CA2265491C - Single operator exchange biliary catheter - Google Patents
Single operator exchange biliary catheter Download PDFInfo
- Publication number
- CA2265491C CA2265491C CA002265491A CA2265491A CA2265491C CA 2265491 C CA2265491 C CA 2265491C CA 002265491 A CA002265491 A CA 002265491A CA 2265491 A CA2265491 A CA 2265491A CA 2265491 C CA2265491 C CA 2265491C
- Authority
- CA
- Canada
- Prior art keywords
- guide wire
- catheter
- channel
- shaft
- wire lumen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0169—Exchanging a catheter while keeping the guidewire in place
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Endoscopes (AREA)
- Thermotherapy And Cooling Therapy Devices (AREA)
Abstract
Catheter for use in biliary procedures, including a shaft having a proximal end and a distal end. A guide wire lumen is carried by the shaft extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft. A channel extending longitudinally between a first end and a second end is included for accessing the guide wire lumen from a location exterior the catheter shaft located distal the proximal end of the shaft. The catheter may be used in rapid exchange catheter procedures. The channel may be U-shaped, containing the guide wire yet allowing radial removal of the guide wire from the channel. The catheter may also be part of a device including an endoscope exchange sheath for constraining guide wire movement to the catheter channel while inside a large endoscope working channel.
Description
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SINGLE OPERATOR EXCHANGE BILIARY CATHETER
Field of the Invention
The present invention relates to a catheter for use in
catheter procedures accessed through the alimentary canal
within the human anatomy and. methods of using such a
catheter. The catheter is particularly useful in
conjunction with an endoscope for accessing the biliary
tree. The present invention includes a catheter having a
single operator exchange or rapid exchange feature which
permits the use of a shorter guide wire, allows less time
consuming procedures, and allows for larger diameter
ancillary lumens within the catheter.
Description of the Prior Art
Endoscopic procedures for treating abnormal
pathologies within the alimentary canal system and biliary
tree (including the biliary, hepatic, and pancreatic ducts)
are increasing in number. The endoscope provides access to
the general area of a desired duct using direct
visualization. However, the duct itself must be navigated
using a catheter in conjunction with fluoroscopy and guide
wires.
Catheters are known for treatment of
anatomical regions.
targeted
Known methods and devices for using
biliary catheters for accessing the biliary tree for
performing catheter procedures are disclosed in Weaver et
al., U.S. Patent No. 5,397,302 and Karpiel, U.S. Patent No.
5,320,602, the disclosures of which are herein incorporated
by reference.
In general, for treatment of an abnormal pathology
within E1 patientâs biliary tree, an endoscope is first
introduced into the mouth of the patient. The endoscope
includes a proximal end and a distal end, and has a lumen
extending longitudinally between the proximal and distal
ends. The endoscope is guided through the patientâs
alimentary tract or canal until an opening at the distal
end of the endoscope is proximate the area to receive
treatment. At this point, the endoscope allows other
components, such as a catheter, to access the targeted
area.
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For visualization or treatment within the biliary
tree, the distal end of the endoscope is positioned
proximate the papilla of vater leading to the common bile
duct and the pancreatic duct. A catheter is guided through
the lumen of the endoscope until a distal tip of the
catheter emerges from the opening at the distal end of the
endoscope.
The catheter may be used for accessing the biliary
tree. The distal end of the catheter is guided through the
orifice to the papilla of vater (located between the
sphincter of oddi) leading to the common bile duct and the
pancreatic duct. A guide wire may be used in conjunction
with the catheter to
location within the biliary tree.
facilitate accessing a desired
The guide wire is
inserted in an opening at a proximal end of the catheter
and guided through the catheter until it emerges from the
distal end of the catheter.
If visualization of the.common bile duct is desired,
the guide wire is guided into the common bile duct. The
catheter is advanced over the guide wire, as previously
until the distal end of the catheter is
positioned in the common bile duct at the desired location.
described,
The catheter is now in position for delivery of contrast
media for fluoroscopic visualization of anatomical detail
within the common bile duct. Once the guide wire is in
place relative to the targeted area, it is highly desirable
to maintain that position of the guide wire during
subsequent catheter procedures, including catheter exchange
procedures.
Present biliary endoscopic procedures include the use
of multi-lumen catheters for endoscopic retrograde
cholangiopancreatography, endoscopic retrograde
sphincterotomy, the use of balloon catheters having
retrieval balloons, and other therapeutic and diagnostic
procedures. As described in general above, these present
biliary endoscopic procedures are performed using guide
wire techniques. The present devices utilized in these
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procedures are at least 180 cm long since they pass through
the endoscope, which is commonly at least 150 cm long.
Therefore, when using a standard catheter having a guide
wire lumen extending the full length of the catheter, guide
wires used during these procedures must be at least 400 cm
in length to accommodate the exchanging of different
devices while maintaining access and position within the
biliary tree. The exchange of devices over a 400 cm guide
wire is both time consuming and cumbersome.
Due to the length of the guide wire, physicians
require at least two assistants in the room to perform the
biliary endoscopic procedure. Typically, one assistant is
responsible for the patient and device-related concerns,
while the other assistant is responsible for the guide
wire. The additional hands required due to the length of
the guide wire results in a relatively more time consuming
and costly procedure.
It is desirable to have an exchange catheter suitable
for use within the alimentary canal for accessing targeted
anatomical regions, such as the biliary tree, having
features which facilitate rapid exchange and allow an
exchange procedure to be performed by a single operator.
It is desirable to have a biliary exchange catheter which
may be used in connection with a shorter guide wire, and
requires less personnel for performing biliary procedures.
It is desirable to have a biliary exchange catheter which
limits the amount of guide wire over which the catheter
must travel.
It is also desirable to have a biliary rapid exchange
catheter
which may be convertible for use
between
conventional guide wire techniques and rapid exchange guide
wire techniques. It is desirable to have a biliary rapid
exchange catheter which is easily removable from the guide
wire, and adaptable for use with most catheter systems used
within the alimentary canal.
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Summary of the Invention
The present invention relates to a biliary catheter
for use in biliary endoscopic procedures which incorporates
rapid exchange catheter features. Rapid exchange features
include an effective guide wire lumen which is much shorter
than the overall catheter length to facilitate rapid
exchange of the device over the guide wire.
In one preferred embodiment, the present invention is
an improved catheter for use in biliary procedures which
includes a shaft having a proximal end and a distal end.
The improvement includes a guide wire lumen carried by the
shaft extending from a location proximal of the distal end
of the shaft to a location proximate the distal end of the
shaft. Means are provided for accessing the guide wire
lumen from. a location exterior to the catheter shaft,
located a substantial distance distal of the proximal end
of the shaft.
The guide wire lumen may be formed integral with the
shaft. The means for accessing the guide wire lumen may
include an open channel extending through a wall of the
catheter shaft.
