U.S. patent application number 10/902492 was filed with the patent office on 2005-03-31 for system and method for introducing a prosthesis.
Invention is credited to Clark, Victor D. JR., Deal, Stephen E., Skerven, Gregory J., Waller, David F..
Application Number | 20050070821 10/902492 |
Document ID | / |
Family ID | 34119811 |
Filed Date | 2005-03-31 |
United States Patent
Application |
20050070821 |
Kind Code |
A1 |
Deal, Stephen E. ; et
al. |
March 31, 2005 |
System and method for introducing a prosthesis
Abstract
A method and apparatus for introducing a first elongate medical
device and short wire guide that are coupled together into a work
site and remotely disconnecting them within the work site such that
a secondary device comprising a catheter member can be introduced
over the wire guide to the work site, and/or a second wire guide
can be introduced to the work site via a passageway of the primary
access device. A system of indicia, such as radiopaque or viewable
markers, permits the operator to monitor the relative alignment of
the devices within the work site to determine when uncoupling has
occurred. In one example of the method, a wire guide and primary
access device (e.g., a sphincterotome) is coupled to the wire guide
and introduced via a duodenoscope into the biliary system. After
performing a first medical operation, the devices are uncoupled
with the wire guide being left within the biliary system such that
a secondary access device, such as a balloon, biopsy device, stent
delivery catheter, dilator, etc., can be introduced to perform a
second medical operation without a traditional over-the-wire
exchange being required. In another example of the method, a
prosthesis, such as a valve or stent, is placed within the work
site coupled to a wire guide which is remotely disconnected within
the work site and a secondary device, such as a dilation balloon or
second prosthesis, is introduced into the work site after the first
delivery system is removed.
Inventors: |
Deal, Stephen E.;
(Charlotte, NC) ; Skerven, Gregory J.;
(Kernersville, NC) ; Clark, Victor D. JR.;
(Pfafftown, NC) ; Waller, David F.;
(Winston-Salem, NC) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE/CHICAGO/COOK
PO BOX 10395
CHICAGO
IL
60610
US
|
Family ID: |
34119811 |
Appl. No.: |
10/902492 |
Filed: |
July 29, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
60491408 |
Jul 31, 2003 |
|
|
|
60563968 |
Apr 21, 2004 |
|
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|
60570656 |
May 13, 2004 |
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Current U.S.
Class: |
600/585 |
Current CPC
Class: |
A61F 2002/9511 20130101;
A61M 25/0029 20130101; A61M 25/0662 20130101; A61B 6/12 20130101;
A61F 2002/041 20130101; A61B 2017/2212 20130101; A61F 2/95
20130101; A61M 2025/0681 20130101; A61M 2025/0183 20130101; A61B
17/221 20130101; A61B 1/018 20130101; A61M 25/10 20130101 |
Class at
Publication: |
600/585 |
International
Class: |
A61B 005/00 |
Claims
What is claimed is:
1. An apparatus for delivering a prosthesis into a work site within
a bodily lumen of a patient comprising: an elongate inner member
comprising a shaft extending between a distal end and a proximal
end, a lumen extending through at least a portion of the shaft, a
distal opening in communication with the lumen and disposed near
the distal end of the shaft, a proximal opening in communication
with the lumen and disposed a substantial distance from the
proximal end of the shaft and a relatively shorter distance from
the distal end of the shaft; an elongate outer member slidably
disposed over the shaft of the elongate inner member, the elongate
outer member including a distal end portion having a distal end;
and a wire guide removably disposed through the lumen of the
elongate inner member, wherein the prosthesis is disposed over the
shaft of the elongate inner member and is engaged by the distal end
of the elongate outer member; and wherein the prosthesis is
prevented from being removed from the elongate inner member when
the wire guide is disposed through the lumen of the elongate inner
member, and is permitted to be removed from the elongate inner
member when the wire guide is not disposed through the lumen of the
elongate inner member.
2. The apparatus of claim 1, wherein the wire guide engages the
prosthesis when the wire guide is disposed through the lumen of the
elongate inner member.
3. The apparatus of claim 2, wherein a proximal end of the
prosthesis abuts the distal end of the elongate outer member and a
distal end of the prosthesis abuts the wire guide when the wire
guide is disposed through the lumen of the elongate inner
member.
4. The apparatus of claim 1, wherein the proximal opening in the
elongate inner member comprises a port through a wall of the shaft
that is located distal of the distal end of the elongate outer
member when the wire guide is disposed through the lumen of the
elongate inner member.
5. The apparatus of claim 4, wherein a proximal end of the
prosthesis abuts the distal end of the elongate outer member and a
distal end of the prosthesis abuts the wire guide when the wire
guide is disposed through the lumen of the elongate inner member,
the prosthesis abutting a portion of the wire guide extending out
from the lumen and through the port in the wall of the shaft.
6. The apparatus of claim 1, wherein the wire guide does not extend
through the elongate outer member when the wire guide is disposed
through the lumen of the elongate inner member.
7. The apparatus of claim 1, wherein the prosthesis comprises a
non-expanding stent.
8. The apparatus of claim 7, wherein the non-expanding stent
comprises a plurality of anchor flaps projecting from an exterior
surface thereof, the anchor flaps configured to engage an interior
surface of the bodily lumen of the patient.
9. The apparatus of claim 7, wherein the non-expanding stent
comprises a proximal end that abuts the distal end of the elongate
outer member.
10. The apparatus of claim 1, wherein the prosthesis comprises a
self-expanding stent.
11. The apparatus of claim 10, wherein the self-expanding stent is
expandable from a contracted delivery configuration to an expanded
delivered configuration, the self-expanding stent being maintained
in the contracted delivery configuration by being disposed within
the elongate outer member, the self-expanding stent being allowed
to expand to the expanded delivered configuration when not disposed
within the elongate outer member.
12. A method for delivering a non-expanding prosthesis into a work
site within a bodily lumen of a patient comprising the steps of: a)
providing a wire guide; b) providing a delivery catheter comprising
an elongate inner member and an elongate outer member, the elongate
inner member having a shaft and a wire guide lumen extending
between a distal opening and a proximal opening, the distal opening
being located near a distal end of the shaft, the proximal opening
being located a substantial distance from a proximal end of the
shaft, the elongate outer member being slidably disposed over the
shaft of the elongate inner member; c) positioning a distal end of
the wire guide within the work site; d) positioning the prosthesis
on the delivery catheter by placing the prosthesis over the
elongate inner member so as to abut against a distal end of the
elongate outer member; e) inserting a proximal end of the wire
guide through the distal opening, the lumen, and the proximal
opening of the elongate inner member, the wire guide engaging the
prosthesis so as to secure the prosthesis to the delivery catheter;
f) passing the delivery catheter over the wire guide in a distal
direction until the prosthesis is within the work site; and g)
moving the prosthesis in a proximal direction by retrieving the
delivery catheter along the wire guide in a proximal direction, the
wire guide preventing the prosthesis from separating from the
delivery catheter.
13. The method of claim 12, wherein step g) comprises the step of
retrieving the prosthesis from the work site and removing the stent
from the patient.
14. The method of claim 12, wherein step g) comprises the step of
re-positioning the prosthesis within the work site of the
patient.
15. The method of claim 14, further comprising the following steps:
h) uncoupling the wire guide from the delivery catheter by moving
the wire guide in a proximal direction relative to the elongate
inner member until distal end of the wire guide has been retracted
from the lumen of the elongate inner member; and i) delivering the
prosthesis within the work site by moving the elongate inner member
in a proximal direction relative to the elongate outer member until
the prosthesis has been pushed off the distal end of the elongate
inner member.
16. The method of claim 12, wherein step e) comprises the step of
abutting a distal end of the prosthesis against a portion of the
wire guide exiting outwardly from the proximal opening of the
elongate inner member.
17. A method for delivering a plurality of non-expanding prosthesis
into a work site within a bodily lumen of a patient comprising the
steps of: a) providing a wire guide; b) providing a delivery
catheter comprising an elongate inner member and an elongate outer
member, the elongate inner member having a shaft and a wire guide
lumen extending between a distal opening and a proximal opening,
the distal opening being located near a distal end of the shaft,
the proximal opening being located a substantial distance from a
proximal end of the shaft, the elongate outer member being slidably
disposed over the shaft of the elongate inner member; c)
positioning a distal end of the wire guide within the work site; d)
positioning a first prosthesis on the delivery catheter by placing
the prosthesis over the elongate inner member so as to abut against
a distal end of the elongate outer member; e) inserting a proximal
end of the wire guide through the distal opening, the lumen, and
the proximal opening of the elongate inner member; f) passing the
delivery catheter over the wire guide in a distal direction until
the first prosthesis is within the work site; g) uncoupling the
wire guide from the delivery catheter by moving the wire guide in a
proximal direction relative to the elongate inner member until
distal end of the wire guide has been retracted from the lumen of
the elongate inner member; h) maintaining the distal end of the
wire guide within the work site, the wire guide being disposed in a
side-by-side configuration with the first prosthesis; i) delivering
the first prosthesis within the work site by moving the elongate
inner member in a proximal direction relative to the elongate outer
member until the first prosthesis has been pushed off the distal
end of the elongate inner member; j) removing the delivery catheter
from the patient; k) positioning a second prosthesis on the
delivery catheter by placing the prosthesis over the elongate inner
member so as to abut against a distal end of the elongate outer
member; l) re-inserting the proximal end of the wire guide through
the distal opening, the lumen, and the proximal opening of the
elongate inner member; m) passing the delivery catheter over the
wire guide in a distal direction until the second prosthesis is
within the work site; n) uncoupling the wire guide from the
delivery catheter by moving the wire guide in a proximal direction
relative to the elongate inner member until distal end of the wire
guide has been retracted from the lumen of the elongate inner
member; and o) delivering the second prosthesis within the work
site by moving the elongate inner member in a proximal direction
relative to the elongate outer member until the second prosthesis
has been pushed off the distal end of the elongate inner
member.
18. The method of claim 17, wherein step o) comprises the step of
positioning the second prosthesis in a side-by-side configuration
with the first prosthesis.
19. The method of claim 17, wherein step f) further comprises the
step of moving the prosthesis in a proximal direction by retrieving
the delivery catheter along the wire guide in a proximal direction,
the prosthesis being engaged by the wire guide so as to prevent the
prosthesis from separating from the delivery catheter during
proximal movement of the delivery catheter.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a non-provisional application which
claims priority of provisional applications Ser. No. 60/491,408,
filed Jul. 31, 2003, Ser. No. 60/563,968, filed Apr. 21, 2004, and
Ser. No. 60/570,656, filed May 13, 2004.
TECHNICAL FIELD
[0002] This invention relates to medical devices, more particularly
catheters and the like that are introduced into the patient over a
wire guide.
BACKGROUND OF THE INVENTION
[0003] Minimally invasive medicine, the practice of gaining access
into a blood vessel, duct, or organ using a wire guide to
facilitate the subsequent introduction or placement of catheters
and other medical devices, has been evolving since the Seldinger
technique was first popularized during the late 1950s and 1960s. A
significant advance was gaining the ability to exchange medical
devices over a single indwelling wire guide without requiring
displacement of the wire in the process and loss of access to the
site. This `over the wire` (OTW) exchange technique requires an
extra long guide wire so that control over the wire could be
maintained at all times during the procedure. To accomplish this,
the portion of the wire extending out of the patient must be at
least as long as the device itself so that a proximal portion of
the wire could be secured at all times maintain longitudinal
positioning, typically by an assistant standing well behind the
physician. For example, endoscopic catheters that are used to
access the biliary system are typically 200 cm or more in length,
requiring a wire guide of more than 400 cm (e.g., 480 cm) to be
long enough to remain in the duct during the exchange. To remove
the catheter over the wire, the physician and an assistant must
carefully make a series of well-coordinated, one to one movements
between the exchange wire and device. The assistant pushes the wire
the same amount as the physician pulls back on the catheter until
the device is completely outside of the patient and the physician
gains control over the wire at the port of the scope. The assistant
then pulls the device off of the wire such that a second device can
be fed back over the wire and into the patient to perform a second
operation, requiring the same push-pull technique in reverse. This
procedure requires a well-trained assistant, who actually is
responsible for the advancement of the wire, instead of the
physician. In biliary ERCP, this lack of wire guide control can be
a disadvantage when cannulating the ampullary orifice because the
techniques used are typically highly dependent on good verbal
communication between the physician and assistant, and the
experience of the latter.
[0004] Although the `long wire` or OTW technique still remains a
commonly used method of exchanging devices in the biliary system, a
technique was developed which allowed for a much shorter wire guide
and more physician control over the wire. Variously known as the
`rapid exchange,` `monorail,` or `short-wire` technique, it differs
from the OTW technique in that instead of the device being
introduced over the length of the wire guide, the wire guide is
coupled for only a portion of the length of the catheter device.
The device is fed over the wire guide, which then exits the
passageway or a coupling portion of the catheter at a point between
the catheter's distal end and the proximal portion via a port or
channel formed in the side of the catheter, typically located
within the distal portion of the device. This allows the physician
to have control of the proximal or external portion of the wire at
all times as it exits the patient or scope and reduces the need for
coordinating device movements with an assistant. When the coupled
portion exits the patient (or endoscope in the case of
gastroenterological or other endoscopic procedures), the physician
performs a short exchange (instead of the traditional long-wire
exchange, which in biliary procedures, requires the assistant to
stand well out of the sterile field in order to assist with the
exchange). With certain other devices, the catheter is split or
torn away to uncouple it from the wire as the catheter exits the
patient. To introduce the device, the coupled portion of the
catheter is advanced over the proximal end of the wire guide, while
the physician is careful to maintain the wire in position so that
its distal end is maintained within the work site and access is not
lost.
[0005] Rapid exchange or short wire techniques have proven
particularly desirable in coronary and vascular medicine whereby it
is common for a sequence of procedures using multiple
catheter-based devices to be performed over a single wire, such as
stent placement following angioplasty. Another example of where
short wire exchange techniques are often used is in endoscopic
procedures performed in the pacreatobiliary system. Typically, an
ERCP (endoscopic retrograde cholangiopancreatograph- y) procedure
is performed by introducing a catheter device from a duodenoscope
through the ampullary orifice (Papilla of Vater) and into the
biliary tree, which includes the bile duct, pancreatic duct, and
hepatic ducts of the liver. The cannulation device, which typically
comprises a sphincterotome/papillotome or ECRP catheter, is
introduced into the biliary tree to perform a first operation,
which could be diagnostic in nature, such as injecting contrast
media, or for therapeutic purposes, such as enlarging the ampullary
orifice. When a second medical operation is required, such as to
remove a stone, open a stricture, sample tissue, etc., a second or
peripheral device, e.g., balloon, basket, snare, biopsy brush,
dilator, stent delivery catheter, etc., can be introduced over the
original wire guide to perform a secondary therapeutic
procedure.
[0006] While OTW techniques have permitted the exchange of devices,
the development of short wire techniques has found acceptance by
physicians who prefer to maintain greater control of the wire guide
at the scope. Well-known examples of this rapid exchange technology
are the devices comprising the MICROVASIVE RX BILIARY SYSTEM.TM.
