delicate environment for the
subject fluid, liquid or gas flowing through the pump 3500.
Although the flow inhibiting area 3608 and rounded edges 3612 are
shown in specific locations in FIG. 36C, these features can be
present in any area of the pump desired.
[0298] Referring now to FIG. 37 an exemplary embodiment of the pod
pump is shown. In this figure, the ports are shown having valves
3712 within. Again, as shown in this figure, the pod pump housing
has three portions 3702, 3704, 3706. Portion 3702 includes the
actuation chamber 3704 and alignment features 3706 for assembly
with the other two pump housing portions 3704, 3706. In this
embodiment the pump housing portions 3704, 3706 include areas where
one way valves may be installed 3712. The housing portions 3702,
3704, 3706 may be joined by ultrasonic welding, laser welding, snap
together features, screws, bolts, adhesive or other joining methods
commonly used in the art.
[0299] The diaphragm 3714 is shown with ribs in this embodiment.
However, in alternate embodiments, the diaphragm 3714 may include
one or more of the variable surfaces as described above, or
alternatively, may be a smooth surface. Although each of the
various figures herein show one embodiment of the diaphragm, any
embodiment of the diaphragm may be used in conjunction with any
embodiment of the pod pump.
[0300] Referring now to FIGS. 38A and 38B, an alternate embodiment
of the pod pump 3800 is shown. In various embodiments, the pod pump
3800 is connected to a system, container or otherwise, where fluid
is pumped from and/or into. In some embodiments, the fluid is
pumped to/from a system, container or otherwise via a line or
tubing. In one embodiment, the fluid is pumped through flexible
tubing. In any case, in these embodiments, the line or tubing is
connected to the inlet and outlet ports 3814 of the pod pump.
However, in alternate embodiments, the fluid can be pumped through
a molded fluid line, or the ports can be directly connected to the
fluid source, or where the fluid is being pumped.
[0301] Still referring to FIGS. 38A and 38B, the housing is a multi
portion design, similar to the design shown in FIG. 37, including a
two portion pump chamber housing 3704, 3706. However, in this
embodiment, barbed hose connectors 3802 are shown for the
connection of flexible tubing (not shown). Other means of
connection to a system may be used in other embodiments. These
means include, but are not limited to, quick connects, press fit or
gluing of tubing directly into the inlet or outlet ports or other
means and methods commonly used in the art.
[0302] Referring now to FIG. 38B a section view of the embodiment
shown in FIG. 38A is shown. In this embodiment valves 3816 are
installed in the interior of the port 3814 portion of the housing
portions (as shown as 3806, 3804 in FIG. 38A). The valves 3816
control the flow of subject fluid in and out of the pump chamber
3818 as the diaphragm 3808 is actuated by variations in liquid or
gas pressure in the actuation chamber 3810. As shown in this
embodiment, the valves 3816 are duck bill valves, however, in other
embodiments, the valves 3816 can be any passive or active valves,
including but not limited to, ball check valves, flapper valves,
volcano valves, umbrella valves, a poppet, a controlled valve or
other types of valves used in the art. In this embodiment the fluid
path 3812 is located near the top of the pump chamber 3818 and has
a portion not inhibited by the diaphragm 3808 even when the
diaphragm is fully extended into the pump chamber 3806 by liquid or
gas pressure applied to the actuating chamber 3810 via the
actuation port 3820.
[0303] As shown in this embodiment, the diaphragm 3808 includes
rings, however, as described above, the diaphragm 3808 can include
dimples, rings, and/or ribs, or any other variation on the surface,
or, in some embodiments, no variation on the surface. The varying
embodiments of the diaphragm can be used in any of the embodiments
of the pod pumps.
[0304] Referring now to FIG. 39, an exploded pictorial view of one
embodiment of a pod pump 3900 is shown. Valves 3902, in some
embodiments, may be installed in the inlet and or outlet ports 3904
of the pump housing portions 3906 and 3916. The valves 3902 may any
passive or active valve, including but not limited to, duck bill
valves, ball check valves, flapper valves, volcano valves, umbrella
valves, a poppet, a controlled valve or other types of valves used
in the art to control the flow of fluid. A diaphragm 3908 is
attached between the pump chamber housing portions 3906 and 3916
and the actuation housing portion 3910. The diaphragm 3908 is made
of any sufficiently flexible and durable material that it may flex
in response to fluid pressure or vacuum applied to the actuation
chamber 3910. The diaphragm 3908 material may also be chosen for
particular bio-compatible, temperature compatibility or
compatibility with various gases or liquids that may be introduced
to the pump or actuation chambers.
[0305] The diaphragm 3908 may have a ring of thick material 3912
near its outer diameter to be located or fastened in mating
features of the pod pump housing components 3906, 3916 and 3910.
The moveable portion of the diaphragm 3908 includes two surfaces,
for purposes of description; these will be referred to an exterior
surface and an interior surface. The exterior surface is the pump
chamber surface and the interior surface is the actuation chamber
surface. Either surface of the movable portion of the diaphragm may
be of uniform or variable thickness, and both surfaces do not have
to be the same. Various embodiments of the surface are shown in
FIGS. 35B-E. Either or both surfaces may be smooth or include one
or more features including but not limited to dimples, dots, rings,
ribs, grooves or bars that stand above or below surrounding
surfaces. In this embodiment, an arrangement of dots 3914 are shown
on the exterior surface of the diaphragm.
[0306] The surface features, or lack thereof, may serve a number of
various functions. One of these may be to provide space for fluid
to pass through the pump chamber. Another may be to aid in the
diaphragm sealing against the pump chamber housing for applications
where it is desirable to prevent the flow of fluid through the pump
chamber when the diaphragm is pressed against the pump chamber
housing by liquid or gas pressure in the actuation chamber. Some
diaphragm surfaces may provide one or more of these features, or
provide another function or feature.
[0307] Geometry on the exterior or interior surface of the
diaphragm may also serve to cushion the movement of the diaphragm
at either end of the diaphragm stroke. When geometry on the
diaphragm contacts the pump or actuation chamber walls those
features will stop moving but the diaphragm material between the
features may continue to move to allow the fluid that is being
pumped to be gently accelerated or decelerated as it enters or
leaves the pump chamber.
[0308] Referring now to FIG. 40A, a pictorial view of portions 3906
and 3916 of the multi portion pump shown in FIG. 39 is shown. For
illustration purposes only, the pump housing portions 3906 and 3916
are shown oriented base to base to illustrate the relationship of
the alignment and joining features that may be used in the pump
portion of a multi-part pod pump housing. The portions 3906 and
3916 align and join together in two locations in this exemplary
embodiment. However, in other embodiments, these features may vary,
and the location of the joining of the two portions may vary. For
purposes of description, one of the alignment and joining features
will be described with respect to FIG. 40B, however, it should be
understood, that although one is described, the details can apply
to both.
[0309] Referring now to FIG. 40B, a close up pictorial view of one
area of FIG. 40A is shown. Pump housing portion 3916 has an
alignment feature 4002 that may align with a complimentary
alignment groove 4004 on housing portion 3906. In this embodiment
the aligning feature 4002 includes an energy director 4006 so the
housing portions 3906 and 3916 may be joined by ultrasonic welding.
In this embodiment the energy director is located in line with a
relieved area 4008 in the base of the pump housing 3916. The
relieved area 4008 may accommodate the outer ring of a diaphragm
(not shown), in embodiments where the diaphragm includes an outer
ring.
[0310] The relieved area 4008 is continued in pump housing portion
3906 but is only visible as the edge 4010. In this embodiment where
ultrasonic welding is used, flash from the energy director 4006 may
attempt to flow beyond the edge 4010 upon assembly. By virtue of
the energy director 4006 being in line with the outer ring of the
diaphragm (not shown) any flash will be adjacent the outer ring of
the diaphragm which flexes to seal despite the presence of flash on
the diaphragm outer ring sealing surface. When alternate joining
methods such as, but not limited to, laser welding, adhesives,
screws or other fasteners are used, the energy director 4006 may be
excluded and the geometry of the alignment features 4002 and 4004
may vary form the embodiment shown. In the embodiment an additional
aligning feature 4012 and energy director 4014 are present to
orient the pump housing components 3906 and 3916 such that they are
joined down to their base where they will be joined to an actuation
housing (not shown) as shown in earlier and subsequent figures.
[0311] Referring now to FIG. 41A, a pictorial view of a partially
assembled pod pump 4100 is shown. For illustration purposes, only
one portion of the pump housing 3916, a portion of a possible
embodiment of a diaphragm 4102 and a portion of an actuator housing
4104 are shown.
[0312] Referring now to FIG. 41B, a close up pictorial view of one
area of FIG. 41A is shown. In this embodiment of the actuator
housing 4104, two energy directors 4106 and 4108 are shown for
joining by ultrasonic welding although other joining methods are
possible. In this embodiment energy director 4108 is in line with
energy director 4014 on pump housing portion 3916. Aligning the
energy directors as shown in this embodiment ensures that flash
from one weld is consumed by the other ultrasonic weld thereby
creating a reliable seal between all three housing portions, one
housing portion is excluded from this figure for clarity.
[0313] Still referring to FIGS. 41A and 41B, the alignment of
energy director 4006 with the outer portion of the diaphragm 4102
is shown. Aligning energy director 4006 with the diaphragm 4102 in
this way allows any flash resulting from an ultrasonic weld in the
area of energy director 4006 to be sealed by the flexible material
of the diaphragm 4102. The pod pump housing can be made from any
material including any plastic, metal, wood or a combination
thereof. In one exemplary embodiment, the pod pump housing is made
from medical grade polycarbonate. In another exemplary embodiment,
the pod pump housing is made from polysulfone. As described in more
detail in the description, the compatibility of the materials
selected to the subject fluid may be one factor in some
embodiments.
[0314] Referring now to FIGS. 42A-42D, an alternate shape
embodiment of the pod pump 4200 is shown. The shape embodiments
shown herein are meant for illustration and description purposes
only. In alternate embodiments, it should be understood that the
pod pump can be any shape desired.
[0315] The pod pump housing can be manufactured using any one of a
number of methods of manufacturing, including but not limited to
injection molding, compression molding, casting, thermoforming or
machining. In some embodiments, for example, where the housing is
machined, the housing can be fused together using mechanical
fasteners or heat fused.
[0316] The wall thickness of the pod pump housing may vary between
embodiments. A myriad of variables may contribute to wall thickness
selection. These include, but are not limited to, the housing
material used, pressure at which the fluid will be pumped; size of
the chambers; overall size of the pod pump, strength needed in
response to the materials using, durability, assembly method, the
device in which the pod pump may be working in conjunction with,
cost and manufacturing time. In some embodiments, the pod pump wall
thickness is variable.
[0317] The wall thickness, in the various embodiments, can range
from 0.005 to any thickness. The term "any thickness" is used
because in some embodiments, the pod pump can be integrated into a
device or machine. Thus, the wall of the pod pump may be the same
thickness as the overall machine. Thus, in some cases, the wall
thickness is quite large. In the exemplary embodiment described
herein, the wall thickness ranges from 0.04 inch to 0.1 inch. In
another embodiment, the wall thickness ranges from 0.06 inch to
0.08 inch.
[0318] The material selection and method of manufacture of the
various embodiments of the pod pump may depend on a number of
variables. Some include durability, cost, pressure from the fluid,
performance, and many others. In some embodiments, the pod pump
housing and diaphragm is intended to last months or years. In other
embodiments, the pod pump is intended to be a one-use disposable.
In still other embodiments, the pod pump is intended to last any
number of hours, days, weeks or years. In some embodiments, even
where the pod pump is a one-use disposable, the pod pump is
designed to pump for a much longer period of time, for example,
days, weeks, months or years.
[0319] In one embodiment of the disposable, the housing is made
from a thin film made of a material which includes, but is not
limited to PETE, PETG, and PET. In these embodiments, the housing
may be thermoformed, for example, vacuum or pressure formed, and
the diaphragm is formed from a thin plastic film that can be heat
sealed to the housing. In some embodiments, the housing is a
multi-layer film. This embodiment is conducive to bonding the
housing to another component.
[0320] The pod pump can be incorporated and/or integrated into
another device, machine, container, or other, or act in conjunction
with another device, machine, container or other. In some
embodiments, a single pod pump is used. However, in other
embodiments, two or more pod pumps are used. In some embodiments,
the pod pump is incorporated into a device which is then integrated
or attached to a machine, device, container or other. One example
of this embodiment is a cassette having integrated pod pumps, fluid
paths, fluid ports, actuation ports and actuation fluid paths. Two
embodiments of a cassette are described with respect to FIGS.
43A-43C and 44A-44B. Many additional embodiments will be
understood. For purposes of description, an exemplary embodiment
and an alternate embodiment will be described. However, these are
only exemplary and other embodiments, with greater or less than two
pod pumps, using different valves, various flow paths and
incorporating additional containers or other devices, are
understood.
[0321] Referring now to FIGS. 43A-43C,one embodiment of a pod pump
cassette 4300 is shown. Referring now to FIG. 43A, this embodiment
of the pod pump cassette includes two pod pumps 4310. The pod pumps
4310 can be any pod pump embodiment, but in this exemplary
embodiment, the pod pumps 4310 are similar to the pod pump shown in
FIGS. 33A-33B. The cassette 4300 includes three plates, an
actuation plate 4320, a mid plate 4330 and a pump chamber plate
4340.
[0322] The actuation plate 4320 includes, for each pod pump 4310, a
pod pump actuation chamber housing 4312 portion and two valves
actuation housing 4314 portions. The valve actuation housing 4314
includes a valve actuation port 4316. In addition to pod pumps, the
cassette 4300, in some embodiments, may contain additional ports
and/or containers for various fluids to be pumped to and from.
[0323] The mid plate 4330 includes, for each pod pump, a pump
diaphragm 4332 and two valve diaphragms 4334. In the embodiment
shown, the valves are volcano or active valves actuated by a
diaphragm 4334 which is actuated by a fluid, which in this
embodiment is pneumatic air. Also shown on this embodiment of the
cassette 4300 are additional diaphragms in the mid plate 4330.
These are for embodiments that may contain additional container for
various fluids to be pumped to and from.
[0324] Referring now to the pump plate 4340, each pod pump 4310
includes a pump chamber housing 4342 which includes an integral
fluid path 4344. The pump chamber housing 4342 is in fluid
connection with an exterior fluid path 4346. In this exemplary
embodiment, the three plates 4320, 4330, 4340 are laser welded
together. However, in other embodiments, various modes of
attachment, some of which are described above, may be used.
[0325] Referring now to FIG. 43B, a cross sectional view of the
cassette 4300 is shown. The volcano valves are shown including the
valve diaphragms 4334, the valves actuation housing 4314 portions
and the exterior fluid line 4346. The valves are actuated by
pneumatic air through actuation ports 4318.
[0326] Referring now to FIG. 43C, in some embodiments, an air
filter 4350 and an additional fluid line 4352 may be included in
the cassette.
[0327] An alternate embodiment of the cassette is shown in FIGS.
44A and 44B. Referring now to FIG. 44A, the cassette 4400 includes
greater than three portions. The portions include a mid plate 4410
with multiple covers 4412-4416 laser welded onto the mid plate.
These multiple covers 4412-4416 are used rather than the pump plate
shown in FIG. 43A as 4340. Referring now to FIG. 44B, the mid plate
4410 again is shown. However, in this embodiment, multiple covers
4442-4444 are used rather than an single actuation plate as shown
in FIG. 43A as 4320. As shown in FIGS. 44A-44C, this is one
embodiment, however, in other embodiments, the number of multiple
covers may vary.
1.5. Exemplary Embodiments Incorporating Multiple Pump Pods
[0328] It should also be noted that pumping systems may employ
multiple pump pods for pumping fluid. Pump pods may be employed
individually, in which case the pump pods may be individually
controlled, or pump pods may be interconnected in various ways,
such as, for example, interconnecting the inlets of multiple pump
pods in order to draw fluid from a common source, interconnecting
the outlets of multiple pump pods in order to pump fluid to a
common destination, and/or interconnecting the pneumatic ports of
multiple pump pods in order to control the pump pods through a
common pneumatic interface. In various embodiments, multiple pump
pods may be operated out-of-phase (i.e., one pumping chamber is
emptying while the other is filling) in order to provide a
substantially continuous flow, in-phase in order to provide a
pulsatile flow, or in other ways. For in-phase operation, a single
pneumatic interface may be provided for multiple pump pods so that
the base station can operate the pump pods simultaneously.
Similarly, a single pneumatic interface may be provided for
multiple valves so that the base station can operate the valves
simultaneously.
[0329] In the embodiments shown in FIGS. 2 and 48, two individual
self-contained pump pods 25a and 25b of the type shown in FIG. 3
are included in a disposable system. In this embodiment, each of
the pump pods 25a and 25b has its own pneumatic port 38, so the
pump pods 25a and 25b can be controlled separately.
[0330] In the embodiment shown in FIGS. 5A and 5B, two pump pods
25a and 25b are incorporated into larger assembly 2004 such that
the inlets of two pump pods 25a and 25b are connected to a common
inlet line 54 and the outlets of both pump pods 25a and 25b are
connected to a common outlet line 57. FIG. 5B shows the pneumatic
ports 38 of the pump pods 25a and 25b. The inlets 34 and outlets 37
of the pump pods 25a and 25b are arranged to direct the flows into
and out of the pumping chambers at angles that are substantially
tangential with the rigid pumping-chamber walls 31 of each pump
pod, in order to--as discussed above--reduce shear force and
turbulence on the fluid and to improve circulation through the
pumping chambers. In this embodiment, the pump pods 25a and 25b
have purge ports 55, which allow air to be purged from the system,
for example, during priming. Also in this embodiment, the common
inlet line 54 is fitted with a number of luer ports 2001 (e.g., to
permit attachment of additional fluid sources, such as medical
solutions, chemical solutions, dilutants, etc.) and is also fitted
with a thermocouple 2002 (e.g., to allow for monitoring the
temperature of the fluid entering the pump pods 25a and 25b). Also
in this embodiment, the assembly 2004 includes two flow-through
ports 2003 having tube connections on the top side (shown in FIG.
