U.S. patent application number 16/133078 was filed with the patent office on 2019-01-17 for methods and devices for aseptic irrigation, urine sampling, and flow control of urine from a catheterized bladder.
The applicant listed for this patent is Hospi Corporation. Invention is credited to Igal Ladabaum, Bradford Macy, JR..
Application Number | 20190015626 16/133078 |
Document ID | / |
Family ID | 54264211 |
Filed Date | 2019-01-17 |
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United States Patent
Application |
20190015626 |
Kind Code |
A1 |
Macy, JR.; Bradford ; et
al. |
January 17, 2019 |
METHODS AND DEVICES FOR ASEPTIC IRRIGATION, URINE SAMPLING, AND
FLOW CONTROL OF URINE FROM A CATHETERIZED BLADDER
Abstract
A connector system includes a catheter connector port to attach
to a urinary catheter, a urine exit port to connect to a urine
collection device, an irrigation port to receive an irrigation
syringe, and an internal valve. The irrigation port includes a
pliable membrane that has a self-sealing opening to allow a tip of
the syringe to extend therethrough. The internal valve cooperates
with the syringe to shut off flow of fluid to the urine exit port
when the syringe is inserted and allow for flow of fluid to the
urine exit port when the syringe is removed. A distance between a
proximal surface of the membrane and a distal end of the internal
valve is such that the tip of the syringe can extend from a
proximal end of the self-sealing opening to the distal end of the
internal valve.
Inventors: |
Macy, JR.; Bradford;
(Concord, CA) ; Ladabaum; Igal; (San Carlos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hospi Corporation |
Newark |
CA |
US |
|
|
Family ID: |
54264211 |
Appl. No.: |
16/133078 |
Filed: |
September 17, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14747972 |
Jun 23, 2015 |
10076635 |
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16133078 |
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13414205 |
Mar 7, 2012 |
9060752 |
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14747972 |
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61464705 |
Mar 8, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/162 20130101;
A61M 39/105 20130101; A61M 25/0017 20130101; A61F 5/442 20130101;
A61B 10/007 20130101; A61F 5/4405 20130101; A61M 2025/0019
20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 39/10 20060101 A61M039/10; A61B 10/00 20060101
A61B010/00; A61M 39/16 20060101 A61M039/16 |
Claims
1. A method of irrigating a urinary catheter comprising: draining
urine from an indwelling urinary catheter through a catheter
connector port, a channel and out through a urine exit port;
simultaneously opening an irrigation port and closing off flow to
the urine exit port; and injecting irrigation fluid through the
irrigation port, the channel, the catheter connector port and into
the catheter.
2. The method of claim 1, wherein the irrigation port surface is
sanitized prior to insertion of the irrigation syringe.
3. The method of claim 1, further comprising simultaneously closing
the irrigation port and opening the urine exit port, thereby
allowing urine to drain from the indwelling urinary catheter
through the channel and out the urine exit port.
4. The method of claim 1, wherein the step of simultaneously
opening the irrigation port and closing the urine exit port
comprises moving a valve from a first position in which the urine
exit port is in fluid communication with the catheter connector
port to a second position in which the urine exit port is not in
fluid communication with the catheter connector port.
5. The method of claim 4, wherein the moving step comprises moving
the valve with a distal tip of a syringe.
6. The method of claim 5, further comprising inserting the syringe
through a self-sealing opening in the irrigation port.
7. The method of claim 1, wherein the step of simultaneously
opening the irrigation port and closing the urine exit port
comprises inserting a syringe through the irrigation port and into
a valve.
8. The method of claim 7, wherein the step of simultaneously
opening the irrigation port and closing the urine exit port further
comprises seating an outside surface of the syringe in a valve seat
of the valve.
9. A method of operating a urinary catheter system comprising:
establishing flow of urine from an indwelling urinary catheter
through a connector and into a drainage bag; actuating a valve to
stop the urine flow; and permitting the valve to automatically open
after a time period without operator intervention.
10. The method of claim 9, wherein the actuating step comprises
expanding a balloon to block flow through the connector.
11. The method of claim 10, wherein the permitting step comprises
permitting the balloon to deflate.
12. The method of claim 10, wherein the expanding step comprises
compressing a valve actuation chamber.
13. The method of claim 10, wherein the expanding step comprises
injecting fluid into the balloon with a syringe.
14. A method of operating a urinary catheter system comprising:
establishing flow of urine from an indwelling urinary catheter
through a connector and valve opening and into a urine drainage
connector; inflating a balloon manually to stop the urine flow
through the valve opening and drainage connector; and deflating the
balloon manually to allow urine to flow through the valve opening
and drainage connector.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/747,972, titled "METHODS AND DEVICES FOR
ASEPTIC IRRIGATION, URINE SAMPLING, AND FLOW CONTROL OF URINE FROM
A CATHETERIZED BLADDER," filed on Jun. 23, 2015, now U.S. Pat. No.
10,076,635, which is a continuation-in-part of U.S. patent
application Ser. No. 13/414,205, titled "METHODS AND DEVICES FOR
ASEPTIC IRRIGATION, URINE SAMPLING, AND FLOW CONTROL OF URINE FROM
A CATHETERIZED BLADDER," filed Mar. 7, 2012, now U.S. Pat. No.
9,060,752, which claims the benefit under 35 U.S.C. .sctn. 119 of
U.S. Provisional Patent Application No. 61/464,705, titled
"`SELF-CLOSING PORT AND VALVE ASSEMBLY` AN APPARATUS FOR IMPROVED
IRRIGATION AND DRAINAGE OF THE CATHETERIZED BLADDER," filed Mar. 8,
2011, the disclosure of which is incorporated herein by
reference.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD
[0003] This invention relates to methods, systems, and apparatuses
to assist with the irrigation, urine sampling, and drainage of the
catheterized bladder, and more particularly, but not limited to,
aseptic methods, systems, and apparatuses to assist with improved
irrigation, urine sampling, and drainage of the catheterized
bladder.
BACKGROUND
[0004] Existing urinary catheter technology results in numerous
health and safety issues for patients, medical personnel, and the
community at large. The technology of indwelling urinary catheters
has barely changed over the last 50 years. Improvements in existing
urinary catheter systems are highly desirable. A urinary catheter
drainage system is made up of the catheter itself, which is
inserted into the bladder, and the urine collection device, which
attaches to the catheter with tubing and collects the urine into a
receptacle. One example of a urine collection device is a bedside
drainage bag, which usually includes a tube connected to the
catheter leading to a large bag that hangs on the bedside to
collect the urine. Another example is a leg bag, which is worn when
a patient is up and around and includes a shorter tube attached to
a smaller bag that is attached to the leg and collects urine.