More particularly, the preferred means or channel for
accessing the guide wire lumen includes a channel distal
end through the wall of the catheter shaft into the guide
wire lumen located proximal of the distal end of the shaft
and a channel proximal end into the guide wire lumen
located proximal of the intermediate opening. The channel
is further defined by a longitudinal opening to the
exterior of the catheter shaft extending between the
channel distal end and the channel proximal end in
communication with the guide wire lumen. The longitudinal
opening preferably is equal to or greater than the diameter
of a guide wire used therewith.
In one embodiment, the open channel has a "U" shape.
The open channel is in communication with the guide wire
lumen, allowing the guide wire to run within the guide wire
lumen and U-channel over the length of the catheter.
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Additionally, the preferred embodiment includes an
endoscope sheath selectively positioned about at least a
portion of the channel so as to provide an inside diameter
sufficiently small to constrain the guide wire
substantially within the channel. The endoscope sheath may
be used in conjunction with an endoscope working channel
large enough to otherwise allow the guide wire to move
radially out of the open channel and become pinched between
the catheter exterior and the endoscope working channel
wall interior. The sheath allows the guide wire to be
externally radially accessible, yet not loose within the
endoscope working channel, with the sheathed catheter and
guide wire presenting a generally circular profile to the
endoscope working channel.
In the preferred embodiment, the endoscope sheath
includes a longitudinal slit, allowing for selective guide
wire radial removal through the slit. This configuration
facilitates expedient sheath removal and exchange, while
maintaining guide wire and/or catheter position within the
patient. In yet another embodiment, the endoscope sheath
has a circumferential overlap along its length, providing
an alternate opening for radially removing a guide wire.
In another embodiment, the present invention includes
a method of positioning a k?liary catheter including a
shaft having a proximal end and a distal end, within a
patientâs alimentary canal. The method includes the step
of providing a catheter with a guide wire lumen therein.
The guide wire lumen extends from a location proximal of
the distal end of the shaft to a location proximate the
distal end of the shaft. An open channel is provided
through a sidewall of the shaft into the guide wire lumen.
The channel is located distal of the proximal end of the
shaft. The method further includes the step of moving a
guide wire into and through the channel, relative to the
shaft. The method may further include the step of
advancing the catheter over the guide wire.
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In another embodiment, the present invention includes
a method of exchanging a catheter during a biliary
endoscopic procedure. The method includes the step of
passing an endoscope, lumen extending
longitudinally therethrough, through a patient's mouth into
the alimentary canal.
having a
A distal end of the endoscope is
positioned proximate an opening into the biliary tree. A
guide wire is passed through the lumen of the endoscope.
A catheter is provided. having a guide wire lumen
carried by the shaft, extending from a location proximal of
a distal end of the shaft to a location proximate the
distal end of the shaft. The shaft includes a channel into
the guide wire lumen, located distal of the proximal end of
the shaft. The channel is defined by a channel proximal
end and a channel distal end. The catheter is advanced
over the guide wire, wherein a proximal end of the guide
wire exits from the channel. The method further comprises
the step of passing the guide wire radially through the
channel opening while inserting or retracting the catheter
until the guide wire exits the second opening.
Brief Description of the Drawings
The invention will be further described with reference
to the accompanying drawings, wherein like numbers refer to
like parts in several views and wherein:
Fig. 1 is a perspective view of a catheter in
accordance with the present invention having a U-shaped
channel and guide wire lumen for directing a guide wire
along its shaft and for facilitating rapid catheter
exchange;
Fig. 1A is a cross-sectional view of the catheter of
Fig. 1 taken along the line 1A-1A;
Fig. 1B is a cross-sectional view of the catheter with
guide wire of Fig. 1 taken along the line 1B-1B;
Fig. 1C is an enlarged fragmentary perspective view of
the encircled catheter section of Fig. 1 at 1C;
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Figs. 2A-2D are cross-sectional views of the catheter
of Fig. 1 located within increasingly larger endoscope
channels;
Fig. 3 is a perspective view of an endoscope exchange
sheath assembly, without slit, suitable for receiving the
catheter of Fig. 1;
Fig. 3A is an enlarged fragmentary perspective view of
the encircled sheath section of Fig. 3 at 3A;
Fig. 4 is a perspective view of an alternative
embodiment sheath assembly having a slit sheath and two-
piece hub, shown in unlocked position;
Fig. 4A is a perspective View of the two-piece hub of
Fig. 4 in locked position;
Fig. 4B is an enlarged fragmentary perspective view of
the encircled sheath section of FIG. 4 at 4B, having a
slit;
Fig. 4C is an enlarged fragmentary perspective view of
a sheath having an overlap, an alternate
embodiment of the sheath in Fig. 4B;
section,
Fig. 5 is a perspective view of the catheter of Fig.
1 inserted through the endoscope sheath assembly of Fig. 4;
Fig. 6 is a perspective view of a endoscope sheath
section containing a catheter having a U-shaped channel
containing a guide wire;
Fig. 7 is a partial perspective view of a guide wire
within the catheter of Fig. 1 inserted through the
endoscope sheath assemblyâ of Fig. 4, which is in âturn
within an endoscope;
Fig. 7A is a perspective view of the sheath assembly
of Fig. 7, having the catheter removed;
Fig. 8 is a partial perspective view of an alternative
embodiment of a sheath assembly, including an introducer;
Fig. 8A is an enlarged perspective view of the
introducer of Fig. 8;
Fig. 9A is an enlarged, cross-sectional view of an
alternative embodiment of the introducer of Fig. 8;
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cross-sectional view of
another alternative embodiment of the introducer of Fig. 8;
Fig. 9B is an enlarged,
Fig. 9C is an enlarged, cross-sectional view of
another alternative embodiment of the introducer of Fig. 8;
cross-sectional view of
another alternative embodiment of the introducer of Fig. 8;
Fig. 9D is an enlarged,
Fig. 9E is an enlarged, perspective view of another
alternative embodiment of the introducer of Fig. 8;
Fig. 9F is an enlarged, cross-sectional view of
another alternative embodiment of the introducer of Fig. 8;
Fig. 10 is a partial elevational view of a catheter
showing another application of the present invention; and
Fig. 11 is a partial elevational view of a catheter
showing another application of the present invention.
Detailed Description of the Invention
Fig. 1 shows a perspective view of a catheter assembly
Catheter
assembly 30 is used in catheter procedures for accessing
30 in accordance with the present invention.
targeted anatomical regions through the alimentary canal.
The present invention incorporates features which allow
rapid. exchange of catheter" by a single operator. The
catheter of the present invention allows shorter length
guide wires to be used, resulting in procedures which
require less medical personnel, are less time consuming,
and less costly. Additionally, the present invention is
adaptable to most catheter devices used for catheter
procedures within the alimentary canal.
