Note: Descriptions are shown in the official language in which they were submitted.
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~ URE/PAT:101
Title of In~ention: CHEST DRAINAOE APPARATUS
Technical Field
This invention relates generally to catheter apparatus, and more
particularly to an improved intrapleural catheter apparatus and
combined apparatus for installing the improved ;n~rapleural catheter.
Background Art
Catheter apparatus, particularly useful for the drainage of the
chest cavity, i.e. the region surrounding the lungs, in the treabment
of certain chest injuries, illnesses and in post-operative treatment,
was disclosed in U.S. Paten$ No. 3,463,15g. The apparatus disclosed in
the patent, commonly known as the Heimlich valve, has been a successful
improvement over earlier catheters in providing means for continuous
drainage of the chest cavity, while eliminating the need for cumbersome
drainage apparatus, particularly apparatus requiring water traps, such
as those shown in U.S. Patent Nos. 3,363,626; 3,363,627 and 3,683,913.
While the Heimlich valve is quite useful, it must be used with
additional apparatus to insert a catheter into the body cavity to be
drained, to connect the catheter to the valve and to provide for
discharge of fluids removed from the body cavity from the discharge o~
the valYe. It has been necessary to obtain the additional apparatus,
usually from several sources, and to assure the sterility of each of
the components to be placed in communication with the body cavity or in
the area of the patient's body in which the catheter is to be inserted.
Moreover, while the use of the Heimlich valve permitted rapid emergency
treatment and transportation of patients, the additional apparatus
frequently restricted the freedom of movement of the patient.
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URE/PAT: lDl
It is therefore an object of the present invention to provide
compact, self-contained means for the drainage of a body cavity.
It is another object of the present invention to provide body
cav~ty drainage apparatus ;n which a catheter is preassembled to the
drainage valYe apparatus, and the entire assembly is llghtweight and
portable.
Still another object of the invention is to provide a
self-conta;ned sterile kit which can be readily used for drainage of a
body cavity.
These and other objects, features and advantages of the present
invention will become apparent from the following description when
considered in connection with the accompanying drawings.
Disclosure of the Invention
In general, the objects and advantages of the present invention
are achieved by apparatus for drainage of a body cavity which includes
a housing body generally sealed to the ambient a~mosphere except for
controlled venting as may be specifically prov`ided, an elongated
one-way valve mounted within the housing body, and a catheter supported
by the housing body and exte~ding outwardly therefrom. The apparatus
thus described is intended to be used with a trocar, as ~ill be
hereinafter described. In accordance with the invention, the drainage
apparatus and a trocar ~ay be packaged in a sterile package to form a
sterile kit for the drainage of a body cavity.
More particularly, the objects and advantages of the present
invention are achieved by the following apparatus: A housing body is
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URE/PAT: lo
provided having portions which define an inlet chamber and a discharge
chamber. The housing body portion defining the inlet chamber includes
mounting means for supporting a catheter, preferably an intrapleural
catheter, in sealed arrangemen~ with the chamber. The catheter
suppor~ed by the mounting means extends outwardly from the inlet
chamber and is in fluid communication with th~e chamber. An inlet port
is provided in the housing body portion defining the inlet chamber and
is adapted ~o reversibly receive a trocar and is positioned to enable
at least a portion of the trocar to pass through the inlet chamber and
the catheter. The inlet port is adapted to seal the in1et chamber from
the ambient atmosphere in the absence or presence of the trocar.
The apparatus includes a one-way elongated valve mounted in the
housing body which couples in fluid communication the inlet chamber
with the discharge chamber, so as to permit the passage of fluid
between the chambers only through the valve. The valve can be
substantially as described in Heimlich U.S. Patent No. 3,463,159, and
can be formed of a sleeve of substantially resilient fluid-impervious
material, for example of latex rubber, or preferably, of urethane or
silicone elastomer. The sleeve has ;ts inlet end held open and in
communication with the inlet chamber, whi1e its normally c70sed outlet
end resides in the discharge chamber. The valve is normally held
closed alcng a substantial length of the sleeve by the substantial
resilience of the sleeve material, and is adapted to progressively open
and close to permit the irreversible passage of drainage material
passing therethrough from its inlet end to its outlet end.
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URE/PAT:101
In the use of ~he appara~us of the present invention, a trocar
having an external diameter almost as large as the internal diameter of
the catheter portion of the apparatus is inserted throu~h the inlet
port of the inlet chamber and through the catheter supported by the
S mounting means in one wall of the inlet chamber. The trocar end
supporting the outermost end of the cha~ber, with the remainder of the
apparatus supported by the trocar, is inserted into the body cavity.
