U.S. patent application number 09/847494 was filed with the patent office on 2001-11-22 for introducer apparatus with eversible sleeve.
This patent application is currently assigned to Wilson-Cook Medical, Inc.. Invention is credited to Foushee, Jason D., Mezhirov, Mikhail, Reydel, Boris.
Application Number | 20010044595 09/847494 |
Document ID | / |
Family ID | 22744551 |
Filed Date | 2001-11-22 |
United States Patent
Application |
20010044595 |
Kind Code |
A1 |
Reydel, Boris ; et
al. |
November 22, 2001 |
Introducer apparatus with eversible sleeve
Abstract
Disclosed is an introducer apparatus comprising an sleeve
fixation mechanism or introducer member, such as a catheter,
introducer, or ring-like structure, which is attached to a
protective sleeve comprising a thin flexible material such a
polymeric film. The sleeve is inverted into the passageway of a
second member, such as a catheter, feeding tube, introducer, etc.,
that is advanced through the passageway of the introducer member
and is introduced into a bodily passage of a patient, such as the
bile duct, nasal passages, colon, etc. The sleeve everts from the
passageway of the second member during its advancement to lay down
a friction-reducing surface. The sleeve prevents frictional contact
between the second member and delicate or sensitive tissues.
Inventors: |
Reydel, Boris; (Passaic,
NJ) ; Mezhirov, Mikhail; (Bridgeport, CT) ;
Foushee, Jason D.; (Winston-Salem, NC) |
Correspondence
Address: |
COOK GROUP PATENT OFFICE
P.O. BOX 2269
BLOOMINGTON
IN
47402
|
Assignee: |
Wilson-Cook Medical, Inc.
Winston-Salem
NC
|
Family ID: |
22744551 |
Appl. No.: |
09/847494 |
Filed: |
May 2, 2001 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60201116 |
May 2, 2000 |
|
|
|
Current U.S.
Class: |
604/98.02 ;
604/523 |
Current CPC
Class: |
A61F 2/95 20130101; A61M
25/0069 20130101; A61M 25/0068 20130101; A61M 25/0668 20130101;
A61M 25/0152 20130101; A61M 25/0119 20130101 |
Class at
Publication: |
604/98.02 ;
604/523 |
International
Class: |
A61M 029/00; A61M
031/00 |
Claims
What is claimed is:
1. An introducer apparatus for providing a reduced-friction pathway
into a bodily passage of a patient, comprising: an introducer
member having a distal end and a proximal end; a sleeve comprising
a flexible material and which includes a first end, a second end, a
first body portion, and a second body portion, the first body
portion attached to the introducer member, the second body portion,
which includes the second end, moveable responsive to movement of a
second member sized for introduction through the introducer member
into the bodily passage; whereby the second body portion is
eversible from a passageway of the second member such that the
second member passageway, upon full deployment of the second
member, is at least substantially unobstructed; and whereby the
sleeve provides a reduced-friction pathway for at least a portion
of the second member during advancement thereof into the bodily
passage.
2. The apparatus of claim 1, wherein the sleeve is an elongate
tubular member having a passageway therethrough.
3. The apparatus of claim 2, wherein the sleeve comprises a thin
polymeric film.
4. The apparatus of claim 3, wherein the sleeve comprises expanded
polytetrafluoroethylene.
5. The apparatus of claim 3, wherein the sleeve comprises
polyethylene.
6. The apparatus of claim 2, wherein the sleeve body includes a
plurality of apertures disposed thereabout.
7. The apparatus of claim 2, wherein the sleeve includes properties
such that the second member, upon forward advancement with the
sleeve, is biased in a predetermined direction, due at least in
part to the properties of the sleeve.
8. The apparatus of claim 1, wherein the sleeve body includes a
circumferentially open portion extending at least partially along
the length thereof.
9. The apparatus of claim 8, wherein the sleeve body is a
non-tubular in shape, such that it extends only partially around
the circumference of the introducer member to which it is
attached.
10. The apparatus of claim 1, wherein the apparatus includes the
second member.
11. The apparatus of claim 1, wherein the introducer member
comprises an elongate tube.
12. The apparatus of claim 11 wherein the elongate tube has a first
end and a second end, and is of such a length that when the first
end is located within the patient's duodenum, the second end is
located outside of the patient.
13. The apparatus of claim 11, wherein the elongate tube includes
at least a second passageway extending therethrough.
14. The apparatus of claim 11, wherein the introducer member
includes at least one longitudinal predetermined split line that
permits, with manipulation by the operator, external access to the
passageway of the introducer member for purposes of removal of the
inner member therefrom.
15. The apparatus of claim 1, wherein the introducer member
comprises a ring-like member.
16. The apparatus of claim 1, wherein the introducer member
comprises a plurality of longitudinal members that are configured
to cooperate with the second member such that they are slidable
relative to the second member to evert the sleeve from the
passageway thereof.
17. The apparatus of claim 1, wherein the sleeve further includes a
tether attached about the second end thereof, the tether sized such
that the operator can reload the sleeve back into the second member
from the proximal end of the introducer member.
18. The apparatus of claim 1, wherein the first end of the sleeve
is permanently attached about the introducer member.
19. The apparatus of claim 1, wherein the first end of the sleeve
is releasably attached about the introducer member.
20. The apparatus of claim 1, wherein the second end of the sleeve
is loadable into the passageway of the second member.
21. The apparatus of claim 1, wherein the sleeve further comprises
a series of pleats, the pleats adapted to unfold longitudinally as
the sleeve everts from the passageway of the inner member.
22. The apparatus of claim 1, wherein the introducer member
includes a second passageway therein.
23. An introducer apparatus for providing a reduced-friction
pathway into a bodily passage of a patient, comprising: an
introducer member having a distal end, a proximal end, and a
passageway extending therethrough; a second member having a distal
end and a proximal end, the second member being slidably disposed
within the passageway of the introducer member; a sleeve comprising
a flexible material and which includes a first end, a second end, a
first body portion, and a second body portion, the first body
portion attached to the introducer member about the first end, the
second body portion, which includes the second end, being loadable
into the passageway of the second member; whereby the second body
portion is eversible from the second member passageway responsive
to movement of the second member, such that the passageway, upon
full deployment of the second member, is at least substantially
unobstructed; and whereby the sleeve provides a reduced-friction
pathway for at least a portion of the second member during
advancement thereof into the bodily passage.
24. The apparatus of claim 23, wherein the sleeve is at least 6 cm
in length.
25. The apparatus of claim 23, wherein the sleeve is at least 20 cm
in length and the introducer member comprises a feeding tube.
26. The apparatus of claim 23, wherein the introducer member
comprises an elongate tube.
27. The apparatus of claim 23, wherein the introducer member and
second member each comprise catheters having a length of at least
150 cm.
28. The apparatus of claim 23, wherein the introducer member
comprises a ring-like member, the introducer member adapted for
being maintained in a position at least substantially external to
the body passage during introduction of the second member
thereinto.
29. The apparatus of claim 23, wherein the introducer member
includes a second passageway, the second passageway being located
relative to the point of attachment such that second passageway is
not obstructed by a portion of the sleeve during use of the
apparatus.
30. The apparatus of claim 23, wherein the distal end of the second
member includes a friction-reducing mechanism located thereabout to
facilitate passage of the sleeve thereover.
31. The apparatus of claim 23, wherein the second member is
configured such that the second member, upon forward advancement
with the sleeve, is biased in a predetermined direction.
32. The apparatus of claim 31, wherein the distal end of the second
member is asymmetrical in shape.
33. The apparatus of claim 23, wherein the second member is adapted
for delivery of a stent.
34. The apparatus of claim 23, wherein the apparatus is adapted for
the introduction of a third member upon deployment of the second
member.
35. The apparatus of claim 34, wherein the third member is
preloaded within the passageway of the second member, the proximal
end of the second member being configured to receive at least a
portion of the third member.
36. The apparatus of claim 23, wherein the second member includes
an expandable zone extending longitudinally therealong such that
the passageway of the second member can be expanded in
diameter.
37. The apparatus of claim 23, wherein the introducer member
comprises a plurality of longitudinal attachment strips adapted for
attaching the sleeve to the introducer member, at least selected
ones of the plurality of longitudinal attachment strips being
slidably disposed within channels formed in the introducer
member.
38. The apparatus of claim 23, wherein the second end of the sleeve
is attached to the second member.
39. The apparatus of claim 23, wherein the second member includes a
fluid reservoir portion adapted for the delivery of fluids
therefrom.
40. An introducer apparatus for providing a reduced-friction
pathway into a bodily passage of a patient, comprising: an
introducer member having a distal end and a proximal end; a sleeve
comprising a flexible material and which includes a first end, a
second end, a first body portion, and a second body portion, the
first body portion attached to the introducer member, the second
body portion, which includes the second end, moveable responsive to
movement of a second member sized for introduction through the
introducer member into the bodily passage; whereby the second body
portion is unattached to the second member and eversible from a
passageway thereof, such that the second member passageway, upon
full deployment of the second member, is unobstructed by the
sleeve; and whereby the sleeve provides a reduced-friction pathway
for at least a portion of the second member during advancement into
the bodily passage.
