Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
wo 9smz46 2 T 9 ~ ! 3 ~
PCTIUS95I06457
-1-
Descri tion
ADTJaT'at'L18 T~O~" PeT'formi n~ 17i agnost~ c and per neutic
Mpdalities in the B~~~a~r Tree
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a~ical
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This invention generally relates to apparatus that is
useful in performing diagnostic and therapeutic modalities
in the biliary tree and more particularly to apparatus
that is adapted for facilitating the diagnosis of
gallstones in the bile duct and other portions of the
biliary tree and the removal of such gallstones.
Backaround Art
Historically the migration of gallstones into an
individual's common bile duct was corrected by general
surgical procedures. A surgeon would incise the bile duct
and remove the gallstones and normally remove the
gallbladder. In recent years less invasive treatment
modalities have replaced these general surgical procedures
and reduced patient trauma, long hospital stays and
recovery periods.
For example, United States Letters Patent No.
4,696,668 and United States Letters Patent No. 4,781,677,
both to Wilcox, disclose a treatment modality involving
the administration of a dissolution agent in the bile duct
to essentially dissolve any gallstones. More
specifically, a catheter contains several lumens for
inflating and deflating each of two balloons, venting
bile, and infusing and aspirating the dissolution agent.
Inflating the balloons occludes the bile duct at two
spaced sites and creates a sealed spaced that receives the
dissolution agent. As the space is sealed from the
remaining biliary tree, the dissolution agent finds a
t
ccess
to the gallbladder and any gallstones therein through the
cystic duct with the exclusion of bile from the
gallbladder fundus. The dissolution agent also will be
confined in high concentration around bile duct
gallstones. After the gallstones dissolve the balloons
are deflated and the catheter can be withdrawn. In this
particular approach, the catheter is directed into the
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biliary tree using a standard duodenoscope that passes
through the alimentary tract. Although this and analogous
approaches have the potential of minimizing patient
trauma, such treatments require extended placement of the
duodenoscope in the patient, exhibit low efficacy and
introduce a potential for adverse reactions to the
dissolution agents.
In an alternative approach, a surgeon directs a
surgical extractor into the biliary tree through at least
an incision in the bile duct. For example, in United
States Letters Patent No. 3,108,593 to Glassman a surgeon
incises both the bile duct and duodenum. Then the surgeon
directs an extractor through the bile duct incision,
biliary tree, sphincter of Oddi and duodenum to exit
through the duodenum incision. This extractor includes a
series of longitudinally spaced cages for trapping any
gallstones in the bile duct and removing them through
either of the incisions.
United States Letters Patent No. 4,627,837 to Gonzalo
discloses a catheter device with a pair of inflatable
balloons at its distal end. This catheter is led through
an incision in the bile duct toward the duodenum. After
the distal balloon passes through the sphincter of Oddi,
both balloons are expanded to anchor the catheter in
place. This enables the catheter to be used for
irrigating and flushing through other lumens in order to
capture any gallstone in the second balloon for removal
through the incised bile duct.
In accordance with still another modality as for the
treatment of strictures, a surgeon may insert a catheter
device through the bile duct or duodenum for the purpose
of dilating or enlarging the sphincter of Oddi. For
example, United States Letters Patent No. 4,705,041 to Aim
discloses a dilator that is directed through an incision
in the bile duct and the sphincter of Oddi. An expandable
tip dilates the sphincter of Oddi. United States Letters
Patent No. 5,035,696 to Rydell discloses an
electrosurgical instrument that is directed through the
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duodenum and to the sphincter of Oddi for performing a
sphincterotomy. This apparatus contains a cutting wire
_
. that is heated to cut the sphincter muscle. United States
Letters Patent No. 5,024,617 to Karpiel
discloses a
,
similar device that can be directed through a
duodenoacope. United States Letters Patent No. 5,152,772 .
to Sewell, Jr. discloses a device for performing a
ephincterotomy that is directed through an incision in th
e
bile duct and includes a knife for cutting the sphincter'
1D muscle.
