U.S. patent application number 16/834079 was filed with the patent office on 2020-10-08 for method for automatically removing urine from a female patient.
The applicant listed for this patent is Boehringer Technologies, LP. Invention is credited to Christopher L. Radl, Michael Reed Vennel.
Application Number | 20200315837 16/834079 |
Document ID | / |
Family ID | 1000004753030 |
Filed Date | 2020-10-08 |
United States Patent
Application |
20200315837 |
Kind Code |
A1 |
Radl; Christopher L. ; et
al. |
October 8, 2020 |
METHOD FOR AUTOMATICALLY REMOVING URINE FROM A FEMALE PATIENT
Abstract
A method for automatically removing by suction urine voided by a
female by use of a system that includes an external catheter, a
suction canister and a suction regulator. The external catheter is
applied at the urethra opening to receive urine voided by the
female. The suction canister collects the urine and is coupled to a
source of suction providing suction having a first value. The
suction regulator is interposed between the external catheter and
the canister to regulate the amount of suction to a regulated value
which is applied the external catheter, whereupon urine from the
external catheter is carried through the suction regulator and into
the canister.
Inventors: |
Radl; Christopher L.;
(Malvern, PA) ; Vennel; Michael Reed;
(Phoenixville, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boehringer Technologies, LP |
Phoenixville |
PA |
US |
|
|
Family ID: |
1000004753030 |
Appl. No.: |
16/834079 |
Filed: |
March 30, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62829731 |
Apr 5, 2019 |
|
|
|
62872397 |
Jul 10, 2019 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/4405 20130101;
A61F 5/455 20130101 |
International
Class: |
A61F 5/455 20060101
A61F005/455; A61F 5/44 20060101 A61F005/44 |
Claims
1. A method for automatically removing by suction urine voided by a
female comprising: providing an external catheter in fluid
communication with a urethra opening of the female, whereupon urine
voided by the female is received by said external catheter;
providing a receptacle or canister for collecting urine; coupling
said receptacle or canister to a source of suction providing
suction having a first value; and interposing a suction regulator
between said external catheter and said receptacle to apply said
suction at said first value to said regulator; operating said
suction regulator to automatically regulate the amount of suction
from said first value to a regulated value lower than said first
value and applying regulated suction at said regulated value to
said external catheter, whereupon urine from said external catheter
is carried through said suction regulator and into said receptacle
or canister.
2. The method of claim 1 wherein said regulated value of suction is
within the range of approximately 40-175 mmHg.
3. The method of claim 1, wherein the urine is carried through said
suction regulator into said receptacle or canister by air which is
flowing at a flow rate up to approximately 100 standard cubic feet
per hour (SCFH).
4. The method of claim 2, wherein the urine is carried through said
suction regulator into said receptacle or canister by air which is
flowing at a flow rate up to approximately 100 standard cubic feet
per hour.
5. The method of claim 1, wherein said source of suction is
provided at a wall suction connector, and wherein said receptacle
or canister is connected to said wall suction connector without a
regulator interposed between said wall suction connector and said
receptacle or canister.
6. The method of claim 5, wherein said receptacle or canister is
connected to said wall suction connector via an adapter.
7. The method of claim 6, wherein said adapter includes a valve
configured to be in either an open state or a closed state, wherein
said method comprises causing said valve to be in said open state
whereupon said source of suction is coupled to said receptacle or
canister to provide suction at said first value thereto.
8. The method of claim 6, wherein said adapter includes a valve
configured to be in either an open state or a closed state, wherein
said method comprises causing said valve to be in said closed state
whereupon said source of suction is isolated from said receptacle
or canister.
9. The method of claim 7, wherein said adapter includes a coupler
configured to be connected to some component to provide suction
thereto at the same time that said valve is open and providing
suction at said first value to said receptacle or canister.
10. The method of claim 5, wherein said receptacle or canister can
be disposed at any elevation with respect to said wall suction
connector without affecting optimal drainage of urine into said
receptacle or canister.
11. The method of claim 1, wherein the urine is carried through
said suction regulator into said receptacle by air flow, wherein a
differential pressure between said external catheter and said
suction regulator results, and wherein a differential pressure of
no more than approximately 55 mmHg provides an air flow rate of
greater than 25 LPN.
12. The method of claim 11, wherein the urine is carried through
said suction regulator into said receptacle by air flow, wherein a
differential pressure between said external catheter and said
suction regulator results, and wherein a differential pressure of
no more than approximately 100 mmHg provides an air flow rate of
greater than 35 LPN.
13. The method of claim 1, wherein the urine is carried through
said suction regulator into said receptacle by air flow and wherein
a rate of said air flow is greater than 45 LPM.
14. The method of claim 1, wherein the urine is carried through
said suction regulator into said receptacle by air flow and wherein
said system exhibits a ratio of an air flow rate in LPM squared to
said regulated value of at least 13.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This utility application claims the benefit under 35 U.S.C.
.sctn. 119(e) of Provisional Application Ser. No. 62/829,731, filed
on Apr. 5, 2019, entitled System Including Suction Regulator For
Automatically Removing Urine From A Female Patient And Method Of
Use Of The System, and Provisional Application Ser. No. 62/872,397
filed on Jul. 10, 2019, entitled System Including Sound Suppressed
Suction Regulator For Automatically Removing Urine From A Female
Patient Via An External Catheter And Method Of Removing Urine From
A Female Patient Using An External Catheter. The entire disclosures
of those two provisional applications are incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] This invention relates generally to medical devices and
methods and more particularly to devices and methods for
automatically removing urine from a female patient using suction
applied to an external catheter.
BACKGROUND OF THE INVENTION
[0003] Various external catheters are available for non-invasive
urine output management in female patients. The PUREWICK.RTM.
female external catheter available from C.R. Bard, Inc. is an
example of one such device. That external catheter is a soft member
having a hollow flexible body including a side opening exposing
soft absorbent gauze. The catheter is configured to be positioned
so that soft gauze is disposed between the patient's separated
gluteus and labia and in fluid communication with the urethral
opening of the patient, whereupon urine voided by the patient is
wicked into the gauze. The catheter is arranged to be attached via
suction tubing to a suction canister, which should in turn be
connected to either a suction regulator on a hospital wall or a
portable suction pump, such as the DRYDOC.TM. vacuum suction
station of C.R. Bard, Inc., whereupon the urine wicked into the
external catheter is carried by the suction into the canister for
collection. The Instructions for Use (IFU) of the PUREWICK.RTM.
female external catheter indicates that the suction source should
be set to a minimum of 40 mmHg continuous suction.