41. An arrangement for locating an elongated member within a bodily
passage of a patient, wherein at least a substantial part of a
flexible sleeve is to be movably located within the elongated
member, wherein means are provided for fixing another part of the
sleeve at a location outside of the elongated member so that when
the latter is moved in a distal direction, a distal part of the
elongated member engages the sleeve and unfurls it between the
outside surface of the elongated member and the inside of the
bodily passage.
42. An arrangement according to claim 41, wherein a sleeve fixation
mechanism is provided for clamping the said other part of the
sleeve relative to part of the anatomy of the patient whilst the
said substantial part of the sleeve is unfurled.
43. An arrangement according to claim 42, wherein the said first
part of the sleeve is clamped by or relative to the distal end of
an introducer member through which the said elongated member is to
be fed to the bodily passage.
44. An arrangement according to claim 43, wherein the introducer
member, and/or the flexible sleeve is/are made of splittable
material so that one or both of them can be peeled back and removed
in order to leave only the elongated member in the bodily
passage.
45. An arrangement according to claim 41, wherein means are
provided for orienting the distal end of the elongated member
during insertion of the latter.
46. An arrangement according to claim 41, wherein the flexible
sleeve is pleated when within the elongated member in order to
minimize frictional effects.
47. An arrangement according to claim 41, wherein the elongated
member and/or the introducer member are in the form of tubes.
48. A method of reducing frictional effects when introducing an
elongated member having a passageway into a bodily passage, the
elongated member comprising a flexible sleeve with a substantial
length of the sleeve disposed in the elongated member and with a
part of the sleeve fixed at a location outside of the elongated
member, so that when the elongated member is moved in a distal
direction, a distal part thereof engages the sleeve and unfurls it
between the elongated member and the bodily passage, the sleeve
being adapted such upon unfurling from within the passageway of the
elongated member, the passageway is at least substantially
open.
49. An introducer apparatus for providing a reduced-friction
pathway into a bodily passage of a patient, comprising: an
introducer member comprising an elongate tubular member having an
outer surface, a distal end, a proximal end, and a passageway
extending therethrough; a second member comprising an elongate
tubular member, the second member slidably disposed within the
passageway of the introducer member; a tubular sleeve comprising a
thin polymeric film and which includes a first end, a second end, a
first body portion, and a second body portion, the first body
portion, which includes the first end, being attached about the
outer surface of the introducer member, the second body portion,
which includes the second end, being disposed with the passageway
of the second member, the sleeve being responsive to movement of
the second member as the second member advances relative to the
introducer member; and whereby the second body portion is
completely eversible from the second member passageway, thereby
providing a reduced-friction pathway for at least a portion of the
second member as it is advanced into the bodily passage.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority of provisional application
Ser. No. 60/201,116 filed May 2, 2000.
TECHNICAL FIELD
[0002] This invention relates to medical devices, more particularly
to catheters introduced into body lumens.
BACKGROUND OF THE INVENTION
[0003] Despite the efforts of medical device manufacturers to
reduce the coefficient of friction for their catheters, especially
those intended for introduction through a sphincter or narrow body
lumen, there is very often a problem with discomfort to the patient
or trauma to delicate or sensitive tissues as the catheter is being
advanced. Lubricants and lubricious polymers or other coatings can
reduce these effects, but not always to a sufficient degree. In the
biliary system, for example, passing a biliary catheter through the
Papilla of Vater and into the common bile duct very often results
in swelling and subsequent closure of the opening, compromising
normal drainage and making subsequent access difficult. Similar
problems with discomfort or edema can be experienced by the
patients when other anatomical sites are being accessed, for
example, in the nasal passages, urethra, rectum, etc. While patient
comfort may not be an issue when navigating internally such as
within the biliary tree, the introduced device may be difficult or
even impossible to advance from frictional forces acting against
it, especially since these obstructions and narrowed passages often
cannot be adequately visualized.
[0004] One approach to reduce patient discomfort when introducing a
catheter or similar device, is to include a sheath or sleeve which
is laid down by the advancing device to prevent frictional contact
between the device and the delicate lining of the bodily passage. A
urethral catheter with an outer sleeve is disclosed in U.S. Pat.
No. 5,779,670 to Bidwell in which the latex sleeve is fixedly and
sealingly attached to the inside of the catheter by a sliding
retention sled and to the outside of the catheter by a slidable
collar. The sleeve allows relative movement of the catheter to the
urethra without the normal friction that causes patient discomfort
during introduction and wearing of the device. A lubricant fills
the space created between the sleeve and the catheter which is
intended to further reduce friction between the two surfaces. While
the '670 concept may be suitable to traverse the urethra for
purposes of draining the bladder, it is not useful for other
anatomical sites and procedures in which having the sleeve attached
to the inside of the catheter is not desired, such as in an ERCP
(Endoscopic Retrograde Cholangiopancreatography) procedure or
placement of a nasal-jejunal feeding tube or colonic decompression
catheter. In these procedures, the sleeve might be used
advantageously in combination with the introduced device to access
a narrow duct or opening, to cannulate a stricture, or navigate
over folds of tissue, but its eventual removal from the inner
member passageway is typically required to complete the procedure.
In the case of a feeding or decompression tube, continued presence
of the sleeve over the catheter would block critical side holes.
For these reasons, the Bidwell concept is not suitable for the
introduction of a second medical device into the body.
[0005] Besides the biliary system, other sites within the body
present an opportunity for improved patient comfort and reduced
trauma by the reduction of friction during the introduction of a
device. For example, the nasal passages are especially sensitive
and recent trends have brought about an increase in the number of
devices, such as endoscopes and tubes, being introduced via that
route concomitant with the use of analgesics or sedatives to reduce
patient discomfort. Another situation where reduction of friction
would be important is in the lower gastrointestinal tract where
folds within the colon can provide sufficient resistance to an
introduced catheter or other device where in many cases, the tip of
the catheter bends back on itself, rather than continuing to
advance to the treatment site. Therefore, what is needed is a
friction-reducing introducer apparatus that can be used with a
separate catheter, sheath, or other medical devices to permit the
safe and comfortable passageway thereof into and/or through a
bodily passage, and is removable from the treatment site so as not
to possibly interfere with the function of the introduced
device(s).
SUMMARY OF THE INVENTION
[0006] The foregoing problems are solved and a technical advance is
achieved in an apparatus for introducing a second medical device,
such as an inner member or an elongated member, into a bodily
passage, the introducer apparatus comprising a sleeve fixation
mechanism, such as an introducer member. The sleeve fixation
mechanism facilitates engagement of the sleeve with the opening of
the bodily passage and can include a variety of structures, such as
an introducer sheath, tube, ring-like member, barbs, or other
structure which is permanently or releasably attached to a full or
partial sleeve which is made of a thin, flexible material. The
sleeve, which can be made of variety of biocompatible materials
such as expanded polytetrafluoroethylene (ePTFE) or polyethylene
film, is sufficiently flexible to be made eversible or such that
one end can be inverted back through the passageway of an
introducer member and loaded into the passageway of a second
member, such as a catheter, that functions as a coaxial inner
member and also serves as the medical device being introduced into
the bodily passage. The inverted sleeve is then pulled from the
inner member passageway and laid down within the bodily passage or
the opening thereto by the inner member as it advances out of or
through the introducer member, which is typically maintained in a
nearly stationary position and generally does not enter the target
bodily passage, although, such as in the case of a biliary
catheter, may be introduced through other body lumens to position
the inner member at the opening to a remote bodily passage.
[0007] As a result of the cooperation between the sleeve, the
introducer member, and the inner member, neither the sleeve nor the
inner member frictionally slides against the bodily passage during
advancement, thereby providing improved patient comfort and/or
facilitating forward movement which may reduce trauma to the
sphincter, duct or body lumen through which it is being introduced.
In addition to reducing friction, the sleeve can act to provide a
smooth track over an uneven surface, such as the tissue folds that
occur within the Papilla of Vater or the intestinal tract. The
sleeve is designed to be completely or functionally eversible at
full deployment from the inner member passageway (maximum extension
of the inner member relative to the sleeve), such that the
passageway of the inner member can be at least substantially
cleared and be functionally unobstructed. Typically, but not
essentially, the second end of the sleeve is unattached to the
inner member; however, if it attached, it has the ability to
substantially clear the passageway such that the sleeve or
attachment does not interfere with the passage of devices or
materials through the inner member. Partial deployment of the inner
member, which may also be desired in some applications, can result
in a portion of the sleeve still remaining in the inner member
passageway. In addition to making it simpler and cheaper to
manufacture, leaving the second end unattached, makes it easier to
remove the introducer assembly from the patient while maintaining
the inner member in place. Additionally, it allows the passageway
of the inner member to be free of obstructions and have a maximum
possible diameter for passage of other devices, once the sleeve has
completely everted. Alternatively, the sleeve may also be attached
to the inner member in a manner, such as around the distal tip,
that the sleeve can evert out of the passageway to a sufficient
degree as not to interfere with the passage of a third medical
device, such as a endoscope, through the inner member conduit.
