U.S. patent application number 13/796073 was filed with the patent office on 2014-09-18 for features to enhance grip of balloon within airway.
The applicant listed for this patent is ACCLARENT, INC.. Invention is credited to Andrew Chen, Siddhi K. Desai, Dexter D. Hernando, Martin J. Madden, Tapan Mistry, Ketan P. Muni, Shrirang V. Ranade, Robert J. Tannhauser, Show-Mean Wu.
Application Number | 20140277071 13/796073 |
Document ID | / |
Family ID | 50349830 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140277071 |
Kind Code |
A1 |
Wu; Show-Mean ; et
al. |
September 18, 2014 |
FEATURES TO ENHANCE GRIP OF BALLOON WITHIN AIRWAY
Abstract
A dilation assembly includes a shaft and a dilator coupled with
the distal end of the shaft. The dilator includes a proximal end, a
distal end, and a center portion positioned between the proximal
end and the distal end. The center portion dilates from a first
configuration to a second configuration. The center portion has a
larger diameter than the proximal end and the distal end when the
center portion is in the second configuration. At least one
gripping feature is positioned on at least a portion of the
exterior surface of the center portion. The gripping feature
provides friction between the center portion and a bodily lumen
when the center portion is in the second configuration.
Inventors: |
Wu; Show-Mean; (Fremont,
CA) ; Mistry; Tapan; (Fremont, CA) ; Hernando;
Dexter D.; (Union City, CA) ; Desai; Siddhi K.;
(San Jose, CA) ; Tannhauser; Robert J.;
(Bridgewater, NJ) ; Ranade; Shrirang V.; (Foster
City, CA) ; Muni; Ketan P.; (San Jose, CA) ;
Madden; Martin J.; (New Hope, PA) ; Chen; Andrew;
(Menlo Park, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ACCLARENT, INC. |
Menlo Park |
CA |
US |
|
|
Family ID: |
50349830 |
Appl. No.: |
13/796073 |
Filed: |
March 12, 2013 |
Current U.S.
Class: |
606/196 ;
606/192 |
Current CPC
Class: |
A61M 29/02 20130101;
A61B 17/24 20130101; A61M 2025/1075 20130101; A61M 2025/1088
20130101; A61M 2025/109 20130101; A61B 2017/22061 20130101; A61B
17/320725 20130101; A61M 25/104 20130101; A61M 2210/1025 20130101;
A61M 2025/1086 20130101; A61M 2025/1072 20130101 |
Class at
Publication: |
606/196 ;
606/192 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1. A dilation assembly, wherein the dilation assembly comprises:
(a) a shaft, comprising a distal end and a proximal end; and (b) a
dilator coupled with the distal end of the shaft, wherein the
dilator comprises: (i) a proximal end, (ii) a distal end, (iii) a
center portion positioned between the proximal end and the distal
end, wherein the center portion is dilatable to have a larger
diameter than the proximal end and the distal end, wherein the
center portion is configured to dilate from a first configuration
to a second configuration, and (iv) at least one gripping feature
positioned on at least a portion of an exterior surface of the
center portion, wherein the gripping feature is configured to
provide friction between the center portion of the dilator and a
bodily lumen when the center portion is in the second
configuration.
2. The dilation assembly of claim 1, wherein the shaft and dilator
are sized to fit within an airway of a patient.
3. The dilation assembly of claim 1, wherein the shaft and dilator
are sized to fit within an ostium of a sinus.
4. The dilation assembly of claim 1, wherein the gripping feature
comprises a corrugated surface.
5. The dilation assembly of claim 1, wherein the gripping feature
comprises a plurality of knobs, wherein the knobs are flexible such
that the knobs are configured to expand as the center portion
expands from the first configuration to the second
configuration.
6. The dilation assembly of claim 1, wherein the gripping feature
comprises a plurality of knobs, wherein the knobs comprise
micro-protrusions such that the knobs are applied to the center
portion, wherein the knobs are configured to retain a constant
shape as the center portion expands from the first configuration to
the second configuration.
7. The dilation assembly of claim 1, wherein the gripping feature
comprises a coating, wherein the coating comprises polyurethane or
neoprene.
8. The dilation assembly of claim 1, wherein the gripping feature
comprises a non-slip material, wherein the non-slip material is
adhered to the exterior surface of the center portion.
9. The dilation assembly of claim 1, wherein the gripping feature
is aligned in alternating longitudinal rows along a length of the
center portion.
10. The dilation assembly of claim 9, wherein the center portion is
configured to be wrapped, wherein the longitudinal rows of gripping
features are configured to be folded underneath the exterior
surface of the center portion when the center portion is
wrapped.
11. The dilation assembly of claim 1, wherein the gripping feature
comprises at least one non-slip element, wherein the non-slip
element is configured to wrap around the center portion, wherein
the non-slip element comprises a point configured to engage the
bodily lumen.
12. The dilation assembly of claim 11, wherein the gripping feature
comprises a base, wherein the base is configured to be positioned
between the non-slip element and the dilator such that the base is
configured to fix the non-slip element at a longitudinal position
along the dilator.
13. The dilation assembly of claim 1, wherein the gripping feature
comprises a net.
14. The dilation assembly of claim 1, wherein the gripping feature
comprises a first collar, a second collar, and at least one scoring
element, wherein the scoring element is positioned between the
first collar and the second collar, wherein the first collar is
translatable relative to the dilator such that the first collar is
operable to expand the scoring element from a first position to a
second position.
15. The dilation assembly of claim 14, wherein the dilator is
operable to expand the scoring element to the second position when
the dilator is expanded to the second configuration.
16. The dilation assembly of claim 14, wherein the gripping feature
comprises an actuator, wherein the actuator is operable to
translate the first collar relative to the dilator to expand the
scoring element to the second position.
17. A dilation assembly, wherein the dilation assembly comprises:
(a) a shaft, comprising a distal end and a proximal end; and (b) a
dilator coupled with the distal end of the shaft, wherein the
dilator comprises: (i) a first anchor portion, wherein the first
anchor portion is configured to receive fluid via a first conduit,
wherein the first anchor portion is dilatable from a first size to
a second size in response to receiving fluid via the first conduit,
and (ii) a second anchor portion adjacent to the first anchor
portion, wherein the second anchor portion is configured to receive
fluid via a second conduit, wherein the second anchor portion is
dilatable from a first size to a second size in response to
receiving fluid via the second conduit, wherein the second size of
the first anchor portion is larger than the second size of the
second anchor portion, wherein one or both of the first anchor
portion or the second anchor portion are sized to engage a bodily
lumen when the first and second anchors are dilated to the
respective second sizes.
18. The dilation assembly of claim 17, wherein the first anchor
portion is proximal to the second anchor portion.
19. The dilation assembly of claim 18, wherein the dilator further
comprises a third anchor portion adjacent to the second anchor
portion, wherein the third anchor portion is distal to the second
anchor portion, wherein the third anchor portion is configured to
receive fluid via a third conduit, wherein the third anchor portion
is dilatable from a first size to a second size in response to
receiving fluid via the third conduit.
