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This invention relates to gastraintestinal tubes.
The effective control of adhesions is necessary to any surgical procedure
which may disrupt the intestine. After such surgery it is very difficult,
if not impossible, to prevent the formation of adhesions (i.e., new
adhesive fixations) around the intestine; however, failure to control this
formation may lead to serious post-operative complications such as
intestinal obstructions caused by the adhesions forming around sharp
curves in the intestine and crimping the intestinal lumen. In most cases,
this type of complication requires additional surgery, and this, in turn,
may generate the formation of more adhesions and further complicate the
patient's condition.
To prevent this type of adhesion related problem, the surgeon may insert a
flexible tube into the intestine to ensure that it will lie in gentle,
obstruction free curves as the adhesions form during healing. This
procedure is termed intestinal stent plication and has been described in
articles such as "Long Tube Gastrostomy With Internal Intestinal Splinting
in Inflammatory Disease of the Small Intestine," by G. Bruce Thow, M.D.,
Diseases of the Colon and Rectum, Vol. 15, No. 1, January-February, 1972,
published by J. P. Lippincott Company, U.S.A.
Typically, these tubes are either surgically inserted or threaded downward
through the nasal passage through the stomach and into the intestine. The
former method is preferred because of the extreme discomfort associated
with the nasal-gastric technique. In the use of intestinal tubes several
problems arise. For example, it is often necessary to withdraw fluids from
(i.e., to decompress) both the stomach and the intestine both during and
after surgery. In addition, it is often times desirable to decompress the
stomach and the intestine independently with a high degree of control over
each. This is difficult with typical prior art intestinal tubes which
either alternatively provide means to decompress the stomach or the
intestine or provide a single lumen that is vented into both the stomach
and the intestine.
In addition, percutaneous tubes must be held in position; the incision must
be closed, and a good seal formed between the tube and the flesh during
the 5 to 20 day period that the tube may remain in the patient's body. An
effective seal is needed to prevent bacteria from entering the wound and
gastric fluids from leaking. The importance of an effective seal at this
point becomes apparent when one realizes the high risk of infection and
tissue damage due to contact with digestive fluids associated with any
gastric incision which must remain open for an extended period of time.
These risks are compounded if there is any significant internal leakage
from the stomach into the abdominal cavity. In addition, if the tube is
partially withdrawn, it is difficult, if not impossible, to reposition the
tube and probability of the aforementioned adhesion related problems is
significantly increased. In the past, these problems have been managed wih
the combination of a purse string suture to seal the incision around the
tube and a retention suture to hold the tube in position; this is at best
a "make do" technique.
This invention provides a percutaneous gastrointestinal tube specifically
designed to be inserted through a gastrostomy and easily threaded downward
into the small intestine to provide both intestinal stent plication and
effective and independently controllable, gastric and or intestinal
decompression.
This invention also provides a percutaneous gastrointestinal tube which
greatly reduces the danger of infection by helping to effectively seal the
incision, and which also greatly reduces the possibility of the
inadvertent partial withdrawal of the tube.
The subject gastrointestinal tube comprises a flexible elongated
elastomeric member having two decompression lumens and two inflatable
cuffs. One decompression lumen extends from the proximal end (that end
which remains outside the patient's body) of the subject gastrointestinal
tube through the entire length of the subject tube and is vented at or
near the distal end (opposite to proximal) to provide decompression to the
lower sections of the intestine. The other decompression lumen extends
from the proximal end into the stomach and is vented there to provide
gastric decompression. One inflatable cuff is located at or near the
distal end of the subject tube and is preferably inflated as the surgeon
inserts the subject tube to facilitate the threading of the distal end of
the subject tube downward from the stomach into the intestine. The upper
inflatable cuff is positioned on the tube so that, once the tube is in
place, this cuff will be in the stomach at the inner surface of the
incision to help seal the incision and to prevent the inadvertent partial
withdrawal of the tube. Preferably, the subject tube also has two
independently controllable inflation-deflation lumens, with one extending
from the proximal end of the subject tube to each inflatable cuff. In
addition, the subject gastrointestinal tube preferably has a molded end
portion securely attached to the proximal end of the subject tube to
provide ready access to and independent control over each lumen. Any or
all of the lumens in the subject tube may be equipped with a control valve
which would preferably be located in the molded end portion.
