Note: Descriptions are shown in the official language in which they were submitted.
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DEVICES FOR EXTRACTING BILIARY OR URINARY STONES
Description
Technical Field
This invention relates generally to medical devices, and more
particularly to devices for engaging and extracting or removing stones,
calculi or the like from the biliary or urinary tracts.
Background of the Invention
A variety of tracts or ducts in the body are subject to the
development of stones, calculi or the like. (For convenience, such stones,
calculi and the like may sometimes be referred to herein by the words
"stone" or "stones.") For example, stones may develop in the kidneys and
migrate down the ureters. Sometimes such stones become lodged in the
ureters, requiring surgical intervention for their removal. Similarly,
gallstones
may develop in the gallbladder, and migrate down the biliary duct (the
common bile duct), through the ampulla of Vater, and out the Sphincter of
Oddi into the duodenum. As with kidney stones, such stones occasionally
become lodged in the biliary duct, the pancreatic duct or the ampulla of
Vater. Indeed, gallstones can be of such a size as to be unable to pass
through the Sphincter of Oddi. In either case, surgical intervention is again
required for their removal.
A number of surgical devices are known for engaging and
extracting or removing stones from the biliary or urinary tracts. However,
the satisfactory introduction of such devices into the ampulla of Vater or the
associated ducts may require the surgical cutting of the papilla of Vater (in
which the Sphincter of Oddi is formed). Such cutting is commonly
performed with sphincterotomes, in particular, papillotomes. Such cutting
devices are typically used in conjuction with an endoscope.
A very useful papillotome is disclosed in U.S. Patent No.
5,024,617 (J. Karpiel, Jun. 18, 1991 ). The specification of the patent
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notes that a survey conducted by the American Society for Gastrointestinal
Endoscopy revealed that the most common major complication from
endoscopic sphincterotomy was bleeding. The specification of the patent
further notes that the vast majority of such bleeding typically results when
the retroduodenal artery is cut. Other major complications include
pancreatitis, perforation and cholangitis. The device disclosed in the patent
is intended to enhance the control a physician has while performing a
sphincterotomy, and thereby reduce the risk of such injury to the patient
from the procedure. While the device disclosed in the patent appears to
achieve this desired reduction in risk, healing of the papilla of Vater after
cutting can be problematic. Moreover, the physical arrangement of useful
surgical cutters may hinder visualization of the site being cut. Further, U.S.
Patent No. 5,383,849 (F. Johlin, Jr., Jan. 24, 1995) notes that, when a
cannula is used in endoscopic retrograde cholangiopancreatography (ERCP),
difficulty is sometimes encountered in the attempt to successfully cannulate
(that is, enter with a cannula) the desired duct among the bile and pancreatic
ducts.
Attempts have been made to avoid the problems associated with
cutting of the papilla of Vater. For example, catheter devices including
inflatable balloons have been used to temporarily dilate the Sphincter of Oddi
(or other biliary structure) so as to permit the passage of retrieval baskets
or extraction balloons therethrough. One such biliary balloon dilator is sold
by Wilson-Cook Medical Inc., Winston-Salem, NC, under the name Quantum
TTC°. That dilator includes a biliary dilation balloon carried on a
dual-lumen
catheter, one lumen serving for the introduction of an inflation medium into
the dilation balloon, and the other lumen accepting a conventional 0.89 mm
(0.035 in.) guide wire therein. An associated apparatus (the Quantum Biliary
Inflation Device, or Q.B.I.D.T"') is used to control the inflation pressure or
inflation volume of the balloon.
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During use, the deflated balloon of the device is first positioned
via an endoscope across the structure to be dilated, for example, across the
Sphincter of Oddi, and then inflated to dilate the structure. The balloon is
then deflated and removed from the structure, and the device removed from
the patient. It has been found that the Sphincter of Oddi remains dilated for
a few minutes before it closes; during the time it is dilated, a retrieval
basket
or extraction balloon is introduced through the endoscope and through the
dilated Sphincter, into engagement with the stones to be removed.
An example of an extraction balloon device useful for this purpose
is the Tri-ExTM Triple Lumen Extraction Balloon sold by Wilson-Cook Medical
Inc. The device includes a triple lumen catheter which carries on it a
distending latex balloon. One lumen serves to deliver an inflation medium
to the balloon, a second serves to contain a conventional guide wire, and a
third permits the introduction of a contrast medium distal (above) or proximal
(below) the balloon. The volume of inflation medium is determined by a pre-
measured syringe connected to the first lumen. In use, the deflated balloon
of the device is introduced through the Sphincter of Oddi (for example, via
the endoscope) past the stones, then inflated and employed to urge the
stones towards and out the Sphincter of Oddi. Other retrieval balloons are
of course useful for this purpose as well.
A variety of retrieval baskets are known for the endoscopic
removal of stones and other foreign bodies from both the biliary and urinary
tracts. Such baskets can be exemplified by the WEBT"" Extraction Basket
sold by Wilson-Cook Medical Inc., which includes a plurality of filaments or
wires constructed of a shape memory material. Nitinol in a superelastic
state is an example of a shape memory material. As a further example, U.S.
Patent No. 4,295,464 (A.A. Shihata, Oct. 20, 1981 ) discloses a ureteric
stone extractor having two ballooned catheters, in particular, an inner
dislodger catheter slidable within a relatively larger outer dilator catheter.
