U.S. patent application number 10/300702 was filed with the patent office on 2003-09-11 for method for implanting a percutaneous endoscopic gastrostomy/jejunostomy tube in a patient and access needle for use in said method.
Invention is credited to Adams, Mark L., Brenner, Laurence D., Carter, Michele, DeLegge, Mark, DeLegge, Rebecca.
Application Number | 20030171718 10/300702 |
Document ID | / |
Family ID | 26989836 |
Filed Date | 2003-09-11 |
United States Patent
Application |
20030171718 |
Kind Code |
A1 |
DeLegge, Rebecca ; et
al. |
September 11, 2003 |
Method for implanting a percutaneous endoscopic
gastrostomy/jejunostomy tube in a patient and access needle for use
in said method
Abstract
Method for implanting a percutaneous endoscopic jejunostomy tube
in a patient and access needle for use in the method. In one
embodiment, the method comprises the steps of (a) providing an
access needle wherein the distal end of the stylet extends distally
for an appreciable distance beyond the distal end of the cannula;
(b) inserting the stylet, but not the cannula, into the jejunum;
(c) grabbing the stylet with an endoscopically-positioned snare;
(d) anchoring the jejunum against the abdominal wall of the patient
using the snared stylet; (e) loosening the snare slightly while
advancing the cannula into the jejunum and into the loosened snare;
(f) tightening the snare around the cannula; (g) removing the
stylet from the cannula; (h) inserting a guide wire or suture
through the cannula and into the jejunum; and (i) proceeding in the
conventional fashion to implant a PEJ tube into the patient using
the guide wire or suture.
Inventors: |
DeLegge, Rebecca; (Mt.
Pleasant, SC) ; DeLegge, Mark; (Mt. Pleasant, SC)
; Brenner, Laurence D.; (Northboro, MA) ; Adams,
Mark L.; (Stoughton, MA) ; Carter, Michele;
(Ashland, MA) |
Correspondence
Address: |
KRIEGSMAN & KRIEGSMAN
665 Franklin Street
Framingham
MA
01702
US
|
Family ID: |
26989836 |
Appl. No.: |
10/300702 |
Filed: |
November 20, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60335681 |
Nov 21, 2001 |
|
|
|
60418990 |
Oct 15, 2002 |
|
|
|
Current U.S.
Class: |
604/164.01 ;
606/148 |
Current CPC
Class: |
A61B 17/32056 20130101;
A61B 17/3415 20130101 |
Class at
Publication: |
604/164.01 ;
606/148 |
International
Class: |
A61M 005/178 |
Claims
What is claimed is:
1. A method for implanting a percutaneous endoscopic jejunostomy
tube in a patient, said method comprising the steps of: (a)
providing an access needle, the access needle comprising a stylet
and a cannula, the stylet being removably insertable into the
cannula, wherein the distal end of the stylet extends distally for
an appreciable distance beyond the distal end of the cannula; (b)
inserting the stylet, but not the cannula, into the jejunum; (c)
grabbing the stylet with an endoscopically-positioned snare; (d)
anchoring the jejunum against the abdominal wall of the patient
using the snared stylet; (e) loosening the snare slightly while
advancing the cannula into the jejunum and into the loosened snare;
(f) tightening the snare around the cannula; (g) removing the
stylet from the cannula; (h) inserting a guide wire or suture
through the cannula and into the jejunum; and (i) using the guide
wire or suture to implant a PEJ tube into the patient.
2. The method as claimed in claim 1 wherein the distal end of the
stylet extends distally beyond the distal end of the cannula by
about 1.5 inch.
3. The method as claimed in claim 1 wherein the distal end of the
cannula has a marking to facilitate distinguishing the cannula from
the stylet.
4. The method as claimed in claim 1 wherein the access needle
further includes a cannula hub fixed to the proximal end of the
cannula and a stylet hub fixed to the proximal end of the stylet,
said cannula hub being removably securable to said stylet hub to
prevent unwanted longitudinal movement of said stylet relative to
said cannula.
5. The method as claimed in claim 4 wherein said cannula hub and
said stylet hub are threadingly engageable with one another.