(Boston Scientific Corporation, Natwick, Mass.) in which the
catheter portion of the devices include an internal lumen extending
between a distal opening and a proximal side opening spaced 5-30 cm
therefrom, depending on the device, thereby requiring an exchange
of that length as the device is being removed over the 260 cm
JAGWIRE.RTM. Guidewire guide developed for that system. An example
of a sphincterotome of this system (AUTOTOME.TM. Cannulating
Sphincterotome) is depicted in FIG. 1. Extending proximally from
the proximal side opening, the lumen forms a `C-channel` (shown in
FIG. 2) that holds the wire guide within the catheter as the
catheter portion is introduced into the scope, but allows the wire
to be laterally pulled out of the channel to gain access of the
wire at the biopsy port of the scope as the catheter is being
removed from the scope (FIG. 3), so that a second catheter type
device (e.g., balloon, basket, stent delivery catheter, etc.) can
be subsequently fed over the proximal end of the wire. As the
distal portion of the first device is exiting the scope, a short
exchange is required (coordinated push-pull movements between the
physician and assistant) that is similar in practice to that used
in an OTW procedure, until the physician gains control of the wire
and the assistant can pull off the first device without risking
loss of access. The proximal end of the wire guide is typically
secured to the scope during much of the procedure to prevent loss
of access, but it must be disengaged from the scope to allow the
exchange and removal of the catheter.
[0007] While the Microvasive system has offered modest time
savings, more physician control of the wire, and placed less
reliance on the skill of the assistant to help perform the
exchange, a short exchange procedure is still required in which
care must be taken to prevent loss of wire guide access to the
duct, particularly since the wire guide cannot be secured to the
scope during removal of the catheter. Because the wire guide
resides in the channel of the catheter and the coupled devices are
constrained together in the accessory channel, uncoupling must take
place as the distal portion of the catheter exits the proximal end
of the scope. The process is further slowed by the frictional
resistance between the wire and catheter, which remains a problem
in subsequent exchanges as devices are fed or removed over the wire
residing in the catheter lumen or C-channel.
[0008] Having a C-channel extending along the catheter can result
in certain clinical disadvantages. For example, the split in the
catheter provides an entry point for blood and bile, a known source
of viruses and bacteria, to enter the catheter lumen and migrate to
the proximal end of the device where they typically leak out onto
the floor and clothing of those involved in the procedure. The
channel also represents a point of potential air leakage, which can
compromise the ability to maintain adequate insufflation within the
duodenum during the procedure. Another disadvantage of a C-channel
is that it degrades the integrity of the catheter, which can be
problematic in a cannulating device (such as a deflecting
Sphincterotome) when attempting to push through or `lift` the
papilla to straighten the entry pathway into the duct, or when
pushing through a stricture.
[0009] The current rapid exchange or short wire system also fails
to address some of the shortcomings found in the traditional OTW
method. For example, recannulation of the papilla is required when
placing multiple plastic drainage stents side by side since the
delivery system must be removed to disconnect the wire.
Furthermore, existing devices do not offer the ability to place a
second wire guide after the first one, such as to place stents in
multiple ducts, since the catheter, which could otherwise serve as
a conduit, must be removed from the patient and work site before it
would have a free lumen for a second wire. Another disadvantage of
current systems for exchanging biliary devices is the
incompatibility between the two systems. Long wire devices lack the
side access port for use with a short exchange wire and the
MICROVASIVE RX BILIARY SYSTEM=198 devices with C-channels are
poorly configured for long wire exchange since once the C-channel
has been breached during the first exchange, it is difficult to
introduce a long wire through the proximal wire guide access port
(which includes the open channel) and keep it from slipping from
the channel as it is being introduced. Further, the C-channel is
typically not compatible with smaller-diameter wire guides (less
than 0.035") for the same reason. Incompatibility between systems
means that physicians cannot take advantage of all of the choices
available when selecting the best device and treatment for a
particular patient.
[0010] What is needed is an improved short-wire system and
technique for efficiently and reliably exchanging devices within a
work site which is compatible with long wire exchange method and
which addresses the other deficiencies described above.
SUMMARY OF THE INVENTION
[0011] The foregoing problems are solved and a technical advance is
achieved in an illustrative system and method for introducing and
exchanging multiple elongate medical devices, e.g., tubular members
such as catheters and the like, over an indwelling guiding member,
such as a wire guide, within a patient by remotely uncoupling the
first device (primary access device) from the guiding member within
the work site (defined as a lumen, duct, organ, vessel, other
bodily passage or cavity, or the pathway leading thereto in which
wire guide/guiding member access is maintained throughout a
particular procedure or series of procedures), thereby facilitating
the removal of the device and simplifying introduction of a
secondary access device over the indwelling wire without an
exchange of devices taking place outside of the patient. While the
primary focus of this application is the exchange of devices within
the pancreatobiliary system or elsewhere in the gastrointestinal
tract, the system and method of remote uncoupling of devices within
a work site can be adapted for any part of the body to perform any
suitable procedure where the exchange of devices takes place over
an indwelling guiding member. Examples include, but are not limited
to the introduction and placement of balloons, stents, grafts,
occluders, filters, distal protection devices, catheters for
ablation, phototherapy, brachytherapy etc., prosthetic valves, or
other instrumentation or devices into the vascular system,
including the coronary arteries, peripheral arterial system (e.g.,
carotid or renal arteries), or venous system (e.g., the deep veins
of the legs). Other exemplary sites include the genito-urinary
system (e.g., bladder, ureters, kidneys, fallopian tubes, etc.),
and the bronchial system. Additionally, the present system and
method can be used for exchanging devices within body cavities,
e.g., the peritoneum, pleural space, pseudocysts, or true cystic
structures, via percutaneous placement and exchange through a
needle, trocar, or sheath.
[0012] The basic system of devices for remote uncoupling comprises
a guiding member, typically a wire guide. It should be understood
that hereafter, the term `wire guide` is used in the specification
in a generic sense to include any device (e.g., small-diameter
catheter, laser fiber, string, plastic beading, stylet, needle
etc.) configured to perform the same function, although such a
device technically may not be considered a wire guide (or
`guidewire`) as the term is most commonly used in the medical arts.
Remote uncoupling permits a shorter guiding member/wire guide to be
used than for other short wire methods (e.g., rapid exchange), and
thus hereafter, the methods described in this specification are
referred to collectively as the `ultra-short wire` technique, or
depending on the work site, `intraductal exchange` (IDE),
`intravascular exchange` (IVE), etc. The reason that the wire guide
can be of a shorter length than traditional rapid exchange wire
guides is that there is no exchange outside the patient. In fact,
remote uncoupling allows for the exchange wire guide to be shorter
than the devices being introduced since the devices are not removed
over the wire. For example, the wire guide of the present inventive
system of biliary devices (for use in a 145 cm channel
duodenoscope) is typically 185 cm (minimum functional length of
about 180 cm), as opposed to the 260 cm wire guide typically used
for the Microvasive `rapid exchange` procedures in which a 5 to 30
cm external exchange must be performed each time, depending on the
device used. The shorter wire is easier to manipulate by a single
operator and helps prevent it from contacting non-sterile surfaces,
such as the floor, patient bed, instrument table, imaging unit,
etc. The 185 cm length still permits most external changes to be
performed, if necessary. To accommodate a longer wire for
exchanging a device otherwise not compatible with the system, an
optional coupling mechanism on the proximal end of the wire can be
included to engage a wire guide extender portion to lengthen the
wire (e.g., to 260 or 480 cm) and permit a traditional exchange to
take place.
[0013] Coupled to the guiding member/wire guide is a first elongate
medical device (the primary access device), typically a tubular
member or catheter device, which includes a coupling region, such
as a passageway or lumen, external channel, outer ring, or other
interface area, located about the distal portion and which is
configured to receive a portion of the wire guide such that both
devices can comprise a releasably coupled pair while operating
within a work site. The coupling region may be an integral part of
the elongate medical device or may located about a separate element
disposed therewith (e.g., an elongate engagment member), which for
purposes of this application is considered part of the elongate
medical device. A separate elongate engagement member can provide a
primary or secondary means of releasably securing the wire guide
and catheter device until they are to be repositioned or uncoupled.
The elongate engagement member, typically but not necessarily
disposed within the passageway of the tubular member, can further
comprise the coupling region as well. Preferably, the primary
access devices used with this system have a closed or self-sealing
passageway extending to the proximal (external) portion of the
device (instead of an open or split channel) such that the system
can be readily converted to introduce a long wire if a long
wire-compatible device is selected. Further, the devices of this
invention are configured for traditional short wire exchange back
over the wire, if so desired, or when remote uncoupling becomes
problematic (e.g., due to unexpected anatomical constraints).
[0014] In a first aspect of the invention, the system further
includes an alignment indicator system, such as a system of indicia
(e.g., radiopaque markers, external markings, endoscopic markings,
etc.) located about the wire guide and/or first elongate medical
device that can be utilized by the operator in locating the
position of the distal end or distal portion of the wire guide
relative to the proximal end of the coupling region, such as at a
side access port or aperture (e.g., scive) through which the wire
exits. The alignment indication system advantageously allows the
physician to control when the two devices are coupled or uncoupled
within the work site and helps provide confirmation that uncoupling
has occurred. Without the ability to receive such confirmation, it
would be extremely difficult for the physician to attempt, with any
confidence, the uncoupling of the catheter from the wire guide
(e.g., under fluoroscopic guidance) without knowing when uncoupling
has occurred or is about to occur. Depending on the location or
work site within the body and the device being delivered, an
attempt to `blindly` uncouple devices can lead to loss of wire
guide access, especially if the device is prematurely withdrawn
with the wire guide still engaged. Furthermore, the amount of
relative movement between the device and the wire guide required to
ensure that uncoupling had occurred would generally be much greater
than if indicia were utilized, thus increasing risks such as the
wire guide being withdrawn too far and access lost or encountering
situations where there is insufficient space within the work site
left for uncoupling to take place. Typical rapid exchange devices
are not configured with the necessary radiographic or other
appropriate indicia since the exchange procedure is intended to
take place outside of the patient. The external exchange is a
slower process and dictates removal of the first catheter before
another catheter or wire guide can be advanced to the work site
over an existing device (which always must be a wire guide or
guiding device in traditional rapid exchange).
[0015] A first series of embodiments of the system of indicia
includes radiographic or ultrasonically reflective markings located
about one or more of the devices which are used by the operator
under an appropriate external guidance system (fluoroscopy, MRI, CT
scan, x-ray, ultrasound, etc.) to determine the state of alignment
and engagement between the primary or secondary access device and
guiding device. A first example comprises radiopaque or
high-density bands, markings, etc., located on the distal portions
of the wire guide and first elongate medical device. In particular,
the distal tip of the wire guide includes a radiopaque portion that
typically comprises at least the length of the coupling region of
the first elongate medical device, which itself includes a
radiopaque marker, such as a band comprising iridium, platinum, or
other suitable material, located about the proximal end of the
coupling region (e.g., at, or just distal to the side access port),
thus allowing the operator to know when the distal tip of the wire
is nearing or has exited the point of the catheter at which the
devices become uncoupled or separate within the work site.
Additionally, other radiopaque markers may be present that are
generally not used to assist in remote uncoupling, such as at the
distal end of the catheter or indicia used for stent or balloon
placement.
[0016] A second series of embodiments of the system indicia
comprises directly viewable indicia located about the proximal
portions of the wire guide and the tubular member to which it is
coupled during the procedure. In one example, the wire guide
comprises a visually distinctive alignment point, such as a single
mark (e.g., colored band) or a transition point between different
colored and/or patterned regions of the wire guide outer coating,
which when aligned with a specified first marking on the proximal
portion of the elongate medical device, indicates that the distal
ends of the wire guide and tubular member are in alignment with
respect to one another. The catheter further includes a second mark
that represents the disengagement point, that when aligned with the
designated alignment marking of the wire guide, is indicative that
the two devices are about to or have uncoupled or disengaged with
the distal tip of the wire guide having exited the coupling region.
Preferably, the first (distal) and second (proximal) markings on
the proximal portion of the catheter are located within a region
that remains external of the patient or scope during a procedure
and are spaced apart by the same distance as the length of the
coupling region. For very short coupling regions (e.g., rings), a
single mark on the catheter may be preferable to indicate
disengagement, if proximal indicia are to be used.
[0017] A third series of embodiments of the system of indicia
include markings that are configured to be viewable by a fiberoptic
endoscope or videoendoscope (e.g., duodenoscope, gastroscope,
bronchoscope, ureteroscope, etc.). In devices configured for
accessing the pancreatobiliary system, the indicia comprise a
marking located on both the wire guide and elongate medical device
disposed within an intermediate portion of each, which is typically
located distal to the viewing lens or video chip of the scope, but
proximal to the ampullary orifice during a typical procedure, such
that they can be aligned by using the video monitor (or viewing
port) to ascertain that uncoupling within the duct has occurred.
The device may include other endoscopic indicia useful during the
remote uncoupling procedure. For example, a biliary catheter may
include a depth marking at a designated distance from the catheter
tip (e.g., 10 cm) which when buried within the papilla, indicates
that IDE can be performed safely within the duct without risking
loss of wire guide access. Furthermore, the distal portion of the
wire guide can be distinctive in appearance (e.g., black) as a
visual cue to warn the physician if the tip is in danger of pulling
completely out of the duct, which would require recannulation of
the papilla. The second and third system of indicia do not require
external imaging, thus the physician can advantageously limit the
time that the patient is exposed to fluoroscopy. For example,
fluoroscopy can be used only at selected, critical times during the
procedure with at least one of the other types or indicia being
used elsewhere for alignment guidance.
[0018] In addition to the use of visual indicia to confirm whether
the wire guide and first elongate medical device (and subsequent
devices) are engaged or uncoupled, the present invention includes
other types of alignment indication systems, such as a tactile
system that includes one or more protuberances and/or indentations
along one or more of the devices or the endoscope accessory channel
port to allow the physician to `feel` or sense the point where
disengagement has occurred or is imminent due to the discrete
point(s) of increased resistance between the device as they move
relative to one another. Magnets can be a part of a tactile system
as well. Other embodiments of the alignment indicator system
include sensor-based systems in which a sensor located within the
system, such as along the catheter or endoscope channel/port,
detects a calibrated location elsewhere in the system (e.g., the
wire guide or catheter) and emits or provides a signal or cue
(e.g., electrical signal) that is relayed to the operator in the
form of an audio or visual alert that warns the operator that the
devices have or are about to become uncoupled. The alignment system
can comprise a single system or means for alignment, or any
combination of visual and non-visual indicators.
