U.S. patent application number 09/951555 was filed with the patent office on 2002-03-14 for filter bag and connector cartridge.
Invention is credited to Ellsworth, James R., Verkaart, Wesley H..
Application Number | 20020030002 09/951555 |
Document ID | / |
Family ID | 27485521 |
Filed Date | 2002-03-14 |
United States Patent
Application |
20020030002 |
Kind Code |
A1 |
Verkaart, Wesley H. ; et
al. |
March 14, 2002 |
Filter bag and connector cartridge
Abstract
A filter bag (200) and connector cartridge are used for
collection of physiological fluids. The bag (200) includes an
internal filter (206) and two seals (218, 220) on the perimeter. An
inner seal (218) bonds the outer sheets (202, 204) of the bag and
the filter, while the outer seal (220) bonds only the two outer
sheets (202, 204) and acts as a safety seal. The bag includes a
verification element that cooperates with a verification connector
to ensure that the bag is properly attached to the fluid supply
line before a fluid pump is enabled.
Inventors: |
Verkaart, Wesley H.;
(Norwell, MA) ; Ellsworth, James R.; (Norwell,
MA) |
Correspondence
Address: |
Clark & Brody
Suite 600
1750 K Street, NW
Washington
DC
20006
US
|
Family ID: |
27485521 |
Appl. No.: |
09/951555 |
Filed: |
September 14, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09951555 |
Sep 14, 2001 |
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09051481 |
Jun 5, 1998 |
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09051481 |
Jun 5, 1998 |
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PCT/US96/16772 |
Oct 18, 1996 |
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Current U.S.
Class: |
210/94 ; 210/445;
285/93 |
Current CPC
Class: |
A61M 1/3627 20130101;
A61M 1/79 20210501; B01D 29/908 20130101; A61M 1/631 20210501; F04B
43/1253 20130101; B01D 36/001 20130101; F04B 43/0072 20130101; A61M
2206/16 20130101; F04B 43/1284 20130101; A61J 1/1475 20130101; A61M
60/113 20210101; B01D 29/036 20130101; A61J 1/10 20130101; A61M
39/10 20130101; A61M 2039/1044 20130101; A61M 2205/75 20130101;
A61M 1/0001 20130101; A61M 2205/3393 20130101; A61M 1/78 20210501;
A61M 1/3626 20130101; A61M 2205/14 20130101; A61M 1/0023
20130101 |
Class at
Publication: |
210/94 ; 210/445;
285/93 |
International
Class: |
B01D 035/02 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 20, 1995 |
US |
60/008127 |
Oct 20, 1995 |
US |
60/008128 |
Oct 20, 1995 |
US |
60/005772 |
Jun 28, 1996 |
US |
60/020754 |
Claims
We claim:
1. A container for a fluid comprising first and second outer sheets
forming a cavity and a filter between said sheets dividing said
cavity into first and second chambers in communication with each
other through said filter, fluid inlet means communicating with
said first chamber for conducting fluid into said cavity, and fluid
outlet means communicating with said second chamber for conducting
fluid out of said cavity, wherein said sheets and filter are bonded
together at a first peripheral bond and only said sheets are bonded
together at a second peripheral bond.
2. A container according to claim 1 wherein said first peripheral
bond lies radially inward of said second peripheral bond.
3. A container according to claim 1 wherein said fluid inlet means
is secured between a first of said sheets on one side of said inlet
means and the other of said sheets and said filter on the other
side of said inlet means.
4. A container according to claim 1 wherein said filter comprises a
40.mu. mesh.
5. A container according to claim 1 wherein one of said fluid inlet
and fluid outlet means comprises a first connector element and
means for verifying proper attachment of said first connector
element to a second connector element.
6. A container according to claim 5 wherein said means for
verifying comprises an optical element.
7. A container according to claim 6 wherein said optical element
comprises a transparent cylinder.
8. In combination, a first connector element and means for
verifying whether said first connector is connected to a second
connector element, wherein said means for verifying comprises an
optical element.
9. A combination according to claim 8 wherein said connector is a
Luer connector and said optical element comprises a transparent
cylinder.
