Note: Descriptions are shown in the official language in which they were submitted.
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CASTRO-JEJUNAL FEEDING DEVICE
Thi~ invention relateq to a new and improved
feeding tube, and more specifically to a gastro-jejunal
Peeding tube that i~ inqertable through a stoma Ln the
patient's stomach wall and secured within the patient'~
stomach and against the abdominal wall. Alternatively,
the device may be employed to by-pass the stomach and
feed directly into the jejunum, or for drainage and/or
decompression.
Some types of patient feeding devices employ a
gastrostomy feeding tube. However, if the patient has
a problem with gastric reflux or vomiting, or ii the
stomach is not adequate for the patient's digestive
proceqs requirements, another ~eeding mode must be
chosen. This can be accompli3hed by by-passing the
stomach and supplying ~ood directly into the jejunum
with a feeding tube.
Many types of feeding devices have been
developed, but they suffer from various drawbacks.
These include: the ejection or loss of liquids from the
stomach and back through the device; leaking around the
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per1phery of the device; and, premature deterioration
of the materials of construction. Also, lt 1~
difficult to maintain the device in place in a stable
manner in the patient, and this latter problem can
result in the device being ingested into the ~tomach,
and eventually into the pylorum. Devices presently on
the market are not 9 ized properly, and they use
material~ that are prone to fairly rapid deterioration.
Moreover, they can become entangled and
dislodged from the patient due to improper sizing and
inadequate locking of the device to the patient. In
some prior art devices, the exterior of the gastrostomy
tube is taped to the wearer7s body. This procedure can
cause infection at the stoma entry, and along the taped
area, as well as causing irritation due to the
dif~iculty in maintaining these areas clean.
Other prior art devices employ a spring biased
or threaded locking mechanism to secure a locking ring
to the wearer's body, the locking ring being fastened
on the gastrostomy tube. But these devices maintain a
fixed pres3ure or position of the locking ring on the
gastrostomy tube, and do not self adjust to peristaltic
pressure of the stomach. This is of particular
importance in the case of neonatal patientq or others
such as Lncoherent or unconscious patients who are
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unable to communicate the nature of their discomfort.
Cenerally, the use of tape or mechanical locking
devicea require~ extra care which is usually provided
by trained personnel such as nurses.
According to one aspect of the inventlon, a
gastrostomy of ~ejunostomy Peeding tube is provided for
in~ertion through the stoma of the patient's stomach
wall and into the patient's stomach and~or jejunum.
The feeding tube is provided with an inflatable balloon
at one end to position and secure the tube within the
stomach. The outer end of the tube is provided with a
moveable locking ring that can be adjusted by
frictional engagement of the locking ring with the
gastrostomy or jejunal feeding tube to accommodate to
the size of the wearer. Since the locking ring does
not require or employ tape to secure the device in
place, problems associated with skin irritation and
with maintaining both the taped areas and the stoma
area clean are greatly reduced. The locking ring can
simply be moved along the tube against the frictional
force between the ring and the tube to permit cleaning
of the stoma entry through which the catheter is
inserted. The locking ring is then repositioned to its
normal location, i.e. in close contact with the
wearer's abdomen.
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The balloon and locking ring thu~ both function
to maintain the device in place, and prevent the
device, by frictional engagement between the locking
r~ng and tube, from being drawn into the ~tomach, or
being inadvertently pulled out. If desired, a mushroom
tip can be used in place of a baloon, and this can be
important during the firqt few post-operative days when
a balloon tip ls rnore vulunerable to being ruptured.
In the case of a gasto-jejunal feeding system,
one embodiment of the invention involves extending the
tube through the stomach and feeding directly into the
jejunum. In another embodiment, the feeding system of
thi~ invention permits liquid food to be supplied to
the jejunum while the stomach is drained by means of a
comounted gastrostomy tube. This represents a
significant benefit for patient's who have a problem
with ga~tric re~lux or vomiting. However, if the
stomach ~unction is only somewhat impaired and vomiting
or gastric re~lux are not a problem with a particular
patient, liquid food can be qupplied to both the
~ejunum and the stomach through both tubes.
