U.S. patent application number 15/276893 was filed with the patent office on 2017-03-23 for air trap for intravenous pump.
The applicant listed for this patent is Q-CORE MEDICAL LTD.. Invention is credited to Boaz Eitan, Shaul Eitan, Omer Havron, Shachar Rotem.
Application Number | 20170080146 15/276893 |
Document ID | / |
Family ID | 44799102 |
Filed Date | 2017-03-23 |
United States Patent
Application |
20170080146 |
Kind Code |
A1 |
Rotem; Shachar ; et
al. |
March 23, 2017 |
AIR TRAP FOR INTRAVENOUS PUMP
Abstract
An intravenous pump system includes an intravenous pump having
an air bubble detector, a separate air trap module and a patient
line. The air trap module is connectable to a set interface upon
which the pump can operate. The air trap module includes an air
chamber capable of receiving fluids and air, a plurality of valves
controlling the flow of the fluids and air, and an air vent. The
patient line is connectable to the air trap module and to a
patient. The air trap module includes an actuator to control the
state of the valves to enable, at least during a venting mode, the
pump to push air out of the air chamber via the vent without
disconnecting the patient from the patient line.
Inventors: |
Rotem; Shachar; (Kibbutz
Metzer, IL) ; Eitan; Boaz; (Hofit, IL) ;
Eitan; Shaul; (Hofit, IL) ; Havron; Omer; (Tel
Aviv, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Q-CORE MEDICAL LTD. |
Netanya |
|
IL |
|
|
Family ID: |
44799102 |
Appl. No.: |
15/276893 |
Filed: |
September 27, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13640519 |
Jan 15, 2013 |
9457158 |
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PCT/IB2011/051586 |
Apr 12, 2011 |
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15276893 |
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61282858 |
Apr 12, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/36 20130101; A61M
5/1413 20130101; A61M 2205/6054 20130101; A61M 5/142 20130101; A61M
5/365 20130101 |
International
Class: |
A61M 5/142 20060101
A61M005/142; A61M 5/14 20060101 A61M005/14; A61M 5/36 20060101
A61M005/36 |
Claims
1. An intravenous system comprising: a set interface configured to
be mounted upon an intravenous pump such that a pumping action of
said intravenous pump acts upon fluid contained within said set
interface, pumping the fluid from an input of said set interface to
an output of said set interface; a separate air trap connectable to
said set interface, said air trap comprising: (a) an air chamber
capable of receiving fluids and air, (b) a supply connection to
receive a supply line, (c) a set interface connection connectable
to the input of said set interface and configured to facilitate
transfer of fluid from said air trap to said set interface, (d) an
air vent, (e) a lower valve configured to control flow of fluid
from said air chamber to said input of said set interface through
said set interface connection, (f) a bypass line connecting said
supply connection to said set interface connection, bypassing said
air chamber, and (g) a bypass valve configured to control flow of
fluid through said bypass line; a return line connecting the output
of said set interface to said air chamber and to an outgoing
patient line and including one or more return valves configured to
control flow of fluid from the output of said set interface to
either flow: (i) into said air chamber, or (ii) into an outgoing
patient line, based on a state of said return valves; and actuators
to control a state of said valves to enable: (i) a venting mode in
which said return valves direct fluid from the output of said set
interface to said air chamber, said lower valve prevents flow of
fluid from said air chamber to said input of said set interface and
said bypass valve directs fluid to flow through said bypass line;
and (ii) a treatment mode in which said return valves direct fluid
from the output of said set interface to the outgoing patient line
said lower valve directs flow of fluid from said air chamber to
said input of said set interface and said bypass valve prevents
flow of fluid through said bypass line.
2. The system according to claim 1, further comprising a venting
valve adapted to control flow of air out of said air chamber.
3. The system according to claim 2, wherein said venting valve
includes a syringe connection adapted to facilitate an airtight
connection between said air chamber and a syringe when said venting
valve is open.
4. The system according to claim 1, further comprising a supply
valve configured to control flow of fluid from said supply
connection into said air chamber and wherein said actuators control
said supply valve to: (1) direct fluid from said supply connection
to said air chamber in the treatment mode and (2) prevent flow of
fluid from said supply connection to said air chamber in the
venting mode.
5. The system according to claim 3, wherein said actuators are
further adapted to open said venting valve during the venting
mode.
6. The system according to claim 1, further comprising an upper
valve configured to control flow of fluid from an upper portion of
said air chamber to said input of said set interface through said
set interface connection and wherein said actuators are further
adapted to control all of said valves to enable a priming state
wherein said upper fluid valve, near the top of said air chamber,
is open.
7. The system according to claim 3, wherein said actuators are
further adapted to open all of said valves during a sterilization
mode.
8. The system according to claim 1, further comprising a controller
and wherein said actuators comprise one or more electro mechanical
actuators controlled by said controller.
9. The system according to claim 8, wherein said controller causes
said actuators to change between modes based on signals received
from a bubble detector.
10. The system according to claim 1 including: a venting valve to
control the flow of air out of said air chamber; a patient valve
controlling flow into said patient line; and an upper fluid valve,
near the top of said air chamber.
