Note: Descriptions are shown in the official language in which they were submitted.
8539
APPARATUS AND METHOD FOR INTRODUCING
FLUID INTO A~lD REMOVING FLUID
FROM A LIVING SUBJECT
BACKGROI~ND OF THE INVENTION
The present invention is directed to improved
devices and me-thods for reducing infection associ-
ated with the collection of body fluid from a human
or animal subject and the introduction of fluids
into the body.
In modern medical practice it is often desir-
ab]e either to drain fluids from or to introduce
fluids into a human or animal subject under sterile
conditions. For example, it is a routine practice
to catheterize hospital patients for urinary or
closed wound drainage. Similarly, a number of body
cavities, such as the urinary bladder and the peri-
toneal cavity, for example, are routinely irrigated
during treatment of various disorders. In these
and other, similar situations the continued steril-
ity of all associated devices used for passing fluid
to and rom the body may be critically important,
for a contaminated device will in many cases lead
to infection of the patient.
It is well recognized that conventional drain-
age devices are a prime source of infection in cathe-
.
~6853~
-2-
terized patients. For example, in the area of blad-
der drainage, a large proportion of catheterized
patients sufer rom urinary tract infections attribut-
able to ~ontaminated drainage devices. In many cases,
the drainage collection device itself becomes con-
taminated in use and infection then ascends in a
retrograde manner from the drainage collection
device to the patient via the drainage catheter.
Such retrograde infection from a contaminated
drainage or infusion device has been observed in
patients undergoing urinary, wound, biliary,
gastro-intestinal drainage, peritoneal dialysis,
and hyperalimentation treatment for example. See,
e.g., E. M. Goldberg, et al., "Peritoneal Dialysis",
v 15 Dialysis and Transplantatlon, ~4--T-===~i J. H.
Isaacs, et al., "Foley Catheter Drainage Systems
and Bladder Damage", Surgery, Gynecolo~_&
Obstetrics, May 1971, p. 889; R. E. Desautels, "The
Causes of Catheter-Induced Urinary Infections and
Their Prevention", J. Urolo~y, 1969, 101: 757;
R. E. Desautels, et al., "Technical Advances in the
Prevention of Urinary Tract Infection", J~ Urology,
1962, 87: 487; R. E. Desautels, "Aseptic Management
of Catheter Drainage", New Eng. J~ Med., 1960, 263:
189; E. H. Kass, et al., "Prevention of Infection
of Urinary Tract in Presence of Indwelling Catheters",
J.A.M.A., 1959, 169: 1181; and E. H. Kass, et al.,
"Entry of Bacteria into the Urinary Tracts o Patients
with Inlying Catheters", New Eng. J. Med., 1957,
256: 556.
Retrograde infection via drainage devices is
in many cases attributable to the fact that conven-
tional drainage devices are open systems which are
repeatedly opened to the atmosphere and, therefore,
subject to contamination during use.
11~8539
--3--
Many conventional drainage devices are con-
tainers designed to be filled repeatedly with
drained body fluid and emptied. For example, the
evacuator described by McElhenny in U.S. Patent No .
3,115,138 includes a capped fluid outlet. After
the evacuator becomes filled it is emptied for reuse
by removing the cap and expelling collected fluid
via the outlet. During this operation the interior
of the evacuator is exposed to the atmosphere and
contamination of the evacuator may result.
Efforts have been made to reduce the contamina-
tion of drainage devices during periodic emptying.
For example, U.S. Patents Nos. 3,779,243 and 3,774,611
disclose evacuators which employ a special valve
over the fluid outlet. This valve operates to close
the outlet at all times except for the time when
fIuid is actually being purged from the evacuator.
Such evacuators may succeed in reducing the contami-
nation brought on by purging, but they are not true
closed systems. Because these evacuators are periodi-
cally opened for purging, it is still possible for
them to become contaminated and a source of infection.
One object of the present invention is to provide
improved drainage devices and methods for reducing
the incidence of retrograde infection due to contamina-
tion of drainage devices.
In addition to infection due to contamination
of drainage devices, a second source of patient infec-
tion is contamination of devices for introducing
fluid into the body.~ For example, in peritoneal
dialysis large volumes of a dialysate are introduced
into and then drained from the peritoneal cavity
daily. One conventional approach to this mode of
treatment is to use a permanent indwelling catheter
and then simply to connect the catheter successive-
-
'
::
~6~5~9
--4--
ly to ~ series of containers, each of which contains
a portion of the total fluid introduced into the
body.
In this approach the indwelling catheter is
connected to and then disconnected from a number of
containers in sequence. The same connection point
on the catheter is repeatedly brought into contact
with the dialysate and then exposed to the atmo-
sphere This repeated wetting and exposure to
atmosphere is believed to contribute to contamina-
tion of the catheter and associated infection. In
much the same way, d~vices for irrigating body
cavities such as the bladder may become infected as
they are connected to and then disconnected from a
number of containers of irrigation fluid in s~cces-
sion.