5A) and o-ring connections on the bottom side (shown in FIG. 5B).
The flow-through ports 2003 can be used to facilitate installation
or use of the assembly 2004 with a base station, for example, by
allowing all pneumatic and fluidic connections to be made from the
bottom of the assembly 2004, in which case the inlet line 54 may be
pre-connected via tubing to one of the flow-through ports 2003 and
the outlet line 57 may be pre-connected via tubing to the other
flow-through port 2003.
[0331] In the embodiment shown in FIGS. 22A and 22B, two pump pods
2025a and 2025b of the type shown in FIG. 20 and a number of valves
2000a-2000d of the type shown in FIG. 21 are incorporated in a pump
cassette 2015 along with various fluid paths and other components.
The pump cassette 2015 includes a common inlet 2005 in fluid
communication with pump pod 2025a via fluid paths 2007 and 2009 and
with pump pod 2025b via fluid paths 2008 and 2010. The pump
cassette 2015 also includes a common outlet 2006 in fluid
communication with pump pod 2025a via fluid paths 2011 and 2013 and
with pump pod 2025b via fluid paths 2012 and 2014. Thus, pump pods
2025a and 2025b draw fluid from the common inlet 2005 and pump
fluid to the common outlet 2006. That being said, valve 2000a is
used to control fluid flow at the intersection of fluid paths 2008
and 2010 (i.e., at the inlet to pump pod 2025b); valve 2000b is
used to control fluid flow at the intersection of fluid paths 2007
and 2009 (i.e., at the inlet to pump pod 2025a); valve 2000c is
used to control fluid flow at the intersection of fluid paths 2011
and 2013 (i.e., at the outlet of pump pod 2025a); and valve 2000d
is used to control fluid flow at the intersection of fluid paths
2012 and 2014 (i.e., at the outlet of pump pod 2025b). Each of the
pump pods 2025a and 2025b has its own pneumatic interface 2106a and
2106b, respectively. Also, each of the valves 2000a-2000d has its
own pneumatic interface 2096a-2096d, respectively. Thus, each of
pump pods and each of the valves can be independently controlled by
a base station.
[0332] FIG. 23 is a schematic representation of dual-housing
arrangement 2016 according to another embodiment of the invention.
This arrangement may be advantageously used with disposable
cassettes that include many pneumatically actuated pumps and/or
valves. If the number of pneumatically actuated pumps and/or valves
in a cassette is large enough, the cassette containing these pumps
and valves can become so large--and the pressures involved can
become so great--that it may become difficult to properly seal and
position all of the pumps and valves. This difficulty may be
alleviated by using two different housings. The valves and pumps
(such as pump pods 2042) are placed in a main housing 2041, from
which connecting tubes 2045 lead from pneumatic ports 2044. The
main housing 2041 also has inlet and outlet tubes 2043, which allow
liquid to flow into and out of the main housing. The connecting
tubes 2045 provide pneumatic communication between valves and pumps
in the main housing 2041 and a smaller, secondary tube-support
housing 2046, which is provided with a pneumatic interface 2047 for
each of the tubes. The proper positioning and sealing of all the
pneumatic interfaces 2047 against receptacles in the base unit can
be accomplished more easily with the smaller tube-support housing
2046 than it would be if the pneumatic actuation was applied to the
larger main housing directly.
1.6. Alternative Chamber Configurations and Stroke Sizes
[0333] It should be noted that pump pods of the types described
above can be configured with different chamber configurations
and/or different stroke sizes. Thus, for example, pump pods having
different pump volumes may be provided. Furthermore, pump pods
having different pump volumes may be provided with a standardized
pneumatic port configuration (and perhaps standardized actuation
chamber wall configuration) so that pump pods having different
volumes may be easily swapped into and out of a common pumping
system or apparatus (e.g., a base unit) having a corresponding
standardized pneumatic port interface. For example, the base unit
may be able to receive lower-volume pump pods for pediatric use and
receive higher-volume pump pods for adult use. The pneumatic ports
are preferably adapted to be quickly and easily connected to--and
disconnected from--the pneumatic actuation system of the base unit.
In certain embodiments, the pump pods may be considered to be
disposable and may be provided individually or as part of a larger
disposable system.
[0334] Thus, for example, in the embodiments shown in FIGS. 2 and
48, disposable systems (specifically for use in a heat-exchange
system, as discussed more fully below) include two self-contained
pump pods 25a and 25b. Different versions of such disposable
systems having pump pods of different pump volumes could be
provided for different applications (e.g., one version with smaller
pump volumes for children, another version with larger pump volumes
for adults). Similarly, in the embodiment shown in FIGS. 5A and 5B,
different versions of the assembly 2004 having pump pods of
different pump volumes could be provided, and in the embodiment
shown in FIGS. 22A and 22B, different versions of the cassette 2015
having pump pods of different pump volumes could be provided.
Similarly, in the embodiment shown in FIG. 23, different versions
of the main housing 2041 having pump pods of different pump volumes
could be provided for use with a common secondary tube-support
housing 2046.
[0335] It should be noted that the pumping chamber wall may be
molded, formed, produced, or otherwise configured with various
features facilitate intake, circulation, and/or delivery of the
fluid. For example, the inside wall of the pumping chamber may
include certain features or materials to help induce circulatory
flow, induce smooth/laminar flow, reduce boundary layer effects, or
even produce turbulence (e.g., to facilitate mixing of materials or
prevent coagulation within the pumping chamber).
1.7. Exemplary Diaphragm Configurations
[0336] In certain embodiments, the pump pod diaphragm may be
provided with small raised bumps, grooves, or other structures,
particularly on the side of the membrane facing the pumping
chamber. FIGS. 46A and 46B show an exemplary membrane 33 having
raised bumps 39, in accordance with an exemplary embodiment of the
present invention. Such raised bumps 39 or other raised structures
prevent pockets of fluid from being caught away from the inlet and
outlet, specifically by keeping the membrane spaced away from the
rigid pumping chamber wall even when the pumping chamber volume is
at a minimum. This spacing keeps flow passages open for blood to
flow from the periphery of the pumping chamber to the outlets. In
the exemplary embodiment shown in FIGS. 46A and 46B, the bumps 39
are located on a portion of the membrane spaced away from the edge
of the membrane such that the membrane lacks bumps in the area near
the edge of the membrane. Generally speaking, such a configuration
allows the portion of the membrane around the edge to contact the
pumping chamber wall, which tends to force fluid from the edge
toward the outlet.
[0337] In addition to, or in lieu of, bumps or other raised
structures on the membrane, the pump chamber wall may include
spacers or conduits to allow for fluid flow as the pumping chamber
approaches and reaches its minimum volume.
[0338] The membrane may be made from any of a wide variety of
flexible materials, but is preferably made of a high-elongation
silicone or similar material in order to maintain smooth pumping of
the membrane and to reduce the tendency of membrane to "snap hard"
into its minimum-pumping-chamber-volume position. By reducing hard
snapping, sharp localized spikes of force on the fluid are reduced.
Such hard snapping could cause disruptions in the fluid rotation in
the chamber and could result in excessive shear forces and
turbulence, which, the case of blood pumping, could cause
hemolysis, and in the case of surfactant pumping, could result in
foaming. Alternatively, the membrane may be made of a variety of
thermoplastic elastomers or rubbers. Also, the membrane may be
provided with dimples or grooves to make the membrane more
flexible.
[0339] It should be noted that the membrane may be molded, formed,
produced, or otherwise configured so as to bias reciprocation of
the membrane in a predetermined pattern or manner. For example, the
membrane may be formed with portions of having different thickness
or stiffness so that certain portions move more freely than others
(e.g., a portion of the membrane proximate to the pump inlet may be
configured to be more flexible than a portion of the membrane
proximate to the pump outlet so that the inlet side of membrane
retreats more quickly during the draw stroke and collapses more
quickly during the delivery stroke, which could facilitate filling
and emptying of the pumping chamber in some embodiments).
2. Exemplary Pump Control Systems
2.1. Pressure Actuation System
[0340] FIG. 4 is a schematic showing an embodiment of a pressure
actuation system 40 that may be used to actuate a pump pod, such as
the pump pod 25 shown in FIG. 3, in accordance with an exemplary
embodiment of the present invention. The pressure actuation system
40 is capable of intermittently or alternately providing positive
and negative pressurizations to the gas in the actuation chamber 42
of the pump pod 25. The pump pod 25--including the flexible
membrane 33, the inlet 34, the outlet 37, the pneumatic port 38,
the pumping chamber 41, the actuation chamber 42, and possibly
including an inlet check valve 35 and an outlet check valve 36 or
other valves--may be part of a larger disposable system. The
pneumatic actuation system 40--including an actuation-chamber
pressure transducer 44, a positive-supply valve 47, a
negative-supply valve 48, a positive-pressure gas reservoir 51, a
negative-pressure gas reservoir 52, a positive-pressure-reservoir
pressure transducer 45, a negative-pressure-reservoir pressure
transducer 46, as well as an electronic controller 49 including a
user interface console (such as a touch-panel screen)--may be part
of a base unit.
[0341] The positive-pressure reservoir 51 provides to the actuation
chamber 42 the positive pressurization of a control gas to urge the
membrane 33 towards a position where the pumping chamber 41 is at
its minimum volume (i.e., the position where the membrane is
against the rigid pumping-chamber wall 31). The negative-pressure
reservoir 52 provides to the actuation chamber 42 the negative
pressurization of the control gas to urge the membrane 33 in the
opposite direction, towards a position where the pumping chamber 41
is at its maximum volume (i.e., the position where the membrane is
against the rigid actuation-chamber wall 32).
[0342] A valving mechanism is used to control fluid communication
between each of these reservoirs 51, 52 and the actuation chamber
42. In FIG. 4, a separate valve is used for each of the reservoirs;
a positive-supply valve 47 controls fluid communication between the
positive-pressure reservoir 51 and the actuation chamber 42, and a
negative-supply valve 48 controls fluid communication between the
negative-pressure reservoir 52 and the actuation chamber 42. These
two valves 47, 48 are controlled by the controller 49.
Alternatively, a single three-way valve may be used in lieu of the
two separate valves 47, 48. The valves 47, 48 may be binary on-off
valves or variable-restriction valves.
[0343] The controller 49 also receives pressure information from
the three pressure transducers shown in FIG. 4: an
actuation-chamber pressure transducer 44, a
positive-pressure-reservoir pressure transducer 45, and a
negative-pressure-reservoir pressure transducer 46. As their names
suggest, these transducers respectively measure the pressure in the
actuation chamber 42, the positive-pressure reservoir 51, and the
negative-pressure reservoir 52. The actuation-chamber-pressure
transducer is located in the base unit but is in fluid
communication with the actuation chamber 42 through the pump pod's
pneumatic port 38. The controller 49 monitors the pressure in the
two reservoirs 51, 52 to ensure they are properly pressurized
(either positively or negatively). In one exemplary embodiment, the
positive-pressure reservoir 51 may be maintained at around 750
mmHG, while the negative-pressure reservoir 52 may be maintained at
around -450 mmHG.
[0344] A compressor-type pump or pumps (not shown) may be used to
maintain the desired pressures in these reservoirs 51, 52. For
example, two independent compressors may be used to respectively
service the reservoirs 51, 52. Pressure in the reservoirs 51, 52
may be managed using a simple bang-bang control technique in which
the compressor servicing the positive-pressure reservoir 51 is
turned on if the pressure in the reservoir 51 falls below a
predetermined threshold and the compressor servicing the
negative-pressure reservoir 52 is turned on if the pressure in the
reservoir 52 is above a predetermined threshold. The amount of
hysteresis may be the same for both reservoirs or may be different.
Tighter control of the pressure in the reservoirs can be achieved
by reducing the size of the hysteresis band, although this will
generally result in higher cycling frequencies of the compressors.
If very tight control of the reservoir pressures is required or
otherwise desirable for a particular application, the bang-bang
technique could be replaced with a PID control technique and could
use PWM signals on the compressors.
[0345] The pressure provided by the positive-pressure reservoir 51
is preferably strong enough--under normal conditions--to urge the
membrane 33 all the way against the rigid pumping-chamber wall 31.
Similarly, the negative pressure (i.e., the vacuum) provided by the
negative-pressure reservoir 52 is preferably strong enough--under
normal conditions--to urge the membrane all the way against the
actuation-chamber wall 32. In a further preferred embodiment,
however, these positive and negative pressures provided by the
reservoirs 51, 52 are within safe enough limits that even with
either the positive-supply valve 47 or the negative-supply valve 48
open all the way, the positive or negative pressure applied against
the membrane 33 is not so strong as to damage the pump pod or
create unsafe fluid pressures (e.g., that may harm a patient
receiving pumped blood or other fluid).
[0346] It will be appreciated that other types of actuation systems
may be used to move the membrane back and forth instead of the
two-reservoir pneumatic actuation system shown in FIG. 4, although
a two-reservoir pneumatic actuation system is generally preferred.
For example, alternative pneumatic actuation systems may include
either a single positive-pressure reservoir or a single
negative-pressure reservoir along with a single supply valve and a
single tank pressure sensor, particularly in combination with a
resilient diaphragm. Such pneumatic actuation systems may
intermittently provide either a positive gas pressure or a negative
gas pressure to the actuation chamber of the pump pod. In
embodiments having a single positive-pressure reservoir, the pump
may be operated by intermittently providing positive gas pressure
to the actuation chamber, causing the diaphragm to move toward the
pumping chamber wall and expel the contents of the pumping chamber,
and releasing the gas pressure, causing the diaphragm to return to
its relaxed position and draw fluid into the pumping chamber. In
embodiments having a single negative-pressure reservoir, the pump
may be operated by intermittently providing negative gas pressure
to the actuation chamber, causing the diaphragm to move toward the
actuation chamber wall and draw fluid into the pumping chamber, and
releasing the gas pressure, causing the diaphragm to return to its
relaxed position and expel fluid from the pumping chamber.
2.2. Alternative Embodiments Using Active Inlet/Outlet Valves
[0347] As discussed above, active valves may be used instead of
passive check valves at the pump pod inlet and output. Active
valves would allow for greater control and flexibility (generally
at the expense of added complexity and cost). Among other things,
active valves would allow for reversal of fluid flow, which could
be used, for example, to facilitate priming, air purging, and/or
detection and mitigation of certain conditions (e.g., occlusion,
blockage, leakage, line disconnect). With regard to detection of a
line disconnect, a reversal of flow may cause air to be drawn into
the pumping chamber through the outlet if the outlet line is
disconnected. Such air flow could be detected using any of a
variety of techniques, including the amount of work needed to move
the pump diaphragm. If the line is safely connected, some amount of
work would normally be necessary to reverse flow and draw fluid in
through the outlet, whereas if the return line has been
disconnected, much less work would generally be necessary to
reverse flow, since the pump would be drawing air into the return
line. If upon reversing flow, the controller detects an aberrant
flow condition, the controller would preferably cause the system to
stop pumping blood from the patient.
[0348] During normal pump operations, the active valves generally
would be operated as follows. During a fill stroke, when fluid is
drawn into the pumping chamber, the controller 49 would typically
open the inlet valve and close the outlet valve so as to allow
fluid to enter the pumping chamber through the inlet but prevent
fluid from being drawn back in from the outlet. During a delivery
stroke when fluid is pumped out of the pumping chamber (e.g., after
the pumping chamber is full or at other appropriate times), the
controller 49 would generally close the inlet valve and open the
outlet valve so as to allow fluid to be pumped out of the outlet
but prevent fluid from being pumped back through the inlet. Between
strokes, the controller 49 may cause both the inlet valve and the
outlet valve to be closed for some time interval.
[0349] It should be noted that for embodiments in which
pneumatically actuated inlet and outlet valves (e.g., binary on-off
valves either integral to the pump pod or external to the pump pod)
are used in place of passive inlet and outlet check valves, such
valves may be coupled to the positive and/or negative pressure
reservoirs 51, 52 through appropriate supply valves actuated by the
controller 49.
[0350] The use of active inlet and outlet valves can facilitate
detection of air in the pumping chamber. For example, following a
full draw stroke to bring the pumping chamber to its maximum
volume, positive pressure can be applied to the actuation chamber
and the rate at which the pressure in the actuation chamber (or the
pumping chamber) increases can be monitored. If the pumping chamber
is full of air, then the pressure should increase more gradually,
as the air in the pumping chamber will allow the diaphragm to move
more readily. If, however, the pumping chamber is full of liquid,
then the pressure should increase more rapidly because the pump
diaphragm will be held more firmly by the uncompressible
liquid.
2.3. Pump Operation
[0351] During normal pumping operations, the controller 49
typically monitors the pressure information from the
actuation-chamber-pressure transducer 44 and, based on this
information, controls the valving mechanism (valves 47, 48) to urge
the membrane 33 all the way to its minimum-pumping-chamber-volume
position and then after this position is reached to pull the
membrane 33 all the way back to its maximum-pumping-chamber-volume
position. In this embodiment, volume may be measured by counting
full strokes of fluid delivery (e.g., volume=number of full strokes
x pumping chamber volume).
[0352] In typical embodiments of the invention, the controller may
be able to detect the end of a stroke, i.e., when the membrane
reaches one of the rigid pumping-chamber or actuation-chamber
walls. Referring to FIG. 4, an expel stroke is started by opening
positive-supply valve 47, thereby resulting in positive pressure
being exerted against the membrane 33. Preferably, the
positive-supply valve 47 is cycled on and off (dithered) to create
a ripple in the actuation chamber's pressure as long as the
membrane 33 is moving. When the membrane 33 reaches the
pumping-chamber wall 31 the pressure ripple stops. The controller
49, receiving pressure information from actuation-chamber-pressure
transducer 44, monitors this pressure ripple and detects the end of
stroke when this pressure ripple stops.
[0353] When the controller 49 detects the end of the expel stroke,
the controller closes positive-supply valve 47 and dithers the
negative-supply valve 48, thereby causing a vacuum to be applied to
the membrane 33. The same process followed in the expel stroke is
repeated for the fill stroke. The controller determines the time to
complete each stroke and uses that information to calculate flow
rate. The flow rate information is then used to set the commands
for pressure and valving for the next stroke.
