U.S. patent application number 10/039423 was filed with the patent office on 2002-05-09 for fluid-recovery system with integrally molded components.
This patent application is currently assigned to Lahive and Cockfield, LLP. Invention is credited to Autote, David R., Cochran, Thomas S., Corbeil, Scott E., Gillis, Ralph L., Herweck, Steve A., Karwoski, Theodore, Want, Nicholas.
Application Number | 20020055690 10/039423 |
Document ID | / |
Family ID | 26815898 |
Filed Date | 2002-05-09 |
United States Patent
Application |
20020055690 |
Kind Code |
A1 |
Want, Nicholas ; et
al. |
May 9, 2002 |
Fluid-recovery system with integrally molded components
Abstract
The present invention relates to fluid recovery systems for
collecting fluid from a patient. A fluid recovery system according
to the teachings of the invention includes a housing having a
collection chamber for collecting fluid from a patient, and further
includes a plurality of components and/or structures that are
integrally formed with the housing. Such integrally molded
components can include valves for controlling fluid flow within the
fluid recovery system and a tamper resistant disposal system.
Inventors: |
Want, Nicholas; (Manchester,
NH) ; Karwoski, Theodore; (Hollis, NH) ;
Herweck, Steve A.; (Nashua, NH) ; Cochran, Thomas
S.; (Antrim, NH) ; Corbeil, Scott E.;
(Litchfield, NH) ; Autote, David R.; (Nashua,
NH) ; Gillis, Ralph L.; (Nashua, NH) |
Correspondence
Address: |
Kevin J. Canning Esq.
Lahive & Cockfield, LLP
28 State Street
Boston
MA
02109
US
|
Assignee: |
Lahive and Cockfield, LLP
|
Family ID: |
26815898 |
Appl. No.: |
10/039423 |
Filed: |
January 4, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10039423 |
Jan 4, 2002 |
|
|
|
09358944 |
Jul 22, 1999 |
|
|
|
60118034 |
Jan 29, 1999 |
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Current U.S.
Class: |
600/573 |
Current CPC
Class: |
A61M 1/61 20210501 |
Class at
Publication: |
600/573 |
International
Class: |
A61B 005/00 |
Claims
What is claimed is:
1. A fluid recovery system for collecting fluid from a patient
comprising a housing having a collection chamber for collecting the
fluid, a valve for controlling fluid flow within the fluid recovery
system, the valve including a valve member that selectively engages
a valve seat surrounding a fluid opening to seal the fluid opening,
the valve seat being integrally molded to the housing of the fluid
recovery system.
2. The fluid recovery system of claim 1, wherein the valve is a
vacuum protection valve providing air flow communication with the
collection chamber to permit air flow in one direction out of the
chamber.
3. The fluid recovery system of claim 2, wherein the valve member
is constructed of an elastomeric material and has a generally
umbrella-like shape.
4. The fluid recovery system of claim 1, wherein the fluid recovery
system is a chest drain.
5. The fluid recovery system of claim 1, wherein the valve is a
negative pressure protection valve that opens to provide air flow
between the collection chamber and the outside environment through
the fluid opening when pressure in the collection chamber is lower
than a predefined threshold.
6. The fluid recovery system of claim 5, wherein the negative
protection valve further includes a valve housing for seating a
spring and the valve member, said valve member being biased by the
spring against said integrally molded valve seat to seal the fluid
opening, wherein a pressure in the collection chamber lower than
the predefined threshold causes the spring to contract thereby
moving the valve member and providing air flow between the
collection chamber and the outside environment.
7. The fluid recovery system of claim 6, wherein said valve housing
is integrally molded to said housing of said fluid recovery
system.
8. The fluid recovery system of claim 6, further comprising an
integrally molded raised structure protruding outwardly from the
fluid opening and configured to inhibit occlusion of the
opening.
9. The fluid recovery system of claim 8, wherein said raised
structure includes a hollow frusta-conical member surrounding the
opening from the outside and having ports for providing air flow
from the outside environment through the opening.
10. The fluid recovery system of claim 6, wherein the valve housing
includes a first cylindrically tubular portion for receiving the
spring and extending to a second portion for seating the valve
member, the second portion of the valve housing having at least one
port therein for providing air flow between the valve housing and
the collection chamber.
11. A fluid recovery system for collecting fluid from a patient,
comprising a housing having a collection chamber for collecting a
volume of the fluid from the patient, and a vacuum protection valve
for allowing air flow in one direction out of the collection
chamber, said vacuum protection valve including an enclosure
integrally molded within the housing that has a base extending to
an opening for providing air flow communication with the collection
chamber.
12. The fluid recovery system of claim 11, wherein the vacuum
protection valve includes a hollow flexible retaining member, the
valve being secured to the housing by snap action placement of the
flexible retaining member in said opening.
13. The fluid recovery system of claim 12, wherein the vacuum
protection valve includes an umbrella valve member for sealing the
opening, thereby providing one way air flow through the
opening.
14. The fluid recovery system of claim 13, wherein the vacuum
protection valve further includes a retaining member for retaining
the umbrella valve member over the opening.
15. A fluid recovery system for collecting fluid from a patient,
comprising a housing having a collection chamber for collecting a
volume of the fluid from the patient, and a positive pressure
relief valve for reducing pressure in the collection chamber when
the pressure in the chamber exceeds a pre-defined value, wherein
said positive pressure relief valve includes an integrally molded
enclosure formed in said housing, said integrally molded enclosure
having an integrally molded ramped rib.
16. The fluid recovery system of claim 15, wherein said integrally
molded enclosure includes a first opening for air flow
communication with the collection chamber and a second opening for
air flow communication with the outside environment, said first
opening being sealed by a sealing ball to provide a fluid-tight
seal between the collection chamber and the integrally molded
enclosure, said ball being dislodged from the first opening when
pressure within the collection chamber exceeds the pre-defined
value to allow air flow between the collection chamber and the
outside environment, and wherein said integrally molded ramped rib
provides a rolling surface to bias the ball toward said first
opening when said fluid recovery system is destabilized from a
normal operating orientation.
17. The fluid recovery system of claim 16, wherein the positive
pressure relief valve further includes an integrally molded raised
surface surrounding the second opening, said raised surface
providing a valve seat for a sealing element to seal the housing
from the outside environment.
18. A fluid-recovery system for collecting fluid from a patient,
comprising a housing having a front face and a collection chamber
for collecting a volume of fluid from the patient, and a vacuum
indicator for indicating when pressure in the collection chamber is
below a selected threshold, the vacuum indicator including an
integrally molded seat in the front face of the housing, a
translucent diaphragm positioned in the seat, and a cap mounted to
the seat to compress the diaphragm into sealing engagement with the
seat, the cap having a marking on a surface facing the diaphragm
and further having an opening that provides air flow between the
collection chamber and the diaphragm.
19. The fluid-recovery system of claim 18, wherein the diaphragm is
formed of an elastomeric material.
20. The fluid recovery system of claim 18, wherein the front face
includes a translucent portion and the vacuum indicator is
positioned within the housing such that it is externally visible
through the translucent portion of the front face, and the
diaphragm contacts the marked surface of the cap when pressure
within the collection chamber is below the selected threshold,
thereby rendering the marker visible.
21. A fluid-recovery system for collecting fluid from a patient,
comprising a housing having a front face, said front face having a
translucent portion and said housing further having a collection
chamber for collecting a volume of the fluid from the patient, and
a vacuum indicator for indicating when pressure in the collection
chamber is below a selected threshold, the vacuum indicator
including a seat, a translucent diaphragm positioned in the seat,
and a cap mounted to the seat to compress the diaphragm into
sealing engagement with the seat, the cap having a marking on a
surface facing the diaphragm and further having an opening that
provides air flow between the collection chamber and the diaphragm,
wherein the vacuum indicator is positioned within the housing such
that it is externally visible through the translucent portion of
the front face, and the diaphragm contacts the marked surface of
the cap when pressure within the collection chamber is below the
selected threshold, thereby rendering the marker visible.