[0019] In a second aspect of the invention, a method is provided
for uncoupling the first elongate medical device from the wire
guide while both are still dwelling within the work site (i.e., the
basic ultra-short wire technique). Both devices are introduced into
the work site, using a standard introduction method and introducer
member such as an endoscope, introducer sheath, etc., with the wire
guide engaged through the coupling region of the medical device
being introduced. In one embodiment for use in the pancreatobiliary
system, the coupling region comprises a passageway within the
distal portion of the catheter, such as the distal 6 cm thereof,
with the wire guide exiting at that point through a side access
port (e.g., scive) such that the wire guide coextends along the
outside of the proximal portion of the catheter as both reside side
by side along the introduction pathway, which in the biliary
embodiment comprises the channel of the duodenoscope. For example,
a wire guide or primary access device, such as a sphincterotome,
needle knife, ERCP catheter, etc., may be introduced first to
cannulate the duct, with the primary access device being
subsequently advanced over the wire to perform a first medical
operation that is diagnostic and/or therapeutic in nature. During
this time, the wire guide is preferably secured in place by
attaching the proximal portion to the endoscope via a locking
device, clip, other means located about wire guide entry port
(biopsy port), thus fixing its position longitudinally to assist
with maintaining access to the work site. Once the first device has
performed its intended operation (inject contrast media, ablate the
sphincter, etc.), the operator preferably uses the radiographic,
endoscopic, and/or proximal system of indica to provide visual
guidance during repositioning of the devices to permit
disengagement. One technique (referred to herein as `device IDE`)
includes advancing the primary access device over the stationary
wire guide until uncoupling has occurred. A second technique
(referred to herein as `wire guide IDE` includes withdrawing the
wire guide while maintaining the primary access device in a
stationary position until the alignment indicia indicates that
uncoupling has occurred. A third technique would involve a
combination of the device and wire guide IDE. Also, there typically
is a characteristic `whipping` action of the radiopaque wire guide
tip portion upon exit from the passageway that is viewable under
fluoroscopy which also provides a visually distinctive indicator of
uncoupling.
[0020] When the physician, using at least one component of the
alignment indicator system, has determined that the tip of the wire
guide has disengaged from the coupling region of the primary access
device, the first device can be easily removed by merely pulling it
back out of the endoscope accessory channel (or introducer sheath
in the case of vascular or certain other non-endoscopic
applications). Removal is greatly facilitated by the elimination of
friction which would have otherwise existed between the wire guide
and catheter if the wire resided within the channel or lumen.
Although some of the aforementioned MICROVASIVE RX.TM. biliary
devices (e.g., the AUTOTOME.TM. sphincterotome) include a side port
within the distal portion, all of the devices lack the combination
of indicia that make a remote or intraductal exchange clinically
practical or even possible. Furthermore, those devices that include
an open channel extending proximally of the side access port cannot
be uncoupled within the duct or work site regardless of the lack of
indicia since the proximal portion of the wire guide tends to
`seek` and reenter the channel when both devices are residing
within the accessory channel of the scope. Thus, remote
disconnection is rendered impossible without some means to
releasably disengage the wire from the channel.
[0021] After the catheter and wire guide are uncoupled, the
proximal end of the wire is available for a third elongate medical
device (e.g., a secondary access device or a second device that is
the same as the first) to be advanced thereover to the work site.
In one example of the method, the proximal end of the indwelling
wire is fed through the distal opening and out of the side access
port of the secondary device, which is then advanced to the work
site. If after the second medical operation using the secondary
device, another secondary device is required for another operation,
the first secondary device (third medical device) is removed from
the wire guide and the patient, and the wire guide is available to
provide access for a fourth device in the same manner as the first
two.
[0022] In a variation of the present method, the primary access
device may be left in place at the work site after disengagement
with the wire guide to serve as an introduction pathway or conduit
for a second wire guide, such as for a procedure where two branches
of a duct or vessel are to be cannulated. An example of such a
procedure is when a stent must be placed in two different ducts
draining separate lobes of the liver. The second wire guide is
typically introduced through a proximal wire guide port or hub of
the first device, typically disposed about the handle portion, the
port communicating with the passageway. This technique typically
requires a long-wire exchange of the catheter. A second option is
to introduce the wire through a proximal side access port (e.g., a
scive) formed through the wall of the tubular member so that full
control of the wire is maintained. In this embodiment, the catheter
walls are configured to be splittable between the proximal and side
access ports, or include an open or self-sealing channel through
which the wire guide can be stripped out toward the distal portion
of the device such that a long exchange is not required. Removing
or stripping the wire guide laterally from the passageway can be
done by any well-known means, such as scoring or structurally
weakening a wall of the catheter, using a splittable, isotropically
oriented catheter wall material (e.g., PTFE), incorporating a
sealable or locking seam therealong, or by thinning the wall and/or
using a material that allows the wire guide to split the wall and
form its own exit pathway when sufficient force is supplied.
Alternatively, a wire guide that includes a coupling region, such
as an attached sleeve, can be used to couple to a standard wire
guide that is already indwelling, or both wires can be coupled
together and advanced through the passageway of the elongate
tubular member.
[0023] After gaining access to the passageway by one of the
aforementioned routes, the wire guide is guided under external
imaging, such as fluoroscopy, into the desired location.
Optionally, if the first device is a sphincterotome or other type
of deflectable catheter, the operator can manipulate the shape and
orientation of the catheter tip portion to help guide the tip of
the second wire guide into the opposite (or side) branch of the
duct or vessel. Orientation within the work site can be facilitated
with a rotatable handle to direct the tip. Furthermore, it has been
demonstrated that certain shorter wire guides, such as the
illustrative 185 cm biliary wire guide of the present invention,
are sufficiently torqueable such that an operator can simply rotate
the wire with his or her fingers to achieve similar results in most
instances.
[0024] In another aspect of the invention, primary access devices
further include an elongate engagement member configured to
releasably engage with the wire guide within or about the coupling
region (e.g., the distal passageway of the tubular member).
Embodiments include using a flexible wire stop (e.g., a nylon
stylet) configured to wedge the wire guide within the passageway
when in the fully advanced position, and a thread-like member
(e.g., suture) that ensnares the wire guide and provides tension to
maintain it in a longitudinally secure position relative to the
tubular member. When an elongate engagement member is not used
during introduction, such as when secondary access devices are
being introduced over the already indwelling wire guide, a
stiffening stylet may be optionally maintained in the passageway of
the tubular member to add rigidity to the device during
introduction and/or for advantageously traversing scives in the
tubular member, such as the side access port, to prevent kinking
thereabout.
[0025] In still another aspect of the invention, the system of
devices adapted for remote uncoupling or ultra-short wire
techniques includes a delivery catheter for plastic tubular
drainage stents and a technique for deployment that allows for
placing multiple stents side by side within the bile duct using a
single cannulation procedure. By placing the side access port on
the inner carrying member (over which the stent is mounted) at a
point distal to the stent, the wire guide can be uncoupled within
the duct and the stent deployed without having to withdraw the
entire system, including the wire, in the process. The junction
between the inner carrying member and wire guide can be
advantageously used to `catch` the stent when the inner member is
pulled back, thus allowing the entire delivery system, including
the stent, to be pulled back within the duct. This feature, which
is not present in other stent delivery systems, is especially
important to address situations when the stent is advanced too far
into the duct and needs to be repositioned. After the stent is in
the correct position for deployment, the inner carrying member is
advanced and/or the wire guide withdrawn to uncouple the two,
allowing the inner carrying member to be withdrawn through the
stent and from the duct while the wire guide remains behind for a
second stent delivery catheter (and additional stents) to be
advanced into the duct and placed along side the first stent.
Pigtail stents and others that include shaped distal portions for
anchoring can be temporarily straightened during delivery by the
wire guide which traverses the coupling region.
[0026] In still another aspect of the invention, the wire guide can
be placed through the mouth by dragging or carrying the wire down
using a endoscope and guide wire carrying mechanism that either
resides in the channel of the scope and engages the wire guide
about the scope tip, or attaches to (or co-extends with) the scope
and engages the wire guide alongside. The treatment site, such as
the gastroesophageal (GE) junction, is visualized and the distance
to the mouth is measured using scale indicia located on the
proximal portion of the scope. The wire guide, still coupled to the
wire guide carrying mechanism, is then advanced a known distance
(e.g., 10 cm) past the treatment site and into the stomach where
uncoupling takes place following treatment. The wire guide includes
a reference marking (e.g., at 10 cm) which lies at a known
reference point relevant to treatment, such as the GE junction. The
proximal portion of the wire guide preferably includes scale
indicia, such as different colored bands or interverals (e.g., 5
cm) having different numbers or types of markings that reference a
particular distance (typically using non-numerical indicia) to the
reference mark at the GE junction. With the wire guide in position,
the operator advances a primary access device, such as a dilator,
PDT balloon, achalasia balloon etc., using corresponding indicia on
the proximal portion thereof that align with that of the wire guide
to guide placement of the device to the desired treatment site,
such as the GE junction. If a secondary access device is required,
such as a larger dilator, the first device is advanced into the
stomach over the wire and uncoupled so that the wire becomes
available for the next device to be fed thereover. Carrying the
wire outside of the scope to a treatment site, which may also
include the jejunum or other portions of the gastrointestinal
tract, adventageously provides a means for placing devices larger
than scope accessory channel, while still retaining the benefit of
endoscopic navigation within the patient.
BRIEF DESCRIPTION OF THE DRAWING
[0027] Embodiments of the present invention will now be described
by way of example with reference to the accompanying drawings, in
which:
[0028] FIG. 1 depicts a perspective view of a prior art
sphincterotome adapted for short-wire exchange;
[0029] FIG. 2 depicts a cross-sectional view taken along line 2-2
of FIG. 1;
[0030] FIG. 3 depicts the device of FIG. 1 being used with an
endoscope;
[0031] FIG. 4 depicts a side view of an illustrative catheter
configured for use in the illustrative system and method;
[0032] FIG. 5 depicts a cross-sectional view of the distal portion
of the embodiment of FIG. 4 and illustrative wire guide coupled
thereto;
[0033] FIG. 6 depicts a side view of an embodiment of the present
invention wherein the coupling region comprises an external
channel;
[0034] FIG. 7 depicts a side view of a wire guide in which the
proximal portion is oriented at an angle relative to the distal and
intermediate portions;
[0035] FIG. 8 depicts a side view of an embodiment of proximal
system of indicia located on the first elongate medical device and
wire guide;
[0036] FIGS. 9a-f depict the steps of an example of the present
method in which multiple catheter devices are exchanged over a
guide wire within the common bile duct;
[0037] FIG. 10 depicts a side view of an embodiment of the present
invention wherein the first elongate medical device comprises a
balloon catheter;
[0038] FIG. 11 depicts a view in situ of a sphincterotome of the
present invention being used to introduce a second wire guide into
a branch of a passageway;
[0039] FIG. 12 depicts a perspective view of an illustrative wire
guide holding device of the present system and method;
[0040] FIG. 13 depicts a side view of a wire guide having a
coupling mechanism for attaching a second wire guide to the
proximal end thereof;
[0041] FIG. 14 depicts a side view of a retrieval basket of the
present invention that includes a coupling ring to engage the wire
guide;
[0042] FIGS. 15-16 depict cross-sectional views of sphincterotome
catheters comprising a splittable wire guide passageway;
[0043] FIG. 17 depicts a side view of a biliary stent and delivery
catheter of the present invention;
[0044] FIG. 18 depicts a side view of an embodiment of the present
invention comprising a splittable region in the tubular member;
[0045] FIG. 19 depicts a side view of a dilation balloon of the
present invention;
[0046] FIG. 20 depicts a side view of an extraction balloon of the
present invention;
[0047] FIG. 21 depicts a side view of a biopsy device of the
present invention;
[0048] FIG. 22 depicts a side view of a self-expanding prosthesis
delivery apparatus of the present invention;
[0049] FIG. 23 depicts a partially sectioned side view of a first
embodiment of an elongate engagement member (distal portion)
comprising a wire stop member;
[0050] FIG. 24 depicts a side view of the proximal portion of the
embodiment of FIG. 23;
[0051] FIG. 25 depicts a partially sectioned side view of a second
embodiment of the elongate engagement member comprising a
thread-like member;
[0052] FIGS. 26a-b depict a third system of indicia located on the
intermediate, viewable portion of the coupled devices of the
present invention;
[0053] FIG. 27 depicts a cross-sectional view of a stent and pusher
apparatus of the present invention;
[0054] FIG. 28 depicts a cross-sectional view of radioactive seed
delivery apparatus of the present invention;
[0055] FIGS. 29a-e depict a method of delivering multiple stents
within the common bile duct using the system embodied in FIG.
17.
[0056] FIG. 30 depicts a partially sectioned view of a wire-guided
wire of the present invention;
[0057] FIGS. 31-32 depict partially sectioned views of embodiment
of the present invention in which the coupling region is located on
a separate member;
[0058] FIG. 33 depicts a side view of an embodiment of the present
invention have two distal side access ports;
[0059] FIG. 34 depicts perspective view of an embodiment of the
present invention in which the wire guide hooks into the side
access port;
[0060] FIGS. 35a-b depicts side views of a hooked wire guide before
and after uncoupling;
[0061] FIG. 36 depicts a side view of an embodiment of the present
invention comprising a pair of slotted coaxial members.
[0062] FIG. 37 depicts a cross-sectional view of the embodiment of
FIG. 36 taken along line 37-37;
[0063] FIG. 38 depicts a partially sectioned view of an introducer
member of the present invention;
[0064] FIG. 39 depicts a partially sectioned view of a delivery
catheter of the present invention;
[0065] FIG. 40 depicts a side view of and embodiment of the present
invention comprising a tactile alignment indication system;
[0066] FIG. 41 depicts a side view of a pigtail drainage catheter
of the present invention in its deployed configuration;
[0067] FIG. 42 depicts a partially sectioned view of the embodiment
of FIG. 41 coupled to a wire guide;
[0068] FIG. 43 depicts a side view of an alternate embodiment of a
drainage catheter having anchoring flaps;
[0069] FIG. 44 depicts a side view of a dilator catheter of the
present invention;
[0070] FIG. 45 depicts a side view of a wire guide of the present
invention adapted for being carried by an endoscope to a work
site;
[0071] FIG. 46 depicts a side view of device attached to an
endoscope which for carrying the wire guide of FIG. 45;
[0072] FIG. 47 depicts an end view of the embodiment of FIG.
46;
[0073] FIG. 48 depicts a side view of a wire guide carrying
mechanism of the present invention;
[0074] FIG. 49 depicts a cross-sectional view of the distal portion
of embodiment of FIG. 48 engaging a loop tip wire guide;
[0075] FIG. 50 depicts a side view of the loop tip wire guide of
FIG. 49;
[0076] FIG. 51 depicts a side view of a photodynamic therapy
balloon of the present invention;
[0077] FIG. 52 depicts a plan view of a the devices of FIG. 50 and
51 being introduced through a bite block/wire guide holder of the
present invention;
[0078] FIG. 53 depicts a side view of an achalasia balloon of the
present balloon;
[0079] FIG. 54 depicts a partially sectioned view of a naso-enteric
tube of the present invention including a stiffening stylet;
[0080] FIG. 55a-f depicts steps of esophageal dilation using the
present method;
[0081] FIG. 56 depicts a side view of an dilator having a reduced
diameter portion proximal to the side access port; and
[0082] FIG. 57 depicts a wire guide of the present invention that
includes a lubricious intermediate portion.