Thus, a second important object of the present
invention is to provide improved devices and methods
for introducing fluid into human and animal subjects
with reduced possibilities of contamination thereby
improving sterility and reducing infection.
SUMMARY OF THE INVENTION
The present inv~ntion is directed to improved
devices and methods for drawing fluid from and intro-
duciny fluid into a human or animal subject, whichare less susceptible to contamination and inf~ction
than devices and metllods of the prior art.
The invention in its broader claimed aspect pertains
to a device for holding and transferring liquids that
are to be moved into or out of a body cavity o a human
or animal subject, in a manner so as to maintain sterility,
and to reduce contamination and the incidence of retro-
grade infection of the subject. The improved device
includes a body defining an air tight manifold for
receiving thereinto liquid to be transferred and means
~ . ~
-4a- ~ 53~
connect the interior of the manifold to a plurality of
elongated tubular conduits through which liquid may be
selectively caused to be passed. Each tubular conduit
has one end opening to the interior of the manifold
and the other end positioned outside the manifold. Some
of the plurality of tubular conduits serve to provide
waste channels, through which contaminated waste liquid
may be selectively caused to flow outwardly from the
interior of the manifold. A discardable waste-
receiving container is connected to each such waste
channel conduit at a point outwardly of the manifold to
provide a plurality of waste-receiving containers
associated with the manifold. A valve is operatively
associated with each waste channel conduit, and located
in the conduit outwardly of the manifold, between the
manifold and the discardable container, the valve being
adapted to be selectively manipulated to either permit
liquid ~low between the manifold and container, or to
isolate the waste-containing container from the manifold.
According to a first feature of this invention,
a completely closed drainage device is provided in
which the interior of the device need never be opened
to atmosphere during use. This invention is suitable
for widespread use in many types of drainage, and
2S can be used in conjunction with either suction or
gravity drainage treatment.
J~
_5~ 539
The drainage device of this invention includes
a central manifold adapted for connection to a
source of body fluid. For example, the manifold
may be connected to a drainage catheter which is
S conventionally located to drain urine from the
bladder of a human subject. A plurality of con-
tainers are separately connected to the manifold by
conduits, and individual ~onduits are provided with
valves which can be positioned to close off the
conduits, thereby isolating the associated con-
tainers from the manifold. Each of the conduits is
selectively severable ~t a point between t~e associated
valve and container.
In use, this improved drainage device is
coupled to a subject so that fluid flows from the
patient into the manifold. The valves are posi-
tioned to direct the fluid into one of the con-
tainers, and fluid is allowed to collect in this
container for a period of time. The associated
valve is then closed in order to isolate this fluid
filled container from the manifold, and the associ-
ated conduit is severed between the container and
the valve. The fluid filled container is then re-
moved for testing or disposal, and another valve is
opened to allow fluid to collect in another container.
The separate containers are sequentially filled and
removed until either all containers are filled or
drainage from the subject is discontinued.
One of the principal advantages of this improved
drainage device and method is that each of the multiple
containers can be filled and removed from the manifold
without ever opening the device to atmosphere duriny
use. When drainage be~ins the entire device, complete
with a number of containers already attached to the
manifold, is a sealed, ~terile unit. Containers
.
~6~S39
--6--
are sequentially filled and removed, but the re-
moval of individual containers is performed only
after the respective valve has been closed and the
container isolated. Preferably, each valve is capped
to further seal it from the environment after the
associated container has been removed. In this way
cGntamination of the manifold and resultant infeckion
of the subject are reduced.
Since the drained body fluid is removed
in a series of containers of convenient size, the
volume of fluid stored in the drainage device at
any one time can be kept small in spite of the large
total volume of the drainage device. Thus, the pa- -
tient is not required to carry the total volume of
drained fluid. The portability and the convenience
of the improved drainage device of this invention
provide important advantages over large capacity
drainage devices of conventional design.
Furthermore, each of the individual containers
can be made of a collapsible material which can be
folded into a compact volume for storage before use.
In this way a compact drainage device can be made
which is readily stored and transported before use,
and is relatively low in bulk during use.
This feature of the invention can be advantage-
ously used in urinary drainage, wound drainage, and
peritoneal dialysis. It is also well suited for
removing other fluids from the body in cases where
a low incidence of contamination or infection is
important.
According to a second feature of this inven-
tion, an improved device for introducing fluid into
the human body is provided. This device includes a
central manifold adapted for connection with means
for introducing fluid into the body, such as a cathe-
--7--
ter. The manifold includes a plurality of valvedinput ports. Each po~t is provided ~lith a separate
valve by means of which the port may be isolated
from the manifold. Each port is preferably pro-
vided with a cap for sealing the port when not inuse.
This device is used with a plurality o~ con-
tainers, each of which contains fluid to be intro-
duced into the body. Preferably each container is
provided with a dry, sterile catheter and each capped
input port is also dry and sterile. To connect the
container to the manifold the cap is removed from
one of the input ports and then the container catheter
is mated to the port. After the catheter is connec-
ted, the associated valve is opened and fluid isallowed to flow from the container, through the port,
into the manifold, and from there into the body.