22. A fluid-recovery system for collecting fluid from a patient,
comprising a housing having a top surface and a collection chamber
for collecting a volume of the fluid from the patient, and a
pressure relief valve having a manually actuable diaphragm sealing
an integrally molded enclosure within the top surface from outside
environment, the molded enclosure being in air flow communication
with the collection chamber, and the diaphragm being manually
actuated by an integrally molded actuating element to provide air
flow between the collection chamber and the outside environment to
reduce pressure in the collection chamber.
23. A fluid recovery system for collecting fluid from a patient,
comprising a housing having a top surface and a collection chamber
for collecting a volume of fluid from the patient, and a connecting
element of a latching connector integrally molded to the top
surface of the housing and configured to receive a mating
connecting element of the latching connector.
24. The fluid recovery system of claim 23, wherein said integrally
molded connecting element is a female portion of a latching
connector.
25. The fluid recovery system of claim 23, wherein said integrally
molded connecting element is a male portion of a latching
connector
26. A fluid recovery system for collecting fluid from a patient,
comprising a housing having a collection chamber for collecting a
volume of the fluid from the patient, and a pressure measuring port
integrally molded within said housing and configured to be in fluid
communication with the collection chamber and to receive a pressure
gauge for measuring pressure within the collection chamber.
27. A fluid recovery system for collecting fluid from a patient,
comprising a housing having a collection chamber for collecting the
fluid, and a tamper-resistant disposal system for disposal of the
collected fluid.
28. The fluid-recovery system of claim 27, wherein said
tamper-resistant disposal system includes a a disposal port
integrally formed within said housing, a seal positioned on said
disposal port for sealing said disposal port, and a cap having a
cap body, a cap base, and a plurality of break-away tabs along a
circumference thereof, said break-away tabs joining said cap body
to said cap base, said cap being secured to said disposal port to
close said disposal port.
29. The fluid-recovery system of claim 28, wherein said disposal
port includes a first plurality of ratchet-like teeth and said cap
includes a second plurality of ratchet-like teeth, said first and
second plurality of ratchet-like teeth being in mating engagement
upon threaded engagement of said cap with said disposal port to
inhibit rotation of said base relative to said disposal port when
said cap body is rotated relative to said disposal port.
30. The fluid-recovery system of claim 29, wherein said cap
includes a translucent portion to allow visual inspection of said
seal.
31. A fluid recovery system for collecting fluid from a patient,
comprising a housing having a top surface and a collection chamber
for collecting a volume of the fluid from the patient, and a handle
attached to the top surface and raised above other components on
the top surface for carrying the fluid recovery system, the handle
having a length that allows two people to simultaneously hold
it.
32. The fluid recovery system of claim 31, wherein said handle is
integrally molded to said housing.
33. The fluid recovery system of claim 32, wherein the length of
said handle is approximately 5 inches.
34. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, the method comprising the steps of
forming a housing through injection molding having a collection
chamber and an integrally molded valve seat for selective
engagement with a valve member of a valve for controlling fluid
flow within the fluid recovery system.
35. The method of claim 34, wherein the valve is a vacuum
protection valve providing air flow communication with the
collection chamber to permit air flow in one direction out of the
chamber.
36. The method of claim 34, wherein the valve member is constructed
of an elastomeric material and has a generally umbrella-like
shape.
37. The method of claim 34, wherein the valve is a negative
pressure protection valve and is configured to open to provide air
flow between the collection chamber and the outside environment
through the fluid opening when pressure in the collection chamber
is lower than a predefined threshold.
38. The method of claim 37, further including the step of
configuring said negative protection valve to include a valve
housing for seating a spring and the valve member, said valve
member being biased by the spring against said integrally molded
valve seat to seal the fluid opening, wherein a pressure in the
collection chamber lower than the predefined threshold causes the
spring to contract thereby moving the valve member and providing
air flow between the collection chamber and the outside
environment.
39. The method of claim 38, further including the step of
integrally molding said valve housing to said fluid recovery
system.
40. The method of claim 39, further including the step of providing
an integrally molded raised structure protruding outwardly from the
fluid opening, said raised structure being configured to inhibit
Occlusion of the port.
41. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, comprising the steps of forming a
housing having a collection chamber for collecting a volume of the
fluid from the patient and having a vacuum protection valve for
allowing air flow in one direction out of the collection chamber,
said vacuum protection valve including an enclosure integrally
molded within the housing, said enclosure having a base extending
to an opening for providing air flow communication with the
collection chamber.
42. The method of claim 41, wherein the step of forming a housing
includes employing injection molding to form said housing.
43. The method of claim 41, further including the step of
configuring the vacuum protection valve to include a hollow
flexible retaining member, the valve being secured to the housing
by snap action placement of the flexible retaining member in said
opening.
44. The method of claim 43, further including the step of
configuring the vacuum protection valve to include an umbrella
valve member for sealing the opening, thereby providing one way air
flow through the opening.
45. The method of claim 44, further including the step of
configuring the vacuum protection valve to include a retaining
member for retaining the umbrella valve member over the
opening.
46. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, comprising the steps of forming a
housing having a collection chamber for collecting a volume of the
fluid from the patient and having a positive pressure relief valve
having an integrally molded enclosure within the housing, the
positive pressure relief valve reducing pressure in the collection
chamber when the pressure in the chamber exceeds a predefined
value.
47. The method of claim 46, wherein the step of forming the housing
includes employing injection molding to form said housing.
48. The method of claim 46, wherein the step of forming the housing
further includes providing the integrally molded enclosure of the
positive pressure relief valve with a first opening for air flow
communication with the collection chamber and for seating a sealing
ball for providing a fluid tight seal between the collection
chamber and the integrally molded valve enclosure.
49. The method of claim 48, wherein the step of forming the housing
further includes providing the integrally molded enclosure of the
positive pressure relief valve with a second opening for providing
air flow communication with the outside environment.
50. The method of claim 48, wherein the step of forming the housing
further includes configuring a wall of the integrally molded
enclosure to provide a ramped rib for guiding the sealing ball
toward the first opening when the fluid recovery system is
destabilized from a normal operating orientation.
51. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, comprising the steps of forming a
housing having a front cover and a collection chamber for
collecting a volume of the fluid, and providing a vacuum indicator
for indicating when pressure in the collection chamber is below a
selected threshold, the vacuum indicator having a seat integrally
molded in the front cover and having a translucent diaphragm seated
in the integrally molded seat and having a cap mounted to the seat
to compress the diaphragm into sealing engagement with the seat,
the cap having a marking on a surface facing the diaphragm and
further having an opening that provides air flow between the
collection chamber and the diaphragm, wherein the diaphragm
contacts the marked surface of the cap when pressure within the
collection chamber is below the selected threshold, thereby
rendering the marking visible.
52. The method of claim 51, wherein the step of forming the housing
includes employing injection molding to form said housing.
53. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, comprising the steps of forming a
housing having a top surface and a collection chamber for
collecting a volume of the fluid from the patient, and further
having an integrally molded enclosure within the top surface in air
flow communication with the collection chamber, said integrally
molded enclosure having an integrally molded actuating element, and
sealing the integrally molded enclosure with a manually actuable
diaphragm being actuated by said integrally molded actuating
element for providing a pressure relief valve.
54. The method of claim 53, wherein the step of forming the housing
includes employing an injection molding process.
55. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, comprising forming a housing
having a top surface and a collection chamber for collecting a
volume of the fluid from the patient, and further having a
connecting element of a latching connector integrally molded to the
top surface of the housing and configured to receive a mating
connecting element of the latching connector.