Following insertion, the trocar is removed from the catheter, while
leaving the end and at least ~he portion of the catheter adjacent
thereto in the body cavity, and withdrawing the trocar fro~ at least a
substantial portion of the inlet chamber to provide communication from
the catheter to the inlet chamber and the one-way valve. Preferably,
the trocar is completely removed from the inlet cha~ber and the inlet
port, and hence the apparatus, so as to avoid accidental reinsertion of
the trocar or manipulation of the apparatus by accidental movement of
the trocar. Upon removal of the trocar from the inlet port, the inlet
port provides a seal to the ambient atmosphere. Fl~ids and other
ma~erials to be drained from the body cavity can now flow through the
catheter into the inlet chamber and pass through the one-way elongated
valve and into the discharge chamber where it is prevented from
reentering the ca$heter and the body cavity by the presence of the
one-way valve.
It can be seen that the apparatus of the present invention is most
particularly adapted for insertion into the chest cavity in the area of
the lungs, for the purpose of draining air and other fluids, as well as
blood clots, particles and the like therefrom.
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URE/PAT~
The apparatus of the present invention can further include on the
exterior surface of the housing body por~ion de~ining the inlet chamber
wh;ch includes the mounting means for supporting the catheter, a
material which ;s adapted to adhere to the e~terior of ~he body having
the body cav;ty to be drained. Most preferably a self-adhesive strip
is posit;oned on the described housing body port;on defin;ng the inlet
chamber, and has a protective release sheet, which may be removed prior
to insertion of the catheter into the body cavity to be drained. Upon
insertion of the catheter, the adhesive strip adheres to the skin of
~he patient surrounding the opening formed by the trocar and catheter
to support the apparatus thereon and to support he catheter within the
body cavity upon the removal of the trocar from the inlet chamber and
catheter.
Additionally, or in plàce of the adhesive strip positioned on the
housing body portion, tape means can be provided extending from the
housing body for releasably securing the apparatus to the skin of the
patient adjacent the area in which the catheter of the apparatus is
inserted. Preferably, the tape means comprises a plurality of tapes
wh;ch are at least part;ally adhes;ve to adhere to the skin of the
patient. Alternatively, the tape means can be a plurality of straps
optionally with buckles, ~hich can be used to tie or strap the housing
body to the patient.
The apparatus of the present invention can be conven;ently formed
of relatively few parts by having as the housing body portion defining
the inlet chamber a substantially solid body having one or more bores
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URE/PAT: 101
therein forminy the inlet cha~ber. The substantially solid body can be
formed of any rigid polymeric ma~erial, for example an acrylic po7ymer
of polystyrene. The housing body portion can include a first bore
extending therethrough in fluid communication with the catheter and the
S inlet port and is adapted to reversibly receive the trocar for passage
through the bore from the inlet port to and through the catheter
supported by the mounting means and extending outwardly from the inlet
chamber. The substantially solid body preferably further includes
means for mounting the one-way elongated valve thereto, for example, by
having an annular shoulder, preferably of an oval shape, to which the
inlet end of the sleeve of the valve can be secured. The substan~ially
solid body preferably includes a second bore therein in fluid
communication with the ~irst bore and extending to the outside of the
body and in fluid communication ~ith the inlet end o~ the sleeve of the
one-way valve. Most preferably, the portion of the second bore
extending to the outside of the body is surrounded by the annular,
preferably oval, shoulder to which the inlet end of the sleeve of the
valve is mounted.
The mounting means for supporting the catheter in the housing body
portion defining the inlet chamber can simply be a recess of the first
bore into which the catheter can be molded, or can comprise a cannula
sealingly affixed, for example by an adhesive, such as an epoxy
adhesive~ ;nto a recess formed about the end ~f the first bore. The
catheter can be sealed to the cannula, for example, through the use of
an adhesive, such as an epoxy adhesive, or can be swaged to ~he
cannula.
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The discharge chamber of the apparatus can b~ formed of a molded,
open topped, hollow housing body portion defining the chamber. The
housing body portion is preferably formed of a polymeric material, such
as the material of wh;ch the housing body portion defining the inlet
chamber is formed. The several wall se~ments forming the housing body
portion defining the discharge chamber preferably is formed with at
least one wall, and most preferably the wall which extends from the
surface of the housing body portion defining the inlet chamber which
includes the mounting means for supporting the catheter, which is
angled inwardly at the lower portion thereof, so as to provide
clearance between the body of the patient and the wall o~ the discharge
chamber. As will be hereafter described, the discharge chamber of the
apparatus preferably includes hydrophobic filter means, and by placing
the filter means on, and the ports therefor in, the angled wall,
clearance is provided between the patient and the ports or vents and
filter means. If the wall containing or supporting the filter means
and vents or ports is another wall of the discharge chamber, clearance
is normally provided between the wall and any clothing or materials
placed over the apparatus and the patient, and that wall may or may not
be angled as desired.