[0354] The controller 49 sets the flow rate using a timed sequence
of alternately applying positive pressure and vacuum to the
membrane 33. A positive pressure will be applied for a determined
time interval to achieve a desired delivery (i.e., expelling) flow
rate. When this time interval has expired, a vacuum is applied to
achieve a fill flow rate. This control of time intervals can be an
open-loop system without feedback on flow rate; thus, there can be
delays between the end of one stroke and the start of another. Such
an open-loop time-based system may be used when closed-loop systems
based on flow-rate will not operate properly, such as during
priming when there is a mixture of liquid and air in the pump
pods.
[0355] As mentioned above, a stroke is preferably effected by
delivering a sequence of pressure pulses (forming a pressure
ripple) to the membrane 33. The speed of a stroke can be adjusted
by changing how frequently a supply valve is opened and/or by
changing how long it is opened each time it is opened. A pressure
pulse involves opening the valve between the actuation chamber and
the reservoir for a fixed time and then closing it for the rest of
the pulse period. The total length of a pressure pulse is 1/(pulse
pumping frequency). In one embodiment, the pulse pumping frequency
increases from 2 Hz to 16 Hz as the controller's pumping command
increases from 0 to 100%. The minimum frequency of 2 Hz is intended
to ensure a minimum flow rate is met when there is water in the
system. A maximum frequency of 16 Hz is intended to correspond to
the minimum time required for the valve to be at a 50% duty cycle.
The pumping algorithm preferably divides a stroke into two periods,
the initial pumping period and the end-of-stroke period. During the
initial pumping period, the valve open time of the pressure pulse
is preferably 166 ms (100% duty cycle at 16 Hz). Thus, with a
maximum command from the controller, the valve to the reservoir is
always open. The number of pressure pulses in the initial period is
increased from one to ten as the pumping command increase from zero
to 100%.
[0356] After the initial pumping period, there is a transition to
the end-of-stroke pumping period. In this respect, software filters
are preferably used to determine when a stroke ends, with at least
five pressure pulses used in the end-of-stroke period for the
end-of-stroke filters to initialize. The end-of-stroke period ends
when the end of stroke is detected. During the end-of-stroke
period, the valve open time of the pressure pulse is preferably
83.3 ms (50% duty cycle at 16 Hz). FIGS. 7 and 8 show the pressure
pulses during the initial and end-of-stroke periods. FIG. 7 shows
pressure pulses for a low-flow command by the controller, and FIG.
8 shows a pressure pulse for a large-flow command by the
controller. Note that the on time for a pulse is much longer for
higher commands.
[0357] The pressure pulses generate a ripple in the measured
pressure in the actuation chamber while the membrane is moving. By
filtering and isolating this pressure ripple, the end-of-stroke
algorithm can detect when the diaphragm has reached the chamber
wall and stopped moving. This end-of-stroke information may be used
for flow calculations and for sequencing the pump pods for fill and
expel strokes.
[0358] In the first stage of filtering, the pressure signal for
each pump pod is passed through a band-pass filter. This filter is
used to isolate the pulse-pumping frequency. As discussed above,
the pulse-pumping frequency preferably increases from 2 Hz to 16 Hz
as the pumping command increases from 0% to 100%. FIG. 9 shows the
output of the band-pass filter.
[0359] The absolute value of this filtered signal is then passed
through a second-order low-pass filter with a damping ratio of one.
The corner frequency of this filter is varied based on the pulse
pumping frequency. FIG. 10 shows the output of this low-pass
filter. The output from the low-pass filter is divided by the
absolute value of the supply pressure to normalize the ripple
value. This final value of the pressure ripple is then used to
detect the end of stroke. Once in the end-of-stroke period, this
ripple characteristically drops down to zero when the diaphragm is
stopped by the chamber wall.
[0360] FIG. 11 is a graph showing pressure measurements in the
actuation chambers of each of the pump pods in the disposable unit,
and also showing the results of the filtering described above. It
should be noted that the unfiltered pressure readings show that the
two pump pods are out of phase, with one pump pod expelling liquid
while the other is filling with liquid. As can be seen in the plots
of filtered readings, these filtered readings drop to zero at the
end of each stroke.
[0361] At the end of the stroke, the flow rate is calculated for a
given pump pod and flow direction by dividing the chamber volume by
the time for the stroke to complete. Once the expel stroke has
ended, the variables for the stroke are reset, and this process
repeats for the fill stroke.
[0362] The pressure ripple causes pressure readings to vary
significantly for the duration of the stroke. Thus, an average
pressure is calculated and logged. As shown in FIG. 12, the average
pressure is preferably computed by integrating pressure between the
fifth and tenth pulse. In this embodiment, the fifth and tenth
pulses are chosen as the start and end of the average to ignore
effects of the pressure when initiating the stroke and when the
diaphragm hits the chamber wall.
[0363] To check whether any of the pressure transducers (the
actuation-chamber-pressure transducer 44, the
positive-reservoir-pressure transducer 45 or the
negative-reservoir-pressure transducer 46) may be malfunctioning,
the controller preferably compares pressure readings at the end of
a stroke. Referring to FIG. 4, at the end of an expel stroke, while
the positive-supply valve 47 is open, the pressure reading of the
actuation-chamber-pressure transducer 44 is compared to the reading
of the positive-reservoir-pressure transducer 45. Since at the end
of the expel stroke the pressure readings from these two
transducers should be the same, any difference in pressure readings
from these two transducers indicates a malfunction in one of the
two transducers. Similarly, at the end of a fill stroke, while the
negative-supply valve 48 is open, the controller 49 preferably
compares the pressure reading of the actuation-chamber-pressure
transducer 44 to the reading of the negative-reservoir-pressure
transducer 46. If the controller detects a significant change in
these pressure readings, the controller generates an alarm signal
indicating a malfunction in one of the transducers.
[0364] The controller can also detect aberrant flow conditions by
integrating the pressure readings over time to obtain a measure of
the work done in moving the liquid. If the amount of work done goes
up or down, the controller preferably generates an alarm signal
indicating that something has gone wrong in the line, such as an
occlusion, a leak, or a disconnect. The ability to detect a
disconnect or a leak may be important, particularly when pumping
blood or other life-critical fluids, because of the relatively
large flow rates of fluids being pumped. In one embodiment, by
integrating the pressure readings and determining the work
function, the controller can detect a line disconnect within
approximately three seconds.
[0365] This calculation can also take into account the head height
between the pod pumps and the patient, although this height may be
assumed to be constant during a thermal-therapy procedure. This
calculation can be represented as
K.sub.fluidpath.times.m.sub.pod=.intg..sub.stroke(P.sub.pod-P.sub.height.-
sub.--.sub.diff)dt where [0366] K.sub.fluidpath is the resistance
in the fluid path, [0367] m.sub.pod is the mass of fluid contained
in the pod, [0368] P.sub.pod is the pressure in the pump pod, and
[0369] P.sub.height.sub.--.sub.diff is the pressure due to head
height between the pod and the patient. Since both K.sub.fluidpath
and m.sub.pod should be constant during a thermal therapy
procedure, any variation in the integrated pressure should indicate
a change in resistance in the fluid and/or a change in the amount
of mass displaced during a stroke, and thus indicate an aberrant
flow condition, such as an occlusion or a disconnect.
[0370] In one embodiment, the head height is not monitored during
the procedure. The head height is calculated based on the first few
pumps of the pod. Those first few pumps set the standard for the
head height calculation, based on the following calculation
P.sub.pod=K.sub.fluidpathm'+P.sub.height.sub.--.sub.diff where m'
is the mass flow rate.
[0371] In particular, since normally the flow rate is low in the
first few strokes of the pod, m' may be assumed to be zero and the
pressure in the pod equal to the head pressure;
P.sub.pod=P.sub.height.sub.--.sub.diff. Based on this calculation,
the head height is presumed to be constant.
[0372] In one embodiment, the controller looks for a change in the
integrated pressure between consecutive strokes or a change (with a
smaller tolerance) over three strokes of the low-pass filtered
value of the integrated pressure. If either of these changes is
excessive, an error is declared and pumping is stopped until a
medical technician intervenes. This detection algorithm is not run
during priming due to the large variations in the integrated
pressure signal that occur when there is a mixture of air and
liquid in the pods.
[0373] Another method of detecting occlusions at low flow rates may
be run in tandem with the pod-pressure-integration method. In this
method, the controller looks for multiple consecutive short strokes
of the exact same length. If such strokes are detected, the pod
pump is probably not completing strokes due to an occlusion or a
pneumatic problem. In one embodiment, if more than six short
strokes occur on a given pod pump, an error signal is generated.
During priming, this detection method is not used because fast,
short strokes are common when the chambers are filled with air.
[0374] If the end of a stroke does not occur within a predetermined
number of pressure pulses (e.g., 100 pressure pulses as discussed
above in connection with FIGS. 7-12), the controller preferably
generates an error signal. Excessive time to complete a stroke may
indicate a pneumatic leak. Such a check can be run during priming
as well as during the procedure.
2.4. Fluid Flow Management
[0375] Generally speaking, a single pump pod operates in a
pulsatile fashion, first drawing in fluid and then pumping out
fluid. Pulsatile operation may be necessary, desirable, or inherent
in certain applications (e.g., extracorporeal blood treatment in
which blood is drawn from a patient and returned to the patient
through a single needle is inherently pulsatile, since blood
generally cannot be drawn from the patient and pumped back into the
patient at the same time through the single needle).
[0376] In a dual pump configuration, the two pump pods may be
operated from a zero degree phase relationship (i.e., both pumping
chambers act in the same direction) to a 180 degree phase
relationship (i.e., the pumping chambers act in opposite
directions). A zero degree phase relationship can be used to
produce a substantially pulsatile fluid flow, similar to a single
pump pod. A 180 degree phase relationship can be used to produce a
substantially continuous fluid flow both toward the pumps and from
the pumps. A 90 degree phase relationship can be used to produce a
substantially sinusoidal fluid flow. FIGS. 74A-74C show plots for
volume flow, pod volumes, and total hold up flow for a zero degree
phase relationship, a 180 degree phase relationship, and a 90
degree phase relationship, respectively.
[0377] In some applications, it may be necessary or desirable to
provide substantially continuous fluid flow to the pump pod(s)
and/or from the pump pod(s). As discussed above, substantially
continuous fluid flow may be provided using two pump pods operating
with a 180 degree phase relationship. For one or more pump pods
operating in a pulsatile mode (e.g., a single pump pod or two pump
pods operating in a zero degree phase relationship), one way to
produce a more continuous fluid flow output is to fill the pump
pod(s) as quickly as possible and then pump out the fluid over an
extended period of time (e.g., the desired deliver time could be
set to be a total desired stroke time minus the time that the fill
stroke took).
[0378] Even when operating two pump pods in a 180 degree phase
relationship, it is possible for there to be discontinuous fluid
flow under some conditions, particularly when the input impedance
is significantly different than the output impedance. For example,
in extracorporeal blood treatment applications, input impedance may
be higher than output impedance due to such things as needle size
(e.g., the needle used to draw blood from the patient may be
smaller than the needle used to return blood to the patient), blood
viscosity (e.g., the patient may have very viscous blood that is
thinned as part of the treatment), or poor patient access (e.g.,
poor patient circulation may limit the rate at which blood can be
drawn). Such impedance differences can result in different pump pod
fill and delivery times, particularly if the system cannot be
balanced by applying more pressure to one pump pod than the other
pump pod (in theory, it should be possible to ensure a precise 180
degree phase relationship if there were no limit on the amount of
pneumatic pressure that could be applied to the pump pods, but
there are typically both physical limits--the maximum pressures in
the two reservoirs--and practical limits to the amount of pressure
that can be applied). Therefore, in some situations, the stroke of
one pump pod might finish before the corresponding stroke of the
other pump pod, in which case it may be necessary to delay the
former pump pod while the latter pump pod completes its stroke,
resulting in a pause in the fluid flow produced by the former pump
pod. One possible solution is to limit the flow rate to the slowest
of the fill and deliver strokes. Although this would result in
slower blood delivery flow rates, the flow rate would still be
known and would be continuous.
2.5. Alternative Embodiment Using Variable-Restriction Pneumatic
Valves
[0379] As noted above, the positive-supply valve 47 and the
negative-supply valve 48 in the pneumatic actuation system 40 of
FIG. 4 may be variable-restriction valves, as opposed to binary
on-off valves. By using variable valves, the pressure applied to
the actuation chamber 42 and the membrane 33 can be more easily
controlled to be just a fraction of the pressure in reservoirs 51,
52, instead of applying the full reservoir pressure to the
membrane. This facilitates use of the same reservoir or set of
reservoirs for pump pods having different operating parameters,
such as pump volume, pump stroke size, or pump actuation pressure.
Of course, the reservoir pressure generally needs to be greater
than the desired pressures to be applied to various pump pod's
membranes, but one pump pod may be operated at, say, half of the
reservoir pressure, and another pump pod may be actuated with the
same reservoir but at, say, a quarter of the reservoir pressure.
Thus, even though different pump pods may be designed to operate at
different pressures, these pump pods may all share the same
reservoir or set of reservoirs but still be actuated at different
pressures, through the use of variable valves. The pressures used
in a pump pod may be changed to address conditions that may arise
or change during pumping. For example, if flow through the system's
tubing becomes constricted because the tubes get twisted, one or
both of the positive or negative pressures used in the pump pod may
be increased in order to compensate for the increased
restriction.
[0380] FIG. 28 is a graph showing how pressures applied to a pod
pump may be controlled using variable valves. The vertical axis
represents pressure with P.sub.R+ and P.sub.R- representing
respectively the pressures in the positive and negative reservoirs
(items 51 and 52 in FIG. 4), and P.sub.C+ and P.sub.C- representing
respectively the positive and negative control pressures acting on
the pump pod's membrane. As can be seen in FIG. 28, from time
T.sub.0 to about time T.sub.1, a positive pressure is applied to
the actuation chamber (so as to force fluid out of the pumping
chamber). By repeatedly reducing and increasing the flow
restriction caused by the positive variable valve (item 47 in FIG.
4), the pressure being applied to the actuation chamber can be held
at about the desired positive control pressure, P.sub.C+. The
pressure varies, in a sinusoidal manner, around the desired control
pressure. An actuation-chamber pressure transducer (item 44 in FIG.
4) in communication with the actuation chamber measures the
pressure in the actuation chamber and passes the
pressure-measurement information to the controller (item 49 in FIG.
4), which in turn controls the variable valve so as to cause the
actuation chamber's pressure to vary around the desired control
pressure, P.sub.C+. If there are no fault conditions, the membrane
is pushed against a rigid wall of the pumping chamber, thereby
ending the stroke. The controller determines that the end of stroke
has been reached when the pressure measured in the actuation
chamber no longer drops off even though the restriction created by
the variable valve is reduced. In FIG. 28, the end of the expelling
stroke occurs around time T.sub.1. When the end of stroke is
sensed, the controller causes the variable valve to close
completely so that the actuation chamber's pressure does not
increase much beyond the desired control pressure, P.sub.C+.
[0381] After the positive variable valve is closed, the negative
variable valve (item 48 in FIG. 4) is partially opened to allow the
negative pressure reservoir to draw gas from the actuation chamber,
and thus draw fluid into the pumping chamber. As can be seen in
FIG. 28, from a time shortly after T.sub.1 to about time T.sub.2, a
negative pressure is applied to the actuation chamber). As with the
expelling (positive pressure), stroke described above, repeatedly
reducing and increasing the flow restriction caused by the negative
variable valve can cause the pressure being applied to the
actuation chamber can be held at about the desired negative control
pressure, P.sub.C- (which is weaker than the pressure in the
negative pressure reservoir). The pressure varies, in a sinusoidal
manner, around the desired control pressure. The actuation-chamber
pressure transducer passes pressure-measurement information to the
controller, which in turn controls the variable valve so as to
cause the actuation chamber's pressure to vary around the desired
control pressure, P.sub.C-. If there are no fault conditions, the
membrane is pulled against a rigid wall of the actuation chamber,
thereby ending the draw (negative pressure) stroke. As described
above, the controller determines that the end of stroke has been
reached when the partial vacuum measured in the actuation chamber
no longer drops off even though the restriction created by the
variable valve is reduced. In FIG. 28, the end of the draw stroke
occurs around time T.sub.2. When the end of stroke is sensed, the
controller causes the variable valve to close completely so that
the actuation chamber's vacuum does not increase much beyond the
desired negative control pressure, P.sub.C-. Once the draw stroke
has ended, the positive variable valve can be partially opened to
begin a new expelling stroke with positive pressure.
[0382] Thus, two variable-orifice valves may be used to throttle
the flow from the positive-pressure source and into the
negative-pressure. The pressure in the actuation chamber is
monitored and a controller uses this pressure measurement to
determine the appropriate commands to both valves to achieve the
desired pressure in the actuation chamber. Two advantages of this
arrangement are that the filling and delivering pressure may be
precisely controlled to achieve a desired flow rate while
respecting pressure limits, and that the pressure may be varied
with a small sinusoidal signature command. This signature may be
monitored to determine when the pump reaches the end of a
stroke.
[0383] Another advantage of using variable valves in this way,
instead of binary valves, is that by only partially opening and
closing the variable valves the valves are subject to less wear and
tear. The repeated "banging" of binary valves all the way opened
and all the way closed can reduce the life of the valve.
[0384] If the end of stroke is detected and the integrated value of
the correlation function is very small, this may be an indication
that the stroke occluded and did not complete properly. It may be
possible to distinguish upstream occlusions from downstream
occlusions by looking at whether the occlusion occurred on a fill
or a delivery stroke (this may be difficult for occlusions that
occur close to the end of a stroke when the diaphragm is near the
chamber wall). FIGS. 73A-73B depict occlusion detection (lines 2703
and 2704 represent when occlusion is detected) in accordance with
an exemplary embodiment of the present invention.
[0385] Under normal operation, the integrated value of the
correlation function increases as the stroke progresses. If this
value remains small or does not increase, then the stroke is either
very short (as in the case of a very low impedance flow or an
occlusion) or the actual pressure may not be tracking the desired
sinusoidal pressure, e.g., due to a bad valve or pressure signals.