The dislodger catheter includes a lumen having a stiffening metal stylet
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disposed in it. The balloon of the dilator catheter must remain inflated
during use of the extractor, thus preventing visualization of the stone by an
endoscope.
Unfortunately, the successful use of many of such devices is
often not possible. In particular, the closure time of the papilla of Vater
(that
is, the time in which the Sphincter of Oddi closes after dilation by the
balloon) is so short that the Sphincter of Oddi often closes before the
dilation balloon catheter is removed from the patient and the retrieval basket
or extraction balloon is introduced and advanced to the Sphincter. Even
when the guide wire has been advanced through the Sphincter, cannulation
of the extraction balloon through the collapsed Sphincter may still be
difficult. Moreover, guide wires are not generally used with retrieval
baskets; unless the basket is introduced quickly enough, the dilation of the
Sphincter is a wasted effort. Further, since the dilation balloon is typically
axially aligned with the line-of-sight of the endoscope, ensuring that the
balloon actually lies across the Sphincter of Oddi or other structure may be
difficult as well.
It would be highly advantageous to have devices which permitted
the engagement and extraction or removal of stones, calculi or the like from
the biliary tract, the urinary tract or other body structure without requiring
any surgical cutting of body tissue. It would also be highly advantageous
to have devices which permitted the introduction of a retrieval basket,
extraction balloon or the like quickly enough to take advantage of the time
the Sphincter of Oddi or other structure remained dilated, so as to permit the
ready passage of the basket or balloon through the Sphincter and allow the
ready observation of the engagement of the stones by the basket or balloon
via the endoscope. It would further be highly advantageous to have devices
which permitted the basket, balloon or the like to urge the stones through
the Sphincter of Oddi or other structure while it was still dilated. Finally,
it
would be highly advantageous to have dilation balloon devices which
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affirmatively ensured the position of the dilation balloon with respect to the
Sphincter of Oddi or other body structure during its dilation.
Summary of the Invention
The foregoing problems are solved and a technical advance is
5 achieved in illustrative devices for dilating sphincters or other structures
in
the body of a human or veterinary patient, and engaging and extracting or
removing stones, calculi or the like (hereinafter, "stones") from the body of
a human or veterinary patient, for example, from the biliary or urinary tract
of the patient. The purpose of the device is to provide firstly means of
dilating a sphincter or tract opening, and secondly means of extracting or
retrieving stones from a tract beyond the sphincter or opening. Thus, in the
present invention, a device comprises a catheter shaft, a first expandable
apparatus fixed on the catheter shaft for dilating the tract entrance, and a
stone retrieving apparatus associated with the catheter shaft for urging the
stone through the tract entrance. The stone retrieving apparatus may be a
second expandable apparatus. Either (or both) of the first and second
expandable apparatus may be a balloon or may be a basket or cage. Both
may be balloons, each on a discrete tube in a telescoping arrangement, or
upon a single catheter device. The first expandable apparatus may be
retained in the expanded position or condition during stone retrieval, or it
may be deflated or collapsed and removed.
More particularly, in a first embodiment, the device of the present
invention comprises a plural lumen catheter shaft which carries affixed to it
both an appropriate inflatable dilation balloon, and a suitable inflatable
retrieval balloon dimensioned and adapted for urging the stones through the
biliary or urinary tract of the patient. Preferably, the dilation balloon is
of
nondistendable (nonstretchable) material, such as polyethylene terephthalate
(PET), and the retrieval balloon is of distendable material, such as latex.
Affixing both balloons to a single catheter shaft, as in the first embodiment,
advantageously minimizes the profile of the device, advantageously
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minimizes the manipulative steps required for introduction and advancement
of the device, and eliminates the time previously required to remove the
dilation balloon from the patient and introduce a separate extraction balloon
into the patient. The relatively small profile of the device readily allows
the
deflated balloons to be advanced along a previously inserted guide wire, for
example, advanced through the Sphincter of Oddi or other structure or
entrance to a small tract such as a ureter. When the dilation balloon lies
fully across the Sphincter or other entrance, the dilation balloon is inflated
so as to dilate the Sphincter or other entrance; the dilation balloon is then
deflated so as to allow observation of the extraction balloon through the
Sphincter or entrance via an endoscope. The extraction balloon is advanced
until it has been moved to a position past the stones, and then is inflated
and manipulated to urge the stones through the biliary or urinary tract of the
patient.
This is not to say that the extraction balloon is itself employed to
fully remove the stones from the patient. For example, with gallstones it is
likely sufficient merely to urge the stones past the Sphincter of Oddi into
the
duodenum, and allow the stones to pass from the body naturally after that.
Similarly, urging kidney stones from the ureters to the bladder is likely to
be
sufficient to ensure the subsequent elimination of the stones from the body.
Moreover, it should be noted that, in general, it is anticipated that the
endoscope will not pass through the Sphincter of Oddi or other structure;
only the catheter shaft, dilation balloon and extraction balloon will.