11. An airtrap for an intravenous system, said airtrap comprising:
an air chamber capable of receiving fluids and air; a supply
connection to receive a supply line; a set interface connection
connectable to an input of a set interface, the set interface being
configured to connect to an intravenous pump such that the pump
applies a pumping action to the set interface, wherein the pumping
action pumps fluid from the input of the set interface to an output
of the set interface; an air vent; a lower valve configured to
control flow of fluid from said air chamber to said input of said
set interface through said set interface connection; a bypass line
connecting said supply connection to said set interface connection,
bypassing said air chamber; a bypass valve configured to control
flow of fluid through said bypass line; a return line connecting
the output of said set interface to said air chamber and to an
outgoing patient line and including one or more return valves
configured to control flow of fluid from the output of said set
interface to either flow: (i) into said air chamber, or (ii) into
an outgoing patient line, based on a state of said return valves;
and actuators to control a state of said valves to enable: (i) a
venting mode in which said return valves direct fluid from the
output of said set interface to said air chamber, said lower valve
prevents flow of fluid from said air chamber to the input of the
set interface and said bypass valve directs fluid to flow through
said bypass line; and (ii) a treatment mode in which said return
valves direct fluid from the output of said set interface to the
outgoing patient line said lower valve directs flow of fluid from
said air chamber to the input of the set interface and said bypass
valve prevents flow of fluid through said bypass line.
12. The airtrap according to claim 11, wherein said air chamber
holds 2-4 ml.
13. The airtrap according to claim 11, further comprising a venting
valve adapted to control flow of air out of said air chamber.
14. The airtrap according to claim 13, wherein said venting valve
includes a syringe connection adapted to facilitate an airtight
connection between said air chamber and a syringe when said venting
valve is open.
15. The airtrap according to claim 11, further comprising a supply
valve configured to control flow of fluid from said supply
connection into said air chamber and said actuators control said
supply valve to: (1) direct fluid from said supply connection to
said air chamber in the treatment mode and (2) prevent flow of
fluid from said supply connection to said air chamber in the
venting mode.
16. The airtrap according to claim 13, wherein said actuators are
further adapted to open said venting valve during the venting
mode.
17. The airtrap according to claim 14, wherein said actuators are
further adapted to open all of said valves during a sterilization
mode.
18. An airtrap for an intravenous system, said airtrap comprising:
an air chamber capable of receiving fluids and air; a supply
connection to receive a supply line; a set interface connection
connectable to an input of a set interface, the set interface being
configured to connect to an intravenous pump such that the pump
applies a pumping action to the set interface and the pumping
action pumps fluid from the input of the set interface to an output
of the set interface; an air vent; a lower valve configured to
control flow of fluid from said air chamber to the input of the set
interface through said set interface connection; a bypass line
connecting said supply connection to said set interface connection,
bypassing said air chamber; a bypass valve configured to control
flow of fluid through said bypass line; a return line connecting
the output of the set interface to said air chamber and to an
outgoing patient line and including one or more return valves
configured to control flow of fluid from the output of the set
interface to either flow: (i) into said air chamber, or (ii) into
an outgoing patient line, based on a state of said return valves;
and actuators to control a state of said valves.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a Continuation Application of
U.S. patent application Ser. No. 13/640,519, filed on Jan. 15,
2013, which '519 application is a National Stage Application of PCT
Application No. PCT/IB2011/051586, filed Apr. 12, 2011, which
claims priority from U.S. Provisional Application No. 61/282,858,
filed on Apr. 12, 2010. Each of the aforementioned applications is
hereby incorporated into this application by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to infusion pumps for medical
treatments generally and to handling of air and air in the pump
system in particular.
BACKGROUND OF THE INVENTION
[0003] An intravenous (IV) system typically includes a bag holding
the fluids to be infused, tubes connecting the bag to the patient
and a pump to regulate the flow of fluids into the patient. Such
pumps are utilized for providing many types of fluid, chemotherapy
being but one example.
[0004] The chemicals for chemotherapy are typically very expensive
and very toxic. This requires that minimal amounts of the chemicals
be wasted and that the medical staff, who are generally healthy,
not be exposed to the toxic drugs. Unfortunately, current pump
technology does not ensure this.
[0005] The problem is that the toxic fluids generate air as they
move through the IV tubes and only a small amount of air may be
introduced into a patient's bloodstream. Current pumps have an air
bubble detector, to detect the presence of air (as an air bubble)
and to stop the operation of the pump as a result of a small amount
of air (for example, 1 ml) passing to the patient within a
pre-defined period of time (such as 15 min) or single bubbles that
are more than a pre-determined size (0.2 ml as an example). The
pump then alerts the medical staff, which detaches the tubes,
refills them with fluid (usually by spilling some of the fluid into
a container of some kind) removing the air bubbles in the process
and restarts the pump. Unfortunately, patients receiving
chemotherapy are very sensitive to contamination, which may happen
when the tubes are detached.
[0006] Moreover, this procedure can expose the medical staff to the
toxic fluids and air and it spills the expensive drugs. Moreover,
detaching the tubes exposes them and can lead to contamination of
the patient. Another issue is that the air bubbles tend to stop
treatment in short intervals.
[0007] The following patent publications discuss various attempts
to solve these problems, including adding traps for air in the pump
and after the pump: U.S. Pat. No. 7,131,966 to Tamari, U.S. Pat.
No. 4,954,256 to Degen et al, US 2002/0056675 to Hegde, U.S. Pat.
No. 6,280,408 to Sipin, U.S. Pat. No. 5,308,333 to Skakoon, U.S.
Pat. No. 7,048,720 to Thome, Jr. et al and U.S. Pat. No. 4,927,411
to Pastrone et al.