Attachment of the sleeve, while substantially maintaining the
patency of the passageway, would be functionally equivalent to
having an unattached and fully-eversible sleeve, and thus, fall
within the scope of the present invention.
[0008] In another aspect of the present invention, the introducer
apparatus is adapted to permit the inner member to laterally
deflect as it advances from the introducer member and causes the
sleeve to evert. This can be accomplished by the addition of an
asymmetrical tip to the inner member or making the inner member
itself asymmetrical such that the sleeve has more drag on one side,
thereby causing the inner member to deflect in that direction. This
property is advantageous in certain clinical situations such as in
the biliary tree where there is a bifurcation between the bile and
pancreatic ducts. Another means of causing the inner member to
deflect in a given direction is to modify the sleeve such that one
side has a greater coefficient of friction than the other. This can
be accomplished by removing a portion of sleeve longitudinally to
make a half sleeve, making the sleeve out of two materials, or
treating one half of the sleeve such that the half having a greater
coefficient of friction causes the inner member to bend in that
direction as it advances through the bodily passage.
[0009] In still another aspect of the present invention, the
introducer member and sleeve are made splittable with a
predetermined split line such that they can be removed from over
the inner member within the patient, without requiring its removal
or causing its dislodgement. Other methods of removing the
introducer member from the inner member include making the inner
member twice as long as the outer so that is can be removed from
the patient and left over the external portion of the indwelling
inner member, or having a removable/replaceable connector on the
inner member so that the introducer member can be removed over the
proximal end of the inner member.
[0010] In yet another aspect of the present invention, a tether is
affixed to the second (inverted) end of the sleeve for reloading
the sleeve once it has partially everted. The attachment may be
such that the sleeve passageway is maintained in an open state to
facilitate access by other medical devices, such as a wire guide,
being introduced therethrough. This can include a reinforcing
annular ring within or external to the second end of the sleeve
and/or a second tether.
[0011] In still yet another aspect of the present invention, the
introducer apparatus can include means for reducing friction
between the sleeve and inner member during its use. One embodiment
includes folding or pleating the sleeve to shorten it within the
passageway and reduce the amount of contact with the inside of the
inner member passageway. This pleated sleeve unfolds as it is
everted by the advancing inner member. Another method is to modify
the distal end of the inner member to reduce friction. Besides
changing the surface energy of the tip, including adding a second
more lubricious material, the tip can be made to ease frictional
movement of the sleeve by the addition of ball bearings or rollers
to the tip which rotate as the sleeve is passed thereover.
[0012] In still yet another aspect of the present invention, the
introducer member comprises a short annular ring or collar that is
slidable over the inner member that is being introduced
therethrough, rather than an elongated introducer catheter. This
embodiment has utility when directly accessing the target bodily
passages from outside the body such as when placing nasal-gastric
or nasal-jejunal feeding tubes, colonic decompression catheters,
and urethral catheters, etc. In these types of procedures, the
operator can grasp the outer ring directly adjacent the
introduction site and deploy the inner member, rather than to first
navigate the introducer apparatus to a remote location in the body,
such as the Papilla of Vater and common bile duct. The outer ring
can also be provided by forming a thickened portion of the sleeve
material at or near the first end of the sleeve.
[0013] In still yet another aspect of the present invention, either
the introducer member or second member can include additional
lumens for passage of other devices or injection of materials such
as contrast agents with one passageway receiving the eversible
sleeve and at least one other adjacent passageway remaining free to
serve a different function. Contrast media, as well as other
agents, can also be introduced through the sleeve itself via a
plurality of apertures in the material, such as a mesh.
[0014] In still yet another aspect of the present invention, the
introducer apparatus can be placed over a nasal-gastric (NG) tube,
or other medical device such that the inner member comprises a
cap-like structure with the sleeve everting from within the lumen
of the inner member which frictionally protects the bodily passage
from the NG tube and advancing inner member. The sleeve everts from
a distal chamber in the inner member which is separated by a
proximal receiving chamber housing the distal end of the NG tube by
a partial septum. The introducer member ring is tethered to the
inner member for pulling the inner member proximally over the inner
NG tube, allowing the latter to advance through the partial septum
and out of the inner member for final placement.
[0015] In still yet another aspect of the present invention, the
inner member of the introducer apparatus is made radially
expandable such that once it is introduced into the body, e.g., the
back of the throat for placement of an NG tube, the sleeve is
removed and a larger device (the NG tube) can be introduced
therethrough as the inner member expands to accommodate its
passageway. Embodiments of this concept include having the inner
member comprise a cut, rolled tube with overlapping edges that
allow for its expansion, and an inner member having a folded pleat
on one or more sides that permits limited expansion of the
introducer during passage of a device such as an NG tube.
[0016] In still yet another aspect of the present invention, the
inner member includes a fluid reservoir, such as a bottle for
delivery of an enema. The outer member comprises a ring-like
structure that slides over the neck of the bottle, the neck
utilizing the eversible sleeve to reduce patient discomfort when
traversing the anal sphincter as the outer member ring abuts the
peri-anal area.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Embodiments of the present invention will now be described
by way of example with reference to the accompanying drawings, in
which:
[0018] FIG. 1 depicts a side view of a first embodiment of the
present invention;
[0019] FIGS. 2-3 depict enlarged partially sectioned pictorial
views of the embodiment of FIG. 1;
[0020] FIG. 4 depicts a cross-sectional view of the embodiment of
FIG. 1 in situ;
[0021] FIG. 5 depicts an enlarged partially sectioned view of an
embodiment of the present invention having an asymmetrical tip;
[0022] FIG. 6 depicts the embodiment of FIG. 5 being directionally
guided within the body of a patient;
[0023] FIGS. 7-8 depict partially sectioned side views of various
embodiments of the present invention having asymmetrical tips;
[0024] FIG. 9 depicts a partially sectioned side view of an
embodiment of the present invention with an asymmetrical eversible
sleeve;
[0025] FIG. 10 depicts a side view of an embodiment having a sleeve
with asymmetrical properties;
[0026] FIG. 11 depicts a side view of an embodiment with a
splittable introducer apparatus and sleeve;
[0027] FIG. 12 depicts a partially sectioned side view of an
embodiment of the present invention having a tethered sleeve;
[0028] FIG. 13 depicts a partially sectioned detail side view of an
embodiment of the present invention with an open tethered
sleeve;
[0029] FIG. 14 depicts an enlarged side view of a second embodiment
of the present invention having an open tethered sleeve;
[0030] FIG. 15 depicts a partially sectioned side view of an
embodiment of the present invention having a pleated sleeve;
[0031] FIG. 16 depicts a cross-sectional view of an embodiment of
the present invention having a ring-like introducer member;
[0032] FIG. 17 depicts a cross-sectional view of an embodiment of
FIG. 16, taken along line 17-17;
[0033] FIG. 18 depicts an enlarged pictorial view of the present
invention in which the introducer member comprises attachment
strips;
[0034] FIG. 18A depicts a partial cross-sectional view of the
embodiment of FIG. 18, taken along line 18A-18A;
[0035] FIG. 19 depicts a partially sectioned view of an embodiment
of the present invention for introducing a third member;
[0036] FIGS. 20-21 depicts a cross-sectional view of embodiments of
the present invention used to deliver stents;
[0037] FIGS. 22-22A depict enlarged partial views of embodiments of
the present invention having a reduced friction tip;
[0038] FIG. 23 depicts a side view of an embodiment of the present
invention having a preformed introducer member;
[0039] FIG. 24 depicts a side view of an embodiment of the present
invention having a preformed inner member;
[0040] FIG. 25 depicts an end view of an embodiment of the present
invention having a dual lumen introducer;
[0041] FIGS. 26-27 depict distal end pictorial views of embodiments
of the present invention having a multiple lumen introducer
member;
[0042] FIGS. 28-30 depict an embodiment of the present invention
being used with a bodily passage;
[0043] FIGS. 31-33 depict partially cutaway pictorial views of
embodiments of the present invention having an expandable inner
member;
[0044] FIG. 34 depicts an embodiment of the present invention in
which the sleeve is partially pleated;
[0045] FIG. 35 depicts an embodiment of the present invention
adapted such that it is not to be preloaded into an inner
member;
[0046] FIG. 36 depicts a partially sectioned view of an embodiment
of the present invention in situ, where the sleeve is also attached
about the inner member; and
[0047] FIG. 37 depicts a side view of an embodiment of the present
invention where the inner member comprises a fluid reservoir.
DETAILED DESCRIPTION
[0048] The present invention comprises an introducer apparatus 10
for reducing friction of a medical device being introduced into a
bodily passage 26, a first embodiment of which is depicted in FIGS.
