U.S. patent application number 14/265787 was filed with the patent office on 2014-11-13 for systems and methods for transnasal dilation of passageways in the ear, nose or throat.
This patent application is currently assigned to Acclarent, Inc.. The applicant listed for this patent is Acclarent, Inc.. Invention is credited to John Y. Chang, William M. Facteau, Eric Goldfarb, Hung V. Ha, Isaac J. Kim, Sivette Lam, Ketan P. Muni.
Application Number | 20140336693 14/265787 |
Document ID | / |
Family ID | 39926056 |
Filed Date | 2014-11-13 |
United States Patent
Application |
20140336693 |
Kind Code |
A1 |
Goldfarb; Eric ; et
al. |
November 13, 2014 |
SYSTEMS AND METHODS FOR TRANSNASAL DILATION OF PASSAGEWAYS IN THE
EAR, NOSE OR THROAT
Abstract
Devices, systems and methods useable for dilating the ostia of
paranasal sinuses and/or other passageways within the ear, nose or
throat. A dilation catheter device and system is constructed in a
manner that facilitates ease of use by the operator and, in at
least some cases, allows the dilation procedure to be performed by
a single operator. Additionally, the dilation catheter device and
system may be useable in conjunction with an endoscope and/or a
fluoroscope to provide for easy manipulation and positioning of the
devices and real time visualization of the entire procedure or
selected portions thereof. In some embodiments, an optional handle
may be used to facilitate grasping or supporting a device of the
present invention as well as another device (e.g., an endoscope)
with a single hand.
Inventors: |
Goldfarb; Eric; (Belmont,
CA) ; Chang; John Y.; (Los Altos, CA) ;
Facteau; William M.; (Atherton, CA) ; Lam;
Sivette; (Milpitas, CA) ; Ha; Hung V.; (San
Jose, CA) ; Kim; Isaac J.; (San Jose, CA) ;
Muni; Ketan P.; (San Jose, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Acclarent, Inc. |
Menlo Park |
CA |
US |
|
|
Assignee: |
Acclarent, Inc.
Menlo Park
CA
|
Family ID: |
39926056 |
Appl. No.: |
14/265787 |
Filed: |
April 30, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11789704 |
Apr 24, 2007 |
8747389 |
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14265787 |
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11355512 |
Feb 16, 2006 |
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11789704 |
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11150847 |
Jun 10, 2005 |
7803150 |
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11355512 |
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10944270 |
Sep 17, 2004 |
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11150847 |
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10829917 |
Apr 21, 2004 |
7654997 |
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10944270 |
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Current U.S.
Class: |
606/196 |
Current CPC
Class: |
A61M 25/10 20130101;
A61M 25/1002 20130101; A61M 2025/0681 20130101; A61M 29/02
20130101; A61M 2210/0681 20130101; A61M 2025/0046 20130101; A61M
25/09 20130101; A61M 2210/0618 20130101; A61M 25/0662 20130101;
A61M 2025/1086 20130101; A61M 2029/025 20130101; A61M 2210/0618
20130101; A61M 25/0045 20130101; A61M 2230/005 20130101; A61M
25/0041 20130101 |
Class at
Publication: |
606/196 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1-118. (canceled)
119. A system comprising: (a) a guide catheter that is insertable
into the head of the subject, wherein the guide catheter comprises:
(i) a substantially rigid shaft, (ii) a proximal opening, (iii) a
distal opening, and (iv) a lumen extending between the proximal
opening and the distal opening; (b) a handle, wherein the handle is
configured to couple with the guide catheter; (c) a working
catheter, wherein the working catheter comprises: (i) a
substantially rigid proximal shaft portion, (ii) a flexible distal
shaft portion, and (iii) a guidewire lumen, wherein the working
catheter is insertable through the lumen of the guide catheter to a
position where some of the distal shaft portion but none of the
substantially rigid proximal portion extends out of the distal end
of the guide catheter and some of the substantially rigid proximal
shaft portion but none of the distal shaft portion extends out of
the proximal end of the guide catheter; (d) a guidewire that is
advanceable through the guidewire lumen; and (e) a first member
attached to the guidewire, wherein the first member is configured
to facilitate grasping of the guidewire, wherein the first member
is further configured to limit the extent to which the guidewire is
advanceable through the guidewire lumen.
120. The system of claim 119, wherein the working catheter
comprises dilation catheter and the working element comprises an
expandable dilator that is positionable within a passageway of the
ear, nose or throat and useable to dilate that passageway.
121. The system of claim 120, wherein the expandable dilator
comprises a balloon.
122. The system of claim 121, wherein the working catheter further
comprises: (i) a inflation fluid lumen configured to communicate
fluid to and from the balloon, (ii) a proximal hub having an
inflation port in communication with the inflation lumen, and (iii)
a guidewire port in communication with the guidewire lumen, wherein
the inflation port is substantially perpendicular to said guidewire
port.
123. The system of claim 122, wherein the guidewire port is on the
proximal end of the hub and the inflation port is on a side of the
hub.
124. The system of claim 119, wherein the expandable dilator is
sized to be positioned within the ostium of a paranasal sinus while
in a non-expanded state and to be thereafter expanded to an
expanded state whereby the expandable dilator is configured to
cause dilation of the ostium.
125. The system of claim 124, wherein the expandable dilator, when
in its expanded state, has a diameter in the range of approximately
2.5 mm to approximately 10 mm.
126. The system of claim 119, wherein the guidewire lumen has a
lubricious coating or liner disposed therein.
127. The system of claim 119, wherein the working catheter has an
overall length of about 21 cm, wherein the substantially rigid
proximal shaft portion of the working catheter is at least 12.5 cm
in length.
128. The system of claim 119, wherein the handle is sized and
configured to be grasped by a single hand of an operator.
129. The system of claim 119, further comprising a stabilization
device that is attachable to the guide catheter, wherein the
stabilization device is configured to facilitate control of the
guide catheter and an endoscope by a single hand of an
operator.
130. The system of claim 119, wherein at least a portion of the
handle is shapeable so that it may be deformed to a desired bend or
shape by the operator.
131. The system of claim 119, wherein the first member is
configured to frictionally engage a hub on the working
catheter.
132. The system of claim 119, wherein at least a distal portion of
the guide catheter is curved.
133. The system of claim 119, wherein the distal shaft portion of
the working catheter is configured to telescope out of the distal
end of the guide catheter.
134. The system of claim 119, further comprising a second member
that is attachable to the working catheter, wherein the second
member is configured to limit the extent to which the working
catheter is advanceable through the guide catheter.
135. The system of claim 119, wherein the handle defines a bore,
wherein a portion of the handle is insertable into the proximal
opening of the guide catheter such that the bore of the handle is
in alignment with the lumen of the guide catheter.
136. The system of claim 135, wherein the working catheter is
insertable through the bore of the handle.
137. A system comprising: (a) a guide catheter that is insertable
into the head of the subject, wherein the guide catheter defines a
working catheter lumen; (b) a working catheter, wherein the working
catheter defines a guidewire lumen, wherein the working catheter is
insertable through the working catheter lumen of the guide
catheter; (d) a guidewire that is advanceable through the guidewire
lumen of the working catheter; and (e) a stop member attached to
the guidewire, wherein the stop member is configured to facilitate
grasping of the guidewire, wherein the stop member is further
configured to limit the extent to which the guidewire is
advanceable through the guidewire lumen of the working
catheter.