When the container is emptied, a second container
is then connected to the manifold via a second port.
In each case the associated port valve is only opened
after the container has been connected to the port
and the valve is closed before the container is removed.
Preferably, each port is only used once so that a
fresh, sterile surface on a fresh port is mated to
the container catheter each time. By never using a
port twice it is believed that the incidence of con-
tamination and infection is reduced.
This second feature of the invention can be
advantageously used in irrigation of the bladder,
peritoneal dialysis and hyperalimentation treatment,
as well as other modes of treatment in which fluid
from several containers must be introduced into the
body over a period of time.
Both of the above described features of the
; 35 invention can be utilized in a dialysis manifold
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-
~16~5~9
--8--
for use in peritoneal dialysis. In this case a
central manifold can be provided both with (1) a
number of containers connected to the manifold via
valved conduits and (2) a number of valved input
ports. The dialysis manifold is coupled to the
peritoneal cavity of a subject and the separate con-
tainers ~re used as previously described to remove
dialysa'e from the manifold without opening it to
the atmosphere The input ports are also used as
described above, thereby reducing infection associ-
ated with the introduction of dialysate into the
manifold.
Alternately, a manifold for peritoneal dialy~is
may be constructed with only a plurality of valved
ports and the attached containers may be omitted.
In this embodiment of the invention containers of
dialysate are sequentially coupled to different
ports. As before, each port is used only once to
reduce infection. In this embodiment, however, a
dialysate container is not immediately removed from
the associated port after the dialysate has been
drained into the peritoneal cavity. Instead, the
container is left connected to the port and the
dialysate is then drained from the peritoneal
cavity into the same container from which it came.
It is only then that the container is removed from
the port. This embodiment provides the important
advantage that the total drainage capacity of the
manifold is no longer limited by the number of con-
tainers that can conveniently be stored adjacentthe manifold.
The invention itself, together with further
- objects and attendant advantages, will be best
understood by reference to the following descrip-
tion taken in connection with the accompanying
drawlngs .
539
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1 is a perspective view of a preferred
embodiment of a rack mounted drainage manifold for
urinary drainage.
FIGU~E 2 is a cross sectional view of the drain-
age manifold of Figure 1.
FIGURE 3 is a perspective view of a portable
drainage manifold for urinary drainage.
FIGURE 4 is a schematic view of a drainage
manifold coupled to a closed wound suction device.
FIGURE 5 is a perspective view of a preferred
embodiment of an input manifold for wound or bladder
irrigation.
FIGURE 6 is a perspective view of a first pre-
ferred embodiment of a peritoneal dialysis manifoldwhich includes preferred embodiments of both the
closed drainage feature and the multiple input port
feature of the present invention.
FIGURE 7 is a top view taken along line 7-7 of
Figure 6.
FIGURE 7a is a cross sectional view taken along
line 7a-7a of Figure 7.
FIGURE 7b is a cross sectional view taken along
line 7b-7b of Figure 7.
FIGURE 8 is a bottom view taken along line 8-8
of Figure 6.
FIGURE 8a is a cross sectional view taken along
line 8a-8a of Figure 8.
FIGURE 9 is a cross sectional view taken along
line 9-9 of Figure 6.
FIGURE lO is a perspective view of a portion
of a second preferred embodiment of a peritoneal
dialysis manifold.
FIGURE 11 is a cross sectional view taken along
line 11-11 of Figure 10.
~'
-10- ~ i853~
FIGURE 12 is a perspective view of a third
preferred embodiment of a peritoneal dialysis mani-
fold.
FIGURE 13 is a cross sectional view taken along
line 13-13 of Figure 12.
DETAILED DESCRIPTION OF PREFERRED EMBODIME~TS
Referring now to the drawings, Figure 1 repre-
sents a preferred embodiment of a drainage manifold
10 for urinary drainage. This drainage manifold 10
is a generally tubular structure which is provided
with a valved input port 50 and four valved output
ports 30. A collapsible, thin walled container 20
is sealed to each of the output ports 30. In
Figure 1, three of these containers 20 are shown
collapsed and ~olded for storage into small packPts
and one of the containers 20a is shown unfolded,
ready to receive fluid from the manifold 10.
Preferably, each container is formed of a flexible,
plastic material such as vinyl, polyethylene, or
some other suitable material. A support net 90 is
provided which can be positioned around an unfolded
container 20a by means of a hook 92 from the mani-
fold 10. This net 90 serves to support a major part
of the weight of fluid contained in the container
20a, thereby permitting the use of thin, low bulk
material for the containers 20.
The valved input port 50 is adapted for connec-
tion to a catheter 62 which is in turn coupled to a
source of body ~luid. In this exemplary embodiment,
the manifold 10 is a urinary drainage device and
the catheter 62 can be any suitable urinary drainage
cathPter. A snap-on cap 70 is provided adjacent
the input port 50 to cover and protect the input
port 50 prior to use. Anchor points 74 serve as
. ,
means for attachiny the manifold 10 to any conven-
tional mount such as a rack 76.
