U.S. patent application number 09/134413 was filed with the patent office on 2002-01-17 for urethral catheter and urinary drainage bag adaptor for prevention of nosocomial urinary tract infection.
Invention is credited to CHANG, HAU HSIEN.
Application Number | 20020007175 09/134413 |
Document ID | / |
Family ID | 26682473 |
Filed Date | 2002-01-17 |
United States Patent
Application |
20020007175 |
Kind Code |
A1 |
CHANG, HAU HSIEN |
January 17, 2002 |
URETHRAL CATHETER AND URINARY DRAINAGE BAG ADAPTOR FOR PREVENTION
OF NOSOCOMIAL URINARY TRACT INFECTION
Abstract
An urethral catheter and urinary drainage bag adaptor which
includes a substantially cylindrical segment telescoping over a
smaller diameter but longer substantially cylindrical segment. Both
ends of the longer segment are open and both ends of the shorter
segment are closed. Each segment also has a wall and a lumen. The
longer segment includes a first portion, a shorter second portion
and a substantially spherical-shaped third portion located between
the other two portions. A storage chamber for antiseptics is
defined by a closed space between the two segments and communicates
with the lumen of the longer segment through at least one
fenestration located on a wall of the third portion. The longer
segment is a conduit for body fluid. A rotary valve is located in
the third portion for controlling drainage of body fluids and
collecting antiseptics from the chamber. The device allows draining
body fluid to mix with a small aliquot of antiseptic collected from
the chamber by a rotary valve to prevent ascending infection of the
urinary tract without fluxing of the antiseptic into the body.
Inventors: |
CHANG, HAU HSIEN;
(BAKERSFIELD, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Family ID: |
26682473 |
Appl. No.: |
09/134413 |
Filed: |
August 13, 1998 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09134413 |
Aug 13, 1998 |
|
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|
08541120 |
Oct 25, 1995 |
|
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|
08541120 |
Oct 25, 1995 |
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08011511 |
Feb 1, 1993 |
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Current U.S.
Class: |
604/544 ;
604/327 |
Current CPC
Class: |
A61M 25/00 20130101;
G02B 3/12 20130101; G02B 1/06 20130101; A61M 39/16 20130101; A61M
39/18 20130101 |
Class at
Publication: |
604/544 ;
604/327 |
International
Class: |
A61M 001/00; A61F
005/44; A61M 027/00 |
Claims
What is claimed is:
1. An adaptor for connecting an end of a catheter to a connector on
a collection receptacle, said adaptor comprising: an adaptor body
having a flow passage therethrough, a first connector at one end of
the flow passage for removably attaching a catheter to receive
fluid therefrom, and a second connector at another end of the flow
passage for removably attaching a collection receptacle; a chamber
adapted to hold a liquid antiseptic material; a valve in the flow
passage having a first position where the flow passage is closed to
prevent flow between the one end and other end and a second
position where the flow passage is open between the one end and the
other end, wherein the valve has a valve passage which receives a
dose of antiseptic material from the chamber when the valve is
closed and releases the dose into the flow passage when the valve
is opened.
2. An adaptor as in claim 1, wherein the chamber is formed in the
adaptor body and comprises a sealable port for filling the port
with antiseptic material.
3. An adaptor as in claim 2, wherein the plug may be rotated so
that the valve passage is in alignment with the flow passage of the
body to open the valve and further rotated so that the valve
passage is out of alignment with the flow passage to close the
valve.
4. An adaptor as in claim 3, wherein there is at least one opening
between the chamber and the rotary plug, wherein said opening is
positioned in the adaptor body so that antiseptic material flows
into the valve passage when the valve is closed.
5. A method for inhibiting infection of a indwelling catheter
connected to a drainage receptacle by a valve in a connecting line,
said method comprising: closing the valve between the indwelling
catheter and the drainage receptacle; introducing a dose of
antiseptic material into a closed valve passage; disconnecting the
drainage bag and reconnecting a replacement drainage receptacle;
opening the valve wherein the antiseptic material is released
through the valve into the connecting line, whereby the risk of
infection of the indwelling catheter is reduced.
6. A method as in claim 5, wherein introducing the dose of
antiseptic material comprises positioning the valve passage to
receive the dose from a chamber adjacent the valve.
7. A method as in claim 6, wherein the valve is positioned to
receive the antiseptic material each time it is closed and
positioned to release the antiseptic material each time it is
opened.