In another embodiment, the device may be
adapted to feed dlrectly through a jejunal stoma and
into the jejunum.
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The device of thi~ invention is preferably
constructed of a medical grade silicone ela~tomer,
rather than a latex or silicone latex comblnation.
Consequently, use of the silicone elastomer provides a
~uitably inert material compared to the latex. Hence,
the elastomer requires replacement about every 6 - 8
weeks compared to a silicone latex which needs
replacing about every three weeks.
There follow~ a description by way of example
oE specific embodiments of the invention, reference
being made to the accompanying drawings, in which:
Fig. 1 is an external perspective view of the
gastrostomy device of this invention;
Fig. 2 is an external perspective view oP the
said device partly Yragmented, showing the outlet end,
and the balloon when deflated;
Fig. 3 is a perspective view, partly broken
away, olf the said device installed in a patient;
Fig. 4 is an external perspective view of a
preferred form of locking ring employed in the device;
Fig. 5A i~ an external perspective view showing
the use oY a mushroom tip in place of the balloon,
together with a per~orated and rlbbed locking ring;
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Fig. 5B is an external, perspective view of the
~ald devic~ for feeding into the jejunum via a stomach
placed stoma;
Fig. 6 is an external, perspective view of the
said device for feeding into both the stomach and
~ejunum via a stomach placed stoma; and
Fig. 7 is an external, perspective view of the
said device adapted for by-passing the stomach and
feeding directly into the jejunum.
The gastrostomy catheter device 10 of this
invention is shown in Fig. 1, and provides an inlet end
12, through which is fed food and medication, and an
outlet end 13 that extends into the patient's stomach.
A plurality of outlet ports, two of which are shown,
are located ak the outlet end 13. The catheter 10 is
secured inside the stomach by an in~latable balloon 16,
and on the patient's abdomen by an adjustable silicone
locking ring 17. As shown in Fig. 4, the locking ring
17 is provided with a plurality of vent holeq 17A and a
circular ridge 17B to permit air to contact the entry
to the stoma and reduce infection and skin irritation.
As indicated, use of the ring prevents the
catheter from being drawn into the patient's stomach.
In addition, since the adjustable ring does not require
the use of tape, a potential source of skin irritation
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and infection iq eliminated. The portlon 18 o~ the
catheter tube 11 between the ring 17 and balloon 16 iq
secured within the stoma, and thi~ arrangement of the
balloon and ring prevents the catheter from being drawn
lnto the patient'~ qtomach.
In Flg. 1, the balloon ls inflated by liquid or
gas which is pa~sed through a valve 19 and llne 20 into
port.21 that i~ surrounded by the balloon. The line 20
is bonded along the inside of the catheter tube 11 and
extends to the outlet of the catheter where it is end
sealed; the end seal forces the inflating gas into the
port 21. Fig. 2 shows the balloon 16 in a deflated
position.
The inlet end 12 is provided with an integrally
~ormed end plug 22 attached to the catheter by a band
23. A plurality o~ rings, 24, 25 are formed on the
plug to engage corresponding groovss (not shown) on the
inside o~ the bore at the inlet. The combined effect
o~ the plug and bore fit, and the fit between the
grooves and ringY prevent the plug from being dislodged
during use, and hence, will prevent the contents of the
stomach from draining out through the catheter.
Basically, the catheter device is inserted
into the patient through a surgically prepared stoma
created in the abdominal wall using pre-existing
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surgical procedures. These procedures include Stamms
Castrostomy, Witzel Gaatrostomy, and others. ALso, non
surgical procedures may be employed such as
percutaneous ga~trostomy. The Janeway surgical
procedure also may be used.
The catheter tube 10, with surrounding,
concentric pur~e strlng sutures, i9 inserted through
the stoma and gastric wall into the stomach. The purse
strings will permanently invaginate a portion of the
stomach and stoma to shape around the catheter tube and
then will dissolve, leaving the gastrostomy tube in
place and ready for use. Fig. 3 shows the device when
installed. ~he inflated balloon forms a gasket that
seals the entrance to the stoma, and along with the
locking ring 17, secures the device in place. The
device may be constructed in various sizes to
accommodate a particular patient. Sizes such as 12~
14, 16, 18 and 20 French, and corresponding diameters
varying from about 0.157" - 0.263", (4 - 6.7mm), and a
wall thickness of about 0.035" (0.9mm), may be used.