6. An access needle, said access needle comprising: (a) a cannula,
said cannula having a proximal end and a distal end; (b) a cannula
hub, said cannula hub being fixed to said proximal end of said
cannula; (c) a stylet, said stylet having a proximal end and a
distal end and being removably insertable into said cannula; and
(d) a stylet hub, said stylet hub being fixed to said proximal end
of said stylet, said stylet hub being removably securable to said
cannula hub to prevent unwanted longitudinal movement of said
stylet relative to said cannula; (e) wherein the distal end of said
stylet extends distally for an appreciable distance beyond the
distal end of said cannula when said stylet hub is secured to said
cannula hub.
7. The access needle as claimed in claim 6 wherein the distal end
of said stylet extends distally about 1.5 inch beyond said
cannula.
8. The access needle as claimed in claim 6 wherein said cannula has
a length that is approximately two-thirds the length of said
stylet.
9. The access needle as claimed in claim 6 wherein the distal end
of said cannula has a marking to facilitate distinguishing said
cannula from said stylet.
10. The access needle as claimed in claim 9 wherein said marking is
a chemically-etched band located at the distal end of said
cannula.
11. The access needle as claimed in claim 6 wherein said stylet is
solid.
12. The access needle as claimed in claim 6 wherein each of said
cannula hub and said stylet hub is provided with gripping
elements.
13. The access needle as claimed in claim 6 wherein said cannula
hub and said stylet hub are threadingly engageable with one
another.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 U.S.C.
119(e) of U.S. Provisional Patent Application Serial No.
60/335,681, filed Nov. 20, 2001, and of U.S. Provisional Patent
Application Serial No. 60/418,990, filed Oct. 15, 2002, both of
which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to percutaneous
endoscopic gastrostomy (PEG) tubes and percutaneous endoscopic
jejunostomy (PEJ) tubes and methods for their implantation in a
patient and relates more particularly to a novel method for
implanting a PEG tube or a PEJ tube in a patient and to a novel
access needle for use in said method.
[0003] Certain patients are unable to take food and/or medications
transorally due to an inability to swallow. Such an inability to
swallow may be due to a variety of reasons, such as esophageal
cancer, neurological impairment and the like. Although the
intravenous administration of food and/or medications to such
patients may be a viable short-term approach, it is not well-suited
for the long term. Accordingly, the most common approach to the
long-term feeding of such patients involves gastrostomy, i.e., the
creation of a feeding tract or stoma between the stomach and the
upper abdominal wall. Feeding is then typically performed by
administering food through a catheter or feeding tube that has been
inserted into the feeding tract, with the distal end of the feeding
tube extending into the stomach and being retained therein by an
internal anchor or bolster and the proximal end of the feeding tube
extending through the abdominal wall.
[0004] Although gastrostomies were first performed surgically, most
gastrostomies are now performed using percutaneous endoscopy and
result in the implantation of a gastrostomy feeding tube assembly
(also referred to as a percutaneous endoscopic gastrostomy (PEG)
device) in the patient. Two of the more common techniques for
implanting a PEG device in a patient are "the push method" (also
known as "the Sacks-Vine method") and "the pull method" (also known
as "the Gauderer-Ponsky method"). Information regarding the
foregoing two methods may be found in the following patents, all of
which are incorporated herein by reference: U.S. Pat. No.
5,391,159, inventors Hirsch et al., which issued Feb. 21, 1995;
U.S. Pat. No. 5,167,627, inventors Clegg et al., which issued Dec.
1, 1992; U.S. Pat. No. 5,112,310, inventor Grobe, which issued May
12, 1992; U.S. Pat. No. 4,900,306, inventors Quinn et al., which
issued Feb. 13, 1990; and U.S. Pat. No. 4,861,334, inventor Nawaz,
which issued Aug. 29, 1989.
[0005] According to "the push method," the distal end of an
endoscope is inserted into a patient's mouth and is passed through
the esophagus into the stomach. After distension of the stomach by
inflation with air, an entry site on the abdomen is identified, and
an incision is made by passing a needle (or stylet) with an outer
cannula through the abdominal wall and into the stomach. The needle
is then removed while keeping the cannula in place. Next, a snare
is inserted into the stomach via the endoscope and is looped over
the distal end of the cannula. A first end of a flexible guide wire
is then passed through the cannula and into the stomach where it is
grasped by the snare, the second end of the guide wire remaining
external to the patient. The endoscope and the snare are then
withdrawn from the mouth of the patient to deliver the first end of
the guide wire.
