U.S. patent application number 10/230659 was filed with the patent office on 2003-01-09 for polyurethane feeding tube and associated adaptors.
Invention is credited to Comer, Gail M., Duggan, Brendan J., Goldhardt, Donald J., O'Hara, Derek P., Sanmiguel, Liliana M..
Application Number | 20030009152 10/230659 |
Document ID | / |
Family ID | 23651027 |
Filed Date | 2003-01-09 |
United States Patent
Application |
20030009152 |
Kind Code |
A1 |
O'Hara, Derek P. ; et
al. |
January 9, 2003 |
Polyurethane feeding tube and associated adaptors
Abstract
Feeding tube assembly includes a feeding tube made of a
polyurethane, preferably Carbothane, and a feeding tube adaptor
including at least an inlet conduit and an outlet conduit. In one
aspect, the feeding tube adaptor is made of a substantially rigid
material, and the exterior surface of the outlet conduit defines a
retention member to engage an interior surface at a first end
portion of the feeding tube when the outlet end of the outlet
conduit is inserted within a lumen defined in the feeding tube. In
accordance with another aspect, the tube adaptor is provided with a
removable cap to close selectively the inlet conduit, and both the
inlet conduit and the cap are made of polyurethane. The cap has an
engagement surface to engage a corresponding surface of the first
inlet conduit, wherein the engagement surface of the cap has a
surface configuration different than that of the corresponding
surface of the first inlet conduit. This difference in surface
configurations can be established by providing one or both of the
surfaces with a series of protuberances, a series of indentations,
a different cross-sectional shape, or a combination thereof.
Inventors: |
O'Hara, Derek P.;
(Tourlestrane, IE) ; Duggan, Brendan J.;
(Strandhill, IE) ; Comer, Gail M.; (Libertyville,
IL) ; Goldhardt, Donald J.; (Grove City, OH) ;
Sanmiguel, Liliana M.; (Powell, OH) |
Correspondence
Address: |
STEVEN F. WEINSTOCK; ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
DEPT. 377/AP6A
ABBOTT PARK
IL
60064-6008
US
|
Family ID: |
23651027 |
Appl. No.: |
10/230659 |
Filed: |
August 29, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10230659 |
Aug 29, 2002 |
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09416719 |
Oct 13, 1999 |
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6464686 |
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10230659 |
Aug 29, 2002 |
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09010411 |
Jan 21, 1998 |
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6093179 |
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Current U.S.
Class: |
604/538 ;
604/500 |
Current CPC
Class: |
A61M 2210/1042 20130101;
A61J 15/0015 20130101; A61B 17/3415 20130101; A61J 15/0088
20150501; A61M 25/09041 20130101; A61M 39/20 20130101; A61J 15/0019
20130101 |
Class at
Publication: |
604/538 ;
604/500 |
International
Class: |
A61M 031/00 |
Claims
What is claimed is:
1. A feeding tube adaptor comprising: a first inlet conduit; and an
outlet conduit in fluid communication with the first inlet conduit,
the outlet conduit constructed for fluid connection to a first end
portion of a feeding tube, the outlet conduit having an exterior
surface and an outlet end; the exterior surface of the outlet
conduit defining a retention member, the retention member including
a first section having an exterior peripheral dimension increasing
with increasing distance from the outlet end of the outlet conduit,
the retention member further including a second section having an
exterior peripheral dimension decreasing with increasing distance
from the outlet end of the outlet conduit.
2. A feeding tube adaptor according to claim 1, further including a
second inlet conduit in fluid communication with the first inlet
conduit and the outlet conduit.
3. A feeding tube adaptor according to claim 1, wherein the second
section of the retention member is positioned adjacent the first
section of the retention member.
4. A feeding tube assembly comprising: a feeding tube made of
polyurethane, the feeding tube having a first end portion, a second
end portion opposite the first end portion, and at least one lumen
defined therein extending between the first end portion and the
second end portion; and a feeding tube adaptor including a first
inlet conduit and an outlet conduit in fluid communication with the
first inlet conduit, the outlet conduit having an outlet end to be
inserted into the at least one lumen at the first end portion of
the feeding tube for fluid communication therebetween, the outlet
conduit further having an exterior surface defining a retention
member to engage an interior surface at the first end portion of
the feeding tube when the outlet end of the outlet conduit is
inserted within the at least one lumen of the feeding tube.
5. A feeding tube assembly according to claim 4, wherein the
retention member defined by the exterior surface of the outlet
conduit includes a first section having an exterior peripheral
dimension increasing with increasing distance from the outlet end
of the outlet conduit, the retention member further including a
second section spaced further from the outlet end than the first
section and having an exterior peripheral dimension decreasing with
increasing distance from the outlet end of the outlet conduit.
6. A feeding tube assembly according to claim 5, wherein the second
section of the retention member is positioned adjacent the first
section of the retention member.
7. A feeding tube assembly according to claim 4, wherein the
feeding tube adaptor is made of a substantially rigid material.
8. A feeding tube assembly according to claim 4, wherein the
feeding tube adaptor further includes a second inlet conduit in
fluid communication with the first inlet conduit and the outlet
conduit.
9. A feeding tube assembly according to claim 4, wherein the
feeding tube is made of a Carbothane-like; material.
10. A feeding tube assembly comprising: a feeding tube adaptor made
of polyurethane, the feeding tube adaptor including a first inlet
conduit having an inlet port, the feeding tube adaptor also
including an outlet conduit for fluid communication with an inlet
conduit of a feeding tube; and a cap made of polyurethane removably
attached to close selectively the inlet port of the first inlet
conduit, the cap having an engagement surface to engage a
corresponding surface of the first inlet conduit, the engagement
surface of the cap having a surface configuration different than
that of the corresponding surface of the first inlet conduit.
11. A feeding tube assembly according to claim 10, wherein the cap
is permanently connected to the feeding tube adaptor.
12. A feeding tube assembly according to claim 10, wherein the port
of the inlet conduit is defined by an interior surface and the cap
includes a plug to be inserted into the port, the engaging surface
of the cap being an exterior surface of the plug and the
corresponding surface being the interior surface of the inlet
conduit.