138. A system comprising: (a) a guide catheter that is insertable
into the head of the subject, wherein the guide catheter defines a
working catheter lumen, wherein a proximal portion of the guide
catheter defines a longitudinal axis; (b) a handle, wherein the
handle is configured to couple with the guide catheter, wherein the
handle defines a bore, wherein the working catheter lumen of the
guide catheter is in alignment with the bore; (c) a working
catheter, wherein the working catheter defines a guidewire lumen,
wherein the working catheter is insertable through the working
catheter lumen of the guide catheter; (d) a guidewire that is
advanceable through the guidewire lumen; and (e) a member attached
to the guidewire, wherein the member is configured to facilitate
grasping of the guidewire.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/789,704, entitled "Systems for Treating
Disorders of the Ear, Nose and Throat," filed Apr. 24, 2007, now
U.S. Pat. No. 8,747,389, which is a continuation in part of
copending U.S. patent application Ser. No. 11/355,512, entitled
"Devices, Systems and Methods Useable for Treating Frontal
Sinusitis," filed Feb. 16, 2006, which is a is a continuation in
part of U.S. patent application Ser. No. 11/150,847, entitled
"Devices, Systems and Methods Useable for Treating Sinusitus,"
filed on Jun. 10, 2005, now U.S. Pat. No. 7,803,150, which is a
continuation in part of U.S. patent application Ser. No.
10/944,270, entitled "Apparatus and Methods for Dilating and
Modifying Ostia of Paranasal Sinuses and Other Intranasal or
Paranasal Structures," filed on Sep. 17, 2004, now abandoned, which
is a continuation in part of U.S. patent application Ser. No.
10/829,917, entitled "Devices, Systems and Methods for Diagnosing
and Treating Sinusitis and Other Disorders of the Ears, Nose and/or
Throat," filed on Apr. 21, 2004, now U.S. Pat. No. 7,654,997, the
entire disclosures of each such application being expressly
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices
and methods and particularly to balloon catheters other devices
that may be inserted through the nose and used to dilate the ostia
of paranasal sinuses for treatment of sinusitis.
BACKGROUND
[0003] The paranasal sinuses are hollow cavities in the skull
connected by small openings, known as ostia, to the nasal canal.
Normally, air passes into and out of the paranasal sinuses through
the ostia. Also, mucus is continually formed by the mucosal lining
of the sinus and drains through the ostia and into the nasal
canal.
[0004] Sinusitis is a general term that refers to inflammation in
one or more of the paranasal sinuses. Acute sinusitis can be
associated with upper respiratory infections or allergic conditions
which cause tissue swelling and temporarily impedes normal
trans-ostial drainage and ventilation of the sinuses, thereby
resulting in some collection of mucous and possibly infection
within the sinus cavities. Chronic sinusitis is a long term
condition characterized by persistent or long term narrowing or
blockage of the sinus ostia, resulting in chronic infection and
inflammation of the sinuses. Chronic sinusitis is often associated
with long standing respiratory allergies, nasal polyps,
hypertrophic nasal turbinates and/or deviated internasal septum.
While acute sinusitis is typically caused by infection with a
single pathogen (e.g., one type of bacteria, one type of virus, one
type of fungus, etc.), chronic sinusitis is often associated with
multiple pathogen infections (e.g., more than one type of bacteria
or more than genus of microorganism).
[0005] Chronic sinusitis, if left untreated, can result in
irreparable damage to the tissues and/or bony structures of the
paranasal anatomy. The initial treatment of chronic sinusitis
usually involves the use of drugs such as decongestants, steroid
nasal sprays and antibiotics (if the infection is bacterial). In
cases where drug treatment alone fails to provide permanent relief,
surgical intervention may be indicated.
[0006] Functional endoscopic sinus surgery (FESS) is commonly
performed use an endoscope and various rigid instruments inserted
through the patient's nostril. The endoscope is used to visualize
the positioning and use of the operative instruments to perform
tasks intended to improve sinus drainage, such as removal of
polyps, straightening of deviated septum and excision of mucous
membrane and bone to enlarge the narrow the sinus ostia or to
create new openings into the sinuses.
[0007] Recently technique known as the Balloon Sinuplasty.TM.
procedure has been developed by Acclarent, Inc. of Menlo Park,
Calif. for treatment of sinusitis. A number of copending U.S.
patent applications, including parent application Ser. Nos.
11/355,512, 11/150,874, 10/944,270 and Ser. No. 10/829,917,
describe various embodiments of the Balloon Sinuplasty.TM.
procedure as well as various devices useable in the performance of
such procedure. In the Balloon Sinuplasty.TM. procedure, a guide
catheter is inserted into the nose and positioned within or
adjacent to the ostium of the affected paranasal sinus. A guidewire
is then advanced through the guide catheter and into affected
paranasal sinus. Thereafter, a dilation catheter having an
expandable dilator (e.g., an inflatable balloon) is advanced over
the guidewire to a position where the dilator is positioned within
the ostium of the affected paranasal sinus. The dilator is then
expanded causing dilation of the ostium and remodeling of bone
adjacent to the ostium, without required incision of the mucosa or
removal of any bone. The catheters and guidewire are then removed
and the dilated ostium allows for improved drainage from and
ventilation of the affected paranasal sinus.
[0008] Parent application Ser. Nos. 11/355,512, 11/150,874,
10/944,270 and Ser. No. 10/829,917 also describe methods for
transnasal dilation of other passageways in the ear, nose and/or
throat, such as the Eustachian tube and nasolacrimal duct.
SUMMARY OF THE INVENTION
[0009] In accordance with the invention, there is provided a
dilation catheter device and system that is useable for dilating
the ostium of a paranasal sinus, or other passageway within the
ear, nose or throat. This dilation catheter device and system is
constructed in a manner that facilitates ease of use by the
operator and, in at least some cases, allows the dilation procedure
to be performed by a single operator, thereby minimizing the number
of personnel required for the procedure. Additionally, the dilation
catheter device and system of the present invention is useable in
conjunction with an endoscope and/or a fluoroscope to provide for
easy manipulation and positioning of the devices and real time
visualization of the entire procedure or selected portions thereof.
In some embodiments, an optional handle may be attached to the
dilation catheter or to a guide catheter through which the dilation
catheter is inserted and such handle may be graspable along with
another device (e.g., an endoscope) by a single hand. In this
manner, the operator may control the dilation catheter an another
device (e.g., an endoscope) with one hand while being free to use
his other hand for other purposes.
[0010] Further in accordance with the invention, there are provided
systems for treating a disease or disorder of the ear, nose or
throat of a human or animal subject. Such systems generally
comprise a guide catheter and a working catheter. The working
catheter is advanceable through the guide catheter. The guide
catheter has a substantially rigid shaft and the working catheter
has a proximal portion that is substantially rigid. The working
catheter also has a distal portion that is more flexible than the
substantially rigid proximal portion. The working catheter is sized
relative to the guide catheter so that, at least when the distal
portion of the working catheter is advanced out of a distal opening
of the guide catheter and the working element is being used to
perform a desired diagnostic or therapeutic task, only the
substantially rigid proximal portion (or some portion thereof will
extend out of the proximal opening of the guide catheter. In some
embodiments, the working catheter may additionally be sized
relative to the guide catheter so that the working catheter is
initially advanceable to a first position where its distal end of
the working catheter has not yet emerged out of the distal end of
the guide catheter but only the substantially rigid proximal
portion of the working catheter is protruding out of the proximal
end of the guide catheter.
[0011] Still further in accordance with the invention, there are
provided sinus ostium dilation catheter devices that generally
comprise an elongate catheter shaft having proximal shaft section
that is substantially rigid and a distal shaft section that is more
flexible than the proximal shaft section. In some embodiments, the
proximal shaft section may extend along at least about 50% of the
overall length of the device. A guidewire lumen extends through at
least a portion of the catheter shaft to facilitate advancement of
the catheter over a guidewire. A dilator is located on the distal
shaft section, such dilator having a non-expanded configuration and
an expanded configuration.