[0006] A catheter assembly is then inserted over the first end of
the guide wire and is pushed over the guide wire towards its second
end. The catheter assembly typically comprises a gastrostomy
feeding tube, the gastrostomy feeding tube having a dome-shaped
internal bolster disposed at its trailing end and having a tubular
dilator serially connected to its leading end. The gastrostomy
feeding tube and the internal bolster are typically made of a soft,
biocompatible material, like silicone rubber, and may form a
unitary structure. The dilator, which tapers in outer diameter from
its trailing end to its leading end, is typically made of
polyethylene or a like material which is stiffer than silicone but
which still possesses some flexibility. Advancement of the catheter
assembly over the guide wire continues until the front end of the
dilator reaches the cannula and pushes the cannula out through the
abdominal wall of the patient. The front end of the dilator is then
pulled through the abdominal wall until the front end of the
gastrostomy feeding tube emerges from the abdomen and, thereafter,
the internal bolster at the rear end of the gastrostomy feeding
tube engages the gastric wall.
[0007] With the internal bolster in place against the gastric wall,
a proximal portion of the implanted gastrostomy feeding tube is
then typically cut and removed from the implanted tube to reduce
the externally-extending portion of the tube to a desired length.
An external bolster is typically secured to the remaining implanted
portion of the feeding tube to engage the abdomen in such a way as
to prevent longitudinal movement of the feeding tube within the
stoma tract. Additionally, a "Y-port" adapted is typically attached
to the proximal end of the implanted feeding tube, the Y-port
adapter being adapted to receive a pair of connector tips through
which food and/or medications may be dispensed. In addition, a
detachable locking clip is typically secured to the implanted
feeding tube at a point between the external bolster and the Y-port
adapter to prevent gastric fluids from escaping through the
proximal end of the feeding tube when the feeding tube is not in
use.
[0008] "The pull method" differs from "the push method" in that,
after removal of the entry needle from the cannula, a first end of
a suture is passed through the cannula and into the stomach where
it is grasped by the snare, the second end of the suture remaining
external to the patient. The endoscope and the snare are then
withdrawn from the mouth of the patient to deliver the first end of
the suture. The first end of the suture is then coupled to the
leading end of a catheter assembly comprising a gastrostomy feeding
tube having an internal bolster at its trailing end and a plastic
fitting at its leading end. The plastic fitting has a barbed rear
portion mounted within the leading end of the feeding tube and a
conical front portion that serves as a dilator, said conical front
portion tapering in diameter from the leading end of the feeding
tube to a front tip. A wire loop is fixed to the front tip of the
plastic fitting, the first end of the suture being tied to the wire
loop. Using the second end of the suture, the catheter assembly is
then pulled retrograde through the patient until the gastrostomy
feeding tube emerges from the abdomen of the patient and the
internal bolster engages the gastric wall of the patient. Next, as
is the case in "the push method," the implanted gastrostomy feeding
tube is typically cut to a desired length, an external bolster is
typically secured to the cut implanted tube, a Y-port adapter is
typically attached to the proximal end of the implanted feeding
tube, and a detachable locking clip is typically secured to the
implanted feeding tube at a point between the external bolster and
the Y-port adapter.
[0009] Although gastrostomies are the most common approach to the
long-term feeding of patients unable to swallow, there are
situations in which it is desirable to provide food directly into a
patient's jejunum without passing through the patient's stomach.
This has typically been accomplished by using a technique similar
to that described above to implant a feeding tube into the jejunum,
instead of into the stomach. One difficulty, however, that has been
encountered in implanting feeding tubes into the jejunum has been
in the piercing of the jejunum by the needle/cannula assembly (said
assembly also referred to in the art as "an access needle") so as
to create an insertion hole through which a guide wire or suture
may be inserted. This difficulty arises, in part, because the
jejunum is narrow and thus hard to locate externally and, in part,
because the jejunum is not fixed within the body at any particular
location. As a result, not only is it difficult to actually pierce
the jejunum with an access needle (the access needle frequently
missing the jejunum or just pushing the jejunum aside without
penetrating it), but even if the jejunum is actually pierced by the
access needle, subsequent movement of the jejunum may cause the
access needle to become dislodged therefrom. Consequently, it is
generally desirable to use as small a diameter needle as possible
to pierce the jejunum. This maximizes the chance that the jejunum,
if struck by the access needle, will be pierced thereby and also
minimizes the size of the insertion hole (which is desirable for
obvious reasons).