20. A dilation kit, wherein the dilation kit comprises: (a) a
dilator assembly, wherein the dilator assembly comprises a dilator
configured to dilate from a first position to a second position,
wherein the dilator is sized to be positioned within an anatomical
passageway in a patient, wherein the dilator assembly further
comprises at least one magnetic or ferrous element; and (b) a
positioning assembly, wherein the positioning assembly comprises a
shaft and a magnetic or ferrous element positioned on the shaft,
wherein the magnetic or ferrous element of the positioning assembly
is attracted to the magnetic or ferrous element of the dilator
assembly.
Description
BACKGROUND
[0001] In some instances, it may be desirable to dilate an
anatomical passageway in a patient. This may include dilation of
ostia of paranasal sinuses, dilation of a patient's airway (e.g.,
to treat a stenosis within the larynx), dilation of the nasal
cavity, dilation of the Eustachian tube, dilation of other
passageways within the ear, nose, or throat, dilation of blood
vessels, dilation of the urethra, etc. One method of dilating
anatomical passageways includes using a guide wire and catheter to
position an inflatable balloon within the anatomical passageway,
then inflating the balloon with a fluid (e.g., saline) to dilate
the anatomical passageway.
[0002] Airway stenosis (or "airway narrowing") is a medical
condition that occurs when some portion of a patient's airway
becomes narrowed or constricted, thus making breathing difficult. A
stenosis may occur in any part of the airway including the larynx,
trachea, bronchi, or a combination of any of the above mentioned
regions. Both adults and children may develop a stenosis. In some
instances, a stenosis is caused by intubation, which is when a tube
is placed in the airway for ventilation/breathing assistance in a
patent who cannot breathe. Intubation for prolonged periods of time
may traumatize the airway, causing scar tissue formation that forms
the stenosis.
[0003] Therapies for treating an airway stenosis range from
endoscopic treatments, such as dilation and laser resection, to
open procedures, such as laryngotracheal reconstruction. In one
technique, a series of rigid dilators of increasing diameter are
pushed down the airway, gradually expanding the constriction but
also applying shear forces to the airway. Balloon catheters may
also be used to perform dilation of an airway or other anatomical
passageway. For instance, the expandable balloon may be positioned
within a stenosis in an airway (e.g., larynx, trachea, bronchi,
etc.) and then be inflated, to thereby dilate the airway and
increase airflow. The dilated airway may then allow for improved
breathing. Once the balloon is deflated or subjected to negative
pressure, however, the balloon may tend to lose its shape and
become flat, folded, or otherwise non-cylindraceous. An example of
a system that may be used to perform dilation procedures is
described in U.S. Pub. No. 2010/0168511, entitled "System and
Method for Dilating an Airway Stenosis," published Jul. 1, 2010,
the disclosure of which is incorporated by reference herein.
[0004] While several airway dilation systems have been made and
used, it is believed that no one prior to the inventor(s) has made
or used the invention described in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] While the specification concludes with claims which
particularly point out and distinctly claim the invention, it is
believed the present invention will be better understood from the
following description of certain examples taken in conjunction with
the accompanying drawings, in which like reference numerals
identify the same elements and in which:
[0006] FIG. 1 depicts a side view of an exemplary system for
dilating a stenosis in the airway, including a balloon catheter and
a stylet;
[0007] FIG. 2 depicts a side view of the stylet of FIG. 1;
[0008] FIG. 3A depicts a cross sectional view of the system of FIG.
1 being introduced into an airway, with the balloon positioned at a
stenosis in a collapsed state;
[0009] FIG. 3B depicts a cross sectional view of the system of FIG.
3A, with the balloon inflated to a dilated state;
[0010] FIG. 4 depicts a side view of an exemplary balloon having
gripping features for use in the system of FIG. 1;
[0011] FIG. 5 depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1;
[0012] FIG. 6 depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1;
[0013] FIG. 7 depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1;
[0014] FIG. 8 depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1;
[0015] FIG. 9 depicts an end view of the balloon of FIG. 8 in a
deflated configuration;
[0016] FIG. 10 depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1;
[0017] FIG. 11 depicts an end view of the balloon of FIG. 10;
[0018] FIG. 12 depicts a front view of a gripping element of the
balloon of FIG. 10;
[0019] FIG. 13 depicts a side view of a base of the balloon of FIG.
10;
[0020] FIG. 14 depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1;
[0021] FIG. 15A depicts a side view of another exemplary balloon
having gripping features for use in the system of FIG. 1 in a
collapsed configuration;
[0022] FIG. 15B depicts a side view the balloon of FIG. 15A in an
expanded configuration;
[0023] FIG. 16A depicts a side view of another exemplary balloon
with a gripping assembly for use in the system of FIG. 1 in a
collapsed configuration;
[0024] FIG. 16B depicts a side view of the balloon of FIG. 16A,
showing the gripping assembly in an expanded configuration;
[0025] FIG. 16C depicts a side view of the balloon of FIG. 16A,
showing the balloon in an expanded configuration;
[0026] FIG. 17 depicts a side view of another exemplary balloon
with gripping features for use in the system of FIG. 1;
[0027] FIG. 18 depicts a side view of another exemplary balloon
with gripping features for use in the system of FIG. 1;
[0028] FIG. 19 depicts a cross sectional view of the balloon of
FIG. 18 taken along line 19-19 of FIG. 18;
[0029] FIG. 20 depicts a cross sectional view of the balloon of
FIG. 18 taken along line 20-20 of FIG. 19;
[0030] FIG. 21 depicts a side view of another exemplary balloon
with gripping features for use in the system of FIG. 1;
[0031] FIG. 22 depicts a side view of an exemplary positioning
device for use with the balloon of FIG. 21;
[0032] FIG. 23A depicts a cross sectional view an exemplary system
with the balloon of FIG. 21 being introduced into an airway, with
the balloon positioned at a stenosis in a collapsed state with the
positioning device positioned over the balloon; and
[0033] FIG. 23B depicts a cross sectional view of the system of
FIG. 23A, with the balloon inflated to a dilated state.
[0034] The drawings are not intended to be limiting in any way, and
it is contemplated that various embodiments of the invention may be
carried out in a variety of other ways, including those not
necessarily depicted in the drawings. The accompanying drawings
incorporated in and forming a part of the specification illustrate
several aspects of the present invention, and together with the
description serve to explain the principles of the invention; it
being understood, however, that this invention is not limited to
the precise arrangements shown.
DETAILED DESCRIPTION
[0035] The following description of certain examples of the
invention should not be used to limit the scope of the present
invention. Other examples, features, aspects, embodiments, and
advantages of the invention will become apparent to those skilled
in the art from the following description, which is by way of
illustration, one of the best modes contemplated for carrying out
the invention. As will be realized, the invention is capable of
other different and obvious aspects, all without departing from the
invention. Accordingly, the drawings and descriptions should be
regarded as illustrative in nature and not restrictive.