13. A feeding tube assembly according to claim 10, wherein the cap
includes a peripheral flange, the engaging surface of the cap being
an interior surface of the peripheral flange and the corresponding
surface being an exterior surface of the inlet conduit.
14. A feeding tube assembly according to claim 10, wherein at least
one of the engagement surface and the corresponding surface is
provided with a series of protuberances.
15. A feeding tube assembly according to claim 10, wherein at least
one of the engagement surface and the corresponding surface is
provided with a series of indents.
16. A feeding tube assembly according to claim 10, wherein the
engagement surface of the cap defines a cross-sectional shape
different than that of the corresponding surface of the first inlet
conduit.
17. A feeding tube assembly according to claim 10, further
comprising a feeding tube having a first end portion, a second end
portion opposite the first end portion, and at least one lumen
defined therein extending between the first end portion and the
second end portion; the outlet conduit of the feeding tube adaptor
connected in fluid communication with the first end portion of the
feeding tube.
18. A feeding tube assembly according to claim 17, wherein the
feeding tube is made of a Carbothanel-like material.
19. A feeding tube assembly according to claim 17, further
comprising a retaining member attached to the second end portion of
the feeding tube.
20. A feeding tube assembly according to claim 19, wherein the
retaining member is made of an Estane-like material.
Description
[0001] This is a continuation-in-part application of prior
application Ser. No. 09/010,411, filed Jan. 21, 1998.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to an apparatus useful in the
placement of a percutaneous endoscopic gastrostomy tube. In
particular, the present invention is directed to an introducer
attached to a receptacle about which a placement wire is
positioned. Following insertion of the introducer into a selected
portion of a patient's gastrointestinal tract, the placement wire
is inserted into a patient through the introducer by rotating the
receptacle, thereby advancing the wire through the introducer.
[0004] The present invention also relates to a feeding tube
assembly for placement in the gastrointestinal tract a patient.
Particularly, the feeding tube assembly includes a feeding tube
made of polyurethane, and more preferably Carbothane, and a feeding
tube adaptor provided at a first end portion thereof. In accordance
with one aspect of this invention, the feeding tube connector is
made of a substantially rigid material and includes a retention
member for friction engagement with the feeding tube. In accordance
with another aspect of the invention, the feeding tube connector is
provided with a cap, both of which being made of a polyurethane,
wherein the cap has an engagement surface with a surface
configuration different than that of a corresponding surface of the
feed tube connector.
[0005] 2. Description of Related Art
[0006] Gastrostomy and jejunostomy tubes are used to deliver
nutritional products to the gastrointestinal tract of a patient
having difficulty ingesting food. Gastrostomy tubes deliver the
nutritional products percutaneously from an external source,
through the patient's abdominal wall, and directly to the patient's
stomach, while jejunostomy tubes deliver the nutritional products
percutaneously into the patient's jejunum or small bowel. In
addition to primary placement percutaneously through a patient's
abdominal wall, gastrostomy and jejunostomy tubes can be placed
into the patient's gastrointestinal tract through a mature stoma
formed in the abdominal wall, or through the nasal passage using
nasogastric or nasojejunal tube, respectively. Gastrostomy,
jejunostomy, nasogastric and nasojejunal tubes are referred to
collectively herein as "feeding tubes," unless otherwise noted.
[0007] The first step for the primary percutaneous placement of a
feeding tube in a patient typically involves the passing of an
endoscope down the patient's esophagus in order to view the
esophagus and determine whether there are any obstructions or
lesions in the esophagus that will inhibit or preclude passage of
the feeding tube through the esophagus. The endoscope also is used
to examine the interior of the stomach and/or the small bowel.
Next, the doctor visually selects the site through which the
feeding tube will be introduced into the stomach and
transilluminates the selected site by directing light outwardly
from the endoscope such that the light shines through the patient's
abdominal wall, thereby allowing the doctor to identify the entry
site from a point outside of the patient's body. The doctor then
inserts a catheter or introducer through the patient's abdominal
wall and into the stomach at the selected entry site. A first end
of a placement wire is then passed through the introducer and into
the stomach. The first end of the wire is grasped using a grasping
tool associated with the endoscope, and the endoscope and the
placement wire are drawn outwardly from the patient's stomach and
esophagus through the patient's mouth. Upon completing this step of
the procedure, a second end of the wire remains external to the
patient's abdominal wall while the first end of the wire extends
outwardly from the patient's mouth.
[0008] Placement wires can have a variety of forms. In one
commercially available embodiment, the placement wire is a doubled
wire coated with a biocompatible plastic material. However, other
forms of placement wires are well known. These placement wires
typically are provided in a sterile package for use by a medical
professional. For example, the placement wire can be coiled and
placed in a sealed pouch. The wire is removed from the pouch
immediately prior to placement in a patient. This packaging
methodology presents certain disadvantages in that the wire is
prone to entanglement during insertion into the patient. Thus, the
wire must be carefully manipulated in order to ensure that it is
fed properly through the introducer and into the patient. Such
manipulation may result in touch contamination of the wire as it is
manipulated. Further, in order to ensure that the wire is properly
fed into the patient's stomach, it is sometimes necessary to have
one person manipulate the wire while a second person feeds the wire
into the patient. This need for additional medical personnel
increases the cost of placing the feeding tube in. the patient.
[0009] In a different commercially available embodiment, the wire
is a "silk" type pull thread that is loosely coiled in a provided
holder. The thread extends through a hole in the holder and can be
pulled outwardly from the holder through the hole. As the endoscope
is withdrawn through the patient's esophagus, an assistant must
carefully pull the thread out of the holder and allow it to feed
through the catheter. This embodiment also presents certain
disadvantages due to the fact that an assistant is required in
order to manipulate and feed the thread into the catheter. In
addition, it typically is necessary to create a knot in the end of
the thread before attaching it to a feeding tube. In some cases,
creation of this knot can be difficult due to the physical
characteristics of the silk thread after it has been drawn through
the patient's stomach, esophagus, and mouth.