In a second embodiment, the device of the present invention
comprises a catheter shaft having a dilation balloon fixed on it, and a
reversibly collapsible extraction basket slidably received in, and extendable
from, the catheter shaft. The basket is preferably connected to a control
member disposed in a lumen in the catheter shaft. The control member need
not be a discrete member; for example, when the basket comprises a
plurality of wires, the control member can comprise extending portions of
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the wires extending through the catheter shaft. While the device is
preferably highly flexible, the basket and/or the control member provide
sufficient stiffness to permit the basket (contained in the catheter shaft)
and
the deflated dilation balloon to be advanced through the Sphincter of Oddi
or duct or ureter entrance until the balloon lies thereacross. The balloon is
inflated to dilate the Sphincter or entrance, and then deflated to allow
observation (via endoscope, through the dilated Sphincter or other structure)
of the extension of the basket from the catheter shaft and into engagement
with the stones. The stones are captured by the basket or otherwise urged
by manipulation of the basket through the Sphincter of Oddi or entrance and
into the digestive or urinary tract. Again, it is expected that, in general,
the
endoscope will not pass through the Sphincter of Oddi or entrance dilated.
In a third embodiment, the device of the present invention
comprises a dumbbell-shaped or wasp-waisted balloon catheter for dilating
a sphincter or duct or ureter entrance in a patient, preferably for dilating
the
Sphincter of Oddi. The device comprises an inflatable dilation balloon carried
on a catheter shaft, the balloon having proximal and distal inflatable
portions, and an intermediate inflatable portion between the proximal and
distal portions. Unlike balloons previously used to anchor catheters in the
body, all three portions of the dilation balloon are inflatable to a
significant
degree. More particularly, the intermediate inflatable portion of the balloon
has an inflated diameter which is suited for the temporary dilation of the
sphincter, while the proximal and distal inflatable portions have inflated
diameters which are greater than the inflated diameter of the intermediate
portion. Inflation of the balloon automatically centers the balloon in the
sphincter, establishing a predetermined amount of dilation of the sphincter.
The several portions of the balloon are preferably continuously formed, and
are preferably in fluid communication with one another. Conveniently, the
balloon defines a single inflation chamber, such that there are no walls or
partitions separating the proximal, distal and intermediate portions of the
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dilation balloon. Separate inflation chambers in each of the several balloon
portions are also contemplated within the present invention, of course.
A fourth embodiment provides two telescopically arranged tubes
wherein the first tube is fitted with a first expandable apparatus for
dilating
a sphincter or duct or ureter entrance, and wherein the second tube is fitted
with a second expandable apparatus for extracting or retrieving stones from
the tract. The first tube may be inside or outside of the second tube. Either
or both of the first and second expandable apparatus may be a balloon, a
basket or a "cage". If the expandable apparatus are balloons, the first or
dilator balloon is made of a nondeformable material that is capable of
deforming the sphincter or tract opening when the balloon is inflated. The
second or extraction balloon is made of a material that has to be deformable
when the balloon is inflated to adapt to the tact in which the stones are
located and to be able to withdraw the stones.
The telescopic arrangement of two tubes each having an
expandable apparatus has also the advantage of minimizing the manipulative
steps required for introduction and advancement of the device, and
eliminates the time previously required to remove a dilation device from the
patient and introduce a separate extraction balloon in the patient. The
telescopic arrangement is therefore well suited to a situation where a
sphincter, having been previously dilated, would collapse rapidly before a
surgeon could proceed with the extraction of the stone.
Each of the embodiments of the device of the present invention
is particularly advantageous over prior dilation and extraction devices in one
or more of a variety of ways. For example, the devices of the present
invention may permit the engagement and extraction or removal of stones,
calculi or the like from the biliary tract, the urinary tract or other body
structure without requiring any surgical cutting of body tissue, for example,
of the Sphincter of Oddi. The devices of the present invention may also
permit the introduction of an associated retrieval basket, extraction balloon
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or the like quickly enough to take advantage of the time the Sphincter of
Oddi or tract entrance remained dilated, so as to permit the ready passage
of the basket or balloon through the Sphincter and allow the ready
observation of the engagement of the stones by the basket or balloon via the
endoscope. The devices of the present invention may also permit their
associated basket, balloon or the like to urge the stones through the
Sphincter of Oddi or other entrance structure while it was still dilated.
Finally, the devices of the present invention may affirmatively ensure the
position of the dilation balloon with respect to the Sphincter of Oddi or
other
body structure during its dilation.
As indicated above, the device of the present invention possesses
significant advantages over prior devices.
Brief Description of the Drawings
A better understanding of the present invention will now be had
upon reference to the following detailed description, when read in
conjunction with the accompanying drawing, wherein like reference
characters refer to like parts throughout the several views, and in which:
Fig. 1 is a side view of the preferred embodiment of the present
invention;
Fig. 2 is a cross-sectional view taken along line 2 - 2 of Fig. 1;
Figs. 3 through 5 are partial views of the embodiment of the
present invention shown in Fig. 1;
Fig. 6 is a cross-sectional view of a portion of the preferred
embodiment of the present invention shown in Fig. 1;
Fig. 7 is a cross-sectional view of another embodiment of the
present invention, similar to Fig. 6;
Fig. 8 is a side view of another embodiment of the present
invention;
Fig. 9 is a cross-sectional view taken along line 9 - 9 of Fig. 8;
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Fig. 10 is a cross-sectional view of another embodiment of the
present invention, similar to Fig. 9;
Fig. 11 is a side view of another embodiment of the present
invention;
5 Fig. 12 is a cross-sectional view taken along line 12 - 12 of Fig.
11;
Fig. 13 is a cross-sectional view of a portion of the preferred
embodiment of the present invention shown in Fig. 1 1;
Fig. 14 is a cross-sectional view of another embodiment of the
10 present invention, having telescoping tubes;
Fig. 15 is a cross-sectional view taken along line 15-15 of Fig. 14;
Fig. 16 is a cross-sectional view of another embodiment of the
present invention;
Fig. 17 is a cross-sectional view taken along line 17-17 of Fig. 16;
Fig. 18 is a cross-sectional view of another embodiment of the
present invention; and
Fig. 19 is a cross-sectional view taken along line 19-19 of Fig. 18.