[0036] It will be appreciated that the terms "proximal" and
"distal" are used herein with reference to a clinician gripping a
handpiece assembly. Thus, an end effector is distal with respect to
the more proximal handpiece assembly. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "top" and "bottom" also are used herein with respect to the
clinician gripping the handpiece assembly. However, surgical
instruments are used in many orientations and positions, and these
terms are not intended to be limiting and absolute.
[0037] It is further understood that any one or more of the
teachings, expressions, versions, examples, etc. described herein
may be combined with any one or more of the other teachings,
expressions, versions, examples, etc. that are described herein.
The following-described teachings, expressions, versions, examples,
etc. should therefore not be viewed in isolation relative to each
other. Various suitable ways in which the teachings herein may be
combined will be readily apparent to those of ordinary skill in the
art in view of the teachings herein. Such modifications and
variations are intended to be included within the scope of the
claims.
[0038] I. Overview of Exemplary Balloon Dilation Catheter
System
[0039] FIG. 1 shows an exemplary dilation catheter system (8),
which may be used to dilate a stenosis in an airway; or to dilate
some other anatomical passageway (e.g., within the ear, nose,
throat, cardiovascular system, etc.). At least part of system (8)
may be constructed and operable in accordance with at least some of
the teachings of U.S. Pub. No. 2010/0168511, the disclosure of
which is incorporated by reference herein. It should be understood
that dilation catheter system (8) may be used to dilate either a
naturally occurring passageway in a patient or a surgically created
passageway in a patient.
[0040] Dilation catheter system (8) of this example comprises a
balloon catheter (10) and a stylet (22). Balloon catheter (10)
comprises a shaft (12) positioned between a hub (14) and a balloon
(18). Balloon (18) is coupled to a distal end of shaft (12) and is
configured to receive fluid through balloon catheter (10). Stylet
(22) is slidably positioned through balloon catheter (10). In some
versions, at least a portion of stylet (22) has a greater stiffness
than at least a portion of balloon catheter (10), such that when
stylet (22) is bent and inserted within balloon catheter (10),
balloon catheter (10) at least partially conforms to the shape of
stylet (22). In a dilation procedure, stylet (22) is used to
advance balloon catheter (10) within an airway or targeted
anatomical passageway (e.g., at a stenosis site). Balloon (18) may
then be actuated to an expanded state to open or dilate the
targeted anatomical passageway. Balloon (18) may then be actuated
back to a collapsed state such that balloon (18) is deflated. This
process may be repeated to dilate several anatomical
passageways.
[0041] A. Exemplary Balloon Catheter
[0042] As shown in FIG. 1, balloon catheter (10) comprises a
catheter shaft (12). An inflatable balloon (18) is attached to a
distal end of shaft (12) via adhesive or other attachment means. A
hub (14) is coupled to a proximal end of shaft (12) and comprises a
stylet port (38) and an inflation port (37). Stylet (22) is
inserted within stylet port (38) and generally resides within an
inner lumen of shaft (12). Fluid (e.g., saline, etc.) is introduced
through inflation port (37) through shaft (12) to inflate balloon
(18).
[0043] Balloon catheter (10) may have any number of suitable sizes,
shapes and configurations. For example, balloon (18) may have
different lengths and diameters in different embodiments, to
accommodate different patient anatomies. The overall catheter (10)
length and diameter may also vary. For example, the overall length
of balloon catheter (10) (i.e., from the proximal end of hub (14)
to the distal end of catheter shaft (12)) is about 35-70 cm, such
as less than or equal to about 50 cm, or about 45 cm.+-0.5 cm.
Catheter (10) may be handled and manipulated with one hand. The
working length of balloon (18) in FIG. 1 is about 40 mm+/-0.2 mm.
By "working length" it is meant the length between the two tapered
portions of balloon (18). In some versions, the working length of
balloon (18) may range from between about 10 mm and about 60 mm
such as about 16-45 mm. The outer diameter of the fully inflated
working length of balloon (18) may also vary. In the present
example, balloon (18) has an inflated diameter of about 14.1
mm+/-0.5 mm. In some versions, balloon (18) diameter may range from
about 3 mm to about 24 mm, such as about 5-15 mm. A combination of
balloon diameters and lengths may be provided, such that a
physician may choose an appropriate size for an adult or pediatric
patient. In one example, the following balloon diameters and
lengths may be provided: 5 mm by 24 mm; 7 mm by 24 mm; 10 mm by 40
mm; and 14 mm by 40 mm. Of course, any of a number of other
combinations of sizes of balloons (58) may be provided.
[0044] Any suitable material may be used to form balloon (18).
Balloon (18) may be compliant, semi-compliant or non-compliant.
Balloon (18) may be made of nylon, some other polymer, such as
PTFE, and/or any other suitable material(s). In some versions,
balloon (18) is formed of an elastic/extensible material that is
resiliently biased to assume a shrunken, non-inflated
configuration, such that the material forming balloon (18) is under
increased tension when balloon (18) is in a non-deflated state. In
some other versions, balloon (18) is formed of a material that is
flexible yet substantially inelastic/non-extensible, such that the
material forming balloon does not provide a significant resilient
bias. In other words, balloon (18) does not stretch in response to
increased fluid pressure inside balloon (18), even though the
effective outer diameter of balloon (18) increases in response to
increased fluid pressure. Such inelastic versions of balloon (18)
may nevertheless be filled with fluid, with the fluid pressure
being increased to provide an outwardly directed force via balloon
(18), and this process may be referred to as "inflating." When the
pressure of fluid inside balloon (18) is reduced, this process may
be referred to as "deflating," even if the material forming balloon
(18) does not elastically shrink, since balloon (18) may
nevertheless flexibly collapse in response to reduced fluid
pressure. Thus, it should be understood that the use of terms like
"inflate," "inflated," "deflate," and "deflated" does not
necessarily mean that the material forming balloon (18) undergoes
any elastic stretching or shrinking as the fluid pressure within
balloon (18) changes.
[0045] In some versions, balloon (18) may include an outer
slip-resistant surface, which may be formed by a textured surface
or a coating. Such a surface may help prevent slipping of balloon
(18) out of an airway structure during inflation and/or may
facilitate re-wrapping balloon (18) by hand after deflation if
balloon (18) is to be used for a second or subsequent dilation
procedure. Examples of such balloons are provided in U.S. patent
application No. [FBT DOCKET NO. ACC5059USPSP.600452], entitled
"Features to Enhance Grip of Balloon within Airwary," filed on a
date even herewith, the disclosure of which is incorporated by
reference herein.
[0046] Catheter shaft (12) may also be formed of any suitable
material. It may be desirable to form shaft (12) from material(s)
selected so that shaft (12) is unlikely to kink when bent, such as
when bent by stylet (22) and/or a user. One such material, for
example, is Pebax, although other polymers may be used. Shaft (12)
may also have any suitable color and may include one or more shaft
markings. The shaft color and markings may be built into shaft (12)
by using a colored material or may be added by applying paint or
another colorant. In some versions, shaft (12) may have a dark
color, such as black or dark blue, and one or more light colored
markings may be applied over the dark shaft (12). In some versions,
the markings (not shown) may include direct visualization markings
(viewed directly with the naked eye or an endoscope) and/or
radiographic markings (viewed with a radiographic device such as
intraoperative fluoroscopy). Any suitable combination, size and
color of markings may be used. One example of shaft color and shaft
markings, which could be used or modified for a balloon catheter,
is the Relieva Solo Pro.TM. Sinus Balloon Catheter, manufactured by
Acclarent, Inc. of Menlo Park, Calif.