These and other features, objects and advantages of the subject invention
will be more readily understood in view of the following detailed
description which will make reference to the attached drawings which are:
FIG. 1 is an elevated cut-away view of one preferred embodiment of the
subject percutaneous gastrointestinal tube with both cuffs inflated;
FIG. 2 is a cross-sectional view of the subject percutaneous
gastrointestinal tube taken at section 2--2 of FIG. 1;
FIG. 3 is a cross-sectional view of the subject percutaneous
gastrointestinal tube taken at section 3--3 of FIG. 1;
FIG. 4 is a cross-sectional view of the subject percutaneous
gastrointestinal tube taken at section 4--4 of FIG. 1;
FIG. 5 is a representative view of a patient's stomach and intestines
showing the subject percutaneous gastrointestinal tube in place;
FIG. 6 is an elevated cut-away view of the upper cuff of a second preferred
embodiment of the subject percutaneous gastrointestinal tube, this
embodiment features a slidably attached upper inflatable cuff;
In accordance with a first preferred and illustrative embodiment, as shown
in FIG. 1, the subject percutaneous gastrointestinal tube 10 comprises an
elongated, smooth surfaced, member 16 formed of a soft flexible elastomer
and an end piece 38. The subject tube 10 should be able to withstand a
thorough cleaning and sterilization and also should be compatible with,
that is cause no significant irritation to, human body tissue after
contact therewith for a period of up to several weeks or more. This
compatibility may be provided by either forming the subject tube 10 from a
base elastomer which is, itself, compatible with the human body or coating
a tube with a compatible material. Suitable elastomeric materials which
may be compatible with the human body, if the formulations are controlled
so as to avoid harmful additives, include vulcanized gum rubber, silicone
rubber, butyl rubber, natural rubber, butadienestyrene copolymers, and the
like. However, the particular base elastomer is not critical to the
subject invention and the above are included as merely illustrative and
not limiting examples.
With reference to the aforementioned coating technique, the subject tube 10
may be formed of a silicone rubber coated elastomer such as that described
and fully disclosed in U.S. Pat. No. 3,434,869. This patent is hereby
incorporated by reference to illustrate that particular silicone rubber
coated elastomeric structure.
The subject tube 10 may be viewed as having two portions; an upper proximal
portion 12, in FIG. 1, which remains external to the patient's body during
use and a lower distal portion 14 which is inside the patient's body once
the subject tube 10 is in place. Line A--A indicates the approximate
position on the subject tube 10 of the incision when the subject tube 10
is properly placed in the patient's body and therefore represents the
dividing line between the proximal portion 12 and the distal portion 14.
Preferably, both the proximal portion 12 and the distal portion 14 of the
subject tube 10 will have an outside diameter of about one quarter of an
inch. However, the exact dimensions of the subject tube 10 are not
critical to this invention, as long as the distal portion 14 will readily
fit inside the intestinal lumen.
During any surgical procedure which indicates either intestinal stent
plication, or decompression of the stomach and or the intestine, or both,
the distal portion 14 of the subject tube 10 may, after being suitably
cleaned and sterilized, be surgically inserted into the patient's stomach
40 (See FIG. 5) and then threaded downward into the intestine 44. The
presence of the elongated elatomeric distal portion 14 of the subject tube
10 will ensure that the intestine 44 will remain in a gently curving
configuration during the healing process. Therefore, as the patient
recovers any adhesions, that may form, will not obstruct or crimp the
intestinal lumen because there will be no sharp curves or kinks in the
intestine 44. In addition, it is to be noted that the subject tube 10 may
be extended to plicate and/: or decompress the colon 48.
To provide either or both gastric and intestinal decompression, the subject
tube 10 has two decompression lumens; a stomach decompression lumen 22
(See FIGS. 1, 2, and 3) which extends through the proximal portion 12 and
the upper portion of the distal portion 14 and is vented in the stomach 40
(See FIG. 5) and an intestinal decompression lumen 24 (See FIGS. 1, 2, 3
and 4) which extends the entire length of the subject tube 10 and is
vented at or near the distal end 18. More specifically, the stomach
decompression lumen 22 provides independently controllable fluid
communication between a distal stomach decompression lumen opening 50
which will be in the patient's stomach 40 when the subject tube 10 is in
place, and a proximal stomach decompression lumen opening 52 in the
proximal end 20 of the subject tube 10. This communication provides a
means to withdraw or insert either or both liquids and gases from the
patient's stomach to relieve stress on the stomach 40 and ensure that no
undue pressure will be placed on the stomach wall 42 (See FIG. 5). This is
particularly important if an incision has been made in the stomach wall 42
since such pressure may post-operatively rupture or re-open this incision.
In addition, by removing the excess gases and liquids from the stomach 40,
they are not passed through to stress the distal gastrointestinal tract.
Similarly, the intestinal decompression lumen 24 provides fluid
communication between a distal intestinal decompression lumen opening 54
in the distal end 18 of the subject tube 10 and a proximal intestinal
decompression lumen opening 56 in the proximal end 20 of the subject tube
10. The intestinal lumen 24 is primarily used to withdraw liquids and
gases, that is to decompress, the patient's intestine 44 and/or colon 48.