Catheter assembly 30 includes a catheter hub assembly
32 and a catheter 34, having a guide âwire 36 passing
Catheter 34 includes a shaft
38, which in general terms has a proximal end 40, a U-
channel 42, a distal tip region 44, a distal end 46 and
various lumens described in greater detail below. Catheter
hub assembly 32 is operably connected to proximal end 40 of
shaft 38. Catheter hub
configured to couple to ancillary devices allowing access
to a lumen within shaft 38.
through a portion thereof.
assembly 32 is preferably
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Shaft 38 is a generally tubular shaped member having
a generally uniform outer shape at proximal end 40. Shaft
38 may be sized for slidable passage through the lumen of
an endoscope (not shown). Shaft 38 is preferably formed in
an extrusion process. Shaft 38 may be formed of an
extruded polymeric material. In one embodiment, the
preferred polymeric material is polytetrafluoroethylene,
polyether block amide, nylon or a combination or blend of
these. Catheters which are contemplated include, but are
not limited to, cannulas,
sphincterotomes, cytology
devices, and devices for stone retrieval and stent
placement.
In a preferred embodiment, shaft 38 further includes
a distal taper 48 which tapers to distal tip region 44.
Additionally, tip region 44 nmy include high contrast,
color coded distal markers 50. Finally, distal end 46 may
be radiopaque for fluoroscopic visualization of distal tip
region 44 during a catheter procedure. It should be
understood, however, that these additional features are in
no way required elements.
U-channel 42 of shaft 38 extends between a first,
proximal channel end 52 and a second, distal channel end
54. Uâchannel 42 serves to contain, but not necessarily
constrain, guide wire 36, between channel proximal end 52
and channel distal end 54. The term "U-channel" refers to
a channel shape that allows radial removal of guide wire 36
from the channel 42, and need not be strictly in the shape
of the letter U. Channel 42 in the preferred embodiment is
sufficiently large to allow unhindered radial guide wire 36
movement out of channel 42. Further, the channel walls and
radial opening are substantially equal to or slightly
larger than the diameter of a guide wire lumen, described
in greater detail below. Although it is recognized that
proximal channel end 52 may be located at any location
distal of proximal end 40 of shaft 38, channel distal end
54 is preferably located between 10 and 40 cm from distal
end 46 of catheter shaft 38.
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Finally, as shown in Fig. 1A, which is a cross-
sectional View of shaft 38 taken along line 1A-1A at a
location proximal of channel proximal end 52, shaft 38
includes ancillary lumen 56, ancillary lumen 58 and guide
wire lumen 60.
Ancillary lumen 56 and ancillary lumen 58 extend
longitudinally between proximal end 40 and distal end 46 of
shaft 38. Ancillary lumen 56 and ancillary lumen 58 may be
injection lumens, allowing for high contrast media flow
capability for bubble-free opacification and for excellent
visualization of a desired anatomical region. Additionally
or alternatively, ancillary lumen 56 and/or ancillary lumen
58 may be used for or as part of other ancillary devices,
such as a cutting wire lumen or a retrieval balloon lumen.
Guide wire lumen 60 extends longitudinally between
proximal end 40 and distal end 46 of shaft 38 in the
preferred embodiment. Further, guide wire lumen 60 is
sized to receive guide wire 36. Guide wire lumen 60 may be
a tubular member which is extruded integral catheter shaft
38, or alternatively, guide wire lumen 60 may be a separate
tubular member which is coupled. to catheter shaft 38.
Although in one preferred embodiment the guide wire lumen
60 is a tubular member which is located proximate distal
end 46 of catheter shaft 38, it is recognized that guide
wire lumen 60 may be formed anywhere along shaft 38, may be
an extension of shaft 38 coupled to distal end 46, or guide
wire lumen 60 may run the entire length of shaft 38.
Referring to Fig. 1B, a crossâsectional view of shaft
38 taken along line 1B-1B of Fig. 1 is shown. Guide wire
36 may access guide wire lumen 60 at a point proximal
channel distal end 54. Guide wire 36 extends within
channel 42 to channel distal end 54, continuing within
guide wire lumen 60 through distal tip region 44, and
exiting through an opening in distal end 46.
Referring to Fig. 1C, a section of catheter shaft 38
having U-channel 42 is shown. The embodiment shown also
includes ancillary lumens 56 and 58. Sections of shaft 38
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proximate the channel proximal end 52 and distal channel
distal end 54 contain guide wire lumen 60 in communication
with U-channel 42. In one embodiment, U-channel 42 has an
interior, closed-side geometry, substantially the same as
the geometry of guide wire lumen 60. Further, U-channel 42
walls are spaced further than a diameter of guide wire 36
such that guide wire 36 moves freely into and out of U-
channel 42.
Catheter shaft 38 can be configured such that U-
channel 42 is defined separately from guide wire lumen 60.
With this approach, guide wire lumen 60 is divided into two
sections; a first section extending between proximal end 40
of shaft 38 and channel proximal end 52; and a second
portion extending between channel distal end 54 and distal
end 46 of shaft 38. Alternatively, the shaft can be
configured to define guide wire lumen 60 as extending
longitudinally between proximal end 40 and distal end 46 of
shaft 38. In the alternative embodiment, between channel
proximal end 52 and channel distal end 54, guide wire lumen
60 is integral with U-channel 42. In other words, guide
wire lumen 60 defines a portion of U-channel 42 such that
spacing between outer walls of U-channel 42 is equal to a
diameter of guide wire lumen 60. Regardless of how guide
wire lumen 60 and U-channel 42 are defined, U-channel 42
provides for access to guide wire lumen 60 at channel
distal end 54. In this regard, channel distal end 54 can
be enlarged to more easily direct guide wire 36 into guide
wire lumen 60.
Guide wire lumen 60 and U-channel 42 allowâ rapid
exchange of catheter assembly 30 when an alternative
catheter is necessary during a certain medical procedure.
Shorter length guide wires may be used since guide wire 36
does not pass through shaft proximal end 40 and hub
assembly 32, but rather exits the catheter shaft 38 at U-
channel 42 located substantially distal from proximal end
40. The unique catheter construction in accordance with
the present invention will reduce catheter therapeutic and
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diagnostic procedure time since catheter device exchanges
may be performed relatively more easily and quickly by a
single operator. Additional personnel and time associated
with maintaining the conventional
(approximately 400 cm) guide wire within the targeted
anatomical region is eliminated, reducing the overall costs
of the procedure.
placement of a
Referring to Figs. 2A through 2D, cross-sectional
views of endoscope working channels 70-76 containing a
catheter according to Fig. 1 are shown. In the examples
illustrated in Figs. 2A through 2D, working channel inside
diameters 70, 72, 74, and 76 are 2.8, 3.2, 3.8, and 4.2 mm,
respectively. Fig. 2A illustrates catheter shaft 38 having
ancillary lumens 54 and 56, U-channel 42, and guide wire 36
within U-channel 42. Further, shaft 38 is shown within a
first size endoscope working channel 70. In Fig. 2A, guide
wire 36 is effectively radially constrained by small sized
working channel 70 that closely surrounds U-channel 42.