In another embodiment of the invention, the housing body of the
apparatus defining the inlet chamber can be formed of several integral
walls and separable walls snap fitted thereto. Particularly, the
housing body defining the inlet chamber can be an open-faced enclosure
having back, side, top and botto~ walls, and a separable face wall
URE/PAT. 101
adapted to be snap fitted to the enclosure in fluid-sealing relat;on.
The face wall can include the mounting means and the catheter supported
by the mounting means. The back ~all of the enclosure can include the
inlet port, while the bottom wall can define an aperture therein
adapted to receive the inlet end of the sleeve of the one way elongated
valve. The back, side, top and bottom walls defining the enclosure are
preferably integral with each other.
The apparatus in the embodiment preferably is formed with
substant;dlly flexible bellows-type means for support;ng the inlet
chamber and the discharge chamber in separated relation in which the
inlet end of the sleeve of the one-way elongated valve is supported in
sealed relation so as to communicate the inlet chamber with the
discharge chamber through the valve. The apparatus can further include
collar means positioned within the bellows-type means, ~or receiving
the inlet end of the sleeve of the one-way valve, which can be turned
a~out the collar means, and for sealing the inlet end of the sleeve
th~reagainst between the collar means and a portion of the interior
surface of the bellows-type means. By having the bellows-type means
formed of a resilient material and sized to closely fit the collar
means, the turned portion of the sleeve of the valve may be pressed
against the collar means and prevent the passage of fluid between the
end of the sleeve and the collar means. The collar ~eans can also
include on its exterior portion ridges and recesses substantially
conforming to the interior surface of the bellows-type means to assist
2~ in pressing and maintaining the inlet end of the sleeve of the valve
turned about the collar means in sealed relation therebetween.
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The inlet port of the inlet chamber of the apparatus, as in the
previously described embodiment, fur~her includes sealing means,
including displaceable sealing material, positioned within the inlet
chamber, for sealing the apparatus and ~he inlet port against the
ambient atmosphere in the absence and upon insertion and withdrawal of
a trocar with respect to the inlet chamber and the inlet port. At
least a portion of the sealing means can be in axial alignment and in
communication with the inlet port and at least a portion of the wall
having the mounting means for supporting the catheter extending into
the inlet chamber, whereby the portion of the said wall is supported in
axial alignment with the inlet port in the absence of and upon
withdrawal of a trocar from the inlet chamber.
The discharge chamber of the apparatus preferably includes
hydrophobic filter means in communication therewith. The hydrophobic
filter means can comprise an elongated filter member mounted along on
wall of the discharge chamber, and more preferably, the said wall can
be formed with a plurality of ports with the elongated filter member
positioned exteriorly of the wall, and the wall additionally including
a cover member adapted to ~ightly fit to the wall to support the
elongated filter member therebetween. In one form of the apparatus the
cover member may include a plurality of ports open to the ambient
atmosphere, whereby the discharge chamber is in communication with the
ambient atmosphere only through khe filter member. In another
embodiment of the invention, the cover member or a wall of the housing
can include a port connectable to drainage collection means or to
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URE/PAT: 101
suction means for applying suction to the discharge chamber of the
apparatus through the filter member or through the wall. PrefPrably
the filter means is positioned above the port, and hence above the
expected level of liquid in the discharge chamber, where the port is
included.
~rief Description of The Dra~ings
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Fig. 1 is a perspective view of apparatus in accordance with the
present invention with a trocar inserted into the inlet chamber and the
catheter;
Fig. 2 is a partially sectional view of the apparatus shown in
Fig. 1 taken along lines 2-2 of Fig. 3, with a trocar inserted;
Fig. 3 is a front elevational view of the apparatus shown in Fig.