This intestinal decompression procedure is particularly useful as the
surgeon is threading the subject tube 10 downward from the patient's
stomach 40 into the intestine 44 since the slightly lower pressure ahead
of the distal end 18 helps to pull the tube 10 through the intestinal
lumen.
As shown in FIGS. 2, 3 and 4 the decompression lumens have an oval shape
and are about one hundred mils wide. However, it is to be understood that
the exact size and shape of the lumens, to include both the decompression
and the inflation-deflation lumens, is not critical to the practice of
this invention. The size and shape of all lumens may, within limits, be
dictated by processing or material factors; the primary limit is that the
size and shape should be adequate to provide the desired fluid
communication. A danger to be noted is that as the size of the lumens
decrease, the lumens may be crimped and thereby closed by the curves which
the subject tube 10 will assume in the patient's body.
A particular advantage of the subject tube 10 is that there are separate
and independently controllable means to decompress the stomach 40 and the
intestine 44. This provides the surgeon with an extra degree of freedom to
provide specific and readily controllable relief measures when and where
necessary. This is a significant improvement over prior art
gastrointestinal tubes having one lumen which is vented in both the
stomach 40 and the intestine 44 or colon 48. Such prior art tubes do not
provide the surgeon with adequate control of either the gastric or
intestinal decompression procedures and there are often problems with
leakage and in providing adequate decompression to either or both areas.
Examples of situations where the independence between the stomach
decompression lumen 22 and the intestinal decompression lumen 24, are very
important include where it is necessary to decompress or drain the lower
intestinal tract and where a portion of the intestinal decompression lumen
becomes plugged.
In the former case, which would include procedures such as an intestinal
anastomosis (i.e., where a segment of the intestine is removed and the two
ends rejoined) it is very important to drain any fluids from that region
where the intestine has been rejoined. If this region is not effectively
drained and there is leakage, the complications may be severe. However, if
the lumen, which decompresses the anastomosis region, is also vented in
the stomach, there will be some leakage of the fluids from the anastomosis
region into the stomach 40. This is not an acceptable condition.
In the later case, where the intestinal decompression lumen becomes
plugged, it is not possible to apply either a positive or negative
pressure to the lumen or even to flush the lumen without disrupting the
stomach, because the decompression lumen is also vented in the stomach.
These two situations clearly and effectively demonstrate some of the
advantages of the subject gastrointestinal tube.
The distal portion 14 of the subject tube 10 is provided with two, fixed
and thin walled, inflatable cuffs, an upper inflatable cuff 30 and a lower
inflatable cuff 32. The upper inflatable cuff 30 is positioned near the
proximal portion 12, and is typically inflated after the subject device
has been inserted and positioned in the patient's body. After the upper
inflatable cuff 30 is inflated, it is positioned against the inner surface
of the stomach wall 42 at the incision and serves several purposes during
the extended period of time the device may remain within the patient's
body. First, the upper inflatable cuff 30 positions the subject tube 10
and prevents the inadvertent partial withdrawal of the subject tube 10.
This is important since the subject device will remain in position for up
to two weeks or more until the healing process has progressed to a point
where the adhesions have developed adequately to sustain the intestines in
an obstruction free configuration. Secondly, the upper inflatable cuff 30
helps in sealing the incision and preventing any leakage of intestinal
fluids into the abdominal cavity which could easily lead to peritonitis
and/or other complications.
The lower inflatable cuff 32 is positioned near the distal end 18 of the
subject tube 10 and is preferably inflated after the distal end 18 of the
subject tube 10 and the lower inflatable cuff 32 have been inserted
through the stomach 40 and passed through the pyloris, jejunum, and the
ligament of Trietz. Once the lower inflatable cuff 32 is inflated,
typically with water to provide a firm balloon, the surgeon is able to
manually control the distal end 18 of the subject tube 10 through the
intestinal wall 46 and quickly thread it downward as far as necessary.
An upper cuff inflation-deflation lumen 26 provides fluid communication
between a proximal upper cuff lumen opening 58 in the proximal end 20 of
the subject tube 10 and the upper inflatable cuff 30 through an internal
upper cuff lumen opening 60. Similarly, a lower cuff inflation-deflation
lumen 28 provides fluid communication between a proximal lower cuff lumen
opening 62 in the proximal end 20 of the subject tube 10, and the lower
inflatable cuff 32 through an internal lower cuff lumen opening 64. It is
through these inflation-deflation lumens 26 and 28, that the surgeon may
independently inflate and deflate the cuffs 30 and 32. Preferably, these
are valves (not shown) located in the proximal end 20 in each cuff lumen
to provide a means of controlling the flow of fluids through them. If
desired, valves may be included in the other lumens as well. The term
"controllable lumen" as used herein designates a lumen having a valve or
other means to regulate the flow of fluids therein. The particular valve
and its internal mechanism is not critical to the subject invention and
any valve known in the art which could readily be attached to the subject
tube 10 and adequately provide the necessary opening and sealing functions
would be suitable.