The use of the duodenoscope and sphincterotomy
devices, such as shown in the Rydell and Karpiel patents,
enables an internist to diagnose and treat problems in the
biliary tree with minimal patient invasion. For example,
modalities as described in these patents eliminates the
surgery needed for incising the bile duct. Consequently, ,
these modalities can be performed as outpatient or day
surgical procedures. These procedures greatly reduce
patient trauma, the length of a hospital stay and recove
ry
times. For example, if an internist detezmines that
gallstones are present in the biliary tree, particularly
the common bile duct, the internist can insert a
duodenoscope into the duodenum to view the sphincter of
Oddi. Then a first catheter can be advanced through the
working channel of the duodenoscope with or without a
guidewire and directed through the sphincter of Oddi into
the biliary tree. Contrast agent injected through the
catheter enables fluoroscopy or other imaging procedures
to confirm the presence of gallstones within the biliaxy
tree. Next the internist exchanges the first catheter for
a second catheter for performing a aphincterotomy such as
the types disclosed in the above-identified Rydell and
Karpiel patents. The second catheter is then exchanged
for a third catheter such as shown in the Glasaman patent
or some other equivalent retrieval catheter for drawings
gallstones through the enlarged sphincter of Oddi.
Thereafter the retrieval catheter is manipulated to
release the gallstone into the duodenum. The catheter,
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any guidewire and the duodenoscope can then be removed to
complete the procedure.
This procedure is significantly less traumatic to the
patient than other prior art procedures because the only
incision occurs during the sphincterotomy. However, this
procedure as presently practiced requires three separate
catheters and two catheter exchanges. These exchanges are
required because the first, second and third catheters
function solely to inject contrast agent to perform the
sphincterotomy and to dislodge gallstones, respectively.
The time required for performing each catheter exchange
can increase patient trauma and increase the duration of
the procedure and reduce efficiency. Moreover, each such
procedure requires the use of two or three separate
catheter devices.
pisc~ osure of rnt.A.,r; r",
Therefore, an object of this invention is to provide
apparatus for performing both diagnosis and additional
therapeutic treatment without requiring a catheter
exchange.
Another object of this invention is to provide
apparatus for performing diagnosis and treatment in the
biliary tree that can reduce patient trauma.
Yet another object of this invention is to provide
apparatus that enables the removal of gallstones from the
biliary tree by a procedure that reduces the number of
required catheters and catheter exchanges.
Still another object of this invention is to provide
a single catheter apparatus that can perfoxnt a
sphincterotomy and remove gallstones in the common bile
duct.
Yet another object of this invention is to provide a
single catheter apparatus that can perforni a
sphincterotomy and inject contrast material into the.
biliary tree.
Still yet another object of this invention is to
provide a single catheter apparatus that can inject
contrast agent into biliary tree, performing a
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sphincterotomy and remove gallstones in the bile duct into
the duodenum.
In accordance with one aspect of this invention
,
apparatus can be used in a treatment modality including an
enlargement procedure and another procedure to be
performed. This apparatus includes a catheter with
proximal and distal ends and proximal and distal portions.
The catheter includes first, second and third generally
parallel lumens. The first lumen has a greater diameter
ZO than either of the second and third lumens and the lumens
each extend between proximal and distal portions of the
catheter. The apparatus for performing the enlargement
procedure extends through the second lumen for operating
distally of the catheter in response to manipulations of
an operator at the proximal end of the catheter. The
first lumen has a proximal port for enabling access to the
first Lumen and the third Lumen has a proximal port and a
distal port for enabling the remote control of some other
procedure.
In accordance with another aspect of this invention,
apparatus is provided for removing objects from the
biliary tree. This apparatus includes a catheter that is
directed through the working channel of a duodenoscope and
the sphincter of Oddi into the biliary tree. The catheter
includes first, second and third lumens with the first
lumen being larger than either the second or third lumens
and the lumens generally extending between proximal and
distal portions of the catheter along parallel axes.
Apparatus for cutting the sphincter of Oddi includes a
cutting wire extending through the second lumen and
externally of the catheter means through a distal port
along a length that is coextensive with part of the distal
portion of the catheter,. A handle attaches to the
catheter at the proximal portion and to the proximal wire
portion to control the position and orientation of the
cutting wire. An expansible balloon is mounted on the
distal portion spaced from the cutting wire and can be
inflated through the third lumen in order to move any
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gallstone in the biliary tree through the enlarged sphincter
of Oddi.