After being used for a suitable time, say 6 to
8 or 9 weeks, the catheter tube is, of course,
replaced. This ls accomplished simply by deflating the
balloon, retracting the adjustable ring, and removing
the tube from the patient.
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Fig. 5A illustrates the use of a mushroom tip
employed in place of a balloon, and a locking ring
designed to provide air circulation between the ring
and stoma areas to reduce irrltation and the
possibility of infection. The ga3trostomy catheter
device 30 in¢ludes a tube portion 31, mushroom tip 32,
ad~ustable locking ring 33, and food inlet portion 34.
The locking ring 33 includes a collar 35 and a
plurality of raised, concentric legs 36, air ~ents 37,
and air gaps 38 between the legs 36 to permit
circulation of air between the ring and stoma area.
The mushroom tip 32 is inserted (and removed) with a
stylet through the tube and expands to its final shape
in the stomach when it is pushed through the tube. The
food inlet 34 has the same construction as that shown
in Fig,. 1.
It will be appreciated that while a balloon or
mushroom tip are described above ~or securing the
device internally, components such as a plate may be
used a~ a substitute ~or the balloon or mushroom tip
components.
The operation of the locking ring 33 is the
same as that of the ring 17 in Fig. 1. Basically, the
locking ring 33 i~ adjustable along the tube 31 and
forms a light friction lock against the user's abdomen.
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When the stoma area requires cleaning, the ring 33 i~
slmply retracted agalnst the frictlonal force between
the ring and tube 31, and then forced back against the
abdomen after the stoma area has been cleaned.
Usuallyt the locking ring 33 and tube 31 are both made
Or medical grade ~ilicone material.
Fig~. 5B and 6 Lllustrate the use of a
gastrostomy placed stoma for feeding into the jejunum
(Fig. 5B), or into the stomach and/or the jejunum (Fig.
6). Fig. 7 illustrates the use of a jejunal placed
stoma which by-passes the stomach and feeds directly
into the jejunum.
In Fig. 5B, the jejunal feeding device 30
includes a feeding tube 31 having an open end 31a that
extends through the stomach and into the jejunum. The
device provides an expandable balloon portion 32,
locking ring 33 and an end member 34 having an
inflating valve 35 and feed inlet 36. A gas line 37 is
bonde~ along the interior of the tube and joins the
interior of the balloon with the valve. An outlet port
38 enables the balloon to be filled from the valve via
the ga~ line.
The locking ring 33 includes a collar 40 and
plurality of raised, concentric ribs 41, air vents 42,
and air gaps 43 between the legs to permit clrculation
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of air between the ring and stoma area. The central
portlon of the locking ring defines a bore 44 through
which paqqes the feeding tube 31. The frictlonal
contact between the bore wall and collar 40 with the
tube ls sufficiently great to permit the locking ring
to remain in contact with the patient's abdominal wall
during uqe. However, the frictional contact between
the tube and locking ring i9 sufficiently low so as to
permit outward movement of the locking ring from the
patient if the peristaltic pressure o~ the stomach
becomes too great. Also, the frictional contact
between the locking ring 33 and tube is su~ficiently
low to permit the locking ring to be moved away from
the abdominal wall and enable the stoma area to be
cleaned.
As in Fig. 1, the feed inlet 36 includes an
attached cover plug 45 which can be inserted into the
inlet and remain in place by means of a ring 46 ~hat
engages a corresponding groove (not shown) on the
inside oY the bore at the inlet.
The ~ejunal feeding tube 30 is inserted into
the patient in the same manner as for the gastrostomy
tube shown in Fig. l. Since the jejunal tube is about
2 feet (600mm) longer than the gastrostomy tube, it can
be fed directly into the ~ejunum through a simple
gastrostomy stoma.