DETAILED DESCRIPTION
[0083] An illustrative system and method for introducing a series
of medical devices over a wire guide into a patient by remotely
uncoupling the first device from the wire guide inside of the
patient without utilizing a long wire or standard short wire
exchange procedure is embodied in FIGS. 4-57. A first exemplary
embodiment of the system is depicted in FIGS. 4-5, which comprises
a first elongate medical device 10, such as the illustrative
tubular member 77 or catheter that includes features similar to the
GLO-TIP II.RTM. E.R.C.P. Catheter (Wilson-Cook Medical, Inc.), the
catheter further including a coupling region 14 having a first,
distal end 75 (oriented toward the distal end of the device), a
second, proximal end 76, and an interconnecting passageway 31 sized
and configured to receive a standard-diameter exchange wire guide
11 (e.g., METRO.RTM. Wire Guide; Wilson-Cook Medical, Inc.) or
other guiding device suitable for coupling to the first elongate
medical device 10. The coupling region 14, generally located about
the distal portion 13 of the tubular member 77 (first elongate
medical device 10), may be coincident with the distal portion of
the main passageway 27 (as depicted) or separate therefrom. The
distal portions 13,60 of the fist elongate medical device 10 and
the wire guide 11, to which the former is coupled via the coupling
region 14, are generally defined as the portion of each that are
disposed within the work site during the medical operation and the
subsequent uncoupling of the two devices. For purposes of this
disclosure, the work site is defined as the lumen, duct, organ,
vessel, other bodily passage/cavity, or the pathway leading
thereto, in which wire guide access is maintained to perform a
particular medical procedure/operation or series of procedures. For
example, in a procedure involving the biliary system, the work site
is considered the common bile duct, including the pancreatic duct
and the ducts extending into the lobes of the liver.
[0084] The coupling region is configured to permit the first
elongate medical device 10 to be co-introduced over the wire guide
(either sequentially or together) into the work site in a coupled
state (e.g., with the wire guide 11 traversing the passageway 27 of
the first device 10) such that the proximal portion 59 of the wire
guide exits the passageway and is external to the tubular member 77
as the wire guide 11 and tubular member exit the patient or scope.
Like traditional forms of short wire or rapid exchange, this gives
the physician more control over the wire at that point. In the
illustrative coupling region 14 of FIGS. 4-5, the first end 75
thereof comprises a distal opening 19 in the tubular member 77, and
the second end 76 comprises a side access port 15 or scive
traversing the side wall of the tubular member 77 and located
approximately 6 cm from the distal end 12 of the tubular member.
The illustrative coupling region 14 is located within the distal
portion 13 of the first elongate medical device 10 with the
coupling region passageway 31 comprising the distal portion of the
main wire guide passageway 27. The range of lengths of the coupling
region 14 or the distance of the side access port 15 (or second end
76) from the distal end 12 of the elongate member 10 can vary
according to the device and application as long as the disconnect
point is sufficiently close to the distal end of the device to
allow for remote uncoupling within the work site. It has been
determined that 6 cm is an advantageous coupling region length for
many biliary devices of the present invention in that it provides a
sufficient length to prevent accidental uncoupling, while still
allowing for the anatomical constraints of the duct such that, in
most instances, there remains sufficient room for the relative
movement required for uncoupling.
[0085] For biliary applications, the length of coupling region
could range from less than 1 cm (e.g., a ring) to at least 15 cm. A
more preferred range for most devices would be approximately 3-10
cm with the most preferred range being approximately 5-7 cm. For
devices intended for the pancreatic duct, the ideal distance of the
side access port 15 to the distal end 12 would be 2-5 cm, given the
shorter available distance in which to work. In devices intended
for use in body cavities where space is even tighter, the side
access port 15 may need to be placed closely adjacent to or at the
tip 12 of the device in order for an exchange to be successfully
accomplished. On the other hand, procedures in which loss of wire
guide access in not particularly of concern, such as in certain
vascular procedures and when working in long passageways, such as
in the intestinal tract, there may be more options as to where the
side access port 15 and coupling region 14 can be located.
[0086] The illustrative side access port 15 comprises a
semicircular opening (in a cross-sectional view or ovoid shape from
a top view) that typically comprises approximately 1/4 to 1/3 of
the width of the catheter; however, any opening size or shape that
permits passage of the wire guide therethrough is possible. It may
be advantageous to reinforce the side access port 15 area with one
or more wires, sheaths, bands, braiding, or other means which
traverse, are bonded to, embedded within, or otherwise reinforce
the tubular member at least within the area about the wire guide
exit port (side access port) to prevent kinking at that location.
The wire guide 11 extends proximally from the distal opening 19 of
the first device 10 and exits the passageway 31 and coupling region
14 proximally through the side access port 15, thereby giving the
physician access to the proximal end of the wire such that it can
be manipulated and locked or otherwise secured during the
procedure, if so desired. As noted above, a relatively short
distance of the coupling region 14 advantageously allows the
coupled devices to be moved relative to each another by a
sufficient distance to disengage or uncouple one from the other by
advancing the catheter 10 toward the distal tip 25 of the
stationary wire guide 11, withdrawing the wire guide until it pulls
through the catheter and exits the side access port 15/coupling
region 14, or a combination of forward catheter movement and wire
guide withdrawal, all preferably in such a manner that the wire
guide still remains within the work site (e.g., the duct) to
facilitate access by subsequent devices over the indwelling
wire.
[0087] Insomuch that no external exchange is required with the
present invention, it is only necessary to size the length of the
wire guide 11 to account for the furthest point the distal portion
60 is to be advanced into the work site (e.g., for uncoupling to
take place), the intermediate portion 97 extending from work site,
to the outside of the patient or scope, and the proximal portion 59
(FIG. 7) extending therefrom for a length sufficient to be
manipulated by the operator, such as to lock the wire guide in
place. In the illustrative biliary embodiment, the wire guide 11 is
185 cm in length so as to provide a minimal, but adequate extension
of the wire from the scope accessory channel; however, other
procedures might necessitate a shorter or longer length. Although
the length of the wire guide 11 need only be of sufficient length
to manipulate or lock or secure in place, if necessary, the
proximal portion 59 preferably should be sized to accommodate a
traditional short wire exchange procedure, using the appropriately
configured devices, if one is required (such as when remote
uncoupling may not be possible or desirable for some reason). The
wire guide 11 is preferably sized to slidably and releasably reside
within the coupling region with minimal friction, although a
mechanism is contemplated as part of the present invention in which
the catheter (or coextending ancillary device) releasably engages
and locks with the wire at a particular point therealong. The
coupling region 14 of FIG. 5 comprises the distal portion of the
passageway 27 (passageway 31), with the proximal portion 28 of the
passageway providing a continuation of the lumen that extends
proximally from the point of the side access port 15.
Alternatively, the proximal passageway 28 can be at least partially
blocked or restricted (with a moveable flap or a permanent
obstruction, such a plastic or metal insert) just proximal to the
side access port 15 to serve as a guide or ramp that helps the wire
guide being loaded from the distal opening 19 to be able to more
readily exit through the side access port, rather than continuing
on into the proximal passageway. The blocking means (not shown) may
also advantageously restrict fluid or other materials from passing
through the passageway retrograde direction. In a related
embodiment, the wire guide passageway 27 extends proximally only to
the side access port 15, terminating at that point.
[0088] While the illustrative coupling region 14 of FIGS. 4-5
represent a preferred embodiment for applications in which having
the wire guide 11 extending from the distal opening 19 of the
tubular member 77 is particularly advantageous, such as for primary
access devices used to cannulate a tight stricture, such as the
ampullary orifice, it should be noted that any structural
adaptation that allows for temporary coupling of the wire guide to
a device being introduced therewith or thereover can comprise an
embodiment of the coupling region 14 for purposes of remote
uncoupling. For example, FIG. 6 depicts a alternative embodiment of
the present invention in which the coupling region 14 comprises an
external coupling element or channel 30, rather than a portion of
the tubular member passageway 27. The illustrative external channel
30, which includes a passageway 31 extending therethrough, can
either be integrally formed with the catheter body, or can be
bonded or otherwise attached to the outside thereof. Additionally,
the external channel 30 can comprise a short piece of sheath
encircling the tubular member 77, a plastic or metal ring, or any
structure that can form a passageway 31 capable of forming a
coupling region 14 with the wire guide.
[0089] FIG. 30 depicts an embodiment of an external channel 30 for
a device not having an internal passageway. The elongate medical
device 10 comprises a wire-guided wire 111 in which the coupling
region 14 comprises a outer channel 30 comprising a outer sleeve
112 of shrink wrap material bonded to the wire 111 and a inner
sleeve 113 of a radiopaque material bonded to the first sleeve 112
as indicator 17,18 of the first and second ends 75,76 of the
coupling region 14. Either a standard wire guide (such as a 0.021"
METRO.TM. wire guide) is fed through the coupling region and the
two wires are advanced through an already indwelling tubular member
to the work site, or the wire-guide wire 111 is fed over the
proximal end of an indwelling standard wire guide (which could also
be coupled to a tubular member) and advanced to the work site,
where it is uncoupled therein.
[0090] FIG. 14 depicts another alternative embodiment in which the
coupling region 14 comprises a coupling ring 63, which in the
illustrative embodiment is attached to the distal tip 74 of a
retrieval apparatus 64, such as the illustrative wire retrieval
basket 64 for capturing biliary stones (a modification of the
WEB.TM. Extraction Basket, Wilson-Cook Medical, Inc.). The
illustrative ring 63 is advantageously made to pivot so that it can
better accommodate the wire guide 11 which passes therethrough to
engage with the first device 10. Coupling rings 63, while not
providing as secure of an engagement of the internal passageway,
represents an option for certain types of devices lacking a
suitable passageway within the shaft portion of the elongate
medical device 10 (made of coiled wire in this particular
embodiment). The ring 63 requires the least amount of relative
movement between devices for uncoupling, which can be advantageous
in short work sites or when faced with other anatomical
constraints.
[0091] FIGS. 31-36 depict a series of alternative coupling region
14 embodiments. FIG. 31 depicts a tubular member 77 in which the
coupling region 14 is located on a separate element, which in the
illustrative embodiment, comprises an elongate engagement member 89
comprising a shaft portion 164 slidably disposed in a second
passageway 115 and extends from the distal end 12 of the tubular
member 77 and engages the wire guide 11 via a cannula portion 115
that includes first and second openings 75,76 through which the
wire guide 11 is fed. By locating the elongate engagement member 89
within a second passageway 115, the first passageway 27 remains
available for infusing materials or passing a second wire guide
therethrough. The embodiment of FIG. 32 also includes a separate
elongate engagement member 89 in a second passageway 115 with the
elongate engagement member 89 further comprising the coupling
region 14. In this illustrative embodiment, the elongate engagement
member 89 extends from the side access port 15 and includes a
distal ring or loop 45 which ensnares the wire guide and couples
the devices together. Optionally, the loop 45 can be made
collapsible to pull through the passageway 115 after
uncoupling.
[0092] FIG. 33 depicts a tubular member in which the first end 75
of the coupling region 14 terminates proximal to the distal end 12
of the member, and the second end 76 comprises a side access port
15 located about the distal portion 13 of the tubular member. The
wire guide 11 is fed into the coupling region 14 such that the
distal end 25 of wire guide 11 is directed at an angle from the tip
12 as it exits the most distal side access port (first end 75).
This configuration allows the physician to be able to rotate the
tubular member 77 to advantageously direct the tip 25 of the wire
guide 11 in an intended direction, such as into a particular branch
48,49 of a bifurcated duct or vessel. The distal end 12 of the
tubular member 77 can be closed, or it could include an opening
about the tip that could represent a second, alternative first end
75 of the coupling region so that if preferred, the wire guide 11
can also be coupled in the manner similar to FIG. 5.
[0093] FIGS. 34-35b depict embodiments of the present invention in
which the wire guide 11 is adapted to hook into the coupling region
14 in a coupled configuration. In the embodiment of FIG. 34, the
wire guide 11 includes a hooked distal portion 116, such as the
illustrative `shepherd's crook` in which the distal end 25 and
adjacent distal portion 60 engage the coupling region 14 of the
tubular member 77 via the side access port 15, residing within the
passageway 27 by an amount sufficient to accomplish a secure
engagement. Preferably, the wire guide 11 is sized such that there
is a adequate frictional engagement with the passageway 27 in which
it resides to help prevent accidental dislodgement. In a related
embodiment shown in FIGS. 35a-b, the distal hook portion 116 of the
wire guide 11 is configured to be inserted into the distal opening
19 of the tubular member 77, which includes a radiopaque marker
band 17 closely proximate thereto. The illustrative distal hook
portion 116 comprises nitinol or another superelastic material
which allows it to be heat set in a helical configuration 117 that
once disengaged from the passageway 31 of the coupling region 14,
the hook 116 assumes its predetermined shape and wraps back over
itself to create a closed loop end 118. This configuration better
permits a second device to be fed back over the wire guide 11
without the hooked portion 116 interfering with its passage
thereover. Optionally, the tubular member 77 can include an open
longitudinal channel or recess extending proximally from the side
access port 15 or distal opening 19 in which the coupled wire guide
11 can at least partially reside while the devices are being
advanced together into the work site.
[0094] Another embodiment of a method of coupling a tubular member
77 to a wire guide 11 is shown in FIGS. 36-37 in which the tubular
member comprises a pair of coaxial members 100,119 that each
include a slotted opening or channel 120,121 extending the length
of the coupling region 14 (distal end 12 to side access port 15)
such that when aligned with one another, the wire guide 11 can
laterally disengage from the open passageway 31, which is otherwise
enclosed by one of the inner 119 and outer 100 sheath members when
they are not aligned. Preferably, the proximal portions of the
inner and outer members 100,119 (not shown) include proximal
makings or structure that allows the physician to determine when
rotational alignment has occurred for uncoupling. Alternatively,
the slots 120,121 can include radiopaque stripes extending
therealong that when superimposed on one another or are otherwise
aligned in some manner, indicate radiographically that alignment
has occurred such the wire guide can disengage from the passageway
31.
[0095] The above coupling region 14 embodiments are merely
exemplary of the many options from which a skilled person might
select to couple a catheter and wire guide together for introducing
them to a work site, the choice being influenced by the nature of
the procedure and the devices being used. Other selected examples
include, but are not limited to releasable or breakable sutures or
wires extending along or through the catheter to capture the wire,
compatible, engageable surface structure or elements located on
both devices, temporary or dissolvable bonds or adhesives, magnets,
or other means of temporarily coupling two medical devices.