1 with a trocar inserted, and Fig. 3A is a rear elevational view of the
same apparatus;
Fig. 4 is an exploded, perspective view of the apparatus shown in
Figs. 1-3 and Fig. 3A,
Fig. 5 is a front elevational view of a kit in accordance with the
present invention;
Fig. 6 is a side elevational view of another embodiment of
apparatus in accordance with the present invention with a trocar
inserted into the inlet chamber and the catheter;
Fig. 7 is a partially sectional side e~eYational view of the
apparatus shown in Fig. 6;
Fig. 8 is an exploded, perspective view of the apparatus shown in
Figs. 6 and 7;
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URE/PAT: 101
Fig. 9 is a front elevational view of a kit which includes the
apparatus shown in Figs. 6-8;
Fig. 10 is a partially sectional side elevational view sf still
another embodiment of the present invention with a trocar inserted in~o
the inlet chamber and the catheter;
Fig. 11 is a fragmentary, partially sectional side elevdtîonal
view of the apparatus in accGrdance with the present invention
including a port for suction and/or drainage of the apparatus; and
Fig. 12 is a fragmentaryS partially sectional side elevational
view of the apparatus shown in Fig. 11, with drainage collection
apparatus.
_ es for Carrying Out the Invention
Referring to the drawings, the numeral 10 designated generally
intrapleural catheter apparatus in accordance wi-th the present
invention. Apparatus 10 includes a housing body 11 defining an inlet
chamber 12 and a discharge chamber 13. For illustration purposes,
apparatus 10 is shown with a trocar 14, it being understood that trocar
14 need not be considered a part of the apparatus, although it is used
~n connection with ~he apparatus, and is a member of the kit of th~
present invention, as will be hereinafter descri~ed.
In one preferred embodiment, as illustrated in Figs. 1-4, housing
body 11 includes first portion 15 defin;ng inlet chamber 12 and a
second portion 16 defining discharge chamber 13. In this embodiment,
housing body portion 15 comprises a substantially solid body, for
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URE/PAT:101
example, a rigid acrylic polymer. Portion 15 includes d f;rst b~re 17
extending through portion 15. Bore 17 is enlarged at one end to fDrm a
recess 18 ;nto which a cannula 19 is sealingly affixed, for example, by
an epoxy adhesive. Cannula 19 functions as mounting means for a
catheter 20 supported thereby. Catheter 20 is adhesively sealed to
cannula 19 so as to firmly support the catheter and prevent the passage
of air or other fluids from the outside of housing body 11 to inlet
chamber 12.
The other end of bore 17 is enlarged to form a recess 21 which,
together with displaceable, flexible sealing material 22 resid;ng in
recess 21, constitutes an inlet port through which trocar 14 can be
inserted and withdrawn. Sealing material 22 can be a natural latex
disc through wh;ch an opening is formed by the insertion o~ the trocar,
and which seals itself upon withdrawal of the trocar. Sealing material
22 is held in place by a polymeric disc or washer 23, which is formed
of the same material as body portion 15 and is sealed to portion 15 by
welding by ultrason;c waves or by an adhesi~e, such as an epoxy
adhesive. Preferably, disc or washer 23 is pressure or compressisn
sealed to portion 15, which can be obtained, for examp1e by welding
washer 23 to portion 15 by ultrasonic waves. Bore 17 may have a
tapered, conical shape inwardly of recess 21 so tha~ the end of trocar
14 will be cammed so as to be axially centered in bore 17 upon
insertion into the bore.
Housing body pDrtion 15 in this embodiment, further includes an
external shoulder 24 extending w;thin hous;ng body 11 abDut which the
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URE/PAT:101
inlet end of the sleeve of a one-way elongated valve 2S can be secured.
As heretofore noted~ valve 25 can be substantially as described in
Heimlich U.S. Patent No. 3,463,159, and can be formed of a sleeve of
substantially resilient fluid-impervious material, preferably of
5 urethane or silicone elastomer. Shoulder 24 is preferably an annular
shoulder having an oval shape, about which the inlet end of the s1eeve
is secured by tightly fitting about the shoulder. Alternatively, a
band of heat-shrinkable elastomer (not shown in Figs. 2 and 41 can be
placed about the portion of the inlet end of Yalve 25 positioned about
shoulder 24 and heat shrunk to hold the inlet end of the valve to the
shoulder. In the manner, the inlet end of the sleeve of valve 25 is
held open within housing body 16. A second bore 26 is formed in
housing body portion 15 which intersects and is in fluid communication
with first bore 17 and extends to the outside of body portion 15 so as
to be in fluid communication with the inlet end of the sleeve of valve
25. Bore 26 in body portion 15 can be enlarged adjacent its end in
communication ~ith valve 25 to facilitate the passage`of fluids from
bore 17 to the inlet end of valve 25. In this embodiment, bore 17 and
bore 26, toge~her, comprise the inlet chamber of the apparatus
heretofore described.