8. A method as in claim 5, wherein a volume of antiseptic material
in the range from 0.1 ml to 10 ml is released.
9. A method as in claim 5, wherein the antiseptic material is
betadine, acetic acid solution, or hydrogen peroxide.
Description
[0001] This is a continuation-in-part of, and claims the benefit of
priority from U.S. patent application Ser. No. 08/541,120, filed on
Oct. 25, 1995, which was a continuation-in-part of U.S. patent
application Ser. No. 08/011,511, filed on Feb. 1, 1993, now
abandoned. The full disclosures of each of these applications are
hereby incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to an adaptor that can be mounted
between an end of an indwelling urethral catheter and a connector
to an urinary drainage bag to prevent or reduce the incidence of
urinary tract infection in a patient who needs to wear an
indwelling urethral catheter during the course of the medical
treatment.
[0004] 2. Description of the Prior Art
[0005] Indwelling urethral catheterization in a close drainage
system is the standard of care in present day modern medical care
for a patient who has bladder neck obstruction such as benign
prostatic hypertrophy, or urinary incontinence such as neurogenic
bladder, in surgery requiring perioperative urine output monitoring
or for the patient being observed and treated in an intensive care
unit requiring close urine output monitoring. Nosocomial urinary
tract infection invariably develops within one week after a "Foley"
catheter, i.e. an urethral catheter with a retention balloon at one
end, is left indwelling. Ascending infection by microorganisms
through a lumen of the urethral catheter is thought to be one of
the causes of nosocomial urinary tract infection. Conventional
treatments include oral and intravenous antimicrobial therapy and
intermittent irrigation of the urethral catheter with antibiotics
and acetic acid solution. The treatments frequently fail to
eradicate and control the urinary tract infection. Resistant
strains of microorganisms frequently supersede, rendering the
subsequent treatment more difficult and expensive and mortality
hence increases.
SUMMARY OF THE INVENTION
[0006] The present invention provides apparatus and methods for
connecting and reconnecting catheters, such as indwelling
catheters, and in particular Foley urinary drainage catheters, from
and to drainage bags and other external reservoirs, collection
devices and the like. In particular, the present invention
significantly reduces the risk of infection when an indwelling
catheter is disconnected from and reconnected to a series of
external collection devices of the type just mentioned. In the
exemplary embodiments, the present invention provides for
introducing an antiseptic material to the region where the catheter
is being disconnected as an automatic part of the
disconnection/reconnect- ion procedure. That is, the system user
need take no steps other than disconnecting and reconnecting the
indwelling catheter to the external device, whereby the present
invention automatically dispenses an antiseptic material to reduce
the risk of infection. Although particularly suitable for use with
Foley catheters, the present invention will also find use with
other indwelling and transcutaneous catheters, such as implanted
catheters used for exchanging dialysate with peritoneal catheters
for ambulatory peritoneal dialysis.
[0007] Apparatus according to the present invention comprises an
adaptor for connecting the end of the catheter, typically an
indwelling Foley catheter as described above, to a connector on a
collection bag, typically a urinary collection bag in the case of a
Foley catheter. The adaptor comprises an adaptor body having a flow
passage therethrough with a first connector at one end of the flow
passage and a second connector at the other end of the flow
passage. The first connector is adapted to removably connect a
catheter, typically a proximal hub or other connector on a Foley
catheter and to receive fluid from the connected catheter. The
second connector is adapted removably connect and attach to the
collection bag or other external device. A chamber which holds a
liquid antiseptic is further provided, typically being part of the
adaptor body, preferably being disposed annularly about the adaptor
body. A valve is included in the flow passage and has a first
position where the flow passage is open and a second position where
the flow passage is closed. The valve has a valve passage which
receives a dose of the antiseptic material from the chamber each
time the valve is closed and releases the dose of antiseptic
material into the flow passage each time the valve is opened. In
this way, each time the user turns off the valve to disconnect the
urinary collection bag or other device, a dose of the antiseptic
will automatically be collected in the passage of the valve
mechanism. Then, after the collection bag is reconnected, the valve
is opened and the valve passage automatically releases the
antiseptic into the flow path between the indwelling catheter and
the collection bag. The release of antiseptic will greatly reduce
the risk of infection becoming established and travelling up the
indwelling catheter to harm the patient.