[0005] The complications associated with catheterization of the
bladder include catheter associated urinary tract infections
(CAUTI's), blockage (due to struvite or biofilm formation), bladder
atony (causing a short term or permanent inability to void),
bladder spasms, and thickening of the bladder wall from long term
use.
[0006] In addition to direct patient complications, there are
numerous safety issues related to current urinary catheter systems,
both in the inpatient setting and in the home health setting.
Present systems put clinicians at risk of occupational injury
related to bio-hazardous waste exposure. Clinicians are frequently
sprayed with urine when attempting to irrigate clogged catheters,
such as when pressure from the irrigation syringe causes swelling
of the catheter and spray back to occur. Because the current
available catheter technology demands that the catheter be
disconnected from the urine collection device in order to irrigate
the system, leaking or spilling of urine often occurs during these
procedures. When these spills and splashes occur, clinicians, other
patients, and the community at large are put at risk for cross
contamination and the spread of infection, including antibiotic
resistant pathogens.
[0007] In summary, most of the problems listed above arise, at
least in part, from two primary problems with existing catheter
systems: (1) Current catheter systems do not allow for the
maintenance of a closed, aseptic system; and (2) Current catheter
systems do not allow the bladder to fill and empty in a normal
fashion.
[0008] About 30% of CAUTI's are shown to be caused by intraluminal
bacterial biofilm formation. The primary way that bacteria enter
the inner lumen to cause infection is by entering the drainage end
of the catheter and ascending the inner lumen to the bladder. The
2009 CDC Healthcare Infection Control Practices Advisory Committee
(HICPAH) listed a closed urinary drainage system for all catheters
as a high priority recommendation, essential for all healthcare
organizations caring for patients with catheters. They found both
older and more recent data indicating that disconnection of the
urine collection device from the catheter is a risk factor for
bacteriuria.
[0009] In order to maintain a closed urinary drainage system, the
catheter generally should not be disconnected from the urine
collection device. The most common reason for disconnecting the
catheter from the urine collection device is when the catheter
needs to be irrigated. Many catheters need to be irrigated several
times a day, requiring disconnection of the catheter from the urine
collection device and exposing the patient to infection and the
clinician to bio-hazardous waste repeatedly.
[0010] In order to address the specific problem associated with
closed irrigation of a catheter, Russo U.S. Patent Application Pub.
No. US 2006/0064065 discloses a closed system irrigation connector
for urinary catheters includes a silicone diaphragm that opens when
an irrigation device is attached and closes when it is removed.
However, the device of Russo does not provide for an aseptic
irrigation procedure. In order to maintain an aseptic closed
system, anything entering the system should be free of bacteria.
This means that the system would ideally have entrance portals that
are closed while not being accessed and that are fully sanitizable
prior to access.
[0011] In order to effectively sanitize a surface, the surface
should be easily and fully accessible to apply the needed friction
and anti-infective agent. The surface should not have crevices or
difficult to reach places, as asperities, steps and other such
features can trap bacteria and grow biofilm while remaining
shielded from the sanitizing effects of the alcohol swab. The
plastic entrance port disclosed by Russo does not have a flat,
easily sanitizable surface, but has a crevice that cannot be
effectively sanitized. Bacteria hiding on this un-sanitizable
surface can enter the system during irrigation and infect the
patient.
[0012] The second major problem with current catheter systems is
that they drain the bladder constantly, not allowing it to fill and
empty in a normal manner. This leaves a pool of concentrated,
stagnant urine in the neck of the bladder below the drainage holes
on the catheter. This stagnant urine serves to create a perfect
breeding ground for bacteria. Catheter blockage is another problem
with "constant drain" catheter systems and is caused by the buildup
of biofilm and salt crystals at the opening of the catheter. Much
like a stalactite, the high pH, high mineral fluid in the neck of
the bladder provides the perfect environment for this to occur.
Bladder spasms can be caused by several factors associated with
constant drain systems. The most frequent cause is CAUTI, as
already discussed above. With CAUTI, the bladder wall becomes
irritated and even swells, causing spasms. The loss of normal
stretching and contracting of the detrusor can also cause spasms.
Irritation from highly concentrated and high pH urine can also be
factor. Bladder wall thickening has also been observed in long-term
catheterizations and may be a result of the increasing retention of
urine. Catheter-related bladder atony is another complication
associated with not allowing the bladder to fill and empty. When
the bladder no longer fills and empties in a normal fashion, the
detrusor muscle can atrophy, causing a temporary or even permanent
inability to void after catheterization. These problems could be
solved, at least in part, by allowing the bladder to fill and drain
in a more normal fashion.
[0013] Many types of valved catheters and universal connections
exist that allow for intermittent draining and retention of the
bladder. None of the prior art in this area discloses sanitizable
surfaces on entry ports leading from the outside to the inside of
the closed urinary drainage system. These prior art systems thus
often complicate the problem by introducing bacteria into what
should be a closed system. A system, method, and apparatus is
needed that allows for aseptic irrigation and urine sampling while
maintaining a closed system, while allowing for control of urine
flow, permitting the bladder to fill and empty as needed or
prescribed.
[0014] Moreover, disconnection of the urine collection device from
the catheter is also desirable for many practical reasons, even if
not required for aseptic irrigation and sampling. For example, the
need to disconnect the urine collection device arises in the
following situations, which can occur several times per day: [0015]
1. When the drainage bag needs to be replaced with a new bag.
[0016] 2. When a patient changes the clothing or underclothing on
the lower part of their body. [0017] 3. When a patient switches
from a bedside urinary drainage bag to a leg drainage bag or vice
versa. [0018] 4. When it is desirous to temporarily disconnect a
urinary collection device from the catheter portion of the system
for tests, transfers, bathing and numerous other purposes. [0019]
5. When a patient must have a urinary catheter but desires to avoid
being connected a urinary collection device for a given time
period.
[0020] In order to reuse a urine collection device once it has been
disconnected from the system, the connecting end of the urine
collection device has to be fully protected from contamination and
not come into surface contact with any other non-aseptic surface
per the principles of asepsis. It is not adequate to simply swab an
exposed unprotected end of a urine collection device that was
disconnected from the system with a disinfectant prior to
reconnection to the catheter end. This is because the urine
collection device is open at the connection end, and bacteria can
enter the inside of the urine collection device, which is not
sanitizable. Reusable protective covers or sheaths are currently
employed to cover the connecting end of the urine collection device
when it has been disconnected from the catheter end of the system.
However, these reusable covers are generally not adequate and tend
to lead to contamination of the system. This is because the covers
can be contaminated in between uses and are not sanitizable on the
inside surface that comes into contact with the connecting end. As
a result, the covers can introduce bacteria to the surface of the
connecting end of the urine collection device.