Lack of correlation can be detected and used for error handling in
these cases.
[0386] Under normal circumstances when the flow controller is
running, the control loop preferably adjusts the pressure for any
changes in flow rate. If the impedance in the circuit increases
dramatically and the pressure limits are saturated before the flow
has a chance to reach the target rate, the flow controller
generally will not be capable of adjusting the pressures higher to
reach the desired flow rate. These situations may arise if a line
is partially occluded (e.g., a blockage, such as a blood clot in a
blood pumping embodiment) has formed in the circuit. Pressure
saturation when the flow has not reached the target flow rate can
be detected and used in error handling.
[0387] If there are problems with the valves or the pneumatics,
such as a leaking fluid valve or a noisy pressure signal, ripple
may continue on the stroke indefinitely and the end of stroke
algorithm may not see enough of a change in the pressure ripple to
detect end of stroke. For this reason a safety check is preferably
added to detect if the time to complete a stroke is excessive. This
information can be used for error handling.
2.6. Exemplary Applications for Pump Pods
[0388] Reciprocating positive-displacement pumps and related
control systems of the types described above may be used in a wide
variety of fluid pumping applications, and are particularly
well-suited for (although not limited to) use in applications that
involve artificial or extracorporeal blood pumping such as, for
example, hyperthermic or hypothermic blood treatments, hemodialysis
and other blood processing and filtering treatments (e.g.,
plasmapheresis and apheresis), cardiac bypass and other assisted
blood circulation treatments (e.g., ventricular assist),
cardioplegia (as part of cardiac bypass or otherwise), lung bypass
or artificial lung and other applications involving extracorporeal
blood oxygenation, and chemotherapy and other drug treatments
(e.g., regional hyperthermic chemotherapy), to name but a few. For
example, in certain embodiments, reciprocating
positive-displacement pumps and related control systems of the
types described above may be used in a heat-exchanger system that
can be used to heat or cool a fluid such as blood. Exemplary
heat-exchanger systems are described below.
3. Exemplary Heat-Exchanger Systems
[0389] Embodiments of the present invention relate generally to
heat-exchanger systems that can be used to heat or cool a fluid
such as blood. A blood heating system may be particularly useful
for whole-body hyperthermic treatments (e.g., to raise the body
temperature to combat hypothermia or to combat certain diseases,
such as Hepatitis C and possibly some types of cancer, HIV/AIDS,
rheumatoid arthritis and psoriasis) or for regional hyperthermic
chemotherapy treatments. Exemplary heat-exchanger systems are
described below, one in the context of the pumping and heating of
blood as part of whole-body hyperthermic treatment, and the other
in the context of regional hyperthermic chemotherapy treatment. Of
course, it should be noted that such a heat-exchanger systems may
be used in other applications for heating and/or cooling fluid.
Furthermore, while the exemplary heat-exchanger systems described
below incorporate pump pods of the types described above, it should
be noted that embodiments are not limited to the use of pump pods.
Other types of pumps may be usable in various alternative
embodiments.
3.1. Whole-Body Hyperthermic Treatment
[0390] As discussed above, a blood heating system may be used for
whole-body hyperthermic treatments (e.g., to raise the body
temperature to combat hypothermia or to combat Hepatitis C by
raising the core body temperature to a sufficient level so as to
purge the virus from infected liver cells). Generally speaking,
whole-body hyperthermic treatment for Hepatitis C involves raising
the core body temperature to approximately 41.6 degrees Celsius
(107 degrees Farenheit) for an extended period of time. A typical
treatment might last three to four hours, including a 30-60 minute
warm-up period, 80-120 minute plateau period, and 30-45 minute
cool-down period. Core body temperature, and therefore fluid
temperature generated by the heat-exchanger system, must be
controlled carefully to maintain the patient at the target core
temperature with little variation--if the core temperature is too
low, then the treatment may not be effective; if the core
temperature gets too high, then the patient can be harmed.
[0391] FIG. 24 is a schematic view of a whole-body hyperthermic
treatment system in accordance with an exemplary embodiment of the
present invention. Blood leaves the patient via the 14F left
femoral venous cannulae. Within the heat-exchanger system 10, the
blood is pumped by two pump pods through a heat exchanger for heat
exchange. A control system monitors various parameters (e.g., blood
temperature entering and exiting the heater/cooler as well as
patient core temperature) and adjusts operation of the pump pods
and the heater/cooler accordingly. following the heat exchanger,
the blood passes through a particulate and air filter and returns
to the patient via the 12F right femoral venous cannulae. During
this procedure, the patient is typically supine, intubated,
anesthetized, and monitored by a doctor or other professional.
3.1.1. Exemplary Heat Exchanger Systems
[0392] FIG. 1 shows a heat-exchanger system 10 in accordance with
an exemplary embodiment of the present invention. The
heat-exchanger system 10 includes a base unit 11 and a disposable
unit 16. As described further below, the disposable unit 16 is
installed into the base unit 11 such that a heat-exchanger bag
(e.g., a heat-exchanger bag 21 as shown in FIGS. 2 and 48) of the
disposable unit 16 rests within a heat exchanger portion of the
base unit 11. As blood from a patient circulates through the
disposable unit 16, and specifically through the heat-exchanger bag
21, the blood is heated by the heat exchanger and is returned to
the patient. During such circulation, the blood remains within the
disposable unit 16 and generally does not come into contact with
components of the base unit 11. The disposable unit 16 is
considered to be "disposable" in that it is generally discarded
after a patient treatment, whereas the base unit 11 can be re-used
repeatedly by simply installing a new disposable unit 16. In fact,
the base unit 11 may include mechanisms to prevent re-use of a
disposable unit (e.g., using a bar code, RFID tag, or other
identifier associated with the disposable unit).
3.1.2. Exemplary Base Unit
[0393] FIG. 25 shows the base unit 11 in accordance with an
exemplary embodiment of the present invention. FIG. 47A shows some
of the interior components of the base unit 11 in accordance with
an exemplary embodiment of the present invention, while FIG. 47B
shows a rear perspective view of the base unit 11. The base unit 11
includes, among other things, a heat exchanger 2541, a pneumatic
actuation system 40, a disposables interface 2500 (also referred to
as a manifold interface), a patient interface, a controller, a user
interface console 13, and a ventilation system 2701. The pneumatic
actuation system 40 may be generally of the type shown in FIG. 4,
but with separate pneumatic interfaces, valves, and sensors for
each of two pump pods. The disposables interface may include two
sensors that provide both thermal and electrical connectivity to a
disposable unit to allow for monitoring blood temperature both
upstream and downstream of the heat exchanger and also to allow for
monitoring other parameters, as discussed below. The patient
interface may include one or more temperature inputs 2702 for
receiving temperature information (specifically patient temperature
information) from one or more temperature probes. The user
interface console allows the user to control and monitor operation
of the system. In an exemplary embodiment, the controller controls
operation of the heat exchanger and the pump pods based on, among
other things, blood temperature information received from the
disposables interface, pressure information received from the
pneumatic actuation system, patient temperature information
received from the patient interface, and user inputs received from
the user interface console.
3.1.3. Exemplary Disposable Unit Configurations
[0394] As mentioned above, a disposable unit for a heat-exchanger
system typically includes a heat-exchanger bag through which blood
flows while passing through the heat exchanger. The heat-exchanger
bag may include one or more fluid paths. In one exemplary
embodiment described below, a heat-exchanger bag includes a single
fluid path connecting two fluid inlets to a common fluid outlet. In
another exemplary embodiment described below, a heat-exchanger bag
includes a single fluid path having a single inlet and a single
outlet. Heat-exchanger bags are typically made of a flexible
plastic material, although the heat-exchanger bag may be made from
other materials and may include a metallic material or other
material to improve thermal conductivity.
[0395] FIG. 2 shows relevant components of a disposable unit 16, in
accordance with an exemplary embodiment of the present invention.
The disposable unit 16 includes, among other things, a
heat-exchanger bag 21 (also referred to as a "flow-path bag") with
a manifold 130 and a panel 2017 holding (or configured to hold) two
pump pods 25a and 25b and a filter/air trap 29. The disposable unit
16 preferably also includes a handle (not shown here, but shown in
FIG. 48) that is used to mechanically interconnect the
above-referenced components into a cohesive unit that can be
readily installed into the base unit 11, which preferably includes
a manifold interface (described below) for receiving the manifold
130 and providing pneumatic connections for operating the pumps
25a, 25b. The bag 21 includes a fluid path 150 through which fluid
can be pumped. In this embodiment, the manifold 130 is integrated
with the heat-exchanger bag 21 and is configured with appropriate
tubing connections and supports that are used to interconnect the
heat-exchanger bag 21 with the two pump pods 25a and 25b.
[0396] In the embodiment shown in FIG. 2, the manifold 130 includes
two flow-path inlets 23a and 23b (also referred to as
"heat-exchanger bag inlets") in fluid communication with one end of
the fluid path 150 and a flow-path outlet 27 (also referred to as a
"heat-exchanger bag outlet") in fluid communication with the other
end of the fluid path 150. The blood is preferably pumped from the
patient and through the heat-exchanger bag 21, in this embodiment
by a pair of self-contained pump pods 25a, 25b (referred to
individually as a pump pod 25), which are preferably reciprocating
positive-displacement pumps of the types described herein. In this
embodiment, the manifold 130 includes pneumatic passageways 138a,
138b to facilitate establishment of pneumatic connections
respectively to the pump pods 25a, 25b (typically using tubing). It
should be noted that embodiments are not limited to the use of two
pump pods or, for that matter, to the use of pump pods. The
manifold 130 is described more fully below.
[0397] In this embodiment, each pump pod 25 includes an inlet 34
and an outlet 37 (i.e., pump pod 25a has an inlet 34a and an outlet
37a, while pump pod 25b has an inlet 34b and an outlet 37b). The
various components may be interconnected in at least two
configurations. In a first configuration shown in FIGS. 48 and 72,
the pump pods 25a, 25b may be coupled upstream of the
heat-exchanger bag 21 such that the pump inlets 34a, 34b are
coupled to receive blood directly from the patient (e.g., through a
"Y" connector 2024), the pump outlets 37a, 37b are connected
respectively to the heat-exchanger-bag inlets 23a, 23b by tubes
2026a, 2026b, and the filter/air trap 29 is connected to the
heat-exchanger-bag outlet 27 by tube 2027. In this way, the pump
pods 25a, 25b are operable to urge blood through the heat-exchanger
bag 21, from which the blood exits through the flow-path outlet 27
and then passes through the filter/air trap 29 before returning to
the patient. In a second configuration (not shown), the pump pods
25a, 25b may be coupled downstream of the heat-exchanger bag 21
such that blood from the patient enters the heat-exchanger-bag
inlets 23a, 23b (e.g., through a "Y" connector, not shown), the
pump inlets 34a, 34b are coupled to the flow-path outlet 27 (e.g.,
through a "Y" connector, not shown), and the pump outlets 37a, 37b
are coupled (e.g., through a "Y" connector, not shown) to return
blood to the patient via the filter/air trap 29. In this way, the
pump pods 25a, 25b draw blood through the heat-exchanger bag 21 and
pump the blood through the filter/air trap 29 to the patient. It
should be noted, in an alternate embodiment, the heat-exchanger bag
21 could include separate outlets, which could facilitate its
coupling with the pump pods in some situations. In the embodiments
shown in FIGS. 2 and 48, the filter/air trap 29 is preferably
provided with a purge port to allow air to escape from the filter.
FIG. 48 shows a data key slot 2542 in which a data key can be
placed, for example, during manufacturing.
[0398] FIG. 81 shows a variation of the disposable unit 16 of FIG.
48 including a patient connection circuit 2060 having a sterile
protective covering 2062, in accordance with an exemplary
embodiment of the present invention. Specifically, a configuration
of tubing 2061 is connected between the pump pod inlets and the
filter outlet to form a complete circuit. In this embodiment, the
tubing 2061 includes an air purge/sample port 2019 and a blood
monitoring interface optionally including shunt sensor connections
2020 and/or disposable H/S cuvette 2022. In order to effectuate
connections to the patient, the surgeon or other technician
typically cuts through the tubing 2061 at or about the distal
portion of the tubing (in this embodiment, the U-shaped portion
toward which the arrow for reference numeral 2060 points, which may
be referred to as the "circus maximus") in order to create two tube
ends. The surgeon or technician can then connect appropriate
needles to the two tube end for insertion into the patient.
[0399] In this embodiment, the distal portion is sterilized and
covered with a thin plastic protective material 2062 in order to
maintain sterility. Prior to cutting through the tubing 2061, a
portion of the tubing 2061 in the sterile field is exposed, for
example, by pulling on the protective material 2062 in opposite
directions until it separates. FIG. 82 shows a representation of
the patient connection circuit from FIG. 81 with a portion of
tubing 2061 exposed through the sterile protective covering 2062,
in accordance with an exemplary embodiment of the present
invention. Once the section of tubing 2061 has been exposed, a cut
can be made at location 2063.
[0400] FIG. 83 shows a variation of the disposable unit of FIG. 81
including an additional fluid delivery line 2065, in accordance
with an exemplary embodiment of the present invention. The fluid
delivery line 2065 is in fluid communication with the pump pod
inlets to that fluid from the fluid delivery line 2065 (e.g., IV
fluids) can be incorporated into the patient blood and circulated
through the heat exchanger and into the patient. In this
embodiment, the fluid delivery line 2065 is configured with a
connector 2064 (e.g., a needle for introduction into an IV bag) in
order to facilitate connection with a fluid source.
[0401] FIGS. 15, 16 and 17 show respectively top perspective, end
perspective, and top plan views of an alternative heat-exchanger
bag 121 in accordance with another embodiment of the present
invention. In this embodiment, the bag 121 has a single inlet 123,
a single outlet 127, and a flow path 150 extending between the
inlet 121 and the outlet 123. The inlet 123 and the outlet 127 of
this bag 121 are spaced away from each other, whereas in the bag 21
of FIGS. 2 and 48, the inlet 23a, 23b and outlet 27 are adjacent
each other. Having the inlet and outlet adjacent each other (like
the bags shown in FIGS. 2 and 48) generally makes the disposable
unit less bulky to handle. The bag 121 may be formed from two
sheets of plastic or other appropriate material that are welded at
the seams to produce the flow path 150.
[0402] It should be noted that alternative embodiments may employ
other pump pod configurations as part of the disposable unit 16.
For example, various alternative embodiments could employ the pump
pod assembly 2004 shown in FIGS. 5A and 5B, the pump cassette 2015
shown in FIGS. 22A and 22B, or the dual-housing arrangement 2016
shown in FIG. 23. With regard to pump pod assembly 2004, the common
inlet 54 may be coupled to receive blood from the patient and the
common outlet 57 may be coupled to provide blood to the
heat-exchanger bag 21, or the common inlet 54 may be coupled to
receive heated blood from the heat-exchanger bag 21 and the common
outlet 57 may be coupled to provide blood to the filter/air trap
29. Similarly, with regard to pump cassette 2015, the common inlet
2005 may be coupled to receive blood from the patient and the
common outlet 2006 may be coupled to provide blood to the
heat-exchanger bag 21, or the common inlet 2005 may be coupled to
receive heated blood from the heat-exchanger bag 21 and the common
outlet 2006 may be coupled to provide blood to the filter/air trap
29.
[0403] It should be noted that various components of the disposable
unit 16 may be provided separately and/or in various assemblies and
sub-assemblies, and therefore the word "unit" is not intended to
require that the disposables be provided as a complete system or
kit. Thus, for example, the pump pods (or pump pod
assemblies/cassettes) could be provided separately from the rest of
the disposable unit 16. Among other things, providing the pump pods
separately could allow pump pods of different volumes to be easily
integrated, without requiring separate versions of the main
disposable unit for different pump volumes. Furthermore, the
disposable unit 16 could be provided with some tubing connections
already in place, e.g., with the pump outlets 37a, 37b already
coupled to the heat-exchanger-bag inlets 23a, 23b and/or with the
pump inlets 34a, 34b already coupled to a "Y" connector and/or with
the flow-path outlet 27 already coupled to the filter/air trap
29.
[0404] In typical embodiments, the same controller 49 preferably
controls both pump pods (items 25a and 25b of FIGS. 2 and 48) of
the disposable unit 16, and preferably (although not necessarily)
causes the two pump pods to pump out of phase (i.e., one pumping
chamber is emptying while the other is filling) during normal
blood-pumping operation in order to provide for more continuous
flow to/from the patient and through the heater. Some ways in which
the controller 49 may monitor and control the pumps, heaters, and
other components are discussed above as well as further below.
3.1.4. Exemplary Heat Exchanger Components
[0405] FIG. 13A shows greater detail of the heat exchanger 2541
shown in FIG. 25. In this embodiment, an upper heating plate 12 is
mounted in a door 18 located at the top of the base unit. A lower
heating plate 14 is located in the base unit 11 under the door 18.
The heat-exchanger bag 21, which is part of the disposable unit 16,
is placed on top of the lower heating plate 14, such that when the
door 18 is closed, the bag 21 rests between the two heating plates
12, 14. This arrangement generally permits more heat to be
transferred to the blood more quickly than a single-plate
arrangement would, although alternative embodiments may use a
single plate either above or below the heat-exchanger bag 21 and/or
may use other types of heating elements. The door 18 and/or the
upper plate 12 may include pneumatic sealing tracks to evacuate air
from the heat exchanger or produce a better coupling between the
upper plate 12 and the bag 21 (e.g., by producing a vacuum that
pulls the upper surface of the bag 21 into contact with the upper
plate 12.
[0406] Each of the heating plates 12, 14 may include a single
heating element or multiple heating elements. The heating elements
are typically (although not necessarily) electric heating elements.
FIG. 14 shows an exploded view of one exemplary heating element
configuration in which the upper heating plate 12 includes a single
heater element 141 and a platen 142 and the lower heating plate 14
includes a single heater element 143 and a platen 144. FIG. 18
shows an alternative heating element configuration in each of the
heating plates 12, 14 includes seven heating elements 182, 183,
184, 185. In practice, electricity passing through the heating
elements heats the heating elements, which in turn heat the
platens, which in turn conduct heat to the blood passing through
the heat-exchanger bag. It should be noted that heating elements
can be used without platens, although the platens tend to provide a
more even distribution of heat. In the embodiment shown in FIG. 18,
if one or even several of the heating elements fails, the heat
exchanger should still be able to perform at least some blood
heating, since the platens generally can still be heated with fewer
than all the heating elements working and still impart heat to the
blood passing through the heat-exchanger bag.