SUMMARY OF THE PRESENT INVENTION
[0008] There is therefore provided, in accordance with a preferred
embodiment of the present invention, an intravenous pump system
including an intravenous pump having an air bubble detector; a
separate air trap module and a patient line. The air trap module is
connectable to a set interface which is operatable upon by the
intravenous pump. The air trap module includes an air chamber
capable of receiving fluids and air, a plurality of valves
controlling the flow of the fluids and air, and an air vent. The
patient line is connectable to the air trap module and to a
patient. The air trap module includes an actuator to control the
state of the valves to enable, at least during a venting mode, the
pump to push air out of the air chamber via the vent without
disconnecting the patient from the patient line.
[0009] There is also provided, in accordance with a preferred
embodiment of the present invention, an intravenous line including
an air trap module at least connectable to a source of intravenous
fluid, a set interface connectable to the air trap module and
operatable upon by an intravenous pump, a return line connectable
to the set interface and to the air trap module and a patient line
connectable to the air trap module and to a patient.
[0010] Moreover, in accordance with a preferred embodiment of the
present invention, the system includes a return line connectable to
the set interface and to the air trap module.
[0011] Further, in accordance with a preferred embodiment of the
present invention, at least during the venting mode, the pump pumps
fluid through the return line and back into the air chamber.
[0012] Still further, in accordance with a preferred embodiment of
the present invention, the valves include a venting valve at least
to control the flow of air out of the air chamber, a patient valve
controlling the patient line and a lower valve at least to control
the flow of fluid from the air chamber to the set interface.
[0013] Moreover, in accordance with a preferred embodiment of the
present invention, the venting valve is located generally at the
top of the air trap module.
[0014] Additionally, in accordance with a preferred embodiment of
the present invention, the air trap module includes a bypass path
to pass incoming fluid to the set interface to be pumped into the
air chamber via the return line when the venting valve is open.
[0015] Further, in accordance with a preferred embodiment of the
present invention, the air chamber holds 2-4 ml.
[0016] Still further, in accordance with a preferred embodiment of
the present invention, the actuator includes a unit to change the
valves among a plurality of states.
[0017] Moreover, in accordance with a preferred embodiment of the
present invention, one of the states is a treatment state during
which at least the patient line valve is open, the venting valve is
shut and the bypass path is closed. Another state is a priming
state wherein the patient line valve is open, the venting valve is
shut, the bypass path is closed and an upper fluid valve, near the
top of the air chamber, is open. There may also be a sterilization
state wherein all the valves are open.
[0018] Further, in accordance with a preferred embodiment of the
present invention, the actuator may be either a manual dial or one
or more electro mechanical actuators. For example, the electro
mechanical actuators are controllable by the pump.
[0019] Still further, in accordance with a preferred embodiment of
the present invention, the air detector of the pump detects the
presence of air and controls the valves to change among treatment,
venting and priming states accordingly.
[0020] Moreover, in accordance with a preferred embodiment of the
present invention, there may be a unit to connect the air trap
module upstream of the pump.
[0021] Alternatively, in accordance with a preferred embodiment of
the present invention, the valves may alternatively include a
venting valve at least to control the flow of air out of the air
chamber, a patient valve controlling the patient line, an upper
fluid valve, near the top of the air chamber, and a lower valve at
least to control the flow of fluid from the air chamber to the set
interface.
[0022] Further, in accordance with a preferred embodiment of the
present invention, in the treatment state the patient and the lower
valves are open and the venting and the upper valves are shut. In
the priming state, the patient and upper valves are open and the
venting and lower valves are shut. In the venting state, the
patient and lower valves are closed and the venting and upper
valves are open.
[0023] Still further, in accordance with a preferred embodiment of
the present invention, the manual dial includes an actuator locking
mechanism to lock the actuator between states.
[0024] Moreover, in accordance with a preferred embodiment of the
present invention, the venting valve includes a buoy valve at least
to keep fluid from exiting through the vent. The vent can be a
swabbable valve connector.
[0025] Additionally, in accordance with a preferred embodiment of
the present invention, the air chamber includes unit for indicating
fluid/air level.
[0026] Further, in accordance with a preferred embodiment of the
present invention, the air trap module includes a positioning
connector to connect the air trap module in a predefined position
relative to the pump. For example, the positioning connector can
include an identifier to be sensed by the pump.
[0027] Moreover, in accordance with a preferred embodiment of the
present invention, the line can include a unit to connect the air
trap module upstream of the pump.
[0028] There is also provided, in accordance with a preferred
embodiment of the present invention, a method for an intravenous
pump. The method includes during venting of an air trap module,
pumping a pre-defined volume downstream of the pump.
[0029] Moreover, in accordance with a preferred embodiment of the
present invention, the pre-defined volume is a function of the
volume of an air trap chamber forming part of the air trap
module.