[0004] Sage Products, LLC, now a Stryker Corporation company,
provides an external urine management system for females under the
trademark PRIMAFIT. That system is in many respects similar to the
PUREWICK.RTM. system. In particular, the PRIMAFIT system basically
comprises an external catheter body having an end cap to fit in the
woman's perineal area to secure the catheter in place. The catheter
includes soft wicking fabric that absorbs and diverts urine away
from the patient's skin. Urine is then absorbed into the system's
core and suctioned into a collection canister.
[0005] The patented literature includes various systems and methods
for collecting and transporting urine away from a person's body,
such as: U.S. Pat. No. 4,610,675 (Triunfol); U.S. Pat. No.
4,747,166 (Kuntz); U.S. Pat. No. 5,678,564 (Lawrence et al.); U.S.
Pat. No. 5,894,608 (Birbara); U.S. Pat. No. 6,849,065 (Schmidt et
al.); U.S. Pat. No. 7,018,366 (Easter); U.S. Pat. No. 7,220,250
(Suzuki et al.); and U.S. Pat. No. 8,287,508 (Sanchez).
[0006] All of the references as cited herein are specifically
incorporated by reference
[0007] As will be appreciated by those skilled in the art, most
hospital suction regulators provide insufficient flow at low vacuum
pressures, like the 40 mmHg recommended for use with the
PUREWICK.RTM. female external catheter. Therefore nurses or other
care givers frequently increase the vacuum to get adequate urine
flow. However, the use of higher vacuum pressure poses an increased
risk to the patient, as the only opening in the circuit for air to
relieve the pressure is adjacent the patient's genitalia.
Accordingly, use of increased vacuum pressure to increase the flow
rate of urine being withdrawn into the canister runs the risk of
injury to the delicate issue adjacent the urethral opening.
[0008] Thus, a need exists for a system and method which is
efficient for removing urine from a patient using an external
catheter, wherein the flow rate is sufficiently high for increased
effectiveness, yet is produced by a suction level that is
sufficiently low to minimize the danger of injury to the delicate
tissue of the patient adjacent the patient's urethral opening. The
subject system addresses that need by providing a disposable
suction regulator configured for use between the female external
catheter and a canister coupled to a source of higher suction,
e.g., a regulator at the hospital's suction line. To that end the
disposable female external catheter suction regulator of this
invention is designed in such a way that it allows far greater flow
at low pressures than do the traditional wall regulators. As such,
it is intended to be placed in the same circuit, but between the
external catheter and the canister.
SUMMARY OF THE INVENTION
[0009] One aspect of this invention is a method for automatically
removing urine from a patient. The method comprises providing an
external catheter in fluid communication with a urethra opening of
the female, whereupon urine voided by the female is received by the
external catheter. A receptacle or canister is provided for
collecting urine. The receptacle or canister is coupled to a source
of suction providing suction having a first value. A suction
regulator is interposed between the external catheter and the
receptacle to apply the suction at the first value to the
regulator. The regulator is operated automatically to regulate the
amount of suction from the first value to a regulated value lower
than the first value and the regulated suction at the regulated
value is applied to the external catheter, whereupon urine from the
external catheter is carried through the suction regulator and into
the receptacle or canister.
[0010] In accordance with one preferred aspect of the method of
this invention the regulated value of suction is within the range
of approximately 40-175 mmHg.
[0011] In accordance with another preferred aspect of the method of
this invention the urine is carried through the suction regulator
into the receptacle at a flow rate up to approximately 100 standard
cubic feet per hour (SCFH) (which converts to 47 liters per minute
(LPM)).
[0012] In accordance with another preferred aspect of the method of
this invention the source of suction is provided at a wall suction
connector, and wherein the receptacle or canister is connected to
the wall suction connector without a regulator interposed between
the wall suction connector and the receptacle or canister.
[0013] In accordance with another preferred aspect of the method of
this invention the receptacle or canister is connected to the wall
suction connector via an adapter.
[0014] In accordance with another preferred aspect of the method of
this invention the adapter includes a valve configured to be in
either an open state or a closed state, wherein the method
comprises causing the valve to be in the open state whereupon the
source of suction is coupled to the receptacle or canister to
provide suction at the first value thereto.
[0015] In accordance with another preferred aspect of the method of
this invention the method comprises causing the valve to be in the
closed state whereupon the source of suction is isolated from the
receptacle or canister.
[0016] In accordance with another preferred aspect of the method of
this invention the adapter includes a coupler configured to be
connected to some component to provide suction thereto at the same
time that the valve is open and providing suction at the first
value to the receptacle or canister.
[0017] In accordance with another preferred aspect of the method of
this invention the receptacle or canister can be disposed at any
elevation with respect to the wall suction connector without
affecting optimal drainage of urine into the receptacle or
canister.
[0018] In accordance with another preferred aspect of the method of
this invention the urine is carried through the suction regulator
into the receptacle by air flow, wherein a differential pressure
between the external catheter and the suction regulator results,
and wherein a differential pressure of no more than approximately
55 mmHg provides an air flow rate of greater than 25 LPN.
[0019] In accordance with another preferred aspect of the method of
this invention the urine is carried through the suction regulator
into the receptacle by air flow, wherein a differential pressure
between the external catheter and the suction regulator results,
and wherein a differential pressure of no more than approximately
100 mmHg provides an air flow rate of greater than 35 LPN.
[0020] In accordance with another preferred aspect of the method of
this invention the urine is carried through the suction regulator
into the receptacle by air flow and wherein the rate of the air
flow is greater than 45 LPM.
[0021] In accordance with another preferred aspect of the method of
this invention the urine is carried through the suction regulator
into the receptacle by air flow and wherein a ratio the air flow
rate in LPM squared to the regulated value is at least 13.
DESCRIPTION OF THE DRAWING
[0022] FIG. 1 is an illustration of one exemplary system for
automatically removing urine from a patient constructed in
accordance with this invention;
[0023] FIG. 2 is an enlarged isometric view of one of the
components, i.e., a suction regulator, forming a portion of the
system of FIG. 1;
[0024] FIG. 3 is an exploded isometric view of the components
making up the suction regulator shown in FIG. 2;
[0025] FIG. 4 is an enlarged isometric view of one of the
components, i.e., a cap or lid, of the suction regulator shown in
FIG. 2;
[0026] FIG. 5 is an enlarged isometric view of another of the
components, i.e., a diaphragm, of the suction regulator shown in
FIG. 2;
[0027] FIG. 6 is an enlarged top plan view of another of the
components, i.e., a piston, of the suction regulator shown in FIG.
2;
[0028] FIG. 7 is a more enlarged isometric view of the piston shown
in FIG. 6;
[0029] FIG. 8 is an enlarged sectional view taken along line 8-8 of
FIG. 7;
[0030] FIG. 9 is an isometric view of another of the components,
i.e., a spring, of the suction regulator shown in FIG. 2;
[0031] FIG. 10 is an enlarged isometric view of another of the
components, i.e., a housing, of the suction regulator shown in FIG.