[0012] Still further in accordance with the present invention there
are provided methods for dilating the ostia of paranasal sinus and
other passageways within the ear, nose or throat of a human or
animal subject. In general, such methods comprise the steps of a)
inserting a guide catheter having a proximal end and a distal end
through one of the subject's nostrils and positioning the guide
catheter within or near the passageway to be dilated, b) inserting,
through the guide catheter, a dilation catheter comprising i) an
elongate catheter shaft having a proximal end, a distal end, a
proximal shaft section that is substantially rigid and a distal
shaft section that is more flexible than the proximal shaft
section, ii) a guidewire lumen extending through at least a portion
of the catheter shaft to facilitate advancement of the catheter
over a that is substantially rigid and a distal shaft section that
is more flexible than the proximal shaft section, ii) a guidewire
lumen extending through at least a portion of the catheter shaft to
facilitate advancement of the catheter over a guidewire and iii) a
dilator located on the distal shaft section, said dilator being in
a non-expanded configuration, c) positioning the dilator within the
passageway and d) causing the dilator to expand to an expanded
configuration, thereby dilating the passageway.
[0013] Still further embodiments, aspects, features and details of
the present invention will be understood upon reading of the
detailed description and examples set forth herebelow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a side view of one embodiment of a dilation
catheter of the present invention with its dilator in an expanded
configuration.
[0015] FIG. 1A is a cross sectional view through line 1A-1A of FIG.
1 with an enlarged break-out view of a portion thereof.
[0016] FIG. 1B is an enlarged side view of the dilator and distal
end of the dilation catheter of FIG. 1.
[0017] FIG. 2 shows a collection of transnasal guide catheters
useable as components of the system of the present invention.
[0018] FIG. 3 is a side view of one embodiment of a handle
apparatus of the present invention.
[0019] FIG. 3A is a side view of another embodiment of a handle
apparatus of the present invention.
[0020] FIG. 3B is a side view of yet another embodiment of a handle
apparatus of the present invention.
[0021] FIG. 3C is a side view of yet another embodiment of a handle
apparatus of the present invention.
[0022] FIG. 4 is an exploded, partial view of one embodiment of a
dilation catheter system of the present invention including an
optional handle apparatus.
[0023] FIG. 5 is a schematic diagram of one embodiment of a
dilation catheter system of the present invention (without the
optional handle apparatus) being used to dilate the ostium of a
paranasal sinus.
[0024] FIG. 6 is a schematic diagram of one embodiment of a
dilation catheter system of the present invention (with the
optional handle apparatus) being used to dilate the ostium of a
paranasal sinus.
[0025] FIG. 7A shows a partial view of the system of FIG. 5
including a guidewire stop/connector apparatus of the present
invention mounted on the guidewire prior to advancement of the
guidewire.
[0026] FIG. 7B shows a partial view of the system of FIG. 5
including a guidewire stop/connector apparatus of the present
invention mounted on the guidewire and engaged with the hub of the
dilation catheter following advancement of the guidewire.
[0027] FIG. 8A shows the dilation catheter system of FIG. 5 and an
endoscope being held by one hand of the operator while the
operator's other hand is being used to advance the guidewire of the
system into a paranasal sinus.
[0028] FIG. 8B shows the dilation catheter system of FIG. 6 and an
endoscope being held by one hand of the operator while the
operator's other hand is being used to advance the dilation
catheter so that its dilator becomes positioned within the ostium
of the paranasal sinus.
[0029] FIG. 9 is a flow diagram showing steps in one method for
using a dilation catheter system of the present invention.
[0030] FIG. 10 is a flow diagram showing steps in another method
for using a dilation catheter system of the present invention.
[0031] FIG. 11 is a flow diagram showing steps in yet another
method for using a dilation catheter system of the present
invention.
DETAILED DESCRIPTION
[0032] The following detailed description and the accompanying
drawings are provided for the purpose of describing some, but not
necessarily all, examples or embodiments of the invention. The
contents of this detailed description and the accompanying drawings
are exemplary in nature and do not limit the scope of the invention
in any way.
[0033] A Dilation Catheter of the Present Invention
[0034] FIGS. 1-1B show one example of a dilation catheter device 10
of the present invention with a guidewire GW operatively inserted
therethrough. In this example, the dilation catheter device 10
comprises an elongate catheter shaft 12 having a proximal shaft
section 12prox that is substantially rigid and a distal shaft
section 12.sub.dist that is more flexible than the proximal shaft
section 12.sub.prox. An expandable dilator, such as a balloon 14 or
other suitable mechanical or non-inflational dilator, is mounted on
the distal shaft section 12.sub.dist and a distal tip member 18
protrudes beyond the distal end of the balloon 14, as shown. Also,
a proximal T hub 16 is attached to the proximal end of the proximal
shaft section 12.sub.prox. This proximal T hub 16 has a proximal
Luer connector 20 and a side arm 22 having a female Luer connector
that extends substantially perpendicular to the longitudinal axis
of the hub 16, as shown. When compared to a typical Y hub, the side
arm 22 of this T hub is further away from the proximal Luer
connector 20 and is oriented at a right angle to the proximal Luer
connector 20. Thus, tubing connected to this perpendicular side arm
22 is less likely to obscure or block the proximal Luer connector
20 than in a typical Y hub and the operator is less likely to
confuse the proximal Luer connector 20 with the Luer connector on
the side arm 22.
[0035] Although, in the particular example shown in the drawings,
the expandable dilator comprises a balloon 14, it is to be
appreciated that various other types of expandable dilators such as
expandable cages, struts and other expandable mechanical assemblies
may be used as an alternative to a balloon 14. Some non-limiting
examples of expandable dilators other than balloons have previously
been described in parent U.S. patent application Ser. Nos.
11/355,512, 11/150,874, 10/944,270 and Ser. No. 10/829,917, which
are expressly incorporated herein by reference.
[0036] For use in teenage or adult humans, the overall length of
the catheter shaft 12 may be in the range of about 15 cm to about
25 cm, the proximal shaft section 12.sub.prox may have a length in
the range of about 10 cm to about 15 cm and the distal shaft
section 12.sub.dist may have a length in the range of about 5 cm to
about 10 cm. In the particular example shown in the drawings and
described herein, the catheter shaft 12 has an overall length of
21.2 cm, the proximal shaft section 12.sub.prox being 12.5 cm in
length and the distal shaft section 12.sub.dist being 8.7 cm in
length. These optimal lengths of the proximal shaft section
12.sub.prox and distal shaft section 12.sub.dist have been arrived
at based on a number of considerations, which will be discussed
more fully herebelow in relation to the concurrent use of this
dilation catheter 10 with a trans-nasal guide catheter.
[0037] As may be appreciated from the cross sectional view of FIG.
1A, the proximal shaft section 12.sub.prox comprises a rigid outer
tube 30 a flexible middle tube 32 disposed substantially coaxially
within the lumen of the rigid outer tube 30 and an inner tube 36
disposed substantially coaxially within the lumen of the middle
tube 32. In this particular example, the outer tube 30 is formed of
stainless steel hypotube having an outer diameter of 0.076 inches
and an inner diameter of 0.068 inches. As an alternative to
stainless steel hypotube, this outer tube 30 may be formed of rigid
non-metallic material such as polyetheretherketone (PEEK) or other
rigid plastics suitable for such application. Alternatively, other
rigid reinforcing members may be used in, or in lieu of, the outer
tube, such as wires (round, flat, square or of other cross
section), partial tubes (e.g., arcs), etc. Also, in this particular
example, the middle tube 32 is formed of Pebax having an inner
diameter of 0.055 inches, an outer diameter of 0.065.+-.0.003
inches. The inner tube 36 is formed of polyether block copolymer
tubing (e.g., Pebax.RTM. Resin, Arkema, Inc., Philadelphia, Pa.)
having an inner diameter of 0.038 inches, an outer diameter of
0.048 inches.