[0096] Preferably, devices configured for remote uncoupling include
an alignment indicator system that allows the clinician to
determine the current state of alignment or engagement between a
given device and the wire guide or guiding member to which it is
temporarily coupled for a particular procedure. In procedures that
utilize fluoroscopic guidance of devices within the work site,
strategically located radiopaque indicia conveniently provide a
means for determining relative alignment and confirmation that
uncoupling has occurred. The invention does not require that a
particular imageable maker be of a particular type. For example,
ultrasonically reflective markers can be used in place of
radiopaque bands or other markers. Further, the number and
arrangement of the markers is not critical. The alignment indicator
system of the present invention may comprise any suitable system in
which the first elongate device 10 and wire guide 11 include a
predetermined or precalibrated method or means of providing
guidance to the physician via external imaging, direct observation
(external or endoscopic), tactile sensation, or monitoring of an
audible or visual alarm sensor (e.g., activating an indicator light
located about the proximal end of the apparatus) to indicate that
uncoupling of the two device has occurred within the work site.
[0097] Referring now to FIGS. 4 and 5, the procedure for uncoupling
the first device 10 and wire guide 11 within the work site is
greatly facilitated by the addition of a first system of indicia 16
located about the distal portions 13,60 of the first device 10 and
the wire guide 11, respectively, that comprise a series of
radiopaque markers which provide visual guidance under fluroscopic
imaging to the physician or operator as to when the first device is
coupled with the wire guide and when the wire guide has passed
through and out of the coupling region 14. Since relatively few
exchange procedures can be performed under direct visual
observation, the distal indicia 16 typically include a series of
externally imageable bands, marking, or other indicia comprising a
radiopaque (high density) material, such as, iridium, platinum,
tungsten, gold, barium, tantalum, etc. The indicia are overlaid
upon, bonded to, or incorporated into the device at the desired
locations, typically a location useful for relative alignment with
other radiopaque indicia or structure. The illustrative first (or
distal) system of indicia 16 comprises a series of radiopaque
markings on both the first elongate medical device 10 (tubular
member 77) and the wire guide 11, including an optional distal
imageable marking 17 located about the distal end 12 of the tubular
member (or first end 75 of the coupling region), a proximal
imageable marking 18 located proximate and distal to the side
access port 15, and a distal imageable portion 26 or marker located
about the distal end 25 or distal portion 60 of the wire guide 11.
The illustrative distal marking 17 of FIG. 4 comprises radiopaque
ink having sufficient radiopacity to contrast with the catheter
shaft, which in the illustrative embodiment, is also made
radiopaque by the addition of barium sulfate or other suitable
material into the base polymer. The proximal imageable marking 18
comprises an iridium or platinum band that is glued or otherwise
affixed to the catheter surface closely adjacent the distal end of
the scive comprising the side access port 15. This band comprises
sufficient radiopacity such that it contrasts well with the tubular
member to which it is attached, which also may include radiopaque
material or pigment. In FIG. 5, the distal radiopaque marker 17 of
the tubular member 77 comprises a band similar to band 18 at the
proximal end 76 of the coupling region (side access port 15). The
illustrative distal radiopaque wire guide portion 26 (FIG. 5)
comprises a coilspring comprising platinum, or another radiopaque
material such as tungsten or gold. Use of radiopaque filler
material or ink is also contemplated as a means for creating a
radiopaque wire guide tip portion 26. Placement of a radiopaque
marker 18 about the second end 76 of the coupling region 14
advantageously provides a target point at which the physician knows
if the radiopaque tip 26 of the wire guide has passed proximal
thereto and disengagement has occurred. Although in the
illustrative embodiments, the marker 18 is typically located
proximal and closely adjacent to the side access port, it may also
be placed in any suitable position that is useful for alignment
with the wire guide, such as proximal of the port or in alignment
therewith, such as depicted in FIG. 6. Alternatively, the marker 18
can comprise a radiopaque stripe or sleeve that extends the length
of the coupling region, rather than being limited to the area
adjacent the side access port. One such example is depicted in FIG.
31 in which the illustrative metal coupling cannula 114 comprises a
highly radiopaque material such as platinum or iridium. In the
embodiments of FIGS. 14 and 32, the coupling region 14 comprises a
coupling ring 63 which preferably includes enhanced radiopacity to
assist the physician in determining when the radiopaque distal
portion 26 of the wire guide has passed through and disengaged from
the ring.
[0098] A second system or type of indicia 21 is depicted in FIGS. 4
and 8, and is located on a proximal portion 36 of the first device
10/tubular member 77 that is external to the patient when the
distal portion 13 of the device is residing within the work site.
During normal operation, the proximal indicia 21 are directly
visible by the clinician during the procedure as a primary or
secondary means of determining alignment. In the biliary embodiment
of FIG. 8, the proximal indicia 21 comprise indicia 35 located
about the tubular member 77 and include a series of printed bands
that are preferably of a color or pattern contrasting with that of
the tubular member 77, and which extend from 160 cm (the first or
distal end 62) to the 166 cm mark (second or proximal end 61), as
measured from the distal tip of the catheter. The first end 62 (160
cm) represents the point at which alignment with a corresponding
proximal alignment mark 37 located on the wire guide, comprises the
point of alignment 81 which indicates that uncoupling is imminent
with further relative repositioning between the two devices 10,11.
Repositioning the proximal alignment mark 37 of the wire guide
toward the second end mark 61 results in the two devices reaching
the point of detachment 82 at which uncoupling takes place, the
colored bands serving as warning that the uncoupling is imminent
with further repositioning. In the embodiment of FIG. 4, the
proximal indicia 21 comprise a continuous band of contrasting
coloration extending from 160 to 166 cm. As noted, the location of
the proximal indicia is not particularly critical, but it is
preferably configured such that it remains visible to the operator
during a typical procedure. The band 35 can include a gradation of
colors, (e.g., yellow to orange to red) to indicate the relative
proximity to the point of detachment 82. In the illustrative
embodiment, the 166 cm mark at the proximal end of the indicia band
35 lies proximate the distal end of an optional proximal side
access port 20, which comprises an entry point for a second wire
guide into the passageway 27, the technique therefor being
discussed below. For non-biliary applications, such as for
vascular, pulmonary, or urological procedures, etc., any proximal
indicia 21 most likely would be located at a different lengths from
the distal tip of the catheter, one appropriately correlated with
the distance required to access the work site. The length of the
first device indicia 35 (6 cm) preferably corresponds with the
length of the coupling region 14 (shown in FIG. 5).
[0099] As noted above, the 160-166 cm area of indicia 35 of the
proximal indica system 21 advantageously provides a location on the
tubular member 77 that will most always be external to the patient
and endoscope accessory channel such that it can be viewed by the
clinician during the procedure. In the illustrative embodiment, the
second alignment point 37 of the wire guide is indicated by a color
change between the distal portion 60, which includes helical
striping characteristic of the METRO.RTM. Wire Guide (Wilson-Cook
Medical, Inc.), and the proximal portion 59, which comprises solid
coloration, such as a section of shrink wrap or coating of a
different color and/or pattern that visually contrasts with the
distal portion 60 and/or intermediate portion 97 such that the
distal 160 cm of the illustrative wire guide are distinct from and
different in appearance from the proximal 25 cm. Alternatively, a
contrasting color or ink or suitable material can be applied to the
outer surface of the wire guide 11, or a single band can be affixed
about the junction 37 between the distal 60 and proximal 59
portions at an appropriate location to establish the point of
detachment 82 which occurs by alignment with point 61 of the first
device 10. The second alignment point 37 is located on the wire
guide 11 such that when it is aligned with the distal end 62 of the
proximal indicia 21, the distal end 25 of the wire guide is aligned
with the distal end 12 of the first device 10/tubular member 77.
Alternatively, the wire guide could include a single, narrow
marking at the second alignment point 37, or multiple markings,
e.g., corresponding to both the proximal and distal ends 61,62 of
the proximal indicia 21. The proximal indicia 21 of the wire guide
11 and catheter 10 comprise any suitable means of providing a
visual indicator, such as shrink wrap, ink, bands, surface etching
or other treatment, etc.
[0100] A third type of alignment 83 is depicted in FIGS. 26a and
26b in which the first and second endoscopic alignment indicators
84,85 are located about the intermediate portions of the first
elongate medical device 10 (or second catheter, etc.) and wire
guide 11, respectively, in a location such that when the distal
portions thereof are advanced within the work site 41, the first
and second indicators 84,85 are typically disposed within the
viewable area 86 between the Papilla of Vater 40 and the distal end
87 of the accessory channel. This allows the operator to monitor
the relative alignment of both to determine when uncoupling has
occurred within the duct 41 (biliary system). In the illustrative
example, the distal ends of the wire guide and first catheter
member (not shown) have both traversed the Papilla of Vater 40, and
entered the bile duct 41. An optional marking 29 at 10 cm (depicted
in FIG. 4 as a pair of printed bands) can be included on the first
elongate medical device 10, which is viewable as the device is
being introduced into the duct 41. The 10 cm mark 29 can be used
for guidance to indicate that the first device 10 has been advanced
a minimally `safe` or sufficient distance into the duct, this
occurring once the 10 cm mark 29 has disappeared from view, as
shown in FIG. 26a-b. At this point, the endoscopic alignment
indicators 84,85 are normally located within the viewable area 86.
In FIG. 26a, the first endoscopic alignment indicator 84 of the
catheter is located proximal to the corresponding second endoscopic
(wire guide) indicator 85, indicating that the wire guide 11 is
fully coupled to the first device 10 (i.e., completely traversing
the coupling region). In the illustrative method, the operator
utilizes the intermediate system of indicia 83 to determine when
uncoupling of the devices 10,11 has occurred by advancing the first
device 10 relative to the stationary wire guide 11 (which typically
is locked down or secured against movement to maintain access
within the duct), as shown in FIG. 26b. As the two indicators 84,85
become aligned, the distal end of the wire guide exits the proximal
end of the coupling region or side access port (not shown) and
uncoupling or disengagement takes place. As a further endoscopic
indicator to prevent loss of wire guide access out of the duct
during uncoupling, the distal portion 60 (e.g., the distal 6 cm) of
the wire guide 11 can comprise a different coloration, such as
black, so that it contrasts with the intermediate portion 97
(depicted in FIG. 7). When the physician sees the black portion of
the wire guide emerging from the papilla, the wire should be
advanced back into the duct to minimize the risk of having to
recannulate. If uncoupling has yet to take place and the distal
black portion 60 of the wire guide is visible endoscopically, then
both the wire guide 11 and tubular member 77 should be advanced
further into the duct so that uncoupling can safely take place
without risking loss of access.
[0101] An example of a non-visual system of alignment is depicted
in FIG. 40 in which the wire guide 11 includes a surface
irregularity 160, such as the illustrative bead, that is configured
such that when it passes through the second end 75 of the coupling
region 14, e.g., through the side access port 15, the operator
feels or senses the contact between them, thus indicating that
uncoupling is imminent with further repositioning. The illustrative
side access port 15 is configured to include a flexible skirt 158
that includes an opening 159 sized to allow free passage of the
wire guide 11, but causing temporary resistance as the bead 160
passes therethrough. Furthermore, the skirt portion 158 can
advantageously act as a seal to help prevent leakage of bile,
blood, and air into the passageway of the tubular member. Other
possibly surface irregularities include ridges, bumps, teeth,
indentations, or a roughened portion that along with an
appropriately configured side access port 15 or coupling region 14,
provide tactile feedback to the operator and thus, guidance to the
state of alignment and engagement between the two devices.
[0102] Endoscopic devices used to perform medical procedures within
the biliary system are typically divided into what could be called
`primary access devices`, which typically comprise the initial
device used in the procedure to cannulate the Spincter of Oddi and
access the duct, and `secondary access devices` for which the
primary access device is exchanged to perform one or more
operations within the work site. Examples of primary access devices
of the present invention include sphincterotomes for ablating the
sphincter to enlarge the opening to the duct (depicted in FIGS.
10-11), needles knives (not shown), which are also used to cut the
sphincter, and ERCP catheters (FIGS. 4-5), which are adapted to
infuse contrast media into the duct for radiographic imaging.
Sphincterotomes and needles knives may also be configured to
perform dual or multiple functions or operations, such as the
infusion of contrast media and other agents. Some sphinctertomes
include balloon used for sweeping the duct to remove calculi or
stones lodged therein. Other devices, such as extraction balloons,
may be used as both primary and secondary access devices. In
pancreatobiliary procedures, primary access devices are exchanged
for secondary access devices that are typically configured to
perform a therapeutic function, such as to extract or crush stones,
sample tissue, deliver radiation or light therapy, dilate or stent
strictures (e.g., tumors), or place stents for drainage. If the
secondary access device represents the last device used in a
particular procedure, it need not be adapted for remote uncoupling,
although it preferably would include at least a distal coupling
region so the device can be advanced over a short wire without
requiring an extension being added thereto. Generally speaking,
virtually any secondary access device (extraction, dilation, or
phototherapy balloons, dilator, forceps, brush, stent delivery
catheter, brachytherapy catheter, lithotriptor, basket, snare,
etc.) that is normally introduced into the biliary system over a
wire can be adapted for remote uncoupling by the addition of a
suitable coupling region within the distal portion of the device
and preferably, but not necessarily, at least one of the three
aforementioned systems of indicia to provide positive confirmation
of uncoupling and relative alignment of the devices.
[0103] An exemplary method of using a primary access device (first
elongate medical device 10), a wire guide 11, and a secondary
access device (third elongated medical device 44) of the present
invention to access and perform a medical operation in a work site
41 is depicted in FIGS. 9a-f. The initial steps of the illustrative
method include a standard endoscopic technique for accessing the
biliary duct 41 to perform diagnostic and therapeutic procedures.
FIG. 9a shows a duodenoscope 38 that has been introduced via the
oral cavity into the duodenum 39 to visualize the Papilla of Vater
40 and Sphincter of Oddi, which lie at the opening to the common
bile duct 41 and the pancreatic duct. In the exemplary method, a
dilator catheter 88 and wire guide 11 are advanced from the
accessory channel of the scope 38 to cannulate a stricture 42
within the work site 41 (duct). It is general physician preference
that determines whether the wire guide 11 is advanced past the tip
of the primary access device 10 to assist in cannulation or whether
the distal end 25 of the wire guide is within the passageway 27
during this part of the procedure. As depicted in FIG. 9b, the
dilator catheter 10 (or other secondary access device) is advanced
over the wire guide 11 with the proximal portion of the wire guide
exiting the side access port 15 and extending through the channel
alongside the catheter so that both separately exit the accessory
channel of the scope as depicted in FIG. 12. For applications where
the size of the scope channel is restricted or other applications
where there is limited room to accommodate both devices side by
side, the catheter can be modified to allow for the wire guide to
lie alongside without increasing the overall diameter. This can be
done by forming an open channel (preferably one that would not
capture the wire) or creating a flattened longitudinal portion
along the length of the catheter (not shown).