1-4. The introducer apparatus 10 comprises an introducer assembly
11 that includes a sleeve fixation member 12, such as the
illustrative introducer member, having a passageway 20 therethrough
and a flexible sleeve 13 comprising a body 76, a first end 25 and a
second end 64. The sleeve 13 also includes a first portion 106 and
a second portion 107 (FIG. 4), with the first portion 106, which
includes the first end 25, being attached about the introducer
member by an attachment 14 which preferably, but not essentially,
affixes the sleeve 13 at one or more attachment points 110 to the
outer surface 75 of the introducer member 12 and is fixed against
movement with respect to the introducer member 12. Although the
sleeve 13 is typically attached to the introducer member 12 at the
`true` first end 25 thereof, it is possible that the sleeve 1 may
also extend proximally beyond the attachment 14 such that the
attachment 14 lies within what technically, could be considered the
body 76 of the sleeve 13; however, functionally, the first end 25
would still occur at the point of attachment 110, especially if
fixedly attached, regardless of whether unattached sleeve 13
material extended proximal to that point.
[0049] The sleeve 13 should be made of a material that allows it to
be sufficiently flexible to conform to the shape of a device being
placed therethrough. For most applications, the material, which is
typically thin, should exhibit resistance to tearing and stretching
(i.e., have good linear strength). Generally, the sleeve should be
smooth and lubricious such that the sleeve, as it is laid down by
the advancement of the device, or being withdrawn from the body, is
atraumatic to delicate linings of the body, such as sphincters,
tissue folds, ducts, and other passages. One material with
particularly desirable properties is expanded
polytetrafluoroethylene (ePTFE). Custom extruded ePTFE, which is
available from Zeus Medical Products, Inc., Orangeburg, S.C., is
produced from polytetrafluoroethylene (PTFE) tubing that is
expanded under controlled conditions which advantageously adds
microscopic pores throughout the material. The result is a soft,
flexible material with increased linear strength. The wall
thickness of the sleeve 13 depends largely on the application and
material used and may typically range from 0.001-0.01" for ePTFE. A
more preferred range for ePTFE when introducing a standard ERCP
device would be in the 0.002-0.005" range, most preferably around
0.0025". Many other polymeric films, such as high-density or
low-density polyethylene, have desirable properties, particularly
those with adequate linear strength. Their lower cost can be
significant, particularly for longer devices. Other possible
materials include latex, woven fabrics, or biomaterials that can be
fabricated into a thin, flexible sheet or tube of sufficient
strength. The sleeve can also be coated or impregnated with other
compounds and materials to achieve the desired properties.
[0050] To achieve an attachment 14 between the sleeve 13 and
introducer member 12, a variety of well-known methods can be used.
Permanent bonding methods include, but are not limited to, a
wrapping, such as with a thread or suture material; heat shrink
wrap or tubing; thermal, laser, or ultrasonic welding; an adhesive,
or a combination thereof. A detachable means of securing the sleeve
can also be used, such as a ring, collar, elastic band,
channel/groove, lower-grade adhesive, or another well-known means.
In the illustrative embodiment, the single point of attachment 110
extends around the circumference of the outer surface 75 of the
introducer member 12; however, FIGS. 18-18A depict an embodiment
having more than one point of attachment 110 between the sleeve 13
and introducer member 12. The introducer member 12 can also be
integrally attached to the sleeve 13, thus forming an arrangement
of unitary construction.
[0051] As shown in FIGS. 1-4, the introducer assembly 11 is
intended for use with a separate second member 15, hereafter
referred to as the inner member, that is introduced through the
passageway 20 of the introducer member 12 and into a bodily passage
26 (FIG. 4), such as the common bile duct or other passage. This
inner member 15 can include any of a number of medical devices such
as catheters, introducer sheaths, cannulae, stents, endoscopes,
retrieval or surgical devices, etc. A portion of the sleeve body
76, referred to herein as the second portion 107, resides within
the passageway 22 of the inner member 15 as the inner member is
introduced into the bodily passage 26. The first portion 106 of the
sleeve 13 is generally defined as that part of the sleeve body 76
that typically remains outside of the inner member passageway 22
after the sleeve 13 has been loaded. The second portion 107 is
typically inverted or preloaded into the passageway 22 with that
portion of the sleeve being eversible from the passageway 22 as the
inner member 15 is advanced relative to the introducer member 12,
to which the first end 25 of the sleeve 13 is attached. As used
herein, the terms `evert` or `eversible` refers to the process by
which the sleeve 13 unfurls, unfolds, invaginates, or otherwise
exits the passageway 22 into which it resides, upon which time the
sleeve 13 turns back on itself and conforms over the outer surface
of the inner member 15, forming a barrier between the inner member
15 and the inner surfaces 28 of the bodily passage 36.
[0052] The overall length of the second portion 107 is largely
determined by how far the inner member 15 is typically advanced
into the bodily passage 26 during a particular procedure. The
second end 64 of the sleeve is either completely unattached to the
inner member 15 as it resides in the passageway 20, or is
releasably secured in a manner such that the second end 64 is
completely eversible from the passageway 22 of the inner member if
necessary or so desired. Movement of the inner member 15 relative
to the introducer member 12 is therefore, not normally limited by
the length of the sleeve 13 and the introducer member 12, and the
sleeve 13 can be removed from the patient or treatment site
separately from the inner member 15 once the sleeve 13 has
completely everted from the passageway 22. The introducer member 12
can comprise an elongate catheter, as shown in the illustrative
embodiment, that houses the inner member 15, or it can be much
shorter in length, as shown in later examples.
[0053] The length and shape of the sleeve can be quite variable,
depending on the application. In the illustrative embodiment of
FIGS. 1-4, which is used as a biliary catheter for an ERCP
procedure in an adult patient, the sleeve is tubular and typically
measures from 6-10 cm in length, preferably 7-8 cm, so that the
inner member can cannulate both the opening of the duct and any
strictures that may exist therein. Preferably, it should not be so
long that it cannot completely evert from the inner member 15
during the procedure, since in this particular embodiment, removal
of the sleeve is desired after the inner member is in position.
Other procedures may require a longer sleeve 13. For example, the
sleeve 13 used to introduce a standard feeding tube, e.g., a
nasal-gastric (NG) or nasal-jejunal feeding tube, would be more in
the 20-40 cm range, more preferably around 30 cm. The sleeve 13 is
used to protect the feeding tube through the nasal passage past the
deviation of the septum until it reaches the back of the throat
where natural peristalsis takes over and helps to urge the feeding
tube downward through the esophagus and into the stomach or
jejunum. To assist natural peristalsis, the sleeve 13 or other
portion of the introducer apparatus 10 can be provided with a
surface structure having a bi-directional coefficient of friction
such as disclosed in a pair of co-pending applications, both
entitled, "Medical Instrument Having Bi-directional Coefficients of
Surface Friction," Ser. No. 08/989,413, filed Dec. 12, 1997 and
Ser. No. 09/184,331 filed Nov. 2, 1998.
[0054] A shorter sleeve, e.g., 7-10 cm may be desired for nasal
introduction if the inner member is merely serving as a short
conduit for the subsequent introduction of another device, such as
an endoscope, therethrough. The second device can then be
introduced much more comfortably than would be otherwise possible.
Conversely, a much longer sleeve, e.g., 150-160 cm, might be used
for a colonic procedure. Ideally, the sleeve for a particular
application, should be properly sized such that it completely
everts from the inner member, if so desired, to allow it to be
removed while maintaining the inner member within the patient.
[0055] Continuing with the first embodiment, FIG. 2 depicts an
introducer member 12 that is an elongated catheter in which the
sleeve 13 has been completely inverted into the passageway 22 of
the inner member 15 which in turn, coaxially resides within the
passageway 20 of the introducer member 12. As shown in FIG. 3, the
inner member 15 advances relative to the introducer member 12 with
the distal end 36 or leading edge of the inner member 15 urging the
sleeve 13 forward and thereby, pulling it out of the passageway 22
into which it has been loaded.
[0056] FIG. 4 show the introducer apparatus 10 being used within a
patient. The introducer member 12 is positioned at the opening 27
of a bodily passage 26 into which the inner member 15 is to be
introduced.
[0057] Holding the proximal portion 77 (FIG. 1) of the inner member
15 in place, the introducer member 12 is then urged in a proximal
direction. Typically, this action causes the sleeve 13, which
sheaths the distal end 36 of the inner member, to grip the surface
of the passage opening 27, thereby `self-advancing` the inner
member 15 as the introducer member 12 is `retracted` (as shown). In
these instances, the introducer member 12 does not actually move
any significant distance from the opening, despite the rearward
force be applied, but rather, the inner member 15 is advanced
forward into the bodily passage 26 although it is not actually
being directly advanced by the operation. Thus, the inner member 15
is described as `self-advancing.` In selected embodiments or
certain instances, the operator may need to directly advance the
inner member 15 in order to have the sleeve 13 evert and lay down a
protective track; however, the sleeve still provides the same
protective function. For each of the illustrative embodiments, the
sleeve 13 lays down a track, much like the way a military tank or
bulldozer moves, such that the advancing inner member 15
frictionally slides against the protective sleeve 13 itself instead
of directly contacting the lining 28 of the bodily passage 26.