56. The method of claim 55, wherein the step of forming the housing
includes employing an injection molding process.
57. A method for manufacturing a fluid recovery system for
collecting fluid from a patient, comprising the steps of forming a
housing having a collection chamber for collecting the fluid, and
further having a pressure measuring port integrally molded within
said housing and configured to be in fluid communication with the
collection chamber and to receive a pressure gauge for measuring
pressure within the collection chamber.
58. The method of claim 57, wherein the step of forming the housing
includes employing an injection molding process.
59. A method of manufacturing a fluid recovery system for
collecting fluid from a patient, comprising the steps of forming a
housing having a collection chamber for collecting the fluid, and
further having a tamper-resistant fluid disposal system in said
housing.
60. The method of claim 59, wherein the step of forming the housing
includes an injection molding process.
61. The method of claim 59, further including the step of selecting
said fluid disposal system to include a disposal port integrally
formed with said housing.
62. A method of manufacturing a fluid-recovery system for
collecting fluid from a patient, said method comprising the step of
forming a housing having a top surface and a collection chamber for
collecting a volume of the fluid, said housing further having a
handle attached to the top surface and raised above other
components on the top surface for carrying the fluid recovery
system.
63. The method of claim 62, wherein the step of forming the housing
includes employing an injection molding process.
Description
RELATED APPLICATIONS
[0001] The present application claims priority to a provisional
application entitled "Fluid Recovery System", filed on Jan. 29,
1999, and having a Ser. No. 60/118,034. This provisional
application is herein incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to apparatuses for draining
fluid from a patient, and more particularly, to fluid recovery
systems for draining blood from the thoracic cavity of the
patient.
[0003] A number of fluid-recovery systems have been developed for
drawing fluid, such as blood, from a patient. Such devices
generally apply suction to a body cavity of the patient to remove
blood or other fluid after trauma or surgery. For example, a chest
drain is a relatively compact bedside fluid-recovery system that is
employed to collect fluids post-operatively from a closed surgical
site through a drain tube implanted in the patient's chest.
[0004] Conventional fluid-recovery systems typically include a
housing and a number of components, such as valves and ports, that
are manufactured separately from the housing, and subsequently
attached to the housing. Such separate manufacturing of the
components increases the number of steps in the manufacturing
process, thereby increasing the manufacturing cost. Further,
additional costs are incurred for assembling these components to
the housing. Moreover, each separately manufactured component may
need to be individually calibrated, further increasing the
manufacturing cost of the system.
[0005] Accordingly, there is a need for a fluid-recovery system
that requires fewer number of steps for its manufacturing, and
further minimizes the need for calibration of its components.
SUMMARY OF THE INVENTION
[0006] The present invention provides a fluid-recovery system for
collecting fluid from a patient which includes a housing having
various integrally molded components and/or structures. The term
integrally molded, as used herein, refers to forming a particular
component and/or structure of the housing of the fluid-recovery
system as a single unit with the remaining parts of the housing. In
other words, an integrally molded component and/or structure is not
added to a pre-formed housing, but rather is formed with other
parts of the housing as a single unit. In particular, the
integrally molded components and/or structures of the housing are
not intended to be removed and/or replaced.
[0007] In one aspect, the present invention provides a
fluid-recovery system having a housing and a valve for controlling
fluid flow within the fluid-recovery system. The housing includes a
collection chamber for collecting the fluid, and the valve includes
a valve member that selectively engages a valve seat surrounding a
fluid opening, to seal the opening. The valve seat is integrally
molded to the housing of the fluid recovery system.
[0008] According to one aspect of the invention, the valve for
controlling fluid flow within the fluid-recovery system is a vacuum
protection valve that provides air flow communication with the
collection chamber to permit air flow in one direction out of the
collection chamber. In one preferred embodiment of the invention,
the valve member of the vacuum protection valve is constructed of
an elastomeric material and has a generally umbrella-like
shape.
[0009] In another aspect, the present invention provides a fluid
recovery system for collecting fluid from a patient that includes a
housing having a collection chamber for collecting a volume of the
fluid from the patient, and a vacuum protection valve for allowing
air flow in one direction out of the collection chamber. The vacuum
protection valve further includes an enclosure that is integrally
molded within the housing.
[0010] In a preferred embodiment of the invention, the vacuum
protection valve includes a flexible retaining member whose
snap-action placement within the integrally molded enclosure
secures the valve to the housing. The integrally molded enclosure
can have a base extending to an opening that is sized and shaped to
engage the flexible retaining member of the valve, thereby
attaching the valve to the housing. The vacuum protection valve can
include a valve body having an opening therein, and an umbrella
valve member that is seated within the valve body to seal the
opening. The umbrella valve member provides one way air flow
through the opening when the pressure in the collection chamber
exceeds a pre-defined threshold.
[0011] According to another aspect of the invention, the valve for
controlling fluid flow within the fluid-recovery system is a
negative pressure protection valve that opens to provide air flow
between the collection chamber and the outside environment through
the fluid opening when pressure in the collection chamber is lower
than a predefined threshold.
[0012] In a preferred embodiment of the invention, the negative
pressure protection valve can include a valve housing for seating a
spring, and the valve member. The spring biases the valve member
against the integrally molded valve seat to seal the fluid opening.
A pressure in the collection chamber that is lower than the
predefined threshold causes the spring to contract, thereby moving
the valve member and providing air flow between the collection
chamber and the outside environment. The negative pressure
protection valve can optionally include a filter to filter the air
before it enters the collection chamber. The valve housing can be
integrally molded to the housing of the fluid recovery system.
Alternatively, the valve housing can be a separate component that
is seated within the integrally molded enclosure. The valve housing
can include a first cylindrically tubular portion for receiving the
spring and extending to a second portion for seating the valve
member. The second portion of the valve housing can have at least
one port therein for providing air flow between the valve housing
and the collection chamber.
[0013] Accordingly to one aspect of the invention, an integrally
molded raised structure protruding outwardly from the fluid opening
of the negative pressure protection valve inhibits occlusion of the
opening. The raised structure can include a hollow frusto-conical
member that surrounds the fluid opening from the outside and has
ports therein for providing air flow from the outside environment
through the fluid opening.
[0014] According to yet another aspect of the present invention, a
fluid-recovery system is provided that includes a collection
chamber for collecting a volume of fluid from a patient, and a
positive pressure relief valve for reducing pressure in the
collection chamber when pressure in the chamber exceeds a
pre-defined value. The pressure relief valve includes an integrally
molded enclosure formed in the housing, and further includes an
integrally molded ramped rib. The integrally molded enclosure of
the pressure relief valve can include a first opening for providing
air flow communication with the collection chamber, and a second
opening for providing air flow communication with the outside
environment. The first opening can have a tapered portion for
seating a sealing ball that seals the first opening to provide a
fluid-tight seal between the collection chamber and the integrally
molded enclosure.
[0015] When pressure within the collection chamber exceeds a
pre-defined value, it dislodges the ball from the first opening to
allow air flow between the collection chamber and the outside
environment. The integrally molded ramped rib provides a rolling
surface for the sealing ball to bias the ball toward the first
opening when the fluid recovery system is destabilized from a
normal operating orientation. The term "destabilized" as used
herein refers to situations or conditions in which the fluid
recovery device is bumped. jarred, pushed. tipped or completely
knocked-over, resulting in the device being positioned, temporarily
or permanently, in an orientation other than its normal, preferred
operating orientation, i.e., an orientation in which the fluid
recovery system is upright. The pressure relief valve can include a
raised surface surrounding the second opening to provide a seat for
a sealing element that can seal the housing from the outside
environment, for example when pressure testing the fluid-recovery
system.