[0104] Still referring to FIG. 12, the proximal portion 59 of the
wire guide 11 is typically, but not necessarily, secured in place
once the distal end 25 thereof has been advanced to the desired
position within the work site 41. The illustrative wire guide
holder 50 represents an improvement over prior art devices in that
it is configured to be partially inserted into or over the opening
52 of the access port 51 to the accessory channel and provide a
seal, rather than being secured elsewhere on the scope. The holder
50 further includes an optional integrated sealing element 65
having one or more types of seals, including duckbill, membrane
with slit (e.g., polystyrene, silicone, or another compliant
polymer material), foam seal with small central aperture (e.g.,
silicon, polyurethane, etc.), or other designs having the ability
to seal around the catheter and wire guide to prevent any
proximally migrating fluid from exiting the channel. The wire guide
11 is locked in place by interweaving it through a first series of
spaces 53 (or channels, grooves, slots, etc) between spaced
elements located along one side of a locking portion 66 of the
device, such as the illustrative curved `spine`, using an
alternating under/over manner as depicted. The illustrative holder
includes three slots 53 or spaces on the first side and a second
series of three slots 54 or spaces on the opposite side of the
locking portion 66 to accommodate a second wire, if one is
necessary for the procedure.
[0105] Unlike other wire guide exchange procedures where the
proximal end of the wire guide is well out of the way of the
physician, the short wires typically used in the illustrative
remote uncoupling or ultra-short wire techniques usually result in
the proximal end of the wire guide being within the physician's
working area so that access thereto is readily available for
introducing secondary devices to the work site. While the
illustrative holder is configured to direct the proximal end
portion of the wire guide downward and out of the way of the
physician, the proximal end, when unsecured to feed another device
over the wire, may deflect back up into the working area around the
access port of the scope and can interfere with the physician
during the procedure. To help alleviate this problem, FIG. 7
depicts a wire guide 11 in which the proximal end portion 59
thereof is oriented at an angle 79 with respect to the distal and
intermediate portions of the wire so that the proximal end
58/proximal end portion 59 is typically oriented down and away from
the operator (when rotated as such) and thus, out of the working
area surrounding the access port of the endoscope while still
allowing the physician to access the proximal end for the advancing
the next device. In the illustrative embodiment, which comprises an
185 cm nitinol core wire guide 11 in which approximately 40-45 cm
thereof typically is extending proximally out of the scope as the
third elongate medical device is being advanced thereover, the bend
80 or point of deflection is preferably located about 20-30 cm from
the proximal end, although the useful range may be anywhere from
0-50 cm. The useful angle 79 of deflection depends on physician
preference, the configuration of the scope and wire guide holder,
and other factors, but is generally about 30-120.degree. for
endoscopic procedures with a more preferred range of 45-90.degree.
for the illustrative embodiment. To create the bend 80 in a nitinol
wire guide 11, the material can either be heat set or mechanically
overstressed (`cold working`) to achieve the desired angle 79 of
deflection and radius of the bend 80 (e.g., small, relatively acute
bend or a large, more gradual or rounded bend).
[0106] Referring now to FIG. 9c, once the wire guide has been
advanced to the desired location within the work site, the catheter
is advanced or drawn back over the wire guide to position it for
performing the intended operation. In the illustrative method, this
involves the injection of contrast media 43 into the duct 41 to
visualize the obstruction, which comprises a stricture 42 in this
particular instance. Another common alternative approach to
diagnosing potential obstructions in the ducts would be to
initially introduce a sphincterotome 32 (FIG. 10) to inject
contrast media. 43. If an obstruction is found, such as a stone,
the sphincter might be ablated and a second device, such as a
basket or balloon, is introduced over the original wire guide to
extract the stone from the duct. A variety of other treatment
possibilities exist and thus, it should be understood that the
nature and sequence of the devices used is not critical to the
present invention.
[0107] Once the initial operation has been concluded, the first
elongate device 10 can be removed from the duct 41. As depicted in
FIG. 9d, the operator can conduct a device IDE by repositioning the
distal ends of the ERCP catheter and wire guide 12,25 toward one
another by advancing the catheter (as depicted), or preform a wire
guide IDE by unlocking the wire guide 11 from the wire guide holder
and drawing it back until the distal end 25 disengages from the
catheter. Alternatively, the clinician can disengage or uncouple
the device and wire guide 10,11 by moving both devices
simultaneously until the wire guide exits the coupling region,
typically keeping them within the work site 41 while uncoupling
takes place. As discussed earlier, imageable indicia 18,26 on the
distal portion 13 of the catheter 10 and the distal end 25 of the
wire guide 11, respectively, are utilized to confirm under
fluoroscopy that disengagement or uncoupling has occurred, as shown
in FIG. 9e. The proximal indicia 21, depicted in FIGS. 4 and 8,
and/or intermediate indicia 83 (FIGS. 26a-b) may also be utilized
to provide confirmation that uncoupling has taken place within the
work site. This optional step is shown in FIG. 12 in which the wire
guide 11 is in the locked position 161 within the illustrative wire
guide holder 50, which is attached about the opening 52 of the
biopsy port of the scope (over the rim of the port and/or inserted
therein), is subsequently disengaged and placed in the unlocked
position 162 adjacent the primary access device 10 so that the
proximal indicia 21 of the two devices 10,11 can be aligned. As
long as the proximal mark 37 of the wire guide 11 remains distal of
the alignment mark 81 of the primary access device 10, the operator
knows that distal tip of the wire guide is still protruding from
the distal end of the catheter within the duct (not shown). When
the wire guide 11 is withdrawn (or primary device 10 advanced) such
that the two marks 37,81 are in alignment, the operator knows the
distal ends 12,25 of the two devices 10,11 are generally aligned
within the duct. As the operator continues to draw back the wire
guide 11 or advance the catheter 10, the alignment mark 37 becomes
aligned with the disengagement mark 82, which in the illustrative
embodiment is indicative that the distal end of the wire guide has
pulled completely out of the passageway or coupling area such that
the two devices are uncoupled within the duct.
[0108] Once uncoupling has taken place, either device 10,11 becomes
available as a conduit for introduction of a third elongate medical
device to the work site. In the illustrative method depicted, the
third elongate device 44 comprises a dilation catheter 88 (FIG. 9f)
that is introduced over the wire guide 11 by feeding the back end
58 of the wire guide 11 (not shown) into the distal opening 19 of
the dilation catheter 88 and out of the side access port 15, then
advancing the dilation catheter 88 into the accessory channel of
the scope, over the wire, and on into the duct 41. Typically, the
operator would choose to remove the first device 10, if no longer
needed, before introducing the third device 44. This is done simply
by having the operator pull the catheter out of the duct and scope
channel in one continuous motion while maintaining the wire guide
in position (e.g., such as locked within the wire guide holder 50
of FIG. 12). Once the first device 10 is removed and the third
device 44 is advanced to the work site, the second medical
operation (e.g., dilation of the stricture) can be performed. If
another operation is required, a third catheter-type device (fourth
elongate medical device) can be advanced over the original wire
guide 11 and so on.
[0109] As noted above, the present system of introducing and
exchanging devices over a wire guide is adaptable such that a long
wire guide can be introduced through a suitably configured medical
device that has been introduced using the ultra-short wire method.
In other instances, it may be desirable to convert an indwelling
ultra-short wire to a longer wire for use with a non-compatible
device. FIG. 13 depicts a wire guide extender 56 for use with the
present system to accommodate an external exchange with either a
conventional medical device (`long wire`) lacking the side access
port for intraductal exchange, or conventional rapid exchange
devices in which a somewhat longer external exchange (e.g., 30 cm)
is required. In the illustrative system, the wire guide 11 includes
a-coupling mechanism 55, such as a thread or wire loop, on the
proximal end 58 that is configured to engage with a second coupler
57, such as the illustrative hook, located on the distal end of the
wire guide extender 56. This effectively extends the length of the
wire guide so that a conventional over-the-wire exchange can take
place in the event that a particular device not designed for
ultra-short wire exchange is to be used with the present system.
One skilled in the art would readily appreciate the various types
of coupling mechanisms that would be suitable to accomplish the
extension of the wire guide for purposes of an exchange. They
include locking or screw mechanisms, sheaths, bands, etc. that
permit the two portions 11,56 to be joined temporarily or
permanently. Another option is to use an adhesive strip or similar
device to attach the wire guide 11 and extender 56 to one
another.
[0110] The illustrative system of devices that allow for uncoupling
within the work site and elimination of the external exchange over
the wire can also be adapted for the introduction of second wire
guide via an indwelling, uncoupled catheter into the work site,
after placement of the first wire guide. FIG. 10 depicts catheter
10 that includes a proximal access port 20 (third opening) located
within the proximal portion of the catheter at a point that
typically lies outside of the patient during a procedure
(approximately 166 cm in the illustrative biliary device example).
The proximal side access port 20 may include an optional sleeve
cover that slides over and closes the access port when it is not in
use.
[0111] To introduce a second wire 46, the illustrative
sphincterotome 32, once disconnected from the first wire guide 11,
is not removed from the patient as in the method depicted in FIGS.
9a-f. Rather, the tip of the second wire guide 46 (third elongate
medical device 44) is fed into the wire guide passageway 27 via the
proximal opening 20 and advanced through the scope and into the
duct 41. In the example of FIG. 11, the first wire guide 11 resides
in a first branch 48 of a bifurcation, such as where the common
bile duct 41 branches into the two lobes of the liver. The
sphincterotome 32 carrying the second wire guide can be rotated and
deflected by the physician, by using the handle to pull back the
cutting wire, to advantageously direct the advancing second wire
guide into the opposite branch 49 such that each branch is now
cannulated by the wire guide 46. A sphincterotome 32 having a
handle that provides axial rotation of the catheter body is
preferable for orienting the distal cutting portion 33 into or
toward the opposite duct for placement of the wire. Once the second
wire 46 is in its desire location, it can be locked in place (e.g.,
using the second series of slots 54 of the illustrative wire holder
50 of FIG. 12). After the sphincterotome or other primary access
device 10 has been removed from the second wire 46, both wires
11,46 are available for subsequent placement or introduction of
additional devices, such as stents to restore or improve patency of
the ducts.
[0112] Removal of the original catheter device 10 from the short
second wire 46 requires that either an exchange must take place,
such as by adding the wire guide extender 56 of FIG. 13 to perform
a long-wire exchange; or the catheter may be peeled off of the wire
46 if the portion of the wire guide lumen 27 that lies between the
distal (side) and proximal side access ports 15,20 is configured to
allow wire to laterally exit the passageway. This can be
accomplished in a number of well-known ways including forming a
weakness in the wall, such as making a score line, slit 67 or other
pre-weakened area inside of the wall, such as that depicted in FIG.
15, or intermittent perforations formed partially or completely
through the wall to weaken it longitudinally. Alternatively, the
tubular member can comprise an intact catheter wall that is
configured to fail when sufficient lateral pressure is exerted by
the wire guide residing in the passageway. One method of doing this
is to make the wall 68 adjacent the wire guide lumen 27
sufficiently thin (FIG. 16) and and/or of a suitable polymer such
that when lateral force is applied against the catheter, the wire
guide 46 readily splits or tears through the thin wall 68 as the
catheter is being withdrawn from the patient. A material with a
suitable molecular structure to encourage splitting, such as an
isotropically oriented polymer, may be used or the polymer may be
treated in some manner to encourage splittability. The entire
catheter wall can be configured to facilitate splittability, or the
splittable portion may be limited to one specific region along the
circumference thereof, such as including a longitudinal coextrusion
of a second, lower durometer extending to the outside of the wire
guide lumen. Rather than (or in addition to) configuring the wall
to increase splittability, a tab or other element can be attached
or integrated into the catheter to facilitate a manual split to
remove the wire guide. A sharp tool or similar device represents
yet another alternative method of accessing the guide wire lumen to
separate the catheter from the wire. Another option is to extend
the groove completely through the wall to form a narrow, open
channel or a sealable or locking seam such that the two edges
either are biased against one another or interlock by virtue of
their complimentary structure. The seam is designed to split open
or unlock when the lateral force supplied by pulling the wire guide
thereagainst is sufficient to force it open.
[0113] Returning now to the IDE method depicted in FIGS. 9a-f, it
has been noted that the friction encountered when introducing a
primary access device and a coupled wire guide through the
accessory channel of an endoscope can, in some instances, cause
premature disengagement of the two device before they reach the
work site. FIGS. 23-25 depict different embodiments of an elongate
engagement member 89 which is configured to releasably secure the
wire guide 11 to the tubular member 77, such that unwanted
disengagement or relative movement does not occur as the devices
are being introduced or manipulated within the patient. In FIG. 23,
the elongate engagement member comprises a wire stop member 90
preferably made of a flexible polymeric material with adequate
column strength, such as nylon, which is similar in configuration
to a standard pusher member. Preferably, the wire stop member 90
comprises a diameter (e.g., 0.035") that substantially fills the
inner diameter of the passageway 27 of the tubular member 77 such
that when fully advanced to a point distal to the side access port
15 where the wire guide 11 enters the coupling region 14
(passageway 31), the wire stop member contacts and wedges the wire
guide 11 against the inner wall of the passageway, thereby
substantially preventing longitudinal movement of the wire guide 11
relative to the tubular member 77. FIG. 23 illustrates the wire
stop member 90 disposed within a single-lumen tubular member 77;
however, it may be used in multi-lumen device (e.g., a
sphincterotome) as well. FIG. 24 depicts the proximal hub 92 (a
male luer fitting) of the wire stop member 90 in a retracted
position 94 in which the wire stop member 90 is not sufficiently
advanced to engage and lock or wedge the wire guide 11 within the
passageway 27 a region or point 91 just distal to the side access
port 15. To do so, the proximal hub 92 is advanced to a forward
position 95 in which the hub 92 contacts and engages the proximal
(female) fitting 93 located at the proximal access port 23 of the
primary access device 10. Once the operator wishes to reposition
the two devices 10,11 relative to one another, the proximal (male)
hub 92 is disengaged from the female proximal hub 93 and drawn back
until the wire guide 11 is released. Preferably, but not
necessarily, the wire stop member 90 is removable from the
passageway 27 such that agents, additional wire guides, etc., may
be introduced therethrough. An elongate engagement member 89 is
typically not used with a secondary access device insomuch that the
wire is already indwelling within the work site and the need to
secure the wire guide to the device is unnecessary.
[0114] A second embodiment of an elongate engagement member 89,
depicted in FIG. 25, comprises a thread-like snare member 96 made
of suture, wire, cable, or other strand of material which loops
around, ensnares, or otherwise releasably engages the wire guide
within the passageway 27. The snare member 96 can be attached to an
actuating portion of the handle to give the operator sufficient
control over its operation. When the operator wishes to disengage
the wire guide 11 from the tubular member 77, tension is released
on the snare member 96, or it can be cut or one end released so
that it can be withdrawn from the passageway 27. Alternatively, the
snare member 96 can be disposed on the outside of the tubular
member 77 to releasably engage and secure the wire guide 11. The
depicted embodiments represent but two possible types of devices
adapted for securing the first elongate medical device 10 and wire
guide 11 so that they can be co-introduced through a channel
without disengaging therein.