[0008] In the exemplary embodiments, the valve comprises a rotary
plug having the flow passage therein. The plug may be rotated so
that the valve passage is in alignment with the flow passage in the
adaptor body in order to open the valve. Similarly, the valve may
be rotated so that the valve passage is out-of-alignment with the
flow passage in the adaptor body in order to close the valve. With
such configuration, the antiseptic material may be conveniently
dispensed by providing openings between the chamber holding the
antiseptic and the rotary plug, where the openings are positioned
in the adaptor body so that fluid flows into the valve passage each
time the valve is closed and the valve passage falls out of
alignment with the flow passage. In one exemplary embodiment, the
plug rotates about an axis which is perpendicular to the valve
passage. In another embodiment, the plug rotates about an axis
parallel to but spaced laterally apart from the valve passage.
[0009] The present invention further comprises methods for
inhibiting infection of an indwelling catheter, such as a Foley
urinary drainage catheter. The catheters are connected to a
receptacle, usually a drainage bag, and a valve is provided in a
connecting line to isolate the proximal end of the indwelling
catheter when it is desired to remove one drainage bag and replace
it with an empty drainage bag or other receptacle. The method
comprises closing the valve between the indwelling catheter and the
drainage receptacle and introducing a dose of antiseptic material
into a valve passage of the closed valve. The drainage bag may then
be disconnected and a new bag reconnected while the valve remains
closed. When the valve is opened to reestablish a drainage path
from the catheter to the drainage bag, the antiseptic material is
automatically released through the valve and into the connecting
line between the catheter and the drainage bag. As described above
with respect to the device, such release of antiseptic material
greatly reduces the risk of infection travelling up the indwelling
catheter to the patient.
[0010] The antiseptic introducing step usually comprises
positioning the valve passage to receive a dose from a chamber
located adjacent the valve, typically located annularly about the
valve an flow passage in the adaptor. Usually, the valve will be
positioned to receive antiseptic each time it is closed and further
positioned to release antiseptic to the indwelling catheter and/or
the drainage bag each time the valve is opened. The volume of
antiseptic material released will typically be in the range from
0.1 ml to 10 ml, and suitable antiseptic materials include
betadine, acetic acid solution, hydrogen peroxide, and the like. It
will also be possible to use antibiotics in place of or in
combination with antiseptic agents.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is the front external view of the urethral catheter
and urinary drainage bag adaptor.
[0012] FIG. 2 is the side external view of the urethral catheter
and urinary drainage bag adaptor.
[0013] FIG. 3 is a longitudinal cross-sectional view of the adaptor
taken along line J-J' in FIG. 2.
[0014] FIG. 4 is a longitudinal cross-sectional view of the adaptor
taken along line I-I' in FIG. 1.
[0015] FIG. 5 is a top view of the urethral catheter and urinary
drainage bag adaptor.
[0016] FIG. 6 is a top view of another embodiment of the
adaptor.
[0017] FIG. 7 is a longitudinal cross-sectional view of the cap
taken along line K-K' in FIG. 5.
[0018] FIG. 8 is a transverse cross-sectional view of a rotary
valve when a lumen of a spherical portion of the valve is in a
"draining" or "vertical" position.
[0019] FIG. 9 is a longitudinal cross-sectional view of a rotary
valve when a lumen of a is in a "draining" or "vertical"
position.
[0020] FIG. 10 is a schematic view of one clinical applications
using an adaptor attached to a discharge end of a "FOLEY"
catheter.
[0021] FIG. 11 is a schematic view of another clinical applications
using an adaptor attached to the discharge end or spigot of an
urinary drainage bag.
[0022] FIG. 12 is a schematic view of still another clinical
applications using one adaptor attached between a "FOLEY" catheter
and an urinary drainage bag and one adaptor attached to the
discharge end or spigot of the urinary drainage bag.
[0023] FIG. 13 is a longitudinal cross-sectional view of another
embodiment of an adaptor taken along a line similar to line J-J' in
FIG. 2.
[0024] FIG. 14 is a transverse cross-sectional view of another
embodiment of a rotary valve.
[0025] FIG. 15 is a longitudinal cross-sectional view of an adaptor
taken along J-J' of FIG. 2 but with another embodiment of the
rotary valve of FIG. 14.
[0026] FIG. 16 is a longitudinal cross-sectional view of still
another embodiment of an adaptor taken along a line similar to line
J-J' in FIG. 2.
[0027] FIG. 17 is a side cross-sectional view of yet another
embodiment of the valve of the present invention.