Catheter 20, in this embodiment, is preferably formed of a
stainless steel spring as a core 27 covered with an elastomer 28, which
preferably is a polyurethane coating molded thereto. The tip 29
preferably is of resilient polymer, such as of urethane or silicone
polymer, and is bonded to the end of spring core 27. The end of tip 2g
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is open to pPrmit the end of trocar 14 to pass therethro~gh. Tip 29 is
spaced from the end of coating 28 so as to provide an annular aperture
spaced from the end of catheter ?0, i.e., adjacent the tip end thereof,
to facilitate assembly of catheter, and the annular aperture is filed
with clear adhesive, such as epoxy adhesive. Elastomer covering 28
includes a plurality of ports 30, spaced from each other adjacent
filled aperture 27. Following insertion of the catheter into a body
cavity to be drained and removal of trocar 14~ the ports 30 in coating
28 permit fluids and other drainage material from the body cavity to
pass through the thus exposed coils of core 27 beneath the ports 30,
into the interior passage of catheter 20 formerly occupied by trocar 14
and into bores 17 and 26 to the inlet end of the sleeve of one-way
valve 25.
Housing body portion 16 (hereafter "housing 16"), defining
discharge chamber 13 is a molded, open topped, housing defining the
discharge chamber 13. Housing 16 can be Inolded of the same ~aterial as
housing body portion 15. As best shown in Fig. 2 one-way elongated
valve 25 freely resides within housing 16 which is adapted to receive
drainage material passing from the outlet end of the valve. Housing 16
includes an opening or port 31 which is adapted to be closed by a cover
32 supporting an elongated hydrophobic filter 33 which can be affixed
to the cover ~ith an adhesive, such as an epoxy adhesive. Cover 32
defines a plurality of ports or vents 34 which permits gaseous fluids,
including air, to pass through filter 33 and through vents 34 to the
atmosphere. In addition, cover 32 tightly fits to the edges of port
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URE/PAT: 101
31, and can be adhesively affixed thereto, to provide an air-tight seal
of the cover t~ the port.
In the embodiment shown, housing 16 is provided with a truncated
or angled portion in the area forming port 31, and cover 32 is adapted
to assume the angle provided by port 31, to cause a tapered space
between the body of the patient and the vents 34 of cover 32 to permit
gaseous fluids to escape from discharge chamber 13 when apparatus 10 is
installed to the body of the patient. Alternatively, port 31~ and
consequently cover 32 and filter 33, can be formed in ano~her portion
of housing 16 so that the filter and cover will face in another
direction so as not to be blocked by the body of the patient upon
installat;on of the apparatus.
Housing body portion 15, and particularly the surface thereof from
which catheter 20 extends includes on its ex~erior surface a self
adhesive strip 35 which is adapted to adhere to the exterior of the
body of the patient having the body cavity to be drained. Adhesive
strip 35 is covered by a protective release sheet 36 which is removed
prior to insertion of catheter 20 into the body cavity to be drained.
The catheter apparatus thus described can be readily assembled, as
part;cularly shown in F;g. 4. In such assembly, the inlet port can be
established by inserting sealin~ material 22 into recess 21 and
covering the sealing material with disc or washer 23 and pressure
sealing the sa~e within recess 21 by welding with ultrasonic waves.
Adhesive strip 35 can be applied to the surface of housing body portion
15 having recess 18, and release sheet 36 can be placed over adhesive
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URE/PAT: lo
strip 35. Cannula 19 is fitted within recess 18 and sealed thereto.
Catheter 20 is desirably preformed with co~ering 28 bonded to
stainless steel spring core 27, tip 29 bonded to the end of core 27,
and the annular space about core 27 between ~he end of covering 28 and
tip 29 filled with a clear adhesive, such as an epoxy adhesive w;th its
shoulder 29a against the end of core 27. The opposite end of catheter
20 can be inserted into the sealed to cannula 19 as heretofore
described. The inlet end of one-way elon~ated valve 25 is fitted to
shoulder 24 of body 15, and if desired, sealed thereto by means of heat
shrinking a band o~ heat-shrinkable material (not shown) placed about
the inlet end of the sleeve of valve 25. Filter 33 can be affixed to
cover 32, and cover 32 affixed to port 31 of housing 16 to complete the
latter. Housing 16 can then be placed about the sleeve of valve 25
and can be forced upwardly to surround the bottom or a step-shaped
shoulder of housing body 15 in a fluid tight manner, or adhesively
affixed thereto, to complete the apparatus. Trocar 14 is conveniently
provided with a handle 37 which can be molded or affixed thereto with
an epoxy adhesive.