Fig. 2B illustrates catheter containment within a
second size working channel 72, slightly larger than the
working channel 70 of Fig. 2A. In Fig. 2B, guide wire 36
is able to move out of U-channel 42 to a position denoted
with dashed lines at 80. Fig. 2C shows shaft 38 contained
within a third, even larger sized. working channel 74.
Guide wire 36 is able to move completely out of U-channel
42 to position 82 shown with dashed lines. Finally, Fig.
2D demonstrates catheter shaft 38 within a fourth size
working channel 76. In this even larger working channel,
guide wire 36 lies within an even larger cross-sectional
area, and is able to move to a position shown in FIG. 2D
with dashed lines at 84.
As shown with the larger endoscope working channels
(Figs. 2C and 2D), the potential for guide wire 36 to slip
out of U-channel 42 creates a potential for the guide wire
36 to become pinched and restrict desired movements of both
guide wire 36 and catheter shaft 38. For this reason, when
larger endoscope working channels are used, an exchange
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sheath having a sufficiently small inner diameter so as to
constrain guide wire movement to within the catheter U-
channel 42 is employed. with the preferred embodiment.
Generally speaking, an endoscope sheath in
accordance with the preferred embodiment allows for use of
a radially accessible guide wire, which is longitudinally
aligned with the catheter, while presenting a c?xcular
profile to an endoscope and mitigating guide wire pinching
problems between the catheter and the endoscope working
channel wall.
exchange
Referring to âFig. 3, an endoscope exchange sheath
assembly 100 having sheath hub assembly 102 and a sheath
104 is shown. The sheath 104 includes a lumen 106 and a
distal end 108. Fig. 3A shows a section of sheath 104,
having lumen 106 for receiving a catheter. Basically, with
reference to Fig. 1, catheter 34 is fed through lumen 106
of sheath 104 such that sheath 104 encompasses guide wire
36 within U-channel 42. Sheath 104 is adapted. to be
disposed within an endoscope working channel, thereby
providing a smaller diameter channel than that of the
surrounding endoscope working channel constraining the
guide wire 34 (Fig. 1) to the Uâchannel 50 (Fig. 1), and
mitigating the potential problems shown in Figs. 2C and 2D.
Referring to Fig. 4, an alternate endoscope exchange
sheath assembly 110 is shown. Sheath assembly 110 includes
a two-piece hub assembly 112 and a sheath 114 defining
lumen 116 and having slit 118 extending longitudinally over
its length, terminating at distal end 120. Slit 118 in
sheath 114 is shown in more detail in Fig. 4B.
Referring again to Fig. 4, two-piece hub assembly 112
has a proximal hub portion 122 and a distal hub portion
124, having a proximal slit 126 and a distal slit 128,
respectively. Sheath slit 118 is in communication with hub
slits 126 and 128, allowing a guide wire (not shown) to be
radially slid into or out of sheath assembly 110. Proximal
hub portion 122 is shown unlocked (position "A") in Fig. 4,
aligning hub proximal slit 126 with hub distal slit 128 and
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sheath slit 118, providing a continuous slit for guide wire
radial movement into and out of the sheath assembly 110.
Proximal hub portion 122 is shown locked, in position "B",
in Fig. 4A, whereby proximal hub slit 126 is rotated with
respect to distal hub slit 128, preventing a guide wire
(not shown) within hub assembly 112 from being moved
radially out of hub assembly 112. Proximal hub portion 122
is set to position B (Fig. 4A) when radial guide wire
movement is not desired.
Fig. 4C illustrates a portion of an alternate
embodiment sheath 130 having a lumen 132, a sheath wall
opening 134 and sheath wall overlap 136. A guide wire (not
shown) is able to be slid out of lumen 132 of sheath 130 by
maneuvering the guide wire into sheath wall opening 134 and
through overlap 136.
Referring to Fig. 5, catheter assembly 30 depicted in
Fig. 1 is shown inserted within endoscope exchange sheath
assembly 110 depicted in Fig. 4. More particularly,
catheter 34 is inserted through slitted sheath assembly
110, extending distally out sheath distal end 120. Guide
wire 36 (shown partially in Fig. 5) is positioned within U-
channel 42 of catheter 34, along guide wire lumen 60 (Fig.
IB), and extends from shaft distal end 46. Further, guide
wire 36 is engaged by hub assembly 112. More particularly,
guide wire 36 passes within and is engaged by proximal slit
126 and distal slit 128 of hub assembly 112. Sheath
proximal hub portion 122, having proximal slit 126, is
shown in locked position relative to sheath distal hub
portion 124, having distal slit 128. Thus, in the locked
position, hub assembly 112 of sheath assembly 110 prevents
radial withdrawal of guide wire 36, otherwise inserted in
U-channel 42 of catheter 34, from distal the channel
proximal end 52.
Referring to Fig. 6, a section of Fig. 5 is shown in
detail, having endoscope sheath 114 containing catheter
shaft 38, which further maintains guide wire 36 within U-
channel 42. As shown, sheath 114 is able to constrain
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movement of guide wire 36 from Uâchannel 42 when sheath 114
is within a larger endoscope working channel, for example
as illustrated in Figs. 2C and 2D. Importantly, the sheath
114 embodiment illustrated in Fig. 6 includes longitudinal
slit 118, allowing guide wire 36 to be peeled from catheter
shaft 38 and endoscope sheath 114. In other words, as
previously described, U-channel 42 is sized larger than
guide wire 36 such that guide wire 36 can displace radially
from U-channel 42. Sheath 114 prevents undesired
displacement of guide wire 36 front U-channel 42 under
normal operating conditions. However, if adequate radial
force is placed on guide wire 36 by an operator, guide wire
36 will separate sheath 114 along slit 118 such that guide
wire 36 is displaced from sheath 114 and U-channel 42.
Referring to Fig. 7, guide wire 36 is shown inserted
within catheter assembly 30 of Fig. 1, which is inserted
through endoscope sheath assembly 110 of Fig. 4, which is
in turn within an endoscope 150. Sheath assembly 110
includes sheath 114 that has slit 118 and two-piece hub
assembly 112, shown at a locked position "B" (also in Fig.
4A). Having hub assembly 112 locked prevents guide wire 36
from moving radially out of sheath 114 through slit 118.
Guide wire 36 can be restrained from longitudinal movement
by applying finger pressure on the guide wire 36 against
hub assembly 112.
Referring to Fig. 7A, endoscope 150 and sheath
assembly 110 of Fig. 7 are shown without the catheter
assembly 30 inserted, as after catheter withdrawal. Sheath
hub assembly 112 is shown in unlocked position at "A" (also
in Fig. 4). Having hub assembly 112 unlocked allows radial
movement of guide wire 36 out of sheath 114 through slit
118, but such movement may be restrained by trapping guide
wire 36 against the outside of sheath 114 using one finger,
providing ease of guide wire 36 control during catheter
exchanges.