2;
[0032] FIG. 11 is an enlarged sectional view taken along line 11-11
of FIG. 2;
[0033] FIG. 12 is an enlarged sectional elevation view of the
portion of the suction regulator shown within the broken oval
designated by the reference number 12 in FIG. 11;
[0034] FIG. 13 is a sectional view, like that of FIG. 11, but
showing another exemplary embodiment of a suction regulator
constructed in accordance with this invention;
[0035] FIG. 14 is an enlarged sectional elevation view of the
portion of the suction regulator shown within the broken oval
designated by the reference number 14 in FIG. 13;
[0036] FIG. 15 is a sectional view taken along line 15-15 of FIG.
14;
[0037] FIG. 16 is an enlarged isometric view, partially in section,
of an alternative rolling diaphragm forming a portion of the
suction regulator of FIGS. 13-15;
[0038] FIG. 17 is an illustration of another exemplary system for
automatically removing urine from a patient constructed in
accordance with this invention wherein the system includes an
adapter connecting the system to a conventional threaded male wall
connector of a hospital suction line;
[0039] FIG. 18 is an enlarged front view of the adapter shown in
FIG. 17;
[0040] FIG. 19 is an end view of the adapter taken along line 19-19
of FIG. 18;
[0041] FIG. 20 is a longitudinal sectional view of the adapter
taken along line 20-20 of FIG. 19;
[0042] FIG. 21 is an enlarged isometric view of a valve member
forming a portion of the adapter shown in FIGS. 18-20;
[0043] FIG. 22 is an end view of the valve member shown in FIG.
21;
[0044] FIG. 23 is an illustration of still another exemplary system
for automatically removing urine from a patient constructed in
accordance with this invention wherein the system includes an
adapter and a splitter connecting the system to a conventional
threaded male wall connector of a hospital suction line to enable
the suction from the hospital's male wall connector to be used with
some other apparatus while the system of the subject invention is
connected to that wall connector;
[0045] FIG. 24 is an enlarged front view of the adapter and
splitter shown in FIG. 23;
[0046] FIG. 25 is a side view of the adapter and splitter shown in
FIG. 24;
[0047] FIG. 26 is an end view of the adapter and splitter taken
along line 26-26 of FIG. 25;
[0048] FIG. 27 is a longitudinal sectional view of the adapter and
splitter taken along line 27-27 of FIG. 26;
[0049] FIG. 28 is a side elevation view showing the adapter of
FIGS. 18-20 being mounted on a conventional externally threaded
connector of a port in the wall of a hospital or other care
facility providing line suction;
[0050] FIG. 29 is a side elevation view, similar to FIG. 28, but
showing the adapter with splitter of FIGS. 24-27 being mounted on a
conventional externally threaded connector of a port in the wall of
a hospital or other care facility providing line suction and with a
conventional suction regulator being mounted on the splitter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0051] Referring now to the various figures of the drawing wherein
like reference characters refer to like parts, there is shown in
FIG. 1 one exemplary embodiment of a system 20 constructed in
accordance with one exemplary preferred embodiment of this
invention for automatically removing urine from a female patient.
The system 20 may also be referred to as an external catheter urine
collection system and the details of its construction and operation
will be described later. Suffice it for now to state that the
system 20 basically comprises a urine wicking member or device 22,
a section 24 of conventional flexible suction tubing, a suction
regulator 26, another section 28 of conventional flexible suction
tubing, a urine collection suction receptacle or canister 30, and
still another section 32 of conventional flexible suction tubing.
The urine wicking device is preferably a female external catheter
that can be constructed like any of the external catheters of the
prior art described above. In the exemplary embodiment shown the
device 22 is constructed like the PUREWICK.RTM. female external
catheter.
[0052] The receptacle or canister 30 is of conventional
construction and includes a port (to be described later) that is
configured to be connected to suction source, e.g., a wall
regulator 10 of the hospital's main suction line. The wall
regulator 10 should be set to line vacuum or the maximum available
vacuum pressure if a line function is not available. The canister
30 includes another port (also to be described later) which is
connected to the proximal end of the tubing section 28. The distal
end of the tubing section 28 is connected to one port, hereinafter
identified as the "line suction port" 26A, of the suction regulator
26. The suction regulator 26 includes another port hereinafter
identified as the "regulated suction port" 26B, which is connected
to the proximal end of the tubing section 24. The distal end of the
tubing section 24 is connected to the external catheter 22.
[0053] As will also be described later the suction regulator 26 is
configured to enable fluid to flow through it from the external
catheter to the canister nearing the maximum the hospital's suction
line or regulator 10 is capable of sustaining without allowing the
pressure to rise above a desired operating value, e.g., 40 mmHg, of
the suction regulator 26 in the event the external catheter becomes
sealed against the patient. With the preferred circuit of the
system 20, i.e., with the suction regulator 26 located between the
external catheter 22 and the urine collecting canister 30, the
regulator 26 will be closer to the catheter 22 than if it was
located between the canister 30 and the hospital suction line or
regulator 10, thereby enabling the maximum possible urine flow, but
necessitates the urine flowing through the regulator. To that end,
the suction regulator 26 is intended to be a non-sterile,
single-patient-use disposable unit having a fixed (e.g.,
factory-established) regulated set-point value to be described
later.
[0054] The external catheter 22 basically comprises a soft,
elongated hollow flexible member 22A in which a body of soft gauze
22B is located. The member 22A includes a longitudinally extending
side window or opening 22C exposing the soft gauze body. The
external catheter is designed to be disposed between the woman
patient's separated gluteus and labia and in fluid communication
with her urethral opening. A suction port 22D is located at one end
of the member 22A and in fluid communication with the gauze body.
The suction port is configured to be connected to the distal end of
the tubing section 24, whereupon suction will be applied by that
tubing section to the interior of the member 22A, whereupon any
urine which the female patient had voided into the gauze body 22B
will be pulled into the suction tubing 24 and carried by air from
there to the suction regulator 26.
[0055] The suction receptacle or canister 30 is a conventional unit
which serves to collect by suction urine automatically removed from
the patient by the external catheter 22. To that end the receptacle
or canister 30 is coupled to the hospital suction line or a wall
mounted suction regulator 10 via the section of suction tubing 32.
In particular, the canister or receptacle includes an inlet port
30A to which the distal end of the tubing section 32 is connected.