Because the sleeve 13 does not slide against the internal lining 28
of the bodily passage 26, there is minimal irritation and trauma to
the opening 27 and bodily passage 26 during its initial
introduction. The sleeve 13 protects the bodily passage 26 for a
distance up to its own length, after which, it completely everts
from the inner member 15 and any further advancement will typically
result in normal frictional contact between the inner member 15 and
the bodily passage 26. In the case of the biliary tree, it may only
be important to provide protection for a short distance to traverse
the Papilla of Vater, or it may be necessary or desirable to extend
this protection further into the duct such as to cannulate a
stricture. For certain applications, the sleeve 13 should
completely or functionally evert from the passageway 22 of the
inner member 15, or a particular application may not require that
it does so.
[0058] With respect to the embodiment of FIG. 1, which is
configured for accessing the biliary tree, the introducer member 12
should be at least 150 cm for an adult patient, typically 157-160
cm. The introducer member 12 normally must be removed from the
patient while the inner member 15 remains in place. To accomplish
this, the inner member 15 is made at least twice as long as the
introducer member 12 such that the entire length of the introducer
member 12 can remain over the inner member 15 and extend outside
the patient. This is especially useful when there is a proximal
connector 21 on the inner member 15 of this embodiment which may
not permit removal of the introducer member 12 thereover. The
proximal connector 21, such as a luer fitting, is useful in this
embodiment because the injection of contrast media, which would be
infused through the inner member 15, is typically important in ERCP
procedures. A removable connector may be used, such as a
Tuohy-Borst adaptor, that can be unscrewed and removed to allow
removal of the introducer assembly 11, then reattached. A
reattachable proximal connector 21 is particularly advantageous
when the inner member 15 is made long (e.g., 400 cm) to allow the
introducer member over the inner member, which remains in place
within the patient. Once the introducer member 12 is discarded, the
long inner member 15 can be cut to a more manageable length (e.g.,
closer to 200 cm) before replacing the proximal connector 21.
[0059] In certain clinical procedures, it is advantageous to be
able to direct or deflect the tip of the inner member as it is
being advanced into the bodily passage, for example, to negotiate a
particular branch when confronted with a bifurcation. FIGS. 5-10
depict various means of causing the inner member 15 to deflect in
one particular direction over the other. In the embodiment of FIG.
5, a separate distal tip 29 is affixed at the distal end 36 of the
inner member 15. As depicted, the distal tip 29 is configured to be
an asymmetrical-shaped tip 30 which includes a proximal portion 34
that is inserted into the passageway 22 of the inner member and a
distal portion 33 that forms the leading edge of the inner member
15. The distal portion 33 of the asymmetrical-shaped tip 30 is
divided longitudinally into a first side 31 and a second side 32.
In the illustrative example, the first side 31 is considerably more
rounded than the flattened second side 32. As a result, the
enlarged first side 31 provides more drag against the sleeve 13
than the second side 32 as the sleeve 13 is everting out of the
inner member 15, which in turn, causes the distal end 36 of the
inner member 15 to laterally deflect toward the direction
corresponding to the first side 31.
[0060] FIG. 6 depicts a laterally deflectable embodiment of the
present invention accessing the bile duct. When the introducer 11
is advanced from an endoscope 78 and placed at the Papilla of Vater
27, the opening to the common bile duct 26, there is a marker 69
that indicates the direction in which the inner member 15 will
deflect. To accomplish this, it is essential that the inner member
15 and introducer member 12 be aligned such that the means for
deflection, whether part of the inner member 15 or the sleeve 13,
is aligned with the marker 69 printed on the sleeve 13 or
introducer member 12. This can be done by providing guide marks
(not shown) on the proximal area of both the outer and inner
members 12,15 such that they can be rotated into alignment prior to
advancement of the inner member 15. Once alignment has occurred and
the position of the marker 69 is established endoscopically, the
inner member 15 is advanced into the common bile duct 26 where it
deflects into the bile duct 37 as desired, avoiding the pancreatic
duct 38. To access the pancreatic duct 38 instead, the introducer
assembly would be simply rotated such that the marker 69 is
positioned approximately 180.degree. in the opposite direction.
Alternate methods of providing a visual marker on the sleeve 13
would be to place a radiopaque marker on either the sleeve 13, the
inner member 15 or the introducer member 12 such that the
orientation of the asymmetrical tip 30 can be determined under
fluoroscopy when contrast media is injected into the biliary tree.
It should be noted that the natural folds of tissue 105 just inside
the common bile duct 26 may be utilized to help provide increased
grip on the sleeve 13, thereby pulling the inner member 15
preferentially toward the bile duct 37 branch.
[0061] Besides incorporating a separate asymmetrical tip 30 to
cause the advancing inner member 15 to deflect, as shown in FIG. 5,
the distal end 36, or the region thereabout, of the inner member 15
itself can be configured (FIGS. 7-8) to provide unequal drag
between the different sides 31,32 of the inner member, thereby
causing the sleeve 13 to pull the inner member 15 laterally in a
particular direction as it advances. In the embodiment of FIG. 7,
the first side 31 of the inner member 15 includes a lateral
protuberance 41 that increases resistance to the sleeve 13 passing
thereover. The resistance differential relative to the second side
32, which lacks a protuberance 41, causes the inner member to
deflect toward the first side 31. In the embodiment of FIG. 8, the
distal end 36 of the inner member 15 includes a bevel 42 to provide
different degrees of resistance to the sleeve 13 between the first
side 31 and the second side 32 of the inner member. The long second
side 32 of the bevel 42 provides increased resistance over the
first side 31, therefore causing the sleeve 13 to deflect the inner
member in that particular direction.
[0062] In addition to modifying the inner member 15 to achieve
controlled directionality during its advancement, the sleeve itself
13 can be modified to achieve similar results. In FIG. 9, a sleeve
is shown having a distal portion 79 that is tubular in shape and a
proximal portion 80 in which the material on one half is removed to
create a partial sleeve 43 which is semi-circular in cross-section
during deployment of the apparatus 10. In this design, the full
sleeve 13 or distal portion 79 is used to cannulate the opening to
the bodily passage, whereby as the partial sleeve 43 portion
everts, a situation is created in which there is a friction
differential between the two sides 31,32 of the inner member 15
that results in the inner member 15 being laterally deflected in
the direction of the open portion 81 of the sleeve 13. Another
means of accomplishing this effect is depicted in FIG. 10 whereby
the sleeve is divided longitudinally into two halves 44,45, each
having different properties. In the illustrative embodiment, the
first half 44 of the sleeve comprises a porous material with a
plurality of apertures 109, such as a fabric mesh, while the second
half 45 comprising a material more suitable for friction reduction.
One purpose of the porous material would be allow contrast media to
be pushed through the apertures 109 into the bodily passage to
improve imaging of the target site for diagnosis or treatment. A
large open mesh, e.g., 0.02-1.0 mm, would also allow drugs to be
infused into the bodily passage. The amount of porous material can
range from a narrow longitudinal strip, to an area comprising the
majority of the circumference of the sleeve 13. Another clinical
application for a large open mesh would be for obtaining cytology
samples, whereby withdrawal of the sleeve within the bodily passage
traps cells within the apertures 109 in the mesh and allows the
cells to be collected for laboratory analysis.
[0063] In another variation of the embodiment of FIG. 10, the two
halves 44,45 of the sleeve 13 can given a different coefficient of
friction, which causes the sleeve to deflect toward either the
first side 31 or the second side 32, depending on which half of the
sleeve 44,45 offers the most resistance against the inner member 15
as the sleeve 13 as it is being everted. The first and second
sleeve halves 44,45 can either be made of different materials that
are joined along the longitudinal axis by an appropriate means such
as stitching, welding, gluing, etc., to form a tubular composite
sleeve 13, or a sleeve 13 of a single material can be treated to
increase the coefficient of friction on one side. For example, the
material could be mechanically or chemically roughed to increase
friction; a second material, such as silicone beads, could be
applied to the surface to increase friction; or a lubricious
material could be added to reduce friction on a particular
side.
[0064] Another means of adding directionality to the introducer
apparatus is to incorporate a desired amount of curvature to a
component thereof during its manufacture. FIG. 23 depicts an
introducer apparatus 10 in which the introducer member 12 has been
preformed with a particular curvature to improve accessibility to a
target site in certain clinical situations. It might be desirable
to limit the curvature to the very distal portion or the curvature
might extend over a greater portion of the inner member 15. The
inner member 15 itself can be preformed with a curvature as well,
as depicted in FIG. 24 to aid in certain procedures, especially an
ERCP, where the ability to successfully navigate a bifurcation may
be required. In the illustrative embodiment, the introducer member
12 has sufficient integrity relative to the inner member 15 (i.e.,
stiffer materials, increased wall thickness, etc.) that it acts to
constrain the curved inner member 15 into a straight configuration,
wherein the inner member assumes its predetermined shape upon
advancement from within the introducer member 12. In another
embodiment, the curved inner member 15 would force the otherwise
straight introducer member 12 to assume the inner member's
predetermined shape. In still another embodiment, both the inner
member 15 and introducer member 12 can be both given a
predetermined curvature, which may approximately match that of the
other. One result of added curvature to both the outer and inner
member 12,15 would be to allow for an overall double curvature
wherein the introducer member 12 permits a lateral access in one
direction, while the advancing inner member 15 can positioned such
that it deflects back in a second direction (e.g., an S-curve). It
should be noted that in some applications, such as an ERCP
procedure, the inner member 15 must be made sufficiently flexible
to bend back on itself when it cannot find a suitable passageway,
thereby not creating a false passage.