In accordance with still another aspect of this
invention, the apparatus is provided for directing contrast
agent into the biliary tree and performing a sphincterotomy
through the working channel of a duodenoscope. This
apparatus includes a catheter that is directed through the
working channel of the duodenoscope and the sphincter of
Oddi into the biliary tree. The catheter includes first,
second and third lumens with the first lumen being larger
than either the second or third lumens and the lumens
generally extending between proximal and distal portions of
the catheter along parallel axes. Apparatus for cutting the
sphincter of Oddi includes a cutting wire extending through
the second lumen and externally of the catheter means
through a distal port along a length that is coextensive
with part of said distal portion of the catheter. A handle
attaches to the catheter into the proximal wire portion to
control the position and orientation of the cutting wire.
The proximal port of the third lumen connects to a contrast
agent source and the third lumen delivers contrast agent
into the biliary tree through a distal port in the distal
end of the catheter.
In accordance with a further aspect of this
invention, there is provided apparatus for use in a
treatment modality including an enlargement procedure and
another procedure to be performed within a patient, said
apparatus comprising: A. catheter means for being directed
through internal passageways in the patient guided by a
guidewire previously positioned in the passageways, said
catheter means having proximal and distal ends and proximal
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and distal portions adjacent to said proximal and distal
ends respectively, first, second and third generally
parallel lumens adapted for receiving a guidewire
therethrough with said first lumen being larger than said
second and third lumens, said lumens extending between said
proximal and distal portions, B. enlargement means for
performing the enlargement procedure extending through said
second lumen for operating at said distal portion in
response to manipulations at said proximal end, C. operator
means at said proximal end attached to said catheter means
and said proximal portion of said enlargement means for
operating said enlargement means from a point proximal of
said catheter means, D. a first lumen proximal port in said
proximal portion of said catheter means for enabling access
to said first lumen, E. third lumen proximal port at said
proximal end of said catheter means for providing access to
said third lumen to enable a user to control the other
procedure at the distal end of said catheter means through
said third lumen and F. a distally facing port at said
distal end thereof in said first lumen whereby said first
lumen is adapted to receive the pre-positioned guidewire
therethrough so that said catheter means is slidable along
the guidewire.
In accordance with an even further aspect
apparatus for the removal of objects from the biliary tree
through the working channel of a duodenoscope, said
apparatus comprising: A. catheter means for being directed
through the working channel and the sphincter of Oddi into
the biliary tree, said catheter means having proximal and
distal ends and proximal and distal portions adjacent to
said proximal and distal ends respectively and having first,
second and third generally parallel lumens with said first
lumen being larger than said second and third lumens, said
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lumens extending between said proximal and distal portions,
each of said lumens having a proximal port and a distal port
at said proximal and distal portions of said catheter means,
said distal port of said first lumen being located at said
distal end of said catheter means and being adapted for
receiving a guidewire therethrough, B. sphincterotomy means
for cutting the sphincter of Oddi, said sphincterotomy means
including a cutting wire extending through said second lumen
and externally of said catheter means through said distal
port of said second lumen along a length that is coextensive
with a part of said distal portion of said catheter means
and handle means attached to said catheter means proximal
portion and a proximal portion of said cutting wire exiting
said proximal port of said second lumen for positioning said
cutting wire, and C. an expansible balloon mounted on the
distal portion of said catheter means and coextensive with
said distal port of said third lumen thereby to enable
inflation of said expansible balloon by the administration
of an inflation fluid at said proximal port of said third
lumen.
In accordance with a still further aspect
apparatus for the diagnosis of objects in the biliary tree
by means of a contrast agent delivered from a source, said
apparatus being directed through the working channel of a
duodenoscope and comprising: A. catheter means for being
directed through the working channel and the sphincter of
Oddi into the biliary tree, said catheter means having
proximal and distal ends and proximal and distal portions
adjacent to said proximal and distal ends respectively and
having first, second and third generally parallel lumens
with said first lumen being larger than said second and
third lumens, said lumens extending between said proximal
and distal portions, each of said lumens having a proximal
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port and a distal port at said proximal and distal portions
of said catheter means, said distal port of said first lumen
being located at said distal end of said catheter means,
B. sphincterotomy means for cutting the sphincter of Oddi,
said sphincterotomy means including a cutting wire extending
through said second lumen and externally of said catheter
means through said distal port along a length that is
coextensive with a part of said distal portion of said
catheter means and handle means attached to said catheter
means proximal portion and a proximal portion of said
cutting wire exiting said proximal port of said second lumen
for operating said cutting wire, and C. means for connecting
the proximal port of said third lumen to the contrast agent
source, said distal port of said third lumen being located
at the distal end of said catheter.