[0021] An improved connector system is therefore needed to allow
for aseptic disconnection and reconnection of the urine collection
device from the catheter in all of the above circumstances while
maintaining a closed urinary drainage system under these
circumstances.
[0022] It is therefore desirable to provide an improved urinary
drainage connector system that allows for aseptic disconnection and
reconnection of the urine collection device from the catheter, in
addition to a system that obviates the need for disconnection
during irrigation/sampling.
SUMMARY OF THE DISCLOSURE
[0023] Systems, methods, and apparatuses for improved aseptic
irrigation, urine sampling, and flow control of urine from the
catheterized bladder are disclosed. The disclosed invention, also
referred to for the purposes of easy reference only, as a port and
valve assembly, allows for aseptic irrigation and urine sampling of
the catheterized bladder without disconnecting the catheter from
the drainage bag by including a sanitizable self-closing port and
allowing for bypassing of the drainage bag during irrigation. An
irrigation syringe, irrigating device, or urine sampling device can
be inserted into a self-closing port on the apparatus to irrigate
or urine sample the bladder without disconnection of the catheter
from the urine collection device, and the bladder can be irrigated
or urine sampled while maintaining a closed, aseptic system. When
the syringe is removed, the port closes. The flat closed surface of
the port is easily sanitizable with standard medical sanitizer,
such as 70% alcohol, so bacteria cannot enter the system when a
device is attached. This allows for aseptic access to the interior
of the urinary catheter system so that irrigation can be performed
without contamination of the urinary drainage system by bacteria or
exposure to body fluids and infectious waste.
[0024] Another aspect of the invention employs an inner mechanism
that prohibits shuts the flow of fluid to the urine collection
device while an irrigation syringe, irrigation device, or
collection device is inserted in the port. This mechanism allows
for effective irrigation and urine sampling of the catheter and
bladder without fluid or air being shunted into, or pulled from,
the drainage collection device. Shutting flow off from the urine
collection device is essential for irrigating a catheter that is
attached to the urine collection device. If not done, fluid would
flow into the collection device and not the catheter being
irrigated. The system disclosed herein makes the collection of
urine samples easy by sealing the urine collection device end,
allowing for suction of urine from the bladder.
[0025] In yet another aspect, within some embodiments of the
present invention, the system and apparatus has an externally
controlled mechanism to shut off the flow of urine from the bladder
to the urine collection device for a prescribed adjustable period
of time, enabling the bladder to fill and empty in a more normal
fashion. This feature is important because it allows clinicians to
set the amount of time for bladder filling, without worrying about
releasing the urine at a particular time, an important safety and
convenience feature. This feature also allows for bladder training
of patients, allowing for increased increments of time in which the
bladder can fill with urine, thus slowly training the bladder to
hold more urine before needing to empty.
[0026] The improved utilities of the present invention can decrease
the chance of urinary tract infection or bladder atony, decrease
the risk of blood and body fluid exposure, and greatly simplify the
procedure of bladder irrigation of the catheterized patient.
[0027] One aspect of the invention provides a urinary catheter
connector system having a housing, a catheter connector port
supported by the housing and configured to attach to a urinary
catheter, a urine exit port supported by the housing and configured
to connect to a urine collection device, an irrigation port
supported by the housing and configured to receive an irrigation
syringe, a channel in the housing fluidly connecting the catheter
connector port, the urine exit port and the irrigation port, and a
valve supported by the housing and adapted to cooperate with the
irrigation syringe to shut off flow of fluid and air to the urine
exit port when the irrigation syringe is inserted and allow for
flow of fluid and air to the urine exit port when the irrigation
syringe is removed. In some embodiments, the valve has a first
position in which the urine collection device is in fluid
communication with the catheter connector port and a second
position in which the urine collection device is not in fluid
communication with the catheter connector port. The valve may be
biased to the first position by, e.g., a spring. The valve may also
be adapted to be moved from the first position to the second
position by a syringe tip inserted into the irrigation port.
[0028] In some embodiments, the valve includes a thickening in the
wall of the housing, wherein the thickening decreases the diameter
of the channel and is configured to approximate the size of the tip
of an irrigation syringe and to mate snugly with the irrigation
syringe. When the irrigation syringe is inserted into the valve,
the urine collection device is not in fluid communication with the
catheter connector port, and when the syringe is not inserted in
the valve opening, the urine collection device is in fluid
communication with the catheter connection port. In some
embodiments, the valve has a valve seat adapt to mate with an
exterior surface of the irrigation syringe to shut off the flow of
fluid and air to the urine exit port when the irrigation syringe is
inserted and allow for the flow of fluid and air to the urine exit
port when the irrigation syringe is removed.
[0029] Some embodiments of the invention also include a valve
control mechanism adapted to move the valve from the first position
to the second position without inserting a device into the
irrigation port. The valve control mechanism may be adapted to
automatically permit the valve to move from the second position to
the first position after a time period without operator
intervention. In some embodiments, the valve control mechanism
includes a compliant balloon.
[0030] Some embodiments of the invention have a valve control
mechanism with a compliant balloon adapted to be inflated to close
the valve. Some such embodiments also include a compressible
fluid-filled actuation chamber, first and second passages
connecting the actuation chamber with the interior of the balloon,
and a one-way valve disposed in the first passage to permit fluid
flow from the actuation chamber into the balloon and block fluid
flow from the balloon into the actuation chamber. The valve control
mechanism may also have a syringe port adapted to permit inflation
of the balloon by a syringe.
[0031] Some embodiments of the invention also have a pliable
membrane extending over the irrigation port. The membrane has a
self-sealing opening adapted to permit insertion of a syringe tip.
In some embodiments, the irrigation port has an exterior surface
that is flat and completely exposable to friction applied with a
medical sanitizing agent so that the irrigation port is fully
sanitizable. The irrigation port may connect to the channel between
the catheter connection port and the urine exit port.
[0032] Another aspect of the invention provides a method of
irrigating a urinary catheter, including the steps of: draining
urine from an indwelling urinary catheter through a catheter
connector port, a channel, and out through a urine exit port;
simultaneously opening an irrigation port and closing off flow to
the urine exit port; and injecting irrigation fluid through the
irrigation port, the channel, the catheter connector port and into
the catheter. In some embodiments, the irrigation port surface is
sanitized prior to insertion of the irrigation syringe. In some
embodiments, the method also includes the step of simultaneously
closing the irrigation port and opening the urine exit port,
thereby allowing urine to drain from the indwelling urinary
catheter through the channel and out the urine exit port.