[0010] One approach that has recently been devised to address the
above-identified problems with piercing the jejunum involves
piercing the jejunum with a small diameter needle, grabbing the
distal end of the needle with an endoscopically-placed snare, using
said small diameter needle (with the snare secured thereto) to
anchor the jejunum against the abdominal wall, piercing the
thus-anchored jejunum with an access needle at a site proximate to
the first piercing site, transferring the snare from the small
diameter needle to the cannula of the access needle, removing the
small diameter needle from the jejunum, and then proceeding in the
conventional fashion by removing the needle of the access needle
from its cannula, inserting a guide wire or suture into the cannula
for grabbing by the snare, etc.
[0011] Access needles of the type that are typically used in
percutaneous endoscopic gastrostomies and in percutaneous
endoscopic jejunostomies have their genesis in radiology and
cardiology and typically come in two different varieties. One such
access needle is referred to in the art as a Seldinger needle and
comprises a solid metal needle (or stylet) removably mounted within
a metal cannula. A plastic needle hub is fixed to the proximal end
of the metal needle, and a plastic cannula hub is fixed to the
proximal end of the metal cannula. The needle hub and the cannula
hub are sized and shaped to permit a portion of the needle hub to
be removably inserted into the cannula hub in such a way as to
delimit insertion of the needle through the cannula. A tab is
provided on the needle hub and a corresponding slot is provided on
the cannula hub, said slot being adapted to receive said tab in
order to permit said needle and said cannula to be placed in a
particular rotational orientation relative to one another. The
cannula hub is also shaped to include a lateral flange upon which a
user may rest, for example, his forefinger and middle finger.
[0012] The other type of access needle commonly used to perform
percutaneous endoscopic gastrostomies and jejunostomies is referred
to in the art as an Angiocath needle and comprises a hollow metal
needle removably mounted within a plastic cannula. A plastic needle
hub is fixed to the proximal end of the metal needle, and a plastic
cannula hub is fixed to the proximal end of the plastic cannula.
The needle hub and the cannula hub are sized and shaped to permit a
portion of the needle hub to be removably inserted into the cannula
hub in such a way as to delimit insertion of the needle through the
cannula. No means is provided in an Angiocath needle for fixing the
rotational orientation of the needle relative to the cannula when
the needle hub is inserted into the cannula hub.
[0013] In both a Seldinger needle and an Angiocath needle, the
lengths of the needle and the cannula are such that, with the
needle fully inserted into the cannula, only the needle tip extends
distally beyond the distal end of the cannula. Seldinger needles
typically have a smaller diameter than do Angiocath needles (20
gauge needle and 18 gauge cannula vs. 16 gauge needle and 14 gauge
cannula, respectively); however, more doctors have been trained
using Angiocath needles and, therefore, are more comfortable with
and use Angiocath needles.
[0014] In both a Seldinger needle and an Angiocath needle, it is
possible for the needle to be withdrawn unintentionally from its
respective cannula as no means is provided in either device for
longitudinally securing the needle hub to its respective cannula
hub.
SUMMARY OF THE INVENTION
[0015] It is an object of the present invention to provide a novel
method for implanting in a patient a feeding tube, such as a PEG
tube, a PEJ tube or the like.
[0016] It is another object of the present invention to provide a
method as described above which, as applied to PEJ tube
implantation, overcomes at least some of the difficulties described
above in connection with conventional PEJ implantation methods.
[0017] It is yet another object of the present invention to provide
a novel access needle adapted for use in the above-described
method.
[0018] Therefore, according to one aspect of the invention, there
is provided an access needle, said access needle comprising, in a
preferred embodiment, a stylet and a cannula, the stylet being
slidably mounted within the cannula. A stylet hub is secured to the
proximal end of the stylet, and a cannula hub is secured to the
proximal end of the cannula. The stylet hub and the cannula hub are
correspondingly threaded to permit the stylet and the cannula to be
removably secured to one another. The stylet and the cannula are
dimensioned relative to one another so that, when the stylet and
the cannula are secured to one another, the stylet extends distally
beyond the distal end of the cannula for a considerable distance.