[0047] B. Exemplary Stylet
[0048] FIG. 2 shows stylet (22) in greater detail. Stylet (22)
comprises a core member (26) with a proximal section (28) and a
distal section (30). A coil (32) is disposed around at least part
of distal section (30) of core member (26). A luer lock member (35)
is coupled with a proximal end of core member (26) for coupling
with a hub on balloon catheter (10). In some versions, stylet (22)
does not include a coil (32). Core member (26) and/or coil (32) may
be formed of nitinol, stainless steel, or other biocompatible
materials. Distal portion (30) of stylet (22) includes a bend or
curve (34) that is stiff enough to bend balloon catheter (10)
during the placement of balloon catheter (10) within the airway of
the patient. In some versions, stylet (22) may be provided in a
generally straight configuration. Stylet (22) may be pre-formed to
have a bend (34), or stylet (22) may be malleable, such that a user
may bend stylet (22) and stylet (22) maintains the user-created
bend. This malleability allows a user to adjust a bend angle
according to the airway anatomy of a particular patient. Proximal
section (28) of stylet (22) may be generally stiff, a distal
section (30) may be generally malleable, and an extreme distal
portion may be atraumatic and very flexible or even floppy. This
variation in flexibility along the length of stylet (22) may be
achieved by using different materials, such as stainless steel and
nitinol. Alternatively, one material, such as stainless steel, may
be used and the diameter of stylet (22) may be altered to achieve
the variation in flexibility along the length of stylet (22).
[0049] Stylet (22) has an overall length approximately as long or
slightly longer than balloon catheter (10). In some versions,
stylet (22) includes an atraumatic, flexible distal tip portion
that extends distally out of balloon catheter (10) when stylet (22)
is fully disposed within catheter (10). This tip portion may be,
for example, between about 0.25 cm to about 8 cm (e.g., about 1-5
cm) in length; and may facilitate the ability of a user to advance
system (8) through a patient's airway atraumatically. The overall
length of stylet (22) may vary from about 30 cm to about 80 cm,
such as from about 45 cm to about 60 cm. Of the overall length, a
flexible distal portion of stylet (22) may be from about 5-20 cm,
such as from about 10-15 cm. Bend (34) may have any suitable angle,
such as from greater than 0 degrees to about 20 degrees. The
diameter of stylet (22) may be less than about 1.3 mm, such as 0.9
mm or less. The diameter may decrease distally to about 0.13
mm+/-0.013 mm. Of course, the foregoing dimensions are mere
examples. Any other suitable dimensions may be used.
[0050] Stylet (22) may be attached to balloon catheter (10), or
stylet (22) may be removably connected to balloon catheter (10).
Stylet (22) comprises a luer lock member (35) with threads on
proximal section (28) that screw into opposing threads disposed on
a luer (36) of balloon catheter (10). In some versions, balloon
catheter (10) may include a locking mechanism (not shown) to lock
stylet (22) in position within catheter (10). The locking mechanism
can be any mechanical device, including a lever, a ball and pin, a
luer, etc. All or part of distal section (30) of stylet (22) may
extend out of the distal end of catheter (10). Stylet (22) may be
locked to balloon catheter (10) at different positions or lengths
so the distal end of stylet (22) extends out of or is positioned
within balloon catheter (10) at different lengths. The length,
diameter(s) and stiffness characteristics of stylet (22) may be
varied in different embodiments to confer different performance
characteristics to the overall system (8).
[0051] Use of stylet (22) to insert balloon catheter (10) helps to
guide the distal end of balloon catheter (10) through the airway of
the patient and to the stenotic region. Stylet (22) provides
increased steerability during advancement of balloon catheter (10).
Torquability of balloon catheter (10) is also increased when using
stylet (22). In some versions, luer lock member (35) of stylet (22)
and luer (36) of balloon catheter (10) mate together, so that
stylet (22) and balloon catheter (10) may be rotated together and
thus steered into a constricted portion of an airway.
[0052] In some versions, stylet (22) may have a light emitting
portion, such as a light emitting distal end or tip. For example,
stylet (22) may include one or more light fibers to transmit light
from a light source attached to the proximal end of stylet (22) to
its distal end. Light from a light emitting stylet (22) may be used
to help a user visualize a patient's airway from the inside using a
scope and/or in some cases from the outside via transillumination
through the patient's skin. A light emitting guidewire device that
may be used or modified to achieve such an illuminating stylet (22)
is the Relieva Luma.TM. Sinus Illumination Guidewire/System,
manufactured by Acclarent, Inc. of Menlo Park, Calif. Such an
illuminating stylet (22) may have any of the features described
above with the additional feature of light emitting capability.
[0053] C. Exemplary Method of Use of the System
[0054] FIGS. 3A and 3B show a method for dilating an stenotic
region (4) in an airway (2), such as in a case of subglottic
stenosis. Dilation system (8) is introduced through the mouth and
into the airway of the patient. Optionally, a bronchoscope (not
shown) or other scope device may be used to visualize the
positioning of dilation system (8). Dilation system (8) may be bent
either by the user or by the manufacturer of system (8). For
example, stylet (22) may be bent and then inserted into balloon
catheter (10), while in other cases stylet (22) and balloon
catheter (10) may be bent together, with stylet (22) already
residing in catheter (10). The support of stylet (22) and the bend
in the overall system (8) may help a physician navigate system (8)
through the patient's airway to position balloon (18) within at
least a portion of stenotic region (4). As shown in FIG. 3A,
inflatable balloon (18) of the catheter (10) is in an unexpanded
configuration during advancement and placement of balloon catheter
(10). As shown in FIG. 3B, once balloon (18) is positioned within
stenotic region (4) of the airway (2), inflatable balloon (18) is
inflated to dilate stenotic region (4). Balloon (18) is then
deflated to enable removal from airway (2). By way of example only,
balloon (18) may be deflated by actively drawing the fluid from
balloon (18); by venting the fluid in balloon (18), allowing the
inward pressure imposed by airway (2) to drive fluid from balloon
(18); or in any other suitable fashion as will be apparent to those
of ordinary skill in the art in view of the teachings herein.
[0055] In some versions, stylet (22) remains in balloon catheter
(10) during inflation of balloon (18). Maintaining stylet (22) in
catheter (10) during inflation may give catheter (10) added column
strength and help maintain the position of balloon (18) within
stenotic region (4), thus avoiding slipping. In some versions,
stylet (22) is removed from balloon catheter (10) before inflating.
Stylet (22) may be removed from balloon catheter (10) after balloon
catheter (10) is properly positioned within airway (2) of the
patient, or stylet (22) can be removed after stenosis (4) has been
dilated but before removing balloon catheter (10) from the
patient.