In a typical application the length of the tubing section 32 is
approximately 6 feet, with the inner diameter of the passageway
through the tubing section 32 being approximately 0.25 inch. The
canister also includes an outlet port 30B to which the proximal end
of the tubing section 28 is connected. The line suction port 26A of
the suction regulator 26 is connected to the distal end of the
tubing section 28. In a typical application the length of the
tubing section 28 is approximately 3 feet with the inner diameter
of the passageway through the tubing section 28 being approximately
0.25 inch. The regulated suction port 26B of the suction regulator
26 is connected to the proximal end of the tubing section 24. The
distal end of the tubing section 24 is connected to suction port
22D of the external catheter 22. In a typical application the
length of the tubing section 24 is approximately 6 feet, with the
inner diameter of the passageway through the tubing section 24
being approximately 0.25 inch.
[0056] With the system 20 as just described when suction is applied
to the system 20 from the hospital's suction line or wall regulator
10, that high level of suction is conveyed through the canister and
the associated tubing section 28 to the line suction port 26A of
the suction regulator 26, whereupon it is regulated (e.g., reduced)
by operation of the suction regulator to a much lower operating
level, e.g., 40 mmHg. That reduced or regulated suction will appear
on the suction port 26B of the regulator and from there through the
associated tubing section 24 to the external catheter 22 to thereby
draw urine from the external catheter back through the tubing
section 24 into and through the regulator 26, and out through the
tubing section 28 into the receptacle or canister 30 for collection
therein. It should be noted that for many applications the
operating level is preferably approximately 40 mmHg. However, that
level could be raised up to approximately 80 mmHg, since some
hospitals are comfortable with higher vacuum pressures. As will be
appreciated by those skilled in the art the higher pressure makes
the height of the receptacle or canister 30 relative to the patient
less important.
[0057] If desired the system 20 may also include an overflow
detector of any suitable construction to provide an indication that
the amount of urine within receptacle has reached a predetermined
threshold, e.g., is about to overflow, and/or to provide a signal
to a controller (not shown) stop to halt the operation of the
system so that no further urine is drawn into the receptacle until
it can be emptied. For example, the canister 30 may include a shut
off float valve and/or a filter at outlet 30A to prevent possible
contamination of the hospital's main suction. Including a filter
can create a pressure drop across the filter. In such circumstances
it is advantageous to have the suction regulator 26 positioned
upstream of the filter in order to maximize airflow rate while
maintaining a low safe suction set-point.
[0058] The suction regulator 26 serves to ensure that a desired
level of suction is applied to the external catheter to ensure
proper and safe operation of the system, i.e., to maximize the rate
at which urine may be withdrawn from the catheter into the
receptacle or canister without subjecting the delicate tissue of
the woman at her urethral opening to injury, e.g., a hematoma, from
excess suction thereat.
[0059] Turning now to FIG. 3 the construction of the suction
regulator 26 will now be described. To that end as can be seen the
suction regulator basically comprises a label 34, a lid or cover
36, a flexible diaphragm 38, a piston 40, a sealing disk 42, a
helical compression spring 44, and a housing body 46. The lid or
cover 36 and the housing body 46 are configured to be connected
together, as will be described later, to form a hollow housing
assembly for housing the other components making up the regulator
26. The housing body 46 and the cover 36 are each formed of a rigid
plastic, such as ABS.
[0060] As best seen in FIGS. 3, 10, 11 and 12, the housing body 46
includes a circular annular sidewall 48 projecting upward from a
bottom wall 50. The circular sidewall extends about a central axis
X of the suction regulator. A tubular extension 46A extends
generally parallel to the undersurface of the bottom wall 50. The
tubular extension 46A forms the heretofore identified line suction
port 26A and includes a passageway 52 extending through it. The
passageway 52 includes a linear section 52A extending radially from
the axis X and whose outer or free end is open. Thus, that the
distal end of the tubing section 28 can be connected to the tubular
extension 46A whereupon the passageway extending through that
tubing section will be in fluid communication with the linear
passageway section 52A. The opposite end of the linear passageway
section 52 terminates in an axially directed passageway section 52B
centered about the axis X and terminates at the bottom wall 50. The
upper end of the passageway section 52B is open at 52C, with the
portion of the bottom wall 50 contiguous with the opening 52C
forming a beveled or conical surface valve seat 54. The opening 52C
is in fluid communication with a lower chamber 56 within the
interior of the suction regulator 26. The lower chamber 56 will be
described later. Suffice it for now to state that it is partially
defined by the inner surface of the annular sidewall 48 and the
diaphragm 38. Another tubular extension 46B projects radially
outward from the annular sidewall 48. That tubular extension forms
the heretofore identified line suction port 26B and includes a
passageway 58 extending through it. The passageway 58 extends
radially from the central axis X and parallel to the longitudinal
axis of the passageway section 52A. The outer or free end of the
passageway 58 is open. The inner end of the passageway 58
terminates at the sidewall 48 and is open and in fluid
communication with the lower chamber 56 of the suction regulator.
Thus, that the proximal end of the tubing section 24 can be
connected to the tubular extension 46B, whereupon the passageway
extending through that tubing section will be in fluid
communication with the passageway 58 and the lower chamber 56.
[0061] The lid or cover 36 is a generally cup-shaped member having
a top wall 60 and a circular annular sidewall 62. The sidewall
includes a pair of diametrically opposed notches 64 immediately
adjacent the lower edge of the sidewall. The notches are configured
to receive respective diametrically opposed projecting tabs 66 of
the housing body 46 to secure the lid or cover 36 to the housing
body 46 and thus complete the housing assembly. The sidewall 62 of
the lid or cover also includes an arcuate recess 68 (FIGS. 2 and 4)
in the lower edge of the sidewall located midway between the
notches 64. The recess 68 serves to receive the tubular extension
46B when the lid or cover is secured to the housing body.
[0062] The piston 40 is best seen in FIGS. 3, 6, 7 and 8 and
basically comprises a unitary body formed of a rigid plastic, such
as ABS. The body includes a central hub 70 whose top end terminates
in a circular flange 72. The top surface of the flange is planar,
but includes a circular recess 74 in the center thereof and
extending into the hub 70. A plurality of ribs 76 extend outward
radially from the hub and serve to reinforce the flange and center
the spring 44 about the central axis X. The bottom surface of the
hub 70 includes a recess 78 for receipt of the sealing disk 42. The
disk 42 is fixedly secured in the recess 78 on the underside of the
hub serves as a valve member to engage the valve seat 54 in the
lower chamber 56 when excess suction is applied (as will be
described later). The sealing disk 42 is formed of any suitable
material, e.g., silicone rubber.