[0065] Other methods for curving the inner member 15 include having
the sleeve 13 extruded such that it includes curvature of its own.
If the sleeve 13 has sufficient linear strength or stiffness and
the inner member 15 is sufficiently pliable, the curved sleeve 13
would force the inner member 15 to deflect in the direction of the
curvature of the sleeve 13, much like the example depicted in FIG.
24 which is also provided to illustrate a pre-curved inner
member.
[0066] FIG. 34 depicts another sleeve configuration for
preferentially directing the inner member 15, whereby the sleeve 13
is extruded or shaped such that one half 44 includes pleat or folds
55, while the other half 45 is of the typical smooth, cylindrical
shape. Under selected conditions, the inner member 15 would
generally tend to deflect in the direction oriented with the
second, smooth half 45 of the sleeve.
[0067] As discussed, using the present invention in certain types
of procedures may require that the introducer member 12 and sleeve
13 be removed from the patient, or at least from around the inner
member 15, while the inner member 15 remains in place. In addition
to making the inner member 15 such that the introducer member 12
can either be removed over the proximal end 19 (i.e., a detachable
hub) or the inner member is at least twice as long as the
introducer member 12, another methods would include making the
introducer member 12 and sleeve 13 splittable as depicted in FIG.
11 such that they can be peeled back from the proximal end 19 and
removed without requiring disruption to the inner member 15. One
preferred material for a splittable introducer member 12 is
molecularly oriented (non-isotropic) polytetrafluoroethylene
(PTFE), such as that used in the PEEL-AWAY.TM. Introducer Sheath
(Cook Incorporated, Bloomington, Ind.). The advantages of the
material is that it does not require a prescored line and as it is
being split open as the progressive tear maintains a straight and
predictable pathway. At the proximal end 19 of the introducer
member 12, the sheath has been modified to comprise two opposing
ears 83 or tabs that are divided by opposing cut points 84. The
operator grabs the ears 83 and pulls them apart from each other,
starting the split at the cut points 84. Once the splitting action
has commenced along opposing predetermined split lines 47, it
progresses distally as the two halves of the introducer member 12
sheath are pulled apart. Depending on the design, the split
continues through the sleeve attachment 14 and splits the sleeve
13, which may include a tear line 46 such as a perforation, or the
split may stop at the attachment point or sleeve and the operator
will then manually split the remainder of the introducer assembly
11 that is now outside the patient, such as with a scalpel, taking
care not to nick the inner member 15. A third method of removing
the introducer member 12 from over the indwelling inner member 15
is depicted in FIG. 27. The introducer member 12 includes a
longitudinal opening 74 or split extending the length of the
introducer member 12 through which the inner member 15 can be
removed from the passageway 20 thereof. The introducer member 12
can then be removed from the patient while the inner member 15
remains in place.
[0068] FIG. 12 depicts an embodiment of the present invention in
which the sleeve 13 is reloadable by use of a tether 48 attached to
the second end 64 of the sleeve 13 and where the attachment point
49 includes a knot or other means to secure the tether 48 to the
sleeve 13. The sleeve 13 remains basically eversible from the
passageway 22 of the inner member 15; however, the inner member 15
is limited in it's forward movement once it does. The everted
sleeve 13 can advantageously retrieved by grasping the accessible
portion of the tether 48 and pulling in a proximal direction. This
pulls the sleeve 13 back into the passageway 22 whereby the sleeve
13 again becomes inverted into the inner member 15, making
available to be used again, if necessary or so desired. To maintain
patency of the sleeve 13, the embodiment of FIG. 13 includes a
tether 48 where the attachment point 49 to the sleeve 13 is located
along only one side of the second end 64 such that the sleeve
passageway 24 remains in an open condition and thus, better able to
receive a wire guide, deliver contrast media, etc. A second tether
52 and attachment point 50 can be added to add stability and
maintain patency as depicted in FIG. 14. An annular ring 51 can
further serve to hold the sleeve passageway 24 open and provides an
anchoring point for the attachment points 49,50 of the respective
tethers 48,52. If the annular ring 51, is made of an elastic
materials, it is possible for the inner member 15 to push through
the annular ring 51 and not be limited advancement of the inner
member 15, especially if the annular ring 51 is given a larger
diameter than the inner member 15 and compressed within the
passageway 22. If not, the ring 51 will typically stop at the
distal end 36 of the inner member 15, limiting the further
advancement thereof.
[0069] FIG. 15 depicts an embodiment of the present invention in
which the sleeve 13 is configured to include a series of pleats 55,
resulting in the body 76 of the sleeve 13 become somewhat
accordion-shaped while inverted into the passageway 22 prior to
deployment. The pleats 55 permit the sleeve to unfold and expand
longitudinally as it everts. This can be especially useful when the
eversible sleeve must extend over a considerable distance, such as
for a small bowel nasal feeding tube which can be 150 cm in length.
The primary value of folding the sleeve to reduce its length is to
provide less drag between the sleeve 13 and the inside of the inner
member passageway 22, since a long sleeve 13 is more difficult to
pull out of or load into the inner member 15 due to the increased
frictional load.
[0070] FIGS. 15-17 show a modification of the apparatus 10 in which
the introducer member 12, rather than comprising a elongated tube,
is an external ring 53 or carriage-like structure that is slidable
with respect to the inner member 15 that is to be introduced into
the bodily passage. As shown in FIG. 16, the external ring 53 can
optionally be prevented from being removed from the distal end 36
of the inner member by inclusion of a stop 54 that is incorporated
into the inner member 15. Additionally, the external ring 53 can
include at least one projection 92 that fits within a groove 93 on
the inner member 15 such that the external ring 53 cannot twist or
rotate relative to the inner member 15 which could also result in
the twisting of the sleeve 13. In its simplest form, the external
ring 53 can be made integral with the sleeve 13 material such as by
forming a thickened portion thereof at or near the first end 25 of
the sleeve 13. Having the introducer member 12 comprise a
relatively short external ring 53 rather than an elongated tubular
member is preferable, or at least possible, in applications where
the entire introducer member 12 is outside the patient's body, or
nearly so, such as a nasal tube or urinary catheter introduction,
or when accessing the lower gastrointestinal tract via the rectum.
In these instances, the clinician can grasp the external ring 53
which generally abuts the introduction site, whereby the inner
member 15 spontaneously advances or is manually advanced into the
bodily passage. In a remote access situation as with the biliary
system, the introducer member 12 must be sufficiently long such
that the proximal end 19 is outside the body (FIG. 1) so that it
can be manipulated from that point, rather than from within the
duodenum.
[0071] In a related embodiment shown in FIG. 37, the inner member
15 comprises a container 115, such as a bottle, used to supply
fluid used in the administration of an liquid agent, such as to
perform an enema. The bottle 115 includes a proximal reservoir
portion 116 which narrows distally to form a neck portion 117 that
is inserted into the patient. The introducer assembly 11 includes
the sleeve 13, the sleeve attachment 14, and outer member 12, which
in the illustrative embodiment, comprises a ring-like member 53
with a proximal collar. The ring-like member 53 is sized larger
than the anal orifice 118 and is designed to abut the peri-anal
area 119. The illustrative embodiment is configured for
self-delivery whereby the patient gently inserts the distal tip 36
of the bottle (covered by forward edge of the sleeve 17) into the
anal orifice 118. The sleeve 13, provided to reduce friction and
discomfort caused by the insertion of the bottle 115, then
spontaneously everts as the neck 117 of the bottle is drawn through
the anal sphincter 121 into the rectum where the contents of the
bottle 115 are delivered. The wider reservoir portion 116 can
provide a stop to ensure that the neck portion 117 traverses the
anal sphincter 121 without extending too far into the rectum 120.
The sleeve 13 can either be unattached within the interior
passageway 22 of the bottle 115 or be eversible by attaching to the
inner member 15 in a manner such that it does not obstruct fluid
flow therethrough (i.e., glued or otherwise bonded against the
passageway 22 wall or about the distal end 36. It is not necessary
to attach the ring member 53 to the bottle 115, which can be
packaged together with plastic wrap or some other means to both
keep the apparatus sterile and maintain the ring member 53 in a
fixed pre-delivery position. At deployment, the neck 117 of the
bottle advances through the ring member 53, which is held
stationary against or adjacent to the peri-anal area 119. The same
concept, i.e., container 115 with eversible sleeve 13, can be
applied for delivery of therapeutic agents via the nasal passages
or elsewhere in the body and maybe include a syringe, bag, pump, or
other container adapted to hold and deliver a liquid, gas, or a
suitably formulated solid material. The neck portion 117 may
comprise various shapes and materials depending on the desired
application.