[0016] In another aspect, the fluid-recovery system of the
invention can include a housing having a front face, a collection
chamber integrally formed within the housing for collecting fluid,
and a vacuum indicator for indicating when pressure in the
collection chamber is below a selected threshold. The vacuum
indicator includes a seat integrally molded in the front face of
the housing, a translucent diaphragm, preferably formed of an
elastomeric material, positioned in the seat, and a cap that is
mounted to the seat to compress the diaphragm into sealing
engagement with the seat. The cap has an opening therein that
provides air flow between the collection chamber and the diaphragm,
and further has a marking on a surface facing the diaphragm. When
the pressure in the collection chamber is below the selected
threshold, a pressure differential across the diaphragm develops
that forces the diaphragm to contact the inside surface of the cap,
thereby rendering the marking inside the cap discernable.
[0017] Alternatively, the front face can include a translucent
portion, and the vacuum indicator can be a separate component that
is positioned within the housing such that it is externally visible
through the translucent portion of the front face.
[0018] In yet another aspect, the present invention provides a
fluid-recovery system having a top surface, a collection chamber
for collecting a volume of fluid from a patient, and a manually
actuable pressure relief valve. The manually actuable relief valve
includes an integrally molded enclosure within the top surface that
is in air flow communication with the collection chamber. The
integrally molded enclosure is sealed from the outside environment
by a manually actuable diaphragm that is actuated by an integrally
molded actuating element to provide air flow between the collection
chamber and the outside environment to reduce pressure in the
collection chamber.
[0019] Another aspect of the invention relates to providing a
fluid-recovery system having a top surface, a collection chamber
for collecting fluid from a patient, and a connecting element of a
latching connector that is integrally molded to the top surface of
the housing, and is configured to receive a mating connecting
element of the latching connector. In one preferred embodiment of
the invention, the connecting element is a female portion of a
latching connector. In another preferred embodiment of the
invention, the connecting element is a male portion of a latching
connector.
[0020] In yet another aspect, the invention provides a
fluid-recovery system having a housing that includes a collection
chamber, and a pressure measuring port integrally molded within the
housing. The integrally molded pressure port is configured to be in
fluid communication with the collection chamber, and to receive a
pressure gauge for measuring pressure within the collection
chamber.
[0021] Another aspect of the fluid recovery system of the invention
relates to a tamper-resistant disposal system for disposal of fluid
collected within the collection chamber. The tamper-resistant
system can preferably include a disposal port integrally molded to
the housing, a seal positioned on the disposal port for sealing the
disposal port, and a cap positioned over the seal and secured to
the disposal port, to provide a air-tight seal of the disposal
port. In a preferred embodiment of the invention, the cap includes
a cap body, a cap base, and a plurality of break-away tabs along a
circumference thereof, joining the cap body to the cap base. The
cap further includes a plurality of ratchet-like teeth that can
matingly engage with a plurality of ratchet-like teeth on the
disposal port upon threaded engagement of the cap with the disposal
port. The mating engagement of the two sets of teeth inhibits
rotation of the base of the cap relative to the disposal port when
the cap body is rotated relative to the disposal port. The cap can
include a translucent portion to allow visual inspection of the
seal.
[0022] Another aspect of the invention relates to providing a
handle for the fluid-recovery system of the invention that is sized
and shaped such that it allows safe and easy transport of the
fluid-recovery system from one location to another. Such a handle
is preferably formed as an integral part of the housing of the
fluid recovery system, and is raised above other components on the
top surface of the fluid recovery system. The length of the handle
is selected such that it allows two people to simultaneously hold
it. For example, in a preferred embodiment of the invention, the
handle is approximately 5 inches long. Nevertheless, those skilled
in the art will appreciate that handles having other lengths may be
used to practice the present invention.
[0023] A preferred method for manufacturing various embodiments of
the present invention includes forming a housing through an
injection molding process, wherein the housing includes a
collection chamber for collecting fluid and further includes other
integrally molded components and/or structures for providing a
number of different functions, such as relieving excess pressure in
the collection chamber or indicating that the pressure in the
collection chamber is below a selected threshold. For example, the
injection molding process can be utilized to form an integrally
molded enclosure within the housing for matingly engaging a vacuum
protection valve.
[0024] These and other features and advantages of the present
invention will be more fully understood by reference to the
following detailed description in conjunction with the attached
drawings in which like reference numerals refer to like elements
through the different views.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a perspective view of a fluid recovery system
according to the present invention with the front cover removed
having various integrally molded components and structures.
[0026] FIG. 2 is an exploded perspective view of a vacuum
protection valve that is engageably received within an integrally
molded enclosure of the fluid-recovery system of FIG. 1, to relieve
pressure in the collection chamber.
[0027] FIG. 3A is a fragmentary front elevational view in
cross-section of the fluid-recovery system of FIG. 1, illustrating
an integrally molded enclosure for receiving the vacuum protection
valve of FIG. 2, and further illustrating the vacuum protection
valve before mating engagement within a tapered opening of the
integrally molded enclosure.
[0028] FIG. 3B is a fragmentary front-elevational view in
cross-section of the fluid-recovery system of FIG. 1, illustrating
the vacuum protection valve of FIG. 3A matingly engaged within the
integrally molded enclosure for receiving the vacuum protection
valve.
[0029] FIG. 3C is a fragmentary front-elevational view in
cross-section of the fluid recovery system of FIG. 1, illustrating
a mating engagement of the vacuum protection valve of FIG. 3B
within the tapered opening of the integrally molded enclosure for
receiving the vacuum valve, and further illustrating an O-ring
sealing against the interior surface of the tapered opening.
[0030] FIG. 4 is a fragmentary front-elevational view in
cross-section of the fluid-recovery system of FIG. 1, illustrating
the vacuum protection valve of FIG. 3 seated in its integrally
molded enclosure in a closed position, wherein an umbrella valve
member of the valve seals the tapered opening of the integrally
molded enclosure.
[0031] FIG. 5 is a front-elevational view in cross section of the
fluid recovery system of FIG. 3, illustrating air flow through the
vacuum protection valve of FIG. 3 when the valve is an open
position.
[0032] FIG. 5A is a fragmentary front-elevational view in
cross-section of an integrally molded valve seat of a vacuum
protection valve according to the teachings of the present
invention.
[0033] FIG. 5B is a fragmentary front-elevational view in
cross-section of a retaining member and a valve member coupled to
the integrally molded valve seat of FIG. 5A to form a vacuum
protection valve according to the teachings of the present
invention.
[0034] FIG. 6A is a fragmentary perspective view of the
fluid-recovery system of FIG. 1, illustrating an integrally molded
enclosure for receiving a negative pressure protection valve, and
further illustrating various components of the negative pressure
protection valve in an exploded view.
[0035] FIG. 6B is a side-elevational view in cross-section of the
fluid recovery system of FIG. 6A, illustrating the negative
pressure protection valve of FIG. 6A assembled and seated within
the integrally molded enclosure for receiving the valve, and
further illustrating a raised structure for inhibiting occlusion of
the opening to the valve.
[0036] FIG. 7 is a fragmentary perspective view of the back surface
of the fluid-recovery system of FIG. 1, illustrating the raised
structure for inhibiting occlusion of the valve opening of FIG.
6B.
[0037] FIG. 8 is a fragmentary, side elevational view in
cross-section of the fluid recovery system of FIG. 1, illustrating
schematically air flow through the negative pressure protection
valve of FIG. 6b when the valve is in an open position.
[0038] FIG. 9A is a fragmentary perspective view of the top surface
of the fluid-recovery system of FIG. 1, illustrating a positive
pressure relief valve integrally molded within the housing of the
fluid-recovery system.
[0039] FIG. 9B is a cross-sectional view of the positive pressure
protection valve of FIG. 9A in an open position, illustrating an
opening to the outside environment, a tapered opening for access to
the collection chamber of the fluid-recovery system, and a sealing
ball for sealing the tapered opening.