[0063] The diaphragm 38 is a rolling diaphragm formed of any
resilient flexible material, e.g., Nitrile. The diaphragm includes
a generally planar circular central portion 80 and a folded
generally V-shaped or U-shaped edge portion 82 surrounding the
central portion and terminating in a flanged generally planar
thickened periphery 84. When fabricated the diaphragm is a molded
component which is somewhat flat, but whose peripheral edge portion
contiguous with the planar thickened periphery is everted (turned
inside out) to assume the shape shown in FIGS. 3, 5, and 11 for use
in the suction regulator 26. A small opening or hole 86 is located
in the center of the central portion 80. The central portion 80 is
disposed on the planar top surface of the piston 40, with the
thickened periphery 84 of the diaphragm disposed on an annular
ledge 88 at the upper end of the sidewall 48 of the housing body 46
between that ledge and the undersurface of the lid or cover 36.
With the lid or cover secured to the housing base 46 the thickened
periphery 84 of the diaphragm is tightly sandwiched between the
ledge and the inner surface of the lid or cover. This arrangement
divides the interior of the suction regulator into two chambers,
the heretofore identified lower chamber 56 and an upper chamber 90.
The upper chamber is formed between the inner surface of the cover
or lid and the upper surface of the diaphragm. The lower chamber 56
is formed between the inner surface of the sidewall 48 of the
housing body 46, and the undersurface of the portion of the
diaphragm located adjacent its periphery and a portion of the
undersurface of the piston.
[0064] The cover or lid includes a small opening or vent to the
ambient atmosphere which will be referred to as the atmospheric
reference port 92 (FIGS. 2 and 11). The atmospheric reference port
ensures that the upper chamber 90 will be at the pressure of the
ambient atmosphere. In particular, the port 92 extends through the
thickness of the cover and is in fluid communication with the
interior of upper chamber 90 to maintain that chamber at
atmospheric pressure. Inasmuch as the atmospheric reference port 92
is located in the top surface of the cover, it is susceptible to
being blocked or covered by a sticker, some other object or even
the finger of a user. To prevent such an occurrence the lid or
cover is shaped to prevent blockage of the port 92. In particular,
the lid or cover includes a thickened portion 94 located adjacent
the port 92 with an elongated shallow tripartite or T-shaped recess
or slot 96 extending into the thickened portion. The outer or top
end of the atmospheric reference port 92 is located at the bottom
of the slot 96 at the intersection of the slot's various three
sections and is in fluid communication with each of those sections.
The outer end of each of the slot sections is open. Thus, if
something should be on the top surface of the thickened portion 94
of the lid or cover disposed over the atmospheric reference port 92
air can still enter into that port via any open end of the T-shaped
slot 96.
[0065] The label 34, which is configured to bear indicia or
information regarding the suction regulator 26, e.g., the text and
graphics like shown in FIGS. 2 and 3, is fixedly secured within a
very shallow recess 98 (FIG. 4) in the top surface of the lid or
cover adjacent the thickened portion 94 so its presence does not
block the T-shaped slot 96.
[0066] The spring 44 is a helical compression spring formed of any
suitable material, e.g., stainless steel. As best seen in FIGS. 11
and 12, the spring is located within the lower chamber 56, with the
upper end of the spring in engagement with the undersurface of the
flanged portion 72 of the piston and surrounding a piston's central
hub 70 and with the lower end of the spring located within an
annular recess 100 in the bottom wall 50 of the housing body. The
spring is under compression to bias the piston and diaphragm
upward.
[0067] As mentioned above, the suction regulator 26 regulates the
level of suction to a desired operating value, e.g., 40 mmHg, and
provides the regulated suction to the external catheter (the urine
wicking member) 22. To that end, the regulator 26 is configured to
limit the amount of suction applied to the external catheter to
that desired value even if a level of suction greater than that
predetermined value is applied to the suction regulator from the
suction source (particularly if the suction source is at a much
higher level, which will typically be the case if the suction
source is the hospital's suction line). The predetermined or
desired suction value (hereinafter referred to has the "regulator's
set-point" or "regulated set-point value") is fixed and is
factory-established by the spring 44 and the dimensions of the
housing body 46, the cover or lid 36, the piston 40, the sealing
disk 42, and the stiffness of the diaphragm 38. In this regard the
pressure within the upper chamber 90 will be equal to atmospheric
pressure by virtue of the communication of that chamber with the
ambient atmosphere via the atmospheric reference port 92. With
suction applied, the pressure within the lower chamber 56 will be
lower than the atmospheric pressure within the upper chamber 90.
The differential pressure between the chambers 90 and 56 will force
the diaphragm 38 and the piston 40 downward toward the valve seat
54. The spring 44, however, will impart a counter force on the
piston and diaphragm that opposes the differential pressure force
forcing the piston downward such that the level of suction
appearing at the regulated suction port 46B is the desired
operating value, e.g., 40 mmHg.
[0068] If the suction applied via line suction port 26A is greater
that the predetermined value or level the piston 40 and diaphragm
38 will move such that the sealing disk 42 on the bottom of the
piston's hub 70 comes into engagement with the valve seat 54
thereby isolating the lower chamber 56 from the suction appearing
on the line suction port 26A. This action thereby limits the level
of suction in lower chamber and ultimately at external catheter 22
to the predetermined level (operating value). If, however, the
suction applied via line suction port is less than the
predetermined operating level the piston and diaphragm will only
move part of the way downward. As such the level of suction applied
to the line suction port 26A will equal that in the regulated
suction port 26B and that applied to the external catheter 22.
[0069] It should be pointed out at this juncture that the suction
regulator 26 is also configured to prevent the sealing disk 42 on
the bottom of the piston from becoming stuck for an extended period
of time on the valve seat 54 in the event of what will be referred
to hereinafter as an "over-travel situation". In this regard, it
has been determined that if the suction regulator 26 is operated in
a manner such that a high level of suction is applied very rapidly,
the piston may experience an over-travel wherein it moves downward
very quickly such that the sealing disk 42 on the underside of the
piston becomes stuck on the valve seat 54. Under this condition the
suction tubing section 24 to the external catheter would have a
higher level of vacuum (suction) than the regulator 26 was set to
provide, e.g., 40 mmHg. The regulator could stay in that state for
an extended/indefinite period of time, particularly if the external
catheter becomes blocked, e.g., its wicking portion is in tight
engagement with the vaginal tissue surrounding the urethral opening
and not over the urethral opening itself. To prevent such an
occurrence, the regulator 26 includes two "bleed holes". One bleed
hole is the heretofore identified small hole 86 located in the
center of the diaphragm 38. The second bleed hole 102 is located in
the piston 40.
[0070] As best seen in FIGS. 3, 6, 7 and 8 the cylindrical cavity
74 in the piston contiguous with the planar top surface of the
flanged portion 72 includes a radially extending recess. The bleed
hole 102 is located in that recess and extends through the flanged
portion of the piston to the underside of the flanged portion as
best seen in FIG. 7.
[0071] Since the bleed hole 86 in the diaphragm is located in the
center thereof, i.e., on the central axis X, it will overlie and be
in fluid communication with the cylindrical cavity 74 in the
piston. The recess 104 is in fluid communication with the
cylindrical cavity 74. Thus, the bleed hole 102 in the piston will
be in fluid communication with the bleed hole 86 in the diaphragm.