The distal end of the cannula is marked (e.g., by chemical etching)
so as to be easily identifiable when viewed endoscopically. The
respective diameters of the stylet and the cannula of the subject
access needle are small, e.g., 20 gauge and 18 gauge,
respectively.
[0019] According to another aspect of the invention, there is
provided a method for implanting a PEJ tube in a patient, said
method comprising, in a preferred embodiment, the steps of (a)
providing an access needle wherein the distal end of the stylet
extends distally for an appreciable distance beyond the distal end
of the cannula; (b) inserting the distal end of the stylet, but not
the distal end of the cannula, into the jejunum; (c) grabbing the
distal end of the stylet with an endoscopically-positioned snare;
(d) anchoring the jejunum against the abdominal wall of the patient
using the snared stylet; (e) loosening the snare slightly while
advancing the distal end of the cannula into the jejunum and into
the loosened snare; (f) tightening the snare around the distal end
of the cannula; (g) removing the stylet from the cannula; (h)
inserting a guide wire or suture through the cannula and into the
jejunum; and (i) proceeding in the conventional fashion to implant
a PEJ tube into the patient using said guide wire or suture.
[0020] Additional objects, as well as aspects, features and
advantages, of the present invention will be set forth in part in
the description which follows, and in part will be obvious from the
description or may be learned by practice of the invention. In the
description, reference is made to the accompanying drawings which
form a part thereof and in which is shown by way of illustration
various embodiments for practicing the invention. The embodiments
will be described in sufficient detail to enable those skilled in
the art to practice the invention, and it is to be understood that
other embodiments may be utilized and that structural changes may
be made without departing from the scope of the invention. The
following detailed description is, therefore, not to be taken in a
limiting sense, and the scope of the present invention is best
defined by the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The accompanying drawings, which are hereby incorporated
into and constitute a part of this specification, illustrate
various embodiments of the invention and, together with the
description, serve to explain the principles of the invention. In
the drawings wherein like reference numerals represent like
parts:
[0022] FIG. 1 is a side view of one embodiment of an access needle
constructed according to the teachings of the present
embodiment;
[0023] FIG. 2 is a partially exploded, perspective view of the
access needle of FIG. 1;
[0024] FIG. 3 is a side view of the stylet assembly shown in FIG.
1;
[0025] FIG. 4 is a side view of the cannula assembly shown in FIG.
1;
[0026] FIG. 5 is a fragmentary longitudinal section view of the
cannula assembly shown in FIG. 1;
[0027] FIG. 6 is a schematic view showing the access needle of FIG.
1 just prior to its insertion into a patient during
transillumination of the patient's jejunum;
[0028] FIG. 7 is a schematic view showing the access needle of FIG.
1 inserted into the patient so that the distal end of the stylet of
the access needle, but not the distal end of the cannula of the
access needle, is inserted into the jejunum for capture by an
endoscopic snare;
[0029] FIG. 8 is a schematic view showing the jejunum being held
stationary against the abdominal wall by the combination of the
access needle stylet and the endoscopic snare and also showing the
access needle cannula being inserted into the jejunum;
[0030] FIG. 9 is a schematic view showing the loosened snare being
moved from the distal end of the stylet to the distal end of the
cannula;
[0031] FIG. 10 is a schematic view showing the snare tightened
around the cannula, the stylet withdrawn proximally from the
cannula and the distal end of an insertion wire about to be
inserted through the cannula and into the jejunum;
[0032] FIG. 11 is a schematic view showing a PEJ tube coupled to an
insertion wire and positioned in a patient using the pull method;
and
[0033] FIG. 12 is a schematic view showing a PEJ tube implanted in
a patient following practice of the present method.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0034] Referring now to FIGS. 1 and 2, there are shown side and
partially exploded perspective views, respectively, of a preferred
embodiment of an access needle constructed according to the
teachings of the present invention, said access needle being
represented generally by reference numeral 11.
[0035] Access needle 11 comprises a stylet assembly 13 and a
cannula assembly 15.
[0036] Referring now to FIGS. 1 through 3, stylet assembly 13
comprises a stylet (or sounding needle) 17 and a stylet hub 19.
Stylet 17, which is preferably made of stainless steel, is a solid
cylindrical member of small diameter, preferably 20 gauge, having a
sharp, three-sided tip 21 at its distal end.