Detailed Description
With reference first to Figs. 1 and 2, an embodiment of a device
10 according to the present invention is thereshown, useful for extracting
biliary or urinary stones, calculi or the like 104 (hereinafter, stone 104)
from
the biliary or urinary tract 100 of a patient. The device 10 and the other
embodiments of the present invention are most preferably employed for
temporary dilation of the Sphincter of Oddi 102 within the biliary tract 100,
and will therefore be described with respect to a stone 104 located within
the ampulla of Vater 106.
The device 10 of the present invention first comprises a catheter
shaft 12 having a proximal end 32 and a distal end 34. The catheter shaft
12 preferably comprises silicone or another suitable medical grade material.
When intended for use at the Sphincter of Oddi 102, the catheter shaft 12
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is advantageously about 5 to about 7 French ( 1.67 to 2.33 mm) in size.
Moreover, as explained in more detail below, when the device 10 is
employed for engaging the stone 104 via an antegrade approach (that is, the
device 10 is introduced into the patient through the patient's mouth), the
catheter shaft 12 as advantageously about 180 to about 200 cm long.
The device 10 of the present invention also comprises a first
inflatable balloon 14 fixed on the catheter shaft 12. The first balloon 14 is
preferably dimensioned and adapted for the temporary dilation of a tract
entrance, such as the Sphincter of Oddi, from an undilated diameter (Fig. 1 )
to a dilated diameter (Fig. 3), in a manner described in more detail below.
To this end, the first balloon 14 is preferably about 3 to about 6 cm long,
and is inflatable to a diameter of about 4 to about 10 mm. The first balloon
14 preferably comprises PET or another suitable medical grade materia such
as irradiated polyethylene or polyimide.
The device 10 of the present invention further comprises a second
inflatable balloon 18 fixed on the catheter shaft 12. The second balloon 18
is dimensioned and adapted for urging the stone 104 through the biliary or
urinary tract 100 of the patient. Preferably, the second balloon 18 is
dimensioned and adapted for urging the stone 104 through the Sphincter of
Oddi 102, after temporary dilation of the Sphincter of Oddi 102 to its dilated
diameter by inflation of the first balloon 14 and deflation of the first
balloon
14, and before closure of the Sphincter of Oddi 102 to its undilated
diameter. The second balloon 18 is preferably affixed to the catheter shaft
12 distal of the first balloon 14. The second balloon 18 advantageously
comprises latex or another suitable medical grade material of comparable
softness or elasticity such as silicone rubber. The selection of such other
material for the second balloon 18 should be well within the skill of the art,
for example, on a trial-and-error basis after considering softness or
elasticity.
The second balloon 18 is preferably inflatable to a diameter about
2 to about 5 mm larger than the inflated diameter of the first balloon. A
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particularly preferred shape for the second balloon 18 is shown in cross-
section in Fig. 6. When intended for use in engaging a stone 104 in the
ampulla of Vater 106, the second balloon 18 is advantageously inflatable to
a diameter of about 8 to about 15 mm, and to a volume of about 1 .5 to
about 4 cm3. It is highly desirable that the device of the present invention
be arranged to affirmatively establish a tension in the second balloon which
is suitable for urging movement of the stones, calculi or the like, and
minimize any risk of rupture of the second balloon from overpressure. For
this purpose, the device 10 of the present invention preferably also
comprises a structure 44 (Fig. 1 ) for delivery of a fixed, predetermined
volume of inflation medium to the second balloon 18. The structure 44 can
comprise the syringe shown in Fig. 1 or another suitable structure, such as
the Wilson-Cook Q.B.I.D.TM apparatus.
The catheter shaft 12 of the device 10 of the present invention
includes at least three (and preferably three) longitudinally extending lumens
16, 20 and 24 defined therein (Fig. 2). The first lumen 16 is dimensioned
and adapted for the supply of a suitable inflation medium to the first balloon
14. The first lumen 16 is connected via a coupling 36 to an inlet 38 for the
inflation medium, for example, supplied from a pressurized source 54 of the
inflation medium. The second lumen 20 is similarly dimensioned and
adapted for the supply of a suitable inflation medium to the second balloon
18. The second lumen 20 is connected via the coupling 36 to an inlet 40,
connected in turn to the inflation medium delivery structure 44. (The
inflation media for the first and second balloons 14 and 18 need not be the
same, of course, and preferably may not be the same.) The third lumen 24
is dimensioned and adapted for receiving a guide wire 22 therein. The guide
wire 22 can be a conventional 0.89 mm (0.035 in.) guide wire, or other
guide wire suitable for the intended use of the device 10. The device 10 of
the present invention can further comprise such a guide wire 22 receivable
in the third lumen 24.
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Imaging during use of the device 10 can be carried out in several
ways. It is an important advantage of the present invention, however, that
the stone 104 and the engagement of the second balloon 18 with the stone
104 can be viewed directly through the temporarily dilated Sphincter of Oddi
102. To this end, the device 10 is introduced into the patient via an
endoscope, such as an over-the-wire endoscope 30 (shown only
schematically), to which the catheter shaft 12 is connectable. Such
connection occurs, for example, by feeding the catheter shaft 12 through
the endoscope 30. The device 10 of the present invention can of course
further comprise the endoscope 30.