[0056] Inflatable balloon (18) may be inflated more than once to
dilate stenotic region (4) of airway (2). The physician inflates
inflatable balloon (18) to a desired pressure during each dilation
of stenosis (4). Proper dilation of stenotic region (4) can be
confirmed by visualizing the region with the
bronchoscope/endoscope.
[0057] II. Exemplary Balloon Gripping Features
[0058] The airway of each patient has a unique anatomical make-up
and is coated with mucus or other bodily fluids. This may cause
balloon (18) to slip a small amount during inflation, which may
result in balloon (18) sliding longitudinally out of position from
within stenotic region (4). Similar conditions may occur in other
anatomical passageways in a patient where balloon (18) might be
used (e.g., Eustachian tube, within an ostia of a patient's sinus,
other passageways within the ear, nose, or throat, etc.).
Accordingly, it may be desirable to provide gripping features on
balloon (18) to decrease or prevent balloon (18) from slipping
within the airway during inflation. The gripping features may be
provided on a surface of balloon (18) or gripping elements may be
added to balloon (18). Several examples of balloon gripping
features are described in greater detail below, while other
examples will be apparent to those of ordinary skill in the art in
view of the teachings herein.
[0059] A. Exemplary Balloon Surface Gripping Features
[0060] Balloon gripping features may be incorporated into the
surface of balloon (18) to increase friction between balloon (18)
and a patient's airway and decrease or prevent balloon (18) from
slipping within the airway. The examples below provide several
versions of surface gripping features that may be readily
incorporated into balloon (18).
[0061] FIG. 4 shows an exemplary balloon (118) with a corrugated
surface (126). Balloon (118) comprises a proximal end (120), a
working length (124), and a distal end (121). Proximal end (120)
and distal end (121) are sized to attach with shaft (12) of
catheter (10). Working length (124) is positioned between proximal
end (120) and distal end (121). Working length (124) has a larger
diameter than proximal end (120) and distal end (121) when balloon
(118) is dilated and is configured to be positioned within an
airway to treat a stenosis (4). A tapered portion (122) couples
proximal end (120) and working length (124). A tapered portion
(123) couples working length (124) and distal end (121).
[0062] Working length (124) comprises a corrugated surface (126).
Corrugated surface (126) is configured with a plurality of annular
ridges positioned along working length (124). Corrugated surface
(126) provides hills and valleys on working length (124) to
increase the friction between balloon (118) and an airway.
Corrugated surface (126) may cover the entire surface of balloon
(118) or may cover a portion of balloon (118). For instance,
corrugated surface (126) may cover 50% of the surface of balloon
(118). Corrugated surface (126) may be created by wrapping balloon
(118) with a stiffer plastic or metal string to create the ridges
when balloon (118) is inflated. Corrugated surface (126) may also
be formed by knurling or chemically via etching. Other suitable
ways in which corrugated surface (126) may be provided will be
apparent to one with ordinary skill in the art in view of the
teachings herein. Corrugated surface (126) may also reinforce
balloon (118) against internal pressure and decrease the compliance
of balloon (118). Balloon (118) may be made from nylon,
polyethylene terephthalate, or any thermoplastic with similar
properties. In the present example, the wall thickness of balloon
(118) is about 0.001'' to about 0.005''. Of course, any other
suitable thickness may be used.
[0063] FIG. 5 shows another exemplary balloon (218) with a knobby
surface. Balloon (218) is similar to balloon (118), except that
working length (224) of balloon (218) comprises a plurality of
knobs (226). Knobs (226) extend outwardly from working length (224)
to increase the friction between balloon (218) and an airway. Knobs
(226) may cover the entire surface of balloon (218) or may cover a
portion of balloon (218). For instance, knobs (226) may cover 50%
of the surface of balloon (218). In the present example, knobs
(226) are configured in rows positioned transversely across balloon
(218). However, knobs (226) may have any configuration or pattern
on balloon (218). Knobs (226) may be molded on balloon (218) such
that knobs (226) expand as balloon (218) expands. Knobs (226) may
also be micro-protrusions applied or mounted on the surface of
balloon (218). Such micro-protrusions may be made by imprinting
silicon and Ni molds. The micro-protrusions would thus maintain
their shape as balloon (218) expands. Knobs (226) may also be a
frictional skin formed similar to the material of a conventional
Nitrile glove and may be mounted on balloon (218) in longitudinal
and radial patterns. In some versions, knobs (226) are oriented
obliquely and/or are in the form of barbs to further resist
longitudinal movement of balloon (118) within the airway. For
instance, some knobs (226) may be oriented obliquely distally to
resist distal movement of balloon (118) in the airway; while other
knobs (226) may be oriented obliquely proximally to resist proximal
movement of balloon (118) in the airway. Other suitable knob (226)
configurations will be apparent to one with ordinary skill in the
art in view of the teachings herein.
[0064] FIG. 6 shows another exemplary balloon (318) with a coating
(326). Balloon (318) is similar to balloon (118), except that
working length (324) of balloon (318) comprises a coating (326).
Coating (326) is a non-slip or textured coating applied to working
length (324) of balloon (318) to increase the friction between
balloon (318) and an airway. Coating (326) may cover the entire
surface of balloon (318) or may cover a portion of balloon (318).
For instance, coating (326) may cover 50% of the surface of balloon
(318). Coating (326) may comprise a thermoplastic elastomer, such
as polyurethane, neoprene, or any other material having a low
durometer rating and a rubber-like consistency. Coating (326) may
also comprise a moisture activated, degradable tissue adhesive.
Various suitable materials will be apparent to one with ordinary
skill in the art in view of the teachings herein. In the present
example, coating (326) has a thickness of about 0.0003'' to about
0.005''. Of course, any other suitable dimensions may be used.
Balloon (318) may be dipped in coating (326) or coating (326) may
be sprayed onto balloon (318). Other suitable ways in which coating
(326) may be provided will be apparent to one with ordinary skill
in the art in view of the teachings herein. Coating (326) may also
reinforce balloon (318) to increase the burst strength of balloon
(318) and decrease the risk of balloon (318) being inadvertently
punctured.
[0065] FIG. 7 shows another exemplary balloon (418) with a non-slip
material (426). Balloon (418) is similar to balloon (118), except
that working length (424) of balloon (418) comprises a non-slip
material (426). Material (426) is a non-slip or textured material
applied to working length (424) of balloon (418) to increase the
friction between balloon (418) and an airway. Material (426) may
cover the entire surface of balloon (418) or may cover a portion of
balloon (418). In the present example, material (426) is applied to
balloon (418) in a plurality of longitudinal strips extending
across the surface of balloon (418). Although strips of material
(426) are used in the present example, any suitable shape of
material (426) may be used (e.g., ring, circle, square, rectangle,
triangle, etc.). Similarly, although material (426) is aligned in
rows in FIG. 7, material (426) may also be aligned in any other
suitable configuration that will be apparent to one with ordinary
skill in the art in view of the teachings herein. In some versions,
material (426) is a different material than balloon (418). In some
other versions, material (426) has the same material composition as
the material forming balloon (418), but has a different texture
and/or other different properties. Material (426) may have a higher
coefficient of friction than balloon (418). For instance, material
(426) may be a rubber-like material (e.g., polyurethane, neoprene,
etc.) or a fabric. Material (426) may be adhered to balloon (418)
or applied as a coating to balloon (418). Material (426) also forms
an uneven surface along balloon (418) to further increase friction.