[0028] FIG. 18 is a cross-sectional view taken along line 18-18 of
FIG. 17.
[0029] FIG. 19 is a partial cross-sectional view of the valve of
FIGS. 17 and 18, shown with the valve closed in a position in which
antiseptic fills the valve plug passage.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0030] The invention is an urethral catheter and urinary drainage
bag adaptor for preventing nosocomial urinary tract infection. The
adaptor comprises a body including first, substantially cylindrical
segment having a length, a diameter, a wall, an axis and opposite
open ends. One of the ends is adapted to receive body fluids from a
discharge end of an indwelling urethral catheter or a discharge
spigot of an urinary drainage bag and the other of the ends is
adapted to discharge the body fluids. The first segment further has
a first portion adjacent the one of the ends, a second portion
adjacent the other of the ends and a third portion interposed
between the first and second portions. The first portion has a
length, a constant diameter lumen and a side wall. The second
portion has a length shorter than the length of the first portion,
a lumen having a diameter and a side wall. The third portion has a
lumen. The third portion and the lumen thereof being
spherically-shaped. The third portion and the lumen thereof having
diameters which are larger than diameters of the first and second
portions and the diameters of their respective lumens,
respectively. The third portion further has a wall, a circular
opening through the wall which opening has an axis, and at least
one fenestration through the wall in at least one of an upper or
lower hemispherically-shaped portion of the third portion. The
lumen of the third portion fluidically communicates with the lumens
of the first and second portions so as to define a lumen of the
first segment.
[0031] The adaptor further comprises a second, substantially
cylindrical segment having a length shorter than the length of the
first segment, a diameter larger than the diameter of the first
segment, a side wall, an axis, a first open end adjacent the first
portion, a second end opposite the first open end and adjacent the
second portion and a circular opening through the side wall which
opening has an axis. The second segment surrounds, is spaced from
and concentric with the first segment. The axes of the circular
openings of the second segment and the third portion are aligned
with each other but at right angles to the axes of the first and
second segments. The second end of the second segment has an
external diameter which tapers toward and to an exterior of the
side wall of the second portion where the second end is fused
thereto.
[0032] The adaptor still further comprises a third, substantially
cylindrical segment connecting the circular openings of the second
segment and the third portion. The third segment has a longitudinal
axis at a right angle to the axes of the first and second segments,
a lumen having a diameter no greater than the diameter of the lumen
of the third portion, a wall and a circumferential groove on an
interior surface of a midsection of the wall.
[0033] The adaptor includes a waterproof cover enclosing the first
open end of the second segment. The first portion is sealingly
received through a large central opening of the cover. A chamber is
defined by and between the first segment, the second segment and
the cover. The chamber is adapted to store antiseptics. The cover
further has a small opening at a peripheral portion covered by a
rubber seal. The small opening and the seal define an injection
port adapted for refilling the chamber with antiseptics. The second
segment and cover enclose the third portion. There is at least one
fenestration which directly fluidically communicates with the
chamber.
[0034] A substantially drumstick-shaped rotary valve is specially
designed for controlling movement of the body fluids through the
adaptor, i.e., is the key portion of the invention. The valve
comprises a substantially spherical portion located within the
third portion and a handle portion extending from the spherical
portion through the lumen of the third segment. The substantially
spherical portion has an external diameter slightly smaller than
the diameter of the lumen of the third portion, a side wall and a
constant diameter lumen. The constant diameter lumen of the
spherical portion has a diameter no greater in size than the
diameters of the lumens of the first and second portions, opposite
open ends and an axis which is coplanar with axes of the first,
second and third portions. The handle portion comprises a
substantially column-shaped stick having an end connected to a
midportion of an exterior surface of the side wall of the spherical
portion, a length greater than a length of the third segment, a
cross-sectional diameter smaller than the diameter of the lumen of
the third segment, an axis at a right angle to the axis of the
lumen of the spherical portion, a wall and a circumferential groove
on an exterior surface of a midsection of the wall of the
handle.
[0035] A fourth, substantially cylindrical segment fills a space in
the lumen between the wall of the third segment and the wall of the
stick to prevent fluid leakage. The fourth segment has a length the
same as the length of the third segment, a concave-shaped open end
facing the spherical portion of the rotary valve, an opposite
linear-shaped open end, a wall having a circumferential protrusion
on a midportion of each of inner and outer surfaces thereof
received in the grooves of the stick and third segment,
respectively, and an axis coaxial with the axis of the third
segment but perpendicular to the axes of the first and second
segments.