[0038] The outer tube 30 terminates at the end of the proximal
shaft section 12.sub.prox. The middle tube 32 and inner tube 36
extend beyond the distal end of the outer tube 30, forming the
distal shaft section 12.sub.dist.
[0039] As seen in the enlarged break-out segment of FIG. 1A, a
polyether block copolymer film laminate 31 (e.g., Pebax.RTM. Resin,
Arkema, Inc., Philadelphia, Pa.) is heat shrunk onto the outer
surface of the catheter shaft 12 from the proximal hub 16 to the
balloon 14. This laminate 31 provides a smooth outer surface and
smoothes the step-down in diameter from the distal end of the
proximal shaft section 12.sub.prox to the proximal end of the
distal shaft section 12.sub.dist (i.e., it provides a smooth
surface over the distal end of the outer tube 30 and the adjacent
outer surface of the middle tube 32). The smooth step down may also
be formed by an adhesive fillet. In other embodiments, the smooth
step down may be formed by tapering or chamfering the structure of
the distal end of the proximal shaft, eliminating the need for a
laminate or adhesive.
[0040] The proximal end of the middle tube 32 extends into and is
secured to the hub 16, distal to side arm Luer connector 22. The
proximal end of the inner tube 36 extends into and is secured
within hub 16, proximal to the side arm Luer connector 22 and in
direct alignment and fluid communication with proximal Luer
connector 20. The distal end of the middle tube 32 terminates
within the balloon 14 and the proximal end of the dilator is
secured to the outer surface of the middle tube. The distal end of
the inner tube 36 also extends through the balloon 14 and protrudes
distally beyond the balloon 14, forming the relatively flexible
distal tip member 18 as shown in FIG. 1. The distal end of the
balloon 14 is secured to the outer surface of the inner tube 36. In
this manner, the inner tube lumen 38 extends through the entire
catheter shaft 12 from the proximal Luer connector 20 through the
distal tip 18 and may be used a guidewire lumen or as a working
lumen for infusion of irrigation solution, medicaments, contrast
media or other substances and/or for aspiration of blood, fluids or
debris. Guidewires that may be advantageously used in conjunction
with this dilation catheter 10 may have a length of 60 cm to 80 cm
and may be either 0.014 inch or 0.035 inch, such as those
commercially available as the Relieva.RTM. Sinus Guidewires
(Acclarent, Inc., Menlo Park, Calif.) or sizes in between such as
0.018 inch, 0.020 inch, or 0.033 inch. Although the drawings show
an over-the-wire catheter having a guidewire lumen that extends
through the entire length of the catheter, it is to be appreciated
that guidewire lumens extending less than the entire length of the
catheter (e.g., rapid exchange guidewire lumens) may be used as an
alternative to the over-the-wire lumen shown. Additionally, in some
embodiments, rather than advancing the catheter over a guidewire,
the catheter may be equitted with a fixed guidewire tip such as any
of those described in U.S. patent application Ser. No. 11/438,090
entitled Catheters with Non-Removable Guide Members Useable for
Treatment of Sinusitis, the entire disclosure of which is expressly
incorporated herein by reference.
[0041] The inner tube lumen 38 may be lined or coated with a
lubricious material to facilitate passages of the guidewire GW
through that lumen 38. The diameter of the inner tube 36 may be
changed to accommodate guidewires of different diameter. In the
particular embodiment described, the inner tube lumen 38 is sized
to receive a 0.035 inch diameter guidewire GW. The inner tube lumen
38 may be internally lined or coated with a 2% solution of linear
polydimethylsiloxane (PDMS) (e.g., Dow Corning.RTM. 360 Medical
Fluid, Dow Corning Corporation, Midland, Mich.) diluted in
isopropyl alcohol or another silicone material (such as a 2%
solution of Dow-Corning MDX4-4159 in isopropyl alcohol). The
coating is cured at room temperature.
[0042] The luminal space 34 between the outer surface of the inner
tube 36 and the inner surface of the middle tube 32 is in fluidic
communication with the side arm Luer connector 22 and extends to
the interior of the balloon 14. Thus, this luminal space 34 serves
as the passageway through which inflation fluid is passes into and
out of the balloon 14. The size of this luminal space 34 and the
relatively short length of the catheter shaft 12 are optimized to
minimize drag on inflation fluid passing through this luminal space
34 and allows for rapid deflation of the balloon 14. The clearance
of 0.006 to 0.007 inches between the inner and outer member is
desired for catheter length of 20-35 cm. The desired deflation time
is 5-10 seconds and the deflation time is measured with application
of negative pressure on the inflation/deflation lumen using a 20 cc
inflation device that is filled with 10 cc contrast/saline
mixture.
[0043] Balloon Construction and Coating
[0044] FIG. 1B shows details of the balloon 14. In this example,
the balloon 14 is a non-compliant balloon formed of polyethylene
teraphthalate (PET) film having a thickness of 0.8 mils. The
balloon 14 has a cylindrical midregion 44 and tapered proximal and
distal end regions 46.sub.prox and 46.sub.dist. The balloon 14 has
an overall length of 2.6 cm. The cylindrical midregion 44 of the
balloon 14 has a length of 16 mm (i.e., the "working length") and
each tapered end region 46.sub.prox, 46.sub.dist has a length of 5
mm. The balloon 44 has a burst pressure of at least 14 to
16_atmospheres. The outer diameter of the balloon 14, when inflated
to a pressure of 14 atmospheres, may be in the range of 5.0 mm to
5.5 mm. In this particular example, the balloon 14 is sized for
dilation of the ostia of paranasal sinuses and such balloon 14 is
offered in sizes having outer diameters of 5 mm or 7 mm when
inflated to a pressure of 14 atmospheres. Dilation catheters 10
having the 5 mm diameter balloon 14 may be more suitable for use in
subjects of small body size while dilation catheters 10 having the
7 mm diameter balloon 14 may be more suitable for use in subjects
having a large body size. Smaller or larger balloons may be used
for dilating structures other than the ostia of paranasal sinuses
(e.g., Eustachian tube or naso-lacrimal duct dilations). Larger
balloons and higher pressures may be used for dilating revision
patients (i.e., patients who have had prior ostial dilations or
who's ostia have been previously modified by surgery).
[0045] The tapered end regions 46.sub.prox, 46.sub.dist are tapered
at angle A relative to the longitudinal axis LA of the catheter
shaft 12 on which the balloon 14 is mounted. This angle of taper A
may be in the range of about 10 degrees to about 30 degrees. In the
particular example shown in the drawings, such angle of taper A is
20 degrees. This 20 degree angle of taper provides improved
transition from balloon working length to the necks, lower profile,
improved crossing, improved track, easier withdrawal in the sinus
guide after balloon inflation. It also provides optimal performance
with minimum increase of overall balloon length.
[0046] In some embodiments, it may be desirable for the relatively
stiff proximal shaft portion 12.sub.prox to extend all the way to
or near the proximal end of the balloon 14 or other dilator. Such
catheter having a rigid shaft from its proximal end to or near the
dilator may be advanced directly into the sphenoid sinus ostium
with or without the use of a guide catheter. In some embodiments,
the proximal end of the balloon 14 could be bonded to the
relatively rigid proximal shaft portion 12prox. Such a construction
would allow the flexible distal tip 18 to track turns in the
anatomy and may be useable to dilate certain passageways (e.g., the
sphenoid sinus ostium) without disrupting the normal anatomy.
Additionally, embodiments with relatively short distal shaft
sections (e.g., 1-2 cm beyond the distal end of the rigid proximal
shaft portion are particularly suitable for dilating the ostia of
frontal sinuses. Also, in some embodiments, the proximal shaft
section 12prox may be malleable so that it may be shaped (e.g.,
bent or formed to a desire curve or multi-curvate shape) to
facilitate access to any desired passageways or locations.
