Multi-lumen enteral feeding and medicating device

A multi-lumen enteral feeding and medicating device having a gastric tube adapted to be introduced into the interior of a patient's stomach through a stoma. The gastric tube has a balloon to engage and seal against the interior wall of the stomach around the stoma and a locking ring to engage the skin of the patient surrounding the exterior opening of the stoma. A jejunal tube is slidably engaged in the gastric tube for relative longitudinal sliding displacement so that the distal end of the jejunal tube may be threaded through the stomach into the jejunum for introduction of a fluent material through ports adjacent the distal end of the jejunal lumen. A fluid lumen is provided in the gastric tube for applying positive and negative pressure to the interior of the balloon to extend and retract the same and an inlet attachment is provided for accessing the gastric lumen for introducing fluent material into the stomach through the gastric lumen. The jejunal tube passes through the gastric lumen and out through the inlet attachment. A sealing plug is provided to seal the inlet to the gastric lumen at the point where the jejunal tube exits the gastric lumen. The sealing plug operates to anchor the jejunal tube within the gastric lumen at the desired location which positions the distal end of the jejunal tube within the jejunum.

FIELD OF THE INVENTION 
The present invention relates to a gastrointestinal or enteral feeding and 
medicating device which allows a single variable length appliance to 
accommodate pediatric as well as adult patients who require long-term 
gastric and jejunal feeding and medication. The invention provides a 
gastric feeding lumen combined with an adjustable jejunal catheter whose 
length can be determined at the time of clinical placement to accommodate 
individual patient anatomical differences. These differences are typical 
of the range of intestinal variations found in pediatric, post-surgical 
adults, and congenitally gastrointestinally abnormal patients. 
The device can be employed in hospital and homecare patients to reduce the 
number of recurrent surgical procedures and to reduce the cost and the 
extent of routine nursing care required to maintain gastric stoma sites 
for those individuals needing long-term enteral nutrition and medication 
support. 
BACKGROUND OF THE INVENTION 
Many types of feeding catheters have been developed to provide gastric or 
intestinal access for patients who cannot meet their nutritional needs 
eating by mouth. These catheters have been designed and constructed to 
allow fixed length tubes for insertion through a stoma in the patient's 
abdomen. These devices are made to accommodate the typical adult patient 
anatomical sizes. They do not accommodate pediatric patients, adult 
patients who have undergone surgical procedures which have altered their 
small intestine, or those patients who suffer intestinal tract congenital 
abnormalities. Frequently, clinical practitioners have tried to overcome 
these shortcomings by inserting two tubes through the patient's abdominal 
stoma: one tube of the appropriate size for gastric feeding, and a second 
tube sized for the patient's jejunal anatomical structure. 
U.S. Pat. No. 4,666,433 (S. K. Parks), U.S. Pat. No. 4,701,163 (S. K. 
Parks), and U.S. Pat. No. 4,701,162 (P. Rosenberg) all show such a device 
for gastric feeding. All of these existing tubes require a separate 
jejunal catheter to be placed alongside the gastric feeding device. During 
placement of any of the above existing tubes, the patient's stoma must be 
temporarily or permanently enlarged to allow both individual tubes to pass 
through the small abdominal opening. This is particularly aggravating in 
small pediatric patients. After placement, during extended use, all of 
these two tube methods are subject to extensive leakage of gastric 
contents. This is primarily due to the inability of these combinations of 
separate devices to seal the gastric stoma. Patients using these devices 
require significant routine nursing care to treat the caustic effects of 
stomach acid leaking onto the skin. These two tube through the stoma 
methods also require the patient to undergo repeated surgical procedures 
to excise granuloma growth at the stoma site. This granuloma growth is 
caused by the side to side and rotational movements of the two tubes 
within the stoma opening. These problems with the existing devices require 
the patient to undergo several costly follow-up surgical procedures and 
continual nursing care over extended nutritional support periods. The 
existing devices all require this additional medical, surgical and nursing 
care in the hospital setting and make home care of these patients very 
demanding. This combination of problems with the existing devices is 
particularly serious for small pediatric patients in marginal medical 
condition. 
Gastrointestinal or enteral feeding devices currently available under U.S. 