[0030] Further, in accordance with a preferred embodiment of the
present invention, the method includes receiving input of the
volume of a receiving collecting unit and determining when the
collecting volume is at least close to filled as a function of
multiple pumping cycles of the pre-determined volume.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The subject matter regarded as the invention is particularly
pointed out and distinctly claimed in the concluding portion of the
specification. The invention, however, both as to organization and
method of operation, together with objects, features, and
advantages thereof, may best be understood by reference to the
following detailed description when read with the accompanying
drawings in which:
[0032] FIGS. 1 A, 1 B and 1 C are schematic illustrations of three
operational modes of an infusion pump with a connectable air trap
module, constructed and operative in accordance with a preferred
embodiment of the present invention. FIG. 1D is a schematic
illustration of an operational mode of an infusion pump with a
connectable air trap module, constructed and operative in
accordance with an embodiment of the present invention;
[0033] FIGS. 2A, 2B and 2C are schematic illustrations of three
operational modes of an infusion pump with an alternative
connectable air trap module, constructed and operative in
accordance with an alternative, preferred embodiment of the present
invention. FIG. 2D is a schematic illustration of an operational
mode of an infusion pump with a connectable air trap module,
constructed and operative in accordance with an embodiment of the
present invention;
[0034] FIGS. 3A and 3B are isometric illustrations of an exemplary
embodiment of air trap module of FIG. 1 connected to a pump;
[0035] FIGS. 4A and 4B are isometric illustrations of the air trap
module of FIG. 3 with a dial knob actuator in the front and an air
trap chamber in the back;
[0036] FIG. 5 is a back view illustration of the air chamber of
FIG. 4B indicating the locations of the various valves in air trap
module;
[0037] FIG. 6A is an exploded view of the elements of the air trap
module of FIG. 3;
[0038] FIG. 6B is an isometric illustration of the some of the
inner elements of FIG. 6A combined together;
[0039] FIG. 6C is a sectional view of the module of FIG. 6A (not
exploded);
[0040] FIGS. 7 A and 7B are schematic cross sectional illustrations
of a typical valve in the air trap module of FIG. 3, detailing the
disengagement (open) and engagement (close) of a typical valve
spool, respectively;
[0041] FIG. 8 is an isometric illustration of an undulating
underside of a dial of the air trap module of FIG. 3;
[0042] FIGS. 9A, 9B, 9C and 9D are schematic illustrations of the
fluid flow for each of a treatment, priming, venting and
sterilization states, respectively; and
[0043] FIGS. 1 OA and 1 OB are schematic illustrations of elements
of the air trap module of FIG. 3 utilized in manufacture and, in
particular, for the sterilization mode during manufacture.
[0044] It will be appreciated that for simplicity and clarity of
illustration, elements shown in the figures have not necessarily
been drawn to scale. For example, the dimensions of some of the
elements may be exaggerated relative to other elements for clarity.
Further, where considered appropriate, reference numerals may be
repeated among the figures to indicate corresponding or analogous
elements.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0045] In the following detailed description, numerous specific
details are set forth in order to provide a thorough understanding
of the invention. However, it will be understood by those skilled
in the art that the present invention may be practiced without
these specific details. In other instances, well-known methods,
procedures, and components have not been described in detail so as
not to obscure the present invention.
[0046] Applicants have realized that adding a stand-alone air trap
chamber, separate from the pump and as part of the tubing
connecting the bag to the pump, may enable the air bubbles to be
collected in one place, to be safely removed. Moreover, Applicants
have realized that the fluid already in the tubes may be utilized
to push the air out of the air trap chamber and into a closed
container, thereby removing the air without detaching the tubes
from the pump or from the patient and without the need to spill
fluid to refill the tubes. As a result, there may be little or no
contamination of the patient. For expensive drugs like chemotherapy
drugs, the lack of spillage represents a significant savings, not
to mention the fact that, with little or no spillage, the dosage
prescribed is the dosage received.
[0047] In one embodiment, which has a bypass path, the bypass fluid
may be returned to the air trap chamber to push the air out of the
air trap. In another embodiment, the pump may pull the air out of
the air trap chamber directly to the vent. In both cases, the air
trap is refilled with fresh fluid.
[0048] The apparatus described below is particularly relevant for
chemotherapy applications, where spillage is of great concern;
however, it will be appreciated that the apparatus may be utilized
for all types of infusion operations since the apparatus of the
present invention may maintain a closed system which may minimize
patient contamination. It will also minimize the time needed to
remove air from the IV system.
[0049] It will be appreciated that, as described in more detail
hereinbelow, the air removal and refilling of the fluid are all
done by the pump operating in its normal (i.e. forward) mode of
operation and without stopping all the pump standard alerts. This
further enhances the safety of the patient while removing the air
from the system.
[0050] Reference is now made to FIGS. 1A, 1B and 1C, which
illustrate three alternate operational modes of an infusion pump 10
with a connectable air trap module 12, connected to the tubes
providing fluids, such as chemotherapy fluids, to the patient. Pump
10 may operate on a "set interface" 14, which may be a portion of
the tubes capable of receiving the pumping action. Pump 10 may also
provide an air bubble detector (not shown) to stop the pump action
if an air bubble is detected in set interface 14. As described
hereinbelow, the air trap chamber may be combined with the set
interface as one physical unit. Reference is further made to FIG.
1D, which is substantially similar to FIG. 1A further including air
bubble detector 50.
[0051] Air trap module 12 may be connected to set interface 14,
prior to pump 10 and above it, thereby to receive air flowing in
the supply line 21. Air trap module 12 may have an air trap chamber
16 and a vent 18 therein, as well as a plurality of valves to
control the flow of fluid into and out of air trap chamber 16 and
to control the flow of air out of air trap chamber 16. In the
embodiment of FIGS. 1A, 1B and 1C, there are 7 valves, labeled 1-7.
In the embodiment of FIGS. 2A, 2B and 2C, described hereinbelow,
there are 4 valves.