[0010] In another commercially available embodiment, the placement
wire is retained in a coil of rigid tubing. The wire can be
difficult to manipulate and therefore may require the presence of
an assistant to withdraw the wire from the coiled tubing. However,
this embodiment does tend to reduce tangling of the placement wire
during placement of the wire in the patient. Yet another
commercially available embodiment includes a placement wire
provided in a circular dispenser. Although this embodiment tends to
minimize tangling of the placement wire, the wire still can be
difficult to dispense from the circular dispenser and therefore
require the presence of an assistant.
[0011] It is preferable to provide a placement wire in such a way
that (a) the possibility of entanglement of the wire is minimized;
(b) the possibility of touch contamination of the wire is
minimized; and (c) withdrawal of the wire from its packaging does
not require additional personnel. The present invention addresses
each of these.
[0012] With the wire properly inserted, initial or primary
placement of a feeding tube percutaneously into the
gastrointestinal tract of the patient can be performed. In one
technique for primary feeding tube placement, the first end of the
placement wire is attached to a first end of a feeding tube.
Attachment of the feeding tube to the first end of the placement
wire is facilitated by a loop on the first end of the placement
wire and by a complementary loop on the first end of the feeding
tube. By pulling on the second end of the wire positioned external
to the patient's abdominal wall, the feeding tube is pulled through
the patient's mouth and esophagus, and into stomach. Further
pulling of the second end of the wire causes the first end of the
feeding tube to exit percutaneously from the stomach through a
tract in the abdominal wall formed by the introducer. The feeding
tube is pulled outwardly through the tract until a retaining member
mounted on the second end of the feeding tube engages the interior
of the stomach. This technique is referred to as a "pull"
technique.
[0013] In an alternative technique for primary feeding tube
placement, a channel defined through the feeding tube is positioned
over the wire such that the feeding tube can be pushed along the
length of the wire. As the feeding tube is pushed over the wire, it
passes through the patient's mouth, esophagus, and stomach until
the first end of the feeding tube exits through the incision in the
abdominal wall. The feeding tube is then drawn outwardly through
the abdominal tract until a retaining member on the internal or
second end of the feeding tube engages the interior of the stomach.
The wire is then withdrawn from the patient through the feeding
tube channel. This technique is referred to as a "push"
technique.
[0014] Yet another method may be used for percutaneous placement of
the feeding tube, particularly when passage through the esophagus
is precluded. This method, which is commonly known as the "poke"
technique, is most often used for placement of a feeding tube
having a balloon-type internal retaining member. Once a safe site
into the stomach is identified, the poke technique requires that
the stomach wall be retracted and secured against the abdominal
wall of the patient using a known anchoring device, such as
T-Fasteners.RTM.. One or more dilators are then used in sequence to
form an adequate tract of sufficient size through which the feeding
tube and the retaining member, in a deflated state, can be
inserted. The retaining member is then inflated in its proper
position to secure the placement of the feeding tube.
[0015] After a stoma tract has fully formed through the abdominal
wall of the patient using any of the techniques summarized above,
the initial feeding tube can be removed if secondary placement of a
different feeding tube is desired or necessary. In this manner, a
new feeding tube can be inserted directly into the mature stoma
tract that is formed through the patient's abdominal wall and
retained in a conventional manner.
[0016] A variety of feeding tube configurations made of different
materials are well known, and are each suitable for its intended
purpose. There remains a continued need, however, for feeding tube
assemblies of enhanced operational characteristics and cost
effective construction.
SUMMARY OF THE INVENTION
[0017] The purpose and advantages of the present invention will be
set forth in and apparent from the description that follows, as
well as will be learned by practice of the invention. Additional
advantages of the invention will be realized and attained by the
methods and systems particularly pointed out in the written
description and claims hereof, as well as from the appended
drawings.
[0018] To achieve these and other advantages and in accordance with
the purpose of the invention, as embodied and broadly described,
the invention includes a method for placing a feeding tube
placement wire in a patient. The method includes the step of
providing a placement wire dispenser. The dispenser includes a
rotatable placement wire receptacle that defines a placement wire
outlet. The dispenser further includes a tube extending outwardly
from the placement wire receptacle. The tube defines a placement
wire inlet that is in communication with the placement wire outlet
of the receptacle. A placement wire is wound about the receptacle,
and is in mechanical engagement with the receptacle, such that
rotation of the placement wire receptacle causes a first end of the
placement wire to be advanced through the placement wire outlet,
through the placement wire inlet of the tube, and through the tube.
A first end of the tube is constructed for insertion through a
patient's abdominal wall and into a patient's stomach. The method
further includes the step of placing the first end of the tube
through a patient's abdominal wall and into a patient's stomach.
Rotational movement is imparted to the receptacle so as to advance
the placement wire through the placement wire outlet, through the
placement wire inlet, through the tube, and into a patient's
stomach.
[0019] The present invention also includes a placement wire
dispenser. The dispenser includes a rotatable placement wire
receptacle that defines a placement wire outlet. The dispenser
further includes a tube extending outwardly from the placement wire
receptacle. The tube defines a placement wire inlet that is in
communication with the placement wire outlet of the receptacle. A
placement wire is wound about the receptacle, and is in mechanical
engagement with the receptacle, such that rotation of the placement
wire receptacle causes a first end of the placement wire to be
advanced through the placement wire outlet, through the placement
wire inlet of the tube, and through the tube. A first end of the
tube is constructed for insertion through a patient's abdominal
wall and into a patient's stomach.
[0020] The present invention further is directed to a feeding tube
placement kit. The kit includes a placement wire dispenser. The
dispenser includes a rotatable placement wire receptacle that
defines a placement wire outlet. The dispenser further includes a
tube extending outwardly from the placement wire receptacle. The
tube defines a placement wire inlet that is in communication with
the placement wire outlet of the receptacle. A placement wire is
wound about the receptacle, and is in mechanical engagement with
the receptacle, such that rotation of the placement wire receptacle
causes a first end of the placement wire to be advanced through the
placement wire outlet, through the placement wire inlet of the
tube, and through the tube. A first end of the tube is constructed
for insertion through a patient's abdominal wall and into a
patient's stomach. The kit further includes a feeding tube having a
first end portion and a second end portion. The feeding tube
defines a feeding lumen therethrough. A retaining member is
disposed on the second end portion of the feeding tube.