The subject gastrointestinal tube may be formed by any of several different
processes and combinations thereof including extrusion, molding and the
like. Preferably, the subject tube 10 is formed from three basic
components: (1) a sleeve portion 34 which is preferably an extrusion
product; (2) an insert portion 36 which, also is preferably an extrusion
product; and (3) an end piece 38, which is preferably a molded product. As
clearly shown in FIGS. 1, 2 and 3 the sleeve portion 34 is relatively
short when compared to the insert portion 36, and as shown in FIG. 5
extends through the incision and terminates in the patient's stomach. In
addition, the sleeve portion 34 haa an elongated tubular shape and
preferably a circular cross-section and contains the stomach decompression
lumen 22 and the upper cuff inflation-deflation lumen 26 which vents into
the upper inflatable cuff 30 through the internal upper cuff lumen opening
60. The sleeve portion 34 also carries the insert portion 36 (See FIGS. 2
and 3) in an insert carrying lumen 29. In turn, the insert portion 36
contains the intestinal decompression lumen 24 and the lower cuff
inflation-deflation lumen 28 which vents into the lower inflatable cuff 32
through the internal lower cuff lumen opening 64. Typically the sleeve
portion 34 and the insert portion 36 would be formed separately, by an
extrusion or molding technique. As these two portions are separately
formed, the inside dimensions of the insert carrying lumen 29 in the
sleeve portion 34 and the outside dimensions of the insert portion 36 are
controlled so that the former are slightly smaller than the latter. To
form the assembly of the sleeve portion 34 and the insert portion 36, the
sleeve portion 34 is immersed briefly in a suitable solvent to swell the
sleeve portion 34 and more specially to increase the diameter of the
insert carrying lumen 29. The insert portion 36 is then inserted into the
insert carrying lumen 29 and the solvent is removed to form a solvent
shrink fit.
The insert portion 36 also has an elongated tubular shape and forms a major
portion of the distal portion 14 of the subject tube 10. The insert
portion 36 contains the intestinal decompression lumen 24 and the lower
cuff inflation-deflation lumen 28 through which the shape of the lower
inflatable cuff 32 is controlled.
The end piece 38 is securely attached, preferably with a suitable adhesive,
to proximal end 35 of the sleeve portion 34 and serves to separate the
four lumens and provide easy access thereto. In addition, the end piece
38, may contain valves (not shown) for each of the lumens and/or connector
means to facilitate the attachment of suction or pressure providing
appliances to each of the lumens. Typically, the cuffs are formed
separately and securely attached, by means of a suitable adhesive to
assembled distal portion 14.
In accordance with a second preferred embodiment the solvent shrink fit,
which securely attaches the sleeve portion 34 to the insert portion 36, is
replaced with a lubricated slidable fit (See FIG. 6). By this technique,
it is possible to slide the sleeve portion 34 along the insert portion 36,
and this allows the surgeon to adjust the length of the distal portion 14
of the subject tube 10. Typically, the subject tube 10 is about 9 feet
long and the distal portion 14 is about 81/2 feet in length. However, it
may not be desirable, in all cases, to have 81/2 feet of tubing within the
patient's body for an extended period of time, especially when the distal
end 18 is not fully threaded into the intestine 44 and a significant
portion is left coiled in the stomach 40.
To provide a slidable fit between the sleeve portion 34 and the insert
portion 36, either the diameter of the insert carrying lumen 29 is
increased or the outside diamter of the insert portion 36 is decreased or
both. In addition, a lubricating fluid film 45 is provided between the
inner surface 51 of the insert carrying lumen 29 and the outer surface 53
of the insert portion 36. A low to moderate viscosity silicone fluid would
be a suitable lubricant. To prevent the lubricating fluid from leaking
out, O-rings 59 would be used to seal each end of the insert carrying
lumen 29.
As shown in FIG. 6, the insert portion 36 would extend completely through
the sleeve portion 34 and two separate end pieces could be used to provide
separate access to the individual lumens. One end piece 41 would fit onto
that section of the insert portion 36 which would extend beyond the
proximal end of the sleeve portion 34 and a second end piece 39 would fit
onto an extension of the proximal end of the sleeve portion 34.
While my invention has been described in terms of certain specific
embodiments, it will be appreciated that other forms thereof could readily
be adopted by one skilled in the art. Therefore, the scope of my invention
is not to be limited to the specific embodiments disclosed.
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