[0052] In accordance with a preferred embodiment of the present
invention, air trap module 12 may also have four line connections,
a supply connection 20 to a supply line 21, a set interface
connection 22 to tubing connected to set interface 14, a return
connection 24 connectable to a return line 25 connected after set
interface 14 and a patient connection 26 connectable to a patient
line 27 connectable to the patient.
[0053] Air trap module 12 of FIG. 1 may have 7 valves (indicated by
circles), to control the fluid and air flow through the various
lines. The 7 valves may be a supply line valve 1 controlling supply
line 21 into air trap chamber 16, an upper valve 2 controlling
fluid (or accumulated fumes) flowing from the top of air trap
chamber 16, a patient valve 3 controlling fluid flow from return
line 25 into patient line 27, a lower valve 4 controlling fluid
flow into set interface 14, a bypass valve 5 controlling flow from
supply line 21 into an internal bypass line 29, a return valve 6
controlling flow from return line 25 back into air trap chamber 16
and a venting valve 7 venting air out of air trap chamber 16.
[0054] In general, there may be 3 operational modes, a treatment
mode shown in FIG. 1A, during which the fluid (chemotherapy or
otherwise) may be provided to the patient, a priming mode shown in
FIG. 1B, during which the various tubes may be filled completely
with fluid, and a venting mode shown in FIG. 1 C, during which
toxic air, in the chemotherapy case, trapped in air trap chamber 16
may be pushed out of vent 18 and into any suitably closed unit,
such as a syringe 19 (shown), an empty bag, etc., thereby to keep
the toxic air from affecting any of the staff.
[0055] It will be appreciated that vent 18 and its associated
venting valve 7 may be located generally at the top of air trap
chamber 16, thereby to allow the air to rise and to be pulled out
without squeezing air trap chamber 16.
[0056] In a further pre-operation mode (not shown in the figures),
all valves 1-7 may be open, thereby connecting all internal
passages. This may allow free flow of sterilization gases
throughout module 16, a typical requirement for an ETO type of
sterilization. Typically, this mode may be active only during
manufacturing or by a specially trained technician and may no
longer be accessible once regular operation begins.
[0057] Referring now to FIG. 1A, during the treatment mode, fluid
may flow from the supply line, through pump 10, to the patient.
Thus, in this mode, supply valve 1 is open (indicated by an open
circle) for fluid to flow from supply line 21 into air trap chamber
16 and lower valve 4 is open for fluid to flow out of air trap
chamber 16 and into set interface 14. During this mode, air bubbles
flowing with the fluid may break away from the flow and may rise
into air trap chamber 16 where they will start to accumulate.
Patient valve 3 is open for fluid to flow from return line 25 into
patient line 27. However, the remaining valves are closed
(indicated by an X in the circle) to keep fluid from flowing to the
wrong places. It will be appreciated that air trap chamber 16 may
have some fluid in it, as indicated by a fluid line 30. Typically
in this mode at least part of the air trap module is filled with
fluid.
[0058] Referring now to FIG. 1B, during the priming mode, fluid may
flow to fill up the lines, before the lines are attached to the
patient. No air may be allowed to be in the system. Thus, air trap
chamber 16 may be filled fully with fluid such that the fluid will
flow out of upper valve 2 directly to set interface 14. In
addition, supply valve 1 is open for fluid to flow into air trap
chamber 16 and patient valve 3 is also open for fluid to flow from
return line 25 into patient line 27. The remaining valves are
closed. Fluid may be allowed to flow to the end of patient line 27,
in order to prime the system.
[0059] As mentioned hereinabove, during treatment, the chemotherapy
fluid may generate gases which form air bubbles in the flow,
typically as the fluid flows from supply line 21. Air trap chamber
16 may trap these gases and may fill up. Thus, FIG. 1C shows a
fluid line 32 in the lower portion of air trap chamber 16. It is
also possible that air trap chamber 16 may be filled entirely with
air. After air trap chamber 16 may be full with air, air bubbles
may start to flow through valve 4 until they enter set interface
14, where they may be detected by the air bubble detector forming
part of pump 10. The air bubble detector may shut off the action of
pump 10 and may activate an alarm which may not stop until a member
of the medical staff may come to shut it off. The staff member may
then switch air trap module 12 to the venting mode, to remove the
air from air trap chamber 16 and from set interface 14, as
follows:
[0060] In the venting mode, in accordance with a preferred
embodiment of the present invention, the input to pump 10 may be
switched to come directly from supply line 21, via bypass line 29,
thereby to ensure that fluid may be pushed through return line 25
back into air trap chamber 16, to push the air out through vent 18.
To enable this, bypass valve 5, return valve 6 and vent valve 7 are
opened. Bypass valve 5 may provide fluid directly from supply line
21 through set interface 14 to return line 25 and return valve 6
may allow the fluid from return line 25 to flow back into air trap
chamber 16, thereby filling air trap chamber 16 with fluid
(indicated by arrow 34) which, in turn, may push the toxic air
through valve 7 and out vent 18, preferably into a closed unit,
such as syringe 19.
[0061] The remaining valves, supply valve 1, lower valve 4, upper
valve 2 and patient valve 3, are all closed, to keep the air from
the patient. Thus, with pump 10 pushing fluid, via return line 25,
back into air trap chamber 16, the present invention may flush
undesired air out of air trap chamber 16, without disengaging
patient line 27 from the patient and without exposing staff members
to any of the noxious air.