[0021] The present invention also is directed to a feeding tube
adaptor having an outlet conduit and an inlet conduit. An exterior
surface of the outlet conduit is configured such that it has a
first section having an increasing circumferential dimension from
an outlet end of the adaptor to an inlet end of the adaptor. The
exterior surface of the outlet conduit further is configured such
that it has a second section having a decreasing circumferential
dimension from an outlet end of the adaptor to an inlet end of the
adaptor. The first and second sections of the exterior surface of
the outlet conduit define a tube retention member, and preferably
are positioned adjacent each other.
[0022] Additionally, the present invention is directed to a feeding
tube assembly including a feeding tube made of a polyurethane,
preferably Carbothane. The feeding tube has a first end portion, a
second end portion and at least one lumen defined therein. The
feeding tube assembly further includes a feeding tube adaptor
having an inlet conduit and an outlet conduit, preferably made of a
substantially rigid material, wherein the outlet conduit has an
outlet end to be inserted into a lumen at the first end portion of
the feeding tube for fluid communication therebetween. The exterior
surface of the outlet conduit defines a retention member to engage
an interior surface at the first end portion of the feeding tube
when the outlet end of the outlet conduit is inserted within the
lumen of the feeding tube. The retention member includes a first
section having an exterior peripheral dimension increasing with
increasing distance from the outlet end of the outlet conduit, and
a second section having an exterior peripheral dimension decreasing
with increasing distance from the outlet end of the outlet
conduit.
[0023] In accordance with another aspect, the present invention is
directed to a feeding tube assembly including a feeding tube, a
feeding tube adaptor having a first inlet conduit, and a removable
cap made of polyurethane to close selectively an inlet port of the
first inlet conduit. The cap has an engagement surface to engage a
corresponding surface of the first inlet conduit, wherein the
engagement surface of the cap has a surface configuration different
than that of the corresponding surface of the first inlet conduit.
For example, the inlet conduit can include a port defined by an
interior surface and the cap can include a plug to be inserted into
the port, wherein the engaging surface of the cap is an exterior
surface of the plug and the corresponding surface of the inlet
conduit is an interior surface of the inlet conduit. Alternatively,
the cap can include a peripheral flange, such that the engaging
surface of the cap is an interior surface of the peripheral flange
that engages a corresponding surface of the exterior surface of the
inlet conduit. The difference in surface configurations can be
established by providing one or both of the surfaces with a series
of protuberances, a series of indentations, a different
cross-sectional shape, or a combination thereof.
[0024] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and are intended to provide further explanation of the invention
claimed.
[0025] The accompanying drawing, which is incorporated in and
constitutes part of this specification, is included to illustrate
and provide a further understanding of the method and system of the
invention. Together with the description, the drawing serves to
explain the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] In the accompanying drawings that form part of the
specification, and in which like numerals are employed to designate
like parts throughout the same:
[0027] FIG. 1 is a perspective view of a placement wire dispenser
constructed in accordance with the present invention;
[0028] FIG. 2 is an exploded view of a placement wire dispenser
constructed in accordance with the present invention;
[0029] FIG. 3 is a second perspective view of a placement wire
dispenser constructed in accordance with the present invention;
[0030] FIG. 4 is a perspective view of a feeding tube constructed
in accordance with the present invention;
[0031] FIG. 5 is a perspective view of an adaptor constructed in
accordance with the present invention;
[0032] FIG. 6 is a plan view of a feeding tube assembly in
accordance with an additional aspect of the invention;
[0033] FIG. 7 is a cross-sectional view of the feeding tube
assembly of FIG. 6, taken along line 7-7;
[0034] FIG. 8 is an enlarged perspective view of the feeding tube
adaptor of the feeding tube assembly of FIG. 6;
[0035] FIG. 8A is an enlarged cross-sectional view depicting one
possible surface configuration between the engagement surface of
the cap and the corresponding surface of the inlet conduit of the
feeding tube adaptor of FIG. 8;
[0036] FIG. 8B is an enlarged cross-sectional view depicting
another possible surface configuration between the engagement
surface of the cap and the corresponding surface of the inlet
conduit of the feeding tube adaptor of FIG. 8;
[0037] FIG. 8C is an enlarged cross-sectional view depicting an
additional surface configuration between the engagement surface of
the cap and the corresponding surface of the inlet conduit of the
feeding tube adaptor of FIG. 8;
[0038] FIG. 9 is an enlarged perspective view of an alternative
embodiment of the feeding tube adaptor of the feeding tube assembly
of FIG. 6.
DETAILED DESCRIPTION
[0039] Reference will now be made in detail to the present
preferred embodiments of the invention, an example of which is
illustrated in the accompanying drawings. The method and
corresponding steps of the invention will be described in
conjunction with the detailed description of the system.
[0040] While this invention is susceptible of embodiment in many
different forms, this specification and the accompanying drawings
disclose specific embodiments as examples of the invention. The
invention is not intended to be limited to the embodiments so
described or shown. The scope of the invention is pointed out in
and defined by the appended claims.
[0041] The figures illustrating the apparatus show some elements
that are known and that will be recognized by one skilled in the
art. The detailed descriptions of such elements are not necessary
to an understanding of the invention, and accordingly, are herein
presented only to the degree necessary to facilitate an
understanding of the novel features of the present invention.
[0042] The present invention is practiced with certain conventional
components the details of which, although not fully illustrated or
described, will be apparent to those having skill in the art and an
understanding of the necessary functions of such components.
[0043] A method of the invention will be described herein in the
context of the accompanying figures which depict a method for
placing a feeding tube percutaneously into the stomach of a
patient. However, it will be appreciated by one of ordinary skill
in the art that this method of the present invention can be
employed for the purposes of placing feeding tubes into other
preselected sections of the gastrointestinal tract of a patient,
e.g., the small bowel. Accordingly, the detailed description set
forth herein is intended to cover methods for placing feeding tubes
into any preselected section of the gastrointestinal tract of a
patient, including, but not limited to, the stomach and the small
bowel.
