Note: Descriptions are shown in the official language in which they were submitted.
1 155725
BACXGROUND OF THE INVENTION
-
This invention concerns equipment for continuous ambu-
latory peritoneal dialysis and, more particularly, a novel solu-
tion container for continuous ambulatory peritoneal aialysis and
a novel luer lock assembly for use therewith and for use in other
medical applications.
The present invention is particularly suited for use in
continuous ambulatory peritoneal dialysis in which a dialysis
solution is introduced to the peritoneal cavity of the patient,
allowed to remain there for several hours and then drained from
the patient's peritoneal cavity with this process being repeate~
on a substantially continuous basis. One manner of achieving this
type of dialysis incl~des the steps of connecting a dialysis
solution container to a catheter connected to the patient's
peritoneal cavity, uncla~.ping the tubing between the dialysis
solution container and the patient's peritoneal cavity so as to
allow the dialysis solution to flow from the container to the
peritoneal ca~ity, thereafter reclamping the tubing, allowing the
dialysis solution to remain within the patient's peritoneal cavity
for several hours, for example, four hours, unclamping the tubing
and draining the solution from the patient's peritoneal cavity
back to the dialysis solution container, disconnecting the dialysis
solution container from the catheter tube and connecting to the
catheter tube a fresh dialysis solution container, and repeating
the aforementioned steps.
We have discovered that the aforesaid process can be
enhanced with the patient having greater freedom of movement if
the dialysis solution container is in bag form, partlcularly a
flexible, foldable plastic bag. In this manner, once the dialysis
solution has exited the dialysis solution bag, the bag can be
-2-
~ 155725
olded and carried about by the patient. A very effective
connection and disconnection system between the dialysis solu-
tion bag and the patient's catheter tube can be achieved by
using a luer lock connector system. In this manner, the transfer
tube extending from the dialysis solution bag c~rries a first
luer connector and the catheter tube extending from the patient's
peritoneal cavity carries a complementary luer lock connector.
The desirability of achieving, in the absence of liquid, and
maintaining an uncontaminated connection at the luer connector
is apparent and is achieved by means of the present invention.
It has been found desirable for the luer lock connector
which is carried by the patient to be of a relatively permanent
type, while the cooperating luer lock connector which is carried
by the tubing extending from the solution container may be
relatively disposable. Further, it is necessary that the luer
lock connection be secure and that leakage be prevented in order
to prevent contamination which could result in peritonitis.
Where ~he dialysis solution bag is such that it carries
a transfer tube extending therefrom, which transfer tube couples
to the patient's catheter tube, it may be desirable to prevent
the dialysis solution within the dialysis solution bag from
flowing into the transfer tube carried by the dialysis solution
bag. By utilizing a frangible connector in series with the
dialysis solution bag tubing, the flow of dialysis solution from
the dialysis solution bag into the tubing can be prevented until
the frangible connector is broken.
It is an object of the present invention to provide a
novel solution container for continuous ambulatory peritoneal
dialysis, which container is constructed so as to permit
significant freedom of movement for the patient.
Another object of the present invention is to provide
novel means for preventing the solution within the dialysis
solution container from flowing into the transfer tubing of the
1 155725
lialysis solution container until a frangible mem~er is broken
thereby allowing the connection to be made in the absence of
]iquid.
A further object of the present invention is to provide
a novel luer lock connector which maintains the integrity of the
connection and alleviates contamination.
Another object of the present invention is to provide a
luer lock connection device which includes a seal-type engagement
between the male and female luer lock connectors thus preventing
leakage and maintaining a water tight bacteria barrier at the
connection.
A still further object of the present invention is to
provide a luer lock connection device in which one of the luer
lock connectors is relatively permanent while the other luer
lock connector may be relatively disposable.
Another object of the present invention is to provide
a novel solution container for continuous ambulatory peritoneal
dialysis having a particulate filter and clamping means in series
with the transfer tube extending from the solution container so
as to provide a simple but highly effective tubing set carried
by the solution container, with the solution container being
formed of a flexible, foldable plastic material.
Other objects and advantages of the present invention
will become apparent as the description proceeds.
SUMMARY OF THE INVENTION
In accordance with the invention, equipment is provided
for continuous ambulatory peritoneal dialysis in which a solution
container is coupled via flexible tubing to a patient's tube that
communicates with the patient's peritoneal cavity. The equipment
comprises a flexible, foldable plastic dialysis solution container
having a transfer port extending therefrom. A flexible tube
extends from the transfer port and has a luer connection at its
1 155725
distal end for connecting to a luer connection carried by the
patient's tube.
In the illustrative embodiment, a frangible member is
provided in the flexible tube. The frangible member normally
blocks fluid flow in the flexible tube but permits fluid flow
after the frangible member is broken.