[0062] As mentioned hereinabove, during manufacture of any medical
device, all passages of the device must be sterilized. For ETO
sterilization, sterilization gases are passed through the device.
In the present invention, when all the valves are open, the
sterilization gases may pass from one section of the chamber to the
next and thus, the device may be sterilized.
[0063] Reference is now made to FIGS. 2A, 2B and 2C, which
illustrate the same three modes as FIGS. 1A, 1B and 1C but for a
four valve air trap module 40. Similar items carry similar
reference numerals. As in the previous embodiment, there is an air
trap chamber 16 and there are four line connections 20, 22, 24 and
26, connected as in the previous embodiment to line 21, set
interface 14, return line 25 and patient line 27, respectively.
Reference is further made to FIG. 2D, which is substantially
similar to FIG. 2A further including air bubble detector 50.
[0064] However, in this embodiment, there may be four valves 41-44
to air trap module 40, two controlling flow through air trap
chamber 16 and two controlling the output flow, either to patient
line 27 or to vent 18. The two controlling flow through air trap
chamber 16 may be an upper valve 41 controlling fluid and air
flowing from the top of air trap chamber 16 and a lower valve 42
controlling fluid flow from air trap chamber 16 into set interface
14. The two controlling the output may be a patient valve 43
controlling fluid flow into the patient, and a venting valve 44
venting undesired air out of air trap module 40.
[0065] Referring now to FIG. 2A, during the treatment mode, fluid
may flow directly from supply line 21 into air trap module 40,
being pulled into air trap module 40 by the operation of pump 10.
Lower valve 42 is open for fluid to flow out of air trap module 40
and into set interface 14. Patient valve 43 is also open, for fluid
to flow out of air trap module 40 and into patient line 27.
However, the remaining valves are closed.
[0066] Referring now to FIG. 2B, during the priming mode, fluid may
flow to fill air trap module 40 such that the fluid may flow out of
upper valve 41 directly to set interface 14, through return line
25, and into patient line 27 via patient valve 43. As in the
previous embodiment, fluid may be allowed to flow to the end of
patient line 27, in order to prime the system.
[0067] In the venting mode, with air trap module 40 full of air,
the air may be pumped by pump 10 out of upper valve 41, through
return line 25 and out through vent 18. Thus, lower valve 42 and
patient valve 43 are closed, to keep air from the patient, and
upper valve 41 and vent valve 44 are opened. As the air is being
removed, fluid will begin to flow from supply line 21, filling air
trap chamber 16 and return line 25, such that, once all of the air
is removed, the system may return to the treatment mode.
[0068] It will be appreciated that, in this embodiment, the air
detector of pump 1 0 may be shut off during removal of the air, so
as not to detect the air flowing past the pump during the removal
process.
[0069] Venting valve 7 or 44 may be any suitable venting valve. For
example, it may have a buoy to prevent the flow fluid out vent 18
once all of the air has been removed. If the buoy is a one
directional buoy, the buoy may rise up the valve as the fluids rise
in air chamber 16 and may block the opening of valve 7 or 44 as a
result. This may keep fluids from being vented into the collection
bag or syringe 19. If the buoy is a two directional buoy, it may
also prevent the return of existed fluids collected in a collection
bag back to the air trap chamber system. Vent 18 may have a check
valve, typically a swabbable valve connector, which may prevent
accidental air discharge.
[0070] It will be appreciated that, in both embodiments, air trap
chamber 16 has two valves, lower valve 4 or 42 and upper valve 2 or
41 to control the flow of fluid and/or air, depending on the
operational mode. It will be appreciated that this enables air trap
module 12 or 40 to handle both the presence of fluid and the
presence of air without having to disconnect the patient from
patient line 27.
[0071] It will further be appreciated that air trap chamber 16 may
provide a buffer for collecting air. Its size may define the amount
of air to be collected which, in turn, may define the amount of
time the medical staff has between air removals. It is possible
that, with the existence of this buffer per patient, the medical
staff may be able to clear the various air trap chambers of a
treatment room of patients before the various air trap chambers 16
fill up completely.
[0072] It will further be appreciated that air trap modules 12 and
40 may be connected to any suitable type of pump. For each of the
operational modes, pump 10 merely pumps in a forward direction;
where the fluid or air goes is controlled by valves 1-7 or
41-44.
[0073] It will further be appreciated that, for air trap module 12,
air may reach the air detector of pump 10 which may cause pump 10
to stop operating. However, since, during the venting operation,
the substance flowing through the pump is fluid from the bypass
path, the air detector of pump 10 may remain operative during
venting of the air.
[0074] It will further be appreciated that valves 1-7 or 41-44 may
be implemented mechanically or electro-mechanically. In the
mechanical configuration, there may preferably be a single actuator
controlling all valves states. In the electro-mechanical case, each
valve may be separately programmed or they may be programmed to
open or close as a group. In this embodiment, there may be an
external actuator connected to pump 10.
[0075] Reference is now made to FIGS. 3A and 3B which illustrate an
exemplary embodiment of the seven valve air trap module,
implemented as a round unit with mechanically controlled valves.
FIG. 3A illustrates the air trap module 50 connected to the pump
and FIG. 3B details how the connection to pump 10 is implemented.