[0115] The elongate engagement member 89 embodiments of FIGS. 31
and 32 also include the coupling region 14 of the device 10 that
may be configured to be partially retractable back into the
secondary passageway 115. This action creates a frictional
engagement with the wire guide such that the elongate engagement
member 89 further acts as a stop to prevent the wire guide 11 from
sliding freely within the coupling region 14.
[0116] The present invention and method includes using devices in
procedures where once the primary access device is used within the
work site, a secondary access device is introduced over the guiding
device (wire guide) which has been uncoupled from the primary
device within the work site. In the biliary tree, a number of
possible devices may be introduced to perform a variety of medical
procedures, a few selected examples of which are depicted in FIGS.
9F,14,17,19-22, 27-28, 39, 41-44, 51, and 53. The exemplary devices
are certainly not representative of all secondary access devices
appropriate for use in the bilary tree, nor is their use
particularly limited to being a secondary device used following a
primary device. The illustrative devices depict some of the general
types of medical devices used endoscopically in the biliary tree,
as well as other non-biliary and non-endoscopic procedures
performed elsewhere in the body.
[0117] FIG. 17 depicts a system for delivering a biliary or
pancreatic drainage stent 69 mounted on a delivery catheter 110
(elongate medical device 10) of the present invention. The
illustrative COTTON-LEUNG.RTM. Biliary Stent (Wilson-Cook, Medical
Inc.) is mounted on an OASIS.RTM. One Action Stent Delivery System
(Wilson-Cook Medical, Inc.), modified for IDE, which extends
through the internal lumen 72 of the stent 69, which is slidably
mounted thereover (when used with a pusher member 101 (see FIGS.
29a-c). It should be noted that the illustrative stent delivery
catheter 110 is configured to accept different kinds of tubular
drainage stents in addition to the type shown. The coupling portion
14 of the delivery catheter 110 comprises the passageway 27 between
the distal opening 19 and the side access port 15, which is located
1.5-2.0 cm from the distal tip. A proximal marking 18, such as the
illustrative iridium band, is located at about 1 cm, just distal to
the access port 15. The wire guide 11 exits the side access port 15
at a point distal to the distal end 71 of the stent 69 to
advantageously provide a means for withdrawing the stent 69 along
with the delivery catheter 110, which greatly assists in the
ability to reposition the stent within the duct. When the catheter
10 and wire guide 11 are withdrawn together relative to the stent
(which is held stationary by the pusher member), the distal edge 71
of the stent 69, which is slidably positioned over the catheter,
lodges in a triangular wedge point 70 formed by the junction of the
delivery catheter and the wire exiting therefrom. Thus, the stent
69 is pulled backward along with the delivery catheter, providing
the clinician with a simple and reliable means to pull the stent
partially out of the duct so that the proximal anchor flaps 73 can
extend outside of the duct, if so desired. Once positioned at the
desired location, the wire guide 11 and delivery catheter 110 are
uncoupled and the latter is withdrawn from the lumen 72 of the
stent 69. In delivery systems in which the wire guide 11 extends
through the lumen 72 of the stent 69, pulling back on the delivery
catheter 110 would not allow the clinician to pull the stent back
with it without an additional mechanism to releasably couple the
stent to the delivery catheter. It should be noted that this method
can be readily adapted for other stent designs as well,
particularly other non-expandable tubular stents and those having
pusher members.
[0118] The illustrative stent delivery system of FIG. 17 is
particularly well-adapted for placement of multiple stents as
depicted in the method of FIGS. 29a-e, insomuch that remote
uncoupling of the wire guide 11 and apparatus 10 can be performed
within the duct, unlike previous biliary stent delivery systems,
thereby eliminating the need for recannulating the papilla for each
stent placed. As depicted in FIG. 29a, the inner delivery member
110, which is coupled to the wire guide 11, is advanced out of the
endoscope 38, through the ampullary orifice 40 and into the duct
41. The wire guide 11 does not extend through the lumen of the
stent 69 and pusher member, which is not yet shown. In FIG. 29b,
the pusher member 101 urges the stent over the inner member 110
until the distal end 71 thereof reaches the junction 70 formed
where the wire guide 11 exits the side access port (alternatively,
the inner member 110 and stent 69 can be pulled back while the
pusher member 101 contacts the stent and causes it to advance
further up over the inner member 110). As noted above, the junction
70 can be used to contact the distal end 71 of the stent and pull
back or reposition the stent 69, such as when it had been advanced
too far into the duct for ideal deployment. Once the stent 69 is in
the proper position for deployment, as depicted in FIG. 29c, the
inner member 110 is advanced further into the duct 41 so that there
is sufficient room for the uncoupling procedure to take place. The
wire guide 11 is unlocked from the wire guide holder 50 (see FIG.
12) and pulled back until it exits the side access port 15, as
depicted in FIG. 29d. The inner member 110 is then withdrawn
through the stent 69, along with the pusher member 101, and removed
from the channel of the endoscope. The wire guide 11 is then
re-advanced further into the duct to serve as a conduit for the
next stent delivery system, shown in FIG. 29e, such that a second
stent 109 can be deployed alongside the first in the manner shown
in FIGS. 29a-d. Subsequent deployments of additional stents can be
also be made using the same technique over the original wire
guide.
[0119] Other stent or prosthesis delivery systems configured for
use with the present invention are depicted in FIGS. 22, 27, and
39. FIG. 22 depicts a delivery system 99 for a self-expanding
prosthesis 98, which could include a self-expanding stent, such as
the Wilson-Cook ZILVER.TM. Biliary Self-Expanding Stent or any
nitinol, stainless steel, or other self-expanding stent; artificial
valve (e.g., venous, heart, pulmonary, etc.) prosthesis, vessel
occluder, filter, embolic protection device, shunt, stent graft,
etc. The illustrative apparatus comprises an inner member (elongate
medical device 10) on which the prosthesis 98 is mounted and an
outer member 100 or sheath which constrains the self-expanding
prosthesis 98 until deployment. The side access port 15 is located
about 3 cm from the distal tip 12 of the inner member 10 with the
coupling region 14 being completely distal to the prosthesis
98.
[0120] An alternative system for deploying a self-expanding
prosthesis is depicted in FIG. 39 which includes a series of
corresponding slots in the inner and outer members 10,100 to allow
for relative repositioning during deployment (the sheath 100
typically being drawn back while the inner member 10 of the
delivery system is maintained in position). This permits the
coupling region 14 to extend through the prosthesis 98 and allow
the wire guide 11 to exit the side access port 15 proximal to the
prosthesis 98, which would allow the wire guide to reside inside
and be deployed inside prosthesis 98, and as a result, less chance
of losing access to the work site. This may be especially
advantageous in deployment of stents, other prostheses, and other
ancillary devices, such as dilation balloons, within the vascular
system in that recannulation through the deployed stent may be
problematic, possibly leading to complications such as dislodgement
or catching on the deployed stent, dislodgement of plaque, etc.
With regard to placement of artificial venous and other types of
artificial valves, maintaining wire guide access through the valve
may be particularly advantageous in that recannulation through the
leaflets or valve structure to deploy additional valves or
introduce a seating balloon to fully expand the valve support frame
against the walls of the vessel may prove particularly difficult,
possibly leading to damage of delicate leaf structure and
compromise of valve function.
[0121] FIG. 27 depicts an endoscopic biliary stent 69 and pusher
apparatus 101 (typically 5.0-7.0 FR) which is configured for
ultra-short wire and rapid exchange use. It primarily differs from
the embodiment of FIG. 17 in that it lacks the inner member. Both
the stent 69 and pusher member 101 (the elongate medical device 10
in this particular embodiment) are introduced through an outer
introducer member 100, where the distal end 12 of the pusher
apparatus 101, which includes the coupling region 14 about its
distal portion 13, urges the stent forward for deployment within
the duct. The side access port 15 is located about 6 cm from the
distal end 12 of the pusher member 101 (elongate medical device 10)
such that the wire guide traverses the passageway of the stent
69.
[0122] FIGS. 41-42 depict another embodiment in which the stent 69
comprises a pigtail drainage stent 126, such as the illustrative
naso-biliary drainage stent, that includes a curved anchor portion
127 in the deployed configuration 128 (FIG. 41) that is configured
to assume a straightened configuration 129 when placed over a wire
guide 11 for introduction into the bile duct, as shown in FIG. 42.
Preferably, but not necessarily, the drainage holes 130 disposed
along the distal portion of the stent 126 are sized such that the
wire guide 11 cannot readily exit therethrough (e.g., 0.025"),
whereas the side access port 15 is sized to easily accommodate the
exiting wire guide (e.g., 0.035" or larger). In the illustrative
naso-biliary embodiment, there are five drainage holes distributed
about 6 mm apart along the distal portion 13 distal to the side
access port 15 and marker band 18. In this particular embodiment,
there is a series of optional drainage holes 130 proximal to the
side access port 15 as well. The spacing of the drainage holes can
vary according to the diameter of the curl, generally ranging from
5 mm to 1 cm or more. As the wire guide 11 is repositioned relative
to the stent 126 to perform an intraductal exchange, the anchoring
portion 127 recoils into its intended shape when the wire guide is
no longer inside the coupling region passageway 31. The
illustrative embodiment could also be adapted for use as a
naso-pancreatic drainage stent, ureteral or urethral stent, or
other stent having one or more curved or pigtailed end portions and
various configurations of drainage holes. The illustrative
embodiment of FIG. 41 further includes an intermediate curved
portion that allows the stent to better conform with the anatomy of
the pancreatobiliary tract and duodenum into which it is
placed.
[0123] Another embodiment of naso-biliary and naso-pancreatic
drains is depicted in FIG. 43 that is similar to the embodiment of
FIGS. 41-42, except that it includes a pair of distal anchoring
flaps 180 and lacks the pigtail anchoring portion. Furthermore, the
side access port is preferably located closer to the distal end 12
of the device (e.g., about 2 cm vs. about 6 cm for the pigtail
embodiment). Typically naso-biliary drains are 5-10 FR in diameter
while the naso-pancreatic drains are 5-7 FR. Both the pigtail and
non-pigtail drain embodiments may advantageously include a
stiffening stylet (depicted in FIG. 43) that extends to about the
side access port 15 and provides pushability, as well as
straightening out a loop or bend, if present, located proximal to
the side access port. Such a bend may allow the device to conform
to the anatomy of the patient, such as to better traverse the
contours of the duodenum. An example of the bend or curved portion
172 is shown in FIG. 41.
[0124] FIGS. 19-20 depict balloon 47 embodiments of the present
invention that are adapted for short wire use. FIG. 19 comprises a
dilation balloon 47 (a modified QUANTUM.TM. Biliary Balloon,
Wilson-Cook Medical, Inc.), which is made of a non-compliant
material (e.g., PET) such that balloon member 102 can be inflated
to a predetermined diameter to dilate a stricture within the duct.
FIG. 20 comprises an extraction balloon 47, such as a modified
TRI-EX.TM. Triple Lumen Extraction Balloon (Wilson-Cook Medical,
Inc.), which comprises a non-compliant material (latex, silicone,
etc.) which is adapted for sweeping the duct of material, such as
stones, sludge, etc. Both embodiments include a side access port 15
about 6 cm from the distal end 12 of the catheter 10 such that the
coupling region 14 extends through the balloon member 102 and exits
proximal thereto. The embodiment of FIG. 20 further illustrates a
removable stiffening stylet 103 that is maintained within the
passageway 27 of the catheter member 10 to provide rigidity,
especially across the side access port 15 (and optional proximal
side access port, not shown) such that kinking is less likely to
occur at that point. The stylet, preferably made of metal (e.g.,
stainless steel) or a relatively stiff plastic or other material,
would not provide any engagement function similar to the distal
wire lock 90 of FIG. 23 in most applications since that would
interfere with the ability to advance the device over the wire
guide.
[0125] FIG. 21 depicts a biopsy device 104 for collecting cells
within the biliary tree. The illustrative embodiment, which
comprises a modified CytoMAX II.TM. Double Lumen Biliary Brush
(Wilson-Cook Medical, Inc.), includes a side access port 15 about 6
cm from the distal end 12 of the tubular portion 77 of the device
10 and a brush element 105 disposed about the distal end and
extending beyond such that the coupling region 14 terminates
proximal of the brush element 105, the distal opening 19 for the
wire guide 11 being disposed about the distal end of the tubular
member 77 about the base of the brush element 105. An alternative
device for delivering a biopsy device 104 or other device within a
work site is depicted in FIG. 39. The illustrative tubular member
77 includes a standard coupling region 14 about the distal end
except that the passageway 27 of the tubular member, rather than
communicating with the passageway 31 of the coupling region 14,
terminates about a ramped external opening 122 that is configured
to accommodate a separate elongate medical device for introduction
to the work site which is not directly coupled to the wire guide
11. The illustrative biopsy device 104 can be advanced to gather a
tissue sample, then withdrawn back into the passageway 27 and
either removed from the patient with the introducing member 77, or
removed therefrom and a second medical device advanced into the
passageway to perform a different procedure. In addition to the
radiopaque marker band 18 to indicate the location of the second
end of the coupling region 14, the illustrative tubular member
includes an additional marker 123 located about the ramped opening
which provides additional guidance to the operator. The
illustrative biopsy device is but one example of a device
deliverable in the manner shown in FIG. 39.
[0126] Another secondary access device is depicted in FIG. 38,
which comprises a brachytherapy or radioactive seed delivery
catheter 106 which includes a passageway 27 for the wire guide 11
(and which includes the coupling region 14) and second,
closed-ended passageway 107 for receiving a radioactive element
108, such as a catheter, stylet, or individual radioactive seeds
that are introduced thereinto. The brachytherapy device 106 is
introduced over the wire guide 11 to the treatment site, where it
is positioned for a period of time sufficient to deliver an
effective therapeutic dose of radiation to adjacent tissue, such as
a tumor within the biliary tree. Typically, the side access port 15
is located about 6 cm from the tip which is preferably made of a
pliable, atraumatic polymer material. The second passageway is
preferably located centrally so that radiation is dispersed evenly
in all directions. As a result, the first wire guide passageway may
either terminate distal thereto, about the side access port 15, or
be offset therefrom, at least becoming so at a point proximal to
the side access port 15 and coupling region 14.
[0127] FIGS. 44-57 depict a series of non-biliary devices
configured for introduction through the patient's mouth, rather
than through the accessory channel of a duodenoscope, such as the
aforementioned embodiments. Placement of the embodiments of FIGS.