Various other suitable ways in which material (426) may be provided
will be apparent to one with ordinary skill in the art in view of
the teachings herein.
[0066] FIG. 8 shows another exemplary balloon (518) with gripping
features (526). Balloon (518) is similar to balloon (118), except
that gripping features (526) of are aligned in alternating
longitudinal rows along working length (524) of balloon (518).
Gripping features (526) may be formed from any of the gripping
feature materials described above. When balloon (518) is deflated,
balloon (518) is wrapped to form folds as shown in FIG. 9. Due to
the alternating longitudinal rows of gripping features (526),
gripping features (526) are folded underneath the exposed working
length (524) surface of balloon (518) when balloon (518) is in the
wrapped configuration. Gripping features (526) may be resiliently
biased inwardly when balloon (518) is deflated. When balloon (518)
is inflated, gripping features (526) may pivot outwardly to bear
into the tissue defining the airway. Gripping features (526) may
also expose a material similar to material (426) when gripping
features (526) pivot outwardly. Balloon (518) is positioned within
an airway in the wrapped configuration. This allows the smooth,
lubricated surface of working length (524) to be exposed during
positioning of balloon (518) to facilitate delivery of balloon
(518) to the targeted site. Once balloon (518) is positioned,
balloon (518) is inflated. When balloon (518) is inflated, as shown
in FIG. 8, gripping features (526) are exposed to increase friction
between balloon (518) and the airway to decrease or prevent
slipping of balloon (518) within the airway.
[0067] B. Exemplary Balloon Gripping Elements
[0068] Gripping features may also be provided by applying gripping
elements to a balloon (18) as a separate external component. The
examples below provide several versions external gripping features
that may be readily coupled to balloon (18).
[0069] 1. Exemplary Non-Slip Elements
[0070] FIGS. 10-13 show an exemplary gripping assembly (600).
Gripping assembly (600) comprises a balloon (618), a plurality of
non-slip elements (626), and a base (628). Balloon (618) is similar
to balloon (18). Non-slip elements (626) are positioned around
working length (624) of balloon (618). As shown in FIG. 10,
non-slip elements (626) are positioned along a portion of the
length of balloon (618). Although three elements (626) are shown,
any number of elements may be used. For instance, one element (626)
may extend continuously across balloon (618) and have a length of
30 mm; or two elements (626) may be used where each element (626)
has a length of 15 mm. Elements (626) have a wall thickness of
about 0.008'' to about 0.0025'' and are sized to correspond to the
diameter of balloon (618) when balloon (618) is inflated, as shown
in FIG. 11. Of course, any other suitable dimensions may be
used.
[0071] Elements (626) may be flexible such that elements (626)
expand and deflate with balloon (618). As shown in FIG. 12, element
(626) is shaped as a pentagon. The corners of element (626) help to
increase friction and grip an airway. Other suitable shapes (e.g.,
circle, triangle, square, rectangle, etc.) may be used and will be
apparent to one with ordinary skill in the art in view of the
teachings herein. Elements (626) may be made from stainless steel,
nitinol, etc., such that elements (626) are configured to withstand
bending and twisting as balloon (618) is inflated and/or deflated.
Elements (626) may be at least partially encompassed by balloon
(618) (e.g., covered by folds created by the outer surface of
balloon (618), etc.) when balloon (618) is in a deflated state to
prevent inadvertent snagging on tissue while balloon (618) is
positioned within an airway. Alternatively, a sheath may be
provided to cover elements (626) and balloon (618) when balloon
(618) is in the deflated state while balloon (618) is positioned
within the airway. The sheath could then be retracted prior to
inflation of balloon (618). Other suitable ways in which elements
(626) may be covered during transit within an airway will be
apparent to one with ordinary skill in the art in view of the
teachings herein.
[0072] Elements (626) are coupled with base (628). As shown in FIG.
13, base (628) comprises a plurality of recesses (629) on a bottom
surface to correspond to elements (626). As shown in FIGS. 10 and
11, base (628) is coupled to a surface of balloon (618). Elements
(626) are positioned within recesses (629) and coupled to base
(628) such that elements (626) wrap around balloon (618) and base
(628). Base (628) thus longitudinally fixes elements (626) relative
to balloon (618). Base (628) may be molded from a plastic material.
Elements (626) may be adhered to base (628), or elements (626) may
be snap fitted into recesses (629). In some versions, elements
(626) are adhered directly to balloon (618) such that a base (628)
is not used.
[0073] 2. Exemplary Net
[0074] FIG. 14 shows another exemplary gripping assembly (700).
Gripping assembly (700) comprises a balloon (718) and a net (710)
positioned around balloon (718). Balloon (718) is similar to
balloon (18). Net (710) comprises a proximal end (725) and a distal
end (729). Proximal end (725) is attached to proximal end (720) of
balloon (718) and is sized to correspond to the diameter of
proximal end (720). Distal end (729) is attached to distal end
(723) of balloon (718) and is sized to correspond to the diameter
of distal end (723). Net (710) comprises a center portion (726)
positioned between proximal end (725) and distal end (729). Center
portion (726) extends along the length of working length (724) of
balloon (718) and is sized to correspond to the diameter of working
length (724) when balloon (718) is inflated. A tapered portion
(727) couples proximal end (725) of net (710) with center portion
(726). Tapered portion (728) couples distal end (729) of net (710)
with center portion (726). Net (710) may cover the entire surface
of balloon (718) or may cover a portion of balloon (718). For
instance, net (710) may cover 50% of the surface of balloon (718).
Net (710) is flexible and is configured to expand and deflate with
balloon (718). Net (710) may be resilient, such that net (710)
returns to its original shape when balloon (718) is inflated. Net
(710) may comprise polyurethane, neoprene, and/or any other
suitable material(s).
[0075] Net (710) has a mesh configuration that creates shallow
dimples over the exterior of balloon (718). This allows mucus or
other bodily fluid within an airway to be displaced around net
(710) to increase the friction between balloon (718) and the airway
to decrease or prevent slipping of balloon (718) within the airway.
Net (710) may press against the mucosa lining hard enough to make
some of the lining bulge through net (710) to provide a shear
stress to increase traction. Net (710) may also increase the burst
strength of balloon (718).
[0076] 3. Exemplary Scoring Elements
[0077] FIGS. 15A-15B show another exemplary gripping assembly
(800). Gripping assembly (800) comprises a balloon (818) and a
scoring assembly (810) positioned around balloon (818). Balloon
(818) is similar to balloon (18). Scoring assembly (810) comprises
a proximal collar (812), a distal collar (816), and a plurality of
scoring elements (826) extending between collars (812, 816). In the
present example, scoring elements (826) are positioned in a helical
configuration between collars (812, 816). However, other
configurations may be used, such as a longitudinal configuration,
as will be apparent to one with ordinary skill in the art in view
of the teachings herein. Scoring elements (826) may have a sharp
outward edge configured to engage the airway of a patient. Scoring
elements (826) may be made from nitinol and/or any other suitable
material(s).