Thus, FIG. 3A shows air trap module 50, with vent 18, connected to
pump 10 with return line 25 and patient line 27. FIG. 3A also shows
a housing 52 for set interface 14. FIG. 3B shows a holder 54
forming part of a pump cradle used to hold pump 10 to an IV pole.
Holder 54 may include flanges 55 to hold a stick-like portion 53 of
air trap module 50 in place.
[0076] Optionally, stick 58 may include an identification element
57, such as a small magnet, therein and holder 54 may include an
identifying sensor 59, such as a Hall effect sensor. Sensor 59 may
sense the presence or absence of identification element 57 and may
provide its output to pump 10. Element 57 and sensor 59 may enable
automatic set recognition when air trap module 12 or 40 may be
attached on to the pump.
[0077] It will be appreciated that stick 53 may allow the air trap
module to be maintained in its correct position, upstream of the
pump, allowing proper air accumulation in air chamber 16. Thus,
when the AT chamber is full with air and bubbles are starting to
flow into the pump, the internal air bubble sensor of pump 10 may
detect the bubbles and may stop pumping fluid, thereby protecting
the patient. Stick 53 is only one embodiment; other fastening
elements may maintain proper air accumulation as well
[0078] FIGS. 4A and 4B, to which reference is now made, detail air
trap module 50 with a dial knob 56 in front and an approximately
oval shaped volume 58 functioning as air trap chamber 16 in the
back. Volume 58 may be of any size; for example, it may hold 2-4
ml. Module 50 may also include fluid gauge minimum and maximum
level indicators 60 and 62, to provide an indication of the level
of fluid in volume 58. Volume 58 may be formed of a clear plastic
such that a user can see the air/fluid level at any time; thus,
indicators 60 and 62 may simply mark the lowest and highest volume
levels. In an alternative embodiment, module 50 may be connected to
a fluid level meter to better determine the air level in chamber
16. For example, the meter may be a floating ball. In a still
further embodiment, the air trap chamber may have an integrated
electrical level meter which may trigger alarms and/or may trigger
the start or stop of various modes.
[0079] The knob in FIG. 4A may be rotated only after the user
pushes it slightly inwards. After releasing the knob, it will
spring back to lock itself safely in one of the operating
modes.
[0080] Dial knob 56 may have multiple positions, each controlling a
different mode of operation. Four positions are shown, for
infusion, venting, priming and an optional sterilization mode
(labeled ETO). As will be described in more detail hereinbelow, as
knob 56 moves from one position to another, the valves open and
close to come to the states discussed hereinabove. It will be
appreciated that knob 56 is a single handle which provides all
modes. This may provide a simple and relatively reliable
operation.
[0081] FIG. 5, to which reference is now briefly made, indicates
the locations of the various valves 1-7 in air trap module 50. Note
that venting valve 7 is near vent 18, bypass valve 5 is above a
bypass path 64 and patient valve 3 is above connection 26 to
patient line 27.
[0082] FIGS. 6A, 6B and 6C, to which reference is now briefly made,
detail air trap module 50, where FIG. 6A provides the elements of
air trap module 50 in exploded view, FIG. 6B illustrates the inner
elements combined and FIG. 6C is a sectional view of the
module.
[0083] Module 50 may comprise a top cover 70, dial knob 56, a dial
72, seven valve spools 74, a hive 76 of holes, a flexible seal
membrane 78, a main body 80 and a bottom cover 82. Note that volume
58 is formed when bottom cover 82 is connected to body 80.
[0084] FIG. 6B shows valve spools 74 positioned above dial 72. Note
the central cylinder, labeled 81, within which dial knob 56
rotates. It will be appreciated that each valve spool 74 may move
up and down within an associated hole 84 of hive 76 and may press
against seal membrane 78 to open and close its associated valve.
Dial 72 may be designed, as described hereinbelow, to press the
appropriate set of valve spools 74 for each mode.
[0085] It will be appreciated that other configurations of valves
are possible and are incorporated within the present invention.
[0086] FIGS. 7 A and 7B together illustrate a schematic cross
section of a typical valve in air trap module 50, detailing the
disengagement and engagement of a typical valve spool 74.
[0087] Spool 74 may be held in place by one of holes 84 in hive 76
and may be held against flexible seal membrane 78. Dial 72 may
comprise an undulating underside 90 which may have recesses 92 and
protrusions 94, where protrusions 94 may press each spool 74 down
into seal membrane 78 while recesses 92 may allow each spool 74 to
rise, typically pushed back by seal membrane 78. The arrangement of
the recesses 92 and protrusions 94 may determine which valves open
and which close for each of the operational modes.
[0088] In accordance with one embodiment of the present invention,
there may be a concentric valve configuration comprising a first
conduit 96, optionally vertical, in the center of the valve module
and a second conduit 98, optionally horizontal, connected together
via a circular ditch-like groove 100. The top circular lips of
conduit 96 and groove 100 may be located underneath membrane
78.
[0089] In FIG. 7A, recess 92 may be above spool 74 and thus, spool
74 may not press against seal 78. As a result, groove 100 may be
open and the two conduits 96 and 98 may be connected and fluid
and/or air may flow therebetween. In FIG. 7B, protrusion 94 may
engage spool 74, thereby pushing it into seal membrane 78 which may
then push against groove 100, disconnecting the two conduits 96 and
98 and stopping the flow of fluid and/or air.
[0090] FIG. 8, to which reference is now briefly made, illustrates
undulating underside 90 of dial 72. Underside 90 may have a
plurality of recesses 92 and protrusions 94, not evenly spaced
around dial 72. The distance between neighboring protrusions 94 may
be a function of which valves 1-7 are open or closed for which
mode.