In accordance with yet another aspect apparatus
for use in a treatment modality including an enlargement
procedure and another procedure to be performed within a
patient, of the type comprising: A. catheter means for being
directed through internal passageways in the patient guide
by a guidewire previously positioned in the passageways,
said catheter means having proximal and distal ends and
proximal and distal portions adjacent to said proximal and
distal ends respectively, and including a first lumen
extending between said proximal and distal portions, said
first lumen having a distally facing port at said distal end
thereof and a proximal port at said proximal portion for
enabling access to said first lumen, whereby said first
lumen is adapted to receive the pre-positioned guidewire
therethrough so that said catheter means is slidable along
the guidewire, and B. characterized in that: C. said
catheter means further includes second and third lumens
disposed generally parallel to said first lumen and
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extending between said proximal and distal portions, said
first lumen being larger than said second and third lumens,
said third lumen having a proximal port at said proximal
portion for providing access to said third lumen to enable a
user to control the other procedure at said distal end
through said third lumen, said third lumen having a radially
facing distal port at said distal end whereby fluid
introduced at said third lumen proximal port discharges from
said third lumen distal port, and D. said apparatus further
includes enlargement means for performing the enlargement
procedure, extending through said second lumen for operating
at said distal portion in response to manipulations at said
proximal end, and operator means at said proximal end
attached to said catheter means and a proximal portion of
said enlargement means for operating said enlargement means
from a point proximal of said catheter means.
In accordance with a yet further aspect apparatus
for use in a treatment modality including an enlargement
procedure and another procedure to be performed within a
patient, said apparatus comprising: A. catheter means for
being directed through internal passageways in the patient
said catheter means having proximal and distal ends and
proximal and distal portions adjacent to said proximal and
distal ends respectively, first, second and third generally
parallel lumens adapted for receiving a guidewire
therethrough with said first lumen being larger than said
second and third lumens, said lumens extending between said
proximal and distal portions, B. enlargement means for
performing the enlargement procedure extending through said
second lumen for operating at said distal portion in
response to manipulations at said proximal end, said
enlargement means comprising a cutting wire having a distal
end attached to said catheter means at the distal end of
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said second lumen, a portion thereof external to said
catheter means along a length coextensive with a portion of
said distal portion of said catheter means and a proximal
end of said cutting wire attached to said operator means,
C. operator means at said proximal end attached to said
catheter means and said proximal portion of said enlargement
means for operating said enlargement means from a point
proximal of said catheter means, D, a first lumen proximal
port in said proximal portion of said catheter means for
enabling access to said first lumen, and E. a third lumen
proximal port at said proximal end of said catheter means
for providing access to said third lumen to enable a user to
control the other procedure at the distal end of said
catheter means through said third lumen.
Brief Description of Drawings
The appended claims particularly point out and
distinctly claim the subject matter of this invention. The
various objects, advantages and novel features of this
invention will be more fully apparent from a reading of the
following detailed description in conjunction with the
accompanying drawings in which like reference numerals refer
to like parts, and in which:
FIG. 1 is a plan view of one embodiment of
apparatus constructed in accordance with this invention;
FIG. 2 is a cross-section taken along lines 2-2 in
FIG. 1;
FIG. 3 is a cross-section taken along lines 3-3 in
FIG. 2;
W095/31246 219 013 9 PCTIUS95/064i7
FIG. 4 is a cross-section taken along lines 4-4 in
FIG. 2;
FIG. 5 depicts the apparatus of FIG. 1 positioned
through a duodenoscope for injecting contrast agent into
the biliary tree.
FIG. 6 is an enlarged view that depicts the
orientation of the apparatus in FIG. 1 for performing a
sphincterotomy;
FIG. 7 depicts the apparatus of FIG. 1 positioned
through a duodenoscope for dislodging material within the
common bile duct;
FIG. 8 is a cross-section of an alternative
embodiment of the apparatus as viewed generally along
lines 3-3 in FIG. 2.; and
FIG. 9 is a cross-section of still another embodiment
of this invention taken along lines 3-3 in FIG. 2.