Pat. Nos. 4,685,901 and 5,234,417 (S. K. Parks), have attempted to solve 
the previously mentioned leakage problems by employing a fixed length 
jejunal tube as an integral part of the device. These devices, however, do 
not allow clinical practitioners to adjust the length of the jejunal lumen 
to meet the needs of individual pediatric, post-surgical adult patients or 
those with congenital abnormalities. The Park devices employ only a fixed 
length non-adjustable tube. This makes the Park tube unusable in 
situations where the patient's intestinal anatomy does not match the 
standard length tubes currently available. This is particularly critical 
in pediatric and post-surgical adult patients. 
SUMMARY OF THE INVENTION 
None of the prior available devices solves the above problems. The present 
invention provides a solution with a device which has a single multiple 
lumen tube passing through the patient's abdominal stoma, is variable in 
length, and can be adjusted in the clinical setting to meet each 
individual patient's unique anatomical requirements. 
It is an object of the present invention to provide an enteral feeding and 
medicating device comprising multiple lumens within a single assembly for 
gastric and jejunal nutrition support which has a variable length jejunal 
tube. 
It is a further object of the present invention to provide a combined 
gastric and jejunal enteral feeding and medicating device that can be 
adjusted at the time of placement by clinical personnel to meet the 
individual intestinal anatomy of both pediatric and adult patients. 
It is yet a further object of the present invention to provide a gastric 
and jejunal feeding and medicating device which reduces the need for post 
placement surgical procedures and nursing care for both pediatric and 
adult patients in the hospital and in-home care settings. 
More specifically, the present invention provides an enteral device having 
a gastric tube adapted to pass through a stoma and to be anchored therein, 
along with a jejunal tube slidable interiorly of the gastric tube so as to 
be adjustable in its extension through the stomach and into the jejunum.

DESCRIPTION OF THE PREFERRED EMBODIMENT 
Referring now to the drawing, the device of the present invention is a 
feeding assembly 10, having a gastric feeding tube 11 with an internal 
bore 12 which provides a gastric lumen for introducing fluent materials 
into the interior of the stomach 15 through a stoma in the body wall 17 
indicated by the broken lines at 16 in FIG. 5. The feeding tube 11 has a 
balloon 13 adjacent its distal end, which, when extended, as shown in FIG. 
5, is constructed and arranged to bear against the wall of the stomach 15 
surrounding the stoma 16. An anchor ring 14 cooperates with the balloon 13 
to secure the gastric tube 11 in place within the stoma 16. Preferably, 
the mounting of the gastric tube 11 within the stoma seals the stoma 
against leakage or seeping of gastric juices from the stomach. As shown in 
FIG. 1, the sealing ring 14 is frictionally engaged with the external 
surface of the gastric tube 11 so that it may be displaced axially of the 
tube flush against the skin surrounding the stoma 14 following insertion 
of the gastric tube. 
The gastric tube includes a fluid lumen 22, in the present instance formed 
within the annular wall of the tube 11. Near the distal end of the tube 
11, the fluid lumen 22 terminates in the interior of the balloon 13 so 
that upon application of positive pressure to the fluid lumen 22, the 
balloon 13 is extended, as shown in FIGS. 1 and 5. Upon application of 
negative pressure to the lumen 22, the extended balloon 13 is retracted, 
as shown in FIG. 6 so as to be substantially coextensive with the outline 
of the tube 11. After extension of the balloon as shown in FIG. 1, the 
gastric lumen is displaced outwardly to snugly engage the balloon against 
the wall of the stomach around the stoma 16, and the anchor ring 14 is 
slid down the exterior of the tube 11 to engage against the outer surface 
of the skin surrounding the stoma 16 and is held in place as shown in FIG. 
5. The frictional engagement of the ring 14 on the outer surface of the 
tube 11 is normally sufficient to anchor the tube firmly in place and seal 
the stoma at the inside against leakage of gastric juices through the 
stoma and past the ring 14. Engaging flat against the skin around the 
stoma, the ring also serves to exclude leakage through the stoma to the 
outer skin surface. 