In one possible endoscopic procedure, an endoscope
150, as illustrated in Fig. 7, is first introduced into the
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mouth of a patient and is guided through the patient's
alimentary canal. Specifically, endoscope 150 is guided
down the esophagus, through the stomach, past the pyloric
sphincter of the stomach and into the duodenum.
150 has a lumen extending longitudinally between its
proximal end and the distal end.
Endoscope
Endoscope 150 is guided through the alimentary canal
until a distal end (not shown) of endoscope 150 is
proximate the target area within the anatomy to receive
treatment. In an endoscopic biliary procedure, endoscope
150 is guided into the duodenum until the opening at the
distal end of the endoscope 150 is proximate the papilla of
vater. The papilla of vater is located between the
sphincter of oddi, which leads to the common bile duct,
hepatic, and pancreatic ducts. The proximal end (shown in
Figs. 7 and 7A) of endoscope 150 extends and remains
outside the mouth of the patient.
With endoscope 150 properly positioned within the
patient, catheter assembly 30 is prepared for insertion
into the endoscope. First, guide wire 36 is fed into the
guide wire lumen 60 (Figs. 1Aâ1C) of shaft 38. More
particularly, a distal end of guide wire 36 is placed
within U-channel 42, distal the channel proximal end 52.
The guide wire 36 is then fed to channel distal end 54
(Fig. 1) into guide wire lumen 60. Finally, guide wire 36
is fed through shaft 38 to distal tip region 40 (Fig. 1).
In one method, catheter 32 is then inserted directly into
endoscope 150 working channel. This method may be
practiced with an endoscope having a sufficiently small
working channel inside diameter, as illustrated in Fig. 2A,
to constrain guide wire 36 movement without a sheath.
However, in a preferred method (with reference to Fig.
7), catheter assembly 30, threaded with guide wire 36, is
inserted into sheath assembly 110, thereby constraining
guide wire 36 from slipping radially out of U-channel 42.
More particularly, catheter 34 is inserted into endoscope
150 working channel, but leaving channel proximal end 52
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proximate sheath hub assembly 112, and leaving a portion of
guide wire 36 extending from the channel proximal end 52 as
well. Notably, sheath hub assembly 112 includes hub slits
126 and 128 which receive a portion of guide wire 36.
Thus, in the preferred embodiment, hub assembly 112 is
locked, preventing unwanted radial guide wire 36 movement.
In a preferred method, the loading of guide wire 34 into
catheter shaft 38 and catheter shaft 38 into sheath
assembly 110 is done prior to inserting endoscope 150 into
a patient (not shown).
Endoscope sheath 114, containing catheter shaft 38, is
inserted into endoscope 150 working channel. Endoscope
sheath 114 serves to constrain radial guide wire 36
movement over the approximate length of U-channel 42.
Catheter shaft 38 and sheath 114 are inserted together into
endoscope 150 until both are near a distal end (not shown)
of endoscope 150. Catheter shaft 38 and sheath 114 may be,
either or both, advanced until exiting the distal end of
endoscope 150.
In one method, guide wire 36 is advanced until guide
wire 36 distal tip is positioned within the target area in
the biliary tree (including the common bile, hepatic or
pancreatic ducts). For example, the distal tip of guide
wire 36 may be guided through the orifice leading to the
papilla of vater for access to the biliary tree. Catheter
shaft 38 may then be advanced over guide wire 36, tracking
catheter assembly 30, until catheter distal tip region 40
(Fig. 1) exits distal end of endoscope 150 and is
positioned within the desired duct. In another method,
guide wire 36 and catheter assembly 30 are advanced
together until catheter distal end 42 (Fig. 1) is
positioned at the target area. It is also recognized that
the catheter could be first advanced to near the target
area, followed by inserting the guide wire when needed to
advance the catheter further.
Once guide wire 36 is in position at the target area,
catheter procedures, including injecting contrast media,
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such as radiopaque dye, through ancillary lumens 56 or 58
(Fig. 1A-1C) into the common bile duct for visualization of
After the desired catheter
procedure has been completed, catheter assembly 30 can be
exchanged or removed from endoscope 150, leaving guide wire
Catheter
assembly 30 and sheath assembly 110 may also be removed
together.
the duct, can be performed.
36 in position for other catheter procedures.
One method of withdrawing catheter 34 from endoscope
150 is possible using either a slitted/overlapped endoscope
sheath 114 as depicted in Figs. 4 through 5C, or a sheath
104 without a slit as depicted in Figs. 3 through 3A.
Using this method, best visualized with reference to Fig.
7, guide wire 36 is held to prevent longitudinal movement
while catheter 34 is retracted within endoscope sheath 114
(or 104). Catheter 34 retraction leaving the guide wire 36
in position within the patient is enabled by U-channel 42
being radially open to guide wire 36 removal in catheter
shaft 36. Once catheter retraction has brought channel
distal end 54 (Fig. 1) to a point proximate sheath hub
assembly 112, only a relatively short portion of guide wire
36, from channel distal end 54 to distal end 46 (Fig. 1) of
catheter shaft 38, remains within catheter 34. A single
operator can remove this remaining portion of guide wire 36
from catheter 34 by first slightly retracting catheter
assembly 30 (while still holding guide wire 34 in place)
out of sheath assembly 110 (or 100), such that a portion of
guide wire 36 is accessible distal of catheter distal end
46. In other words, a small portion of guide wire 36 is
accessible between distal end 46 of catheter 34 and distal
hub portion 124 of sheath assembly 110. The accessible
portion of guide wire 36 is then held by the operator,
while withdrawing the remaining portion of catheter 34
completely over guide wire 36. In an alternative method,
the distal end of the endoscope can include an elevator
which could be utilized to lock the distal end of the guide
wire in position while the catheter is removed.
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Exchange of endoscope sheath assembly 110 may be
desired, as when a stent (not shown) is to be advanced over
guide wire 36, and the stent has a larger outside diameter
than can be accommodated by the sheath 114. One method of
exchanging an endoscope sheath assembly 110 may be used
where sheath 114 is slitted as in Fig. 4B, or overlapped,
as in sheath 130 in Fig. 4C. Referring to Fig. 7A, two-
piece hub assembly 112 is turned to the unlocked position
"A" (also shown in Fig. 4). Guide wire 36 is pulled
radially away from sheath hub assembly 112 and through slit
118 in sheath 114. Guide wire 36 is then held, preferably
against some portion of endoscope 150, to prevent guide
wire 36 from being dislodged from position within the
patient. Sheath 114 is retracted from endoscope 150, guide
wire 36 being "peeled" away from sheath 114. Sheath
retraction is continued. until sheath 114 is completely
outside of endoscope 150 and over guide wire 36. At this
point, guide wire 36 is within endoscope 150 working
channel, and stents, catheters, and endoscope sheaths may
be advanced over guide wire 36.