Referring now to Figure 2, the manifold 10 is
- a tubular structure which defines a central cavity
100. Both ends of the manifold 10 are sealed to
prevent leakage and contamination. The input port
50 includes a valve 60 which operates to selective-
ly seal the port 50. The valve 60 is provided with
a flange 52 sealed to the manifold 10 and the port
50 extends into the interior of the maniold 10.
The cap 70 is attached to the input port 50 via a
flexible strap 72.
Each of the valved output ports 30 includes a
valve 40 which operates to selectively seal the port
15 30. Each valve 40 includes a flange 32 sealed to
the manifold 10 and each output port 30 extends into
the interior of the manifold 10. Each container 20
includes a narrow neck region 24 which is sealed to
one of the output ports 30.
The manifold is preferably formed from an ex-
truded tube of vinyl or some other suitable plastic.
Standard push-pull valves, such as valve model 320TE
manufactured by Halkey-Roberts of Paramus, New Jersey,
are used to reliably seal the associated input ports
50 and OlltpUt ports 30 against contamination, leakage,
and i.nfection. The entire device including the mani-
fold 10, the Eoldable containers 20 and the input
port 5Q, forms a single sealed unit which is assembled
under standard clean room conditions and then ster-
ilized prior to use. Standard adhesive or heatsealing techniques can be used to bond the manifol~
10, the containers 20, and the ports 30,50 together
to form a sealed, leakproof unit. Whatever sealing
technique is used, however, should provide reliable,
35 leakproof seals which form impermeable barriers to
~6~539
contamination and infection. After assembly, the
single opening into the manifold 10 is the valved
input port 50, which is closed and capped during
the manufacturing process to ensure the continued
sterility of the device.
In use, the drainage device of Figures 1 and 2
functions as a closed system which receives ~luid
drained from the body and permits the drained fluid
to be removed for disposal without ever opening the
drainage device to contamination. As mentioned,
the device is originally sterilized with the input
port 50 closed and capped. To use this drainage
device the input por-t 50 is uncapped and mated ~ith
a suitable catheter under sterile conditions. ~epend-
ing on the application, this can be done either beforeor after the catheter has been inserted into the
patient. In alternate embodiments, the drainage
catheter can ~e sealed to the input port 50 during
the manufacturing process and the entire assembly,
including the catheter, can be sterilized as a unit.
After the input port 50 has been mated to the
catheter 62 and the catheter 62 has been inserted
into the body, the input port valve 60 is opened,
one of the containers 20 is unfolded, and the out-
put port valve 40 associated with that container 20is opened. Fluid then drains from the body, through
the catheter, into the manifold 10, and from there
into the selected container 20. When this container
20 is filled, the associated valve 40 is closed,
and then the filled container is severed from the
associated valve 40 and discarded. A second con-
tainer 20 is then unfolded, the associated valve 40
is opened, and drainage then continues into this
second container 20.
539
-13-
Each of the containers 20 is preferably filled
in sequence so that no more than one container is
receiving drained fluid at any given time. In each
case the associated valve 40 is closed before a con-
tainer 20 is severed, and thus the manifold is neveropened to atmosphere or contamination after it has
been connected to the source of body fluid. Large
quantiti~s of fluid can be drained over an extended
period of time without ever opening the system to
athmosphere.
The closed system drainage device of this in-
vention has widespread application to a host of
situations in which prolonged or large Yolume drain-
age is required and a low incidence of infection is
important. By way of example, this drainage system
can be used in urinary drainage, wound drainage
(either with or without wound suction devices),
drainage of ascites, drainage of pleural effusion,
choledochostomy and T-tube drainage, and pyelo-
nephrostomy to drain kidneys. Of course the numberand capacity of containers 20 is entirely a matter
of choice which should be chosen for the particular
applicatlon. The embodiment of Figure 1 is provided
with four two-liter bags by way of example, for in
urinary drainage the average duration of treatment
is less than four days and the average daily urine
production is less than two liters. Thus, this
embodiment provides a simple, closed system drain-
age device with adequate capacity for the average
case. In situations where drainage is chronic and
the avoidance of in~ection crucial, as in the treat-
ment of some paraplegics, for example, it is prPfer-
able to use a closed system drainage device with
much larger drainage capacity.
,
.
1~6~9
-14-
Turning now to Figure 3, the closed system
drainage device of this invention is well suited
for use with ambulatory patients. Figure 3 shows a
portable urinary drainage device which is generally
similar to that of Figure~ 1-2. A~ before, a cen-
tral manifold 10' is provided with a valved input
~O~ ~0` ~ our valved output ports 30', each of
which is connected to a collapsible container 20'.
The input port 50' is adapted for connection with a
urinary drainage catheter 62', and the entire assem-
bly, including the maniold 10', the containers 20'
and the input port 50', is manufactured as a single
sealed unit which is sterilized prior to use.