[0044] Dispenser 10 constructed in accordance with the present
invention is generally depicted in FIG. 1. Dispenser 10 is
constructed substantially in accordance with the teachings set
forth in U.S. Pat. No. 4,342,313 which is incorporated herein by
reference. U.S. Pat. No. 4,342,313 is assigned of record to Abbott
Laboratories, the assignee of the invention disclosed and claimed
herein. Applicants also hereby incorporate herein by reference the
teachings of U.S. Ser. No. 08/733,900 filed Oct. 18, 1996 which was
a continuation of U.S. Ser. No. 08/365,398 filed Dec. 28, 1994.
These applications also are assigned of record to Abbott
Laboratories.
[0045] Dispenser 10 includes a placement wire 12 wound about a
receptacle 14. Placement wire 12 can be constructed of a variety of
known, biocompatible materials and can have a variety of known
configurations useful in the placement of percutaneous endoscopic
gastrostomy and jejunostomy tubes. In a preferred embodiment, wire
12 includes a pair of wires coated with a biocompatible, plastic
material. Receptacle 14 preferably contains placement wire 12
therein such that placement wire 12 is not exposed to an external
environment of receptacle 14 until it is dispensed therefrom, as
described in detail herein. Receptacle 14 defines wire outlet 16
therethrough. Wire outlet 16 is configured such that placement wire
12 can be passed therethrough, as explained in detail herein.
[0046] Placement wire 12 is in mechanical engagement with
receptacle 14 such that rotation of receptacle 14 causes placement
wire 12 to rotate and advance outwardly from receptacle 14. One of
ordinary skill in the art will appreciate that a variety of methods
can be used to mechanically engage placement wire 12 with
receptacle 14 such that rotation of receptacle 14 will cause wire
12 to be dispensed therefrom. The present invention is intended to
encompass all such methodologies. A spindle or handle 18 can be
mechanically connected to receptacle 14 in order to facilitate
manual rotation of receptacle 14.
[0047] A tubular portion 20 is mounted on receptacle 14 as depicted
in FIG. 1. Tubular portion 20 defines wire inlet 22 therethrough.
Wire inlet 22 is configured such that placement wire 12 can be
passed therethrough. Wire inlet 22 and wire outlet 20 are disposed
such that they are in communication with one another, i.e., such
that placement wire 12 will pass through wire outlet 16, through
wire inlet 22, and into tubular portion 20 when receptacle 14 is
rotated. Tubular portion 20 has a first end portion 24 and a second
end portion 26. In the embodiment of the present invention depicted
in FIG. 1, both first end portion 24 and second end portion 26 are
open such that channel 28 defined by tubular portion 20 is open to
an external environment of tubular portion 20 at first end portion
24 and second end portion 26. However, it will be appreciated that
second end portion 26 can be closed such that channel 28 is not
open to an external environment of tubular portion 20 without
departing from the spirit of the present invention. This will be
explained in greater detail below.
[0048] First end portion 24 of tubular portion 20 can be
constructed such that it has a substantially flat terminal end 30,
as depicted in FIG. 1. In the embodiment depicted in FIG. 1,
piercing member 32 is provided and is constructed such that it can
be inserted through channel 28 of tubular portion 20 from second
end portion 26 to first end portion 24. It will be appreciated that
second end portion 26 of tubular portion 20 must be open to an
external environment of tubular portion 20 in this embodiment of
the present invention in order to permit piercing member 32 to be
inserted therein. Piercing member 32 is constructed such that
piercing tip 34 thereof is disposed outwardly from terminal end 30
when piercing member 32 is properly positioned within tubular
portion 20. Piercing member 32 can be solid. However, in the
embodiment of the present invention depicted in the accompanying
figures, piercing member 32 defines channel 36 therethrough.
Piercing member 36 has a hub end 38 opposite piercing tip 34. Hub
member 40 is mounted on hub end 38. Hub member 40 is configured
such that selected instruments can be attached thereto. For
example, hub member 40 can be constructed such that it can be
fluidly connected to a source of pressurized air and such that
pressurized air can be directed through channel 36 after piercing
tip 34 has been positioned in a patient's stomach, thereby
facilitating insuflation of a patient's stomach. Hub member 40 can
be configured such that it provides a variety of known connections,
including, but not limited to, threading connections, luer
connections, and locking luer connections.
[0049] It will be appreciated that piercing member 32 can be
omitted from the present invention in certain embodiments. For
example, first end portion 24 of tubular portion 20 can be
constructed such that it can be inserted directly through a
patient's abdominal wall and into a patient's stomach, thereby
obviating the need for piercing member 32. That is, a piercing tip
34a can be provided on first end portion 24 of tubular portion 20
where the piercing tip is constructed such that it will penetrate
through a patient's abdominal wall and into a patient's stomach. In
another alternative embodiment, first end portion 24 is
substantially flat, as depicted in the accompanying figures. It
will be appreciated that first end portion 24 of tubular portion 20
can be inserted through a dilator, an introducer, or a catheter of
known constructed that has been inserted through a patient's
abdominal wall and into a patient's stomach. In this way terminal
end 30 of tubular portion 20 can be positioned in a patient's
stomach without the use of piercing member 32 and without the
presence of a piercing tip on tubular portion 20. It is to be
appreciated that in some cases it may be possible to insert first
end portion 24 of tubular portion 20 through a patient's abdominal
wall and into a patient's stomach without the use of a piercing
member, a piercing tip, a dilator, an introducer, and/or a
catheter. If piercing member 32 is not used, it is not necessary
for second end portion 26 of tubular portion 20 to provide
communication between channel 28 and an external environment of
tubular portion 20.
[0050] If piercing member 32 is used, or if first end portion 24 of
tubular portion 20 includes piercing tip 34a, protective sheath 42
can be provided in order to prevent piercing tip 34, 34a from
inadvertently piercing the skin of a medical professional and/or a
patient. In the embodiment depicted in the accompanying figures,
sheath 42 is a substantially tubular member configured to surround
piercing tip 34, 34a. However, it will be appreciated that sheath
42 can have a variety of known configurations without departing
from the scope of the present invention.