[0037] Hub 19 comprises a body 22 and a plug 23. Body 22, which is
preferably made of plastic, is a generally cylindrical hollow
member having a proximal end wall 25, a circular side wall 27 and
an open distal end. The outer surface of side wall 27 is provided
with a plurality of longitudinally extending ribs 29 to facilitate
the gripping of body 22. The inner surface of side wall 27 is
provided with a helical thread 31, the purpose of which will be
described below. Plug 23, which is preferably made of plastic, is a
generally cylindrical solid member fixedly mounted near its
proximal end 33 within an opening (not shown) provided in end wall
25, plug 23 extending coaxially with side wall 27 to define
therebetween an annular space 28. Stylet 17, which extends
coaxially with plug 23, is fixed in distal end 35 of plug 23,
preferably by insert-molding.
[0038] Referring now to FIGS. 1, 2, 4 and 5, cannula assembly 15
comprises a cannula 45 and a cannula hub 47. Cannula 45, which is
preferably made of stainless steel, is a tubular member of small
diameter, preferably 18 gauge, that is appropriately dimensioned
for stylet 17 to be removably inserted thereinto. A circumferential
band 51, which may be produced, for example, by chemical-etching or
the like, extends proximally a short distance (e.g., approximately
{fraction (3/10)} inch or more) from the distal end 53 of cannula
45. Band 51, which is readily distinguishable in appearance, e.g.,
by color, from stylet 17, permits facile differentiation of stylet
17 and cannula 45, which is desirable for reasons to become
apparent below.
[0039] Cannula hub 47, which is preferably made of plastic, is a
unitary member shaped to include a distal portion 61, an
intermediate portion 63, and a proximate portion 65. A plurality of
longitudinal ribs 62 are formed on the outer surface of distal
portion 61 to engage a protective sleeve (not shown) removably
mounted over cannula 45 and stylet 17 when needle 11 is not in use.
A plurality of laterally extending gripping elements 64 are formed
on the outer surface of intermediate portion 63 to facilitate the
gripping of hub 47 by a user. Proximate portion 65 is appropriately
dimensioned to be received in annular space 28 of stylet hub 19.
Threads 66 are formed on the outside surface of proximate portion
65 and are adapted to engage thread 31, thereby permitting hub 19
and hub 47 to be screwed (or twist-locked) together so as to
prevent undesired relative longitudinal movement between stylet 17
and cannula 45.
[0040] A longitudinal bore 67 is formed in hub 47, bore 67 having a
distal region 69 disposed in distal portion 61, an intermediate
region 71 disposed in intermediate portion 63 and a proximal region
73 disposed in proximate portion 65. Distal region 69 is
appropriately dimensioned to securely receive therewithin the
proximal end of cannula 45. Proximal region 73 has a comparatively
large diameter to facilitate the insertion of stylet 17 thereinto,
and intermediate region 71 tapers in diameter from proximal region
73 to distal region 69 so as to facilitate the insertion of stylet
17 into cannula 45.
[0041] Stylet 17 and cannula 45 are dimensioned so that, when hub
19 and hub 47 are coupled together in the twist-lock manner
described above, stylet 17 extends distally beyond distal end 53 of
cannula 45 for a sufficient distance so that, as will hereinafter
be described, tip 21 of stylet 17 may be inserted into a jejunum,
without also inserting cannula 45 thereinto, and a snare may be
tightened around the thus inserted portion of stylet 17. In the
present embodiment, stylet 17 extends approximately 1.5 inch beyond
distal end 53 of cannula 45, cannula 45 having a length of about
2.5 inches. (It should be understood, however, that the above
dimensions of stylet 17 and cannula 45 may be varied. For example,
stylet 17 and cannula 45 could be dimensioned so that cannula 45
has a length that is about 2/3 the length of stylet 17.)
[0042] The use of access needle 11 in the implantation of a PEJ
tube in a patient in accordance with the teachings of the present
invention will now be described. Referring now to FIG. 6, after
properly administering an anesthetic to a patient, an endoscope 8
having an illuminating channel is inserted through the patient's
mouth and into the digestive tract of the patient until it reaches
the patient's jejunum. Scope 8 is used to transilluminate the
jejunum through the abdominal wall, thereby identifying the
location of the jejunum to a surgeon in order to facilitate the
surgeon's insertion of access needle 11 through the abdominal wall
10 and into the jejunum 12 of the patient.