Since the bleed hole 86 in the diaphragm is in communication with
the upper chamber 90, that chamber will be in fluid communication
with the lower chamber 56 via the communicating bleed holes 86 and
102. Hence, if the sealing disk 42 on the bottom of the piston
should become stuck on the valve seat 54, air which enters into the
upper chamber 90 via the atmospheric reference port 92 can then
pass through the bleed hole 86 into the cylindrical cavity 74, and
from there through recess 104 into the bleed hole 102, from whence
it will enter into the lower chamber 56. The ingress of air into
the lower chamber will decrease the vacuum within that chamber,
thus enabling the spring 44 to move the piston 40 upward so that
the sealing disk 42 is off of the valve seat 54.
[0072] In accordance with one exemplary preferred embodiment of the
suction regulator 26, inner diameter of the lower chamber 56 is
approximately 1.5 inch. The inner diameter of the upper chamber is
approximately 1.5 inch. The spring is configured to naturally apply
a bias force of approximately 1.0 pound. The inner diameter of the
passageway 54 is approximately 0.25 inch. The inner diameter of the
passageway 58 is approximately 0.25 inch. The opening 52C located
within the bounds of the valve seat 54 is approximately 0.22 inch.
The atmospheric reference port 92 is approximately 0.035 inch in
diameter. The bleed hole 102 is approximately 0.016 inch in
diameter. The bleed hole 86 is approximately 0.062 inch in
diameter. Each tubing section 24, 28 and 30 is conventional having
an internal passageway of approximately 0.25 inch in diameter, and
each section is approximately six feet in length, but could be
shorter or longer depending upon the application. In any case with
a suction regulator sized as just described, in a system like that
described during typical operation the flow rate of air into
chamber 56 via bleed holes should be in the range of approximately
3 to 10 standard cubic feet per hour (SCFH). In fact, benchtop
testing suggests that one version of the system 20 of this
invention, making use of its disposable regulator 26 is capable of
air flow rates up to 100 SCFH as compared to the 15 SCFH rate
observed with some commercially available wall regulator set to the
suggested 40 mmHg. As is known the conversion between SCFH is that
a 1 SCFH flow is equivalent to 0.47 liters per minute (LMP) flow.
The additional flow allows for increased urine capture at the
interface of the actual catheter, faster drying of the catheter
(which helps prevent skin breakdown and infection) and pulls the
urine through the tubing into the canister 30 more efficiently.
This is especially true if the tubing drapes down below the height
of the patient and canister.
[0073] It must be pointed out at this juncture that the various
components of the system shown and described above are merely
exemplary of various components that may be used in accordance with
this invention to provide the capabilities as discussed above. For
example, the suction regulator 26 may be constructed somewhat
similarly to the suction controller 300 shown in FIGS. 9A and 10A
of pending U.S. application Ser. No. 14/227,587 entitled the
Gastric Sizing Systems Including Instruments And Methods Of
Bariatric Surgery filed on filed on Mar. 27, 2014, which is
assigned to the same assignee as this invention and whose
disclosure is specifically incorporated by reference herein. That
suction controller if used in a system like the subject invention
would be modified to omit the disk 314 and thus result in a cost
saving. In the invention of that pending '587 application the disk
314 is provided to seal off the system when positive pressure is
applied for leak testing. The system 20 of this invention and any
other system constructed in accordance with this invention will
never exceed atmospheric pressure, so a disk 314 is unnecessary.
Moreover, the suction controller 300 of the pending '587
application if used in a system like that of this invention will
need to be sized and configured to produce the desired regulated
suction value, e.g., 40 mmHg.
[0074] In FIGS. 13-15 there is shown an alternative embodiment of a
regulator 126 constructed in accordance with one preferred aspect
of this invention. The regulator 126 is identical in virtually all
respects to the regulator 26, except that the regulator 126 makes
use of an alternative flexible diaphragm 138 and the addition of a
noise suppression assembly 140. In the interest of brevity those
components of the regulator 126 which are common with the regulator
26 will be given the same reference numbers and the details of the
structure, arrangement and operation of those components will not
be reiterated.
[0075] The alternative diaphragm 138 is best seen in FIGS. 13 and
16, and like the diaphragm 38 is molded of a suitable material,
e.g., silicone. However, unlike the diaphragm 38 it is molded into
its ultimate shape and thus does not require any eversion of any
portion of it to be in its final shape state. In particular, as can
be seen in FIG. 16 the diaphragm 138 includes a generally planar
circular central portion 80 and a short height generally U-shaped
edge portion 182 surrounding the central portion and terminating in
a flanged generally periphery 184. The periphery 184 includes a
generally planar top surface 184A and an arcuate undersurface 184B.
The undersurface is configured to rest on the annular ledge 88 of
the housing. The U-shaped portion 182 is of a lower height than the
portion 82 of the diaphragm 38. The diaphragm 138 operates in the
same manner as the diaphragm 38 described above.
[0076] As should be appreciated by those skilled in the art, the
fact that the diaphragm 138 is in its natural molded shape and does
not require eversion of any portion of it renders the diaphragm
less prone to "creep" over time. If the material making up the
diaphragm were to "creep" due to the fact that a portion of the
diaphragm was everted, it could result in some drifting or
variation from the fixed set-point of the regulator. By eliminating
the eversion of the diaphragm, the tendency of the diaphragm to
creep over time is reduced, if not eliminated.
[0077] The diaphragm 138 does not include the heretofore identified
bleed port 86 at the center of the central portion 80 (or at any
other portion of the diaphragm 138 for that matter). The omission
of a bleed port in the diaphragm has been determined to be
acceptable for most applications, particularly if there is a
substantial length of tubing 24 connected between the suction
regulator and the external catheter. In this regard, it has been
determined that even if the operation of the system results in the
heretofore mentioned "over-travel" situation, the amount of suction
applied to the patient would likely not reach an dangerously high
level due to the substantial volume in the tubing 24 between the
suction regulator and the external catheter and the volume of air
within the external catheter. Moreover, there would likely be some
leakage of air into that volume by virtue of movement of the
patient breaking the seal around the catheter or by some leakage at
the connection points of the tubing 24 to the catheter and to the
suction regulator, whereupon the bias provided by the spring would
ultimately result in the lifting of the sealing disk 42 off of the
valve seat 54.
[0078] It has also been discovered that the regulator 26 may have a
tendency to produce a whistling sound during operation caused by
the flow of air fluid through it. In particular, the passageways 58
and 52A are offset from each other and interconnected by the
perpendicularly oriented passageway portion 52B, thereby creating a
tortuous flow path.