Best Mode for Carrvi,~ n"r rr, rn.>o r
FIG. 1 depicts a catheter apparatus 10 that has the
capability of injecting a contrast agent into the biliary
tree, of performing a sphincterotomy and of dislodging a
gallstone into the duodenum. The apparatus 10 includes a
catheter 11 which, for purposes of definition
in
l
d
,
c
u
es a
proximal end portion 12 extending from a proximal end 13
and a distal end 14 with a distal portion 15 extending a
short distance from the distal end 14. In a typical
application, the catheter will have a working length of
200 cm and the distal end portion 15 will have a length of
6 cm to 9 cm. Normally the distal portion 15 will have a
diameter that is smaller than the diameter of the proximal
portion to increase the flexibility of the distal portion
15. The reduction in diameter also makes the tip less
traumatic and allows the tip portion to reach smaller
_ passages while allowing the larger proximal portion to
provide necessary hoop strength and rigidity, particularly
where the proximal portion 13 is coextensive with the
working channel of a duodenoscope. For example, the
proximal and distal portions might have diameters
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corresponding to 7 Fr and 5.5 Fr catheter sizes (i.e.,
0.09" and 0.07" respectively).
As shown particularly in FIG. 2, the catheter 11 has
three lumens. A first lumen 16 has a diameter that is
greater than either a second lumen 17 or a third lumen 20.
In one particular embodiment the lumen I6 has a diameter
of 0.040" in the proximal portion 13 that reduces to about
0.037" in the distal portion 15 to receive a standard
0.035" guidewire. In addition the lumen 16 is offset from
the center of the catheter 11.
The lumens 17 and 2~0 are each smaller in diameter
than the lumen 16 and are radially offset from the
centerline of the catheter, from each other and from the
lumen 16. In one particular embodiment the lumens 17 and
20 each have internal diameters of 0.028" in the proximal
portions 13 that reduces to about 0.020" in the distal
portion 15. As described later, this lumen 20 carries a
cutting wire for performing a sphincterotomy and for
allowing the infusion of a contrast agent at reasonable
2D rates. The angular spacing between the lumens 17 and 20 is
about 45° and the angular spacing between the first lumen
16 and each of the lumens 17 and 20 each is about 157.5°.
In this configuration and with these dimensions the
proximal portion 13 readily passes through the working
channel of any duodenoscope.
Referring again to FIGS. 1 and 2, each of the lumens
16, 17 and 20 includes an entry port in the proximal
portion 13 and an exit port in the distal portion 15.
Generally, and as described in more detail later, the
first lumen 16 has an exit port through the distal end 14
while the exit ports for the lumens 17 and 20 can be sited
at different locations in the distal portion 15 depending
upon a particular application.
In FIG. 1, the entry ports in proximal portion 13
adjacent the proximal end 12 include an entry port 21 that
provides access to the lumen 16 and includes an optional
Leur lock fitting 22. A proximally positioned entry port
23 provides access to the lumen 17 and includes an
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optional Leur lock fitting 24. A proximal entry port 25
for the lumen 20 is located coextensively with a portion -
of a handle 26 attached to the proximal end 12.
Referring to the distal end portion 15, the catheter
11 in this particular embodiment carries an expansible
balloon 30 proximally of the excursion of a cutting wire
31 externally of the catheter 11. As shown in FIG. 3, the
lumen 17 emerges at a distal exit port 32 through the side
of the catheter 11 with the interior of the expansible
balloon 30. An extension of the lumen 17 beyond the
distal port 32 is sealed by known methods of manufacture.
Consequently, fluid forced through the entrance port 23,
as by a syringe (not shown) attached to the Leur lock
fitting 24, expands the balloon 30 into an occluding
I5 orientation as shown in FIG. 3 with an inflated diameter
in the range up to 20 mm.
As will also be apparent from viewing FIGS. 3 and 4,
the first lumen 16 extends through the catheter 11 and
terminates with an exit port 33 in the distal end 14.
Thus the lumen 16 is adapted for receiving a guidewire
through the entrance port 21 that will extend through the
catheter 11 and exit the distal end 14 and allow the ,
catheter to slide over that guidewire.
Referring to FIG. 4, a distal end 34 of the cutting
wire 31 attaches to a clamp 35 formed at the distal end of
the lumen 20. Spaced skived ports 36A and 36B allow an
active portion 37 of the cutting wire 31 to emerge from
the catheter 11 through the skived aperture 36A, parallel
the catheter 11 exteriorly thereof and return into the
lumen 20 through the port 36B and a reinforcing sleeve 38.
