U.S. patent application number 17/065575 was filed with the patent office on 2021-03-25 for guidewire with integral expandable dilator.
The applicant listed for this patent is Acclarent, Inc.. Invention is credited to Itzhak Fang, Don Q. Ngo-Chu, Jetmir Palushi, Henry F. Salazar, David A. Smith, JR..
Application Number | 20210085929 17/065575 |
Document ID | / |
Family ID | 1000005263986 |
Filed Date | 2021-03-25 |
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United States Patent
Application |
20210085929 |
Kind Code |
A1 |
Ngo-Chu; Don Q. ; et
al. |
March 25, 2021 |
GUIDEWIRE WITH INTEGRAL EXPANDABLE DILATOR
Abstract
A dilation apparatus includes a handle assembly, a dilator, a
guidewire, and a steering assembly. The dilator is connected to the
handle assembly and is configured to transition between an
unexpanded state and an expanded state. The guidewire is
longitudinally fixed relative to the dilator. The steering assembly
is configured to laterally deflect at least a portion of the
guidewire relative to the handle assembly. The steering assembly
includes an actuator coupled with the handle assembly and a pull
wire extending between the actuator and guidewire. A portion of the
pull wire is attached to the guidewire. The actuator is configured
to move the pull wire relative to the handle assembly in order to
laterally deflect the at least a portion of the guidewire.
Inventors: |
Ngo-Chu; Don Q.; (Irvine,
CA) ; Palushi; Jetmir; (Irvine, CA) ; Fang;
Itzhak; (Irvine, CA) ; Salazar; Henry F.;
(Pico Rivera, CA) ; Smith, JR.; David A.; (Lake
Forest, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Acclarent, Inc. |
Irvine |
CA |
US |
|
|
Family ID: |
1000005263986 |
Appl. No.: |
17/065575 |
Filed: |
October 8, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15822509 |
Nov 27, 2017 |
10857333 |
|
|
17065575 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00323
20130101; A61M 25/0147 20130101; A61M 25/09 20130101; A61B 2017/003
20130101; A61M 2210/0681 20130101; A61B 1/07 20130101; A61M
2025/09008 20130101; A61M 2025/09083 20130101; A61M 2025/0186
20130101; A61B 34/20 20160201; A61M 29/02 20130101; A61B 1/00195
20130101; A61B 1/313 20130101; A61B 2017/22051 20130101; A61M
2025/1093 20130101; A61M 2025/09175 20130101; A61B 2090/306
20160201; A61B 2034/2051 20160201; A61M 2025/0166 20130101; A61B
2017/22062 20130101; A61M 25/09041 20130101; A61G 15/00 20130101;
A61M 3/0283 20130101; A61B 17/24 20130101; A61B 5/066 20130101;
A61B 2034/2072 20160201 |
International
Class: |
A61M 25/09 20060101
A61M025/09; A61B 5/06 20060101 A61B005/06; A61B 17/24 20060101
A61B017/24; A61B 34/20 20060101 A61B034/20; A61B 1/07 20060101
A61B001/07; A61M 25/01 20060101 A61M025/01; A61M 29/02 20060101
A61M029/02 |
Claims
1-15. (canceled)
16. A dilation apparatus, the dilation apparatus comprising: (a) a
handle assembly; (b) an elongated shaft assembly extending distally
from the handle assembly; (c) a dilator coupled with the elongated
shaft, wherein the dilator is configured to transition from an
unexpanded state to an expanded state; and (d) a guidewire
extending distally from the dilator, wherein the guidewire is
longitudinally fixed relative to the dilator, wherein the guidewire
comprises: (i) a proximal portion defining an axis, and (ii) a
distal portion comprising a bent distal end, wherein the bent
distal end defines an oblique angle with the axis, wherein the
guidewire is directly coupled to the dilator at a fixed location
that is distally spaced apart from the elongated shaft
assembly.
17. The dilation apparatus of claim 16, wherein the bent distal end
of the guidewire is resiliently biased toward the oblique
angle.