Alternatively, depending upon the circumstances of use, it may be
desirable to image the device 10 or the stone 104 by means of radioscopy,
fluoroscopy or the like. Such circumstances may arise, for example, if the
stone 104 is located some distance from the Sphincter of Oddi 102. The
device 10 can further comprise at least one radiopaque band 48 or 50 (and
preferably a pair of radiopaque bands 48 and 50) positioned on the catheter
shaft 12 immediately proximal or distal of the second balloon, respectively.
The radiopaque bands 48 and 50 can comprise a suitable metal or other
medical grade material, and are shown in Figs. 6 and 7.
Similarly for imaging, the device 10 of the present invention can
also or alternatively comprise a fourth longitudinally extending lumen 26
defined in the catheter shaft 12 (see Figs. 6 and 7), having an exit port 28
adjacent the second balloon 18 and being dimensioned and adapted for the
delivery of a contrast medium through the exit port 28 and into the biliary
or urinary tract 100 of the patient. The exit port 28 is shown proximal of
the second balloon 18 in Fig. 6, and distal of the second balloon 18 in Fig.
7. However, should the need for a contrast medium arise, it is probably
preferred to instead either inject the contrast medium around the guide wire
22, or remove the guide wire 22 from the third lumen 24 and introduce the
contrast medium through the third lumen 24. Again, the provision of such
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aids to imaging may not be particularly preferred, since it is intended that
the
second balloon 18 and the stone 104 be viewed through the dilated
Sphincter of Oddi 102.
Use of the device 10 of the present invention for extracting the
stone 104 from the patient can now be easily understood. As mentioned
above, the relatively small profile of the device 10 readily allows the
catheter shaft 12 and the deflated first and second balloons 14 and 18 to
be advanced along a previously inserted guide wire 22, for example,
extending through the Sphincter of Oddi 102. Such a position for the guide
wire 22 and device 10 is shown in Fig. 1, the endoscope 30 first having
been introduced into the patient via an antegrade approach and advanced
along the guide wire 22. Once the first balloon 14 lies fully across the
Sphincter of Oddi 102, the first balloon 14 is inflated so as to dilate the
Sphincter of Oddi 102 (Fig. 3). The first balloon 14 is then deflated so as
to allow observation of the second balloon 18 and the stone 104 through
the Sphincter of Oddi 102 via the endoscope 30 (Fig. 4). The device 10 is
advanced in the direction of arrow 56 until the second balloon 18 has
passed the stone 104. The second balloon 18 is then inflated (Fig. 5) and
manipulated to urge the stone 104 in the direction of arrows 58 through the
Sphincter of Oddi 102 and into the duodenum of the patient. The second
balloon 18 is then deflated and the device 10, the endoscope 30 and the
guide wire 22 withdrawn from the patient.
Of course, the stone 104 can be manipulated by other structures.
More particularly, with additional reference to Figs. 8 and 9, an embodiment
of a device 1 10 according to the present invention is thereshown, useful for
extracting biliary or urinary stones, calculi or the like (such as stone 104)
from the biliary or urinary tract 100 of a patient. Like the device 10, the
device 110 is most preferably employed for temporary dilation of the
Sphincter of Oddi 102 within the biliary tract 100, and will therefore be
described with respect to a stone 104 located within the ampulla of Vater
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106. Reference to Fig. 1 should be had for the biliary tract 100, the
Sphincter of Oddi 102, the stone 104 and the ampulla of Vater 106.
The device 1 10 of the present invention first comprises a catheter
shaft 1 12 and an inflatable dilation balloon 1 14 fixed on the catheter shaft
5 1 12. The catheter shaft 1 12 is comparable to the catheter shaft 12 of the
device 10, while the balloon 1 14 is comparable to the first balloon 14 of the
device 10. The catheter shaft 112 thus preferably comprises silicone or
another suitable medical grade material. When intended for use at the
Sphincter of Oddi 102, the catheter shaft 1 12 is advantageously about 5 to
10 about 7 French ( 1.67 to 2.33 mm) in size, and when the device 1 10 is
employed via an antegrade approach, the catheter shaft 112 is
advantageously about 180 to about 200 cm long.
The balloon 1 14 is preferably dimensioned and adapted for the
temporary dilation of the Sphincter of Oddi 102 from an undilated diameter
15 to a dilated diameter. To this end, the balloon 1 14 is about 3 to about 6
cm
long, and is inflatable to a diameter of about 4 to about 10 mm. The balloon
1 14 preferably comprises PET or another suitable medical grade material.
The device 110 of the present invention also comprises a
reversibly collapsible extraction basket 154 slidably receivable in, and
extendable from, the catheter shaft 1 12. The basket 154 is dimensioned
and adapted for urging the stone 104 through the biliary or urinary tract 100
of the patient. Preferably, the basket 154 is dimensioned and adapted for
urging the stone 104 through the Sphincter of Oddi 102, after temporary
dilation of the Sphincter of Oddi 102 to its dilated diameter by inflation of
the balloon 1 14 and deflation of the balloon 1 14, and before closure of the
Sphincter of Oddi 102 to its undilated diameter. When intended for use in
engaging a stone 104 in the ampulla of Vater 106, the basket 154 is
advantageously expandable to a diameter of about 0.6 to about 3 cm, and
is about 3 to about 6 cm long. The basket 154 preferably comprises a
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plurality of wires 158, the wires 158 being joined distally by an atraumatic
tip 160 on the basket 154.