[0040] FIG. 10 is a perspective view of a front cover for the
fluid-recovery system of FIG. 1, illustrating the components of a
vacuum indicator including a seat integrally molded within the
front cover, a diaphragm, and a cap in an exploded view.
[0041] FIG. 11A is a front-elevational view of the inner surface of
the cap of the vacuum indicator of FIG. 10, illustrating a marking
on the inner surface of the cap.
[0042] FIG. 11B is a perspective fragmentary view of the front
cover of FIG. 10, further illustrating the seat, the diaphragm, and
the cap of the vacuum indicator of FIG. 10 in an exploded view, and
further illustrating vents integrally molded in the front cover for
allowing air flow communication between one surface of the
diaphragm and the outside environment and an opening the cap for
air flow communication with the collection chamber of the fluid
recovery system.
[0043] FIG. 12A is a side-elevational view in cross-section of the
assembled vacuum indicator of FIGS. 11A and 11B when the collection
chamber is not under vacuum and hence the diaphragm of the vacuum
indicator is in a relaxed position.
[0044] FIG. 12B is a side-elevational view in cross-section of the
vacuum indicator of FIG. 12A when the collection chamber is under
vacuum and the diaphragm of the vacuum indicator is forced against
the inner surface of the cap, thereby rendering the marking on the
inner surface of the cap visible.
[0045] FIG. 13 is a perspective view of the top surface of the
fluid-recovery system of FIG. 1 from the rear, illustrating an
integrally molded connecting element for connecting the
fluid-recovery system to a patient, and manually actuable pressure
relief valve, and a handle sized and shaped for safe and easy
transportation of the fluid-recovery system.
[0046] FIG. 13A is a perspective view of two mating portions and a
positioning portion of a latching connector, where one of the
mating portions is the connecting element of FIG. 13.
[0047] FIG. 13B is a perspective view of a latching connector
obtained after assembly of the mating portions and the positioning
portion shown in FIG. 13A.
[0048] FIG. 14 is a fragmentary perspective view of the top surface
of the fluid-recovery system of FIG. 1, illustrating the integrally
molded connecting element of FIG. 13, and an integrally molded port
for measuring pressure within the collection chamber of the
fluid-recovery system.
[0049] FIG. 15A is a fragmentary perspective view of the top
surface of the fluid-recovery system of FIG. 1, illustrating a
tamper-resistant disposal system for draining fluid collected
within the fluid-recovery system or adding sterilizing agents to
the collected fluid.
[0050] FIG. 15B is a perspective view of the tamper-resistant
disposal system of FIG. 15A that includes an integrally molded
disposal port, a seal, and a cap.
DETAILED DESCRIPTION OF THE INVENTION
[0051] A fluid-recovery system in accordance with the teachings of
the invention includes a housing having a collection chamber for
collecting fluid from a patient, and further includes a plurality
of integrally molded components and/or structures within the
housing, such as integrally molded enclosures for housing valves
for controlling fluid flow within the fluid recovery system. The
provision of integrally molding components within the housing of
the system simplifies manufacturing of the system by reducing the
number of necessary components and the number of manufacturing
steps, thus resulting in significant reduction in manufacturing
costs.
[0052] An illustrative fluid-recovery system 10 according to the
present invention, shown in FIG. 1, includes a housing 12 having a
collection chamber 14 for collecting fluid from a patient, an air
leak monitor chamber 16, and a valve housing i8 for a
suction-regulating valve (not shown). The housing 12 further
includes a plurality of integrally molded components therein, as
described in more detail below.
[0053] The air leak monitor chamber 16 includes a large column 16a,
and a narrow column 16b that extends to a portion 16c having an
opening 16d. The opening 16d can include a circular portion and
notched portion extending radially from the circular portion. The
air leak monitor chamber 16 is in air flow communication with the
collection chamber 14 through the opening 16d, and anti-spill
nozzles 12b and 12c. The structure and operation of the anti-spill
nozzles 12b and 12c are provided in a concurrently filed
application entitled "Fluid Recovery Device and Flow Member for
Inhibiting Undesired Fluid Flow" (Attorney Docket No.: ATA-233),
herein incorporated by reference. The air leak monitor chamber 16
is typically filled with a few centimeters of water. In the event
of an air leak from the patient into the collection chamber 14, the
air travels from the collection chamber 14 to the air leak monitor
chamber 16, bubbling through the water in the air leak monitor
chamber as it passes through the chamber 16. This bubbling of the
air through the water in the chamber 16 alerts a medical
professional to the presence of the air leak. Further, a float ball
(not shown) rides up and down the narrow column 16b. In the event
of a high negative pressure, the float ball partially occludes the
opening 16d, for example by occluding the circular portion of the
opening 16d, to impede the flow of water through the opening 16d.
The water leaking through the opening 16d collects harmlessly above
the float ball and ultimately returns to the column 16b when
suction reaches normal levels.
[0054] The structure of and operation of the air leak monitor
chamber including the float ball are described in detail in U.S.
Pat. No. 5,807,358 (herein "'358 patent"), and U.S. Pat. No.
5,114,416 (herein "'416 patent"), both of which are herein
incorporated by reference.
[0055] The suction regulating valve sets the amount of suction
applied through a port 12d at a user-set level in a range of -10 to
-40 centimeters of water by controlling the amount of air entering
the housing 12. The structure and operation of the suction
regulating valve are described in detail in the aforementioned '358
patent.
[0056] With reference to FIGS. 1, 2, 3A, 3B, 3C, 4, and 5, the
housing 12 includes an integrally molded enclosure 20 for matingly
engaging a vacuum protection valve 22. The enclosure 20 is formed
in the housing 12, preferably during an injection molding process
such that the enclosure 20 forms an integral component of the
housing 12. The illustrative vacuum protection valve 22 includes a
valve body 24, a valve member 26 that is constructed of an
elastomeric material and has a generally umbrella-like shape, a
retaining member 28, and an O-ring 30. The retaining member 28
retains the umbrella valve member 26 within the enclosure 20, and
the umbrella valve member 26 seals an opening within the enclosure
20, as described below. The valve body 24 includes one or more
resilient legs 24a extending from a cylindrical housing 24b. The
legs 24a are preferably constructed from a resilient material, for
example a plastic or an elastomeric material, that permits the legs
to flex from a compressed position to a relaxed position. The valve
body 24 includes a groove 24c for seating the O-ring 30 therein,
and further includes an angled retaining member 24d. Each resilient
leg further includes a rib 24e between the O-ring groove 24c and
the retaining member 24d.
[0057] With reference to FIG. 3A, the integrally molded enclosure
20 includes a base 33 extending to a tapered section 32a having an
opening 32b therein for receiving the resilient legs 24a. A
snap-action placement of the resilient legs 24a within the opening
32b matingly engages the valve body 22 within the enclosure 20, as
shown in FIG. 3B, with the angled retaining member 24d protruding
through the opening 32b to prevent the vacuum protection valve 22
from dislodging from the enclosure 20. Further, FIG. 3C shows that
upon engagement of the valve 22 within the enclosure 20, the O-ring
30 contacts the inner surface of the tapered portion 32a.
[0058] The vacuum protection valve 22 operates as a one-way valve,
also known as a check valve, prohibiting air flow in one direction
and allowing air flow in the opposite direction. Specifically, the
retaining member 28 holds the umbrella valve member 26 in place
against a valve seat 24f to seal the opening 32b when there is no
air flow through the valve, as shown in FIG. 4.
[0059] In normal operation, i.e., when the fluid-recovery system is
connected to a patient and suction is applied, the vacuum
protection valve 22 is open, thus allowing air flow from the air
leak monitor chamber 16 through an opening 16e (FIG. 1), via a
channel 12e curved around the suction regulating valve, into a
vacuum port 12d (FIG. 1) that is connected to a pump (not shown).