[0051] In a preferred embodiment of the present invention, a one
way fluid flow valve 25 is disposed in channel 28 of tubular
portion 20 One way fluid flow valve 25 is constructed to impede the
flow of fluid, e.g., air, outwardly from the patient through
tubular portion 20. One way fluid flow valve 25 is configured such
that it permits the movement of placement wire 12 therethrough as
wire 12 is advanced from receptacle 14 through tubular portion 20
and into a patient. One way fluid flow valve 25 can have a variety
of known configurations without departing from the scope of the
present invention set forth in the appended claims. In one
embodiment of the present invention, one way fluid flow valve 25 is
a duckbilled valve of known construction.
[0052] Placement of a feeding tube is facilitated through the use
of dispenser 10 of the present invention. In use, dispenser 10 as
described herein is provided. A medical professional urges first
end portion 24 of tubular portion 20 inwardly through a patient's
abdominal wall and into a patient's stomach. In one embodiment of
the method of the present invention, first end portion 24 does not
include piercing tip 34a and piercing member 32 is not used. In
this embodiment, first end portion 24 of tubular portion 20 is
inserted through a patient's abdominal wall and into a patient's
stomach with or without the use of a dilator, introducer, or
catheter, subject to the discretion of the medical professional. In
a second embodiment, first end portion 24 has piercing tip 34a
associated therewith. In a third embodiment, piercing member 32 is
provided and is inserted through channel 28 such that piercing tip
34 is extends outwardly from terminal end 30 of tubular portion 30.
In each case, first end portion 24 is urged through the patient's
abdominal wall and into the patient's stomach.
[0053] If desired, the medical professional can insufflate the
patient's stomach by directing pressurized air through channel 28
and into a patient's stomach. If piercing member 32 is used, the
pressurized air can be directed through channel 36 of piercing
member 32 and into the patient's stomach. In particular, the source
of pressurized air can be connected to hub member 40 of piercing
member 32. If piercing member 32 is not used, and if second end
portion 26 of tubular portion 20 provides open communication
between channel 28 and an external environment of tubular portion
20, pressurized air can be directed through second end portion 26
of tubular portion 20 and into the patient's stomach through
channel 28 of tubular portion 20.
[0054] If piercing member 32 is used, it is then withdrawn from
channel 28 by pulling on hub end portion 38 thereof until piercing
tip 34 is withdrawn from second end portion 26 of tubular portion
20.
[0055] Rotational movement is then imparted to receptacle 14 such
that placement wire 12 advances through wire outlet 16, through
wire inlet 22, through channel 28, and into the patient's stomach.
Rotational movement can be imparted manually or through the use of
a mechanical means, e.g., an electrical motor.
[0056] After placement wire 12 has been positioned in the patient's
stomach, it is grasped using a grasping tool and withdrawn through
the patient's esophagus and mouth in accordance with known
methodologies. First end portion 24 of tubular portion 20 can then
be withdrawn from the patient's stomach. A feeding tube 44 of known
construction may be connected to placement wire 12, and the
placement wire 12 and the feeding tube 44 are urged through the
patient's esophagus and stomach until the feeding tube 44 passes
percutaneously through the patient's abdominal wall. In a preferred
embodiment, the feeding tube 44 is constructed of a polyurethane
material; particularly, Carbothane. Feeding tube 44 can include a
known radiopaque material that enables it to be visualized via
X-ray or other imaging systems.
[0057] A retaining member 46 is mounted on a second end portion of
feeding tube 44. Retaining member 46 is constructed to prevent the
second end portion of feeding tube 44 from passing through the
patient's abdominal wall. Retaining member 46 can have a variety of
known configurations and can be constructed of a variety of known
materials, including, but not limited to, silicone and
polyurethane. For example, but not by limitation, flexible
element-type retaining member configurations are disclosed by U.S.
Pat. No. 5,080,650 and U.S. Pat. No. 5,391,159, each of which is
incorporated in its entirety by reference herewith.
[0058] It has been found that, under certain adverse conditions,
these flexible element-type retaining members inadvertently can
become detached from feeding tube 44 when feeding tube 44 is
constructed of a polyurethane material. This potential problem has
been found to be particularly present when feeding tube 44 is
constructed of a polyurethane material and retaining member 46 is
constructed of a silicone material. This potential problem can be
obviated by slip molding retaining member 46 on feeding tube 44.
Techniques for slip molding are well known in the art and will not
be described herein in detail.
[0059] Alternatively, it may be desirable to provide a balloon-type
retaining member configuration. Examples of various balloon-type
retaining member configurations are disclosed by U.S. Pat. No.
5,098,378 and U.S. Pat. No. 5,840,065, which are also incorporated
in entirety by reference herein. It is noted that these
balloon-type retaining members generally are configured for use
with a multi-lumen feeding tube, wherein at least one lumen is used
for inflation and deflation selectively of the retaining member in
a known manner. One such multi-lumen feeding tube is depicted in
the representative embodiment of FIG. 7, as will be described in
detail below.
[0060] Upon proper primary placement of feeding tube 44 through the
patient's abdominal wall, a first end portion of feeding tube 44
can be cut to an appropriate length. An external retaining disc 48
can be placed over the first end portion of the feeding tube 44 in
order to prevent undesired inward movement of feeding tube 44
through the patient's abdominal wall. The external retaining disc
48 can have a variety of known configurations.
[0061] An adaptor 50 can be provided in order to interconnect
feeding tube 44 and another in-line feeding element, e.g., a tube
extending from a source of enteral nutritional product. In one
embodiment, adaptor 50 includes outlet conduit 52 having an
exterior surface 54. Adaptor 48 further includes one or more inlet
conduits 56. An example of a suitable adaptor 50 is disclosed in
U.S. Pat. No. 5,057,093 which is incorporated herein by
reference.
[0062] In the event that feeding tube 44 is constructed of a
polyurethane material, and in accordance with another aspect of the
present invention, it is preferable that exterior surface 54 of
outlet conduit 52 define a retention member 58 thereon which
prevents feeding tube 44 from slipping off of exterior surface 54
during use. In a preferred embodiment, retention member 58 includes
a first section 60 on exterior surface 54. First section 60 has an
increasing circumferential dimension viewed from outlet conduit 52
to inlet conduits 56 as shown in FIG. 5. Retention member 58
further includes a second section 62. Second section 62 has a
decreasing circumferential dimension viewed from outlet conduit 52
to inlet conduits 56. First section 60 and second section 62 can be
positioned adjacent to one another as depicted in the accompanying
figures, or can be spaced from one another by an intermediate
section having a variety of configurations, e.g., a surface of
substantially constant circumferential dimension, without departing
from the spirit of the present invention. Preferably, the feeding
tube adaptor of this embodiment, or at least the retention member,
is made of an acrylonitrile-butadien-styrene (ABS) resin or similar
rigid material, such as nylon.