10. A combination according to claim 9 in further combination with
a fluid container and wherein said connector is part of an inlet or
outlet line for said container.
11. A combination according to claim 10 wherein said container
comprises first and second outer sheets forming a cavity and a
filter between said sheets dividing said cavity into first and
second chambers in communication with each other through said
filter, fluid inlet means communicating with said first chamber for
conducting fluid into said cavity, and fluid outlet means
communicating with said second chamber for conducting fluid out of
said cavity, wherein said sheets and filter are bonded together at
a first peripheral bond and only said sheets are bonded together at
a second peripheral bond.
12. Apparatus for connecting two fluid lines, comprising a housing
having means for removably engaging a mounting element on a base
unit, a first connector means in fluid communication with a first
fluid line and adapted to be removably attached to a second
connector means on a second fluid line, and means for verifying
that said first connector means is connected to said second
connector means.
13. Apparatus according to claim 12 wherein said means for
verifying is adapted to cooperate with verifying means on said base
unit when said apparatus is attached to said base unit.
14. Apparatus according to claim 13 wherein said means for
verifying comprises means forming at least one optical channel for
directing a beam of light toward said second connector means when
said second connector means is attached to said first connector
means.
15. Apparatus according to claim 14 wherein said at least one
optical channel comprises an inlet channel positioned to align with
a light source on said base unit and an outlet channel positioned
to align with a light detector when said apparatus is received on
said base unit.
Description
FIELD OF THE INVENTION
[0001] This invention relates to the art of systems for the
collection of fluids. In particular, the invention relates to a bag
for receiving fluids and a connector for connecting the bag to a
supply pump.
BACKGROUND
[0002] It is known to collect fluids in containers such a flexible
bags. For example, it is known to collect blood and other
physiological fluids during surgery by pumping the blood into
flexible bags. The fluids are then redelivered to the patient after
processing. The fluids generally include debris that must be
removed, and filters are used for this. Prior bags that include
filters have not been effective, however, and are often expensive.
Moreover, because the bags are disposable, the fluid lines are
detachable, and it is necessary to provide an effective means for
ensuring that the lines are properly connected before the pumping
operation begins.
SUMMARY OF THE INVENTION
[0003] In accordance with the invention, a novel bag includes an
internal filter, and a connector for attaching the bag to a fluid
supply ensures that the bag is properly connected prior to
operation of the pump.
[0004] The bag for receiving physiological fluids that have been
recovered from a patient includes a filter for removing particles
that are larger than a predetermined size. In the preferred
embodiment, the filter is a 40.mu. mesh. The bag is made of two
layers of flexible plastic with the filter held between the two
layers. The inlet to the bag is placed between the filter and one
of the outer layers, and the outlet is placed between the filter
and the other of the outer layers. The flexible plastic layers and
the filter are bonded together by heat, radio frequency (RF), or
ultrasonic welding at the edges.
[0005] The edges are bonded in two locations. First, the filter and
the outer layers are bonded completely around the bag inward of the
outer edge of the bag, except for the locations where the inlet and
outlet are secured. Then, the two outer layers and inlet and outlet
conduits are bonded without the filter between them. By this
construction, the bond of all three layers positions the filter to
separate the bag into two compartments, and the outer bond acts as
a safeguard to ensure that the contents are not spilled even if the
inner bond fails.
[0006] In accordance with another aspect of the invention, a fluid
supply line is connected to one or more lines, preferably inlet
lines to the bag described above, by a verification connector. The
verification connector includes means for verifying that the lines
are properly connected and for controlling an interlock that
prevents operation of the fluid pumps if the lines are not
connected. The verification elements are easily attached to a base
unit for cooperation with verification elements on the base unit to
verify that the supply line is properly connected to the outlet
lines. In the absence of such verification, operation of the fluid
supply pump is inhibited. The verification connectors preferably
include known Luer connectors for connecting the supply line to the
inlet lines. Other types of connectors may, of course, be used.
[0007] In the preferred embodiment, the verification elements are
optical. A light emitting diode, preferably infrared, and a photo
detector, also preferably infrared, are contained in the base unit
and are located with respect to the verification elements such that
a beam from the light emitting diode will enter a transparent,
conducting, portion of the verification elements when properly
installed. The inlet line verification element will refract the
light through an angle that will cause it to impinge on a detector
in the base unit. Reflecting surfaces may be used to direct the
incident and refracted beams to desired locations in the base unit.