[0079] Thus, the flow of air through that tortuous path,
particularly if the air is flowing at a high rate of speed (which
is the case of with the subject invention) results in the
production of a high pitched whistling sound. Needless to say, that
result is undesirable, particularly in a hospital setting.
Accordingly, the regulator 128 includes the heretofore mentioned
sound suppressor assembly 140. That assembly basically comprises a
noise suppressor tube 142 and a screw 144 for mounting the tube.
The tube 142 is formed from an elongated strip of a multi-hook
fastener component, like that sold under the trademark VELCRO,
which has been bent or curled into an elongated tube 142, with the
hook-like projections 146 of the VELCRO strip extending generally
radially inward. The tube 142 is located in the passageway 52A and
fixedly secured in place by the screw 144. To that end, the screw
144 extends through the bottom wall 50 of the regulator, with the
head of the screw being located within the chamber 56. With the
tube 142 mounted as such the air flowing through the tube is
disturbed by the inwardly directed hook-like projections, which
action tends to suppress any noise that may have been created by
that air flow.
[0080] Turning now to FIGS. 17-20 and 28 there is shown another
exemplary preferred embodiment of the system 220 of this invention
for automatically removing urine from a female patient. The system
220 basically comprises the external catheter urine collection
system 20 described heretofore plus an adapter 222 for connecting
the system 20 to a hospital's line suction port connector. In the
interest of brevity the details of the construction, arrangement
and operation of the various components making up the external
catheter urine collection system 20 will not be reiterated. The
adapter 222 is configured to mount connect the system 20 to the
line suction port 12 of a hospital or some other facility providing
suction to a patient, like shown in FIG. 28. As can be seen in that
figure, the line suction port 12 includes a conventional externally
threaded connector 14. The connector 14 has a passageway (not
shown) through which suction from the hospital's line suction
source is provided.
[0081] The adapter 222 includes a generally L-shaped body formed of
any suitable material, e.g., Plated brass. The body of the adapter
includes a base section 224 and an elongated section 226. The
distal end of the elongated section 226 is in the form of a
conventional bubble barb 228 for receipt of the proximal end of the
tubing section 32. The elongated section 226 is of a generally
circular profile when viewed from the distal end thereof. A
generally L-shaped passageway is located in the body of the adapter
222. The L-shaped passageway includes a linear passageway section
230 extending through the bubble barb and through the elongated
section centered on the central longitudinal axis of the elongated
section. The proximal end of the passageway section 230 merges with
and is in fluid communication with a passageway section 232. The
passageway section 232 extends perpendicularly to the passageway
section 230 and terminates in a larger diameter internally threaded
bore 234. The internally threaded bore 234 serves as the inlet to
the adapter 222 and is configured to receive the external threads
of the hospital's wall connector 14 to mount the adapter 222 onto
the line suction port 12. The internal diameter of the passageway
section 232 preferably matches the internal diameter of the
passageway extending through the line suction connector 14, e.g.,
0.2 in. The internal diameter of the passageway section 230 is the
same as the internal diameter of the passageway section 232.
[0082] The adapter 222 includes a valve 236 configured to be in
either an open or closed position. When in the closed position (to
be described shortly) the valve closes or blocks the passageway
section 230 to isolate the passageway in the bubble barb 228 from
the line suction provided at the connector 14, When the valve is
open the passageway section 230 is unblocked so that the line
suction provided at the connector 14 appears at the passageway in
the bubble barb and hence is provided to the external catheter
urine collection system 20. The valve 236 is best seen in FIGS. 21
and 22 and is a rotatable integral member, formed of any suitable
material, e.g., Plated brass The valve basically comprises a
cylindrical shaft 238, a hub 240 and a handle 242. The cylindrical
shaft 238 is located within a correspondingly shaped cylindrical
bore 244 (FIG. 20) intersecting the passageway section 230
perpendicularly thereto. A central axis Y extends through the bore
244 and serves as the rotation axis about which the shaft 238 of
the valve rotates when the valve is moved from its closed state to
its open state, and vice versa. The shaft 238 includes a hole 246
extending diametrically through it. The internal diameter of the
hole 246 is the same as the internal diameter of the passageway
section 230. The upper end of the shaft terminates in the hub 240,
which is of slightly larger diameter than the diameter of the
shaft. A generally planar handle 242 projects radially outward from
the hub. The handle is configured to be rotated either clockwise or
counterclockwise about the axis Y to either open the valve or close
it. In particular, when the handle is rotated to the position
wherein the hole 246 of the valve is axially aligned with the
passageway 230 (e.g., the handle extending parallel to the
elongated section 226), the valve will be in its open state so that
suction is applied from the passageway section 232 to the
passageway section 230 in the bubble barb 228. When the handle of
the valve is rotated to the position wherein no portion of the hole
246 of the shaft is in communication with the passageway 230 (e.g.,
the handle extending perpendicular to the elongated section 226)
suction appearing at the connector 14 will be isolated from the
system 20.
[0083] In as much as the adapter 222 when mounted on the connector
14 of the port 12 to connect the external catheter urine collection
system 20 to the line suction at the port will take that port out
of service for uses other than removing urine from the patient via
the external catheter 22, this invention also contemplates use of
another adapter enables the port 12 to be used with another suction
device at the same time it is used with the system 20. To that end,
FIG. 23 shows still another exemplary system 320 constructed in
accordance with this invention for automatically removing urine
from a patient and which includes an adapter/splitter 322 to enable
some other suction-required device to access the line suction
provided at the connector 14 of port 12 all the while the external
catheter urine collection system 20 is connected to that connector
by the adapter/splitter. The system 320 basically comprises the
external catheter urine collection system 20 system 20 described
heretofore plus the adapter/splitter unit 322. As in the case of
the system 220, in the interest of brevity the details of the
construction and operation of the various components making up the
external catheter urine collection system 20 will not be
reiterated.
[0084] As best seen in FIG. 29, the adapter/splitter 322 is
configured to connect the external catheter urine collection system
20 to the threaded connector 14 of line suction port 12 of a
hospital (or some other facility providing suction to a patient).
The adapter/splitter 322 is in many ways identical in construction
to the adapter 222, but also includes an externally threaded
connector 324 having a passageway section 326 extending through it.
The externally threaded connector 326 and its passageway section
326 together form the splitter portion of the adapter/splitter 322,
thus providing another site at which the hospital's line suction is
available. For example, as will be described shortly the externally
threaded connector 324 can serve as the means for connecting and
mounting a conventional suction regulator 400 thereon to control
suction to some other device or equipment serving the patient.