The balloon 13 is extended and retracted by the application of positive and 
negative fluid pressure to the lumen 22, and this is accomplished in the 
conventional manner by the use of a syringe 23 which communicates with the 
lumen 22 through a valve 24 in a feeding attachment 25 at the inlet end of 
the gastric tube 11. The valve 24 comprises a conventional self-sealing 
plug which may be penetrated to introduce and withdraw pressure fluid from 
the fluid lumen 22. The valve 24 and fluid lumen 22 are isolated from the 
gastric lumen 12 of the gastric tube so as to not to contaminate the 
pressure fluid with the fluent materials introduced through the gastric 
lumen 12 and, vice versa, not to contaminate the fluent material in the 
gastric lumen with the pressure fluid from the fluid lumen 22. 
The inlet attachment in addition to the branch housing the valve 24 has a 
main branch 26 which is axially aligned with the lumen 12 of the tube 11 
and an auxiliary branch 27 which diverges from the axis of the lumen 12 at 
an obtuse angle. The auxiliary branch 27 has a hollow bore in 
communication with the hollow interior of the main branch 26 interiorly of 
the attachment 25. Each of the branches 26 and 27 has a cover member 
attached to it by a flexible tether. The main branch 26 has a cover 28 
having a central plug which engages within the bore of the branch 26 to 
close the same. The auxiliary branch 27 has a cover 29 having a plug 
adapted to engage in the bore of the auxiliary branch 27. 
As shown in FIG. 1, a jejunal tube 32 is adapted to be threaded through one 
of the branches 26 and 27, for example as shown in FIG. 1, through the 
branch 27. The jejunal tube 32 passes through the bore of the auxiliary 
branch 27 and the bore of the main branch into the bore 12 of the gastric 
tube 11. The jejunal tube 32 extends along the length of the gastric tube 
11 and exits through its distal end. As shown in FIGS. 1 and 2, the distal 
end 31 of the tube 11 tapers down to snugly engage the outer perimeter of 
the tube 32. The tapered portion at the terminal end 31 of the tube 11 is 
provided with ports 33 which afford fluid communication between the 
interior of the stomach outside of the tube end 31 with the gastric lumen 
12 on the interior of the tube end. 
The jejunal tube slidably engages the tapered portion 31 and extends beyond 
the tapered portion into the interior of the stomach as shown in FIG. 5. 
The tube passes through the stomach, through the pylorus, the duodenum and 
into the jejunum which forms the initial sector of the small intestine. 
The distal end of the jejunal tube terminates in the jejunum and is 
provided with means to afford communication between the interior bore 35 
of the jejunal tube 32 and the interior of the small intestine at the 
jejunum. To this end, the distal end of the tube 32 has a series of ports 
36 adjacent to the terminus 37. In the present instance, the terminus 37 
is closed to provide a blunt leading end thereon. The blunt leading end 37 
facilitates the threading of the jejunal tube through the stomach and into 
the jejunum. 
As shown in FIGS. 1, 4 and 5, at the inlet end of the gastric tube 11, the 
jejunal tube 32 passes outwardly into the gastric inlet passage within the 
branch 26 and branches through the jejunal passage 39 in the hollow 
interior of the auxiliary branch 27. After the gastric tube 11 and the 
jejunal tube 32 are properly positioned, the space between the jejunal 
tube 32 and the jejunal passage 39 is sealed with a plug 38 which is 
wedged between the internal wall of the passage 39 and the external 
surface of the jejunal tube 32. The plug 38 may be of any suitable sealing 
material and may incorporate an adhesive to provide a firm interlock 
between the jejunal tube and the fitting so as to anchor the tube against 
inadvertent displacement. 
When assembled in this manner, as shown in FIG. 1, the jejunal tube 
provides access from its inlet 40 through the bore 12 of the gastric tube 
11, out the terminal end 31 of the gastric tube, through the stomach and 
into the jejunum so as to allow the passage suitable fluent material, 
whether food or medication, into the jejunum, bypassing the gastric cavity 
of the stomach. A different fluent material may be introduced directly 
into the stomach through the bore 12 of the gastric tube 11 by introducing 
the same through the main branch 26 and through gastric lumen defined by 
the annular space between the jejunum tube 32 and the bore 12 of the 
gastric tube and out into the stomach through the ports 33. 