In the illustrative embodiment, a particulate filter
is connected in series with the flexible tube. In addition, a
manually-operable clamp is connected in series with the flexible
tube.
In the illustrative embodiment, ~he flexible tube has
a luer connector at its distal end for connecting to a luer
connector carried by the patient's tube. The luer connector at
the distal end and the patient's tube luer connector comprise a
cooperating male luer lock connector and a female luer lock
connector. The male luer connector has a central tubular portion
defining an axial bore with at least a portion of the central
tubular portion being enclosed by an outer sheath having a
generally circular cross-sectional configuration. The outer
sheath is internally threaded.
The female luer connector comprises a main tubular
member having an outwardly radially extending flange adjacent
its distal end. This flange is dimensioned to threadedly
cooperate with the internal threads of the male luer connector's
outer sheath.
In one illustrative embodiment, an elastomeric member
is carried by the female luer connector and is dimensioned and
operable for providing a pressure seal-like engagement with the
internal wall of the rigid outer sheath of the male connector to
aid in maintaining a water tight bacteria barrier at the luer
lock connection. Further, the elastomeric member may be swabbed
or the chamber defined by the outer sheath filled with a
--5--
1 15~725
sterilizing agent by the patient, whi~h would aid in preventing
contamination of the system.
Alternatively, in a second illustrative embodiment the
female luer connector may have a rigid outer wall portion that
is operable with the internal wall of an elas'omeric outer
sheath of the male connector for providing the pressure seal-
like engagement.
In the second illustrative embodiment, the outer wall
portion is contiguous with the external surface of the main
tubular member and has a rearwardly extending outer taper. In
this manner, the pressure engagement of the internal wall of
the outer sheath and the outer wall portion will increase as
the male and female connectors are threaded together.
In the second illustrative embodiment, the male and
female luer lock connectors are each formed in an integral one-
piece construction, and the female luer ~ock connector is formed
of stainless steel or titanium to provide a more permanent
construction while the male luer lock connector is formed of a
resilient plastic material which is readily disposable. It is,
of course, apparent that a variety of materials may be used
without departir.g from the scope of the present invention.
A more detailed explanation of the invention is provided
in the following description and claims, and is illustrated in
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a view of a solution container for continuous
ambulatory peritoneal dialysis, constructed in accordance with
the principles of the present invention;
FIGURE 2 is a rear view of a male luer loc~ connector
constructed in accordance with the principles of the present
invention;
1 ~55725
FIGURE 3 is an elevational view of a male luer loc~
connector constructed in accordance with the principles of the
present invention, with portions broken away for clarity;
FIGURE 4 is a front view thereof;
FIGURE 5 is a front view of a female luer lock connector
constructed in accordance with the principles of the present
invention;
FIGURE 6 is an elevational view thereof, with portions
broken away for clarity;
FI~U~E 7 is a greatly enlarged view of a portion of the
female luer lock connector of FIGURE 6;
FI~URE 8 is an elevational view, with portions broken
away for clarity, of a device for capping the female luer lock
connector of FIGURE 6;
FIGURE 9 is an elevational view, with portions broken
away for clarity, of a capping device for the male luer lock
connector of FIGURE 3;
FIGURE 10 is an elevational view, with portions broken
away for clarity, of another embodiment of a female luer loc~
connector constructed in accordance with the principles of the
present invention; and
FIGURE 11 is an enlarged view of the cooperating
portions of the male luer lo~ connector and the female luer loc~
connector of FIGU~E 10.
~ETAIrr~ DESCRIPTION OF
ILLUSTRATIVE EMBODIMENT
Referring to FIGURE 1, a dialysis solution bag 10 is
shown therein having ports 12 and 14 extending from one side 16 of
the bag 10. Port 14 is capped with an injection site 20 in the
illustrative em~odiment.
1 1S572S
Solution container 10 is preferably formed of flexible
sheet plastic material that is heat sealed at its edges to form a
solution bag. Flexible plastic tubing 22 extends from transfer
port 12 and is coupled to the inlet 24 of a particulate filter 26,
the outlet 28 of which is coupled to flexible tubing 30 carrying a
manually operable clamp 32 in series therewith and having a male
luer lock connector 34 at its distal end.
Male luer lock connector 34 is connected to a female
luer lock connector 36 which is carried at the distal end of a
patient's catheter tube 38 which extends into the patient's
peritoneal cavity. Additional details concerning the construction
of the novel luer lock connection system formed by male luer lock
connector 34 and female luer lock connector 36 are set forth below
and are illustrated in FIGU~ES 2-9.
A frangible member 40 is positioned in series with
transfer port 12 and tubing 22, within the bore defined by the port
and tubing. Frangible member 40 blocks fluid flow from transfer
port 12 to tubing 22 until the frangible member 40 is broken.