[0033] In some embodiments, the step of simultaneously opening the
irrigation port and closing the urine exit port includes the step
of moving a valve from a first position in which the urine exit
port is in fluid communication with the catheter connector port to
a second position in which the urine exit port is not in fluid
communication with the catheter connector port. The moving step may
include the step of moving the valve with a distal tip of a
syringe. The method may also include the step of inserting the
syringe through a self-sealing opening in the irrigation port.
[0034] In some embodiments, the step of simultaneously opening the
irrigation port and closing the urine exit port includes the step
of inserting a syringe through the irrigation port and into a
valve. In some such embodiments, the step of simultaneously opening
the irrigation port and closing the urine exit port further
includes the step of seating an outside surface of the syringe in a
valve seat of the valve.
[0035] Yet another aspect of the invention provides a method of
operating a urinary catheter system including the following steps:
establishing flow of urine from an indwelling urinary catheter
through a connector and into a drainage bag; actuating a valve to
stop the urine flow; and permitting the valve to automatically open
after a time period without operator intervention.
[0036] In some embodiments, the actuating step includes the step of
expanding a balloon to block flow through the connector. In some
embodiments, the permitting step includes the step of permitting
the balloon to deflate. In some embodiments, the expanding step
includes the step of compressing a valve actuation chamber. In some
embodiments, the expanding step includes the step of injecting
fluid into the balloon with a syringe.
[0037] Still another aspect of the invention provides a method of
operating a urinary catheter system including the following steps:
establishing flow of urine from an indwelling urinary catheter
through a connector and valve opening and into a urine drainage
connector; inflating a balloon manually to stop the urine flow
through the valve opening and drainage connector; and deflating the
balloon manually to allow urine to flow through the valve opening
and drainage connector.
[0038] Yet another aspect of the invention provides a urinary
catheter system, including a urinary catheter port, a urine exit
port, an irrigation port configured to receive an irrigation
syringe, a channel connecting the urinary catheter port, urine exit
port and irrigation port, and a valve adapted to cooperate with the
irrigation syringe to shut off flow of fluid and air to the urine
exit port when the irrigation syringe is inserted and allow for
flow of fluid and air to the urine exit port when the irrigation
syringe is removed.
[0039] In general, in one embodiment, a urinary catheter connector
system includes a housing, a catheter connector port, a urine exit
port, an irrigation port, a channel in the housing, and an internal
valve. The catheter connector port is supported by the housing and
is configured to attach to a urinary catheter. The urine exit port
is supported by the housing and is configured to connect to a urine
collection device. The irrigation port is supported by the housing
and is configured to receive an irrigation syringe. The irrigation
port includes a pliable membrane extending thereover. The pliable
membrane has a self-sealing opening therein configured to allow a
tip of the irrigation syringe to extend therethrough. The channel
fluidly connects the catheter connector port, the urine exit port,
and the irrigation port. The internal valve is supported by the
housing and adapted to cooperate with the irrigation syringe to
shut off flow of fluid and air to the urine exit port when the
irrigation syringe is inserted and allow for flow of fluid and air
to the urine exit port when the irrigation syringe is removed. A
distance between a proximal surface of the membrane and a distal
end of the internal valve is selected such that the tip of the
irrigation syringe can extend from a proximal end of the
self-sealing opening to the distal end of the internal valve when
the irrigation syringe is inserted into the irrigation port.
[0040] This and other embodiments can include one or more of the
following features. The internal valve can include a thickening in
the wall of the housing. The thickening can decrease the diameter
of the channel and can be configured to approximate the size of the
tip of the irrigation syringe and to mate snugly with the
irrigation syringe. When the irrigation syringe is inserted into
the internal valve, the urine collection device may not be in fluid
communication with the catheter connector port, and when the
syringe is not inserted into the internal valve, the urine
collection device may be in fluid communication with the catheter
connector port. The internal valve can include a valve seat adapted
to mate with an exterior surface of the irrigation syringe to shut
off the flow of fluid and air to the urine exit port when the
irrigation syringe is inserted and allow for the flow of fluid and
air to the urine exit port when the irrigation syringe is removed.
The proximal surface of the pliable membrane can be flat and
completely exposable to friction applied with a medical sanitizing
agent so that the irrigation port is fully sanitizable. The
irrigation port can connect to the channel between the catheter
connection port and the urine exit port. The pliable membrane can
be without crevices. A pliable membrane can extend over the urine
exit port. The pliable membrane of the urine exit port can have a
self-sealing opening therein configured to allow a tip of the urine
collection device connector to extend therethrough. The pliable
membrane of the irrigation port can be smooth and uniform. The
system can further include an internal valve supported by the
housing at the urine exit port that is configured to allow flow of
liquid through the urine exit port when open and to prohibit the
flow of fluid therethrough when closed.
[0041] In general, in one embodiment, a urinary catheter connector
system includes a housing, a catheter connector port, a urine exit
port, an irrigation port, and a channel. The catheter connector
port is supported by the housing and is configured to attach to a
urinary catheter. The urine exit port is supported by the housing
and is configured to connect to a urine collection device. The
urine exit port includes a first pliable membrane extending
thereover. The first pliable membrane has a self-sealing opening
therein configured to allow a tip of a urine collection device
connector to extend therethrough. The irrigation port is supported
by the housing and is configured to receive an irrigation syringe.
The irrigation port includes a second pliable membrane extending
thereover. The second pliable membrane has a self-sealing opening
therein configured to allow a tip of the irrigation syringe to
extend therethrough. A channel in the housing fluidly connects the
catheter connector port, the urine exit port, and the irrigation
port.
[0042] The urinary connector system can further include an internal
valve supported by the irrigation port housing and adapted to
cooperate with the irrigation syringe to shut off flow of liquid to
the urine exit port when the irrigation syringe is inserted and
allow for flow of liquid to the urine exit port when the irrigation
syringe is removed. The system can further include an adaptor
including a proximal end configured to removably attach to the
urine collection device and a distal end that includes the urine
collection device connector. The adaptor can include a housing with
a sanitizable slit membrane disposed over the distal end. The
adaptor can include a sleeve covering the urine collection device
connector. The sleeve can be configured to retract to expose the
urine collection device connector. The sleeve can include accordion
or telescoping features configured to allow the sleeve to retract.
The urinary connector system can further include an internal valve
supported by the urine exit port housing and adapted to cooperate
with the tip of the urine collection device connector to allow flow
of liquid through the urine exit port into the urine collection
device when open and to shut off flow of liquid to the urine exit
port when closed. The internal valve can include an external
feature configured to allow manual activation of the valve. The
internal valve can be a spring valve or a flap valve. The system
can further include a rigid cap configured to cover and mate with
the tip of the urine collection device connector. The rigid cap can
be configured to be removed from the urine collection device
connector for insertion of the connector into the urine exit port
and to be replaced when the connector is removed from the urine
exit port. The rigid cap can further include a slit-valve
positioned over a proximal end of the rigid cap to seal an inner
space within the rigid cap.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] The novel features of the invention are set forth with
particularity in the claims that follow. A better understanding of
the features and advantages of the present invention will be
obtained by reference to the following detailed description that
sets forth illustrative embodiments, in which the principles of the
invention are utilized, and the accompanying drawings of which:
[0044] FIG. 1 is an illustration of a self-closing port and valve
assembly according to one embodiment of the invention showing an
irrigating syringe inserted into a self-closing port and bypassing
the urine collection device through means of a valve, which closes
flow to the urine collection device when the irrigation device is
attached.