In this case the two ends 12',14' of the mani-
fold 10' are provided with mating hook-and-loop fas-
teners such as those marketed under the trade mark
"Velcro", and the manifold 10' is sized to fit around
the thigh of a patient at a point below the bladder.
The weight of the manifold 10' and any suspended
containers 20' is supported by straps 16' which con-
nect the manifold 10' to a belt 18' sized to fit
around the waist of the patient~
Preferably, each of the output ports 30' is at
least 1/2 inch long, as shown, to permit the port
30' to bend as necessary without closing off as the
patient bends his knee in walking and sitting. If
desired, each container 20' may be provided with a
line 22' at its lower end to hold the containers
securely to the leg of the patient. The method of
use and the internal structural details of this
embodiment are similar to those of Figures 1-2.
Figure 4 shows a schematic view of a closed
system dra:inage device of this invention arranged
to receive drainage material from a closed wound
suction device 150. Once again, the drainage device
}53~
-15-
includes a manlfold 10", a valved input port 50",
and several containers 20" connected to the mani-
fold 10" by valved output ports ~0". In this appli-
cation, the drainage device is connected to a suc-
tion device 150 via a conduit 152, and the suctiondevice 150 is connected to the body of the patient
via a conduit 154.
The suction device lS0 can be a conventional
closed wound suction device, and it is operated in
the conventional manner except that the suction
device 150 is periodically emptied through the
manifold 10" into one of the attached containers
20" without ever opening either the suction device
150 or the manifold 10" to atmosphere. As before,
the closed system drainage device operates to reduce
contamination and resulting retrograde infection of
the patient.
It should be apparent from the foregoing dis-
cussion that the closed system drainage device of
this invention can be used either with or without
suction devices in either fixed instal~ation or
portable embodiments. In alternate embodiments of
the invention the mani~old can be adopted for par-
ticular applications. The manifold can be integra-
ted with a suction device if desired and it can bemade in the shape and with the degree of rigidity
or flexibility best suited for the particular appli-
cation.
As previously mentioned, the present invention
also includes devices and methods for introducing
fluid into the body from multiple sources. In
general, these devices include multiple separately
valved input ports, each of which is preferably
used only once. These devices and methods are well
suited for bladder irrigation, wound irrigation,
"i
353~
-16-
and other situations where sterile fluids are
introduced into the body.
Turning now to Figure 5, a preferred embodi-
ment of the multiple input device of the invention
includes an irrigation manifold 130 which may be
constructed similarly to the manifold 10 of Figure
1. This manifold 130 is provided with a single
output port 132 adapted for connection with a suit-
able catheter. This output port 132 is provided
with a check valve 134, oriented to prevent fluid
from entering the manifold 130 via the output port
132, and a valve 136, which operates to selectively
close the output port 132.
The manifold 130 is also provided with a plurali-
ty of input ports 140, each of which includes a valve
150 and a sn~p-on cap 160. Anchor points 138 are
included on the manifold 130 to facilitate mounting
the manifold 130 to a support structure such as a
rack 180.
This irrigation manifold is manufactured under
standard clean room conditions. The output port
132 is then closed by means of the valve 136 and
capped, each of the input ports 140 is capped and
closed by means of the associated valve 150, and
then the entire sealed manifold assembly is steri-
lized.
In use, the output port 132 is coupled to an
irrigation catheter, such as a bladder irrigation
catheter, for example. As before, the catheter can
be made an integral part of the output port 132, or
the port 132 can be mated with a suitable catheter
either before or after the catheter has been in-
serted into the body. A container of irxigating
solution is then connected to one of the input
ports 140 and the associated valve 150 is opened to
~6~3~
-17-
allow the solution to pass into the manifold 130
and out the output port 132 into the body.
When a second container of nutrient is needed,
the valve 150 on the input port 140 connected to
S the first Gontainer is closed and the first con-
tainer is removed. Then the second container is
coupled to a fresh input port 140 that has not
previously been used and the process is repeated.
Each input port is preferably used only once to
reduce the incidence of infection. Of course,
normal precautions should be taken to ensure that
containers of solution are connected to the input
ports 140 under dry, sterile conditions.
The multiple input port feature of the in-
vention is not restricted to use in irrigation. Itcan be used in many situations where fluid from
multiple sources must be introduced into the body
under sterile conditions. For example, it may be
used in intravenous administration of nutrients and
medicines and in hyperalimentation treatment. In
each application the size of the manifold and the
size and number of the input and output ports
should be chosen to fit the intended use. One
alternate embodiment o~ the irrigation manifold 130
of Figure 5 includes a small, tube-like manifold
which attaches directly to irrigation catheter and
includes a small number of valved input ports. In
this embodiment, the output port is nothing more
than the junction between the manifold and the
catheter, and the output port valve can be
eliminated. This alternate embodiment is well
suited both for collecting s~mples of body fluid as
well as introducing fluid into the bod~.