[0407] In order to improve thermal coupling between the heating
plates 12, 14 and the heat-exchanger bag, the door 18 may produce a
substantially air-tight seal when closed. Furthermore, air may be
evacuated from around the heat-exchanger bag to achieve better
thermal coupling between the bag and the plates. In this regard, a
compressor (not shown) that may be used to produce the positive
and/or negative pressures for the reservoirs 51, 52 may be used to
evacuate air from around the heat-exchanger bag. Cooling fins 131
or other elements may be provided to draw away excess heat.
[0408] The temperature inside the heat exchanger may be monitored
to ensure that the blood does not get so heated as to cause damage
to the blood. In the embodiment shown in FIG. 18, each heating
plate is provided with two temperature sensors 180, 181 located
near the outlet 27 at points near where the blood should be at its
hottest. Since the inlet 23 is near the outlet 27 (in this figure),
the blood flowing through the outlet may be a little cooler than
further upstream, because the cooler blood flowing into the inlet
can cool the warmer blood passing through the outlet nearby. Three
of the heating elements 182, 183, 184 are located towards the end
of the flow path in the heat-exchanger bag 21. Each temperature
sensor 180, 181 may be located between heating elements and near
the outlet 27, and the temperature sensors 180, 181 are preferably
spaced some distance apart with at least one heating element
located between them (in this embodiment, heating element 183).
Thus, as shown in FIG. 18, one sensor 181 is located between the
last two heating elements 183, 184 that the flow path crosses
before the blood exits the outlet 27. The other sensor 180 is
located upstream of both of these two heating elements 183, 184 and
between two heating elements 182, 183. If the two temperature
sensors 180, 181 are working properly and if the heat exchanger is
working properly, the two temperature sensors should have readings
within a certain number of degrees of each other (although they
would not typically have the exact same temperature reading). The
controller preferably receives temperature information from the two
temperature sensors 180, 181 and may generate an alarm, discontinue
operation, reduce power to the heating elements, and/or take other
action if either (or both) of the temperature sensors indicates an
unsafe temperature or if the difference in temperature readings
measured by the two sensors exceeds a predetermined limit. The
maximum temperature of the plates should not be allowed to exceed
the maximum allowable blood temperature, because otherwise, if the
flow of blood were to stop or slow, the blood could be
over-heated.
[0409] In certain embodiments, one or both of the heating plates
12, 14 may be translatable in a vertical direction when the door is
closed, e.g., to facilitate evacuation of air from the
heat-exchanger bag 21 during priming or to squeeze residual blood
out of the heat-exchanger bag 21 and back into the patient at the
end of the blood-heating procedure. The plates may additionally or
alternatively be tiltable so that the bag may be tilted, e.g., in
order to assist in removing air bubbles from the bag during priming
or to assist with returning blood to the patient. Such vertical
translation and/or tilting could be performed manually or could be
performed automatically, for example, under control of the
controller 49.
[0410] Thus, at the end of the blood-heating procedure, the
membranes in the pump pods 25a, 25b may be urged against the
pumping-chamber wall so as to minimize the volume of the pumping
chambers and expel as much blood as possible back toward the
patient. Furthermore, in embodiments that include vertically
translatable and/or tiltable plates, the heat-exchanger bag 21 may
be squeezed and/or tilted to direct as much blood as possible back
toward the patient.
3.1.5. Exemplary Manifold and Manifold Interface
[0411] FIGS. 49A and 49B respectively show a perspective back-side
view and a perspective bottom view of the manifold 130 from FIG. 2,
in accordance with an exemplary embodiment of the present
invention. FIG. 49A shows bag inlet and outlet connectors 2053,
2054 for connection at the inlet and outlet openings of the fluid
channel 150 of the bag 21. The bag inlet connector 2053 is in fluid
communication with the inlets 23a, 23b, while the bag outlet
connector 2054 is in fluid communication with the outlet 27. The
thermowells 133a and 133b are shown in the outlet fluid path and
the inlet fluid path, respectively. The pneumatic interfaces 139a,
139b that are used to provide pneumatic pressure from the base unit
11 to the pneumatic ports 138a, 138b are shown.
[0412] FIG. 13B shows a perspective back-side cross-sectional view
of the manifold 130 of FIGS. 2, 49A, and 49B, in accordance with an
exemplary embodiment of the present invention. In this embodiment,
the manifold 130 includes an inlet thermowell 133a located in a bag
inlet 23a and an outlet thermowell 133b located in a bag outlet 27.
The thermowells 133a, 133b interface with corresponding probes in a
manifold interface of the base unit 11 (discussed below) when the
disposable unit 16 is installed in the base unit 11. FIG. 13C shows
a close-up view of an exemplary thermowell.
[0413] The thermowells 133a, 133b provide for both thermal and
electrical interconnections between the base unit 11 and the
disposable unit 16. Among other things, such thermal and electrical
interconnections allow the controller 49 to monitor blood
temperature as the blood enters and exits the heat-exchanger bag 21
and also allow the controller 49 to take other measurements (e.g.,
to detect the presence of blood or air in the heat-exchanger bag 21
and to perform leak detection) as discussed below. In this
embodiment, each of the thermowells 133a, 133b is coupled so as to
have a portion residing directly in the fluid path (i.e., in
contact with the blood) so as to permit better transmission of
blood temperature from the disposable unit 16 to the base unit 11.
In lieu of, or in addition to, the thermowells, the disposable unit
16 may include other temperature probes/sensors and interfaces by
which the controller 49 can monitor blood temperature as the blood
enters and exits the heat-exchanger bag 21.
[0414] While the exemplary embodiment shown in FIGS. 13B, 49A, and
49B include thermal wells for transmitting thermal information to
the base unit 11 and optionally for use in conductivity sensing, it
should be noted that other types of sensor components may be
additionally or alternatively used. For example, rather than using
a thermal well, a sensor component that sends temperature
measurements or signals to the base unit 11 may be used. Various
types and configurations of sensors are described below.
[0415] Additionally, the manifold 130 includes various tube
supports to holds tubes extending from the pumps (items 25a, 25b in
FIG. 2) and the heat-exchanger bag (item 21 in FIG. 13A). These
tubes include the tubes leading from the outlets (items 37a, 37b in
FIG. 2) of the pumps into the inlets 23a, 23b of the heat-exchanger
bag. The outlet 27 of the heat-exchanger bag is also held by the
tube support. In a preferred embodiment, the tube support 130 also
holds tubes leading to the pneumatic ports (item 38 of FIG. 3) of
the pumps and provides the interface between pumps' pneumatic ports
and base unit's pneumatic actuation system (item 40 of FIG. 4). The
tubes from the pneumatic ports pass into the pneumatic passageways
138a, 138b in the tube support 130; the pneumatic passageways 138a,
138b are respectively in fluid communication with the pneumatic
interfaces 139a, 139b. The pneumatic interfaces 139a, 139b connect
to receptacles in the base unit, and the receptacles in turn
provide fluid communication with pneumatic actuation systems for
each of the pumps. This arrangement allows the disposable unit's
interface to the base unit to be manufactured more easily and eases
the installation of the disposable unit in the base unit. Instead
of manufacturing the pumps so that the pneumatic ports are properly
positioned with respect to each other for installation into the
base unit, the more compact tube support 130 holds the pneumatic
interfaces 139a, 139b in the proper position; the smaller size and
simpler structure of the tube support 130 makes it easier to
manufacture the pneumatic interfaces 139a, 139b with the desired
tolerances for installation into the base unit 11. The disposable
unit 16 may also include a data key or other feature for
interfacing with the base unit 11 in order to provide relevant
information to the base unit 11 (e.g., disposable unit serial
number and prior usage information) and/or store information
provided by the base unit 11 (e.g., usage information).
[0416] A similar arrangement may be used with disposable cassettes
that include pneumatically actuated pumps and/or valves. As
discussed above, if the number of pneumatically actuated pumps
and/or valves in a cassette is large enough, the cassette
containing these pumps and valves can become so large--and the
pressures involved can become so great--that it may become
difficult to properly seal and position all of the pumps and
valves. This difficulty may be alleviated by placing the valves and
pumps in a main cassette, from which connecting tubes lead from
pneumatic ports, so that pneumatic communication is provided
between valves and pumps in the main cassette and a smaller,
secondary tube-support cassette, which is provided with a pneumatic
interface for each of the tubes, as shown in FIG. 23. In this way,
the proper positioning and sealing of all the pneumatic interfaces
can be accomplished more easily with the smaller tube-support
cassette than it would be if the pneumatic actuation needed to be
applied to the larger main cassette directly. Additionally, or
alternatively, valves in the main cassette may be ganged to
together in some embodiments, so that several valves may be
actuated simultaneously through a single pneumatic interface on the
tube-support cassette and through a single connecting tube between
the pneumatic interface and the valves.
[0417] FIG. 26 shows a close-up view of the manifold interface 2500
shown in FIG. 25. The manifold interface 2500 includes, among other
things, probes 61, 62 and pneumatic ports 2539a, 2539b. With
reference again to FIG. 13B, it can be seen that the manifold 130
can be installed in the manifold interface 2500 such that the
probes 61, 62 interface respectively with the thermowells 133a,
133b and the pneumatic ports 2539a, 2539b interface respectively
with the pneumatic interfaces 139a, 139b. The manifold interface
2500 also includes a data key interface 2540 for interfacing with a
corresponding data key in the disposable unit. The data key
interface 2540 preferably provides a bi-directional communication
interface through which the controller 49 can read information from
the disposable unit (e.g., serial/model number, expiration date,
and prior usage information) and write information to the
disposable unit (e.g., usage information). In an exemplary
embodiment, the controller 49 may prevent the start of a treatment
if the data key is not present or if the disposable unit is
unusable, for example, because it includes an unacceptable
serial/model number, is past a pre-configured expiration date, or
has already been used. The controller 49 may terminate a treatment
if the data key is removed. In lieu of a data key interface 2540,
the base unit 11 or manifold interface 2500 may include other types
of interfaces for reading information from the disposable unit
and/or writing information to the disposable unit (e.g., RFID, bar
code reader, smart key interface).
[0418] It should be noted that one or more pumps (e.g., pump pods)
may be integral with a manifold such as the manifold 130 and placed
in a base unit as a single cartridge. The assembly could include
pneumatic connections from the pneumatic ports (which are connected
to the base unit) directly to the pump actuation chambers so that
no external tubing would be needed to make the pneumatic
connections to the pump pods. The assembly could additionally or
alternatively include fluidic connections (e.g., from the pump
outlets to the interface with the heat-exchanger bag) so that no
external tubing would be needed between the pump outlets and the
manifold or bag.
3.1.6. Exemplary Blood Heating Schematic
[0419] FIG. 6 is a schematic of the disposable unit 16 connections
in accordance with an exemplary embodiment of the present
invention. After the disposable unit 16 is primed, an inlet
catheter 67 and an outlet catheter 68 are inserted into a vein or
veins of a patient. Several patient-temperature probes 66 are
disposed in or on the patient; these probes 66 provide
patient-temperature information to the controller in order to
monitor possible overheating of the patient.
[0420] The action of the pump pods 25a, 25b--which are acted on by
the base unit's pneumatic actuation system (under control of the
controller 49) through pneumatic ports 38-raws the blood from the
inlet catheter 67 into the disposable unit's tubing. The pump pods'
inlet and outlet check valves 35, 36 ensure that the blood travels
in the correct direction through the disposable unit's tubing
(i.e., in a clockwise direction in the schematic shown in FIG. 6).
After exiting the pump pods 25a, 25b, the blood is pumped to the
heat-exchanger bag 21, which is preferably installed between two
heating plates in the base unit. Before the blood enters the
heating area, the temperature is measured via a bag-inlet
temperature sensor 61, which communicates inlet temperature
information to the controller 49. After being heated, the blood's
temperature is again measured via a bag-outlet temperature sensor
62, which also provides temperature information to the controller
49. The heated blood then flows through the air trap/filter 29 and
then to the patient through the return catheter 68.
[0421] The controller preferably uses a closed-loop control scheme
based on, among other things, patient temperature information
(e.g., received through the patient interface 2704), blood
temperature information (e.g., received via the thermal wells in
the manifold 130 and the corresponding sensors in the manifold
interface 2500), and pump status information (e.g., reservoir
pressure, actuation chamber pressure, end-of-stroke detection,
volumetric measurements, air detection, occlusion detection, leak
detection) to attain/maintain patient body temperature and ensure
that blood is not overheated locally (e.g., even if the patient
body temperature is at a safe level, it may be possible for the
blood to overheat in the heat-exchanger component, for example, if
the heat exchanger malfunctions or blood is not pumped at a
sufficient rate). Furthermore, the controller typically receives
multiple patient temperature inputs. The controller may adjust the
heat exchanger and/or pump operation dynamically based on patient
temperature information and blood temperature information.
[0422] The bag-inlet temperature sensor 61 and the bag-outlet
temperature sensor 62 may be mounted permanently in the base unit
11 adjacent where the inlet and outlet of the bags are located. In
order to improve thermal conductivity between the blood flowing
within the bag and the temperature sensors located outside of the
bag--and thereby improve the accuracy of the temperature
readings--the bag may be provided with metal thermowells which
extend into the flowpath of the blood at the bag's inlet and
outlet. When the bag is placed between the heating plates, the
thermowells can accommodate and receive the temperature sensors 61,
62 extending from the base unit 11. As discussed below, the metal
thermowells can also be used as electrical conductors and thus be
used to detect leaks or air in the bag 21.
[0423] In the system shown in FIG. 6, a prime line 2021 may be
provided to supply a priming fluid (e.g., water) to the pod pumps.
An air purge/sample port 2019 may also be provided to facilitate
air purging and also to allow for sampling of the blood being
returned to the patient. A blood monitoring interface may also be
provided, for example, including shunt sensor connections (mating
luer locks) 2020 and disposable H/S cuvette 2022 for a CDI.TM.
Blood Parameter Monitoring System 500 blood gas monitor sold by
Terumo Cardiovascular Systems, Corp.
[0424] In various alternative embodiments, the controller 49 may
detect abnormal conditions in the system based on several factors
including: (i) the difference in the bag-inlet and bag-outlet
temperatures measured respectively by the bag-inlet and bag-outlet
sensors 61, 62, (ii) the volumetric flow rate of blood through the
disposable unit 16, and (iii) the power being provided to the base
unit's heating plates. If each the pump pod 25a, 25b expels the
same, known volume of blood during each expel stroke, the
volumetric flow rate can be measured by simply measuring the rate
of expel strokes, and multiplying that rate by volume expelled per
stroke. (The flow rate can be determined in this way as long as
full pump strokes are being performed. As discussed above, the
controller in a preferred embodiment monitors whether full strokes
are being performed by dithering the valving mechanism and
analyzing the pressure information from the
actuation-chamber-pressure transducers.) The product of three
factors--the measured flow rate, the measured increase in blood
temperature, and the specific heat of the blood--should be
proportional to the power going into the heating plates. If this
proportion varies significantly during a procedure, the controller
preferably generates an alarm signal, which may be used to cause an
indication to a medical technician monitoring the procedure or
which may be used directly to stop the procedure.
[0425] Preferably, the controller generates two estimates based on
a given set of temperature and flow-rate measurements, with one
estimate based on all the uncertainties biased one way and the
other estimate based on all the uncertainties biased the other way.
The electrical power being consumed by the heating plates should
always be below one estimate and above the other estimate; if the
power measurement falls outside of this range, the controller will
preferably generate the alarm signal.
[0426] It should be noted that the system may include other types
of sensors and systems. For example, the system could provide
anticoagulant to the patient, particularly to allow for extended
treatments. The system could provide additional fluid to the
patient, and may include a hydration sensor to detect dehydration
of the patient, particularly due to the hyperthermic treatment. The
system could also include a hemolysis sensor to monitor for
excessive amounts of hemolysis. Some of this sensing may involve
conductivity sensing using the thermal wells/sensors or other
mechanisms.
3.1.7. Leak and Air Detection
[0427] In certain embodiments, detection of leaks in the
heat-exchanger bag 21 may be accomplished by measuring the
electrical conductivity between one or both of the thermowells
133a, 133b and one or both of the upper and lower heating plates
12, 14. As discussed above, the base unit 11 includes sensors 61,
62 that interface with the thermowells 133a, 133b for providing
electrical connectivity between the base unit 11 and the disposable
unit 16. The base unit 11 typically also includes electrical probes
connected to each of the heating plates 12, 14, which should also
be electrically conductive. If there is a leak, the electrical
conductivity between the thermowells and the heating plates should
increase substantially (because the fluid passing through the leak
is generally a much better conductor of electricity than the bag
material). Normally, the resistance between the electrical probe
contacting the thermowell and each of the electrical probes on the
heating plates should be quite high, because the plastic material
from which the bag is made is a relatively good insulator. However,
if there is a leak, the liquid (e.g., the blood) passing through
the leak in the bag provides a very good conductor of electricity,
so the resistance drops significantly when there is a leak. Thus,
the controller, which is in communication with these electrical
probes, measures the conductivity between the probes and generates
an alarm signal when the conductivity increases by a certain
amount.
[0428] Similarly, the metal thermowells can also be used to detect
air in the flow path in the bag. If there is air in the bag, the
resistance between the thermowells and the plates will increase,
because air is a poor conductor of electricity. Thus, if the
controller detects a decrease in the electrical conductivity
between the plates and the thermowells, and if the decrease is more
than a certain amount, the controller will preferably generate an
error signal and will preferably cause the procedure to stop.
[0429] Additionally or alternatively, the system could include
other types of sensors to detect leaks, e.g., a carbon dioxide
sensor for detecting blood leakage. A carbon dioxide sensor would
typically be placed in an appropriate location, such as proximate
to the fluidic paths through which blood passes, perhaps within a
partially or fully enclosed space (e.g., within the heat exchanger
with the door closed). The carbon dioxide detector could be
included in the base unit or otherwise in communication with the
base unit controller.