[0063] In another aspect of the present invention, a kit for the
placement of a feeding tube is provided. The kit includes dispenser
10 and feeding tube 44 constructed in accordance with the
above-discussed embodiments thereof. The kit may further include
adaptor 50 constructed in accordance with the above-discussed
embodiments.
[0064] Once a stoma tract has fully formed or matured through the
abdominal wall of the patient, the feeding tube can be removed for
secondary placement of a different feeding tube if necessary or
desired. That is, a new feeding tube assembly can be inserted
through the mature stoma tract in a conventional manner without the
need for a placement wire or placement wire dispenser. A variety of
feeding tube assemblies capable of secondary placement are known
and widely available. FIG. 6, however, shows a representative
embodiment of a feeding tube assembly, designated generally by
reference character 100, in accordance with an additional aspect of
the present invention.
[0065] The feeding tube assembly 100 includes a feeding tube 140
having a first end portion 141 and a second end portion 142
opposite the first end portion 141. At least one lumen 143 is
defined within the feeding tube 140, and extends between the first
end portion 141 and the second end portion 142 thereof. The axial
length and cross-sectional dimensions of the feeding tube 140 are
appropriate for its intended purpose. For example, a feeding tube
140 intended for adult use will have overall dimensions greater
than those of a feeding tube 140 intended for pediatric use. The
feeding tube 140 may be constructed of any of a variety of known
biocompatible materials. Tests indicate, however, that the use of a
polyurethane known as Carbothane PC (3575A-B20), which is available
from Thermedics, or an equivalent material thereof, provides
superior performance and durability.
[0066] The feeding tube assembly 100 embodied herein further
includes a feeding tube adaptor 150 made of polyurethane mounted at
the first end portion 141 of the feeding tube 140. The feeding tube
adaptor 150 includes at least a first inlet conduit 156 having an
inlet port 154, and an outlet conduit 152 in fluid communication
with the first inlet conduit 156. Additional inlet conduits 156'
may be provided, as desired or necessary, to allow the secondary
introduction of beneficial agents or similar additives into the
feeding lumen 143 of the of the feeding tube 140. Furthermore, one
or more additional inlet conduits 157 may be provided to
accommodate operation of a balloon-type retaining member, if
provided, as described further below.
[0067] The outlet conduit 152 is connected in fluid communication
with the first end portion 141 of the feeding tube 140. This
connection between the adaptor and the feeding tube can be
accomplished by a variety of known construction techniques. For
example, insert molding is preferred to establish a relatively
permanent connection, particularly when a multi lumen feeding tube
is used, such as previously described in conjunction with a
balloon-type retaining member. Alternatively, the feeding tube
adaptor 150 can be provided with an insert member (not shown) at
the outlet conduit 152, wherein the insert member is made of an
acrylonitrile-butadien-styrene (ABS) resin or the like and has an
external surface configuration similar to that of the outlet
conduit 152 shown in FIG. 5. As such, a polyurethane feeding tube
adaptor 150 can be connected to a polyurethane feeding tube 140 in
a manner similar to that previously described with regard to the
feeding tube adaptor 150 of FIG. 5.
[0068] A removable cap 160 also is provided to close selectively
each inlet port 154 of the first inlet conduit inserted into the
inlet port 154, the engaging surface of the cap 160 therefore is
defined, at least in part, by the an exterior surface 165 of the
plug 164 and the corresponding surface is defined at least in part
by the interior surface 155 of the inlet conduit 156. Alternatively
or additionally, and as shown in FIG. 9, the cap 160 may be
provided with a peripheral flange 168, such that the engaging
surface of the cap 160 is defined by an interior surface 169 of the
peripheral flange 168 and the corresponding surface of the inlet
conduit 156 is defined by an exterior surface 159 thereof.
[0069] FIGS. 8A through 8C show three possible surface
configurations between the engagement surface of the cap and the
corresponding surface of an inlet conduit of the feeding tube
adaptor of FIG. 8. Each of these three views is taken in
cross-section looking into the inlet port 154 toward the outlet
conduit 152, with the cap 160 positioned against the end of the
inlet conduit 156 opposite the outlet conduit 152 to seal the inlet
port 154.
[0070] Particularly, FIG. 8A shows that at least one of either the
engagement surface or the corresponding surface is provided with a
series, i.e., one or more, of protuberances 161 to define a
different surface configuration therebetween. Although FIG. 8A
shows the protuberances 161 on the plug 164 of the cap 160, such
protuberances 161 likewise can be provided on the corresponding
surface of the first inlet conduit 156. The protuberances 161 may
be provided in any of a variety of forms, including buttons, ribs,
ridges, rings, etc. Similarly, the difference in surface
configurations between the engagement surface and the corresponding
surface can be 156. In this manner, the feeding tube 140, and thus
direct access to the gastrointestinal tract, can be sealed from the
outside environment when not in use. The cap 160 therefore has an
engagement surface to engage a corresponding surface of the first
inlet conduit 156 when the cap 160 is positioned to seal the inlet
port 154. To prevent misplacement of the cap 160, it is preferred
that the cap 160 be permanently connected to the feeding tube
adaptor 150, such as by a tether member 162 or similar connector
element. Although a separate element may be provided for such
connection, it is preferred that the cap 160 be formed integrally
with at least a portion of the feeding tube adaptor 150 to reduce
the cost of construction.