[0072] FIGS. 18-18A depict an embodiment wherein the introducer
member 12, rather than being a coaxial outer tube or ring,
comprising a pair of longitudinal attachment strips 56, such as
flat wires or strips of material, that reside in opposing grooves
57 or channels formed into the outer surface of the inner member
15, and through which the inner member 15 passes as it advances
into a bodily passage. The attachment strips 56 are secured to two
oppositely oriented attachment points along the sleeve 13 with an
attachment mechanism 14 such as adhesive, stitching, etc., or they
are tightly biased against the sleeve 13 such that when the
attachment wires 56 are retracted by the operator, the inner member
15 advances through the bodily passage until the sleeve 13 fully
everts. The attachment wires 56 may then be fully retracted along
and within the grooves 57 to completely remove the sleeve 13 from
the patient. Optionally, the attachment strips 56 can be conjoined
at or near their proximal ends or to allow them to be retracted at
the same rate. In should be noted that the number of longitudinal
attachment strips 56 is not critical to the invention. Furthermore,
the embodiments of FIGS. 18-18A show that the sleever fixation
mechanism 12 or introducer member need not be a tubular or an
annular structure, but rather, can include any structure or series
of structures, including an array of barbs or other fixation
devices, that can attach about the first end 25 of the sleeve and
maintain the first portion 106 of the sleeve outside the opening of
the bodily passage, while facilitating the introduction of the
inner member 15 thereinto. For example, barbs or other structures
of similar function can be configured to engage tissue about the
opening of the bodily passage to facilitate introduction of the
inner member, then disengage when the sleeve 13 is to be discarded.
In this sense, the array of barbs collectively form the sleeve
fixation mechanism 12, which can also be defined as the introducer
member, with the inner member 15 being advanced therethrough.
[0073] FIG. 19 depicts an introducer apparatus that can be used
with a third member or device 59, such as nasal-gastric (NG) or
nasal-jejunal (NJ) feeding tube, endoscope etc. of various sizes.
Such devices can be introduced while having the benefit of the
protective sleeve, yet without the sleeve directly cooperating with
the third device 59. In the illustrative embodiment, the introducer
member comprises an external ring 53 and the sleeve 13 inverts into
an inner member 15 that is separate from the third device 59. The
inner member 15 acts as a distal cap that fits over the distal end
96 of the third device 59 being introduced. The inner member 15 can
be advantageously made of a resilient material, such as silicone,
such that it can stretch over the third device 59 that is inserted
thereinto, although less-resilient materials can be used if tight
cooperation between the second and third members 15,59 is not
necessary. The inner member 15 comprises a distal sleeve chamber 60
that houses the loaded sleeve 13, and a receiving chamber 70 into
which the third device 59 is inserted. The medical device 59 is
advanced through the introducer member 12 (external ring 53) and
into the receiving chamber 70 until it abuts the chamber septum 65
which divides the two chambers 60,70. The external ring 53 has a
complete circumferential attachment 14 to the sleeve 13 which is
inverted into the distal sleeve chamber 60. The external ring 53 is
also attached to the proximal portion 77 of the inner member 15 via
a first and second deployment tether 94,95 at attachment sites 71
on the introducer member 12, usually 180.degree. apart.
[0074] One example of how the embodiment of FIG. 19 is placed is
that of a NG feeding tube 59. The distal ends 16,36 of the outer
and inner members 12,15 are placed into the opening of the nasal
passage and the external ring 53/introducer member 12 is typically
urged in a proximal direction to cause the inner member 15 and NG
feeding tube 59 into be introduced into the nasal passage. The
sleeve 13 protects the lining of the nasal passage from trauma
resulting from the advancing inner member 15 and NG feeding tube 59
as they advance toward the stomach. Deployment of the NG feeding
tube 59 from the inner member occurs within the esophagus, once the
distal end 36 of the inner member 15 has passed through the
sensitive nasal passages. At this point, the tethered ring 53 is
pulled backward until the NG tube 59 pushes through the aperture 66
in the chamber septum 65, then into the distal sleeve chamber 60,
and out the distal end 36 of the inner member 15. The external ring
53 and tethered sleeve 13 are pulled over the external surface of
the indwelling NG feeding tube 59 where they are cut free, once
outside the patient. To help ensure that the NG tube has sufficient
column strength to penetrate chamber septum 65, a stiffening stylet
97 can be introduced into the passageway 98 of the NG tube to
improve its pushability, whereby it is removed once the NG tube 59
has been advanced through the distal end 36 of the inner member
15.
[0075] More simplified embodiments of the universal introducer
concept can be found in FIGS. 31-33. As depicted, the inner member
15 includes an longitudinal expansion zone 103 that allows the
inner member 15 to radially expand, especially following removal of
the introducer assembly 11, to allow variously-sized devices of a
larger diameter to be introduced therethrough. The embodiment of
FIG. 31 includes an inner member 15 with longitudinal expansion
zone 103 comprising an expansion pleat 99. The expansion pleat 99
represents an invagination in the wall of an inner member 15 which
is then folded over to create an inner member 15 of a first,
unexpanded diameter as shown in the figure. The introducer member
12 (external ring 53) acts as a containing mechanism to maintain
the inner member 15 in the first diameter. When the introducer
member 12 and sleeve 13 are removed from over the inner member 15,
it permits a third member or device 59 (like that shown in FIG. 19)
to be introduced through the inner member, which then assumes a
larger, second diameter. The expansion pleat 99 unfolds to allow
passage of a device (e.g., an NG tube) that has a larger diameter
than the first diameter of the inner member 15, these
advantageously providing the combination of a smaller introducer
with a larger, optimally sized indwelling device.
[0076] FIG. 32 depicts another embodiment of an expandable inner
member 15 having a longitudinal opening 74 or split in which the
longitudinal expansion zone 103 comprises an overlapping area 100
of the first edge 101 and the second edge 102 defined by the
longitudinal opening 74. In the illustrative embodiment, the first
edge 101 is folded over the second edge 102 to create the
overlapping area and give the inner member a first, unexpanded
diameter that is maintained by the external ring 53 of the
introducer member 12. When the introducer member 12 and sleeve are
removed, the second, inner edge 102 and first, outer edge are able
to slide toward one another, thereby allowing radial expansion of
the inner member to the second, expanded diameter for passage of a
larger diameter device. In a variation of this embodiment, depicted
in FIG. 33, the first and second edge 101,102 of the cut tube can
be attached via an expandable bridge 104 of a second and usually
more flexible material. The expandable bridge 104 of the
longitudinal expansion zone 103 can extend underneath the first
edge 101, forming an overlap 100 similar to FIG. 32, or the first
and second edges 101,102 may not actually overlap. In the latter
instance, expansion can result from folding or invaginating the
flexible material of the expandable bridge 104 to permit radial
expansion of the inner member 15, or relying on elastic properties
of the expandable bridge 104 to allow the inner member 15 to assume
a second, expanded diameter when a larger diameter device is passed
therethrough.
[0077] FIG. 36 depicts an embodiment of a nasal introducer used to
cannulate the nasal passages 112 to introduce a third member or
device 59, such as a nasal endoscope. Since the sleeve 13 does not
need to be separately removed from the inner member 15, which is
only introduced a relatively short distance to provide a conduit
for passage of the third member 59, the second end 64 of the sleeve
13 is conveniently, but not essentially, affixed to the inner
member 15. Because the second member 15 functions as introducer, it
is generally preferable that the attachment 111 of sleeve 13 to the
second member 15 be located and configured such that the passageway
22 of the inner member 15 remains substantially unobstructed to
facilitate passage of the third member 59. FIG. 36 shows one
example of such an attachment 111, which is affixed about the
distal end 36 of the inner member 15 with the attachment 111
occurring within a groove 114 formed in the distal end 36 thereof,
leaving the passageway 22 clear and unobstructed after the sleeve
13 has fully everted. It would still be within the scope and spirit
of the invention for the attachment 111 to be located such that a
portion of the sleeve remains within the passageway when the inner
member 15 is fully extended, as long as the sleeve 13 is eversible
to the point where the passageway 22 is not significantly or
functionally narrowed or obstructed by the sleeve 13 and/or its
attachment 111. The term `eversible` should therefore be understood
to be equivalent to the concept of being `functionally eversible`,
whereby, unlike the Bidwell '670 device with its internal
`retention sled` to which the sleeve is attached, the sleeve and
attachment of the present invention have the capacity to clear the
passageway 22 to a sufficient degree as not to interfere with the
passage of a third member 59 therethrough. Features described in
the other accompanying embodiments may also have particular utility
for the embodiment of FIG. 36, such as a channel 93 to prevent the
introducer member 12 from rotating relative the inner member 15
(FIG. 16), and a preformed inner member 15 (FIG. 24) that
facilitates navigation of the inner member 15 and/or third member
59 toward the nasopharynx 113.