[0047] Dilation Catheter/Guide Catheter System
[0048] FIG. 2 shows a series of sinus guide catheters 40a-40f that
may be used in conjunction with the dilation catheter 10. These
guide catheters 40a-40f are substantially rigid and each has a
preset distal curve of 0 degrees (40a), 30 degrees (40b), 90
degrees (40d), 70 degrees (40c) or 110 degrees (40e and 40f).
Different curvatures are useable to access the ostia of different
sinuses. For example, a 70 degree guide is typically used to access
the ostium of a frontal sinus, a 90 or 110 degree guide is
typically used to access the ostium of a maxillary sinus, etc. Each
of these guide catheters 40a-40f has a length of 12.7 cm. These
sinus guide catheters are described in parent U.S. patent
application Ser. Nos. and are now commercially available as
Relieva.RTM. sinus guide catheters from Acclarent, Inc., Menlo
Park, Calif.
[0049] FIG. 5 shows a system comprising a guide catheter 40c having
a 90 degree curve formed therein in combination with a dilation
catheter 10 shown in FIG. 1. In optimizing the relative lengths of
the proximal shaft section 12.sub.prox and distal shaft section
12.sub.dist, applicants have determined that, even the maximum
distance that the distal end of the dilation catheter of this
example is required travel beyond the distal end of the guide
catheter 40a-40c is approximately 2.5 cm. However, it will be
appreciated that this is just one example. For other application,
travel beyond 2.5 cm may be desirable or necessary. Also, it is
desirable for the entirety of the more flexible distal shaft
section 12.sub.dist to be advanceable into the guide catheter
40a-40f proximal to any curve formed in the guide catheter. With
these objectives in mind, the example of the dilation catheter 10
shown in the drawings has a shaft that is about 20 cm in length,
with the proximal shaft section 12.sub.prox being 11.3 cm in length
and the distal shaft section 12.sub.dist being 8.7 cm in length.
Thus, prior to or during the procedure, the entire distal shaft
section 12.sub.dist of the dilation catheter 10 may be initially
advanced into the rigid guide catheter 40c without the distal
portion of the dilation catheter 10 passing through the curve of
the guide catheter 40c and with only a portion of the rigid
proximal shaft section 12.sub.prox of the dilation catheter 10
protruding out of the proximal end of the guide catheter 40c. To
facilitate such positioning of the dilation catheter 10 within the
guide catheter 40d, a first shaft marker 26 is provided on the
proximal shaft section 12.sub.prox of the dilation catheter shaft
12. The distal edge of this first shaft marker 26 is 2.7 cm
proximal to the distal end of the proximal shaft section
12.sub.prox and 11.4 cm from the distal end of the distal tip
member 18. If the operator advances the dilation catheter 10 into
the guide catheter 40c until the distal edge of the first shaft
marker 26 is flush with the proximal end of the guide catheter 40c,
the entire distal shaft portion 12dist as well as the distal-most 3
cm of the proximal shaft portion 12.sub.prox will be housed within
the guide catheter 40c such that the distal end of the dilation
catheter 10 is located proximal to the curve formed near the distal
end of the guide catheter 40c. Such positioning of the dilation
catheter 10 within the guide catheter 40c provides a guide
catheter/dilation catheter assembly that is substantially rigid
from the proximal hub 16 of the dilation catheter 10 to the distal
end of the guide catheter 40c. As a result, the operator may hold
or support the entire assembly by grasping or supporting just one
location on either the dilation catheter 10 or guide catheter 40d.
For example, the user may hold or support the entire assembly by
using his fingers to grasp or support either the proximal hub of
the guide catheter 40c, the proximal hub 16 of the dilation
catheter 10 or somewhere on the proximal shaft section 12.sub.prox
of the dilation catheter or on the shaft of the guide catheter 40c.
Such rigidity also substantially eliminates the potential for the
exteriorized portion of the dilation catheter 10 to droop down onto
the subject's chest or onto the adjacent operating table.
[0050] As explained above, in this example, the rigid proximal
shaft segment 12.sub.prox of the dilation catheter 10 is 11.3 cm in
length and the guide catheter 40d is 12.7 cm in length. Thus, when
inserted into the subject's body, the overall length of the portion
of the system that remains exteriorized (e.g., the proximal part of
the guide catheter 10 extending out of the subject's nose and the
proximal part of the dilation catheter 10 extending out of the
proximal end of the guide catheter 40c) is not only rigid, but
sufficiently short (e.g., typically less than 9 cm) to be easily
manageable and capable of being held or supported by a single hand
of the operator, thereby allowing the operator's other hand to be
used for other purposes, such as for advancing/retracting the
guidewire GW or advancing/retracting the dilation catheter 10 in
the manner described herebelow in connection with FIGS. 9-11.
[0051] The second shaft marker 24 correlates to the position of the
balloon. If the dilation catheter 10 is advanced to a position
where the distal edge of the second shaft marker 24 is flush with
the proximal end of the guide catheter 10, the distal tip of the
balloon catheter will be flush with the distal tip of the guide
catheter 40d. When the proximal edge of the second shaft marker 24
is flush with the proximal end of the guide catheter 10, the entire
balloon 14 will have advanced out of the distal end of the guide
catheter 40d and the operator will know that it is safe to inflate
the balloon. Typically, as seen in FIG. 5, the balloon 14 is
advanced some distance out of the distal end of the guide catheter
40d until the balloon 14 is positioned within the sinus ostium SO
or other passageway to be dilated. As seen in the enlarged view of
the balloon 14 shown in FIG. 1B, proximal and distal radiographic
markers 40, 42 are provided on the catheter at either end of the
cylindrical segment 44 of the balloon. A C arm fluoroscope may be
positioned and used to image those proximal and distal markers 40,
42 as well as the sinus ostium SO and the position of the dilation
catheter 10 may be adjusted as needed until the sinus ostium SO is
midway between the proximal and distal radiographic markers 40, 42.
Thereafter, an inflator 50 attached to the side arm Luer connector
22 may be used to inflate the balloon 14, thereby dilating the
sinus ostium SO as shown in FIG. 5. In keeping with the operator's
ability to use a single hand to hold or support the exteriorized
portion of the system, the inflator 50 may be attached to the side
arm Luer connector 22 in advance and may be controlled by a foot
pedal which is actuated by the operator's foot.
[0052] In some applications of the system shown in FIG. 5, an
endoscope may be placed in the nose and used to view all or part of
the procedure. Because the exteriorized portion of the system is
substantially rigid and is typically less than 15 cm in length, the
operator may use a single hand to hold the endoscope as well as the
dilation catheter/guide catheter system. Alternatively, a scope
holder may be used to hold the endoscope in a fixed position while
the operator positions and uses the system seen in FIG. 5.
Alternatively, an optional handle may be used as shown in FIGS.
3-4, 6 and 8A-8B and described below.
[0053] Optionally, a member 61 may be attached to the guidewire.
Such member may serve to prevent the dilation catheter 10 and/or
guide catheter 40a-40f from inadvertently sliding off of the
proximal end of the guidewire. Also, such member 61 may limit the
length of guidewire GW that may be advanced through the dilation
catheter 10. This will prevent the operator from advancing too much
of the guidewire GW into the subject's sinus, as may injure or
damage the mucosa lining the sinus cavity. In some embodiments,
this member 61 may be a standard guidewire torquer of the type
commercially available an well known in the fields of
interventional cardiology and/or radiology. One example of a
commercially available guidewire torquer that is useable in this
application is a two part torquer available as Part No. 97333 from
Qosina, Corp., Edgewood, N.Y.