Another method of exchanging both endoscope sheath
assembly 110 and catheter assembly 30 may be used where the
sheath 114 is slitted as in Fig. 4B, or overlapped, as in
sheath 130 in Fig. 4C. Referring to Fig. 7 and 7A, two-
piece hub assembly 112 is turned to the unlocked position
"A" (Fig. 7A). Guide wire 36 is pulled radially away from
U-channel 42 of catheter 34, from hub assembly 112 and
through slit 118 in sheath 114. Guide wire 36 is then
held, preferably against some portion of endoscope 150, to
prevent guide wire 36 from being dislodged from position
within the patient. Sheath 114 and catheter 34 are
retracted from endoscope 150, with guide wire 36 being
"peeled" away from sheath 114. Sheath assembly 110 and
catheter assembly 30 retraction are continued until sheath
114 and catheter 34 are completely outside of endoscope 150
and over guide wire 36. At this point, guide wire 36
remains in a position within endoscope 150 and patient. A
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single operator can access a small portion of guide wire 36
between distal end 46 (Fig. 1) of catheter 34 to hold guide
wire 36 in place while catheter assembly 30 is completely
removed or disengaged from guide wire 36.
While sheath assembly 110 has
including a two-piece hub assembly 112 in conjunction with
sheath 114, other assemblies may be used. For example,
referring to Fig. 8, an alternate sheath assembly 160 is
shown. Sheath assembly 160 includes an introducer 162, an
attachment means 164 and a sheath 166. Similar to previous
embodiments, sheath 166 defines a lumen (not shown) and
includes a slit 168 extending longitudinally over its
length, terminating at a distal end 170. Sheath 166 is
generally identical to sheath 104 and sheath 114 previously
described. Introducer 162 is attached to sheath 166 by
attachment means 164 such that lumen (not shown) of sheath
166 is in fluid communication with an interior portion of
introducer 162. In one preferred embodiment, attachment
means 164 is a flexible membrane which seals sheath 166 to
introducer 162. Alternatively, other forms of attachment,
an adhesive or frictional engagement between
introducer 162 and sheath 166 may also be useful.
Referring to Fig. 8A,
been described as
such as
introducer 162 is shown in
greater detail. Introducer 162 is a funnel-shaped device
including a horn 172 and a neck 174. In one preferred
embodiment, horn 172 and neck 174 are integrally formed as
a singular body.
Horn 172 is preferably a conically-shaped body having
an outer wall 176. Outer wall 176 defines an interior
space and includes a guide wireâreceiving notch 180 formed
near proximal end 182 of horn 172. Guide wire-receiving
notch 180 is preferably J-shaped and includes an entry end
184 and a locking end 186. As shown in Fig. 8A, entry end
184 is open at proximal end 182 of horn 172.
locking end 186 is closed.
Conversely,
Neck 174 is preferably tubular in shape, and includes
a passage 188. Passage 188 is configured to be in fluid
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communication with interior space of horn 172. In the
preferred embodiment, horn 172 and neck 174 are formed of
a plastic material. Alternatively, any other semi-rigid or
rigid, surgically-safe material may be used.
Referring to Figs. 1, 8 and 8A, during use, catheter
assembly 34 (Fig. 1) is inserted within sheath assembly
160. More particularly, distal end 46 (Fig. 1) of catheter
shaft 38 (Fig. 1), including guide wire 36 (Fig. 1) is
placed within horn 172 of introducer 162. The conical
shape of horn 172 assists in directing distal end 46 of
catheter shaft 38, including guide wire 36, into passage
188 of neck 174. Catheter shaft 38 continues forward
within lumen (not shown) of sheath 166 until distal end 46
of catheter shaft 38 extends from distal end 170 of sheath
166.
Once properly inserted within sheath assembly 160, a
proximal end of guide wire 36 (Fig. 1) is maintained within
guide wire-receiving notch 180. More particularly, a
portion of guide wire 36 is forced by an operator through
entry end 184 of guide wire-receiving notch 180 and forced
within locking end 186 thereof. In this regard, locking
end 186 preferably has a diameter slightly smaller than
that of guide wire 36. Thus, locking end 186 frictionally
maintains guide wire 36. Conversely, guide wire 36 can
easily be released from guide wire-receiving notch 180 by
sliding guide wire 36 from looking end 186 and out of entry
end 184. Thus, sheath assembly 160 functions in a manner
highly similar to sheath assembly 100 and sheath assembly
110 previously described.
Referring to Fig. 9A, an alternative embodiment of an
introducer 190 is shown. Introducer 190 includes a horn
192, a neck 194 and a valve 196. Similar to previous
embodiment, horn 192 and neck 194 are preferably integrally
formed as a singular body. Horn 192 includes an outer wall
197 which defines a guide wire-receiving notch 198 and
valve-receiving slots 200. Valve 196 includes a valve body
202 sized to fit within outer wall 197 of horn 192.
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Further, valve 196 includes ribs 204 extending from valve
body 202. Ribs 204 are preferably sized to mate within
valve-receiving slots 200 of horn 192. Thus, valve 196 is
maintained within horn 192 via interaction of ribs 204 with
valve-receiving slots 200. In this regard, valve-receiving
slots 200 are preferably positioned along horn 192 proximal
neck 194.
material.
Valve 196 is preferably made of a rubber-type
During use, introducer 190 functions in a manner
highly similar to introducer 162 (Figs. 8 and 8A)
previously described. Additionally, however, valve 196
forms a seal about catheter shaft 38 (Fig. 1). Thus, upon
insertion into a human body, valve 196 prevents bodily
fluids, such as bile, from backing up through the sheath
assembly. Additionally, valve 196 can provide for
aspiration, if desired.
Referring to Fig. 9B, an alternative embodiment of an
introducer 206 is shown. Introducer 206 is highly similar
to introducer 190 (Fig. 9A) previously described. In this
regard, introducer 206 includes a horn 208, a neck 210 and
a valve 212. Horn 208 is preferably integrally formed with
neck 210 and includes an outer wall 214 defining a guide
wire-receiving notch 216 and valve-receiving slots 218.
Similar to valve 196 (Fig. 9A), valve 212 includes a valve
body 220 and ribs 222. Ribs 222 are sized to mate within
valve-receiving slots 218 of horn 208. In this regard,
valve-receiving slots 218 are positioned proximate a
proximal end 224 of horn 208. Introducer 206, including
valve 212, functions in a manner highly similar to
introducer 190 (Fig. 9A) as previously described.
It is recognized. that âthe fluid. blocking function
provided by valve 212 can be achieved with other designs.
For example, referring to Fig. 9C, an alternative
embodiment of an introducer 226 is shown. Introducer 226
includes a horn 228, a neck 230 and an O-ring 232. Horn
228 and neck 230 are preferably formed as an integral body.
Horn 228 preferably includes a guide wire-receiving notch
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(not shown) similar to that previously described and an
interior slot 234. slot 234 is preferably
positioned proximate neck 230 and is sized to maintain 0-
ring 232.
Interior
Alternatively, interior slot 234 can be formed
in neck 230.