3.1.8. Patient Temperature Monitoring
[0430] In a blood-heating procedure, the temperature of the patient
must be closely monitored in order to prevent the patient from
overheating beyond a safe limit. In certain embodiments, at least
two separate temperature probes are located in the patient, e.g.,
one in the abdomen--either in the bladder or the rectum, in contact
with the bladder wall or the rectal wall--and the other through the
nasal passage, in contact with back wall of the nasal passage
(patient temperature can be monitored using a single probe or more
than two probes and can be monitored from other locations or
methods, e.g., by monitoring air expired by the patient). If both
sensors are properly positioned, the temperature readings of the
two probes should be within a certain range. If the temperature
readings from the two probes differ from each other too much, the
controller may generate an alarm signal and/or abort the procedure.
During the preparation for the blood-heating procedure, as the
probes are being inserted into the patient, the readings of the two
probes may be compared with each other and also compared normal
patient temperature readings; when the two probes fall within a
pre-set range of each other and within a range of normal patient
temperature readings, the medical personnel positioning the probes
will be able to tell when they have properly positioned the
probes.
[0431] During the blood-heating procedure, the method shown in FIG.
19 is preferably followed in order to ensure that the patient does
not get dangerously overheated. In step 90, temperature readings
from the abdominal and nasal probes are taken. In step 91, the
readings are compared with each other; if the readings fall outside
of a pre-set range, an alarm signal is generated indicating a fault
in the temperature readings. In step 92, the controller monitors
the temperature readings from one of the two probes and compares
those readings to a pre-set upper limit; if a reading is above this
pre-set upper limit, an alarm signal is generated indicating the
patient is getting too overheated.
[0432] As discussed above, the controller of the heat-exchanger
system may monitor patient body temperature using at least two
temperature probes. In actuality, the controller really only needs
temperature readings from a single temperature probe; the second
temperature probe essentially provides a control against which
readings from the first temperature probe can be compared. In
certain embodiments, then, a single temperature probe may be used
to provide patient temperature readings to the controller. In such
embodiments, an operator could independently monitor a second
temperature probe and manually abort the procedure if the two
temperature readings do not match sufficiently.
3.1.9. User Interface
[0433] FIG. 27 shows an exemplary user interface screen in
accordance with an exemplary embodiment of the present invention.
The right-hand side of the screen includes various therapy controls
including (from top to bottom) indicators for the various therapy
phases (i.e., system idle, pre-check, prime, warm-up, plateau,
cool-down, and end-therapy) for displaying the current phase of
treatment (in this example, "warm-up" is highlighted, indicating
that the therapy is currently in the warm-up phase), a phase
progress indicator for showing, e.g., the time remaining or time
elapsed in the current phase, and four control buttons through
which the operator can control the therapy (e.g., pause treatment,
stop treatment, start or re-start treatment, and step to the next
phase). It should be noted that these four control buttons prevent
an operator from stepping backward to a previous stage. The
left-hand side of the screen allows the operator to tab through
screens providing patient information, status information,
temperature graphs, flow graphs, and logs.
3.1.10 Alternative Heat-Exchanger Embodiments
[0434] In the embodiments described above, fluid is heated or
cooled by running the fluid through a heat-exchanger bag that is
placed between two plates of a heat exchanger. Of course, the
present invention is in no way limited to the use of a
heat-exchanger bag or plates. In alternative embodiments,
heat-exchanger bags may be used with other types of heat exchangers
(e.g., a heat-exchanger bag could be rolled up and placed in a
tubular chamber or could be placed in other types of heat
exchangers, such as an oven, refrigerator, water bath, or
radiator). Additionally or alternatively, other types of fluid
conduits (e.g., a length of tubing and/or a radiator) may be used
with one or more plates. The heat exchanger may include heating
and/or cooling capabilities. In fact, the heat-exchanger could
include both heating and cooling capabilities so that the
heat-exchanger system could be used for both heating and cooling
applications, either as part of the same treatment (e.g., so that
blood could be heated for hyperthermic treatment and quickly
returned to normal temperature following treatment) or as part of
separate treatments (e.g., the base unit could be used to provide
hyperthermic treatment to one patient and later to provide
hypothermic treatment to another patient).
[0435] In one particular alternative embodiment, the disposable
unit includes, or is configured to use, a length of tubing as the
heat-exchanger component. The length of tubing is preferably
thin-walled lay-flat tubing, although other types of tubing may be
used. The tubing is placed in the radiator, which may be part of
the disposable (e.g., the radiator may be attached to the manifold
so that the entire unit can be placed in a base unit), part of the
base unit (e.g., the radiator may be integral or attached to one of
the heat-exchanger plates), or a separate component that may be
disposable or reusable. In any case, the radiator preferably
includes a channel for receiving the length of tubing.
[0436] FIG. 75 shows a radiator 8000 in accordance with an
exemplary embodiment of the present invention. The radiator 8000
has a contiguous channel from a first opening 8001 to a second
opening 8002. The channel is configured to receive a length of
tubing 8006 (e.g., thin-walled lay-flat tubing) such that one end
of the tubing will protrude from the opening 8001 and the other end
of the tubing will protrude from the opening 8002, as shown in FIG.
76. The tubing may be placed in the radiator by the user
(particularly if the radiator is part of the base unit or is a
separate, reusable component) or may be provided already installed
in the radiator (particularly if the radiator is part of the
disposable unit). The radiator is generally made of a thermally
conductive material, such as a thermally conductive plastic or
metal. In an exemplary embodiment, the radiator 8000 may be
approximately six inches in diameter and approximately two inches
in height.
[0437] In this embodiment, the channel includes inner and outer
concentric loops (8003 and 8004, respectively) that are connected
via a serpentine section 8005. Among other things, this
configuration allows both of the openings 8001, 8002 to be
accessible along the outer edge of the radiator. Assuming the
opening 8001 (leading to the inner loop 8003) represents the fluid
inlet point and the opening 8002 (leading to the outer loop 8004)
represents the fluid outlet point, then the fluid will flow through
the tubing in the inner loop 8003 in a clockwise direction and will
flow through the tubing in the outer loop 8004 in a
counter-clockwise direction (using the orientation shown in FIG.
76). The serpentine section 8005 connects the two loops and
reverses the flow direction. It should be noted that the inner and
outer loops 8003, 8004 and the serpentine section 8005 are
configured to avoid sharp or abrupt fluid direction changes and
therefore avoid imparting excessive shear forces or turbulence on
the fluid. It should also be noted that the arrangement of tubing
(and particularly lay-flat tubing, which expands when carrying
pressurized fluid) and radiator should provide for efficient heat
exchange because of the close coupling of the tubing with the
radiator and because of the large surface areas involved.
[0438] As discussed above, the radiator 8000 could be provided as
part of the disposable unit or as a separate component, and in such
cases the radiator 8000 would generally be placed into an
appropriately configured heat exchanger of the base unit. For
example, the radiator 8000 could be placed between two plates of a
heat exchanger (similar to the way the heat-exchanger bag is placed
between two plates in various embodiments described above), in
which case the heat exchanger may be configured to accommodate the
radiator 8000, such as, for example, by having the two plates
farther apart and/or using a special door hinge to allow the upper
plate to lie flat against the top of the radiator. The bottom plate
could include guides (e.g., guides 8007 as shown in FIG. 77 in both
top view and front view) or a cylindrical wall (e.g., cylindrical
wall 8008 as shown in FIG. 78 in both top view and front view) to
facilitate placement of the radiator into the heat exchanger. Also
as discussed above, the radiator could be part of the base unit.
For example, the radiator 8000 could be integral to the bottom
plate 14, as shown in FIG. 79.
[0439] Alternatively, certain types of radiators may be used
without separate tubing, such that fluid is carried directly in the
channel of the radiator. Such radiators would typically be
disposable, although they could be reusable, for example, after
being rinsed and disinfected. FIG. 80 shows an enclosed radiator
8009, similar to the radiator 8000 described above, and including
two ports 8010, 8011 for accommodating fluid connections such as
tubing connections to a manifold or directly to one or more pumps.
As with the radiator 8000 described above, the radiator 8009 could
be part of the base unit, part of the disposable unit, or a
separate component.
[0440] It should be noted that these embodiments are exemplary and
are not intended to represent all of the types of heat-exchanger
components that can be used in heat-exchanger systems of the types
described herein.
3.2. Regional Hyperthermic Chemotherapy Treatment
[0441] FIG. 45 shows a representation of a regional hyperthermic
chemotherapy treatment system 2600 in accordance with an exemplary
embodiment of the present invention. The system 2600 is essentially
a smaller version of a heat-exchanger system of the types described
above in that it includes a base unit 2611 and a disposable unit
2601. Similar to the systems described above, the base unit 2611
includes a heat exchanger, a pneumatic control system, a
controller, and a built-in user interface screen 2606. The
disposable 2601 (e.g., a cassette) includes two pump pods 2625a and
2625b, a single inlet 2602, a single outlet 2603, and a drug
delivery interface 2604 (in this example, a syringe interface,
although other types of interfaces, such as a luer port or a spike,
may be included in alternative embodiments).
[0442] An exemplary embodiment of the system 2600 is designed to
circulate approximately 1-2 liters per minute with added medication
delivery, and also provide for draining. The system 2600 may be
used for regional or localized therapies, such as, for example,
filling a body cavity (e.g., upon removal of a tumor) with a
chemotherapy solution at elevated temperature for some period of
time, and then draining the cavity. The system 2600 may also be
used to locally circulate bodily fluid (e.g., blood) with added
medication, e.g., tourniquet a section of the body (e.g., a single
lung) and circulate fluid.
[0443] In a typical application, the pump inlet 2602 may be in
fluid communication with a fluid source (typically a separate
reservoir, although fluid could be drawn directly from the
patient), and the pump outlet 2603 may be in fluid communication
with the patient for delivering fluid from the fluid source to the
patient. A fluid source reservoir or a separate receptacle may
coupled so as to receive fluid drained from the patient. Thus, for
example, a reservoir may be used to provide source fluid and a
separate receptacle may be used to receive the drained fluid or the
same reservoir (which could be the patient) may be used both to
provide the source fluid and receive the drained fluid. The pump
can be any fluid pump, including but not limited to, a pod pump of
the types described herein, or any other type of diaphragm or other
fluid pump. As fluid is pumped to the patient, medications or other
fluids (e.g., one or more chemotherapy drugs) may be introduced
into the fluid through the drug delivery interface 2604, for
example, using an automatic syringe or any other automated or
manual drug delivery device.
[0444] During such pumping, the temperature of the fluid is
controlled and is maintained at a predetermined temperature (e.g.,
about 37.degree. C., or body temperature) during the entire
process. The temperature control can be accomplished by use of a
temperature sensor in conjunction with a heater. In certain
embodiments, the temperatures sensor may be any of the types
described herein. The temperature sensor can be located anywhere in
the fluid path, and in the preferred embodiment, is anywhere in the
fluid path outside of the patient. The fluid may be heated using
any method including, but not limited to, induction heating or
surface heating. The fluid may be heated in the reservoir or
somewhere else along the fluid path.
[0445] In one exemplary embodiment, the patient inlet may be
located in the patient's peritoneum. The fluid and drug may be
pumped into the patient until either a threshold fluid pressure has
been reached or until a threshold fluid volume has been pumped into
the patient, signifying completion of a fill stage. The fluid is
typically allowed to remain in the patient for a certain amount of
time, after which it is typically drained from the patient (e.g.,
by actuating a variable impedance on the patient outlet side).
Fill/drain cycles may be repeated a predetermined number of times
based on the patient's therapy needs.
[0446] In another exemplary embodiment, a portion of the patient
(e.g., a patient's limb) may be isolated, e.g., using a tourniquet
or pressure cuff. Bodily fluid (e.g., blood) mixed with medication
or other fluid may be circulated through the isolated area in a
manner similar to that described above. The fluid temperature may
be maintained using an in-line heater.
[0447] FIG. 84 shows a fluid circuit that may be used for providing
regional hyperthermic chemotherapy treatment, in accordance with an
exemplary embodiment of the present invention. A reservoir holds
fluid to be delivered to the patient. In this example, the fluid is
pumped through a heater and into the patient. In alternative
embodiments, the fluid may be heated in the reservoir and the
in-line heater may be omitted. In some embodiments, the fluid in
the reservoir may include medication, while in other embodiments,
fluid may be added via the pump or by other means (e.g., a separate
inlet into the fluid path. Fluid from the patient may be drained
back to the reservoir or to some other receptacle (or simply
discarded). The volume of fluid pumped and/or drained may be
monitored in the reservoir, e.g., using a capacitive level probe or
other sensor.
[0448] FIG. 85 shows another fluid circuit including a balancing
chamber that may be used for providing regional hyperthermic
chemotherapy treatment, in accordance with an exemplary embodiment
of the present invention. In this example, fluid is heated in the
reservoir, and the volume of fluid in the reservoir is monitored
using a capacitive level probe. Fluid is typically pumped to the
patient through the top balancing chamber by appropriate control
the valves, although fluid may be pumped directly to the patient
(i.e., bypassing the balancing chamber) by appropriate control of
the valves. Fluid drained from the patient flows through the bottom
balancing chamber back to the reservoir. The balancing chambers
help to maintain a constant volume of fluid into and out of the
patient.
[0449] FIG. 86 shows another fluid circuit including a balancing
chamber and a second pump that may be used for providing regional
hyperthermic chemotherapy treatment, in accordance with an
exemplary embodiment of the present invention. In this example, the
second pump is used to pump fluid from the top balancing chamber to
the patient, which also helps to drain fluid from the patient to
the bottom balancing chamber. As in previous embodiments, the fluid
may be heated in the reservoir or in the fluid path.
[0450] FIG. 87 shows a fluid circuit including a drain valve that
may be used for providing regional hyperthermic chemotherapy
treatment, in accordance with an exemplary embodiment of the
present invention. In this example, the drain valve may be
controlled to control the amount of fluid entering and leaving the
patient. For example, with the valve closed, fluid may be pumped
into the patient, e.g., to fill up a cavity of the patient. The
drain valve may be partially or fully opened to drain the fluid
from the patient or to allow for fluid circulation through the
patient.
4. Thermal/Conductivity Sensors
[0451] Various embodiments of thermal and/or conductivity sensors
are described. Such thermal/conductivity sensors can be used in a
wide variety of applications and are by no means limited to
thermal/conductivity measurements of fluids or to
thermal/conductivity measurements in the context of heat-exchanger
systems.
4.1. Thermal Wells
[0452] In one exemplary embodiment, a thermal well is used to
accommodate a temperature sensing probe. The thermal well comes
into direct contact with a subject media (e.g., a liquid such as
blood) and the sensing probe does not. Based on heat transfer
dictated in large part by the thermodynamic properties of the
thermal well and sensing probe construction, the sensing probe can
determine the properties of the subject media without coming into
direct contact with the subject media. The accuracy and efficiency
of the sensor apparatus arrangement depends on many factors
including, but not limited to: construction material and geometry
of both the probe and the thermal well.
[0453] Referring now to FIGS. 50A and 50B, two embodiments of the
sensor apparatus which includes the thermal well 5100 and the
sensing probe 5102, are shown in relation to a fluid line 5108. In
these embodiments, the thermal well 5100 is integrated into the
fluid line 5108. However, in other embodiment, some described
below, the thermal well 5100 is not completely integrated into the
fluid line 5108, i.e., the thermal well 5100 can be made from
different materials as compared with the fluid line 5108. In
alternate embodiments, the thermal well 5100 is not integrated into
any fluid line but can be integrated into anything or nothing at
all. For example, in some embodiments, the thermal well 5100 can be
integrated into a container, chamber, machine, protective sleeve,
fluid pump, pump cassette, disposable unit, manifold, or other
assembly, sub-assembly, or component. For purposes of the
description, an exemplary embodiment is described for illustrative
purposes. The exemplary embodiment includes the embodiment where
the thermal well 5100 is in a fluid line. However, the sensor
apparatus and the thermal well can be used outside of a fluid
line.
[0454] Referring now to FIG. 50A, a side view showing a thermal
well 5100 formed in a fluid line 5108 which provides the space 5104
for subject media to flow through, and a sensing probe 5102 is
shown. Data from the sensing probe is transmitted using at least
one lead 5106. An end view of FIG. 50A is shown in FIG. 50B.
[0455] In this embodiment, the thermal well 5100 is one piece with
the fluid line 5108. The total area of the thermal well 5100 can
vary. By varying the geometry of the thermal well 5100, the
variables, including, but not limited to, the thermal conductivity
characteristic of the thermal well 5100 and thus, the heat transfer
between the thermal well 5100 and the sensing probe 5102 will vary.
As described in more detail below, the material construction of the
thermal well 5100 is another variable in the sensor apparatus. In
some embodiments, the fluid line 5108 is made from a material
having a desired thermal conductivity. This material may vary
depending on the purpose. The material can be anything including,
but not limited to, any plastic, ceramic, metals or alloys of
metals or combinations thereof.
[0456] Referring now to FIGS. 51A and 51B, in these embodiments,
the fluid line 5108 and the thermal well 5100 are separate parts.
In some embodiments, the fluid line 5108 and the thermal well 5100
are made form different materials.
[0457] FIGS. 50A-50B and FIGS. 51A-51B show relatively simple
embodiments of the sensor apparatus. Thus, for these embodiments,
the sensing apparatus includes a thermal well 5100 and a sensing
probe 5102 where the thermal well either is integrated as one
continuous part with the fluid line 5108 or is a separate part from
the fluid line 5108. However, many embodiments of the sensor
apparatus are contemplated. Much of the various embodiments include
variations on the materials and the geometries of the thermal well
5100 and/or the sensing probe 5102. These variations are dictated
by multiple variables related to the intended use for the sensor
apparatus. Thus, the subject media and the constraints of the
desired sensor, for example, the accuracy, time for results and the
fluid flow and subject media characteristics are but a sampling of
the various constraints that dictate the embodiment used. In most
instances, each of the variables will affect at least one part of
the embodiment of the sensor apparatus.