[0054] Alternatively, the member 61 may comprise a guidewire
stop/connector apparatus 61a as shown in FIGS. 7A-7B. This
stop/connector apparatus 61a comprises a rigid plastic body 63
having a lumen extending therethrough and a tapered elastomeric
tube member 65 on its distal end. The stop/connector apparatus 61a
is advanced over the guidewire GW to the desired location. The
inner diameter of the tapered elastomeric tube member 65 fits
snuggly on the guidewire thereby holding the stop/connector
apparatus 61a as seen in FIG. 7A. The guidewire GW is subsequently
advanced through the dilation catheter 10 until the tapered
elastomeric tube member 65 is received within and frictionally
engages the proximal female Luer connector 20 on the hub of the
dilation catheter, as shown in FIG. 7B. This limits advancement of
the guidewire GW and also frictionally locks the guidewire GW to
the dilation catheter 10 so that the operator may move both the
guidewire GW and the dilation catheter 10 as a unit. If the
operator decides to advance more of the guidewire into the sinus,
the operator may grasp and move the stop/connector apparatus 61a by
applying sufficient force to overcome the frictional engagement
between the stop/connector apparatus 61a and the guidewire GW
and/or between the stop/connector apparatus 61a and the guide
catheter hub. The force required to overcome such frictional
engagements will preferably be greater than the forces that would
normally result form routine movement and use of the system,
thereby allowing the stop/connector apparatus 61a to perform its
locking function while still allowing the location of the
stop/connector apparatus 61a to be volitionally adjusted by the
operator when necessary.
[0055] Alternatively or additionally, if desired, another
stop/connector apparatus 61a of larger size (or another suitable
locking apparatus such as a Touhy-Borst valve) may be mounted on
the rigid proximal shaft section 21prox of the dilation catheter 10
and received within the proximal end of the guide catheter 40a-f to
limit the advancement of the dilation catheter 10 through the guide
catheter 40a-f and to frictionally lock the dilation catheter 10 to
the guide catheter 40a-f in the same manner.
[0056] Dilation Catheter/Guide Catheter System with Optional
Handle
[0057] FIG. 3 shows an optional handle 42 that may be attached to
the guide catheter 40a-40d to facilitate single-handed holding of
the guide catheter/dilation catheter system as well as an endoscope
(or other device). The handle shown in FIG. 3 comprises a rigid
head 44 having a male Luer 10 fitting on one end, a lumen 47
extending therethrough and a handle member 48 extending therefrom.
As seen in the exploded view of FIG. 4, the male Luer fitting 46
may be inserted into the proximal end of the guide catheter 40c and
the guidewire GW and guide catheter 10 may then be inserted through
the lumen 47 of the handle head 44 and through the guide catheter.
The handle head 44 may be clear or transparent so that the operator
may view the shaft markers 24, 26 on the dilation catheter shaft 12
as the dilation catheter 10 is advanced through the handle head 44.
Alternatively, the locations of the shaft markers 24, 26 may be
adjusted on the catheter shaft 12 to take into account the
additional guide length added by the handle head 44. The handle
member 48 is preferably about the size of a standard ink pen and
may be conveniently grasped by a human hand. The handle member 48
may have a roughened or elastomeric surface to facilitate gripping
by a gloved hand and to deter slippage of the handle from the
operator's grip. The handle member 48 may be shapeable (e.g.,
malleable or bendable) to allow the operator to adjust the shape
and/or angle of the handle relative to the shaft of the guide
catheter 40c. In some embodiments, the handle member 48 may be
pre-shaped to accommodate a typical user and allow fine tuning by
individual user. Also, in some embodiments, the handle member 48
may have foam or other material on its surface to facilitate grip.
The handle member 48 may have various different cross sectional
profiles (e.g., round, oval, 3 sided, 4 sided, 5 sided, 6 sided,
etc.) The handle 48 serves to facilitate grip and control to
manipulate the dilation catheter along with a separate device
(e.g., an endoscope or other tool) without having to use second
hand. In this manner, the user may adjust rotation of a guide
catheter while observing under endoscope (all with one hand) and
use other hand to advance and place the guidewire or other device.
Also, in some embodiments, the handle member 48 may include finger
loop(s) for easier to translate handle/device attached up/down
relative to other device held (e.g. scope) without need for other
hand to adjust. Also, in some embodiments, a pinch valve or hole
can be strategically placed in handle 48 to actuate/allow control
of suction or fluid delivery via handle device (e.g., the user may
pinch the handle with fingers to restrict flow through handle) or
the handle 48 may have a suction hole where the user must cover the
suction hole to actuate suction through the optional handle 42.
[0058] Alternative embodiments of the handle are shown in FIGS. 3A,
3B and 3C. FIG. 3A shows a handle 42a which is similar to that seen
in FIG. 3, but wherein a fluid channel 52 extends from the lumen 47
downwardly through the head 44a and through the handle member 48a.
A one way valve 50 is disposed within the lumen 47, proximal to the
location where the fluid channel 52 meets the lumen 47. An
irrigation and/or suction tube 54 may be attached to the handle
member 48a to infuse fluid through or suction fluid and debris
through the fluid channel 52. The one way valve will ensure that
fluid infused or aspirated through the fluid channel 52 of the
handle 42a will not escape out of the proximal opening of the lumen
47. However, this one way valve 50 does allow the guidewire GW and
dilation catheter 10 to be inserted through the lumen 47, when
desired. The one way valve may provide the additional benefit of
maintaining the position of the guidewire or dilatation catheter
when it is inserted in the guide handle. It will be appreciated
that other types of valves other than a one-way valve may be used
as an alternative (e.g., Touhy rotating type valve, slide to
compress valve, etc.) Or, some embodiments may have just a valve
and a thumb/finger hole to control the suction force as described
above.]
[0059] FIG. 3B shows another embodiment of an optional handle 42b
comprising a clear or transparent rigid head 44b having a male Luer
fitting 46b on one end and a lumen 47 extending therethrough. In
this embodiment, the handle member 48b is formed of a series or
pivotally interconnected units 56 which allows the handle member
48b to be conveniently formed into various shapes as desired by the
operator.
[0060] FIG. 3C shows yet another handle 42c comprising a malleable
or rigid handle 48c that is substantially the same as that shown in
FIG. 3, but wherein a clip 58 is provided at the top end of the
handle member 48c to clip the handle member 48c onto the shaft of
the guide catheter 40c rather than inserting into the proximal end
of the guide catheter.
[0061] FIG. 6 shows the system of FIG. 5 with the inclusion of the
optional handle 42 on the proximal end of the guide catheter 40c.
FIGS. 8A and 8B show examples of how a handle 42 may be used to
facilitate concurrent holding of an endoscope as well as the guide
catheter (or guide catheter/dilation catheter assembly) by a single
hand (i.e., the "scope hand") of the operator. With reference to
FIGS. 5 and 8A-8B, the handle head 44 may initially be loosely
inserted into the proximal hub of the guide catheter 40c. The
camera 62 and light cable 66 are attached to the endoscope 60.
While grasping the endoscope 60 in the manner shown in FIG. 8A, the
operator may rotate the handle 42 relative to the guide catheter
40c to introduce the handle member 48 to the operator's scope hand.
Alternatively, the handle member 48 could be grasped by the
operator's scope hand along with the endoscope 60 upon initial
introduction. When positioning of the endoscope 60 and guide
catheter 40c have been achieved, the operator's other hand is used
to push the male Luer fitting 46 of the handle 42 firmly into the
female Luer fitting on the proximal end of the guide catheter 40c,
thereby locking the handle 42 to the guide catheter 40c.
Thereafter, the operator's other hand is used to manipulate the
guidewire GW and dilation catheter 10. In this manner, the operator
may maintain continuous endoscopic visualization via the endoscope
60 while using the guidewire GW and dilation catheter to dilate the
ostium of a paranasal sinus or other passageway within the ear,
nose or throat. As explained in more detail below, positioning of
the guidewire GW and/or balloon 14 (or other dilator) may be
confirmed using fluoroscopy, trans-illumination or other techniques
in addition to visualization via the endoscope 60. The guide handle
42 may also be used to allow the operator to hold or support the
guide catheter 40c (or the entire guide catheter/dilation catheter
system) while keeping his hand a spaced distance away from the
guide catheter shaft so as to avoid radiation exposure to his hand
during use of the fluoroscope.