Another embodiment of the apparatus o~ the present invention is
shown in Figs~ 6-8, in which the same reference numerals have been used
for elements which are substanti~lly the same as those in the
embodiment illustra~ed in Figs. 1-4.
Apparatus 10 in this embodiment includes an upper housing 40,
constituting inlet chamber 12, defined by back wall 41, side walls 42,
top wall 43 and bottom wall 44, which are integral with each other. A
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URE/PAT: lo
face or front wall 45 snap-fits into the front of the opening formed by
side walls 42, top wall 43, and bottom wall 44 to complete inlet
~chamber 12.
Face wall 45 of inlet chamber 12 includes an aperture formed
therein surrounded by a thickened portion 46 having an annular,
outwardly facing recess 47 which serves as mounting means for the
catheter 20, portion 46 extending inwardly of wall 45. Catheter 20 is
mounted in the recess 47 of portion 46 and extends outwardly from wall
45. Catheter 20 has an outer end 48 having a trocar receiving aperture
49 and fluid receiving ports 50. Catheter 20 extend outwardly o~ wall
45 a sufficient distance so as to permit the outer end 48 and ports 50
to be positioned in a body cavity to be drained. Portion 46 includes
an opening port 51 (Fig. 7) communicating with the interior of inlet
chamber 12 and arranged to permit fluids and materials drained from the
body cavity by the catheter 20 to enter inlet chamber 12.
Back wall 41 includes thickened portion 52 which defines the inlet
port for trocar 14. Portion 52 extends interiorly of the inlet
chamber, with an annular portion 53 thereof extending concentrically
with the path of trocar 14. Annular portion 53 is formed by an annular
shoulder 53a integral with wall 45, and a cylindrical insert 53b of
which fits snugly within shoulder 53a in a fluid-sealed relation, as
best shown in Fig. 8. Annular portion 53 includes an annular recess
53c adapted to support sealing material 22 for sealing the inlet port
as described. The inlet port is axially aligned with the aperture in
portion 46 of wall 45 and the path of trocar 14 to permit the tubular
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URE/PAT: lo
portion of trocar 14 to progressively and smoothly, reversibly pass
through the inlet ~ort, the aperture in portion 46 and catheter 20.
Portion 46 of wall 45 extends into annular recess 53c of portion 53,
although it does not contact the walls of ~he recess for ease of
assembly of face wall 45 to integral walls 41-44. Flexible sealing
material 22, encircled by recess 53c, serves as ~he sealing means
described above for sealing the inlet port in the absence of trocar 14
and for sealing the inlet port to trocar 14 when the latter is present
therein or during its passage through or withdrawal from chamber 12.
Sealing material 22 further functions to seal portion 46 at its
extension into recess 53c.
Bottom wall 44 includes an aperture 54 formed therein and an
annular, outwardly extending and depending integral L-shaped flange 55.
Suspended beneath bottom wall 44 by a substantially flexible
bellows-shaped member 56, is discharge chamber 13 separated from inlet
chamber 12. Discharge chamber 13 is defined by an upwardly open
housing 16 as in the previously described embodiment. A collar 57 is
positioned w1thin bel10ws-shaped member 56 beneath and separated form
bottom wall 44. Collar 57 is formed with a vertical aperture adapted
to receive the upper, open end of a one-way elongated valve 25 which
extends into housing 16 forming discharge chamber 13. The aperture and
the upper portion of collar 57 which comprises a raised shoulder 58 is
formed substantially to the shape of the upper, open end of valve 25,
which is turned about should 58. The bellows-shaped member 46 is
formed of a resilient material and is sized to closely fit the exterior
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URE/PAT: 101
sides of collar 57 and its shoulder 58. In addition, bellows-shaped
member 56 is formed and shaped to closely fit to flange 55 of bottom
wall 44 so as to ma;ntain a firmt but flexible spaced relatisn between
collar 57 and bottom wall 44 and maintain a sealed relation
S therebetween with respect to ~he ambient atmosphere. Collar 57
includes on its exterior portion ridges 59 and recesses 60 conforming
to the interior sur~ace of bellows-shaped member 56 to assist in
press;ng and maintaining the aforesaid spaced and sealed relation.
As hereto~ore described, housing 16 includes a wall formed with at
least one port 31. Housing 16, as best shown in Fig. 8, includes a
wall which is elongated and defines a plurality of the ports 31 which
in this embodiment extend outwardly from housing 16. An elongated
hydrophobic filter 33 is positioned against the portion of the wall
which defines ports 31. A cover 32 defines a plurality of events 34
positioned along the elongated sides of member 32. Cover 32 is adapted
to tightly fit to the exterior of the wall and supports ~ilter 33
therebetween. In addition, filter 33 is heatsealed to the wall to
prevent ~he discharge of gaseous fluids ~rom dischar~e chamber 13,
except through filter 33 and vents 34.