18. (canceled)
19. A dilation apparatus, the dilation apparatus comprising: (a) a
guidewire extending from a proximal end to a distal end, wherein
the guidewire comprises: (i) a coil comprising an exterior surface,
wherein the coil defines an interior, and (ii) a core wire
extending within the interior of the coil; (b) a connector coupled
with the proximal end of the guidewire; (c) an inflatable dilator
configured to transition between an inflated state and a deflated
state, wherein the inflatable dilator is longitudinally fixed to
the exterior surface of the coil; and (d) an inflation tube,
wherein the inflation tube extends within the interior of the coil,
wherein a portion of the inflation tube extends from the interior
of the coil toward the exterior surface of the coil encompassed by
the inflatable dilator, wherein the inflation tube is in fluid
communication with the inflatable dilator.
20. The dilation apparatus of claim 19, wherein the inflation tube
extends through the connector and terminates into an inflation
port.
21. A dilation apparatus, the dilation apparatus comprising: (a) a
handle assembly; (b) a dilator having a distal dilator end and
being configured to transition between an unexpanded state and an
expanded state, wherein the dilator is expandable along a length of
the dilator to the distal dilator end, wherein the dilator is
connected to the handle assembly; and (c) a guidewire having a
proximal guidewire end and extending distally from the dilator,
wherein the guidewire includes a coil terminating at the proximal
guidewire end, wherein the proximal guidewire end is fixed against
movement relative to the distal dilator end.
22. The dilation apparatus of claim 21, wherein the guidewire has a
distal guidewire end, wherein the coil extends from the proximal
guidewire end toward the distal guidewire end.
23. The dilation apparatus of claim 21, wherein the dilator has a
proximal dilator end, wherein the length of the dilator extends
from the proximal dilator end to the distal dilator end.
24. The dilation apparatus of claim 21, wherein the guidewire
includes a bent distal end.
25. The dilation apparatus of claim 24, wherein the guidewire
comprises: a proximal portion defining an axis, and (ii) a distal
portion presenting the bent distal end, wherein the bent distal end
defines an oblique angle with the axis.
26. The dilation apparatus of claim 25, wherein the bent distal end
is resiliently biased.
27. The dilation apparatus of claim 26, wherein the bent distal end
is resiliently biased toward the oblique angle.
28. The dilation apparatus of claim 21, further comprising a
hollow-elongate shaft extending from the handle assembly to the
dilator.
29. The dilation apparatus of claim 28, wherein the hollow-elongate
shaft defines a first lumen in fluid communication with the dilator
in order to transition the dilator from the unexpanded state to the
expanded state.
30. The dilation apparatus of claim 29, wherein the hollow-elongate
shaft defines a second lumen housing an elongated connecting
member, wherein the elongated connecting member extends from the
handle assembly to a distal end of the guidewire.
31. The dilation apparatus of claim 30, wherein the elongated
connecting member is attached to a coupling unit.
32. The dilation apparatus of claim 31, wherein the elongated
connecting member comprises an illumination fiber.
33. The dilation apparatus of claim 31, wherein the elongated
connecting member comprises a coil, wherein the coil and the
coupling unit are configured for use with an IGS navigation
system.
34. The dilation apparatus of claim 21, wherein the guidewire
includes a core wire.
35. The dilation apparatus of claim 34, wherein the coil defines an
interior, wherein the core wire extends within the interior of the
coil.
36. The dilation apparatus of claim 21, wherein the dilator
comprises an inflatable balloon.
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 (e.g., to treat sinusitis), dilation of
the larynx, dilation of the Eustachian tube, dilation of other
passageways within the ear, nose, or throat, etc. One method of
dilating anatomical passageways includes using a guide wire and
guide 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. For instance,
the expandable balloon may be positioned within an ostium at a
paranasal sinus and then be inflated, to thereby dilate the ostium
by remodeling the bone adjacent to the ostium, without requiring
incision of the mucosa or removal of any bone. The dilated ostium
may then allow for improved drainage from and ventilation of the
affected paranasal sinus. A system that may be used to perform such
procedures may be provided in accordance with the 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. An example of such a system is the Relieva.RTM. Spin
Balloon Sinuplasty.TM. System by Acclarent, Inc. of Irvine,
Calif.
[0002] A variable direction view endoscope may be used with such a
system to provide visualization within the anatomical passageway
(e.g., the ear, nose, throat, paranasal sinuses, etc.) to position
the balloon at desired locations. A variable direction view
endoscope may enable viewing along a variety of transverse viewing
angles without having to flex the shaft of the endoscope within the
anatomical passageway. Such an endoscope that may be provided in
accordance with the teachings of U.S. Pub. No. 2010/0030031,
entitled "Swing Prism Endoscope," published Feb. 4, 2010, the
disclosure of which is incorporated by reference herein.