[0045] FIG. 2 is an illustration of a self-closing port and valve
assembly showing the device of FIG. 1 without an irrigating syringe
inserted into the self-closing port. Here, the valve is open, and
urine can flow into the urine collection device.
[0046] FIG. 3 is an illustration of a preferred embodiment of a
self-closing port and valve assembly according to another
embodiment of the invention. Here, there is no irrigating syringe
inserted into the self-closing port, and urine can flow into the
urine collection device.
[0047] FIG. 4 is an illustration of a self-closing port and valve
assembly showing the device of FIG. 3 with an irrigating syringe
inserted into the self-closing port and bypassing the urine
collection device through means of a valve that closes flow to the
urine collection device.
[0048] FIG. 5 is a detail of a port and valve assembly showing one
embodiment of an optional valve actuator being used with the
assembly shown in FIGS. 1 and 2.
[0049] FIGS. 6A and 6B show another embodiment of an optional valve
actuator being used with the assembly shown in FIGS. 3 and 4.
[0050] FIG. 7 is a flow diagram showing an aseptic port access
procedure for irrigating or collecting a urine specimen from a port
and valve assembly.
[0051] FIG. 8 is a cross section of one embodiment of a port and
valve assembly having a sanitizable self-closing port with flexible
valve body at the urine exit port. The urine collection device
connector is not connected to the port.
[0052] FIG. 9 is a cross section of the same embodiment of FIG. 8
showing the urine collection device connector connected to the
port.
[0053] FIGS. 10A and 10B are cross sections of one embodiment of a
sheath with a sanitizable slit membrane for protecting the
connecting end of a urinary collection device when it is
disconnected from the catheter end of the system. FIG. 10A shows
the connecting end of the urinary collection device not attached to
the sheath. FIG. 10B shows the connecting end of the urinary
collection device attached to and protected within the sheath.
[0054] FIGS. 11A-11C show an adaptor configured to mate to the
urinary collection device and also configured to provide a
compatible mating feature for the port and valve assembly. FIG. 11A
shows the adaptor connected to the urinary collection device and
covering the end of the device. FIG. 11B shows the adaptor
connected to the urinary collection system and in its retracted
state ready for connection to the port and valve assembly. FIG. 11C
shows the adaptor connected to both the urinary collection device
and the port and valve assembly.
[0055] FIGS. 12A and 12B show an alternate embodiment of the
adaptor with a retractable protective sheath. FIG. 12A shows the
adaptor connected to the urinary collection device and covering the
end of the device, and FIG. 12B shows the adaptor connected to the
urinary collection system in its retracted state ready for
connection to the port and valve assembly.
[0056] FIGS. 13A-13B show one embodiment of a port and valve
assembly having an internal valve within the urine exit port. FIG.
13A shows the valve closed, while FIG. 13B shows the valve
open.
DETAILED DESCRIPTION
[0057] The following description and drawings are illustrative and
are not to be construed as limiting. Numerous specific details are
described to provide a thorough understanding. However, in certain
instances, well known or conventional details may not be described
in order to avoid obscuring the description. In accordance with the
present invention, a novel and improved system for aseptic
irrigation and urine specimen collection and/or for disconnection
of urine collection device from a catheterized bladder is
provided.
[0058] The devices, systems, and methods described herein solve the
problem of disconnection and potential exposure to contaminants
during irrigation and urine sampling by providing a port valve
assembly that attaches at one port to the catheter, at a second
port to the urinary collection device, and at a third port to an
irrigation/sampling syringe. Some or all of the ports can be
protected by slit membranes. The slit membranes described herein
can advantageously be sanitized by swabbing 70% alcohol or other
medical disinfectant across its surface prior to the sterile
irrigation/sampling or the urine collection device connector
syringe entering the system, thus providing for aseptic means to:
(1) irrigate the catheter or sample urine without disconnecting the
urine collection device during the irrigation/sampling; and/or (2)
disconnect and reconnect the urine collection device. The slit
membranes can close automatically after removal of the syringe or
urine collection device connector, leaving the system closed and
aseptic.
[0059] In some embodiments described herein, the port and valve
assembly can include three ports. The first port connects directly
to the catheter.
[0060] The second port, the urine exit port, connects to the
urinary collection device. The second contains a valve that opens
when the urinary collection device is connected and closes,
shutting off fluid communication with the outside, when the urine
collection device is disconnected from the port. The second port of
the assembly can be protected by a slit membrane. The slit membrane
ensures that the catheter side of the drainage system remains
aseptically closed. It can be sanitized by swabbing 70% alcohol or
other medical disinfectant across its surface. The outer surface of
the slit membrane assembly is designed to be smooth, uniform, and
free of crevices so that it can be fully sanitized. By placing a
swabbable slit membrane on the urine exit port of the port and
valve assembly, the urinary collection device can be disconnected
and a closed aseptic system is preserved on the catheter end. In
the preferred embodiment, the swabbable slit membrane is designed
to also serve as the valve on the port. In other embodiments, the
slit membrane is just protective, and the valve function (i.e.,
allowing fluid to flow in and out of the port) is provided by an
internal valve.
[0061] The third port of the assembly, the irrigation and sampling
port, contains a valve that closes fluidic communication with the
collection system when an irrigation/sampling syringe is inserted
into the port. The third port can also protected by a slit
membrane. The third port's slit membrane can be sanitized by
swabbing 70% alcohol or other medical disinfectant across its
surface prior to the sterile irrigation/sampling syringe entering
the system, thus providing for aseptic means to irrigate the
catheter or sample urine without disconnecting the urine collection
device during the irrigation/sampling. Upon removal of the syringe,
fluidic communication with the urine exit port is automatically
re-established, and the slit membrane closes automatically, leaving
the system closed, without fluidic communication to the
outside.
[0062] Other embodiments can include few valves or ports and/or the
valved assembly can be used with an adaptor that provides a
connection between the urine collection device and the port and
valve assembly.