As in the preYiously describe~ embodiment, housing body 11, and
particularly wall 45 defining inlet chamber 12 includes on its exterior
surface, a self~adhesive strip 35 covered by protective release sheet
36 which is removed prior to insertion of the catheter into the bvdy
cavity to be drained.
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URE/PAT:101
The catheter apparatus thus described can be readily assembled, as
particularly shown in Fig. 8. In such assembly, the normally open end
of the elongated one-way valve 25 can be inserted through the aperture
in collar 57 and turned about should 58 as shown by the pa~h designated
by arrows 61. Bellows-shaped member 56 can be slipped upwardly about
valve 25 and positioned with its lower portion surrounding and holding
collar 57 and the portion of valve 25 ~hich is turned about shpulder 5B
of the collar. In this position, bellows-shaped member 56 maintains
valve 25 and collar 57 in fluid sealed relation to each o~her so tha~
fluid materials will pass only through the valve. Bellows-shaped
member 56 can then be placed about flange 55 of the bottom wall 44 of
the upper housing 40 as shown by the path designated by arrows 62 to
establish a spaced apart relation between the upper housing 40 defining
inlet chamber 12 and valve 25 in collar 57. The inlet port can next be
established by inserting insert 53b with sealing material 22 residing
in recess 53c into the aperture defend by the cylindrical shoulder 53a.
Wall 45 is snap fitted to the opening in housing 40 formed by walls
41-44~ with a portion of thickened portion 46 extending into recess 53c
and contacting sealing material 22. Adhesive strip 35 can be applied
to wall 45 and release sheet 46 in turn applied thereto, ~r the
adhesive strip and the release sheet can be applied to wall 45 prior to
its assembly to form the inlet chamber. Oatheter 20 can be mounted to
wall 45 through an aperture in release sheet 36 and adhesive strip 35
to complete the assembly of the upper portion of the apparatus. Filter
33 can be applied to cover 32 and heat sealed thereto if desired, and
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URE/PAT: lo
cover 32 applied to port 31 in housing 30 to assemble discharge chamber
13. Finally, housing portion 16 defining the said chamber can be
forced upwardly to surround the bottom of bellows-shaped member 56 to
complete the assembly of the apparatus.
The present invention includes the provision of a sterile kit
particularly adapted for the drainage of a body cavity. As best shown
in Figs. ~ and 9, the sterile kit comprises a sealed package, such as a
backing card 63 and transparent covering filln 64 defining a sterile
interior. Positioned therebetween in the sterile interior of the
package are an intrapleural catheter apparatus 10 in accordance with
the present invention and a trocar 14 including a handle 37. It is
oontemplated that both catheter apparatus 10 and trocar 14 are
maintained in a sterile condition prior to packaging in the sterile
kit9 and that the kit can-be conveniently asse~bled under sterile
conditions by positioning apparatus 10 and trocar 14 on card 63.
Following asse~bly, the kit remains sterile until ~ 64 is pierced or
removed.
The utilization oF the apparatus of the present inven~ion will now
be described. If the catheter apparatus 10 is supplied in the sterile
kit, the apparatus is removed form the kit under sterile conditions.
The trocar, being handled by its handle 37 is inserted through the
inlet port of housing body 11 so that its end opposite handle 37 passes
through inlet chamber 12 and catheter 20. As shown in Figs. 1-3, 6 and
7, catheter 20 will be straightened and aligned by trocar 14 passing
therethrough. With the end of trocar 14 opposite handle 37 extending
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URE/PAT: 101
through and beyond the end of catheter 20, the release sheet 36 is
removed form the adhesive strip 35, and the end of trocar 14 is
;nserted into the body of the patien~ through the skin and underlying
tissue into the body cav;ty to be dra;ned. ~pon ~ull insertion of
trocar 14 and catheter 20 therewith into the body cavity, sel~-adhesive
strip 35 will adhere to the skin of the patient to ma;ntain the
catheter apparatus in place. Therea~ter trocar 14 can be withdrawn by
manipulation of handle 37. Upon withdrawal of trocar 14 from inlet
chamber 12, the inlet por~ is sealed by sealing material 22. Fluid and
other material from the body cavi~y to be drained can now pass through
the aperture and/or ports 30, 50 of catheter 20 and pass therefrom
through into inlet chamber 12 and the open end of valve 25. As
theretofore described, fluids can progressively pass through valve 25
into discharge chamber 13. Gases, particularly air, are vented ~rom
discharge chamber 13 through hydrophobic filter member 33 and out
through Yents 34 formed in cover 32.