. The cutting wire 31 then extends through the lumen 2D to
the handle 26 shown in FIG. 1 where it emerges as a
proximal end portion 40.
The handle 26, as shown in FIG. 1, includes a central
member 41 terminating with a thumb ring 42. The central
member 41 extends through and slides with respect to a
body section 43 having opposed finger rings 44. The
central member 41 also attaches to the catheter 11, and is
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therefore an extension of the catheter 11. The member 43
additionally includes an internal connector 45 for
clamping the proximal end 40 of the cutting wire 31.
Thus, when the body 43 is at its distal position as shown
in FIG. 1, the distal portion of the catheter 15 is in
essentially straight line as shown in FIG. 1 with the
active portion 37 of the cutting wire 31 being closely
adjacent the catheter 11. Retracting the body portion 43,
causes the cutting wire 31 to bend the distal end upwardly
as shown in FIG. 1 to a position that ie essentially at
right angles to the main axis of the catheter, as will be
shown later.
The connector block 45 and the cutting wire 31 are
generally conductive members that attach through an RF
i5 connector 46 to an RF heating source 47. The use of such
RF heating sources 47 for energizing a cutting wire 31
thereby to cut the sphincter muscle is well known in the
art and represents one possible sphincterotomy procedure
that can be adapted for the apparatus of this invention
and is not described further.
With this description of the apparatus structure, it
will now be possible to understand its use in a particular
application. FIG. 5 discloses, in a partially broken and
schematic view, the positioning of a duodenoscope 50 in
the duodenum 51 adjacent the sphincter of Oddi 52. A
catheter 11 such as constructed in FIG. 1 passes through
the sphincter of Oddi-52 into the common bile duct 53,
bypassing the pancreatic duct 54. The distal end 14 does
not extend to the gallbladder 55.
Fluoroscopy allows the appropriate positioning by
utilizing a series of radio-opaque markers 56 at the
distal portion 15 that may include the clamp 35 and the
reinforcing sleeve 38 in FIG. 4. The catheter 11 can be
positioned with or without the presence of a guidewire 57
in the lumen 16 shown in FIGS. 2, 3 and 4. For purposes
of injecting the contrast agent, any guidewire 57 can be
withdrawn to allow the contrast agent to be injected
through the lumen 16 for purposes of fluoroscopic
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examination to confirm the presence of one or more
gallstones 58. It is also possible during the operation
to expand the balloon 30 to occlude the bile duct 53 and
block any migration of contrast agent into the duodenum 51
or the pancreatic duct 54.
FIG. 6 is an enlarged view showing the duodenum 51,
sphincter of Oddi 52, portions of the pancreatic duct 54
and the common bile duct 53. In FIG. 6 the catheter-11 -
has been positioned relative to the duodenoscope 50
through the opening of the sphincter of Oddi 52. The
handle 43 in FIG. 1 has been drawn proximally to deflect
the distal portion 15 into essentially a right angle
configuration such that the cutting wire 31 abuts a
portion of the sphincter of Oddi 52. The application of
RF heating to the cutting wire 31 then will cut the
sphincter of Oddi 52 and enlarge the opening therethrough.
As will be apparent, the sphincterotomy is performed with
direct visualization of the sphincter of Oddi through the
duodenoscope.
Moreover, as has been observed by others, catheters
having guidewire and cutting wire lumens tend to assume a
particular angular orientation when the distal portion 15
emerges from the duodenoscope. This orientation is
essentially independent of the angular position of the
catheter when it is inserted into the duodenoscope. The
offset nature of the lumen 20 as shown in FIG. 2, improves
the location of the cutting wire 31 as the distal portion
15 passes through the sphincter of Oddi 52. Specifically
the angularly offset brings the cutting wire 31 into
better alignment with the common bile duct 53 and
. displaces the cutting wire from the pancreatic duct 54.
FIG. 7 depicts the catheter after the sphincterotomy
and after the catheter li is advanced over the guidewire
57, if used. FIG. 7 also discloses the catheter 11 after
the balloon 30 has been moved beyond a gallstone 58 in the
bile duct 53. The balloon 30 is expanded so that upon
withdrawal of the catheter 11 the balloon 30 will dislodge
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the gallstones 57 and sweep them through the sphincter of
Oddi 52 into the duodenum 51.