[0078] Proximal collar (812) is configured to translate along
proximal end (820) of balloon (818). Distal collar (816) is fixedly
secured to distal end (821) of balloon (818). Scoring elements
(826) are positioned over working length (824) of balloon (818) and
are configured to expand as proximal collar (812) translates. For
example, when proximal collar (812) is in a proximal position, as
shown in FIG. 15A, scoring elements (826) are in a collapsed state.
When proximal collar (812) is in a distal position, as shown in
FIG. 15B, scoring elements (826) are in an expanded state. Proximal
collar (812) may translate and scoring elements (826) may expand
when balloon (818) is inflated, such that balloon (818) pushes
scoring elements (826) to the expanded state. Alternatively,
proximal collar (812) may translate and scoring elements (826) may
expand separately from balloon (818). When scoring elements (826)
are in the collapsed state, scoring elements (826) are sized to be
smaller than an airway such that scoring elements (826) do not
contact an airway during the delivery of balloon (818) to a target
site. When scoring elements (826) expand, scoring elements (826)
engage the airway of a patient to provide a grip and increase
friction to decrease or prevent balloon (818) from slipping within
the airway.
[0079] In some versions, gripping assembly (800) may comprise a
luer (814) or other feature, as shown in FIGS. 16A-16C, to actuate
scoring elements (826). Luer (814) is positioned around shaft (12)
of balloon catheter (10). Leur (814) is coupled to proximal collar
(812) via shaft (815) positioned over shaft (12). Luer (814) is
translatable relative to shaft (12). Shaft (815) is sufficiently
rigid to communicate the translation of luer (814) to proximal
collar (812). As shown in FIG. 16A, luer (814) is in a proximal
position such that gripping assembly (800) is in a collapsed state.
Balloon (818) is also deflated. Gripping assembly (800) is
delivered through the airway to a targeted site in this collapsed
configuration. As shown in FIG. 16B, luer (810) is translated to a
distal position. This pushes proximal collar (812) distally via
shaft (815) to push scoring elements (826) against distal collar
(816) and expand scoring elements (826). Scoring elements (826)
thus engage the airway in the expanded configuration to grip the
airway. As shown in FIG. 16C, balloon (818) is then dilated within
scoring elements (826) to treat the stenosis. Balloon (818) may
also be dilated simultaneously with scoring elements (826), or
balloon (818) may be dilated before scoring elements (826) such
that balloon (818) pushes scoring elements (826) to expand. After
balloon (818) is deflated, luer (814) is pulled proximally to
collapse scoring elements (826) to facilitate the withdrawal of
gripping assembly (800) from the airway.
[0080] C. Exemplary Dumbbell Shaped Balloon
[0081] The shape of a balloon (18) may also be modified to provide
increased friction within an airway. For example, FIG. 17 shows an
exemplary balloon (918) with a dumbbell configuration. Balloon
(918) comprises a proximal end (920), an anchor portion (922), a
working length (924), an anchor portion (923), and a distal end
(921). Working length (924) is positioned between anchor portions
(922, 923). In the present example, working length (924) and anchor
portions (922, 923) form a single chamber. Anchor portions (922,
923) have a larger diameter than working length (924) when balloon
(918) is dilated. For instance, anchor portions (922, 923) may
expand to a diameter that is about 0.5 mm to about 2.5 mm larger
than the diameter of working length (924), such as about 1.0 mm
larger. Working length (924) is configured to treat a stenosis
within an airway and may have a length of about 1.0 mm to about 15
mm. The wall thickness of working length (924) is about 0.001'' to
about 0.004'' thick. Of course, any other suitable dimensions may
be used.
[0082] Anchor portions (922, 923) are configured to engage the
airway and increase the longitudinal stability of balloon (918)
within the airway. Anchor portions (922, 923) would be positioned
proximal and distal (respectively) to the stenosis (4), with
working length (924) being positioned in the stenosis (4). Anchor
portions (922, 923) have outer diameters that are greater than the
inner diameter of the stenosis (4), such that anchor portions (922,
923) engage the ends of the stenosis (4) to hold working length
(924) within the stenosis (4). The wall thickness of anchor
portions (922, 923) may be less than the wall thickness of working
length (924) such that anchor portions (922, 923) expand to a
larger diameter when balloon (918) is dilated. Working length (924)
may also be formed from a stiffer material than anchor portions
(922, 923) such that anchor portions (922, 923) expand to a larger
diameter when balloon (918) is dilated. Other suitable anchor
portion (922, 923) configurations will be apparent to one with
ordinary skill in the art in view of the teachings herein.
[0083] FIGS. 18-20 show another exemplary dumbbell shaped balloon
(1018) having a plurality of chambers. Balloon (1018) is similar to
balloon (918), except that anchor portion (1022), working length
(1024), and anchor portion (1023) each has a separate chamber that
may be inflated individually. Each chamber may be formed and then
bonded together. Because each chamber may be inflated separately,
each chamber may have its own compliance curve and diameter
control. A shaft (1010), as shown in FIGS. 19 and 20, extends
through balloon (1018). Shaft (1010) is coupled to shaft (12) of
balloon catheter (10). As shown in FIG. 19, shaft (1010) comprises
three lumens (1011, 1015, 1013), although any number of lumens may
be used. In the present example, center lumen (1015) is used to
insert an endoscope to provide visualization of the procedure, or
as an air ventilation port. Top lumen (1011) is used to translate
fluid to inflate anchor portions (1022, 1023). Bottom lumen (1013)
is used to translate fluid to inflate working length (1024). As
shown in FIG. 20, shaft (1010) comprises a port (1012) coupled with
anchor portion (1022), a port (1014) coupled with working length
(1024), and a port (1016) coupled with anchor portion (1023). Ports
(1012, 1016) are open to lumen (1011) to fluidly couple anchor
portions (1022, 1023) with lumen (1011). Port (1014) is open to
lumen (1013) to fluidly couple working length (1024) with lumen
(1013).
[0084] Accordingly, anchor portions (1022, 1023) and working length
(1024) are inflated separately, which allows anchor portions (1022,
1023) and working length (1024) to be inflated at different times
and to different diameters. For instance, balloon (1018) may be
inserted within a stenosis (4) in a deflated state. Fluid may then
be translated through lumen (1011) to inflate anchor portions
(1022, 1023) to a sufficient diameter to engage the airway on
either side of the stenosis (4). Once anchor portions (1022, 1023)
are inflated to hold balloon (1018) longitudinally in place within
the airway, fluid may then be translated through lumen (1013) to
inflate working length (1024). Working length (1024) may be
inflated to a smaller diameter than anchor portions (1022, 1023) to
expand the stenosis (4). Although anchor portions (1022, 1023) are
connected to lumen (1011) in the present example, anchor portions
(1022, 1023) may also have separate lumens to inflate anchor
portions (1022, 1023) individually. Other suitable lumen
configurations will be apparent to one with ordinary skill in the
art in view of the teachings herein.