It is highly desirable that the basket 154 resist kinking during use,
that is, during introduction of the device 110 into the patient via an
endoscope 30. It is also highly desirable that the basket 154 possesses a
predetermined shape when extended from the catheter shaft 112.
Accordingly, the wires 158 of the basket 154 preferably comprise a shape
memory material, most preferably nitinol in a superelastic state. The
properties of nitinol alloy in it superelastic state are well known, and need
not be recited here. Other materials include superelastic or pseudoelastic
copper alloys such as copper/aluminum/nickel, copper/aluminum/zinc, or
copper/zinc
As indicated, the basket 154 is slidably receivable in the catheter
shaft 1 12. For this purpose, the catheter shaft 1 12 includes a
longitudinally
extending basket lumen 152 defined therein, the basket lumen 152 being
dimensioned to receive the basket 154 therein. Preferably, the device 1 10
of the present invention further comprises an elongated control member 156
on which the basket 154 is mounted. The control member 156 can be a
discrete elongate member, or can simply be longitudinally extending portions
of the basket wires 158. The control member 156 extends fully through and
is slidable in the basket lumen 152; movement of the control member 156
relative to the catheter shaft 1 12 causes collapse or expansion of the basket
154. Collapse or expansion of the basket 154 may be aided by including a
metal sheath 162 in the basket lumen 152, positioned between the catheter
shaft 1 12, and the control member 156 and the basket 154 (Fig. 10). The
control member 156 is slidably disposed in the metal sheath 162. When the
device 110 is employed for engaging the stone 104 via an antegrade
approach through the endoscope 30, the basket 154 and the control
member 156 together are advantageously about 220 cm long.
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As with the device 10, it is preferred during use of the device 1 10
that the stone 104 and basket 154 be imaged via the endoscope 30 directly
through the temporarily dilated Sphincter of Oddi 102. Of course, depending
upon the circumstances of use, it may be desirable to image the catheter
shaft 1 12, the basket 154 and/or the stone 104 by means of radioscopy,
fluoroscopy or the like. Accordingly, the catheter shaft may include one or
more radiopaque bands (not shown) like the bands 48 and 50 of the device
10. The catheter shaft 1 12 of the device 110 can also or alternatively
include a longitudinally extending contrast lumen defined therein, comparable
to the fourth lumen 26 of the device 10. The contrast lumen has an exit
port 128 positioned distal of the balloon 114 and is dimensioned and
adapted for the delivery of a contrast medium through the exit port 128 and
into the biliary or urinary tract 100 of the patient, preferably into the
ampulla
of Vater 106.
Also as with the device 10, the device 1 10 can further comprise
the endoscope 30 to which the catheter shaft 1 12 is connectable.
Use of the device 1 10 of the present invention for extracting a
stone 104 from the patient is similar to the use of the device 10 as
described above. The endoscope 30 is introduced into the patient. The
basket 154 is received in the catheter shaft 112, and the device 110
introduced through the endoscope 30 and manipulated so that the portion
of the catheter shaft 1 12 bearing the balloon 1 14 on it cannulates and lies
fully across the Sphincter of Oddi 102. The balloon 1 14 is then inflated by
connection to a pressurized source 54 of an inflation medium to dilate the
Sphincter of Oddi 102. The balloon 1 14 is then deflated, and the control
member 156 moved so as to cause the basket 154 to extend from the
catheter shaft 1 12. The basket 154 is manipulated to engage the stone 104
and urge it towards and out the Sphincter of Oddi 102, and into the
patient's duodenum. If the basket 154 has captured the stone 104, the
device 1 10 and endoscope 30 are removed from the patient to complete the
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extraction of the stone 104 from the patient. If instead the stone 104 is not
captured by the basket 154, the stone 104 is allowed to pass naturally from
the duodenum.
Both the device 10 and the device 110 provide for both the
temporary dilation of a structure in the biliary or urinary tract 100,
preferably
of the Sphincter of Oddi 102, and the engagement or extraction and removal
of stones, calculi or the like, without requiring removal of the dilation
balloon
and introduction of another balloon or basket. This significantly shortens the
time necessary for the successful performance of the extraction or removal
procedure, while avoiding the need to surgically cut the Sphincter of Oddi
or other structure in the patient. Without regard to whether the device 10,
the device 110 or some prior art apparatus is employed, however, it is
important that the dilating balloon be positioned so that inflation of the
balloon results in dilation of the sphincter or other structure, rather than
resulting in the application of a longitudinal force tending to move the
dilating balloon inward or outward of the sphincter or other structure. Since
movement of the dilating balloon in the endoscope is generally parallel to the
line of sight of the endoscope, viewing of the position of the dilating
balloon
relative to the sphincter or other structure may be problematic. The present
invention also addresses this problem, however.
More particularly, with reference to Figs. 11 through 13, an
embodiment of a device 210 according to the present invention is
thereshown, useful for temporarily dilating a sphincter 102 in a patient (not
shown). The device 210 is self-centering, such that an appropriate degree
of dilation of the sphincter 102 is assured. The device 210 thereby prepares
the sphincter for the performance of any desired procedure.