As will now be apparent from the description of the
particular catheter apparatus 10 shown in FIG. 1 and its
use as discussed with respect to FIGS. 5, 6, and 7, the
single catheter apparatus of this invention is capable of
providing diagnostic contrast agent injection, of
performing a sphincterotomy and of dislodging gallstones
in the common bile duct or other portions of the biliary
tree without having to exchange a catheter. Moreover,
positioning and sizing of the lumens enables these
functions to be performed with a catheter apparatus that
is readily adapted for use in the working channels of
standard duodenoscopes. Consequently the gallstones can
be removed from the biliary tree without bile duct
incisions and accompanying surgical procedures, as
duodenoscope can be introduced through the alimentary
tract. Consequently the entire procedure is adapted for
being performed more rapidly than prior art procedures and
with fewer components. The net effect is to reduce
patient trauma and the overall time and cost of conducting
the procedure.
In FIG. 1 the balloon 30.is located proximally of the
cutting wire 31. FIG. 8 discloses an alternative
embodiment in which a balloon 60 is located distally of
the cutting wire 31. More specifically, the distal end of
a lumen I7A, corresponding to the lumen 17 in FIGS. 3 and
4, is sealed. A side facing exit port 61 skived or
otherwise formed in the catheter 11 opens into a chamber
62 formed by the balloon 60. A first aealing.portion 63
and a sealing portion 64 of the balloon 60 connect
proximally and distally of the aperture 6i respectively
and seal the chamber 62.
Introduction of a balloon inflation fluid through the
lumen 17A expands the balloon 6D into an occluding
orientation corresponding to the orientation of the
balloon 30 shown in FIG. 3. Retraction of the catheter 11
with the distal balloon 60 inflated enables withdrawal of
WO 95/31246 219 013 9 pCTIUS95106457
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a gallstone from the bile duct. This particular
embodiment is particularly adapted when it is determined
that a gallstone is located high in the biliary tree to
minimize the incursion of the distal portion 15 through
the biliary tree beyond the gallstone or in any
application in which the internist desires to minimize the
length of the distal portion 15 that extends beyond the
occluding balloon.
FIG. 9 discloses another embodiment. of this invention
for enlarging the sphincter of Oddi and performing another
procedure, such as injecting a contrast agent into the
biliaxy tree, as might be used in the diagnosis and
treatment of a stricture in the biliary tree. In this
particular embodiment an exit port 65 from the lumen 17B
is located in the distal end 14 of the distal portion 15.
The lumen 16 then can be used for a guidewire and the
lumen 178, for injecting the contrast agent directly into
the biliary tree while the guidewire remains in place.
The apparatus would then be positioned to perform a
sphincterotomy without having to exchange a catheter
should the procedure be warranted.
As still another alternative, the internist could
utilize a conventional catheter for purposes of injecting
the contrast agent to determine the need for gallstone
removal. If treatment were indicated, the internist could
then utilize apparatus as shown in FIG. 1 with a single
exchange over the guidewire that would pass through the
lumen 16 as previously described.
Therefore, it will now be apparent that apparatus
constructed in accordance with this invention attains the
several objects and the advantages of this invention.
More particularly, catheter apparatus constructed in
accordance with this invention allows the injecti
f
. on o
a
contrast agent, the performance of a sphincterotomy and
dislodging gallstones from the common bile duct through
the enlarged sphincter of Oddi into the duodenum all
without requiring any catheter exchanges. Moreover, this
apparatus allows such a procedure.to occur through a
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WO 95/31246 PCT/U595/06457
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duodenoscope to minimize patient trauma. The use of a
single catheter with ari elimination of catheter exchanges
further reduces the time and costs associated with the use
of multiple, single-function catheter devices.
As will be apparent from the foregoing description,
many alterations can be made to the specifically disclosed
embodiments. Different balloon structures can be used and
located at alternative positions. Different cutting wire
embodiments and orientations can be used. Thus, although
this invention has been disclosed in terms of certain
embodiments, it will be apparent that many modifications
can be made to the disclosed apparatus Without departing
from the invention. Therefore, it is the intent of the
appended claims to cover all such variations and
modifications as come within the true spirit and scope of
this invention.