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The embodiments shown in Figs. 58 and 6
represent a considerable advantage to a patient who has
a problem with gastric rePlux or vomiting,.but does not
require gastric decompre~sion or drainage. In Fig. 6,
the jejunal feeding tube device 50 includes a Jejunal
feeding tube 51, having an outlet end portion 51a which
extends through the stomach into the jejunum1 and which
is perforated at 52 to permit liquid food to be passed
therethrough. The tube 51 connect~ at its inlet end
51b to a food inlet port 53 having a connecting plug
cover 54 bearing one or more circular ridges 55. The
plug cover can be inserted into the inlet port and will
be secured therein by corresponding grooves (not
shown) that engage the ridges 55.
Surrounding the feeding tube 51 i~ a shorter
length gastrostomy tube 56 having a plurality of
drainage inletq or ~ood outlet ports, one such port 57
being shown~ The drainage outlet (or food inlet) end
56a is enlarged to form a port 59 having an attached
cover plug 60. One or more circular ridges 61 formed
on the plug engages corresponding grooves (not shown)
on the inside of the entry port to ensure a tight fit
when the entry port 59 i9 closed.
An inflatable balloon 65 is provided near the
end of the gastrostomy tube and is inflatable through a
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valve 66 bonded lnto the drainage (or inlet) end 56aO
The valve is used to 3upply air to the balloon through
a connecting line 67 and outlet port 68 under the
balloon.
A connector 69 ia employed to ~oin the jejunum
tube 51, inlet end 51b, gastrostomy tube 56, and
drainage (or feeding) end 56a into a rigid package.
An ad~ustable, silicone locking ring 70 is
provlded with a plurality of vent holes 71 to permit
air to contact the entry to the stoma and reduce
infection and skin irridation. This is aided by a
series of concentric ribs 72 being spaced at 73 for
circulation of air therebetween. The central portion
of the locking ring defines a bore 74 through which
pass the jejunal and gastrostomy tubes 51 and 5~.
Frictional contact between the bore 74 and collar 75
with the gastrostomy tube 56 is sufficiently great to
permit the locking ring to remain in contact with the
patient's abdominal wall during use. However, the
frictional contact between the tube and locking ring is
sufficiently low so as to permit outward movement of
the locking ring from the patient Lf the peristaltic
pressure of the stomach becomes too great. Also the
frictional contact between the locking ring 70 ls
sufficiently low to enable the locking ring to be
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retracted ~rom the abdominal wall and permit the stoma
area to be cleaned. As in Fig. 5B, the already
existing ~toma can ~erve either as an entry for a
~e~unal tube of ~or a ga~troqtomy tube without any
additlonal surgery being required.
In Fig. 7, use o~ an inflatable balloon is
elimirlated~ and a plate is employed instead. The
~e~unum feeding device 80 is shown providing a je~unal
tube 81, retaining plate 82, locking ring 83 and food
inlet 84. The device is secured permanently by means
of the plate 82 constructed of say a silicone material,
which presses against the entrance to the stoma on the
inside of the jejunal wall, and by the locking ring 83
which is pressed against the wearer's abdomen at the
stoma entry. As in the other embodiments, the extent
of frictional engagement between the locking ring 83
and the tube 81 i~ sufficient to prevent the device
from being drawn into the user by peristalsis, while
still enabling the ring to move outwardly due to
expansion, or to be retracted so that the stoma may be
cleaned.
The present device is inexpensive and can be
readily manufactured by conventional extrusion and
injection molding techniques. Also, it can be easily
inserted for use without generally requiring the
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~ervices of a physiclan or even outpatient services.
Furthermore, when in a hospital, nursing time with lt~
attendant co~ts have been found to be reduced
signlficantly.
The device may be cleaned during u~e anclcan be
manipulated to permlt cleaning of the stom2 area.
Finally, the device i9 safe in that it cannot be drawn
into the u~er, which can be particularly dangerous to
unsu~pecting in~ant~ and incoherent or unconscious
patients, or the like. During use, it will not
inadvertently drain the contents of the stomach of
jejunum because of the end plug.