FIG. 5 illustrates the flow of air through the vacuum protection
valve 22 when the valve 22 is open. In particular, arrows 34 depict
the movement of air through the vacuum protection valve 22. The air
pressure exerted on the inner surface of the umbrella valve member
26 lifts the edge of the umbrella valve member 26 to allow the air
to flow between the resilient legs 24a into the enclosure 20.
[0060] If the enclosure 20 is exposed to an atmospheric pressure
while the collection chamber 14 is under vacuum, for example if the
suction line connecting the port 12d to a pump is accidentally
disconnected, the vacuum protection valve 22 closes, thus
preserving the vacuum within the collection chamber 14. The closing
of the valve 22 occurs because the pressure differential across the
umbrella member 26 forces the edges of the umbrella member 26
against the valve seat 24f (FIG. 4).
[0061] An alternative embodiment of a vacuum protection valve
according to the teachings of the present invention, shown in
fragmentary views of FIGS. 5A and 5B as a valve 22a, includes a
valve seat 22b that is integrally molded to the housing 12. The
illustrated integrally molded valve seat 22b includes a wall 22c
surrounding a base 22d that extends to an opening 22e. A retaining
member 28a (FIG. 5B) holds a valve member 26a, which is constructed
of an elastomeric material and has a generally umbrella-like shape,
in position over the opening 22e and against the base 22d of the
integrally molded valve seat 22b, to seal the opening 22e. The
vacuum protection valve 22a operates in the same manner as the
vacuum protection valve 22, discussed above.
[0062] Referring to FIGS. 1, 6A, and 6B, the housing 12 further
includes an integrally molded enclosure 36 that is in air flow
communication with the collection chamber 14 through the anti-spill
nozzles 12b and 12c. The enclosure 36 houses a negative pressure
protection valve 38 that is configured to open when pressure in the
collection chamber is lower than a pre-defined threshold, to
provide air flow between the collection chamber and the outside
environment. Such an air flow ensures that the pressure within the
collection chamber remains within a safe range. The pre-defined
threshold at which the negative pressure protection valve 38 opens
is selected to be preferably in the range of -55 to -75 centimeters
of water.
[0063] The illustrative negative pressure protection valve 38
includes a valve housing 40 for seating a spring 42, a valve member
44 in the form of a spring washer 46a, and a sealing element 46b.
The spring washer 46a is preferably formed of stainless steel or
the like, and the sealing element 46b is preferably formed of an
elastomeric material . In an alternative embodiment, the valve
member 44 is formed in one piece having one surface that is formed
of a hard material, such as stainless steel, and an opposed surface
that is formed of an elastomeric material. The valve housing 40 is
preferably integrally molded within the enclosure 36.
Alternatively, the valve housing 40 is a separate component that is
seated within the enclosure 36.
[0064] Upon placement of the negative pressure valve 38 within the
enclosure 36, the valve member 44 is seated over an integrally
molded valve seat 48 protruding above a base 50 of the enclosure
36. In particular, the sealing element 46b covers an opening 52,
that provides access to the outside environment, to seal the
enclosure 36 from the outside environment when the negative
protection valve 38 is closed. The spring washer 46a is seated over
the sealing element 46b, to distribute the load from the spring 42
onto the sealing element 46b. The spring 42 fits within the valve
housing 40 and is sized to provide the requisite amount of force on
the spring washer 46a, and consequently on the sealing element 46b,
such that the valve 38 opens at a desired pressure. A front cover
54 is positioned on the front face of the housing 12, and engages
the valve housing 40 and the spring 42, to seal the valve 38 within
the integrally molded enclosure 36.
[0065] The illustrative integrally molded enclosure 36 includes an
integrally molded raised structure 56 having a frusto-conical
hollow member 56a that surrounds the opening 52 on the back surface
of the housing 12. FIG. 7, which is a fragmentary view of the back
surface of the housing 12, illustrates that the hollow member 56a
includes a plurality of ports 56c therein that allow air flow from
the outside environment through the opening 52. The raised
structure 56 inhibits occlusion of the opening 52 by external
objects. For example, if a medical professional inadvertently
places a finger on the hollow member 56a, the openings 56c remain
unoccluded, thereby ensuring that pressure on a surface 46c of the
sealing element 46b remains at an atmospheric level (FIG. 6B).
[0066] Further, the illustrative valve housing 40 includes ports
40a that provide air flow communication between the inner portion
of the valve housing 40, i.e., the portion within which the spring
42 is seated, and the remaining volume of the enclosure 36. Thus,
the inner portion of the valve housing 40 is in air flow
communication with the collection chamber 14. The surface 46c of
the sealing element 46b is exposed to atmospheric pressure, and a
surface 46d of the sealing element 46b is exposed to the pressure
within the collection chamber 14. Thus, there exists a pressure
differential across the sealing element 46b. When the valve 38 is
closed, i.e., when pressure in the collection chamber 14 is above
the pre-defined threshold, the pressure differential across the
sealing element 46b is fully counter-acted by the compression force
of the spring 42. That is, the spring 42 presses the spring washer
46a, and the sealing element 46b against the valve seats 48 with
sufficient force to seal the opening 52. However, as the pressure
within the collection chamber 14 begins to fall below the
pre-defined threshold, the pressure differential across the sealing
element 46b dislodges it from the valve seat 48 and compresses the
spring 42 toward the front cover 54, thus opening the valve 38.
[0067] FIG. 8 illustrates the flow of air through the valve 38 when
it opens. In particular, arrows 58, depicting the air flow through
the valve 38, indicate that air enters the opening 52 from the
outside environment through the ports 56c in the raised structure
56. This air flow exerts a pressure on the surface 46a of the
sealing element 46. When the pressure in the collection chamber,
and consequently the pressure on surface 46d of the sealing element
46b, is lower than the pre-defined threshold, the differential
pressure across the sealing element 46b is sufficient to dislodge
it from the valve seats 48. This allows air to flow from the
outside environment through the ports 56c into the inner portion of
the valve housing 40, and through the ports 40a into the remaining
volume of the enclosure 36, and through a notched opening 36a (FIG.
6A) to the collection chamber 14. A filter can be optionally placed
in a hollow cylindrical portion 36b of the notched opening 36a to
filter the air before it enters the collection chamber 14. The air
flow from the outside environment into the enclosure 36 lowers the
pressure differential across the valve member 44 until the pressure
differential across the valve member 44 is at a level at which the
force of the spring 42 against the valve member 44 is sufficient to
seat the sealing element 46b on the valve seat 48, thereby sealing
the enclosure 36 from the outside environment.
[0068] One advantage of the illustrated integrally molded enclosure
36 is that a distance L1 (see FIG. 6B) between the valve seat 38
and the front face of the housing 12 is fixed for each housing
manufactured. This distance and the pressure at which the valve 38
is desired to open are the design parameters that determine the
spring constant of the spring 42. Thus, for a given set of design
parameters, no separate calibration of the spring 42 for different
fluid-recovery systems is required. That is, once a spring with a
particular spring constant is shown to work properly in a
fluid-recovery system according to the present invention, other
springs having the same spring constant can be utilized in other
similar fluid-recovery systems without a need for a separate
calibration.
[0069] With reference to FIGS. 1, 9A, and 9B, another feature of
the illustrative fluid recovery system 10 is an integrally molded
positive pressure relief valve 60 (herein "the PPRV") that extends
above a top surface 12a of the housing 12. The PPRV 60 includes two
side walls 60a, 60b, a rear wall 60c, and a top surface 60d that
are arranged to provide a generally rectilinear cross-section for
an integrally molded enclosure 62, although other shapes may also
be utilized. The integrally molded enclosure 62 includes a base 62a
having an opening 64 therein for providing air flow communication
with the collection chamber 14 through the enclosure 20, and an
opening 66 that is open to the outside environment. The opening 64
includes a tapered section 64a for seating a sealing ball 68, to
provide an air-tight seal between the enclosure 20 and the outside
environment.