The device 210 of the present invention first comprises an
elongated catheter shaft 212 (generally comparable to the catheter shaft 12
of the device 10) and an inflatable balloon 264 carried on the catheter shaft
212. Preferably, the catheter shaft 212 has a proximal end 232 and a distal
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end 234, and the balloon 264 is affixed to the catheter shaft 212 adjacent
to the distal end 234 of the catheter shaft 212.
The balloon 264 comprises a proximal inflatable portion 266, a
distal inflatable portion 268 and an intermediate inflatable portion 270
between the proximal and distal portions 266 and 268. The intermediate
portion 270 of the balloon 264 has, upon inflation of the balloon 264, a
diameter suited for temporary dilation of the sphincter 102 in the patient.
The proximal and distal portions 266 and 268 of the balloon 264 have, upon
inflation of the balloon 264, diameters greater than the inflated diameter of
the intermediate portion 270 of the balloon 264. The intermediate portion
270 of the balloon 264 is thereby automatically centered in the sphincter
102 upon inflation of the balloon 264, the proximal and distal portions 266
and 268 preventing longitudinal movement of the balloon 264 in the
sphincter 102.
Preferably, the device 210 of the present invention is dimensioned
and adapted for the temporary dilation of the Sphincter of Oddi 102, the
inflated diameters of the intermediate, proximal and distal portions 270, 266
and 268 of the balloon 264 being selected to be suited therefor. The
balloon 264 preferably comprises nondistendable PET or another suitable
medical grade material. Also preferably, the proximal, intermediate and
distal portions 266, 270 and 268 of the balloon 264 are in fluid
communication with one another. More preferably, the proximal,
intermediate and distal portions 266, 270 and 268 of the balloon 264 are
continuously formed, such that the balloon 264 has only a single inflation
chamber 274 defined in it.
When the device 210 of the present invention is used for the
temporary dilation of the Sphincter of Oddi 102, specific dimensions for the
balloon 264 can be particularly advantageous. Accordingly, it is preferred
that the inflated diameters of the proximal and distal portions 266 and 268
of the balloon 264 are about 2 mm greater than the inflated diameter of the
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intermediate portion 270 of the balloon 264. More preferably, the inflated
diameter of the intermediate portion 270 of the balloon 264 is about 4 to
about 8 mm, while the inflated diameters of the proximal and distal portions
266 and 268 of the balloon 264 are about 6 to about 10 mm. The balloon
5 264 is preferably about 1.5 to about 4 cm long.
The catheter shaft 212 of the device 210 includes at least a first
longitudinally extending lumen 216 defined therein. The first lumen 216 is
dimensioned and adapted for the supply of a suitable inflation medium to the
balloon 264, for example, from a pressurized source 54 of the inflation
10 medium. The catheter shaft 212 also preferably includes a second
longitudinally extending lumen 224 defined therein, comparable to the third
lumen 24 of the device 10. The second lumen 224 is dimensioned and
adapted for receiving a guide wire 222 therethrough. The guide wire 222
can be the same as the guide wire 22 described above. The device 210 can
15 itself further comprise the guide wire 222.
Like the devices 10 and 110, the device 210 of the present
invention is useful with an over-the-wire endoscope 30 to which the
catheter shaft 212 is connectable. The device 210 can, of course,
additionally comprise the endoscope 30. In use, the guide wire 222 is
20 disposed across the Sphincter of Oddi 102, and the endoscope 30 advanced
along the guide wire 222 until its distal end lies adjacent the Sphincter of
Oddi 102. The device 210 is then positioned on the guide wire 222 and
introduced into the endoscope 30, then advanced until the distal end 234
of the catheter shaft 212 lies adjacent to the Sphincter of Oddi 102. The
device 210 is advanced further, until the catheter shaft 212 cannulates the
Sphincter of Oddi 102 and the balloon 264 lies generally across the it. The
balloon 264 is then inflated and dilates the Sphincter of Oddi 102, while
automatically centering in it. The balloon 264 is deflated, and the device
210 withdrawn from the patient. An opportunity is thereby provided for the
performance of any other desired procedure.
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The device 210 can comprise additional features which facilitate
cannulation of the Sphincter of Oddi 102. More particularly, the catheter
shaft 212 of the device 210 preferably includes a curled tip 272 extending
distally of the balloon 264. Advantageously, the curled tip 272 can be
about 4 cm long. Moreover, a distal portion 252 of the curled tip 272 of the
catheter shaft 212 can be tapered, further aiding passage of the distal end
234 of the catheter shaft 212 into and through the Sphincter of Oddi 102.
In the embodiment of Figs. 14 and 15 a first tube 12 is located
outside the second tube 62. First tube 12 has a central axial lumen 24
extending from the proximal end to the distal end of the tube and is
dimensioned to receive the second tube 62. In addition to its central lumen
24, first tube 12 has a lumen 16 parallel to and of a smaller diameter than
the central axial lumen, for supplying fluid to the balloon 14 (represented
inflated), a tapered end 34, a coupling device 36 and an inlet 38 for lumen
16. The second tube 62 has also a central axial lumen 63 and another
lumen 20 parallel to and of a smaller diameter than the central axial lumen
of tube 62 for supplying fluid to the balloon 18 (represent inflated). Means
of supplying fluid for inflating balloons 14 and 18 are provided at the
proximal ends of lumens 16 and 20 respectively /not shown). The device
is introduced through the working channel of endoscope 30, which also
provides means of observing the procedure of dilating the sphincter or tract
entrance and retrieving the stone. Without an endoscope, alternative means
of imaging the area of the sphincter or opening must be provided during the
procedure.