[0085] D. Exemplary Balloon Positioning System
[0086] FIGS. 21-23B show an exemplary balloon positioning system
(1100). Balloon positioning system (1100) comprises a balloon
(1118) and a positioning device (1110). As shown in FIG. 21,
balloon (1118) is similar to balloon (18), except that balloon
(1118) comprises a plurality of magnetic elements (1126). Elements
(1126) are magnetic and are applied to the surface of working
length (1124). Any number, shape, and configuration of elements
(1126) may be used. As shown in FIG. 22, positioning device (1110)
comprises a magnetic portion (1114) positioned on a distal end of
shaft (1112). Magnetic portion (1114) is configured to attract to
magnetic elements (1126) of balloon (1118) with a force sufficient
to decrease or prevent movement of balloon (1118) within an airway.
Magnetic portion (1114) and magnetic elements (1126) may be
permanent magnets (e.g., a rare earth metal, etc.), or
electromagnets. If electromagnets are used, the magnetic portion
(1114) and/or magnetic elements (1126) may be selectively activated
and the force of magnetic portion (1114) and/or magnetic elements
(1126) may be adjusted. It should also be understood that some
versions may use just one magnet. For instance, balloon (1118) may
just include a ferromagnetic material while positioning device
(1110) includes a magnet (e.g., a permanent magnet such as a
neodymium iron boron (NdFeB or NIB), samarium cobalt (SmCo),
alnico, ceramic, or ferrite; or an electromagnet, etc.).
[0087] In an exemplary use, as shown in FIGS. 23A-23B, balloon
positioning system (1100) is used to position balloon (1118) at a
target site within an airway. As shown in FIG. 23A, balloon (1118)
is in a deflated state and is introduced through an airway (2) to a
target site within a stenosis (4). Positioning device (1110) is
positioned outside airway (2) such that magnetic portion (1114) is
above the target site. Positioning device (1110) may be positioned
within the body, or external to the body. Magnetic portion (1114)
attracts magnetic elements (1126) such that magnetic elements
(1126) are introduced through airway (2) with balloon (1118) until
magnetic elements (1126) are adjacent to magnetic portion (1114).
This provides the desired location of balloon (1118).
Alternatively, balloon (1118) may be moved to position within
stenosis (4), then positioning device (1110) may be moved to
position magnetic portion (1114) near magnetic elements (1126).
Balloon (1118) may then be inflated. As shown in FIG. 23B, balloon
(1118) is then dilated to expand the blocked region of airway (2).
The force between magnetic portion (1114) and magnetic elements
(1126) retain balloon (1118) at its longitudinal position within
airway (2) to decrease or prevent balloon (1118) from slipping when
balloon (1118) is dilated. Positioning device (1110) may be moved
away before or after deflation of balloon (1118) to enable removal
of balloon (1118) from airway (2).
[0088] As one merely illustrative variation of system (1100),
magnetic portion (1114) may be incorporated into a variation of
stylet (22) instead of an external positioning device (1110). The
modified stylet (22) may remain disposed within catheter (10) and
may be held stationary during inflation of balloon (1118). A
magnetic portion of the modified stylet (22) may be attracted to a
ferrous or magnetic portion of balloon (1118) or catheter (10) to
prevent longitudinal movement of balloon (1118) during inflation.
Still other suitable variations will be apparent to those of
ordinary skill in the art in view of the teachings herein.
[0089] III. Miscellaneous
[0090] As noted above, the exemplary variations of balloons and
other components described herein may be readily incorporated into
a sinuplasty system, such that the balloons described herein may be
used to dilate an ostium of a sinus. By way of example only, the
exemplary variations of balloons and other components described
herein may be readily combined with various teachings of U.S. Pub.
No. 2011/0004057, entitled "Systems and Methods for Transnasal
Dilation of Passageways in the Ear, Nose or Throat," published Jan.
6, 2011, the disclosure of which is incorporated by reference
herein. As yet another merely illustrative example, the exemplary
variations of balloons and other components described herein may be
readily incorporated into a Relieva.RTM. Spin Balloon
Sinuplasty.TM. System by Acclarent, Inc. of Menlo Park, Calif.
Other suitable ways in which the teachings herein may be applied to
the sinus dilation context and/or other anatomical passageway
dilation contexts will be apparent to those of ordinary skill in
the art.
[0091] It should be appreciated that any patent, publication, or
other disclosure material, in whole or in part, that is said to be
incorporated by reference herein is incorporated herein only to the
extent that the incorporated material does not conflict with
existing definitions, statements, or other disclosure material set
forth in this disclosure. As such, and to the extent necessary, the
disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference. Any
material, or portion thereof, that is said to be incorporated by
reference herein, but which conflicts with existing definitions,
statements, or other disclosure material set forth herein will only
be incorporated to the extent that no conflict arises between that
incorporated material and the existing disclosure material.
[0092] Versions of the devices disclosed herein can be designed to
be disposed of after a single use, or they can be designed to be
used multiple times. Versions may, in either or both cases, be
reconditioned for reuse after at least one use. Reconditioning may
include any combination of the steps of disassembly of the device,
followed by cleaning or replacement of particular pieces, and
subsequent reassembly. In particular, versions of the device may be
disassembled, and any number of the particular pieces or parts of
the device may be selectively replaced or removed in any
combination. Upon cleaning and/or replacement of particular parts,
versions of the device may be reassembled for subsequent use either
at a reconditioning facility, or by a surgical team immediately
prior to a surgical procedure. Those skilled in the art will
appreciate that reconditioning of a device may utilize a variety of
techniques for disassembly, cleaning/replacement, and reassembly.
Use of such techniques, and the resulting reconditioned device, are
all within the scope of the present application.
[0093] By way of example only, versions described herein may be
processed before surgery. First, a new or used instrument may be
obtained and if necessary cleaned. The instrument may then be
sterilized. In one sterilization technique, the instrument is
placed in a closed and sealed container, such as a plastic or TYVEK
bag. The container and instrument may then be placed in a field of
radiation that can penetrate the container, such as gamma
radiation, x-rays, or high-energy electrons. The radiation may kill
bacteria on the instrument and in the container. The sterilized
instrument may then be stored in the sterile container. The sealed
container may keep the instrument sterile until it is opened in a
surgical facility. A device may also be sterilized using any other
technique known in the art, including but not limited to beta or
gamma radiation, ethylene oxide, or steam.
[0094] Having shown and described various versions of the present
invention, further adaptations of the methods and systems described
herein may be accomplished by appropriate modifications by one of
ordinary skill in the art without departing from the scope of the
present invention. Several of such potential modifications have
been mentioned, and others will be apparent to those skilled in the
art. For instance, the examples, versions, geometrics, materials,
dimensions, ratios, steps, and the like discussed above are
illustrative and are not required. Accordingly, the scope of the
present invention should be considered in terms of the following
claims and is understood not to be limited to the details of
structure and operation shown and described in the specification
and drawings.
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