[0070] In normal operation, the sealing ball 68 is seated within
the tapered portion 64a of the opening 64, thereby closing the
valve 60 and sealing the enclosure 20 from the outside environment.
In the event that pressure within the collection chamber 14, and
consequently within the enclosure 20, rises above an undesired
level, e.g., above atmospheric pressure, the force from the air
pressure unseats the sealing ball 68, thereby releasing air to the
outside environment and restoring the pressure within the
collection chamber to a safe level.
[0071] An undesirably high pressure within the enclosure 20 can
develop, for example, in the event that a suction line attached to
the fluid-recovery system 10 is occluded, or is shut off. In such a
situation, the PPRV opens to relieve the pressure, thus protecting
the patient from a pressure build-up within the fluid-recovery
system 10.
[0072] With continuing reference to FIGS. 9A and 9B, the rear wall
60c of the illustrative integrally molded enclosure 62 includes a
ramped rib 70 having an increased thickness proximate the top of
the enclosure 62 and a decreasing thickness toward the base 62a,
thus providing a surface sloped toward the opening 64. The ramped
rib 70 is preferably formed during the manufacturing of the housing
12, for example through an injection molding process, as an
integrally molded structure of the enclosure 62. Those skilled in
the art will understand that any of the other surfaces 66a and 66b
of the PPRV 60, or all of the surfaces 60a, 60b, and 60c, or any
combination thereof can include a ramped rib. The ramped rib 70
operates to bias the sealing ball 68 toward the opening 64, when
the fluid recovery system is destabilized from a normal operating
orientation, i.e., an upright orientation.
[0073] For example, as shown in FIG. 9B, in the event that the
fluid recovery system 10 is knocked over onto its rear surface,
i.e., such that the rear wall of the housing 12 is parallel to the
work surface upon which the fluid recovery system is positioned,
and the sealing ball 68 is dislodged from the opening 64, the
ramped rib 70 provides a rolling surface for the sealing ball 68
that facilitates return of the ball 68 to the tapered section 64a
of the opening 64, thereby closing the valve. Before the return of
the sealing ball to the opening 64, the enclosure 20 is exposed to
atmospheric pressure as a result of air flow through the opening
64. The atmospheric pressure within the enclosure 20 causes the
vacuum protection valve 22 to close, in a manner described above in
connection with the operation of the vacuum protection valve 22,
thereby protecting the vacuum in the collection chamber 14 until
the sealing ball 68 returns to the opening 64.
[0074] A fluid-recovery system is typically pressure tested after
manufacturing to ensure that there are no leaks in the system. In
order to pressure test the system, various ports providing air flow
between the system and the outside environment need to be properly
sealed. To this end, the illustrative PPRV 60 further includes a
raised structure 60d, preferably integrally molded to the housing
12, surrounding the opening 66, which provides a seat for a sealing
element (not shown) for conveniently sealing the PPRV 60 from the
outside environment when pressure testing the fluid-recovery system
10.
[0075] It is desirable to have a readily visible vacuum indicator
on a fluid recovery system, such as the illustrative fluid-recovery
system 10 of FIG. 1, for indicating negative pressure condition
within the collection chamber 14. Such a vacuum indicator can
indicate to a medical professional that a negative pressure exists
in the pleural space of a patient attached to the fluid recovery
system 10. FIGS. 10, 10A, 11A, and 11B show an illustrative vacuum
indicator 72 according to the present invention that includes a
valve seat 74, integrally molded in the front cover 56 of the
fluid-recovery system 10, a translucent diaphragm 76, formed from
an elastomeric material such as silicone, and a cap 78 for
positioning the diaphragm 76 in the seat 74. The valve seat 74
includes integrally molded vents 80 for providing air flow between
one side of the diaphragm 76, i.e., the side not facing the cap,
and the outside environment.
[0076] To assemble the vacuum indicator 72, the diaphragm 76 is
seated over the seat 74, and the cap 78 is secured to the valve
seat 74 to compress the edges of the diaphragm 76 into sealing
engagement with the seat 74.
[0077] FIGS. 11A and 11B show that the cap 78 includes a marking
78a in the form of a "check mark" on its inner surface, i.e., the
surface facing the diaphragm 76. Further, the cap 78 includes a
port 78b therein that permits air from the interior of the housing
12 (FIG. 1) to communicate with the diaphragm 76.
[0078] FIGS. 12A and 12B illustrate the operation of the vacuum
indicator 72. One side of the diaphragm 76 is in air flow
communication with the outside environment through the vents 80,
and the other side of the diaphragm 76 is at a pressure equal to
the pressure within the cap 78. Thus, when pressure within the
collection chamber 14 (FIG. 1), and consequently within the cap 78
that is in air flow communication with the collection chamber 14
through the port 78b (FIG. 11B), is substantially one atmosphere,
there is no significant pressure differential across the diaphragm
76. The diaphragm 76 is hence in a relaxed position, as shown in
FIG. 12A.
[0079] In the event of negative pressure in the collection chamber
14 or negative pressure in the pleural space of the patient, for
example through application of suction to the fluid recovery system
10, a pressure differential across the diaphragm 76 develops. If
the negative pressure in the collection chamber 14 is below a
selected threshold, for example -1 centimeter of water, this
pressure differential forces the diaphragm 76 to move in the
direction of the inside surface of the cap 78, as shown by an arrow
80a, and to contact the inside surface of the cap 78, as shown in
FIG. 12B. Upon contact of the translucent diaphragm 76 with the
inside surface of the cap 78, the marking 78a becomes discernable
through the translucent diaphragm 76 from outside of the fluid
recovery system, thereby providing a visual indication of a
negative pressure condition in the collection chamber.
[0080] An alternative embodiment of the fluid-recovery system of
the invention includes a vacuum indicator that has the same
components as those described above in connection with the vacuum
indicator 72, but is manufactured as a separate component rather
than an integral component of the housing 12. Such an alternative
embodiment further includes a cover for its front face that is at
least partially transparent. The separate vacuum indicator is
placed within the housing such that it can be readily viewed
through the transparent portion of the front cover, thereby
providing an indication of a negative pressure condition in the
collection chamber or in the pleural space of the patient.
[0081] With reference to FIGS. 1 and 13, another aspect of the
illustrative fluid-recovery system 10 relates to providing a
manually actuable relief valve 82 for quickly relieving excess
pressure in the collection chamber 14. The relief valve 82 extends
above the top surface 12a of the housing 12 and includes an
enclosure 84 that is integrally formed within the housing 12, and
is in air flow communication with the collection chamber 14. The
relief valve 82 further includes a diaphragm 86 sealing the
enclosure 84 from the outside environment, and an integrally molded
actuating element 88 that can, for example, be a hinged tab
integrally molded to the housing 12.
[0082] In the event that the pressure in the collection chamber 14
rises above atmospheric pressure, the relief valve 82 can be
manually activated by the actuating element 88 to release air from
the collection chamber 14, thereby relieving the pressure in the
chamber 14. In particular, manually depressing the actuating
element 88 moves the diaphragm 86 to open the valve 82, thus
releasing air from the collection chamber to the outside
environment. Thus, the manually actuable relief valve 82 provides a
mechanism for quickly relieving pressure in the collection chamber
14.
[0083] In a hospital setting, it is important to be able to hook up
a patient to a fluid-recovery system quickly and easily. To this
end, the illustrative fluid-recovery system 12 includes a
connecting element 90, shown in FIG. 13, that is integrally molded
to the housing 12. As shown in FIGS. 13A and 13B, the illustrative
connecting element 90, which is a portion of a latching connector,
is configured to receive a mating connecting element 90a and a
positioning element 90b to a form a latching connector 90c for
receiving a flexible tube (not shown), to connect the patient to
the recovery system. The connecting element 90 extends above the
top surface 12a of the housing 12 so that it can be conveniently
accessed by a medical professional. The integrally molded
connecting element 90 can be preferably a male or a female portion
of a latching connector.