[0043] Referring now to FIG. 7, the distal end of stylet 17, but
not cannula 45, is then inserted through abdominal wall 10 and into
jejunum 12 until it is visible to endoscope 8 through an
observation channel therein. A snare 14, which is inserted into the
jejunum 12 through a snare channel of endoscope 8, is then used to
securely capture the inserted end of stylet 17 and to couple stylet
17 to snare 14. With stylet 17 and snare 14 thus coupled, stylet 17
is pulled proximally so as to engage the wall of jejunum 12.
Further pulling of stylet 17 results in jejunum 12 being held
stationary against abdominal wall 10.
[0044] Referring now to FIG. 8, with jejunum 12 held stationary
against abdominal wall 10 by snare 14 and stylet 17, cannula 45 is
de-coupled from stylet 17 (by unscrewing hub 19 from hub 47), and
the distal end 53 of cannula 45 is then moved distally until it
penetrates jejunum 12 through the opening previously created by
stylet 17.
[0045] Referring now to FIG. 9, snare 14 is loosened slightly from
the inserted portion of stylet 17 and is then moved from stylet 17
to the inserted portion of cannula 45. Snare 14 is then tightened
around the inserted portion of cannula 45.
[0046] Referring now to FIG. 10, with snare 14 now tightened around
cannula 45, stylet 17 is then withdrawn proximally from cannula 45.
At this point, it is the combination of cannula 45 and snare 14
that hold jejunum 12 stationary against to abdominal wall 10. With
stylet 17 removed, the distal end of an insertion wire 16 (or a
suture) is inserted through cannula 45 and into jejunum 12. Snare
14 is then moved from around the inserted portion of cannula 45 to
capture the distal end of insertion wire 16. With snare 14 holding
onto the distal end of insertion wire 16, snare 14 and the distal
end of insertion wire 16 are then withdrawn from the patient
through the jejunum, the stomach and, ultimately, the mouth of the
patient.
[0047] Referring now to FIG. 11, a PEJ tube 18 is then attached to
the distal end of insertion wire 16, which has previously been
pulled out of the patient's mouth. The proximal end of insertion
wire 16 is then pulled proximally, causing PEJ tube 18 to be pulled
through the patient until its proximal end extends out through the
abdominal wall of the patient and its distal end is disposed within
the jejunum of the patient.
[0048] Referring now to FIG. 12, the distal end of PEJ tube 18 can
be seen to have an enlarged end, which serves to anchor the distal
end of PEJ tube 18 in jejunum 12. An external bolster 20 may be
positioned over PEJ tube 18 to hold PEJ tube 18 in place on the
patient. With PEJ tube 18 thus implanted, liquid nutrition
materials and/or medications may be fed into the jejunum through
PEJ tube 18.
[0049] It should be appreciated that, instead of positioning the
PEJ tube in the patient by the pull-method as described above, the
PEJ tube could alternatively be positioned in the patient using the
push method.
[0050] It should also be appreciated that the foregoing method and
device could also be used to implant a PEG tube in a patient or to
implant other types of devices elsewhere in a patient. The present
method and device could also be used, more generally, to position
an organ within the body.
[0051] The embodiments of the present invention described above are
intended to be merely exemplary and those skilled in the art shall
be able to make numerous variations and modifications to it without
departing from the spirit of the present invention. For example,
although stylet 17 is described herein as being a solid member,
stylet 17 could instead be hollow. In addition, although cannula 45
is disclosed herein as having a blunt distal end 53, distal end 53
could instead be tapered. Moreover, whereas hubs 19 and 47 are
described herein as being secured by a twist-lock, other removable
securing means, such as a latch or a clip, could be used. Also,
instead of using a band to differentiate stylet 17 and cannula 45,
stylet 17 and cannula 45 could be colored differently, stylet
and/or cannula 45 could be provided with graduated depth markers,
or stylet and/or cannula could be provided with surface markings,
textures or patterns. It should also be understood that the
diameters of stylet 17 and cannula 45 could be varied. In addition,
barbs or like means could be provided on the distal end of stylet
17 and/or cannula 45 to facilitate the grasping thereof by the
snare. Furthermore, various types of coatings (e.g.,
antithrombotic, antimicrobial, hydrophilic or hydrophobic) could be
applied to access needle 11. All such variations and modifications
are intended to be within the scope of the present invention as
defined in the appended claims.
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