Referring now to Figure 6, both the multiple
valved container feature of the invention and the
-18~ 853~
multiple valved input port feature of the invention
can be used together in a manifold ~or peritoneal
dialysis. Figure 6 represents-a fir~t preferred
embodiment of such a dialysis manifold,
S The dialysis manifold of Figure 6 includes a
belt 210 sized to fit around the abdomen of a
patient. This belt 210 is a tubular structure
which defines a central manifold, as will be shswn
in greater detail in later figures. The belt 210
is preferably extruded from a flexible plastic
material such as vinyl and should have adequate
rigidity to prevent the tube of the belt 210 from
collapsiny during normal use.
A strip of cloth 214 is bonded to the interior
surface of the belt, by heat sealing or adhesive
bonding, for example. In use, the belt 210 is worn
next to the body, and the cloth strip 214 acts to
reduce lateral slippage and chafing of the belt
against the body.
Four fasteners 212 are secured at spaced
intervals to the outside perimeter of the belt 210.
In actual use, a lightweight fabric vest 280 is
secured to the belt 210 by vest fasteners 282 which
couple with the belt fasteners 212. Hook and loop
fasteners are preferably used for both sets of
fasteners 212 and 282 in this preferred embodiment.
Such fasteners are commonly available under the
trade mark "Velcro". The vest 280 serves to sup-
port the weight of the belt 210 on the shoulders of
the wearer, and it improves the comfort and wear-
ability of the belt 210~ In alternate embodiments,
suspenders can be substituted for the vest 280;
however, for many applications, the vest 280 pro-
vides improved long~term wearing comfort as com-
pared with suspenders.
19 ~.~6~
The belt 210 is a single tubular structurewhich is flattened at the end sections 216,218.
Both end sections 216,218 are provided with mating
fasteners, such as hook and loop fastener strips.
These fasteners act to secure the two ends of the
belt together and to hold the belt in place around
the abdomen of the wearer. Hook and loop fasteners
provide the advantage of adjustability.
A set of elght containers 220 is mounted on
each side of the bottom portion of the belt 210 by
means of conduits 230 equipped with valves 240,
These containers 2~0 are prefera~ly thin plastic
bags formed from vinyl or polyethylene, for ~xample,
which can be compactly folded as shown in Figure 6
prior to use. Each bag is sealed to the lower end
of the associated valve 240 which is in turn sealed
to a conduit 230 extending from the belt 210. Ad-
hesives or heat sealing techniques may be used to
secure the containers 220, the valves 240, the
conduits 230, and the belt 210 to form a single
sealed, leakproof unit which provides an imperme-
able barrier to contamination and infection.
Each of the contaîners 220 is originally
folded into a small packet adjacent the associated
valve 240. The use of these containers will be
explained in detail below. Here it is enough to
note that each container can be unfolded to its
full size as shown by the unfolded container 220a.
Each container may be of any desired capacity. In
the presently preferred embodiment the containers
220 have a capacity of two liters and each con-
tainer 220 is provided with a volumetric scale 222
by means of which the volume of fluid contained in
the container may be estimated.
A support net 290 is secured by means of two
hooks 292 to the belt 210 and placed around a
~6~3g
-20-
container 220a as it is filled This net bag 290
serves to support a major part of the weight of the
fluid in the container 220a, and in this way reduces
the strain of the container 220a and the associated
valve 240 and conduit 230.
A set of eight input ports 250 is mounted on
each side of the top of the belt 210. Each port
250 is a -tubular structure which is provided with a
valve 260 and a snap-on cap 270. Once again, the
ports 250, valves 260, and belt 210 are bonded
together to form a single sealed unit which forms
an impermeable barrier to infection.
Turning now to Figures 7-8, further features
of the belt 210 will be explained. Figure 7 shows
a top view of the rear portion of the belt 210 in
which the flattened end sections 216,218 and the
hook and loop fasteners 213 can be clearly seen.
As best shown in Figure 7a, the belt 210 is a
hollow, tubular structure which defines a central
volume 300. This central volume is in fluid com-
munication with each of the inlet ports 250 and
each of the conduits 230.
Figure 7b shows a cross section of the belt
210 in the flattened end section 218. In this
region the tubular belt 210 has been flattened and
two opposed sides of the~belt have been sealed
together to prevent leakage from or con~amination
of the belt 210 via the end section 216,218.
Figure 8 represents a~bottom view of the front
portion of the belt 210 in partial cross section.
A recess 310 is formed in the lower inside of the
front of the belt 210 to house the catheters which
couple the belt 210 to the subject. A belt catheter
320 passes through an opening 312 in the belt 210
and is bonded to the belt 210 via flanye 322. Once
-21- ~6~39
again, it is important that a leakproof seal be
formed to prevent contamination or infection, and
heat sealing or adhesive bonding techniques may be
used.
The belt catheter 320 is coupled to an indwel-
ling catheter 330 which has previously been inserted
into the peri-toneal cavity of the subject under sterile
conditions. The connection between the belt
catheter 320 and the indwelling catheter 330 can be
made in any suitable manner, as for example with a
female-to-female catheter connector 332.