[0036] In order to protect the second end from external
contamination a fifth, substantially cylindrical segment is
provided. The fifth segment has a lumen with a diameter larger than
the external diameter of the second portion, a length longer than a
length of a part of the second portion projecting from the fused
second end of the second segment and extending to the other of the
ends of said first segment, an axis coaxial with the axes of the
first and second segments, a wall spaced from and concentric with
the second portion so as to encircle said part of the second
portion and the other of the ends, a first end fused to the tapered
diameter of the second segment and a second opposite end having a
living hinge on one side and a male locking mechanism on an
opposite side.
[0037] Finally, a circular cover having a diameter slightly larger
than an external diameter of the fifth segment is provided. The
cover has a rim, a female locking mechanism complementary to the
male locking mechanism at one side of the rim and is connected to
the living hinge on a side of the rim opposite to the one side so
as to be anchored to the fifth segment.
[0038] The adaptor can be mounted to an end of a "FOLEY" catheter
alone which catheter is placed in a patient's bladder. This
combination allows an ambulatory patient who wears the catheter to
do so without a urinary drainage bag if desired enabling freer
ambulation. The adaptor may also be mounted to an outlet or
discharge spigot of a urinary drainage bag or one adaptor may be
mounted between the catheter and the urinary drainage bag above the
bag and another adaptor may be mounted to the outlet or discharge
spigot.
[0039] Once the adaptor is mounted, the rotary valve is turned in
one direction until the axis of the lumen of the spherical portion
is at a right angle to the lumens of the first and second portions
stopping any body fluid drainage through the first segment and
preventing communication of prestored antiseptics in the chamber
with the lumen of the spherical portion via the at least one
fenestration. The valve is further turned in the one direction
until the lumen of the spherical portion is aligned with the at
least one fenestration permitting a small aliquot of antiseptics to
drain through the at least one fenestration from the chamber and
collect in the lumen of the third portion. Finally, the valve is
turned further in one direction to align the lumen of the spherical
portion with the first and second portions of the first segment
allowing drainage of body fluids again. As the body fluid drains
through the first segment, the body fluid mixes with the antiseptic
in the lumen of the spherical portion prior to being discharged
from the other end of the first segment. The bactericidal effect of
the antiseptic prevents or reduces the incidence of ascending
urinary tract infection in a patient who wears an indwelling
catheter with the present adaptor for a prolonged period of time,
for example, in a closed body fluid drainage system. Furthermore,
the lumen of the spherical portion does not fluidically communicate
with the lumens of the first and second portions and the at least
one fenestration simultaneously. Thus, unlike the prior art, the
rotary valve prevents antiseptic from fluxing into the body cavity
by providing only intermittent contact of the draining body fluids
with a small quantity of antiseptics rather than continuous
unrestricted contact with the body fluids and body cavity.
[0040] The invention may include structural modifications in order
to enforced the sterile condition of the lumen of the first segment
as well as to prevent flux of antiseptics in the chamber to the
lumen of the first portion. These modifications include the
provision of an additional rotary valve in an additional
spherically-shaped portion located between the one of the ends of
the first segment and the first rotary valve and the third portion,
an eccentrically located lumen in the spherical portion and the at
least one fenestration located in the lower hemispherically-shaped
portion of the third portion.
[0041] The invention may also include at least one fenestration in
the wall of both the upper and lower hemispherically-shaped portion
and the at least one fenestration being coplanar with the axis of
the lumen of the spherical portion of the rotary valve. The adaptor
may also be formed of non-biohazardous material.
[0042] Referring to FIGS. 1, 2, 3 and 4 an embodiment of the
urethral catheter and urinary drainage bag adaptor AD for the
prevention of nosocomial urinary tract infection is illustrated. In
these Figures the device consists of eight parts A-H. Part A (FIGS.