[0071] As noted, the feeding tube adaptor 150 is made of a
polyurethane for its performance characteristics. In the preferred
embodiment, a polyurethane known as Tecoflex (EG80A-B20) available
from Thermedics, or an equivalent material thereof, is used for
construction of the feeding tube adaptor 150. If the cap 160 is
formed integrally with the feeding tube adaptor 150, as preferred,
the cap 160 likewise will be formed of the same or a compatible
material of construction for the feeding tube adaptor 150. Such
polyurethane materials are susceptible to hydrogen bonding and
similar self adhesion phenomenon. As such, and in accordance with
an additional aspect of the present invention, the engagement
surface of the cap 160 is provided with a surface configuration
different than that of the corresponding surface of the first inlet
conduit 156.
[0072] For example, and as shown in FIG. 8, the inlet port 154 of
the inlet conduit 156 is defined by an interior surface 155 and the
cap 160 includes a plug 164 to be defined by a series of indents
163 provided in at least one of the two surfaces as shown by the
exemplary embodiment of FIG. 8B. Furthermore, the difference in
surface configurations between the engagement surface and the
corresponding surface can be defined by providing one of the two
surfaces with a cross-sectional shape that is different than that
of the other surface. For example, but not by limitation, FIG. 8C
shows that the inlet port 154 of the inlet conduit 156 can be
defined by a circular cross-section, while the cap 160 can be
provided with a plug 164 having a generally square or rectangular
cross-section sized such that only the corners of the plug 164
engage the interior surface 155 of the inlet port 154.
[0073] The feeding tube assembly 100 in accordance with this
embodiment of the invention, as thus described, can be used not
only for gastrostomy and jejunostomy applications, but also for
nasoenteric applications. That is, and provided that the feeding
tube 140 has a suitable length and cross-dimension, the feeding
tube assembly 100 as thus described can be inserted via the nasal
passage into the gastrointestinal tract of a patient in a known
manner.
[0074] In accordance with an additional aspect of the invention,
however, the feeding tube assembly 100 also can be provided with a
retaining member 146 attached to the second end portion 142 of the
feeding tube 140 when intended for gastrostomy and jejunostomy
applications. Any of a variety of known retaining members can be
used, including flexible element-type retaining members as
previously described. In a preferred embodiment, a balloon-type
retaining member 146 is attached to the second end portion 142 of
the feeding tube 140. Although the balloon-type retaining member
can be constructed and attached to the feeding tube 140 in a
variety of configurations, the preferred embodiment uses a
configuration similar to that of the balloon catheter construction
disclosed by U.S. Pat. No. 5,522,961, which is incorporated by
reference herewith. This preferred configuration defines an
energy-absorbing end to reduce the risk of trauma to the patient
during placement of the feeding tube 140. Preferably, however, and
unlike the disclosure of U.S. Pat. No. 5,522,961, the balloon-type
retaining member for the feeding tube 140 is attached using a
conventional heat fusion technique. Solvents and epoxy materials
are not required. In the preferred embodiment, the balloon member
itself has a nominal thickness of about 0.002 inches, and is made
of Estane 58309 available from BF Goodrich, or an equivalent
material thereof.
[0075] If a balloon-type retaining member is provided, it is
preferred that the feeding tube 140 define at least two lumen
therethrough; one lumen defining a feeding lumen 143 for the
introduction of enteral nutritional products and the like, and
another lumen defining a filling lumen 145 for inflation and
deflation of the retaining member 146, as shown in FIG. 7. The
feeding lumen 143 therefore extends through the length of the
feeding tube 140, while the filling lumen 145 extends at least from
the first end portion 141 of the feeding tube 140 to an access
opening into the internal chamber of the balloon-type retaining
member 146. FIG. 7 shows the feeding lumen 143 having a
substantially D-shaped cross-section, with the filling lumen 145
disposed proximal the flat interior edge of feeding lumen 143. In
this embodiment, filling lumen 145 can have either a circular or
elliptical cross-section, and preferably the feeding tube 140 has a
generally circular external cross-sectional configuration.
Alternative multi-lumen feeding tube configurations and
constructions also can be used.
[0076] Although not necessary, it is preferred that the feeding
tube assembly 100 of the present invention also include a
radiopaque rod 170 or member provided to assist in proper placement
of the feeding tube 140 using X-ray or similar imaging techniques.
For example, and as embodied herein, the filling lumen 145 can
extend entirely from the first end portion 141 to the second end
portion 142 of the feeding tube 140. A rod 170 of known radiopaque
material thus can be inserted into the filling lumen 145 at the
second end portion of the feeding tube 140 so as to extend up to
the access opening of the retaining member 140. Alternatively, the
feeding tube itself can be made of a known radiopaque material or
be formed with a stripe of radiopaque material extending all or a
portion of the length thereof.
[0077] Secondary placement of the feeding tube assembly 100 of the
present invention can be performed in a conventional manner. For
example, if nasoenteric access is desired, the feeding tube
assembly 100 may or may not be provided with a retaining member, as
well as a weighted tip (not shown) at the second end portion 142 of
the feeding tube 140 as is well known. The second end portion 142
is thus inserted into the patient's nostril and guided to the
desired position in the gastrointestinal tract. The balloon-type
retaining member, if provided, is then inflated to secure placement
of the feeding tube.
[0078] If secondary placement through a mature stoma is desired,
retaining members are provided as previously described. When a
balloon-type retaining member is used, for example, the retaining
member 146 is deflated for initial insertion of the second end
portion 142 of the feeding tube 140 into the stoma. Once properly
positioned, the retaining member 146 is filled with an appropriate
fluid via the appropriate inlet conduit 157 and filling lumen 145
to expand the retaining member 146 and engage an inner wall of the
patient proximate the stoma. The feeding tube 140 of the present
invention also can include an external retaining disc, also known
as a skin disk 172, as described above. The skin disk 172 is
mounted for movement along the feeding tube 140, so as to be
positioned against the patient's exterior abdominal wall to secure
the placement of the feeding tube assembly 100. The removable cap
160 thus can be selectively removed, with limited risk of self
adhesion or bonding to the in-let conduit 156, to allow enteral
nutritional feeding or the like.
[0079] It will be apparent to those skilled in the art that various
modifications and variations can be made in the method and system
of the present invention without departing from the spirit or scope
of the invention. Thus, it is intended that the present invention
include modifications and variations that are within the scope of
the appended claims and their equivalents.
* * * * *