Frangible member 40 is preferably formed of a plastic material
which fills the flow path of transfer port 12 and tubing 22, but
define~ a central bore through the plastic material which is
sealed by a breakoff member 42. When member 42 is manually broken,
the dialys~s solution contained by solution bag 10 can flow
through the frangible member 40 and thence through tubing 22 and
downstream with respect thereto. In this manner, the dialysis
solution within solution bag 10 is maintained adjacent transfer
port 12 until frangible member 40 is bro~en, and not until the
breaking of frangible member 40 can the solution contained within
solution bag 10 flow downstream of the frangible member 40.
1155725
The filter 26 is a particulate type filter, having a
pore size of approximately 5 microns and having a relatively large
surface area. It is preferred that the surface area be at least 4
square centimeters and most desirably, ~bout 7 square centimeters.
It is also preferred that filter 26 comprise a hydrophilic
membrane filter utilizing air venting by hydropho~ic membranes.
Clamp 32 may be any type of flexible tubing clamp as is
well-known in the art, with it preferably being a type of clamp
which may be manually engaged and disengaged, using the thumb and
forefinger.
U~der certain circumstances, it is believed that certain
peritoneal dialysis patients prefer a connection system with
respect to the solution container and the patient's catheter tube
that does not require the insertion and retraction of a spi~e
connector adjacent the solution container. Unless a spike
connector is utilized properly, it is possible that the spike may
cause contamination resulting in peritonitis. It has thus been
discovered that under certain circumstances the use of the luer
connection system of the present invention is advantageous, and
achieves a connection that is less likely to be contaminated.
Male luer connector 34 is illustrated in detail in
Figures 2-4. Referring to these Figures, the male luer connector
34 comprises a central tubular portion 50 defining an axial bore
52, and with the central tubùlar portion 50 extending rearwardly
to ~orm a circular insert 50a. ~nsert 50a is solven~ bonded within
flexible tubing 30 and extends outwardly by means of a plurality
of shoulders 54 to provide an outer sheath 56 which surrounds
central tubular portion 50. Outer sheath 56 has a knurled
manually-graspable portion 58 and carries first means 66 for co-
operative locking with a femal luer connector. First means 60
is illustrated in the form of internal threads 60. The
outer sheath 56 aids in preventing touch contamination duringlockinq and/or unlocking of the luer lock connection system and
r~
~ _g_
1155725
~erves to carry the threads 60 which are engaqed by second means 62
(Figure 6) for coopera~ive locking with thread 60. Second means 62
comprises a flange 62 (Figure 6) carried by female luer lock connec-
tor 36.
Referring to FIGURES 5-7 in which the female luer lock
connector 36 is shown in detail, it can be seen that connector 36
comprises a main tubular member 64 having outwardly radially
extending flange 62 adjacent its distal end 66. A manually
graspable ring 68 surrounds main tubular me~ber 64 and is
preferably formed integral therewith, with ring 68 also being
formed integrally with a barbed rearward extension 70 for bonded
connection within the bore of the patient's catheter tu~e 38. A
knurled portion 72 is provided on the e~ternal surface of ring 68
to aid in manually grasping the same. Rearward extension 70 is
coupled to ring 68 by means of a plurality of shoulders 74, and the
central tubular member 64 and rearwardly extending member 70
define a common axial bore 76.
The flange 62 is shaped and dimensioned so that when
male luer lock connector 34 is engaged with female luer loc~
connector 36, central tubular portion 50 of connector 34 will
enter bore 76, and flange 62 will be threaded along threads ~0 to
form a locking connection.
The diameter of bore 76 tapers inwardly from distal end
76, to a diameter that is smaller than the external diameter of
central tubular portion 50, whereby an engagement will result
between the external surface of central tubular member 5Q and the
internal wall of tubular member 64.
Referring to FIGURES 6 and 7 in particular, it is seen
that a number of projections or rings 78 are carried by tubular
mem~er 64 and an elastomeric member 80 surrounds the tubular
mem~er 64 and overlies the projections 78. Elastomeric member 80
is has an outwardly extending annular bead 82 utilized for sealing
-10-
1 ~55725
urposes. Thus when male connector 34 and female connector 36 are
engaged, e~astomeric member 80 will enter outer sheath 56 and a
sealing action will occur as a result of annular bead ~2 engaging
the internal wall of outer sheath 56. In addition to providing an
effective seal to prevent contamination, elastomeric member 80
also acts to provide a water tight bacteria barrier which
maintains the integrity of the locking connection thus preventing
contamination of the luer connection.