3 and 4) is a first, substantially cylindrical body or segment and
is the longest segment of the adaptor. It is comprised of three
parts: a longer first portion 16, a second shorter portion 14 and a
spherically-shaped third portion 15. The third portion is
interposed between the first and second portions. The first and
second portions have lumens 1, 1a, respectively and the third
portion has a lumen 1b which is spherically-shaped and larger in
diameter than the lumens 1, 1a. The first portion 16 has one open
end 6 adapted to receive body fluids, examination e.g., urine from
the discharge of an indwelling urethral catheter or a discharge end
or spigot of an urinary drainage bag. Another opposite open end 4
is adapted to discharge body fluids and a circular opening 27 is
formed through a wall of the third portion. There is at least one
opening or fenestration 7 through a wall in at least one of a upper
hemisphere or a lower hemisphere of the third portion 15 of
cylindrical segment A. There is a small recess 20 in an interior
surface of the wall of the third portion 15 opposite to the
circular opening 27 to accommodate a pointed projection 19 at a tip
of a rotary valve E. The diameters of the first and second portions
of the first segment are the same as a diameter of a lumen of a
tapered open end or discharge of the catheter, a urinary drainage
bag tubing and the urinary drainage bag discharge end or spigot.
The lumen of the third portion 15 houses a substantially spherical
portion of the rotary valve E. Referring to FIGS. 3 and 4, the
external diameter of the first and second portions 16, 14 taper
toward the ends 6,4, respectively.
[0043] The second, substantially cylindrical segment B, see FIGS. 1
and 3-4, comprises a diameter which is constant throughout most of
the segment. The external configuration is variable and can be
circular, FIG. 5 or rectangular, FIG. 6. The second segment B is
larger in diameter and shorter in length than the first segment A.
It telescopes over the first segment A including the third portion
and defines a space 3 with the wall of the first segment A. The
space 3 adjacent one end of the second segment is sequestered by a
cover D with the center of the cover being cut out to accommodate
the one end 6 of the first segment. Cover is a round D or
rectangular-shaped D' plate with a large central opening 22, 22'
and a smaller eccentric opening 8, 8'. It has a L-shaped waterproof
seal 23 at the peripheral edge. The central opening accommodates
the first segment. Again the junction of the edges of the two
elements is waterproof. Portion 12 is the portion of the first
portion external of the cover D, D'. The smaller eccentric opening
8, 8' is covered by a rubber seal. It is used as an injection port
for antiseptic solutions. A second end of the second segment
adjacent the other end 4 of the first segment has an external
diameter which tapers toward the exterior of the side wall of the
second portion where the second end is fused thereto. This tapered
and fused second end is denoted 11 in FIG. 4. The cover D is of the
same size and shape as the tapered and fused second end. There is a
circular opening 10 in the wall of the second segment. The size of
the opening 10 is the same as that of the side opening 27 on the
third portion of the first segment A. The opening 10 also aligns
with the opening 27. Both openings are connected together by a
third, substantially cylindrical segment C. The space 3 is a
storage space for the antiseptics. The space 3 communicates with
the lumen of the rotary valve and the lumen of the third portion
through the at least one fenestration 7.
[0044] Referring to FIGS. 1, 3-4, 8-9, 14 and 15, part E is a
rotary valve of the adaptor. It comprises a substantially-spherical
portion 28 having a straight tubular lumen 2, a long handle 17
extending from a side wall of the spherical portion, an extension
18 of the handle of the rotary valve to outside of the second
segment for manual manipulation; A pointed protrusion or projection
19 from the middle of the sidewall or tip of the rotary valve
opposite to the point on the side of the wall where the handle is
attached for providing, with recess 20, stabilization of the
spherical portion of the rotary valve within the lumen of the third
portion. The axis of the lumen 2 is at a right angle with an axis
of the handle 17 of the rotary valve. The spherical portion 28 of
the rotary valve resides in the lumen of the third portion, whereas
the handle 17 of the rotary valve lies within the lumen of the
third segment C. The external diameter of the spherical portion of
the rotary valve is slightly smaller than the diameter of the lumen
of the spherical portion so that spherical portion 28 slides
smoothly within the lumen of the third portion without fluid
leakage. The handle 17 of the rotary valve comprises a solid
column-shaped stick with a diameter smaller than the diameter of
the third segment C. The space between the handle of the rotary
valve and the wall of the third segment is filled with a fourth,
substantially cylindrical segment F to prevent fluid leakage. The
diameter of the lumen 2 of the spherical portion is the same as or
slightly smaller than the diameters of the lumens of the first and
second portions. The lumen 2 of the spherical portion can be
located centrally as illustrated in FIGS. 8 and 9 or eccentrically
located as illustrated in FIG. 14 and 15. In the latter case, one
side of the wall 24 is thicker and heavier than the remainder of
the wall 25. The eccentric position of the lumen also enforces the
sterile condition of the lumen of the first segment as well as
prevents the flux of the antiseptics in the chamber to the lumen of
the first portion.