O-ring 232 is
preferably made of a rubberâtype
material. Further, 0-ring 232 has an inner diameter
slightly smaller than that of horn 228 and neck 230. Thus,
during use, O-ring 232 forms a seal about catheter shaft 38
(Fig. 1), blocking passage of bodily fluids, such as bile,
into horn 228.
Referring to Fig. 9D, another alternative embodiment
of an introducer 236 is shown. Introducer 236 is similar
to a touhey-borst system and includes an upper horn section
238, a lower horn section 240 and a grommet 242. Upper
horn section 238 includes an outer wall 244 defining a
proximal end 246, a grommet-receiving flange 248 and a
distal end 250. Proximal end 246 of horn section 238
preferably includes a guide wire-receiving notch (not
shown) similar to that previously described. Distal end
250 is threaded and includes a passage 252 sized to receive
a portion of lower horn section 240.
Lower horn section 240 includes a body 254 defining a
proximal end 256, an intermediate portion 258 and a distal
end 260.
communicate with passage 252 and extends from proximal end
256 to distal end 260. Finally, proximal end 256 includes
a threaded slot 262 sized to threadably receive distal end
250 of upper horn section 238.
An interior passage 266 is configured to
Grommet 242 is preferably made of a rubber-type
material and is sized. to nest. within. grommet-receiving
flange 248 section 238 while abutting
proximal end 256 of lower horn section 240.
of upper horn
Introducer 236 is assembled by placing grommet 242
within grommet-receiving flange 248 of upper horn section
238. Distal end 250 of upper horn section 238 is then
threadably secured to proximal end 258 of lower horn
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section 240. As upper horn section 238 is threadably
secured to lower horn section 240, proximal end 256 of
lower horn section 240 compresses grommet 242 within
grommet-receiving flange 248 of upper horn section 238.
During use, introducer 236 functions in a manner
highly similar to that previously described. In this
regard, grommet 242 forms a seal about catheter shaft 38
(Fig. 1). Further, aspiration can be achieved, if desired,
by loosening lower horn section 240 relative to upper horn
section 238.
alternative
Introducer 266
a neck 270 and a valve 272.
Preferably, horn 268, neck 270 and valve 272 are integrally
formed as a singular body.
Referring to Fig. 9E, yet another
embodiment of an introducer 266 is shown.
includes a horn 268,
In this regard, valve 272 is
formed while molding horn 268 and neck 270 by imparting a
controlled flash at distal end 274 of neck 270.
Introducer 266 performs in a manner highly similar to
that previously described. Thus, valve 272 forms a seal
about catheter shaft 38 (Fig. 1), thereby preventing back
flow of bodily fluids, such as bile, into horn 268.
Referring to Fig. 9F, another alternative embodiment
of an introducer 276 is shown. Introducer 276 includes a
horn 278, a neck 280 and a valve 282.
280 are preferably integrally formed as a singular body.
In this regard, horn 278 and neck 280 are defined by an
outer wall 284. Outer wall 284 forms a guide wire-
receiving notch 286 and an exterior slot 288.
Horn 278 and neck
Guide wire-
receiving notch 286 is similar to that previously
described. Exterior slot 288 is positioned along neck 280
and is sized to maintain a portion of valve 282.
Alternatively, exterior slot 288 can be positioned along
horn 278.
Valve 282 is preferably a rubberâtype sock defined by
an upper rib 290, a sidewall 292 and a shoulder 294. Upper
rib 290 is preferably sized to mount within exterior slot
288 of neck 280. Sidewall 292 is preferably flexible so as
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to stretch along neck 280. Finally, shoulder 294 is
preferably configured to abut a distal end 298 of neck 280.
With this configuration, valve 282 is placed over distal
end 298 of neck 280 such that shoulder 294 contacts distal
end 298. Due to the preferred flexible characteristic of
valve 282, side wall 292 is stretched until upper rib 290
nests within exterior slot 288 of neck 280.
During use, the catheter shaft 38 (Fig. 1) is placed
through introducer 276 such that shoulder 294 of valve 282
fonms a seal about catheter shaft 38. Thus, valve 282
prevents undesired back flow of bodily fluids, such as
bile.
It is recognized that the rapid exchange technology of
the present invention may be utilized in different types of
catheter assemblies used within the alimentary canal.
Referring to Fig. 10, catheter assembly 30 is used as a
rapid exchange retrieval balloon system used for stone
retrieval or isolated visualization techniques. Ancillary
lumens 56 and 58 (Figs. 1A-1C) form a portion of retrieval
balloon catheter 300 having a balloon 302 located at its
distal end, and for passage of dye injection apparatus 304.
With this embodiment, the guide wire lumen 60 (Figs. 1A-1C)
may be accessed using conventional guide wire techniques
through the proximal end 48 of catheter 34 or using rapid
exchange techniques, via U-channel 42.
Referring to Fig. 11, the rapid exchange catheter
assembly 30 design of the present invention may be used for
other alimentary canal catheter applications, such as a
rapid exchange sphincterotome used for endoscopic
retrograde sphincterotomy, shown using a cutting wire
apparatus 310. Again, the guide wire lumen 60 may be
accessed by conventional guide wire techniques at the
proximal end 48 of catheter 34, or alternatively, using the
rapid exchange technology of the present invention,
including U-channel 42.
The rapid exchange catheter of the present invention
is preferably a multi-lumen catheter. With this invention,
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the guide wire lumen is isolated from the ancillary lumens
allowing for exceptional contrast flow for high quality
opacification without the need for guide wire removal.
Treatment and therapeutic devices, such as retrieval
balloon catheters or catheters having cutting apparatus may
be included, without interference of a guide wire located
within the guide wire lumen. Additionally, isolation of
the guide wire lumen from the contrast lumen minimizes the
risk of bubble formation during contrast flow and produces
a contrast-free guide wire surface for efficient device
exchanges.
It will be understood that this disclosure, in many
respects, is only illustrative. Changes may be made in
details, particularly in matters of shape, size, material,
and arrangement of parts without exceeding the scope of the
invention. Accordingly, the scope of the invention is as
defined in the language of the appended claims. For
example, while the rapid exchange catheter of the present
invention has been preferably described as being a biliary
catheter, other applications are also envisioned. Thus,
the catheter of the present invention can be used with
biopsy, metal stent placement, plastic stent placement,
Additionally, the catheter of the
present invention may have vascular applications, where a
guide catheter is substituted for the endoscope to
constrain the guide wire.
snares, baskets, etc.