The recess 310 is sized to receive both the
belt catheter 320 and the indwelling catheter 330
when the belt 210 is in place around the patient,
as shown in Figures 8 and 8a. In this way pressure
on the abdomen and attendant discomfort are reduced.
Figure 9 shows a cross sectional view of the
belt 210 showing the internal arrangement of the
ports 250 and the container conduits 230. Each
conduit 230 penetrates and is in fluid communica-
tion with the central volume 300 and is provided
with an exterior ~lange 232 which is sealed against
khe outside of the belt 210. In order to increase
the packing density, adjacent conduits 230 are stag-
gered by about 20. This permits the folded con~
tainers 220 to overlap, as best seen in Figure 6.
Each container 220 defines a narrow neck region 224
which is sealed to the lower portion of the associ-
ated valve 240.
Each of the valves 240 is an on-off valve which
completely seals off the interior of the belt 210
from infection when the valve 240 is closed. In
the presently preferred embodiment, low bulk, push-
pull valves are used in which the valve is pulled
to open and pushed to close. Such valves are readily
~.~.68539
-22-
available as standard components. Valve model
320TE, manufactured by Halkey-Roberts of Paramus,
New Jersey, is one e~ample of such a valve.
Each of the ports 250 also is in fluid communica-
tion with the central volume 300 and is sealed tothe exterior of the belt 210 via a flange 25~ on
the port 250. The port valves 260 are preferabl~
push-pull valves, similar to the container valves
240. The snap-on cap 270 on each valve 260 servès
to shield and protect the valve 260 from
contamination prior to use. Preferably, each cap
270 is secured to the associated valve 260 by a
thin flexible strap 272. The belt 210 should be
assembled in a clean room and then sterilized prior
to use, utilizing standard manufacturing practices
for medical devices as outlined by the Food and
Drug Administration. It should be understood that
when the belt 210, containers ~20, and ports 250
are assembled, all valves 240,260 are closed, and
the belt catheter 320 is sealed, prior to steriliza-
tion. In this way, the belt is delivered as a single,
sterile unit, ready for use.
In use, the belt 210 acts as a manifold through
which dialysate can be introduced into and removed
from the peritoneal cavity with reduced incidence
of infection. The first step in using this belt
assembly is to connect the belt catheter 320 to the
indwelling catheter 330 of a patient under surgically
sterile conditions. This step will usually be per-
formed in the office of the physician or in a hospital.
The next step is the introduction of dialysateinto the peritoneal cavity of the patient via the
belt 210. First a container of dialysate ~not shown)
is coupled via a tube to one of the valves 260.
The valve 260 will be dry and sterile, for it has
:
8S35~
-23-
been capped since its initial sterilization. The
dialysate tube (not shown) should also be dry and
sterile. After the dialysate container has been
coupled to the valve 260, the valve 260 is opened,
and dialysate is allowed to drain via the valve 260
and the port 250 into the central volume 300 of the
belt 210. From there, the dialysate passes via the
belt catheter 320 and the indwelling catheter 330
into the peritoneal cavity of the subject. After
the dialysate container has been emptied, the associ-
ated valve 260 is closed, the container is removed,
and the cap 270 is replaced. In this way the port
250 is closed by the valve 260 before it is exposed
to atmosphere, thereby reducing contamination and
infection.
The dialysate is allowed to remain in the
peritoneal cavity for a period of time and is then
drained from the peritoneal cavity via the belt 210
into one of the containers 220. Prior to this, a
selected container is unfolded and placed within
the support net 290. The associated valve 240 is
then opened and dialysate flows from the central
volume 300, via the conduit 230 and the valve 240
into the container 220. After the container is
filled, the associated valve 240 is then closed and
the filled container 220 is removed from the belt
210 by severing the neck of the bag 220 below the
valve 240. The severed container 220 and its con-
tents are then discarded.
Because the container 220 is not removed until
after the associated valve 240 has been closed, the
belt 210 is never opened to atmosphere during drain-
age. Instead, the central volllme 300 remains closed
and uncontaminate~.
The next batch of dialysate to be used is then
connected to a second inlet port valve 260, one which
,: ~
~.16E~539
-24-
has not previously been used, and the entire procedure
is repeated. In each case a fresh input port 250
and a fresh container 220 are used. Because no input
port 250 is used twice, it is always a dry, sterile
input port valve 260 which is mated with the dialysate
container. When proper precautions are ta~en to
ensure that each dialysate container is sterile,
this use of each input port only is believed to
reduce the incidence of infection. Furthermore,
since all the drainage containers 220 are sealed in
place from the beginning, dialysate drainage is
accomplished without ever opening the belt 210 to
atmosphere. In this way, infection associated with
drainage is reduced.