Signals from the photo detector are supplied to a control circuit
that allows operation of a fluid supply pump only when the outlet
lines are properly connected.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a front view of a filter bag, partially broken
away, in accordance with the invention.
[0009] FIG. 2 is a cross-section taken along line 2-2 of FIG.
1.
[0010] FIG. 3 is a cross-section taken along line 3-3 of FIG.
1.
[0011] FIG. 4 is a cross-section taken along line 4-4 of FIG.
2.
[0012] FIG. 5 is a cross-section taken along line 5-5 of FIG.
4.
[0013] FIG. 6 is a perspective of a male Luer connector with a
mounting key attached.
[0014] FIG. 7 is a perspective of a base element having
verification components in accordance with the invention.
[0015] FIGS. 8A and 8B are front views of the base element
illustrating attachment of the mounting key to the base
element.
[0016] FIGS. 9a and 9B illustrate the operation of the verification
elements.
[0017] FIG. 10 is a perspective showing the fluids lines properly
connected and attached to the base element.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0018] With reference to FIG. 1, a filter bag 200 is constructed of
respective outer sheets 202 and 204. These sheets are preferably
flexible and may be made of known plastic material. An inner sheet
206 is a filter, which is preferably a 40.mu. mesh of plastic
material that can be easily bonded to the outer sheets. The bag
includes an opening 208 to allow it to be hung from a variety of
locations, such as a known I.V. stand.
[0019] The bag includes an inlet line 210 and an outlet port 212.
The inlet line 210 includes a Luer connector 214 for attaching the
line to a source of the physiological fluid, such as the supply
line shown in FIG. 6. This connector is preferably designed to
connect with other Luer connectors of standard size but also
includes means for verifying whether the line is connected to a
source of supply. While this verification element may take various
forms, both electrical and mechanical, in the preferred embodiment
the verification means is a cylindrical optical element 216. The
cylinder is transparent to light, for example, infrared light from
a light emitting diode. When the Luer connector is properly
attached to the source of supply, the light passes through the
cylinder and is refracted thereby to impinge on a detector. An
electronic control circuit senses the presence of light on the
detector and, in response, allows activation of a supply pump. This
ensures that the line is connected to the source of supply,
preventing inadvertently spilling the physiological fluids.
[0020] The preferred construction of the filter bag is more clearly
shown in FIG. 2. The three layers of material, the two outer sheets
202, 204 and the filter 206, are bonded together at an inner bond
218. This bond, which may be produced by heating, radio frequency
(RF), ultrasound, or other known methods, secures the three layers
together to form two chambers 220 and 222 separated by the filter
206. A second, outer bond 220 is formed at the outer edge of the
bag. This outer bond is between only the two outer sheets and
excludes the filter material. The outer bond 220 provides an
additional measure of safety to prevent separation of the two
sheets and accidental discharge of the contents of the bag, should
the inner bond fail. This is important in situations, such as
pressure infusion, where the contents of the bag are subjected to
pressures as high as 300 mmHg to increase the flow rate.
[0021] FIGS. 4 and 5 show how the sheets 202 and 204 and the filter
206 are secured to the inlet line 210 and the outlet 212. It will
be appreciated that the inlet and outlet could as well be attached
by a variety of means. For example, these could be provided by a
known sidewall connector in each of the sheets 202 and 204.
[0022] In operation, physiological fluid, such as blood obtained
from a surgical site, is supplied to the inlet line 210 by a pump
(not sown). This fluid first flows through the inlet line 210 into
the chamber 222. As the fluid passes through the filter into
chamber 220, the filter removes unwanted particles. As the bag
continues to fill, some of the fluid will remain in chamber 222,
while the remainder will pass through the filter to chamber 220.
When it is desired to use the fluid in the bag, an appropriate
outlet line (not shown), such as an l.V. line is attached to the
outlet 212 to permit fluid to flow out of the bag. Preferably,
outlet 212 is a known spikeport that has a removable cover 226 and
receives a spike in known fashion.