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Claims (21)
1. In a catheter for use in biliary procedures including a shaft having a proximal end, a distal end, and a length extending between the proximal end and the distal end, the improvement comprising:
a guide wire lumen carried by the shaft extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft ;
a channel for accessing the guide wire lumen from a location exterior to the catheter shaft, wherein the channel extends longitudinally along the shaft between a first end and a second end, the first end being located proximal the distal end of the shaft and the second end of the channel being located proximal of the first end of the channel, said channel extending over a substantial portion of the length of said catheter shaft;
wherein the guide wire lumen is sized to receive a guide wire having a diameter; at least a portion of the channel having a width greater than the diameter of the guide wire to allow radial guide wire movement within the channel.
a guide wire lumen carried by the shaft extending from a location proximal the distal end of the shaft to a location proximate the distal end of the shaft ;
a channel for accessing the guide wire lumen from a location exterior to the catheter shaft, wherein the channel extends longitudinally along the shaft between a first end and a second end, the first end being located proximal the distal end of the shaft and the second end of the channel being located proximal of the first end of the channel, said channel extending over a substantial portion of the length of said catheter shaft;
wherein the guide wire lumen is sized to receive a guide wire having a diameter; at least a portion of the channel having a width greater than the diameter of the guide wire to allow radial guide wire movement within the channel.
2. The catheter of claim 1 wherein the guide wire lumen is formed integral with the shaft.
3. The catheter of claim 1, further including an ancillary lumen extending between the catheter proximal end and the catheter distal end.
4. The catheter of claim 1, wherein the channel for accessing the guide wire lumen includes an opening extending through the wall of the catheter shaft into the guide wire lumen.
5. The catheter of claim 4, wherein the opening extends longitudinally between the first end and the second end in communication with the guide wire lumen.
6. The catheter of claim 5, wherein the first end of the channel is in communication with the guide wire lumen.
7. The catheter of claim 1, wherein the channel is formed integral with the guide wire lumen, such that the channel has a width approximately equal to a diameter of the guide wire lumen.
8. The catheter of claim 4 wherein the opening is located proximate the first end of the channel.
9. The catheter of claim 4 wherein the opening is located proximate the second end of the channel.
10. The catheter of claim 9 further comprising another opening located proximate the first end of the channel.
11. A biliary rapid exchange catheter system, comprising:
a biliary catheter sized for passage within the working passageway of an endoscope, the biliary catheter including;
a shaft having a proximal end, a distal end, and an outer wall;
the shaft having a guide wire lumen extending longitudinally therethrough, between a location proximate the distal end of the shaft and a location proximal of the distal end of the shaft, the guide wire lumen adapted for receiving a guide wire;
at least part of the outer wall of the shaft defining a channel, with the channel in communication with the guide wire lumen, an outer diameter of at least a portion of the shaft and the inner diameter of at least a portion of the working passageway of the endoscope being such that the guide wire is substantially maintained in the channel when so arranged.
a biliary catheter sized for passage within the working passageway of an endoscope, the biliary catheter including;
a shaft having a proximal end, a distal end, and an outer wall;
the shaft having a guide wire lumen extending longitudinally therethrough, between a location proximate the distal end of the shaft and a location proximal of the distal end of the shaft, the guide wire lumen adapted for receiving a guide wire;
at least part of the outer wall of the shaft defining a channel, with the channel in communication with the guide wire lumen, an outer diameter of at least a portion of the shaft and the inner diameter of at least a portion of the working passageway of the endoscope being such that the guide wire is substantially maintained in the channel when so arranged.
12. The biliary catheter system of claim 11, wherein the location proximal of the distal end of the shaft is adjacent the proximal end of the shaft.
13. The biliary catheter system of claim 11, wherein the channel includes:
a distal opening into the guide wire lumen at a location proximal of the distal end of the shaft;
a proximal opening into the guide wire lumen at a location proximal of the distal opening; and means extending longitudinally between the proximal opening and the distal opening for allowing a guide wire to be moved between a location exterior of the guide wire lumen and the guide wire lumen.
a distal opening into the guide wire lumen at a location proximal of the distal end of the shaft;
a proximal opening into the guide wire lumen at a location proximal of the distal opening; and means extending longitudinally between the proximal opening and the distal opening for allowing a guide wire to be moved between a location exterior of the guide wire lumen and the guide wire lumen.
14. The biliary catheter system of claim 13, wherein the channel is open between the proximal opening and the distal opening.
15. The biliary catheter system of claim 14, wherein the guide wire lumen is sized to receive a guide wire having a diameter, and further wherein at least a portion of the channel has a width greater than the diameter of the guide wire for allowing radial guide wire movement from the channel.
16. The biliary catheter system of claim 14, wherein the distal opening of the channel is in communication with a portion of the guide wire lumen.
17. The biliary catheter system of claim 14, wherein the channel is integrally formed with the guide wire lumen.
18. The biliary catheter system of claim 14, wherein the channel divides the guide wire lumen into a first and second section such that the first section of the guide wire lumen includes the channel and the second section extends distally of the channel.
19. The biliary catheter system of claim 14, wherein the channel has a U-shape over a majority of the length between the proximal and distal openings.
20. The biliary catheter system of claim 11, wherein the guide wire lumen is defined by a tubular member, and the tubular member is formed integral with the shaft.
21. The biliary catheter system of claim 11, wherein the guide wire lumen is defined by a tubular member, and the tubular member is coupled to the shaft.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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US2523596P | 1996-09-13 | 1996-09-13 | |
US60/025,235 | 1996-09-13 | ||
US08/926,200 | 1997-09-09 | ||
US08/926,200 US6007522A (en) | 1996-09-13 | 1997-09-09 | Single operator exchange biliary catheter |
PCT/US1997/016020 WO1998010821A1 (en) | 1996-09-13 | 1997-09-10 | Single operator exchange biliary catheter |
Publications (2)
Publication Number | Publication Date |
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CA2265491A1 CA2265491A1 (en) | 1998-03-19 |
CA2265491C true CA2265491C (en) | 2008-08-26 |
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CA002265491A Expired - Lifetime CA2265491C (en) | 1996-09-13 | 1997-09-10 | Single operator exchange biliary catheter |
Country Status (9)
Country | Link |
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US (1) | US6007522A (en) |
EP (1) | EP0948372B1 (en) |
JP (1) | JP4443631B2 (en) |
AU (1) | AU732412B2 (en) |
CA (1) | CA2265491C (en) |
DE (1) | DE69734672T2 (en) |
ES (1) | ES2252793T3 (en) |
HK (1) | HK1025058A1 (en) |
WO (1) | WO1998010821A1 (en) |
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- 1997-09-10 DE DE69734672T patent/DE69734672T2/en not_active Expired - Lifetime
- 1997-09-10 ES ES97940999T patent/ES2252793T3/en not_active Expired - Lifetime
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JP4443631B2 (en) | 2010-03-31 |
CA2265491A1 (en) | 1998-03-19 |
DE69734672D1 (en) | 2005-12-22 |
WO1998010821A1 (en) | 1998-03-19 |
AU732412B2 (en) | 2001-04-26 |
JP2001511023A (en) | 2001-08-07 |
AU4265397A (en) | 1998-04-02 |
DE69734672T2 (en) | 2006-08-10 |
US6007522A (en) | 1999-12-28 |
ES2252793T3 (en) | 2006-05-16 |
EP0948372B1 (en) | 2005-11-16 |
EP0948372A1 (en) | 1999-10-13 |
HK1025058A1 (en) | 2000-11-03 |
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