44-57 typically involves using an ultra-short wire guide 11 that is
advanced to the treatment site by being coupled to the outside of
an endoscope. The wire guide is then uncoupled from the scope and
locked in place to serve as a pathway for the introduction of other
devices, such as within the esophagus or elsewhere within the
gastrointestinal tract. Optionally, the wire guide 11 (FIG. 57) can
include a hydrophilic or otherwise lubricious coating or surface
173 (e.g., SLIP-COAT.RTM. Biopolymer, STS Biopolymers, Inc.,
Henrietta N.Y.) to facilitate the advancement of devices thereover
after the wire guide has been placed. The coating is advantageously
restricted to a portion of the wire guide 11, such as the
intermediate portion 97, with the proximal portion 59 that extends
out of the patient and is manipulated and locked by the operation
(e.g., the proximal 10-15 cm) having a standard non-hydrophilic
surface (e.g., PTFE) to make it easier to secure the wire guide in
place. The distal portion 60 (e.g., 2-6 cm) of the wire guide may
also be left uncoated to give the operator a better degree of
control to help avoid accidental, premature uncoupling of the wire
guide from the coupling region of the devices being advanced
thereover. The lubricious intermediate portion 97 of the
illustrative wire guide of FIG. 57 is especially advantageous when
used in the small or colon to allow the device to slide more easily
therewithin, while still allowing the wire to be secured at each
end by the bite block and distal loop 144, respectively.
[0128] FIG. 44 and 45 depict a dilator catheter 88 and wire guide
11 comprising a system for dilating strictures within the
esophagus. The dilator 88 includes a system of scale indicia 133
located about the proximal portion of the tubular member. In the
illustrative embodiment, which is about 75 cm in length, indicia
are located to indicate the 40, 50, and 60 cm mark to help align
the device with the indwelling wire guide 11, which includes a
similar series of indicia 134, such as the illustrative bands that
increase in number at each 10 cm interval to indicate the distance
from a reference point. The alignment indicia 133,134
advantageously permit accurate positioning of the device at the
treatment site, such as the GE (gastroesophageal) junction, a
stricture, or other site that is to be dilated, irradiated, or
otherwise treated, after the treatment site has been confirmed
using the endoscope used to carry the wire guide thereto.
[0129] A method for introducing the wire guide 11 and dilator
catheter 88 of FIGS. 44 and 45 into the esophagus to perform a
series of esophageal dilations using successively larger dilator
catheters is depicted in FIGS. 55a-f. The basic method can also be
used for introducing other devices that are too large to be
introduced through an accessory channel of an endoscope or where
standard endoscopic placement techniques either are not appropriate
or not possible. As shown in FIG. 55a, the wire guide 11 is carried
to the work site using an endoscope 38 and a wire guide carrying
mechanism 174, which in the illustrative embodiment comprises the
endoscopic wire guide holder 140 depicted in FIG. 48, which resides
within the accessory channel 165 of the scope and includes a
mechanism to couple with the wire guide 11 via a distal loop 144
about the distal end 25 thereof. As shown, the endoscopic wire
guide holder 140 comprises a catheter portion having a lateral
recess 142 proximate the distal end 12 thereof and a longitudinal
slidable pin member 141, disposed within a passageway 145 in the
shaft 146 of wire guide holder 140, that is adapted to traverse the
distal loop 144 of the wire guide. The pin member 141 is advanced
to secure the loop 144 within the recess 142 to carry the wire
guide 11, which is at least substantially outside of the scope
accessory channel 165, down to the work site, where it is released
by the operator by actuating the finger ring portion 148 of the
handle 147 relative to the thumb ring 149 until the loop 144 slips
off the retracting pin member 141. When the pin 141 is fully
advanced into a locking channel 143 that extends distally from the
lateral recess 142, the loop 144 is secured and cannot slip free.
The endoscopic wire guide holder 140, which is then withdrawn from
the work site along with the endoscope, can either carry the wire
guide 11 while partially extending from the accessory channel, or
be withdrawn into the accessory channel 165 (as shown) such that
the distal end 25 of the wire guide is pulled thereinto.
[0130] A second embodiment of a wire guide carrying mechanism 174
is depicted in FIGS. 46-47 comprising a ring element 136 that
attaches to the outside of the endoscope 38 about the distal end
thereof using a friction fit, clamping mechanism, or some other
well-known means, and is configured to releasably secure the wire
guide 11 being carried to the work site. The wire guide 11 includes
a detachable element 135, such as the illustrative distal ball,
which is crimped, glued, or otherwise fastened about the end 25 of
the wire guide and designed to slide off or break apart with the
application of a sufficient amount of pull force (e.g., 3 lbs.) and
be safely passed through the gastrointestinal system or be absorbed
thereby. The ball tip 135 is inserted into an open slot 137 in the
ring 136 and then slipped laterally beneath a lip portion 138 and
into a recess 139 that together, help secure the wire guide and
allow it to be pulled along with the scope. With the ball 135
residing in the recess 139 formed along the distal edge of the
ring, the wire guide 11 can be uncoupled from the scope 38 by
pulling on the proximal portion of the wire guide while maintaining
a counter force against the scope 38 to keep it in place. When the
ball 135 is dislodged (FIG. 45a), the wire guide 11 can slip under
the lip portion 138 (FIG. 47) and the endoscope 38 can be withdrawn
from the patient, leaving the wire guide in place.
[0131] Referring again to FIG. 55a, the endoscope is typically
positioned within the work site 41 just proximal to the specific
site (sphincter, stricture, lesion, etc.) therein that is to be
treated. In the illustrative method, the scope 38 is advanced to
the GE junction 156 while depth markings located about the proximal
portion of the scope exiting the patient (not shown) provide the
operator with the distance from the mouth to the treatment site. At
this point, the distal end 25 of the wire guide 11 is also
generally positioned at the GE junction 156 since it is engaged
proximate the distal end of the scope 38. The endoscope 38 and wire
guide are advanced through the esophagus 155 and positioned at the
GE junction 156, where that distance is noted. The operator may
advance the scope 38 10 cm (or some other similar, predetermined
distance), which places the distal end 25 well within the stomach
157 (about 10 cm past the GE junction 156). Or, as depicted in FIG.
55b, the operator may advance the wire guide holding device 140,
which may include proximal depth indicia as well, a similar
distance beyond the scope 38 and into the stomach 157. The wire
guide 11 in the embodiments depicted in FIGS. 45 and 50 include a
reference mark 175 located 10 cm from the distal end 25 (or
whatever distance the wire guide is to be advanced past the GE
junction or other anatomical reference point). The wire guide 11 of
the illustrative embodiment depicted in FIG. 45 includes a series
of proximal indicia 134 that can comprise varying numbers of
markings at selected intervals therealong (e.g., 30,35,40,45,50,
and 55 cm from the reference mark 175). In another embodiment
depicted in FIG. 50, the wire guide includes five 5 cm bands 150 of
different colors that span from the 30 cm mark to the 55 cm mark as
measured from the reference mark 175 which is 10 cm from the tip
25. The indicia 134 may further include 1 cm reference marks 177
(e.g., hash marks) within each colored band 150. Preferably, the
bands 150 of the embodiment of FIG. 50 comprise colors that
contrast with the adjacent band. For example, cool and warm colors
may be advantageously placed adjacent one another to create a
sequence such as yellow, green, red, blue, and then orange.
[0132] Once the wire guide 11 has been advanced 10 cm past the GE
junction 156, it is uncoupled from the wire guide carrying
mechanism 174 and secured in place by some means such as using the
illustrative bite block 151 depicted in FIG. 52 with integral wire
guide securing portion 154, and which includes straps 153 that
secure the bite block 151 around the patient's head. In addition to
functioning as a mechanism 50 for securing the wire guide in place,
it also maintains an open working area 152 through which the scope,
wire guide 11, and primary or secondary devices are passed to the
work site.
[0133] In instances where a narrow stricture exists that cannot
accommodate the scope without risking creating a tear in the
esophagus (at least without being properly dilated beforehand), the
wire guide holding device 140 advantageously provides a means to
safely advance through and traverse the stricture to carry the wire
therebeyond and serve as a pathway for advancing the dilators, the
smallest of which may be less than the scope diameter.
[0134] Now referring to FIG. 55c, the endoscope 38 and wire guide
holding device 140 are typically withdrawn from the work site 41
such that the primary access device 10, which in the illustrative
method comprises a first dilator 167, can be advanced over the wire
guide 11 to perform a medical operation, as depicted in FIG. 55d.
To advance the first dilator 167, the wire guide 11 is temporarily
unlocked from the holding device so that the proximal end thereof
can be threaded through the coupling region 14 of the dilator.
Alternatively, the primary device 10 (e.g., dilator 167) can be
coupled to the wire guide 11 prior to the wire guide being advanced
to the work site 41. The illustrative dilator 167 includes optional
radiopaque marker bands 18,132 located at the side access port 15
and distal edge of the widest portion of the device before the
tapered end, respectively. While it is the GE junction that is
established as the anatomical reference point to which the
illustrative wire guide 11 and primary access device 10 are
aligned, the region of the esophagus having the stricture to be
dilated may lie anywhere proximal to the GE junction. Reference to
the GE junction is preferred to provide a consistent known distance
within the stomach for uncoupling.
[0135] The dilator 167 (FIG. 44) also preferably includes a series
of proximal indicia 133 as well that are aligned with the wire
guide indicia 134 so that the operator can determine when a
particular point along the dilator (e.g., distal end of the widest
portion 132, distal tip 12, side access port 15, etc.) has reached
the GE junction, the tip of the wire guide, or some other reference
point.
[0136] Once the first dilator 167 has been advanced past the
esophageal stricture or the GE junction 156 as the first step of
enlarging the opening thereof, the distal portion 13 is advanced
fully into the stomach 157 of the patient so that uncoupling can
occur, as depicted in FIG. 55e. Typically, this is accomplished by
advancing the side access port 15 past the distal end 25 of the
wire guide 11, which remains locked in place, until the distal end
25 thereof slides free of the coupling region 14. As with the
biliary techniques depicted in FIGS. 9a-f and 29a-e, the uncoupled
primary access device 10 is then removed from the patient and a
secondary access device (third elongate medical device 44) such as
second (larger) dilator 168, is introduced to the work site 41 as
depicted in FIG. 55f. Esophageal dilations typically involve
passage of a series of progressively larger dilators, although one
or more of the smaller sizes may be skipped if resistance is not
felt during the initial dilation.
[0137] An alternate embodiment of a dilator catheter 167 is shown
in FIG. 56 in which the side access port 15 is located on a
proximally facing surface or plane 169 formed as the distal
(larger) diameter portion 170 of the dilator transitions down to
the smaller, proximal portion 171. This advantageously eliminates
having the wire guide 11 lying alongside the widest part of the
dilator 167 during passage of both through the stricture. The
illustrative stepped configuration can also be useful in other
embodiments of the present invention to eliminate friction caused
by a wire guide passing within a sheath or channel, such as within
an endoscope.
[0138] The general method of FIGS. 55a-f can also be adapted for
placement of other devices outside of the endoscope, such as a
photodynamic therapy (PDT) balloon 47, depicted in FIG. 51, or an
achalasia balloon 53, depicted in FIG. 53. Both devices depicted
are commercially available from Wilson-Cook Medical, Inc. and shown
herein as modified for ultra short wire delivery. Positioning of
the PDT balloon 47 is performed by using the endoscope to locate
the GE junction and place the wire guide 11 at a suitable, known
distance therebeyond, such as 10 cm, that distance corresponding to
the reference (or `zero`) mark 175 of the wire guide. In the
illustrative embodiment of FIGS. 50-52, the wire guide includes
colored bands 150 that correspond to those comprising the proximal
indicia 133 of the PDT balloon catheter 47 such that when the
colors are aligned (FIG. 52), the reference point 176 of the device
10, which in the case of the PDT balloon, is the distal edge of the
light-emitting portion 178 of the balloon member 102, is located at
the GE junction. This places the light-emitting portion 178 at the
optimal location to treat the disease (e.g., Barrett's esophagus).
It should be noted that the colored bands 150 or other indicia
133,134 of the illustrative embodiments are configured for aligning
the treatment device 10 with the wire guide 11 and thus, the site
selected for treatment and may or may not have other functions such
as to aid in the alignment of the tips 12,25 of the device with one
another or with the side access port 15 to indicate that uncoupling
is imminent. Separate indicia may be used for alignment relating to
coupling and uncoupling. While the colored bands 150 of the wire
guide 11 are configured to refer back to the reference mark 175
that corresponds (in this embodiment) to the GE junction, the
colored bands 150 of the primary access device 10 are configured
such that alignment with those of the wire guide places the device
in the correct position for treating the disease. Thus, they are
not necessarily (and usually are not) of the same reference
scale.
[0139] FIG. 53 depicts an embodiment in which the primary access
device 10 comprises an achalasia balloon. With the treatment of
achalasia differing in that the balloon is placed across the GE
junction rather than proximal thereto, the reference point 176 that
corresponds to the proximal reference indicia (not shown) and
permits the device to be aligned with the GE junction, is located
at the center of the balloon member 102 rather than the distal edge
as in the PDT balloon.
[0140] The technique of dragging the wire guide outside of the
scope to the work site, uncoupling it, and advancing a device
thereover, is also applicable to a number a larger diameter
catheters (FIG. 54), such as feeding tubes (e.g., nasojejunal,
nasoenteric, etc.) which are advanced via the mouth into the
stomach or small intestines for placement. These catheters may
advantageously include a stiffening stylet 103 in the passageway 27
to prevent the scope from dragging the catheter device 10 with it
as it is being backed out of the work site, which in turn, could
cause the wire guide 11, which is typically locked in place, to
pull out of the coupling region 14. The stiffening stylet 103 is
removed prior to or after the devices are uncoupled using
radiographic, endoscopic, and/or proximally visible indicia located
on the two devices 10,11.
[0141] While the gastrointestinal tract may at present provide the
most obvious anatomical sites for practicing the methods and
techniques of the present invention, further changes in
interventional medicine may bring about increasing opportunities
where remote uncoupling and ultra-short wire techniques may offer a
viable alternative to traditional rapid exchange or other current
techniques. For example, many common urological procedures were
preformed using wire guide exchange until the introduction of
videoendoscopes ideal for urological use. This resulted in direct
visualization becoming the standard methodology for manipulating
and placing devices in the urological tract. Future developments
and improvement in external visualization methodology may result in
a return to wire guided procedures where remote uncoupling offers a
true advantage to the urologist. Similar advancements in other
specialties, especially in vascular and coronary medicine, may
create situations where the potential benefits of remotely
uncoupling may be realized.
[0142] Any other undisclosed or incidental details of the
construction or composition of the various elements of the
disclosed embodiment of the present invention or methods of their
use are not believed to be critical to the achievement of the
advantages of the present invention, so long as the elements
possess the attributes needed for them to perform as disclosed. The
selection of these and other 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. Illustrative
embodiments of the present invention have been described in
considerable detail for the purpose of disclosing a practical,
operative structure whereby the invention may be practiced
advantageously. The designs and methods described herein are
intended to be exemplary only. The novel characteristics of the
invention may be incorporated in other structural forms without
departing from the spirit and scope of the invention. The invention
encompasses embodiments both comprising and consisting of the
elements and steps described with reference to the illustrative
embodiments. Unless otherwise indicated, all ordinary words and
terms used herein shall take their customary meaning as defined in
The New Shorter Oxford English Dictionary, 1993 edition. All
technical terms shall take on their customary meaning as
established by the appropriate technical discipline utilized by
those normally skilled in that particular art area. All medical
terms shall take their meaning as defined by Stedman's Medical
Dictionary, 27th edition.
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