[0023] The spikeport includes a flange 228, which may be used to
support the bag while it is being filled. When the fluid in the bag
is withdrawn, the bag is hung from the opening 208, and the inlet
line 210 is closed with a slide clamp, metal crimp, Luer cap, or
the like. Thus, the bag is filled in an orientation opposite from
the orientation from which it is emptied. This increases efficiency
by providing even usage of the filter layer; the in-flowing fluid
will pass continuously through one end of the filter as it is
filling and the out-flowing fluid will continuously pass through
the opposite end of the filter as it is being discharged.
[0024] With reference to FIG. 6, a male Luer connector 302 is
attached to a tube 304, as known in the art. A mounting key 306
according to the invention is attached to the Luer connector, as by
welding or cement. The key is used to secure the male connector to
the base element shown in FIGS. 7 through 10. The base element 308
is attached to, or is a part of, apparatus for pumping fluids into
a bag, such as bag 200. The base element includes a face plate 310
for receiving the key 306 and the Luer connector. The face plate
includes an opening 312, which is of a shape that will allow the
key to be inserted. A narrower notch 314 is located below the
opening 312, and a slot 316 is formed between the front of the
faceplate and a rear wall thereof. Slot 316 extends vertically from
the bottom of the opening 312 to just above the bottom of the
faceplate. While the key has been shown to be square, other shapes
are possible.
[0025] The installation of the key will be explained with reference
to FIGS. 8A and 8B. The key 306 with the male Luer connected is
first inserted in the opening 312 as shown in FIG. 8A. Then, the
key is slid downward as illustrated in FIG. 8B, whereby the edges
of the key engage the slot 316 to thereby secure the male Luer and
key in the faceplate 310. The key is preferably retained in the
position shown in FIG. 8B by gravity; as well the position may be
maintained by friction or other mechanisms.
[0026] The purpose of this structure is to provide verification of
the proper installation of the Luer connectors. Thus, base element
308 includes a source 318 of electromagnetic energy, such as
infrared energy from a light emitting diode. The base also includes
a window 320 for allowing refracted energy to impinge on a detector
322. The detector is shown located behind the window, but it could
be placed in the element 308 as well. Also, reflectors cold be
employed to direct the beams as desired to detectors located
elsewhere.
[0027] FIG. 9A illustrates the situation when the female Luer
connector 214 is attached to the male Luer connector 302, and the
key 306 is secured in the faceplate 310. In this configuration, the
light beam 324 is refracted by the optical element 216 on the
female Luer. Thus, the light path is as shown in FIG. 9A where is
passes through window 320 and impinges on detector 322. The
detector 322 supplies a signal to a control circuit allowing the
pumps to operate.
[0028] FIG. 9B illustrates the situation where the female Luer is
not properly connected. In this situation, the required refraction
does not occur, and the beam does not pass through the window 322.
Accordingly, the detector 322 does not detect the impingement, and
the control circuit does not enable operation of the pumps.
[0029] FIG. 10 shows the male and female Luer connectors attached
to each other and installed on the base element. The base element
provides an opening at the bottom for receiving the line 304 from
the source of fluid, such as a pump. The line 304 and key may be
installed from the front of the base element prior to connection of
the line 210. Or, the two lines may be attached and then installed
in the base element. One advantage of the key, however, is that the
connector 214 may be easily attached to the connector 302 with one
hand when the key is secure in the base element.
[0030] While any number of inlet lines 210 may be used, only one is
illustrated in the figures. Thus, supply line 304 may be connected
to a Y-connector (not shown), which is in turn connected to the
supply pump As described above, each of the inlet lines 210
includes a female Luer connector 214 that has been modified to
include a verification element. The verification element in the
preferred embodiment is the optical element 216 that cooperates
with the light source and detector in the base element to verify
that the connector 214 is properly in place.
[0031] It will be appreciated that the described verification
system is fail-safe because it requires a predetermined signal to
be received by the photo detectors before connection is verified.
If the Luer connectors are not in place, the light from the source
in the base unit will not be refracted to the photo detectors, and
verification will be precluded. Modifications within the scope of
the claims will be apparent to those of skill in the art.
* * * * *