In some instances it may be desirable to avoid even obtuse angular bends in 
the jejunum tube, in which event the jejunum tube may be passed through 
the main branch 26 instead of the auxiliary branch 27. This arrangement is 
shown in FIG. 6. The gastric tube 11 and the inlet attachment 25 are the 
same as illustrated in FIG. 1. The jejunum tube 32 is likewise is of 
similar design and construction, and the only difference between the 
arrangements shown in FIGS. 1 and 6 is that the jejunum tube is fed 
through the main branch 26 of the attachment 25 and the plug 38 is 
modified to fit between the outside of the jejunum tube 32 and the 
interior bore of the main branch 26. Relocating the jejunum tube into the 
main branch 26 frees the auxiliary branch 27 for use as an inlet passage 
for feeding through the gastric lumen 12 of the gastric tube 11. 
The feeding and medicating device of the present invention facilitates the 
treatment of patients which require the introduction of different fluent 
materials into the stomach and the jejunum respectively. In treating such 
patients, the patient is provided with a stoma which affords access 
through the skin and stomach wall into the interior of the stomach. The 
stoma, as shown at 16 in FIG. 5, is created surgically and is dimensioned 
to snugly receive the gastric tube 11. In order to introduce the feeding 
and medicating device of the present invention, the jejunal tube 32 is 
threaded through the gastric tube 11 and is positioned with the distal end 
37 extended as far as possible from the tapered end portion 31 of the 
gastric tube 11. A feeding wire is threaded through the bore of the 
jejunal tube 32 to abut the leading end 37 of the tube. The feeding wire 
is preferably a stiff flexible component which is opaque to 
electromagnetic waves so as to enable the caregiver to guide the blunt 
leading end 37 of the jejunal tube through the stomach, the pylorus and 
the duodenum into the jejunum, by observing an electromagnetic image of 
the stomach area. The opaque nature of the guide element serves to enable 
a proper positioning of the jejunal tube 32 so that its ports 36 are 
located within the jejunum as desired. Since the external diameter of 
jejunal tube is substantially smaller than the external diameter of the 
gastric tube 11, there is sufficient "play" between the jejunal tube 32 
and the stoma to permit facile threading of the jejunal tube into the 
proper position within the jejunum. Thus, the extension of jejunal tube is 
adjusted to the patient's unique anatomical requirements. 
With the jejunal tube 32 advanced to the proper extent, for example as 
illustrated in FIG. 5, the gastric tube may then be displaced along the 
jejunal tube so as to enter the stoma and penetrate the interior of the 
stomach cavity. A suitable surgical lubricant is used to assist the 
insertion of the tube 11 through the stoma 16. When the balloon portion 13 
of the gastric tube 11 is positioned within the stomach cavity, the 
syringe 23 is applied to the valve 24 and fluid is introduced into the 
fluid lumen 22 to introduce pressure fluid into the balloon 13 and cause 
it to extend, as shown in FIG. 5. With the balloon extended, the syringe 
may be withdrawn from the valve and the self-sealing nature of the valve 
will maintain the balloon extended. The gastric tube 11 is then retracted 
so as to firmly seat the balloon against the internal wall of the stomach 
surrounding the stoma 16, care being exercised to avoid longitudinal 
displacement of the jejunal tube from its adjusted position within the 
small intestine. With the balloon 13 of the gastric tube firmly seated 
against the interior wall of the stomach, the ring 14 is displaced along 
the exterior of the gastric tube to engage flush against the skin 
surrounding the stoma 16 so as to firmly anchor the gastric tube in place 
within the stoma 16. The plug 38 is then applied around the jejunal tube 
32 to anchor the jejunal tube against inadvertent displacement, as shown 
in FIG. 4 and FIG. 6. The guide element within the jejunal tube is removed 
so as to free the bore of the jejunal tube 32 for use as a jejunal lumen 
for the introduction of a suitable fluent material into the jejunum 
through the ports 36. 
While a particular embodiment of a feeding and medicating device has been 
herein illustrated and described, it is not intended to limit the 
invention to the specific embodiment illustrated, but changes and 
modifications may be made therein and thereto within the scope of the 
following claims.