The procedure of dilating the sphincter or tract entrance and
retrieving the stones with the telescopic device of Fig. 2 is based on the
two-step method described with respect thereto. Firstly, the device is
introduced through the working channel of an endoscope 30 up to the region
of the sphincter or opening that needs to be dilated. At this stage, the
distal
extremity of second tube 62 is located proximally with respect to the distal
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extremity of first tube 12. Under direct vision from the endoscope, the
surgeon introduces first tube 12 with balloon 14 deflated within the
sphincter or opening. At this stage, balloon 14 is deflated and the first tube
is withdrawn from its present position within the sphincter. Balloon 18 at
the distal extremity of the second tube is then pushed distally to the distal
extremity of the first tube and is introduced through the opened sphincter
distally to the partially obstructing stone within the tract of the patient up
to its retrieval position. Regarding location of the second apparatus during
a retrieval procedure, the second apparatus is to be positioned via the
catheter either on the distal side of the stone so that it can draw the stone
so that when the second apparatus is a basket or cage, the latter can
capture them and then withdraw them towards the sphincter or opening.
Either of these positions is to be referred to as a "retrieval position".
Balloon
18 is then inflated to its manufactured volume of up to about 4 m13 and the
stones are retrieved by moving the second tube proximally until the stones
are retrieved from the tract of the patient.
A further embodiment is shown in Figs. 16 and 17 that is similar
to the embodiment of Fig. 8. Whereas, in Fig. 8 the control member 15 of
basket 154 is introduced directly within the lumen of catheter 1 12, in the
embodiment of Figs. 16 and 17, a second tube 60 is provided within central
axial lumen 24 of first tube 12, the second tube having a lumen within
which the elongated control member 61 of basket 154 is located. The
procedure for stone retrieval is similar to that used with the embodiment of
Fig. 8, except that when a retrieval basket or cage is used to retrieve the
stone from a tract, the basket or cage has to be positioned adjacent to the
stone so that the basket or cage can capture them and then withdraw them
toward the sphincter or tract opening.
In the telescopic arrangement of Figs. 18 and 19, first tube 12 is
the inner tube and second tube 62 is the outer tube. In Fig. 18, balloon 14
of first tube 12 is deflated while balloon 18 of second tube 62 is inflated.
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First tube 12 has a central axial lumen 24 and an additional lumen 16, for
supplying fluid to balloon 14, lumen 16 being parallel to and of a smaller
diameter than the diameter of lumen 24. The second tube 62 has an axial
lumen 63 into which first tube 12 is located and lumen 20 parallel to and of
a smaller diameter than the diameter of lumen 20. The two-step method
described for the telescopic arrangement of Fig. 14 applies also to the
embodiment of Fig. 18.
The twin balloon arrangement of the present application is well
suited to a situation when a dilated sphincter or opening closes rapidly after
dilation and before a surgeon could proceed to the extraction of the stone.
With a few manipulations, the sphincter could be re-dilated and the
extraction procedure continued. Similarly, the proposed telescopic
arrangement would be advantageous over today's catheters: the surgeon
would be able to maintain the sphincter or entrance opened while proceeding
to the extraction of the stone, and were the central lumen of the expanded
first apparatus sufficiently large, viewing by the surgeon is enabled for
stone
capture. Alternatively, were the dilation expansion apparatus a basket or
cage, or a balloon formed of transparent material, viewing through the
dilation expansion apparatus would be possible when expanded.
In view of the foregoing, it should be clear that the present
invention provides devices 10, 1 10 and 210 for dilating sphincters or other
tract entrances in the body, and engaging and extracting or removing
stones, calculi or the like from the biliary or urinary tract of a patient.
Each
of the embodiments of the device of the present invention is particularly
advantageous over prior dilation and extraction devices in one or more of a
variety of ways. The devices of the present invention may permit the
engagement and extraction or removal of stones, calculi or the like from the
biliary tract, the urinary tract or other body structure without requiring any
surgical cutting of body tissue. The devices of the present invention may
also permit the introduction of an associated retrieval basket, extraction
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balloon or the like quickly enough to take advantage of the time the
Sphincter of Oddi or other structure remained dilated, so as to permit the
ready passage of the basket or balloon through the Sphincter and allow the
ready observation of the engagement of the stones by the basket or balloon
via the endoscope. The devices of the present invention may also permit
their associated basket, balloon or the like to urge the stones through the
Sphincter of Oddi or other structure while it was still dilated. Finally, the
devices of the present invention may affirmatively ensure the position of the
dilation balloon with respect to the Sphincter of Oddi or other body structure
during its dilation.
The details of the construction or composition of the various
elements of the devices 10, 110 and 210 of the present invention not
otherwise disclosed are not believed to be critical to the achievement of the
advantages of the present invention, so long as the elements possess the
strength or mechanical properties needed for them to perform as disclosed.
The selection of any such details of construction are believed to be well
within the ability of one of even rudimentary skills in this area, in view of
the
present disclosure. For practical reasons, however, the devices 10, 1 10 and
210 of the present invention should probably be considered to be single-use
devices, rather than being reusable.
Industrial Applicability,
The present invention is useful for dilating sphincters or other
structures in the body of a human or veterinary patient, and engaging and
extracting or removing stones, calculi or the like from the body of a human
or veterinary patient, for example, from the biliary or urinary tract of the
patient, and therefore finds applicability in human and veterinary medicine.