[0458] Thus, multiple variables affect the various embodiments of
the sensor apparatus, these variables include but are not limited
to: 1) geometry of the thermal well; 2) material composition of the
thermal well; 3) material composition of the sensing probe; 4)
desired flow rate of the subject media; 5) length and width of the
thermal well; 6) desired accuracy of the sensing probe; 7) wall
thicknesses; 8) length and width of the sensing probe; 9) cost of
manufacture; 10) subject media composition and characteristics
including tolerance for turbulence; 11) geometry of sensing probe;
and 12) desired speed of readings.
[0459] In the foregoing, various embodiments of the sensor
apparatus are described. The description is intended to provide
information on the affect the variables have on the sensor
apparatus embodiment design. However, these are but exemplary
embodiments. Many additional embodiments are contemplated and can
be easily designed based on the intended use of the sensor
apparatus. Thus, by changing one or more of the above mentioned
partial list of variables, the embodiment of the sensor apparatus
may vary. Referring now to FIGS. 52A and 52B, two embodiments of
the thermal well 5100 are shown as different parts from the fluid
line 5108. These embodiments show two geometries of the thermal
well 5100. In FIG. 52A, the geometry includes a longer thermal well
5100. In FIG. 52B, the thermal well 5100 geometry is shorter. The
length and width of the thermal well 5100 produce varying
properties and accuracies of the thermal conductivity between the
thermal well 5100 and the sensing probe 5102. Depending on the use
of the sensor apparatus, the thermal well 5100 geometry is one
variable.
[0460] Referring now to FIG. 52A, the longer thermal well 5100
generally provides a greater isolation between the subject media
temperature in the fluid line 5104 and the ambient temperature.
Although the longer thermal well 5100 geometry shown in FIG. 52A
may be more accurate, the embodiment shown in FIG. 52B may be
accurate enough for the purpose at hand. Thus, the length and width
of the thermal well 5100 can be any length and width having the
desired or tolerable accuracy characteristics. It should be
understood that two extremes of length are shown in these
embodiments; however, any length is contemplated. The description
herein is meant to explain some of the effects of the
variables.
[0461] Still referring to FIGS. 52A and 52B, the longer thermal
well 5100 shown in FIG. 52A may impact the fluid flow of the
subject media in the fluid line 5108 to a greater degree than the
embodiment shown in FIG. 52B. It should be understood that the
length of the thermal well 5100 may also impact the turbulence of
the fluid flow. Thus, the length and width of the thermal well 5100
may be changed to have greater or lesser impact on the fluid flow
and turbulence of the fluid, while mitigating the other
variables.
[0462] The shape of the thermal well 5100 is also a variable. Any
shape desired is contemplated. However, the shape of the thermal
well 5100, as with the other variables, is determined in part based
on the intended use of the sensor apparatus. For purposes of
description, an exemplary embodiment is described herein. However,
the shape in the exemplary embodiment is not meant to be
limiting.
[0463] Referring now FIG. 53 for purposes of description, the
thermal well 5100 has been divided into 3 zones. The top zone 5402
communicates with the sensing probe (not shown); the middle zone
5404 provides the desired length of the thermal well 5100. As
described above, the length may dictate the level of protrusion
into the fluid path. The length is dictated in part by the desired
performance characteristics as discussed above. The middle zone
5404 also isolates the top zone 5402 from the ambient. The middle
zone 5404 may also serve to locate, fasten or seal the thermal well
5100 into the fluid line (shown as 5108 in FIGS. 50A-50B).
[0464] The bottom zone 5406, which in some embodiments may not be
necessary (see FIG. 56K) thus, in these embodiments, the middle
zone 5404 and the bottom zone 5406 may be a single zone. However,
in the exemplary embodiment, the bottom zone 5406 is shaped to aid
in press fitting the thermal well into an area in the fluid line
and may locate and/or fasten the thermal well 5100 into the fluid
line 5108. In other embodiments, zone 5406 may be formed to
facilitate various joining methods (see FIGS. 56A-56J, 56L-56S)
Referring now to FIG. 54 a cross section of the exemplary
embodiment of the thermal well 5100 is shown. The dimensions of the
exemplary embodiment of the thermal well 5100 include a length A of
approximately 0.113 inches (with a range from 0-0.379 inches), a
radius B of approximately 0.066 inches and a wall thickness C
ranging from approximately 0.003-0.009 inches. These dimensions are
given for purposes of an exemplary embodiment only. Depending on
the variables and the intended use of the sensing apparatus, the
thermal well 5100 dimensions may vary, and the various embodiments
are not necessarily proportional.
[0465] In some embodiments, the wall thickness can be variable,
i.e., the wall thickness varies in different locations of the
thermal well. Although these embodiments are shown with variable
thicknesses in various locations, this is for description purposes
only. Various embodiments of the thermal well may incorporate
varying wall thickness in response to variables, these varying wall
thicknesses can be "mixed and matched" depending on the desired
properties of the sensing apparatus. Thus, for example, in some
embodiments, a thinner zone 5404 may be used with thinner zone 5406
and vice-versa. Or, any other combination of "thinner" and
"thicker" may be used. Also, the terms used to describe the wall
thicknesses are relative. Any thickness desired is contemplated.
The figures shown are therefore for descriptive purposes and
represent two embodiments where many more are contemplated.
[0466] Referring now to FIGS. 55A and 55B, zone 5402 can be thicker
or thinner as desired. The thinner zone 5402, amongst other
variables, generally provides for a faster sensing time while a
thicker zone may be useful for harsh environments or where sensor
damping is desired. Zone 5404 may be thicker, amongst other
variables, for greater strength or thinner for, amongst other
variables, greater isolation from ambient. Zone 5406 can be thinner
or thicker depending on the fastening method used.
[0467] The thermal well 5100, in practice, can be embedded into a
fluid line 5108, as a separate part from the fluid line 5108. This
is shown and described above with respect to FIGS. 51A-51B. Various
embodiments may be used for embedding the thermal well 5100 into
the fluid line 5108. Although the preferred embodiments are
described here, any method or process for embedding a thermal well
5100 into a fluid line 5108 can be used. Referring now to FIGS.
56A-56S, various configurations for embedding the thermal well 5100
into the fluid line 5108 are shown. For these embodiments, the
thermal well 5100 can be made from any materials, including but not
limited to, plastic, metal, ceramic or a combination thereof. The
material may depend in some part on the compatibility with the
intended subject media. The fluid line 5108, in these embodiments,
may be made from plastic, metal, or any other material that is
compatible with the subject media.
[0468] Referring first to FIG. 56A, the thermal well 5100 is shown
press fit into the fluid line 5108 using the zone 5404 (shown in
FIG. 53). In FIG. 56B, the thermal well 5100 is shown press fit
into the fluid line 5108 using the zone 5406. Referring now to FIG.
56C, the thermal well 5100 is shown retained in the fluid line 5108
with flexible tabs 5704, an O-ring is also provided. Referring now
to FIG. 56D, the thermal well 5100 is shown inserted into the fluid
line 5108 with an O-ring 5702. The thermal well 5100 is also shown
as an alternate embodiment, where the thermal well 5100 zone 5406
includes an O-ring groove. The O-ring groove can be cut, formed,
spun, cast or injection molded into the thermal well, or formed
into the thermal well 5100 by any other method. FIG. 56E shows a
similar embodiment to that shown in FIG. 56D, however, the O-ring
groove is formed in zone 5406 rather than cut, molded or cast as
shown in FIG. 56D. Referring now to FIG. 56F, the thermal well 5100
is shown press fit into the fluid line 5108, zone 5406 includes
flexibility allowing the edge of zone 5406 to deform the material
of the fluid line 5108. Referring now to FIG. 56G, the thermal well
5100 includes cuts 5706 on the zone 5406 providing flexibility of
the zone 5406 for assembly with the fluid line 5108. An O-ring 5702
is also provided. Although two cuts are shown, a greater number or
less cuts are used in alternate embodiments.
[0469] Referring now to FIG. 56H, the embodiment shown in FIG. 56F
is shown with the addition of an O-ring 5702. Referring to FIG.
561, the thermal well 5100 is shown insert molded in the fluid line
5108. Zone 5406 is formed to facilitate or enable assembly by
insert molding.
[0470] FIG. 56J shows an embodiment where the thermal well 5100 is
heat staked 5708 to retain the thermal well 5100 in the fluid line
5108. In some embodiments of FIG. 56J, an O-ring 5710 is also
included. In this embodiment, the O-ring 5710 has a rectangular
cross section. However, in alternate embodiments, the O-ring may
have a round or X-shaped cross section. Likewise, in the various
embodiments described herein having an O-ring, the O-ring in those
embodiments can have a round, rectangular or X-shaped cross
section, or any cross sectional shape desired.
[0471] Referring now to FIG. 56K, the thermal well 5100 is retained
in the fluid line 5108 by adhesive 5712. The adhesive can be any
adhesive, but in one embodiment, the adhesive is a UV curing
adhesive. In alternate embodiments, the adhesive may be any
adhesive that is compatible with the subject media. In this
embodiment, the thermal well 5100 is shown without a zone 5406.
[0472] Referring now to FIG. 56L, thermal well 5100 is shown
ultrasonically welded in the fluid line 5108. The zone 5406 is
fabricated to enable joining by ultrasonic welding. Referring now
to FIG. 56M, a thermal well 5100 is shown insert molded in the
fluid line 5108. Zone 5406 is a flange for the plastic in the fluid
line 5108 to flow around. In the embodiment shown, the flange is
flat, however, in other embodiments; the flange may be bell shaped
or otherwise.
[0473] Referring now to FIG. 56N, the thermal well 5100 is shown
retained in the fluid line 5108 by a retaining plate 5714 and a
fastener 5716. O-ring 5702 is also shown. Referring now to FIGS.
560-56P, an end view is shown of a thermal well 5100 that is
retained in a fluid line 5108 by a retaining ring 5718 (FIG. 560)
or in an alternate embodiment, a clip 5720 (FIG. 56P). O-ring 5702
is also shown. Referring now to FIG. 56Q, the embodiment of FIG.
56C is shown with an alternate embodiment of the thermal well 5100.
In this embodiment of the thermal well 5100 the referred to as zone
5404 in FIG. 53 includes a taper that may allow for easier
alignment with a sensing probe, better isolation of zone 5402 from
the ambient and better flow characteristics in the fluid path. The
thermal well 5100 is shown retained in the fluid line 5108 using
flexible tabs 5704. An O-ring is also provided.
[0474] FIG. 56R shows the embodiment of FIG. 56J with an alternate
embodiment of the thermal well 5100. The thermal well 5100 shown in
this embodiment has a taper in zone 5404 that may allow for easier
alignment with a sensing probe, may allow better isolation of zone
5402 from the ambient and may allow better flow characteristics in
the fluid path. Zone 5402 provides a hemispherical contact for
effective thermal coupling with a thermal probe. The thermal well
5100 is heat staked 5708 to retain the thermal well 5100 in the
fluid line 5108. In some embodiments of FIG. 56R, an O-ring 5710 is
also included. In this embodiment, the O-ring 5710 has a
rectangular cross section. However, in alternate embodiments, the
O-ring can have a round or X-shaped cross section.
[0475] Referring now to FIG. 56S, the embodiment of FIG. 56H is
shown with an alternate embodiment of the thermal well 5100. FIG.
56S is shown with the addition of an O-ring 5702. In this
embodiment of the thermal well 5100 zone 5404 (as shown in FIG. 53)
has convolutions that may allow better isolation of zone 5402 from
the ambient. While several geometries have been shown for zone
5404, many others could be shown to achieve desired performance
characteristics.
4.2. Sensing Probes
[0476] Referring now to FIG. 57, a sectional view of an exemplary
embodiment of the sensing probe 5800 is shown. The housing 5804 is
a hollow structure that attaches to the tip 5802. The tip is made
of a highly thermally conductive material. The housing 5804, in the
exemplary embodiment, is made from a thermally insulative material.
In some embodiments, the housing is made of a thermally and
electrically insulative material. In the exemplary embodiment, the
housing 5804 is made of plastic which is a thermally insulative and
electrically insulative material. The tip 5802 either contacts the
subject media directly, or else is mated with a thermal well.
[0477] In the exemplary embodiment, the tip 5802 is attached to the
housing 5804 using a urethane resin or another thermal insulator in
between (area 5807) the tip 5802 and the housing 5804. Urethane
resin additionally adds structural support. In alternate
embodiments, other fabrication and joining methods can be used to
join the tip 5802 to the housing 5804.
[0478] The tip 5802 of the sensing probe 5800 is made of a
thermally conductive material. The better thermally conductive
materials, for example, copper, silver and steel, can be used,
however, depending on the desired use for the sensing probe and the
subject media; the materials may be selected to be durable and
compatible for the intended use. Additionally, factors such as cost
and ease of manufacture may dictate a different material selection.
In one exemplary embodiment, the tip 5802 is made from copper. In
other embodiments, the material can be an alloy of copper or
silver, or either solid or an alloy of any thermally conductive
material or element, including but not limited to metals and
ceramics. However, in the exemplary embodiments, the tip 5802 is
made from metal.
[0479] In the exemplary embodiment, the tip 5802 is shaped to
couple thermally with a thermal well as described in the exemplary
embodiment of the thermal well above. In the exemplary embodiment
as well as in other embodiments, the tip 5802 may be shaped to
insulate the thermal sensor 5808 from the ambient. In the exemplary
embodiment, the tip 5802 is made from metal.
[0480] In alternate embodiments a non-electrically conductive
material is used for the tip. These embodiments may be preferred
for use where it is necessary to electrically insulate the thermal
well from the probe. In another alternate embodiment, the tip 5802
may be made from any thermally conductive ceramic.
[0481] In the exemplary embodiment, the thermal sensor 5808 is
located in the housing and is attached to the interior of the tip
5802 with a thermally conductive epoxy 5812. In the exemplary
embodiment, the epoxy used is THERMALBOND, however, in other
embodiments; any thermal grade epoxy can be used. However, in
alternate embodiments, a thermal grease may be used. In alternate
embodiments, an epoxy or grease is not used.
[0482] The thermal sensor 5808, in the exemplary embodiment, is a
thermistor. The thermistor generally is a highly accurate
embodiment. However in alternate embodiments, the thermal sensor
5808 can be a thermocouple or any other temperature sensing device.
The choice of thermal sensor 5808 may again relate to the intended
use of the sensing apparatus.
[0483] Leads 5814 from the thermal sensor 5808 exit the back of the
housing 5804. These leads 5814 attach to other equipment used for
calculations. In the exemplary embodiment, a third lead 5816 from
the tip 5802 is also included. This third lead 5816 is attached to
the tip on a tab 5818. The third lead 5816 is attached to the tip
5802 because in this embodiment, the tip 5802 is metal and the
housing is plastic. In alternate embodiments, the housing 5804 is
metal, thus the third lead 5816 may be attached to the housing
5804. Thus, the tip 5802, in the exemplary embodiment, includes a
tab 5818 for attachment to a lead. However, in alternate
embodiments, and perhaps depending on the intended use of the
sensing apparatus, the third lead 5816 may not be included. Also,
in alternate embodiments where a third lead is not desired, the tip
5802 may not include the tab 5818. Referring now to FIG. 58, an
exploded view of the sensing probe 5800 is shown.
[0484] Referring now to FIG. 59 an alternate embodiment of the
exemplary embodiment is shown. In this embodiment, the tip 6002 of
the sensing probe is shown. The tip 6002 includes a zone 6004 that
will contact either a subject media to be tested or a thermal well.
A zone 6006 attaches to the sensor probe housing (not shown). An
interior area 6008 accommodates the thermal sensor (not shown). In
this embodiment, the tip 6002 is made from stainless steel.
However, in other embodiments, the tip 6002 can be made from any
thermally conductive material, including but not limited to: metals
(including copper, silver, steel and stainless steel), ceramics or
plastics.
[0485] In the exemplary embodiment, zone 6006 includes a tab 6010.
A third lead (as described with respect to FIG. 57, 5816) attaches
from the tab 6010. Referring next to FIGS. 60A and 60B, the sensing
probe 6000 is shown including the tip 6002 and the housing 6012. In
one embodiment, the housing 6012 is made from any thermally
insulative material, including but not limited to, plastic. In one
embodiment, the housing 6012 is press fit to the tip 6002, glued or
attached by any other method. In one embodiment, the thermal sensor
6014 is thermally coupled to the tip 6002 with thermal grade epoxy
or, in alternate embodiments, thermal grease 6022. Two leads 6016
from the thermal sensor 6014 extend to the distal end of the
housing. In some embodiments, a third lead 6018 is attached to the
tip 6002 from the tab 6010. As discussed above, in some embodiments
where the third lead is not desired, the tip 6002 does not include
a tab 6010.
[0486] Referring now to FIG. 60B, an alternate embodiment of the
sensing probe 6000 is shown. In this embodiment, the housing 6012
is a plastic molded over zone 6006 of the tip 6002 and the leads
6016, and in some embodiments, a third lead 6018.
[0487] Referring now to FIG. 61, a full side view of one embodiment
of the sensing probe 6000 shown in FIGS. 59-60B is shown. The
sensing probe 6000 includes a housing 6012, a tip 6002 and the
leads 6016, 6018. Flange 6020 is shown. In some embodiment, flange
6020 is used to mount and/or attachment to equipment.
[0488] Referring now to FIG. 62A, the sensing probe 6000 shown in
FIGS. 59-61, is shown coupled to a thermal well 5100 which is
fastened into a fluid line 5108. In the embodiment as shown, two
leads 6016 are shown at the distal end of the sensing probe 6000.
And, in some embodiments, a third lead 6018 is also incorporated
into the sensing probe 6000. FIG. 62B shows an alternate embodiment
where the sensing probe 6000 includes two leads 6016 but does not
include the third lead 6018.
[0489] Referring now to both FIGS. 62A and 62B, the tip 6002 of the
sensing probe 6000 is in direct contact with the thermal well 5100.