[0063] FIGS. 1 and 2 are illustrations of a self-closing port and
valve assembly 10 according to one embodiment of the present
invention. Within this embodiment, the device has a fully
sanitizable self-closing irrigation port 12 that allows a urinary
catheter to remain attached to a urine collection device while
being irrigated without disconnecting the urine collection device
drainage tubing 14 from the urinary catheter (not shown). This
allows for an aseptic, closed system, which keeps bacteria from
entering the catheter and also prevents exposure to body fluids
during the irrigation or sampling process.
[0064] The self-closing port and valve assembly 10 can be located
in numerous places on a urinary catheter drainage system. For
instance, it can be a part of a urinary catheter itself. It can be
a separate device that connects between the catheter and the
drainage bag. It can be a part of the urine collection device. In
the embodiment of FIGS. 1 and 2, the assembly is a part of the
urine collection device and is located at the junction between the
catheter connector port 7 in the catheter connector 11 and the
urine exit port 8 in the drainage tube 14, which drains urine from
the catheter into the urine collection device.
[0065] In the embodiment of FIGS. 1 and 2, an internal valve 15 has
a tension spring 17. The spring tension keeps the internal valve
biased in a first position, in which a urine exit channel 18 is
open to the urine drainage tube 14. Spring 17 can be, for example,
a torsion spring, leaf spring or any other spring or spring-like
element. Insertion of a catheter tip, irrigation syringe, or other
similar device 13 into the self-closing irrigation port 12 pushes
the internal valve 15 to a second position against the urine exit
port to the urine collection device drainage tube 14, closing it
off and bypassing any flow to the drainage tube while keeping the
irrigation port open.
[0066] In the present embodiment, the valve 15 is fashioned so that
a portion of it protrudes into the path of a device 13 inserted
into the self-closing irrigation port 12. The device inserted into
the port pushes the protruding portion of the valve in the
direction of the urine exit port, closing the valve when the device
is inserted into the irrigation port. This automatically shuts off
the flow of fluid and air to the drainage bag, allowing for
irrigation of the catheter and bladder without the irrigation fluid
entering the drainage tube. When the irrigation procedure is
complete and the syringe 13 is removed, the spring 17 moves the
valve back to the open position to allow urine to flow from the
catheter, into the urine collection device and to the drainage
collection receptacle.
[0067] In the embodiment of the device in FIGS. 1 and 2, the port
and valve assembly 10 also has a valve control mechanism 16 to
externally shut the valve 15 without the insertion of a syringe or
other object into the port 12. This would allow the valve 15 to be
closed even when not irrigating or collecting samples from the
catheter. Keeping the valve closed would stop the flow of urine
from the bladder to the urine collection device drainage tube 14
and allow the bladder to fill with urine, an important
physiological function that is normally inhibited in state of the
art urinary catheter systems. In some embodiments, the valve
control mechanism 16 may be designed in such a way as to allow for
the valve to stay closed for a specific prescribed and adjustable
amount of time, allowing for the bladder to fill for a prescribed
amount of time and then empty when that time period ends. Examples
of the valve control mechanism are described below.
[0068] FIG. 3 is an illustration of an alternative embodiment of
the port and valve assembly 10'. In FIG. 3, a syringe is not
inserted through a self-closing port, and fluid 20 is free to flow
through an internal valve 31 through an opening in the valve 30. In
FIG. 4, the flow of fluid to the drainage bag is shut off when an
irrigation syringe is inserted into the port and valve assembly by
means of an internal valve 31, which mates with the tip of the
irrigation syringe when inserted. The tip of the irrigation syringe
fits snugly into the internal valve, sealing flow of fluid or air
from the drainage bag.
[0069] The internal valve 31 in the embodiment of FIG. 3 and FIG. 4
is made by a thickening in the wall of the port and valve assembly,
which decreases the diameter of the channel, forming the valve
opening 30. The internal valve 31 created by the thickened wall
may, in some embodiments, be lined with a flexible material, such
as foam, latex, or silicone, to form a valve seat 32 adapted to
cooperate with an exterior surface of the syringe. When an
irrigation device is inserted through the irrigation port, it
enters the valve opening, and the syringe compresses the expandable
material 32 lining the internal valve. The syringe is held tightly
in place by this compression and creates an air and fluid seal.
[0070] Referring to FIG. 3, the irrigation port 12 can include a
self-sealing membrane 9 made of latex or other highly flexible and
pliable material extending thereover. The membrane 9 is smooth and
uniform (i.e., flat or without crevices), thereby making the entire
surface (including attachment points to the port 12) smooth and
uniform. Further, the membrane 9 has a small pliable hole within in
the center that runs from the external portion of the membrane 9 to
the internal portion of the membrane 9. When a syringe or other
irrigation device is pushed against the external portion of the
membrane 9, the pliable hole 23 spreads open, and the irrigation
device can be passed through the membrane 9 to the internal portion
of the port. When the syringe is removed, the hole 23 closes
tightly, forming a seal that keeps urine in and bacteria out of the
urinary drainage system. The smooth and uniform surface of the port
12 is easily sanitizable with 70% alcohol or other standard medical
sanitizer, allowing for aseptic port access without introduction of
bacteria into the drainage system. FIG. 7 is a flow diagram of an
aseptic port access procedure.
[0071] The embodiment of the valve control mechanism shown in FIG.
5 consists of a small compliant balloon 21 which is inflated by an
air filled chamber 22 that is made of a soft compressible material.
By applying pressure to the air filled chamber manually, typically
with the push of a finger or thumb, air is squeezed out of the
chamber and into the balloon, which, in turn, closes the valve
stopping the flow of urine out of the bladder. The chamber is
fashioned in such a way as to allow air to pass without resistance
into the balloon through a one way valve 24. Once inside the
balloon, the air must pass through a block 27 in which one or more
holes form a balloon deflation orifice. The time period over which
balloon 21 deflates can be controlled by the size and/or number of
holes in block 27, which allows for control of the amount of time
the valve 15 stays open. The air passes through the block and out
the air exit hole 26.
[0072] FIG. 6 is an illustration of an embodiment of a valve
control mechanism for use with the port and valve assembly of FIGS.
3 and 4. This figure demonstrates how the balloon 21 inflates to
close off the flow of fluid from the catheter to the drainage bag
by blocking flow from the opening 30 to the urinary drainage end of
the port and valve assembly.
[0073] In other embodiments, the balloon may be inflated by other
means, such as a syringe. FIGS. 6A and 6B show one embodiment of
the port and valve assembly, in which the compliant balloon is
inflated by a syringe 28. Air or fluid is introduced into the
balloon by the syringe, which attaches onto a luer locking
connection 29 that has a valve 61 attached to a spring 62. When the
syringe is attached, it pushes prongs 63 on the surface of valve
61, depressing the valve and spring and opening a fluid connection
between the syringe and balloon cavity 64. When the syringe is
removed, the spring pushes the valve closed, sealing the
compartment and trapping the air or fluid within the balloon,
keeping it inflated. In order to restart the flow of urine from the
bladder to the urinary drainage bag, a syringe is simply
re-attached to the luer locking port and the air or fluid is
removed from the balloon.