[0078] FIG. 35 depicts an embodiment in which introducer member 12
and sleeve 13 can be introduced into the body without preloading
the sleeve 13 into the inner member 15. In the illustrative
example, the second end 64 of the sleeve 13 is attached to a wire
guide 62 that was been preloaded into the introducer member 12. The
sleeve 13 and wire guide 62 can be coupled such that the wire guide
62 can slide relative to the sleeve 13 or that the sleeve 13 is
fixed over the wire guide 62. A sleeve attachment 108 is used, such
as a small band, suture, adhesive, or other means of gathering and
securing the second end 64 of the sleeve, which allows the sleeve
13 to become detached from the wire guide 62 when the advancing
inner member pulls it loose, either by sliding off the attachment
member 108 from around the sleeve 13 (such as onto the wire guide)
or causing an opening or detachment of the attachment member 108 to
release the sleeve 13. By gathering and attaching the second end 64
of the sleeve 13 about the wire guide 62, the second end 64 is
readily drawn into the passageway 22 of the inner member 15 as it
tracks over the wire guide 62 upon advancing toward the distal end
16 of the outer member 12. While attachment of the second end 64 to
the wire guide 62 facilitates capture of the sleeve 13 within the
passageway 22 of the inner member 15, it is also possible to
eliminate the wire guide 62, especially if not otherwise useful in
the procedure, and gather the end 64 of the sleeve 13 by
configuring the attachment mechanism 108 in such a manner that it
facilitates capture by the advancing inner member 15. In such an
embodiment, adding stiffness to, and/or gathering up the sleeve
over several millimeter or centimeters (such as using a plurality
of attachment bands 108) would improve the reliability of the
sleeve 13 being effectively fed into the passageway 22 as the inner
member 15 is advanced.
[0079] The eversible sleeve introducer 11 of the present invention
can also be used to deliver stents 61 and other tubular prosthetic
devices as depicted in FIGS. 20-21. In the embodiment of FIG. 20, a
stent 61, such as a self-expanding intraluminal stent, is mounted
over the inner member 15 and this assembly is loaded within the
tubular introducer member 12. The sleeve 13 is everted into the
passageway 22 of the inner member 15 which functions as the
delivery or pusher catheter. The inner member 15 includes a lip 63
that maintains a force against the proximal end of the stent 61
that assists in placement of the stent 61 at the desired location.
The stent 61 is advanced out of the introducer member 12 as the
sleeve 13 is everted and subsequently protects the lining of the
bodily passage from the friction that would result from the
advancing stent 61. When the sleeve 13 has finished everting from
the passageway, the stent 61 becomes exposed to the bodily passage
into which it is to be placed. In the case of a self-expanding
stent 61, the sleeve 13 may also provide a restraint that helps
prevent its full expansion. As the sleeve 13 passes over and
exposes the advancing stent, the deploying stent 61 is able to
expand against the walls of the bodily passage. In a related
embodiment shown in FIG. 21, the loaded stent 61 is made of a lower
profile because it is not delivered from within the introducer
member 12 which otherwise adds to the outer diameter of the
introducer apparatus 10. In the illustrative embodiment, the distal
end 16 of the introducer member 12 does not extend over any portion
of the stent 61 which has been mounted over the inner member 15.
The inner member 15 of this embodiment also includes a lip 63.
Without the introducer member 12 extending over the stent 61, the
sleeve 13 provides the only restraint and protection to the stent
as it is delivered. In this particular embodiment, the stent 61 is
sized to include a space 86 between the inside of the stent 61 and
the outer surface of the inner member 15. The space 86 permits the
inner member 15 to be readily withdrawn from within the passageway
87 of the stent 61 without catching thereon and possibly causing it
to be dislodged from the target area of deployment. Alternatively,
the stent could be mounted on a balloon and deployed in that manner
once exposed by everted sleeve and/or introducer member.
[0080] FIG. 22 depicts an embodiment in which a series of friction
reduction means 68 are included about the distal tip 29 of an inner
member of an introducer apparatus 10. In the illustrative
embodiment, the friction reduction means 68 includes three ball
bearings 88 or beads which a mounted in the distal face 67 of the
distal tip 29. The ball bearings 88 are rotatable within their
mountings via friction applied by the sleeve 13 as it drags
thereover, therefore allowing the sleeve 13 to move more freely. A
similar concept is shown in FIG. 22A wherein a series of rollers 89
are mounted about the distal face, encircling the passageway 22
opening. In the illustrative embodiment, the hollow rollers 89 are
threaded over a wire frame 90 which comprises two opposing
semi-circular frame halves 124,125. The adjacent first ends 91 of
the two wire frame halves 124,125 are embedded into the distal face
67 at a point along passageway 22 opening and the seconds ends 123
are embedded into the distal face 67 approximately 180.degree. from
the first ends 91 along the passageway 22 opening, such that the
wire frame 90 is circular with each frame half 124,125 holding
approximately half of the rollers 89. Optional supports 122 mounted
on the distal face 67 support the wire frame 90 and provide spacers
between the rollers 89. Other means of reducing friction include
providing a highly lubricious material to the distal face 67 (e.g.,
a highly polished metal tip annular ring), coating the end of the
device with lubricious polymer coating such as SLIP-COAT.RTM.
(Sterilization Technical Services, Rush, N.Y.), or changing the
surface energy of the distal face 67 through other means such as
ion beam bombardment.
[0081] While the embodiments of the preceding figures generally
provide for a single passageway 22 through which materials or
devices can be introduced to the target site, it possible to
provide for one or more additional lumens in the introducer
apparatus 10 separate from the passageway 22 that houses the
eversible sleeve 13. As depicted in FIG. 25, the inner member 15
includes a second passageway 58 for passage of a device, such as a
wire guide 62, or for injection of contrast media or other
materials. In this embodiment, the sleeve 13 represents a partial
sleeve 43. The partial sleeve 43 allows the second passageway 58 to
remain continually open and accessible at all times, while still
providing a degree of friction reduction between a portion of the
inner member 15 and the bodily passage. FIGS. 26-27 show
embodiments in which the introducer member 12 includes a second
passageway 72. In the embodiment of FIG. 26, the sleeve 13 and the
attachment means 14 to the introducer member 12 are similar to
single passageway embodiments such as that of FIG. 1. The second
passageway 72, located proximal to the sleeve attachment 14, is
especially useful as an injection port, but can also function to
receive a wire guide, if appropriately sized. A second multi-lumen
introducer member 12 is depicted in FIG. 27 wherein the distal end
16 of the introducer member is more truncate than that of FIG. 26
and the sleeve attachment 14 comprises an annular or ring structure
mounted on the distal end 16 with the opening to the second
passageway 72 being positioned on the face of the distal end 16
adjacent to the sleeve 13 and attachment 14. The attachment 14 can
either be a plastic or metal ring to secure the sleeve 13 to the
introducer member 12, or a ring of adhesive. As mentioned, the
embodiment of FIG. 27 also includes a longitudinal opening 74 to
allow the introducer member 12 to be removed from over the inner
member 15 with the sleeve 13 and attachment 14 made splittable or
detachable as well to allow removal over the inner member 15.
Obviously, it is possible to have additional passageways beyond the
second passageway 58,72 depicted in FIGS. 25-27. For example the
second passageway 58,72 might be used for introduction of wire
guides or medical devices while the third passageway is used for
injecting contrast media.
[0082] FIGS. 28-30 depict an example of a method of using a
selected embodiment of the present invention to cannulate a
stricture within a bodily passage. As depicted in FIG. 28, the
distal end 16 of the introducer member 12 is placed against the
opening 27 to the bodily passage 26 where the introducer member 12
is then pulled back relative the inner member 15 which is initially
restrained. This allows the inner member 15 to grip the opening and
-advance into bodily passage 26 as the sleeve 13 is laid down when
everting from the inner member 15. In FIG. 29, the inner member 15
has passed through the stricture and the sleeve 13 has now
completely everted from the passageway 22 of the inner member. The
inner member 15 is maintained at the target site, while the
introducer assembly 11 is removed from the patient by one of
several mean discussed above. In FIG. 30, only the inner member 15
remains from the original introducer apparatus 10. It can serve as
an introducer for a wire guide 62 or other medical treatment device
and may be itself removed from the patient once access across the
stricture is gained, leaving the wire guide and/or other device(s)
in place. It should be noted that unlike procedures such as nasal,
colonic, and urethral access where it is advantageous or desired to
improve patient comfort during both ingress and egress of the
introducer apparatus 10, it may be less important in other medical
procedures, such as cannulation of certain internal sphincters and
strictures, to maintain the sleeve 13 in place during removal of
the inner member 15, the critical function of the sleeve 13 having
been already fulfilled.
[0083] Any other undisclosed or incidental details of the
construction or composition of the various elements of the
disclosed embodiment of the present invention 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 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.
* * * * *