Referring back to FIG. 53 and still referring to FIG. 62A and 62B
the thermal well 5100 includes a zone 5402. The thermal well 5100
is hollow, and the inner part of zone 5402 is formed such that it
will be in mating contact with the sensing probe tip 6002. As shown
in this embodiment, the thermal well 5100 is designed to have a
mating geometry with the sensing probe 6000. Thus, the geometry of
the thermal well 5100 may depend on the geometry of the tip 6002 of
the sensing probe 6000 and vice-versa. In some embodiments, it may
be desirable that the sensing probe 6000 does not have a tight fit
or a perfect mate with the thermal well 5100.
[0490] Referring now to FIG. 63A, one embodiment of the sensing
probe 5800 (as shown in FIG. 57) is shown coupled to a thermal well
5100 which is fastened into a fluid line 5108. In the embodiment as
shown, two leads 5814 are shown at the distal end of the sensing
probe 5800. In some embodiments, a third lead 5816 is also
incorporated into the sensing probe 5800. FIG. 63B shows an
alternate embodiment where the sensing probe 5800 includes two
leads 5814 but does not include the third lead 5816.
[0491] Referring now to both FIGS. 63A and 63B, the tip 5802 of the
sensing probe 5800 is in direct contact with the thermal well 5100.
Referring back to FIG. 53 and still referring to FIGS. 63A and 63B,
the thermal well 5100 includes a zone 5402. The thermal well 5100
is hollow, and the inner part of zone 5402 is formed such that it
will be in mating contact with the sensing probe tip 5802. As shown
in this embodiment, the thermal well 5100 is designed to have a
mating geometry with the sensing probe 5800. Thus, the geometry of
the thermal well 5100 depends on the geometry of the tip 5802 of
the sensing probe 5800 and vice-versa.
4.3. Sensor Apparatus
[0492] For purposes of description of the sensor apparatus, the
sensor apparatus is described with respect to exemplary
embodiments. The exemplary embodiments are shown in FIGS. 62A, 62B,
and FIG. 64, with alternate exemplary embodiments in 63A and 63B.
In alternate embodiments of the sensor apparatus, the sensing probe
can be used outside of the thermal well. However, the sensor
apparatus has already been described herein alone. Thus, the
description that follows describes one embodiment of the exemplary
embodiment of the sensor apparatus which includes, for this
purpose, a sensing probe and a thermal well.
[0493] Referring now to FIG. 64, in an exemplary embodiment, the
sensing probe 6000 shown in FIG. 62A and the thermal well 5100 are
shown coupled and outside of a fluid line. As described above, the
thermal well 5100 can be in a fluid line, a protective sleeve, any
disposable, machine, chamber, cassette or container. However, for
purposes of this description of the exemplary embodiment, the
thermal well 5100 is taken to be anywhere where it is used to
determine thermal and/or conductive properties (FIG. 62A) of a
subject media.
[0494] A subject media is in contact with the outside of zone 5402
of the thermal well 5100. Thermal energy is transferred from the
subject media to the thermal well 5100 and further transferred to
the tip 6002 of the sensing probe 6000. Thermal energy is then
conducted to the thermal sensor 6014. The thermal sensor 6014
communicates via leads 6016 with equipment that can determine the
temperature of the subject media based on feedback of the thermal
sensor 6014. In embodiments where conductivity sensing is also
desired, lead 6018 communicates with equipment that can determine
the conductivity of the subject media. With respect to determining
the conductivity of the subject media, in addition to the lead
6018, a second electrical lead/contact (not shown) would also be
used. The second lead could be a second sensor apparatus as shown
in FIG. 64, or, alternatively, a second probe that is not
necessarily the same as the sensor apparatus shown in FIG. 64, but
rather, any probe or apparatus capable of sensing capacitance of
the subject media, including, an electrical contact.
[0495] Heat transfer from the tip 6002 to the thermal sensor 6014
may be improved by the use of a thermal epoxy or thermal grease
6022.
[0496] Referring now to FIGS. 63A and 63B, in the alternate
exemplary embodiment, whilst the sensing probe 5800 is coupled to
the thermal well 5100, the tip 5802, having the geometry shown,
forms an air gap 6402 between the inner zones 5404 and 5406 of the
thermal well 5100 and the tip 5802. The air gap 6402 provides an
insulative barrier so that only the top of the sensing tip of 5802
is in communication with the top zone 5402 of the thermal well
5100.
[0497] The sensing probe 5800 and thermal well 5100 are shown
coupled and outside of a fluid line. As described above, the
thermal well 5100 can be in a fluid line, a protective sleeve,
disposable unit, machine, non-disposable unit, chamber, cassette or
container. However, for purposes of this description of the
exemplary embodiment, the thermal well 5100 is taken to be anywhere
where it is used to determine thermal and/or conductive properties
(FIG. 63A) of a subject media.
[0498] A subject media is in contact with the outside of zone 5402
of the thermal well 5100. Thermal energy is transferred from the
subject media to the thermal well 5100 and further transferred to
the tip 5802 of the sensing probe 5800. Thermal energy is then
conducted to the thermal sensor 5808. The thermal sensor 5808
communicates via leads 5814 with equipment that can determine the
temperature of the subject media based on feedback of the thermal
sensor 5808. In embodiments where conductivity sensing is also
desired, lead 5816 communicates with equipment that can determine
the conductivity of the subject media. With respect to determining
the conductivity of the subject media, in addition to the lead
5816, a second electrical lead (not shown) would also be used. The
second lead could be a second sensor apparatus as shown in FIG.
63A, or, alternatively, a second probe that is not necessarily the
same as the sensor apparatus shown in FIG. 63A, but rather, any
probe or apparatus capable of sensing capacitance of the subject
media, including, an electrical contact.
[0499] Heat transfer from the tip 5802 to the thermal sensor 5808
can be improved by the use of a thermal epoxy or thermal grease
5812.
[0500] Referring now to FIG. 65, an alternate embodiment showing a
sensing probe 6602 coupled to a thermal well 5100 is shown. For
purposes of this description, any embodiment of the sensing probe
6602 and any embodiment of the thermal well 5100 can be used. In
this embodiment, to increase the thermal coupling between the tip
of the sensing probe 6602 and the thermal well 5100, thermal grease
6604 is present at the interface of the tip of the sensing probe
6602 and the inner zone 5402 of the thermal well 5100. In one
embodiment, the amount of thermal grease 6604 is a volume
sufficient to only be present in zone 5402. However, in alternate
embodiments, larger or smaller volumes of thermal grease can be
used.
4.4. Sensor Apparatus Systems
[0501] Referring now to FIG. 66, a sensor apparatus system is
shown. In the system, the sensor apparatus is shown in a device
containing a fluid line 5108. The sensor apparatus includes the
sensing probe 6000 and the thermal well 5100. In this embodiment,
the thermal well 5100 and fluid line 5108 is a disposable portion
and the sensing probe 6000 is a reusable portion. Also in the
reusable portion is a spring 6700. The spring 6700 and sensing
probe 6000 are located in a housing 6708. The housing 6708 can be
in any machine, container, device or otherwise. The spring 6700 can
be a conical, a coil spring, wave spring, or urethane spring.
[0502] In this embodiment, the thermal well 5100 and the sensing
probe 6000 may include alignment features 6702, 6704 that aid in
the thermal well 5100 and sensing probe 6000 being aligned. The
correct orientation of the thermal well 5100 and the sensing probe
6000 may aid in the mating of the thermal well 5100 and the sensing
probe 6000 to occur. The configuration of the space 6706 provides
the sensing probe 6000 with space for lateral movement. This allows
the sensing probe 6000 to, if necessary; move laterally in order to
align with the thermal well 5100 for mating.
[0503] The sensing probe 6000 is suspended by a spring 6700
supported by the flange 6020. The spring 6700 allow vertical
movement of the sensing probe 6000 when the thermal well 5100 mates
with the sensing probe 6000. The spring 6700 aids in establishing
full contact of the sensing probe 6000 and the thermal well 5100.
The fluid line 5108 can be in any machine, container, device or
otherwise. The fluid line 5108 contains a fluid path 5104. A
subject media flows through the fluid path 5104 and the thermal
well 5100, located in the fluid line 5108 such that the thermal
well 5100 has ample contact with the fluid path 5104 and can sense
the temperature properties and, in some embodiments, the conductive
properties of the subject media. The location of the thermal well
5100 in the fluid path 5104, as described in more detail above, may
be related to the desired accuracy, the subject media and other
considerations.
[0504] The spring 6700 and sensing probe 6000 assembly, together
with the space 6706 in the housing 6708 may aid in alignment for
the mating of the sensing probe 6000 and the thermal well 5100. The
mating provides the thermal contact so that the thermal well 5100
and the sensing probe 6000 are thermally coupled.
[0505] A wire 6710 is shown. The wire contains the leads. In some
embodiments, there are two leads. Some of these embodiments are
temperature sensing. In other embodiments, the wire contains three
or more leads. Some of these embodiments are for temperature and
conductivity sensing.
[0506] Referring now to FIG. 67, an alternate embodiment of the
system shown in FIG. 66 is shown. In this embodiment, the sensing
probe 6000 is suspended by a coil spring 6800. A retaining plate
6802 captures the coil spring 6800 to retain the spring 6800 and
sensing probe 6000. In one embodiment, the retaining plate 6802 is
attached to the housing 6708 using screws. However, in alternate
embodiments, the retaining plate 6802 is attached to the housing
6708 using any fastening method including but not limited to:
adhesive, flexible tabs, press fit, and ultrasonic welding.
Aligning features 6806 on the housing 6708 aid in alignment of the
sensing probe 6000 to a thermal well (not shown). Lateral movement
of the sensing probe 6000 is provided for by clearance in areas
6808 in the housing 6708. A wire 6710 is shown. The wire contains
the leads. In some embodiments, there are two leads. Some of these
embodiments are temperature sensing. In other embodiments, the wire
contains three or more leads. Some of these embodiments are for
temperature and conductivity sensing.
[0507] Referring now to FIG. 68, a sensing probe 6000 is shown in a
housing 6708. In these embodiments, an alternate embodiment of a
spring, a flexible member 6900, is integrated with the sensing
probe 6000 to allow vertical movement of the sensing probe 6000
within the housing 6708. A retaining plate 6902 captures the
flexible member 6900 to retain the flexible member 6900 and sensing
probe 6000. In one embodiment, the retaining plate 6902 is attached
to the housing 6708 using screws. However, in alternate
embodiments, the retaining plate 6902 is attached to the housing
6708 using any fastening method including but not limited to:
adhesive, flexible tabs, press fit, and ultrasonic welding. Lateral
movement of the sensing probe 6000 is provided for by clearance in
areas 6908 in the housing 6708. A wire 6710 is shown. The wire
contains the leads. In some embodiments, there are two leads. Some
of these embodiments are temperature sensing. In other embodiments,
the wire contains three or more leads. Some of these embodiments
are for temperature and conductivity sensing.
[0508] Referring now to FIG. 69, an alternate embodiment of a
sensing probe 6000 in a housing 7002 is shown. In this embodiment,
flexible member 7000 is attached or part of the housing 7002,
provides for vertical movement of the sensing probe 6000. In this
embodiment, the openings 7004, 7006 in housing 7002 are sized such
that the sensing probe 6000 experiences limited lateral movement.
Flexible member 7000 acts on the flange 7008 on the sensing probe
6000. A wire 6710 is shown. The wire contains the leads. In some
embodiments, there are two leads. Some of these embodiments are
temperature sensing. In other embodiments, the wire contains three
or more leads. Some of these embodiments are for temperature and
conductivity sensing.
[0509] The flange, as shown and described with respect to FIGS. 61,
66, 69, can be located in any area desired on the sensing probe
6000. In other embodiments, the sensing probe may be aligned and
positioned by other housing configurations. Thus, the embodiments
of the housing shown herein are only some embodiments of housings
in which the sensor apparatus can be used. The sensor apparatus
generally depends on being located amply with respect to the
subject media. The configurations that accomplish this can vary
depending on the subject media and the intended use of the sensing
apparatus. Further, in some embodiments where the thermal well is
not used, but rather, the sensing probe is used only, the housing
configurations may vary as well.
[0510] The sensing apparatus, in some embodiments, is used to sense
conductivity. In some embodiments, this is in addition to
temperature sensing. In those embodiments where both temperature
and conductivity sensing is desired, the sensing probe typically
includes at least three leads, where two of these leads may be used
for temperature sensing and the third used for conductivity
sensing.
[0511] Referring now to FIG. 70, for conductivity sensing, at least
two sensors 7102, 7104 are located in an area containing the
subject media. In the embodiment shown, the area containing the
subject media is a fluid path 5104 inside a fluid line 5108. The
conductivity sensors 7102, 7104 can be one of the various
embodiments of sensing probes as described above, or one of the
embodiments of the sensor apparatus embodiments (including the
thermal well) as described above. However, in other embodiments,
only one of the sensors is one of the embodiments of the sensor
apparatus or one of the embodiments of the sensing probe, and the
second sensor is any electrical sensor known in the art. Thus, in
the systems described herein, conductivity and temperature can be
sensed through using either one of the sensor apparatus or one of
the sensor probes as described herein and a second capacitance
sensor, or one of the sensor apparatus or one of the sensor probes
as described herein and an electrical sensor.
[0512] Referring now to FIG. 71, an alternate embodiment of a
sensor apparatus including a sensing probe 7200 and a thermal well
5100 is shown in a fluid line 5108. In this embodiment, the sensing
probe 7200 is constructed of a metal housing. The thermal well 5100
is also constructed of metal. The thermal well 5100 and the sensing
probe 7200 can be made from the same metal or a different metal.
The metal, in the preferred embodiment, is a conductive metal,
which may include stainless steel, steel, copper and silver. A lead
7202 is attached to the sensing probe 7200 housing for conductivity
sensing. The thermal sensing leads 7204 are attached to a thermal
sensor located inside the sensing probe 7200 housing. In this
embodiment, therefore, the third lead 7202 (or the lead for
conductivity sensing) can be attached anywhere on the sensing probe
7200 because the sensing probe 7200 is constructed of metal. In the
previously described embodiments, where the sensing probe housing
was constructed of plastic, and the sensing tip constructed of
metal, the third lead for conductivity sensing was attached to the
sensing tip.
[0513] A known volume of subject media may be used to determine
conductivity. Thus, two sensors may be used and the volume of fluid
between the two sensors can be determined. Conductivity sensing is
done with the two electrical contacts (as described above), where
one or both can be the sensor apparatus. The volume of subject
media between the two contacts is known.
[0514] Conductivity sensing is done by determining the conductivity
from each of the sensors and then determining the difference. If
the difference is above a predetermined threshold, indicating an
abnormal difference in conductivity between the first and second
sensor (the designations "first" and "second" being arbitrary),
then it can be inferred that air may be trapped in the subject
media and a bubble detection alarm may be generated to indicate a
bubble. Thus, if there is a large decrease in conductivity (and
likewise, a large increase in resistance) between the first and
second sensor, air could be trapped and bubble presence may be
detected.
[0515] Leaks in a machine, system, device or container may be
determined using the conductivity sensing. Where a sensing
apparatus is in a machine, device or system, and that sensing
apparatus senses conductivity, in one embodiment, a lead from the
sensor apparatus (or electrical contacts) to an analyzer or
computer machine may be present. In some embodiments, the analyzer
that analyzes the electrical signals between the contacts is
connected to the metal of the machine, device, system or container.
If the analyzer senses an electrical signal from the machine, then
a fluid leak may be inferred.
[0516] For the various embodiments described herein, a fluid line
can be made of any material including metal and plastic. In most
embodiments, the fluid line is compatible with the subject media
and has the desired characteristics depending on the configuration
of the thermal well in the fluid line. The fluid line can be part
of a disposable unit that attaches to the sensor apparatus. In some
of these embodiments, the fluid line includes the thermal well. The
subject media is located inside the fluid line and the sensing
probe provides sensing data regarding the subject media once the
sensing probe and thermal well are amply mated.
[0517] The fluid line can be a chamber, a hose, a fluid path or
other space or conduit for holding a volume of subject media. In
some embodiments, the fluid line is a designed to hold fluid having
a flow rate. In other embodiments, the space is designed to hold
mostly stagnant media or media held in the conduit even if the
media has flow.
[0518] In some embodiments, the sensor apparatus may be used based
on a need to separate the subject media from the sensing probe.
However, in other embodiments, the sensing probe is used for
temperature and/or conductivity sensing directly with subject
media.
[0519] In some embodiments, the thermal well may be part of a
disposable portion of a device, machine, system or container. Thus,
the thermal well may be in direct contact with subject media and
may be the only component that is contaminated by same. In these
embodiments, the sensing probe may be part of a machine, device,
system or container, and be disposable or non-disposable.
5. Conclusion
[0520] Various types and configurations of pump pods,
heat-exchanger systems, and thermal/conductivity sensors are
described above. It should be noted that a wide variety of
embodiments can be produced from various combinations of
components. For example, certain heat-exchanger systems may be
configured without pump pods or thermal/conductivity sensors, may
be configured with pump pods but not thermal/conductivity sensors,
or may be configured with thermal/conductivity sensors but not pump
pods. Pump pods can be used in a wide variety of applications and
are by no means limited to use in heat-exchanger systems or for
pumping of bodily fluids or medical fluids. Thermal/conductivity
sensors can be used in a wide variety of applications and are by no
means limited to thermal/conductivity measurements of fluids or to
thermal/conductivity measurements in the context of heat-exchanger
systems.
[0521] Various embodiments are described above with reference to
pneumatic actuation systems, specifically for operating pod pumps.
It should be noted, however, that pod pumps can be operated using
other types of control fluids, such as, for example, hydraulic
fluids, in which case the actuation system would typically include
an appropriate control fluid delivery system for delivering control
fluid under positive and/or negative pressures. Thus, for example,
a heat-exchanger system could include a hydraulic actuation system
rather than a pneumatic actuation system, in which case pressurized
hydraulic fluid could be stored in one or more reservoirs or be
provided using other pressurizing means (e.g., a hydraulic fluid
pump).
[0522] Although the above discussion discloses various exemplary
embodiments of the invention, it should be apparent that those
skilled in the art can make various modifications that will achieve
some of the advantages of the invention without departing from the
true scope of the invention.
* * * * *