[0074] In some embodiments, the air in the balloon slowly leaks out
through a different air passage 26 from which it entered and
through a block 27 with one or more holes, as described above. The
valve control mechanism 16 in some embodiments may employ a lever
instead of a balloon that pushes the valve shut.
[0075] In some embodiments, the port and valve assembly described
herein can further include a slit-valve on the urine collection
port. Referring to FIG. 8, a connector 10 includes, in addition to
the self-closing slit membrane 9 of the irrigation and sampling
port 12, a self-closing slit-valve 40 on the urine exit port 8 at
the proximal end of the urine exit channel 18. The slit-valve 40 is
similar in function and design to the slit membrane on port 12 and
is likewise a fully sanitizable self-closing valve extending over
the port 8. The valve 40 thus includes a smooth and uniform
membrane 49 having a hole or slit 43 therein. Further, an internal
mating mechanism 45, such as a frusto-conical tapered mating
mechanism made from a thickening of the port wall or a locking ring
and taps, can be configured to mate with a distal end of the urine
collection device 46.
[0076] In use, the slit-valve 40 remains closed when the urinary
collection device is disconnected, keeping the urinary catheter end
of the system closed, and its sanitizable feature allows for
aseptic re-connection of a urinary collection device 46. When the
connecting end of a urinary collection device 46 is inserted into
the slit 43 in the center of the slit-valve 40, the slit 43 opens
by stretching around the connecting end. When fully inserted, the
urinary connection device mates with the internal mating mechanism
45, which holds the connecting end firmly in the housing body until
the user desires to disconnect the urinary collection device 46
from the catheter portion of the system. The slit-valve 40 and the
internal mating mechanism 45 thus help to maintain an air and fluid
tight seal. FIG. 9 illustrates a connected urinary collection
device 46 attached to the connection 10 such that urine can flow
(in direction of the arrow 44) into the urine collection device
46.
[0077] Further, referring to FIGS. 13A and 13B, in some
embodiments, an internal valve 63, such as a spring valve or flap
valve, can be positioned within the urine exit port 8 and be
configured to allow urine to flow therethrough when open and to
block the flow of urine when closed. In some embodiments, the
internal valve 63 can be activated when the distal tip of the urine
collection device 46 is inserted therethrough. In other
embodiments, the internal valve can be configured to be activated
manually to open or close the valve. For example, as shown in FIGS.
13A-13B, the valve can include an external dial 65 that, when
rotated, can move the valve from closed (FIG. 13A) to open (FIG.
13B). For example, the internal valve 63 can be a stop cock or a
deformable valve that, when squeezed orthogonally, opens the valve.
Having an externally controlled valve 63 can advantageously allow
the patient to close the valve when disconnecting from the urine
collection device 46, but still open the valve when the patient
wants to void into the toilet. In some embodiments, the internal
valve 63 and the slit-valve 40 can be combined such that external
activation of the internal valve opens the slit valve.
[0078] In some embodiments, a protective sheath or cap can be
provided to cover a distal end of the urine collection device, i.e.
the portion configured to connect to the assembly 10. FIG. 10A
shows one embodiment of a protective sheath 57. The protective
sheath 57 can include a rigid cylindrical housing 50 and an inner
compartment 54 having a mating mechanism 55 configured to mate with
a distal end of the urine collection device 46. Further, the mating
mechanism 55 can be, for example, a frusto-conical tapered mating
mechanism made from a thickening of the housing wall or a locking
ring and taps. A slit-valve 51 can cover the proximal end of the
cylindrical housing 50 to seal the inner compartment 54. The
protective slit valve 51 can be similar in form and function to the
valve 40 on the port and valve assembly, and as such, can be fully
sanitizable and self-closing. Thus, when the urine collection
device is not connected to the urine exit port 8 of the port and
valve assembly 10 described herein, the connecting end of the urine
collection device 46 can be inserted into the protective sheath 57
by pushing it through the slit-valve 51. The distal end of the
device 46 can then mate with the inner compartment 54, where it can
be maintained in an aseptic environment.
[0079] To aseptically disconnect the urine collection device 46
from the urine exit port 8 of the port and valve assembly 10 and
connect it to the protective sheath 57 (e.g., to replace the
drainage bag, etc.), the following steps are involved. Using
aseptic techniques to assure no contamination of the device during
transfer, the user first sanitizes the protective sheath slit-valve
51 with medical sanitizer. Next, the user disconnects the urine
collection device 46 from the urine exit port 8 of the port and
valve assembly 10 by pulling it proximally. The slit-valve 40 shuts
tightly once the distal end of the urine collection device 46 is
fully removed. The user can then push the distal edge of the urine
collection device 46 against the slit-valve 51 to cause the slit 52
therein to open by expansion. The slit-valve 51 can maintain a
tight seal around the distal end of the urine collection device 46,
keeping the interior of the protective sheath closed off from the
outside environment and aseptic. When the connecting end of the
urinary collection device 46 is fully inserted into the protective
sheath 57, it mates with mechanism 55 to hold the urinary
collection device 46 firmly inside the protective sheath 57 until
the user desires to remove it. When the user desires to disconnect
the connecting end of the urine collection device 46 from the
protective sheath 57 and connect to the urine exit port 8 of the
port and valve assembly 10, the same basic process as above can be
followed, first sanitizing the urine exit port slit-valve 40,
disconnecting the connecting end of the urine collection device 46
from the sheath 57, and pushing the connecting end of the urine
collection device 46 against the aseptic surface of valve 40 and
into the assembly 10.
[0080] In some embodiments, an adaptor can be used to connect the
distal end of the urinary collection device 46 to the assembly 10,
thereby allowing one single optimized design of a port and valve
assembly to be connected to various urinary collection devices even
if the mating feature of the urinary collection device varies. The
adaptor can be attached to the urine collection device to ensure
compatibility between the collection device's connector and the
port and valve assembly.
[0081] FIGS. 11A-C show an exemplary adaptor 80 configured to mate
with both the distal end of a urinary collection device 46 and the
urine exit port 8 of the port and valve assembly 10. The adaptor 80
can thus include a first connector 75 configured to mate with the
distal end of the urine collection device 46 and a second connector
76 configured to mate with the urine exit port 8. The connectors
75, 76 can be, for example, frusto-conical tapered mating
mechanisms or locking rings and taps. The adaptor 80 can further
include a protective sheath 73 that extends over the connector 76.