[0062] In embodiments where the handle member 48 is shapeable
(e.g., malleable or bendable) the shape of the handle member 48 may
be modified one or more times prior to or during the procedure to
facilitate comfortable grasping of the handle by the operator's
scope hand and/or to adjust the position or angle of the endoscope
relative to the guide catheter. In this regard, in FIG. 8A, the
handle member 48 is bent to a shape that results in a first angle A
between the shaft of the guide catheter 40c and the endoscope 60,
and the operator's other hand is being used to advance the
guidewire GW through the lumen of the dilation catheter 10. In FIG.
8A, the handle has been modified to a different shape that results
in a lesser angle A between the shaft of the guide catheter 40c and
the endoscope 60, and the operator's other hand is being used to
advance the dilation catheter 10 through the lumen of the guide
catheter 40c.
[0063] The optional handle 42 may also be useful with other
dilation catheters and other trans-nasal devices described in any
or all of the parent applications of which this application is a
continuation-in-part and/or those currently available commercially
under the trademark Relieva from Acclarent, Inc., Menlo Park,
Calif.
[0064] In some applications, the handle 42 may be designed to
connect by way of a unique or proprietary connector to the guide
catheter or other device. Or, in some embodiments, the handle 42
may be pre-attached, integrally formed with or otherwise designed
as a part or portion of the guide catheter or other device. In
embodiments where the handle 42 is not detachable from the guide
catheter or other device, it may nonetheless be rotatable and/or
lockable in a desire position
[0065] Endoscopically Visible Markers and Anti-Glare Coatings
[0066] An additional visible marker 19 may optionally be formed on
the proximal end of the balloon 14 and/or on the distal shaft
portion 12.sub.dist, such as at the location where the proximal end
of the balloon 14 is bonded to the distal shaft portion
12.sub.dist.
[0067] These visible markers 19, 24, 26 are preferably of a color
(e.g., black or blue) that contrasts with the pink color of the
nasal mucosa so as to be easily visible within the nose. The
optional marker 19 on the proximal end of the a balloon 14 allows
the operator to endoscopically view the proximal end of the balloon
even when the remainder of the balloon is within the ostium of a
paranasal sinus. The other visible markers 24, 26 formed on the
proximal shaft are specifically designed for use in conjunction
with a guide catheter as will be discussed in detail herebelow.
[0068] In some cases, endoscopic images obtained of the markers or
other portions of the guidewires GW, guide catheter 40a-40f or
dilation catheter 10 may have areas of glare which can obscure
visualization of certain portions of the markers or devices during
performance of the procedure. To minimize such glare, an anti-glare
(e.g., anti-reflective) treatment or coating may be applied to all
or part of the sinus guide catheter 40a-40f, sinus guidewire GW
and/or dilation catheter 10. Such anti-glare treatment could be
applied by etching or sand-blasting and therefore does not add
profile to the device. Such anti-glare coating could be applied by
dip or spray coating and is very thin. The treatment or coating
does not change the mechanical or functional properties of these
devices. It may be selectively applied. For example, a black
polytetrafluoroethylene (PTFE) coating on the sinus guidewire GW
may provide good anti-reflective characteristics. Some of the
commercially available anti-glare or anti-reflective coating can be
applied. In some embodiments, an anti-glare surface treatment
(e.g., roughening, etching, etc.) may be used or an anti-glare
component such as a sheath, ring, paint, etc. may be used.
[0069] The advantages and benefits of including visible markers
and/or the anti-glare coating include, improved endoscopic
visualization, safer and easier performance of the procedure,
reduced balloon burst or damage to critical structures, accuracy of
placement of devices and reduced fluoroscopy time or elimination of
fluoroscopy.
[0070] Modes of Use of the System
[0071] FIGS. 9-11 are flow diagrams describing three (3) modes of
use by which the system of the present invention may be used to
dilate the ostium of a paranasal sinus.
[0072] Mode 1--Inserting Guide Catheter, Guidewire and Dilation
Catheter Separately
[0073] In the example of FIG. 9, the dilation catheter 10 is
prepared for use separately from the guide catheter 40a-40f. The
guide catheter 40a-40f is initially inserted (along with an
endoscope 60) and is advanced to a position that is within or near
the ostium to be dilated. An endoscope 60 is used to view the
advancement and positioning of the guide catheter 40a-40f and
fluoroscopy may also be used to verify that the guide catheter is
properly positioned near or within the ostium. Optionally, a handle
42 may be attached to the guide catheter 40a-40f as described above
or the operator may simply grasp the guide catheter 40a-40f as well
as the endoscope 60 with the scope hand, thus leaving the
operator's other hand free to be used for subsequent handling and
manipulation of the other devices used in this procedure.
Alternatively, a scope holder or assistant may be used to hold the
endoscope 60 in the desired position thus freeing both of the
operator's hands for handling and manipulation of the other
devices.
[0074] After the guide catheter 40a-40f has been positioned, the
operator will insert the distal end of the guidewire into the
proximal end of the guide catheter 40a-40d and will advance the
guidewire GW through the guide catheter 40a-40d such that a distal
portion of the guidewire GW passes through the sinus ostium and
becomes coiled within the sinus cavity. Fluoroscopy (or any other
suitable technique) may be used to verify that the guidewire has
become coiled within the intended sinus cavity.
[0075] Thereafter, the proximal end of the guidewire GW is inserted
into the distal end of the dilation catheter 10 and the dilation
catheter 10 (with its balloon 14 or other dilator in its
non-expanded state) is advanced over the guidewire and through the
guide catheter 40a-40d to a position where the dilator 14 is
positioned within the sinus ostium. The endoscope 60 may be used to
view the advancement and positioning of the dilation catheter 10.
Although the distal portion of the balloon 14 or other dilator will
be within the sinus and out of the field of view of the endoscope
60, the endoscope 60 may be used to view the proximal end of the
balloon 14 or other dilator and/or the optional marker 19 (if
present) on the proximal end of the balloon 14 or other dilator.
Fluoroscopy may be used to image the radiographic markers 40, 42
and the ostium to confirm that the mid-region 44 of the balloon 14
(or the appropriate portion of any other type of dilator) is
positioned within the ostium.
[0076] After the balloon 14 or other dilator has been positioned
within the ostium, the balloon is inflated (or the other dilator is
expanded) thereby dilating the ostium.
[0077] The balloon is then deflated (or the dilator is returned to
its non-expanded state) and the successful dilation of the ostium
may be confirmed visually using the endoscope 60 and/or
radiographically using a fluoroscope.
[0078] Thereafter, the dilation catheter 10, guidewire GW and guide
catheter 40a-40f are removed.
[0079] Mode 2--Preloading Dilation Catheter into Guide Catheter
then Inserting Guidewire Separately
[0080] In the example of FIG. 10, the dilation catheter 10 is
prepared for use and is pre-inserted into the guide catheter
40a-40f to a position where the first shaft marker 24 is flush with
the proximal end of the guide catheter. When so positioned all of
the flexible distal shaft portion 12dist and a bit of the rigid
proximal shaft portion 12prox will be within the guide catheter
40a-40f.
[0081] Thereafter, the guide catheter 40a-40f in combination with
the pre-inserted dilation catheter 10 is inserted transnasally
(along with an endoscope 60) and is advanced to a position that is
within or near the ostium to be dilated. The endoscope 60 is used
to view the advancement and positioning of the guide catheter
40a-40f and fluoroscopy may also be used to verify that the guide
catheter is properly positioned near or within the ostium.