[0045] Referring to FIGS. 1 and 4, the fourth,
substantially-cylindrical segment F is a water proof seal within
the third segment C. The fourth segment fills the space between the
handle 17 of the rotary valve and the wall of the third segment. It
has the same length as the third segment extending from the side
opening 27 to the side opening 10. The fourth segment has a
concave-shaped open end facing the spherical portion of the valve
and an opposite linear-shaped open end. The fourth segment also
includes circumferential protrusions on a midportion of inner and
outer surfaces thereof received in grooves of the handle and third
portion, respectively. The third and fourth segments have axes
coaxial with one another but perpendicular to the axes of the first
and second segments.
[0046] Part G is a fifth, substantially-cylindrical segment. It
comprises a segment with a lumen having a diameter larger than the
external diameter of the first segment at end 4 and a length longer
than a portion 13 of the second portion projecting from the tapered
fused portion 11. The fifth segment telescopes over portion 13 and
open end 4. A circular edge of one end of the fifth segment is
fused with the tapered fused portion 11. The opposite open end
projects beyond the open end 4. The fifth segment is the circular
guard around the discharge end 4 of the first segment to protect it
from external contamination.
[0047] Part H is a circular plate or cover with a diameter slightly
larger than the external diameter of the fifth segment, one portion
of the peripheral edge or rim of the cover has an inverted invert L
shape female locking device 5 to engage a male locking device 5' on
the opposite open end of the fifth segment. There is a living hinge
26 on the edge or rim of the cover opposite to the female locking
device. The living hinge connects the cover to a point of the
opposite open end of the fifth segment opposite to the male locking
device.
[0048] Referring to FIG. 16, a modified adaptor AD' is illustrated
which includes a second rotary valve E' in a spherically-shaped
portion and lumen 15' like the first rotary valve and third portion
in the first segment. This structure also enforces the sterile
condition of the lumen of the first segment as well as prevents
flux of the antiseptics in the chamber 3 to the lumen of the first
portion.
[0049] Referring to FIGS. 3 and 13, the at least one fenestration
7' is shown on the lower hemispherical portion of the spherical
portion. This structure also enforces the sterile condition of the
lumen of the first segment as well as prevents flux of the
antiseptics in the chamber 3 to the lumen of the first portion.
[0050] FIG. 10 illustrates a schematic view of one clinical
applications in which BC denotes a urinary bladder cavity, BW
denotes the bladder wall, BO represents the balloon of a "FOLEY"
catheter FL and AP is the adaptor.
[0051] FIGS. 11 and 12 illustrated schematic views of other
clinical applications in which FL denotes a "FOLEY" catheter, BA
denotes a urinary drainage bag and AP is the adaptor.
[0052] In the previous embodiments, the rotary valve plugs all
rotated about an axis perpendicular to the valve passage in the
plug. Such an orientation has the disadvantage that the peripheral
surface of the plug which is exposed to the collected urine when
the valve is closed, as shown in FIG. 3, can be turned to face the
Foley or other indwelling catheter, thus increasing the risk of
infection.
[0053] The valve embodiment of FIGS. 17-19 reduces the risk of such
accidental infection by rotating the valve plug about an axis
parallel to but spaced-apart from the valve passage in the plug. As
shown in these FIGS., a valve 100 including a body segment 102, a
surrounding chamber 104 for holding an antiseptic material, and a
rotary valve plug 106 having a valve passage 108 which may be
aligned with a main lumen 110 in the body segment 102 (as shown in
FIG. 17) or which may be rotated out-of-alignment, as shown in FIG.
19. Rotation is effected using a torque shaft FIG. 17. Antiseptic
flows into the passage 108 when the valve is closed to move the
passage 108 beneath a flow passage 112 which permits the flow of
the antiseptic from the chamber 104 to the flow passage. The rotary
plug 106 may be manually turned using a torque member 114 which
extends from the nominally upper surface of the plug 106.
[0054] A particular advantage of the design of FIGS. 17-19 is that
the side of the valve plug 106 which is exposed to the urine
collection side of the valve will never be directly exposed to the
relatively clean patient side of the valve, thus reducing the risk
of infection significantly.
[0055] Although detailed embodiments of the invention are
illustrated in the drawings and previously described in detail.
This invention contemplates any configuration, dimension, design
and relationships of components which will function in a similar
manner and which will provide the equivalent result.
* * * * *