The sheath 73 can include accordion features or bellows 74 that
enable the sheath 73 to retract when connected with the urine exit
port 8 is desired. The material forming the bellows 74 can be made
of a plastic, such as medical grade vinyl (PVC) or polyurethane,
that has enough elasticity to allow the accordion to bend at its
folds. The adaptor 80 can further include a protective slit
membrane 70 that protects the adaptor mating tip of the second
connector 76 and keeps it aseptic when the adaptor 80 is not
connected to the port and valve assembly 10, as shown in FIG. 11A.
FIG. 11B illustrates the adaptor 80 with the sheath 73 in its
retracted state ready for connection, and FIG. 11C illustrates the
adaptor 80 connected to the port and valve assembly 10, with
connector 76 connected to the port 8.
[0082] In use, the adaptor 80 can be provided sterile to the user.
Further, the adaptor 80 can be connected to the urinary collection
device 46 upon first use and not disconnected from this junction
throughout its use. The adaptor 80 advantageously allows for
intermittent connection between the adaptor 80 and the port 8,
keeping the urinary collection device 46 of the system aseptic when
it is disconnected from the port and valve assembly 10. The only
time the connector 76 is exposed to the outside of the system is
when exposed for insertion into the urine exit port 8. This brief
exposure can be performed using aseptic techniques, which when
properly done, can ensure that the connector 76 is not exposed to
any other contaminated surface. With the use of the slit membrane
adaptor 80, the urinary collection device 46 is not exposed to the
environment and is therefore protected from contamination whether
disconnected or connected to the port and valve assembly 10.
[0083] FIGS. 12A-12B illustrates another exemplary adaptor 90. The
adaptor 90 is similar to adaptor 80 except that retraction of the
sheath 73 is provided by two rigid housings 72, 78 that are
slidable relative to one another, i.e., in a telescoping fashion. A
cylindrical connector 77 made, for example, of an elastic material
or film, such as latex or polyurethane, can connect the distal end
of the inner cylinder 72 with the proximal end of the outer
cylinder 78. As shown in FIG. 12B, when the outer cylinder 78 moves
proximally to expose the connector 76, the cylindrical connector 77
can stretch or unroll to maintain connection between the two
cylinders 72, 78, thereby ensuring that no contaminants can get in
between the cylinders 72, 78.
[0084] The sterile adaptors 80, 90 described herein can have
multiple purposes. For example, the adaptor can advantageously
ensure compatibility of the urine exit port of the port and valve
assembly with the mating feature on the urinary collection device.
The port and valve assembly can then be manufactured with a single
connector design, while the adaptor can be customized for different
potential types of urine collection device connectors (both present
and future). The adaptor can also advantageously prevent
contamination of the urine collection device while it is
disconnected from the system.
[0085] In some embodiments, the port and valve assembly described
herein is optimized such that patients can intermittently open the
valve and slit membrane on the urine exit port to allow for
discharge of urine from the catheter and bladder when a urine
collection device is not used. This can be done by an internal
mechanism that aseptically opens the urine exit port valve and slit
membrane to allow for drainage, for example a stopcock valve that
also splays open the slit membrane when open. In another
embodiment, the features of the slit membrane and valve can be
combined into a polymeric slit-valve that can be actuated by the
patient to allow for urine discharge, for example by squeezing the
slit-valve in a direction orthogonal to the slit. The patient could
then void directly into the toilet, for example. Intermittent
drainage from a slit-valve at the urine exit port of the port and
valve assembly can also be achieved by insertion of a sterile
external device into the urine exit port that allows for drainage.
Packs of disposable sterile drainage tubes can be provided along
with the port and valve assembly for situations when a urinary
collection device is not used.
[0086] In some embodiments of the connector system, the inside
walls of the port and valve assembly and/or of the adaptor may
contain a coating that is saturated with an antiseptic agent such
as nitrofurazone, silver salt, or other agent, as an added means of
defense against micro-organism contamination. The contamination
resistant coating may contain geometric features to deter biofilm
formation, such as fractal patterns in the surface microstructure.
In some embodiments, the contamination resistant features may be
contained in the structural material itself, such as
silver-containing micro-particles mixed into plastic.
[0087] The ports described herein can be configured to be large
enough to connect to irrigation syringes and/or the typical
connectors found in urinary drainage systems. For example, the
ports can have a diameter of between 1/4 inch and 1/2 inch, such as
between 3/8 inch and 5/16 inch. These diameters can be larger than
would be required for use, for example, with parenteral
connectors.
[0088] Embodiments of the connector system here are shown as
configured such that the catheter connection port and the
irrigation and sampling port are in-line with one another along a
central axis while the urinary collection port is orthogonal
(approximately 90 degrees) to the central axis. This configuration
can advantageously make irrigation and sampling more intuitive to
the user and can allow the assembly to be attached to the patient
so that gravity will drain urine into the urinary collection
device. For example, for supine in-bed use, the assembly can be
taped such that the in-line catheter connection and
irrigation/sampling ports are along the leg, and the 90 degree
drain from the urine exit port can be pointed toward the floor. In
primarily ambulatory patients using a urine drainage bag, the
assembly can be taped such that the urine exit port points down to
the leg to the ground.
[0089] Advantageously, the systems, methods, and devices described
herein can decrease the chance of urinary tract infection or
bladder atony, decrease the risk of blood and body fluid exposure,
greatly simplify the procedure of bladder irrigation, and allow for
connection and disconnection of the urine collection device from
the catheter end of the urinary drainage system while maintaining a
closed aseptic system from the connecting end of the urine
collection device to the bladder. The systems, methods, and devices
described herein can also improve the quality of life of patients
by allowing them more freedom from the urine collection device,
allowing them to wear a catheter more discreetly during social
interactions or when out of their home. Moreover, the systems,
methods, and devices can improve the quality of life for caregivers
who manage patients' catheters by making use of the device much
easier and safer.
[0090] It will be apparent to a skilled artisan that the
embodiments described herein are exemplary of inventions that may
have greater scope than any of the singular descriptions presented.
There may be alterations made in these examples without departing
from the spirit and scope of the invention disclosed. For example,
any aspect of an improved aseptic urinary drainage device and
system may have components with different shapes or designs within
different embodiments. For instance, spring types, housing shape,
valve diameter and compositions may vary in design from one
embodiment to another, but not overall function. In some
embodiments, the catheter connection port may be the drainage end
of a urinary catheter. In some embodiments, the urine exit port may
be an intrinsic part of the urine collection device, and in some
embodiments the port and valve assembly may be separate from the
urine collection device. These or other features may change in
different embodiments. In some embodiments, the shape or dimensions
of the valves or mating and connection features may change, the
housing shape, valve diameter and compositions may vary in design
from one embodiment to another, but not in overall function.
* * * * *