[0084] One advantage of the integrally molded connecting element 90
is that it significantly simplifies connecting a patient to the
fluid recovery system 10. The connection of a conventional
fluid-recovery system to a patient typically requires holding a
first flexible tubing attached to an input port of the recovery
system with one hand, and using the other hand to connect an end of
a second flexible tubing, whose other end is attached to the
patient, to the first tubing. In contrast, a medical professional
utilizing a fluid recovery system of the invention needs to use
only one hand to connect a patient to the recovery system. For
example, such a medical professional can simply engage a male
portion of a latching connector attached to one end of a flexible
tube, whose other end is attached to the patient, with the
illustrative female portion of a latching connector 90, to connect
the flexible tube to the fluid-recovery system 10. The flexible
tube provides a passageway through the connecting element 90 for
flow of fluid from the patient into the collection chamber 14.
[0085] With reference to FIG. 14, another feature of the
illustrative fluid-recovery system 10 is an integrally molded port
92 that is configured to provide access to the collection chamber
14. In particular, the integrally molded port 92 can be employed to
measure pressure in the collection chamber 14. For example, a
pressure gauge (not shown) can be inserted into the collection
chamber 14 through the integrally molded port 92, to measure
pressure within the collection chamber 14.
[0086] With reference to FIGS. 1, 15A and 15B, the illustrative
fluid-recovery system 10 further includes a tamper-resistant
disposal system 94 that allows proper disposal of fluid drawn from
a patient and collected within the collection chamber 14. The
disposal system 94 includes a disposal port 96 that is preferably
positioned on the upper surface 12a of the housing 12, to provide
access to each chamber within the housing 12. The disposal port 96
is preferably formed as an integral component of the housing 12.
Alternatively, the disposal port 96 can be manufactured separately
and be added to the housing 12 during or after the manufacture of
the housing 12. A cap 98 closes the disposal port 96 during normal
operation of the fluid-recovery 10, e.g., during collection of
fluid from the patient.
[0087] The illustrative cap 98 is threadedly connected to the
disposal port 98. In particular, a neck 100 of the disposal port 96
includes a number of threads 102 for coupling the cap 98, which
includes a number of mating internal threads (not shown), to the
disposal port 96. Alternatively, the cap 98 can be configured to
fit on the disposal port 102 in a substantially friction-tight fit.
Suitable alternative fastening mechanisms, including bonding by
adhesive, can also be employed.
[0088] Further, a base 104 of the disposal port 96 includes a
series of inclined, ratchet-like teeth 106 extending the periphery
thereof. A base 108 of the cap 98 includes a number of inclined,
ratchet-like teeth (not shown) complementary in shape to the teeth
106 provided on the base 104 of the disposal port 96. The base 108
of the cap 98 is coupled to a body 110 of the cap 98 by a plurality
of break-away tabs 112 spaced along the circumference of the cap
body 110.
[0089] Fluid-recovery systems are generally delivered to medical
personnel in a sterile condition prior to use, i.e., prior to
connection to the patient. It is important that this sterile
condition is maintained to prevent the spread of disease or
infection to the patient. The illustrative disposal system 94
provides provisions for indicating whether the sterile condition of
the fluid-recovery system 10 has been compromised, as discussed
below.
[0090] When the cap 98 is positioned on the disposal port 96, the
ratchet-like teeth of the cap 98 engage the ratchet-like teeth 106
of the disposal port 96, thus inhibiting motion of the cap base 108
relative to the base 104 of the disposal port 98. In the event that
the cap 98 is rotated relative to the neck 100 of the disposal port
98, the cap base 108 is prohibited from rotating relative to the
base 104 of the disposal port 98 by the ratchet-like teeth 106. As
a result, the break-away tabs 112 shear and break, thus separating
the base 108 of the cap 98 from the body 110 of the cap 98. Thus,
the separated body 110 of the cap 98 provides evidence of tampering
with the disposal system 94, or removal of the collected fluid from
the fluid recovery system.
[0091] The disposal system 94 can further include a seal 114
positioned on a lip 116 of the neck 100 of the disposal port 96.
The seal 114 is secured to the disposal port 96, preferably by an
adhesive or the like, to inhibit air leakage through the disposal
port 96. Before securing the seal 114 to the disposal port 96, a
foil (not shown) is typically placed on the disposal port 96, and
subsequently the seal 114 is secured to the disposal port 96 over
the foil. The seal 114 is preferably complementary in shape to the
lip 116 of the disposal port 96 and is preferably constructed from
a material that is substantially impermeable to air, such as a
metal or silicon foil. Removal of the seal 114 provides further
indication of tempering with the disposal system 96, or removal of
the collected fluid from the fluid recovery system. The cap 98 can
optionally include a translucent portion 98a that allows visual
inspection of the seal 114 without removing the cap 98.
[0092] In a hospital setting, fluid-recovery systems are frequently
carried from one location to another, and further such systems may
be handed from one medical professional to another. At times, such
handling of the fluid-recovery system may result in an accidental
fall of the system on the floor, which can result in breakage of
the system and spillage of the fluid contained within the system.
The spilled fluid may be contaminated, thus posing hazards to the
medical personnel and the patients. Thus, it is important to
provide provisions for safe handling of the fluid-recovery system,
for example transportation of the system from one location to
another.
[0093] Referring back to FIG. 13, the illustrative fluid-recovery
system 10 of the invention can be easily and safely carried, and
further it can be easily and safely transferred from one person to
another. In particular, the illustrative fluid recovery system 10
includes a handle 118 that is preferably integrally formed in the
top surface 12a of the housing 12 of the fluid-recovery system 10.
The illustrative handle 118 is designed to have a length L2 of
approximately 5 inches, and a width W of approximately 1 inch. The
length of the handle 118 is selected to enable two medical
professionals to simultaneously hold the handle 118, each with one
hand. This allows a medical professional to transfer the
fluid-recovery system 10 to another without any need to first place
the fluid-recovery system 10 on the floor so that a second medical
professional can grab it via the handle 118.
[0094] The illustrative handle 118 further has a height H, selected
to be approximately 2 inches, to ensure that the handle 118 rises
above other components, such as the connector 90 and the vacuum
port 12d located on the top surface 12a of the housing 12. The
raised height of the handle 118 provides some protection for the
other components on the top surface 12a against accidental fall of
objects on the fluid-recovery system 10. In particular, if an
object accidentally falls on the fluid recovery system 10, it is
likely that it would first hit the raised handle 118 rather than
the other components on the top surface 12a. The impact of the
object with the handle would divert the object away from the
fluid-recovery system, thus minimizing any damage to the
fluid-recovery system.
[0095] The illustrative handle 118 is preferably approximately
centered in a front-to-back position and also laterally relative to
the housing 12. This assures that the fluid-recovery system 10 is
well balanced when fluid has been collected, and that the
collection chamber 14 will not tilt excessively downward when the
device is lifted.
[0096] Those skilled in the art will understand that the use of
various components and structures described above is not limited to
the above illustrative fluid-recovery system. In particular, the
various components and structures described above can be utilized
in fluid-recovery systems having both dry or wet suction regulator
mechanisms.
[0097] It will thus be seen that the invention efficiently attains
the objects set forth above among those made apparent from the
preceding description. Since certain changes may be made in the
above constructions without departing from the scope of the
invention, it is intended that all matter contained in the above
description or shown in the accompanying drawings be interpreted as
illustrative and not in a limiting sense. For example, although
some integrally molded enclosures in the above illustrative
embodiment are cylindrical, it is clear to those skilled in the art
that other shapes can also be utilized for these enclosures.
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