If desired, elastomeric member 80 could be swabbed or
the chamber defined by the outer sheath 56 could be filled~by the
patient with a s~erilizing agent, such as Betadiné. rt is
preferred that the female luer connector 36, with the exception of
elastomeric member 80, be formed in a one-piece integral injection
molding construction, and that elastomeric member 80 be formed in
a subsequent step in the injection molding process during
manufacture of the luer connector. Likewise, in this embodiment,
it is preferred that the entire male luer connector 34 be formed in
a one-piece unitary molded construction.
Referring to FIGURES 10 and 11, an alternative female
luer lock connector 202 is illustrated with identical reference
numerals indicating the portions of female luer lock connector 202
and male luer lock connector 210 which are identical to portions
of female luer lock connector 36 and male luer lock connector 34
respectively.
It can be seen that connector 202 comprises a main
tu~ular member 64 having outwardly radially extending flange 62
adjacent its distal end. Main tubular member 64 is contiguous
with a manually graspable rin~ 204 which extends contiguously
rearwardly from the main tubular member 64, with ring 204 also
being formed integrally with a barbed rearward extension 70 for
bonded connection with a flexible plastic tube, such as within the
bore of the patient's catheter tube in Fontinuous ambulatory
1 155~25
~eritoneal dialysis. A knurled portion 72 is provided on the
rear external surface of ring 204 to aid in manually grasping
the same. Rearward extension 70 is coupled to ring 204, and
the main tubular member 64 and rearwardly extending member 70
define a coaxial bore 76.
The male luer lock connector 210 used with the female
luer lock connector 202 shown in FIGURE 10, is identical to the
male luer lock connector 34 shown in FIGUR~ 3 with the exception
that the front end 211 of the o~ter sheath 213 or the entire
outer sheath 213 is formed of an elastomeric material. This may
be accomplished by separately molding the outer sheath 213 and
then attaching it to a male luer connector or by providing a
unitary member formed of the elastomeric material desired.
Outer wall portion 204 of female luer lock connector 202
has a rearwardly extending outward taper 206 so that the pressure
engagement of the internal wall 212 of outer sheath 213 of the
male luer connector 210 and outer wall portion 204 will increase
as the male and female connectors are threaded together.
The flange 62 is shaped and dimensioned so that when
male luer lock connector 210 is engaged with female luer lock
connector 202, central tubular portion 50 of connector 30 will
enter bore 76 and flange 62 will be ~hreaded along threads 60 to
form a locking connection. The internal wall 212 of outer sheath
213 will engage tapered surface 206 of outer wall 204 snugly, and
the engagement will become ti~hter as the luer connectors are
threadedly closed tighter. In this manner, the cooperation of the
internal wall of the outer sheath 213 and surface 206 of outer
wall 204 is operable for providing a pressure seal-like engagement
to prevent leakage and to aid in maintaining a water tight bacteria
barrier.
If female luer lock connector 202 is coupled to a
catheter tube which extends to the patient's peritoneal cavity, it
-12-
1~55725
is desirable that luer lock connector 202 be formed or a more
permanent material. To this end, a stainless steel or titanium
connector 202 would be satisfactory.
Under certain circumstances, the patient may desire
to disconnect the luer lock connection once the dialysis solu-
tion has been introduced into the patient's peritoneal cavity.
For this purpose, a cap 90 (FIGURE 8) for capping the female
luer connector is provided which includes a closed top portion
92 and a downwardly extending sidewall portion 94. Sidewall
portion 94 defines a bore 96 which has an identical diameter
to the opening defined by outer sheath 56, and the internal
wall of sidewall portion 94 carries threads 98 which are
identical in size and configuration to threads 60. A central
tubular portion 50b is also provided. A knurled portion 100
is provided for enabling manual grasping of the cap 90.
Referring to FIGURE 9, a cap 102 for capping t~e male
luer connector is provided that is similar in configuration to
female luer connector 36 except that it does not include rear
tubular connector 70. Identical reference numerals have been
used on the FIGURE 9 cap to represent the portions of cap 102
which are identical to portions of female luer connector 36.
It can be seen that instead of bore 76 extending continuously,
the bore 76 is capped at its end 104. It should also be
realized that male luer lock connector 34 may be carried by the
patient's cathe~er tubing 38 with the female luer lock connector
36 being connected at the distal end of tube 30.
As a result of the cooperation of outer sheath 56 and
elastomeric member 80, and as a result of the cooperation of
outer sheath 211 and outer taper 206, the luer loc~ connection
system has a touch-contamination prevention feature and also
utilizes a sealed closure device when connected to provide a water
tight bacteria barrier, thereby further preventing contamination.
1 ~5~725
Although _wo illustrative embodiments have been shown
and described, it is to be understood that various modifications
and substitutions may be made by those skilled in the art without
departing from the novel spirit and scope of the present invention.
-14-