Optionally, a handle 42 may be attached to the guide catheter
40a-40f as described above or the operator may simply grasp the
guide catheter 40a-40f as well as the endoscope 60 with the scope
hand, thus leaving the operator's other hand free to be used for
subsequent handling and manipulation of the other devices used in
this procedure. Alternatively, a scope holder or assistant may be
used to hold the endoscope 60 in the desired position thus freeing
both of the operator's hands for handling and manipulation of the
other devices.
[0082] After the guide catheter 40a-40f and pre-inserted dilation
catheter 10 have been positioned, the operator will insert the
distal end of the guidewire into the proximal Luer 20 of the
dilation catheter 10 and will advance the guidewire GW through the
dilation catheter 10, out of the distal end of the guide catheter
40a-40d and through the sinus ostium, causing a distal portion of
the guidewire to become coiled within the sinus cavity. Fluoroscopy
(or any other suitable technique) may be used to verify that the
guidewire has become coiled within the intended sinus cavity.
[0083] Thereafter, the dilation catheter 10 (with its balloon 14 or
other dilator still in its non-expanded state) is advanced over the
guidewire GW to a position where the balloon 14 or other dilator is
positioned within the sinus ostium. The endoscope 60 may be used to
view the advancement and positioning of the dilation catheter.
Although the distal portion of the balloon 14 or other dilator will
be within the sinus and out of the field of view of the endoscope
60, the endoscope 60 may be used to view the proximal end of the
balloon 14 or other dilator and/or the optional marker 19 (if
present) on the proximal end of the balloon 14 or other dilator.
Fluoroscopy may be used to image the radiographic markers 40, 42
and the ostium to confirm that the midregion 44 of the balloon 14
(or the appropriate portion of any other type of dilator) is
positioned within the ostium.
[0084] After the balloon 14 or other dilator has been positioned
within the ostium, the balloon is inflated (or the other dilator is
expanded) thereby dilating the ostium.
[0085] The balloon is then deflated (or the dilator is returned to
its non-expanded state) and the successful dilation of the ostium
may be confirmed visually using the endoscope 60 and/or
radiographically using a fluoroscope.
[0086] Thereafter, the dilation catheter 10, guidewire GW and guide
catheter 40a-40f are removed.
[0087] Mode 3--Preloading Guidewire and Dilation Catheter into
Guide Catheter
[0088] In the example of FIG. 11, the dilation catheter 10 is
prepared for use and the distal end of the guidewire is
pre-inserted into the proximal Luer 20 of the dilation catheter 10
and advanced to a position where the distal end of the guidewire is
within protruding just slightly out of the distal end of the
dilation catheter 10. The dilation catheter 10, with the
pre-inserted guidewire GW, is pre-inserted into the guide catheter
40a-40f and advanced to a position where the first shaft marker 24
is flush with the proximal end of the guide catheter. When so
positioned all of the flexible distal shaft portion 12.sub.dist and
a bit of the rigid proximal shaft portion 12.sub.prox will be
within the guide catheter 40a-40f.
[0089] Thereafter, the guide catheter 40a-40f with the dilation
catheter 10 and guidewire pre-inserted therein is inserted through
a nostril (along with an endoscope 60) and is advanced to a
position that is within or near the ostium to be dilated. The
endoscope 60 is used to view the advancement and positioning of the
guide catheter 40a-40f and fluoroscopy may also be used to verify
that the guide catheter is properly positioned near or within the
ostium. Optionally, a handle 42 may be attached to the guide
catheter 40a-40f as described above or the operator may simply
grasp the guide catheter 40a-40f as well as the endoscope 60 with
the scope hand, thus leaving the operator's other hand free to be
used for subsequent handling and manipulation of the other devices
used in this procedure. Alternatively, a scope holder or assistant
may be used to hold the endoscope 60 in the desired position thus
freeing both of the operator's hands for handling and manipulation
of the other devices.
[0090] After the guide catheter 40a-40f and pre-inserted dilation
catheter 10 and guidewire GW have been positioned, the operator
will advance the guidewire out of the distal end of the guide
catheter 40a-40f and through sinus ostium, causing a distal portion
of the guidewire to become coiled within the sinus cavity.
Fluoroscopy (or any other suitable technique) may be used to verify
that the guidewire has become coiled within the intended sinus
cavity.
[0091] Thereafter, the dilation catheter 10 (with its balloon 14 or
other dilator still in its non-expanded state) is advanced over the
guidewire GW to a position where the balloon 14 or other dilator is
positioned within the sinus ostium. The endoscope 60 may be used to
view the advancement and positioning of the dilation catheter.
Although the distal portion of the balloon 14 or other dilator will
be within the sinus and out of the field of view of the endoscope
60, the endoscope 60 may be used to view the proximal end of the
balloon 14 or other dilator and/or the optional marker 19 (if
present) on the proximal end of the balloon 14 or other dilator.
Fluoroscopy may be used to image the radiographic markers 40, 42
and the ostium to confirm that the midregion 44 of the balloon 14
(or the appropriate portion of any other type of dilator) is
positioned within the ostium.
[0092] After the balloon 14 or other dilator has been positioned
within the ostium, the balloon is inflated (or the other dilator is
expanded) thereby dilating the ostium.
[0093] The balloon is then deflated (or the dilator is returned to
its non-expanded state) and the successful dilation of the ostium
may be confirmed visually using the endoscope 60 and/or
radiographically using a fluoroscope.
[0094] Thereafter, the dilation catheter 10, guidewire GW and guide
catheter 40a-40f are removed.
[0095] Although the above described examples refer to use of a
guide catheter 40a-40d and/or guidewire GW to guide the advancement
of the dilation catheter 10 to its intended position within the
ear, nose or throat, it is to be appreciated that in some subjects
and/or in some applications, the dilation catheter may be
advanceable or maneuverable to its intended position without the
use of a guide catheter 40a-40f and/or guidewire GW. For example,
in some subjects, the dilation catheter 10 may be advanced into the
sphenoid sinus ostium without the use of a guidewire GW or guide
catheter 40a-40d. Alternatively the flexible balloon portion may be
manipulated with forceps to enable insertion in the ostium. Similar
techniques may apply to access of the frontal and maxillary
ostium.
[0096] The fact that the system described herein includes a guide
catheter 40a-40f that is separate from the dilation catheter 10 has
certain advantages. For example, by having two separate devices,
the operator has separate control of the guide placement and may,
in some cases, elect not to actually advance the guide into the
ostium or recess before the ostium. Rather, the operator may in
some instances elect to maneuver the guide catheter 40a-40f to a
position that is close to (e.g., aligned with) but not within the
ostium or recess, and may then advanced just the relatively
flexible dilation catheter 10 into the ostium or recess. This may
avoid damage tissue, bone or other anatomical structures. Thus, the
use of a guide that is separate from the dilation catheter allows
flexibility of positioning and potentially less trauma than where a
single rigid device (e.g., a rigid shafted dilation catheter) must
be navigated to the desired location and then actually inserted
into the ostium or other passageway to be dilated.
[0097] It is to be appreciated that the invention has been
described hereabove with reference to certain examples or
embodiments of the invention but that various additions, deletions,
alterations and modifications may be made to those examples and
embodiments without departing from the intended spirit and scope of
the invention. For example, any element or attribute of one
embodiment or example may be incorporated into or used with another
embodiment or example, unless otherwise specified of if to do so
would render the embodiment or example unsuitable for its intended
use. Also, where the steps of a method or process have been
described or listed in a particular order, the order of such steps
may be changed unless otherwise specified or unless doing so would
render the method or process unworkable for its intended purpose.
All reasonable additions, deletions, modifications and alterations
are to be considered equivalents of the described examples and
embodiments and are to be included within the scope of the
following claims.
* * * * *