[0085] In as much as the splitter adapter 322 is very similar in
construction to the adapter 222 in the interest of brevity the
common components of the adapter 322 and the adapter/splitter 222
will be given the same reference numbers and the details of their
structure, arrangement and operation will not be reiterated. Thus,
as can be seen in FIGS. 24-26 the top of the base section 224 of
the adapter/splitter 322 includes the heretofore identified
externally threaded connector 324. As best seen in FIG. 27, the
passageway section 326 is centered in the connector 324 and is
coaxial and aligned with the passageway section 232 so that the
sections 326 and 232 are in fluid communication with each other. As
such passageway section 326 serves to bring suction from the line
suction connector 14 to any device that may be connected to the
externally threaded connector 324 irrespective of whether or not
the valve 236 of the adapter/splitter 322 is open or closed. The
internal diameter of the passageway section 326 is preferably the
same as the internal diameter of the passageway sections 232 and
230.
[0086] Turning now to FIG. 29, the connector 324 of the
adapter/splitter 322 is shown being connected to an internally
threaded bore (not shown) of an exemplary suction regulator 400.
The exemplary suction regulator 400 shown in FIG. 29 is a
conventional suction regulator like that sold by Boehringer
Laboratories, LLC, the assignee of the subject invention, under the
model designation 3844. Other suction regulators available from the
assignee of this invention as well as other manufacturers can be
used by being connected to the threaded connector 324. Thus, while
the system 320 is connected to the bubble barb 228 so that it can
be used to withdraw urine from a patient via system 20, suction can
be provided from the suction regulator 400 mounted on the connector
324 of the adapter/splitter 322 to provide suction for some other
use. To that end, the suction regulator 400 includes a bubble barb
402 for disposition within an open proximal end of a tubing section
404, which will provide suction for some other application for the
patient.
[0087] As should be appreciated from the discussion above the
external catheter urine collection system of this invention and its
method of use provides superior air flow through the external
catheter. That feature is of considerable importance for
transporting urine away from the patient. With prior art systems,
if airflow is not adequate urine may spill out of the external
catheter and the external catheter will remain damp against the
patient's skin. By increasing the airflow through the catheter, as
achieved by the suction regulator of the system of this invention,
urine is more efficiently captured by the external catheter and
leaks are reduced. Additionally, the improved air flow results in a
drier external catheter helping to avoid skin maceration. Prior to
the subject invention with a differential pressure of 55 mmHg
applied to a typical flow circuit between the female external
catheter and the collection canister of a prior art device a
typical flow rate of 13 LPM (liters per minute) resulted. With the
subject invention using three feet of 1/4 inch tubing between the
suction regulator of this invention and the external female
catheter, a flow rate of 62 LPM was achieved with a differential
pressure of 55 mmHg applied to the circuit. An adjustable hospital
wall regulator like the Boehringer model 3844 identified above may
provide free air flow rates of no more than: 18LPM when set to 55
mmHg, 59 LPM when set to 120 mmHg, 64 LPM when set to 175 mmHg. The
regulator of the subject invention provides a free airflow rate of
approximately 100 LPM when factory calibrated to 55 mmHg
differential pressure, approximately 101 LPM when calibrated to 120
mmHg differential pressure and approximately 102 LPM when
calibrated to 175 mmHg differential pressure In fact, the subject
invention enables an air flow rate of at least approximately 25 LPM
with a differential pressure set to no more than 55 mmHg, an air
flow rate of at least 35 LPM with a differential pressure set to no
more than 100 mmHg, and a free flow rate of 60 LPM or more with
higher differential pressures. Moreover, the system of this
invention results in a ratio of the air flow rate (in LPM) squared
to the pressure setting of the regulator (in mmHg) to be
approximately at least 13. Those characteristics of the subject
invention provide considerable advantages over the prior art.
[0088] Other advantages result from the external catheter urine
collection system and its method of use. For example, since the
suction regulator of this invention has a fixed regulated set-point
value, users of the system do not have to pick and set a particular
value for the suction to be applied to the patient's external
catheter. As such a safe level of suction will be automatically be
applied to the patient by the suction regulator without requiring
hospital personnel or other operators to set the desired value of
suction to be applied by the external catheter. Moreover, since the
suction regulator has a fixed regulated set-point value, there is
no need for it to include any dials or other indicators to provide
the hospital personnel or other operators with a reading of the
suction level being applied so that they could set the regulator to
the desired set-point value. Accordingly, suction regulator
constructed in accordance with this can be simple in construction,
low in cost and easy to use. Also, since the suction regulator of
the external catheter urine collection system of this invention
provides controlled suction to the external catheter, the
receptacle or container can be directly connected to the suction
source, e.g., a hospital's wall line suction connector, without any
other suction regulator to be interposed between that wall
connector and the receptacle or canister, thereby reducing the need
for additional capital purchases. Further still, since the suction
regulator of this invention automatically applies a controlled
level of suction to the patient the receptacle or canister can be
located at any height with respect to the wall connector all the
while ensuring that optimal drainage of urine into the receptacle
or container is achieved. The use of a wall suction adapter, with
or without a splitter, to connect the external catheter urine
collection system to the line suction connector of the hospital or
other care facility enables the external catheter urine collection
system of this invention to be readily isolated from the hospital's
suction line when desired. If the wall suction adapter includes a
splitter like described above the hospital's line suction connector
can be used to provide suction to some other device at the same
time that it is providing suction to the external catheter urine
collection system of this invention.
[0089] It must be pointed out at this juncture that various changes
can be made to external catheter urine collection systems of this
invention, in addition to changes in the suction regulators 26 and
126 and in the adapters 222 and 322. For example, while not
preferred, it is contemplated that the suction regulator 26 could
be located between the canister and the hospital suction source.
However, such an arrangement will result in decreased urine flow
due to the increased resistance of the longer flow path. Another
alternative system contemplated by this invention entails
integrating the suction regulator 26 (or a modification thereof)
into the suction receptacle or canister 30. That alternative system
would obviate the need for the suction tubing section 28 and
decrease the number of components needed for the circuit, but may
not make economic sense due to the commoditization of existing
canisters. Still another alternative system of this invention
contemplated entails designing an alternative external catheter or
urine wicking device which has a regulator like that of the subject
invention (or a modification thereof) built into it. That device
should result in the absolute maximum urine flow possible, but
would necessitate more frequent disposal of the regulator
components (external catheters are changed multiple times per day),
driving up the cost to users. Further still, some hospitals in
which the subject system will be used have special regulator
set-ups that allow for connection of a suction canister directly
below the wall regulator. In such a case the tubing section 32 of
the system 20 of this invention may be omitted. Also, it should be
pointed out that the systems of this invention are not limited to
use in hospitals, but can be used in any facility providing care to
a female patient.
[0090] Without further elaboration the foregoing will so fully
illustrate our invention that others may, by applying current or
future knowledge, adopt the same for use under various conditions
of service.
* * * * *