[0091] It will further be appreciated that the location of
protrusions 94 with respect to each other may enable the present
invention to provide a double action safety feature, such as a make
before break feature, for changing from one mode to another. Thus,
recesses 92 may be located such that, when turning from one mode to
another, certain released spools 74 may be closed by their
respective protrusions 94 before other spools 74 may be opened by
their respective recesses 92. This may enable one mode disengage
completely before the next mode engages, which may be useful for
the venting mode which may cause a buildup of pressure in air trap
module 16. This pressure may be released when returning from
venting mode back to treatment mode by ensuring that closed supply
valve 1 will open (to release pressure back into supply line 21
instead of into the patient) before open return valve 6 is closed
and closed patient valve 3 is opened.
[0092] FIGS. 9A, 9B, 9C and 9D illustrate the fluid flow for each
of the treatment, priming, venting and sterilization states,
respectively, for air trap module 50. During treatment, fluid flows
from a fluid bag 110 to supply valve 1, through chamber 58 to lower
valve 4 through set interface 14 (operated on by pump 1 0) and
return line 25 and from return line 25 to patient valve 3.
[0093] During priming, as shown in FIG. 9B, fluid flows from fluid
bag 110, to supply valve 1, through chamber 58 to upper valve 2,
through set interface 14 and return line 25 to patient valve 3 and
from there to patient line 27.
[0094] During venting (FIG. 9C), fluid flows from fluid bag 110 to
bypass valve 5 to bypass path 64 to set interface 14, to return
line 25 into chamber 58 via return valve 6. Air vents through
venting valve 7 and into syringe 19. Patient valve 3 is closed.
[0095] In the optional sterilization mode (FIG. 9D), typically used
during assembly, all valves 1-7 are open to allow sterilization air
to circulate through all of the tubing, air chamber 58, and all
manifolds and conduits.
[0096] As shown in FIGS. 1 OA and 1 OB, to which reference is now
briefly made, dial 72 may have a protrusion 120 that, during
assembly, may be aligned with an assembly recess 122 in top cover
70. Moreover, dial 72 may have a flexible snap edge 124 which may
be aligned, also during assembly, on top of an operating range edge
126 in hive 76.
[0097] In an alternative embodiment, protrusion 120 may be part of
cover 70 and assembly recess 122 may be part of dial 72.
[0098] Typically, air trap module 50 may remain in the
sterilization mode until first use, at which point the user may
switch the dial to one of the operating modes. When this happens,
dial 72 may move out of assembly recess 122, resulting in snap edge
124 moving off of operating range edge 126 and into an operating
range defined by range edge 126 and another range edge 127. The
described mechanism prevents switching the air trap module back to
ETO mode once the user has switched it to one of the other
operational modes (e.g. treatment, priming or venting). However, it
is possible to overcome this restriction, particularly to test the
module during assembly.
[0099] It will be appreciated that the embodiment of FIGS. 3-10 may
be exemplary; other embodiments may be envisioned and are
incorporated within the present invention. For example, each valve
in the air trap module may have its own electro mechanical
actuator. In this embodiment, the actuators may be connected to a
microcontroller which may be located in the module or in the pump.
The microcontroller may control the valves in a predefined manner,
such as that described hereinabove or in accordance with any other
manner or as programmed by a user.
[0100] In an alternative embodiment, the electro mechanical valve
actuators may have a linear or rotary construction.
[0101] The electro mechanical valve actuators may be assembled in a
separate assembly that may be snapped onto the air trap module. It
may be constructed for multiple uses and may also have a secondary,
manual actuator for when the electro mechanical actuator is not
working. In this embodiment, the pump may control the operation of
the air trap module and may activate the various valves according
to the modes discussed hereinabove. The air detector of the pump
may detect the presence of air and may control the valves to change
from the treatment to venting and back It may also control the
priming state. In this embodiment, the air trap module may have 7
or 4 valves, as desired.
[0102] In one embodiment, during venting, the pump may drive an
amount of fluid that is equivalent to the volume of air trap
chamber 50 plus a small amount. This is a safety feature to prevent
the pump from pushing the piston of the syringe out and spilling
the medicine if the nurse forgets to stop the pump operation. The
small amount is provided in case a small pressure is built up in
the syringe, to ensure that all the air is removed. If the syringe
is stuck, a pressure detector of the pump will alert of the
pressure build up.
[0103] On the other hand, for a small syringe (5-10 ml), the
pressure to start moving it may require a higher pressure. For
example, it typically requires 1-2 levels of pressure to start the
air drive to the syringe and a lower level of pressure to continue
to drive it.
[0104] If desired, the pump may require the medical staff to input
the volume of the syringe or collecting bag, typically prior to the
first air removal. The pump may then alert the medical staff after
the total air removed (over the course of a few removals) may reach
the syringe volume.
[0105] Finally, air trap module 50 may include a syringe holder to
physically block the syringe from jumping out of vent 18 if the
pump operation was not stopped in time and resulted in an over
flow.
[0106] While certain features of the invention have been
illustrated and described herein, many modifications,
substitutions, changes, and equivalents will now occur to those of
ordinary skill in the art. It is, therefore, to be understood that
the appended claims are intended to cover all such modifications
and changes as fall within the true spirit of the invention.
* * * * *