The apparatus of the present inven~ion can include an additional
one-way valve, as illustrated in Fig. lO. The apparatus there shown
is, in all major respects, identical to the apparatus in Figs. 1-4, and
like re~erence numerals have been utilized for simllar elements.
Additionally, a second one-way va~ve 65 is mounted to housing body
portion 15 so as to be positioned between and in fluid communication
with inlet chamber 12 and the inlet end of the sleeve of one-way
elongated valve 25. As shown in the drawing, one-way valve 65 can be a
duck-bill valve~ such as those commercially available from Vernay Co.,
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UREiPA~:101
and particularly a duck bill valve with a molded lip at its upper end.
Yalve 65 can be adhesively aff;xed to a disc or washer 66 of polymeric
material, preferably the same material as body portion 15, and the
subassembly of valve 65 and washer 66 adhesive-ly sealed to the bottom
of housin~ body 15 with the exposed lip of valve 65 fitting within the
enlarged recess of bore 26. The outer annular perimeter of washer 66
preferably has substantially the same dia~eter as shoulder 24, ~o that
upon assembly washer 66 becomes an extension of housing body 15 and
shoulder 24. The open inlet end of valve 25 can be placed about washer
66 and shoulder 24, and thereafter `a ring or band of rubber or heat
shrinkable material 67 can be placed about the open, inlet end of the
sleeve of valve 25, and if the latter, heat shrunk, to firmly affix and
seal valve 25 to should 24. The utilization of second valve 65 in
conjunction with the apparatus of the prevent invention further
enhances the utility of the apparatus to prevent ~he back flow of
material if any material should remain in the inlet end of the sleeve
of valve 25 or if any material should move in the reverse direction
through valve 25.
The apparatus of the present invention can also include a port 68,
which can be in the form of a n;pple as shDwn in Fig. 1I for the
purpose of applying suction or for drain;ng discharge chamber 13. In
providing port 68, it is preferable to modify housing body 11, and
particularly housing 30 by moving the hydrophobic filter 33 and the
cover 32 to another wall of housiny 30 between the location of port 68
Z5 and the housing body 15 or upper housing 40 of the apparatus as shown.
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URE/PAT: lo
Port 31 is then closed by a solid wall which is sealed thereto as shown
in the dra~ing. Furthermore, port 68 can be formed in cover 32, so
that suction can be applied to discharge chamber 13 through filter 33,
and thereby facilitate the drainage of fluids, and perm;t the dra;nage
of small amounts of other materials such as small pieces of t;ssue,
through the catheter apparatus in the same manner as fluids.
The apparatus of the present 1nvention including port 68, can be
utilized to collect drainage from the body cavity being dra;ned,- as
illustrated Fig. 12. As shown, a conduit 69 is provided fitted or
coupled to port 68 at one end and to drainage collection apparatus 70,
at its o~her end. Apparatus 70 can comprise a firs~ rotatable disc 71
having a tube 72 passing therethrough and extending upwardly to which
conduit 69 is coupled. A seco~d disc 73 is rotatably mounted to disc
71 by means of a fastener, such as rivet 74. Disc 73 has a plurality
of tubes 75 circumferentially spaced about disc 73 which are each
connected to a valve 76 and the valve in turn connected to drainage
receptacles such as bags 77~ which may be initially rolled, as shown.
As tubes 75 are circumfer4ntially spaced in disc 73 at the same radius
from ~he center as tube 72 is spaced form the center of disc 71, each
of tubes 75, and hence valves 76, and collection receptacles 77 can be
selectively spaced under and in communication with tube 72 upon
rotation of disc 73. In this manner, each of collection bags 77 can be
sequentially filled with drainage material, and can be removed upon
closing of the respective valve 76 for analysis of the material, or for
disposal, or for another purpose.
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3L~:59L 468
UR~/PAT: 101
Alternatively, to provide drainage collection apparatus, a known
collect;on device, such as the medical suction dev;ce described in ~S.
Patent No. 4,404,924 can be connected to port 68 to provide collection
of the dra;na~e material from discharge chamber 13 of the present
apparatus as well as remote indication of the suction being appl;ed to
the apparatus.
Various changes coming wi~hin the spirit of the invention may
suggest themselves to those skilled in the art; hence, the invention is
not limited to the specific embodiments shown or descnibed and uses
men~ioned, but the same is intended to be merely exemplary, the scope
o~ the invention beiny limited only by the appended claims.
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