The belt 210 has been designed to minimize in-
fection of the subject from dialysate contamination
either when introduced into the subject or when
drained. This belt is sim~le to use and easily
portable, and it is anticipated that it will be
useful in the treatment of ambulatory patients who
are not hospitalized. The patient can administer
and drain the dialysate himself, wi-thout assistance
from medical personnel. Only after each of the
ports and containers has been used will the belt be
replaced with a new belt, complete with a new set
of sterile ports and folded containers.
One current regimen of peritoneal dialysis
involves introducing and draining two liter batches
of dialysate, four times a day. The belt 210 shown
in Figures 6-9 is ~7ell suited for this regimen, in
that it includes 16 ports 250 and 16 two~ ter con-
tainers 220. This belt 210 can be used for four
complete days of dialysis before i~ will have to be
replaced.
Figures 10 and 11 represent a second preferred
embodiment of the dialysis belt o this invention.
~.~6~5~9
-25-
This embodiment is similar to that of Figures 6-9
in that it includes 16 valved inlet ports 250 and
16 valved containers 220. For ease of reference,
like components of the two embodiments are provided
with like reference numbers.
As best shown in Figure 11, the belt 340 is
divided by an internal partition 342 which divides
the interior of the belt 340 into two manifolds, or
chambers 350,360 which extend the length of the belt
340. The 16 inlet ports 250 all communicate with
the inner chamber 36G and the 16 valved containers
220 all communicate with the outer chamber 350 via
the valves 240. As shown in Figure 10, the indwel-
ling catheter 330 is connected to a three-way valve
370 which is in turn coupled both to the inner
chamber 360 via an inner belt catheter 334 and to
the outer chamber 350 via an outer belt catheter
336. The three-way valve 370 is a standard valve
which can be set to a first position to couple the
`: 20 inner belt catheter 334 with the indwelling cathe-
ter 330, and to a second portion to couple the
outer belt catheter 336 to the indwelling catheter
330. The three-way valve 370 can also be set to
close off the indwelling catheter when desired.
The embodiment of Figures 10 and 11 is used in
much the same manner as that of Figures 6-9, except
that for introducing dialysate into the peritoneal
cavity the three-way valve 370 is set in the first
position, which couples the inner belt catheter 334
to the indwelling catheter 330; for draining dialy-
: sate valve 370 is set in the second position, which
: couples the outer belt catheter 336 to the indwel-
ling catheter 330.
A principal advantage of this embodiment is
that fresh dialysate is not mixed with previously
:"
53~3
-2~-
drained dialysate in the belt 340. In some applica-
tions, this may reduce the tendency for compounds
leached from the inner walls of the belt 340 by
drained dialysate from being introduced into the
patient.
A third preferred embodiment of the dialysis
belt of this invention is shown in Figures 12 and
13. In this embodiment, the belt 380 defines only
a single internal volume. The belt is provided
with 28 valved input/output ports 250 arranged
along the underside of the belt 380. There are no
attached containers in -this embodiment. Each of
the ports 250 is provided with a valve 260 and a
snap-on cap 270 as before, and the belt 380 in-
cludes a belt catheter (not shown) similar to thatdescribed above in connection with the Figures 6-9.
This belt 380 is designed to utilize the dialy-
sate container ~not shown) as a drainage container.
As before, the belt 380 is originally a sealed
sterile unit in which all 28 of the valves 260 are
closed. After the belt catheter is coupled to the
indwelling catheter (not shown in this view~, dialy-
sate is introduced into the belt from a dialysate
container which is coupled to one of the input/output
ports 250 under sterile conditions. As before, each
port 250 is only used once, and each valve 260 is
kept closed until after the dialysate container has
been connected.
In this case, however, the dialysate container
is not removed from the port 250 after the dialysate
has been drained into the peritoneal cavity. Instead,
the dialysate container is left connected to the
port 250 until it is time to drain the dialysate
from the peritoneal cavity. Then, without ever removin~
the dialysate container, the used dialysate is drained
-27- 1~6~539
into the same container from ~7hich it came. Aftèr
the used dialyste has been returned to its container
the associated valve 260 closed and only then is
the filled dialysate container removed from the port
250.
This embodiment provides the important
advantages of low bulk and low cost. In that
containers need not be sealed to the belt 380 prior
to use, more ports 250 can be easily placed around
the belt 380. Various numbers of ports may be
supplied, depending on the application. The 28
ports of this third preferred embodiment will
support a full week of peritoneal dialysis in which
four batches of dialysa-te are introduced and drained
daily.
of course, it should be understood that various
changes and modifications to the preferred embodi-
ments described herein will be apparent to those
skilled in the art. For example, each of the mani-
folds can readily be made larger or smaller, or withdifferent fabrication technigues, as reguired. The
size and numbex o~ attached containers and input
ports can be readily varied to meet the anticipated
need, as can the size and type of valves used. More-
over, each foxm of the invention may be embodied ineither portable or nonportable devices, fo. u e with
either ambulatory or bedridden patients. Such changes
and modifications can be made without departing from
the spirit and scope of the present invention and
without diminishing its attendant advantages. It
is, therefore, intended that such changes and modi-
fications be covered by the following claims.