[0003] While a variable direction view endoscope may be used to
provide visualization within the anatomical passageway, it may also
be desirable to provide additional visual confirmation of the
proper positioning of the balloon before inflating the balloon.
This may be done using an illuminating guidewire. Such a guidewire
may be positioned within the target area and then illuminated, with
light projecting from the distal end of the guidewire. This light
may illuminate the adjacent tissue (e.g., hypodermis, subdermis,
etc.) and thus be visible to the naked eye from outside the patient
through transcutaneous illumination. For instance, when the distal
end is positioned in the maxillary sinus, the light may be visible
through the patient's cheek. Using such external visualization to
confirm the position of the guidewire, the balloon may then be
advanced distally along the guidewire into position at the dilation
site. Such an illuminating guidewire may be provided in accordance
with the teachings of U.S. Pub. No. 2012/0078118, entitled "Sinus
Illumination Lightwire Device," published Mar. 29, 2012, the
disclosure of which is incorporated by reference herein. An example
of such an illuminating guidewire is the Relieva Luma Sentry.TM.
Sinus Illumination System by Acclarent, Inc. of Irvine, Calif.
[0004] Image-guided surgery (IGS) is a technique where a computer
is used to obtain a real-time correlation of the location of an
instrument that has been inserted into a patient's body to a set of
preoperatively obtained images (e.g., a CT or MRI scan, 3-D map,
etc.) so as to superimpose the current location of the instrument
on the preoperatively obtained images. In some IGS procedures, a
digital tomographic scan (e.g., CT or MRI, 3-D map, etc.) of the
operative field is obtained prior to surgery. A specially
programmed computer is then used to convert the digital tomographic
scan data into a digital map. During surgery, special instruments
having sensors (e.g., electromagnetic coils that emit
electromagnetic fields and/or are responsive to externally
generated electromagnetic fields) mounted thereon are used to
perform the procedure while the sensors send data to the computer
indicating the current position of each surgical instrument. The
computer correlates the data it receives from the
instrument-mounted sensors with the digital map that was created
from the preoperative tomographic scan. The tomographic scan images
are displayed on a video monitor along with an indicator (e.g.,
cross hairs or an illuminated dot, etc.) showing the real time
position of each surgical instrument relative to the anatomical
structures shown in the scan images. In this manner, the surgeon is
able to know the precise position of each sensor-equipped
instrument by viewing the video monitor even if the surgeon is
unable to directly visualize the instrument itself at its current
location within the body.
[0005] Examples of electromagnetic IGS systems that may be used in
ENT and sinus surgery include the InstaTrak ENT.TM. systems
available from GE Medical Systems, Salt Lake City, Utah. Other
examples of electromagnetic image guidance systems that may be
modified for use in accordance with the present disclosure include
but are not limited to the CARTO.RTM. 3 System by Biosense-Webster,
Inc., of Diamond Bar, California; systems available from Surgical
Navigation Technologies, Inc., of Louisville, Colo.; and systems
available from Calypso Medical Technologies, Inc., of Seattle,
Wash.
[0006] When applied to functional endoscopic sinus surgery (FESS),
balloon sinuplasty, and/or other ENT procedures, the use of image
guidance systems allows the surgeon to achieve more precise
movement and positioning of the surgical instruments than can be
achieved by viewing through an endoscope alone. This is so because
a typical endoscopic image is a spatially limited, 2-dimensional,
line-of-sight view. The use of image guidance systems provides a
real time, 3-dimensional view of all of the anatomy surrounding the
operative field, not just that which is actually visible in the
spatially limited, 2-dimensional, direct line-of-sight endoscopic
view. As a result, image guidance systems may be particularly
useful during performance of FESS, balloon sinuplasty, and/or other
ENT procedures where a section and/or irrigation source may be
desirable, especially in cases where normal anatomical landmarks
are not present or are difficult to visualize endoscopically.
[0007] It may be desirable to provide easily controlled placement
of a balloon in dilation procedures, including procedures that will
be performed only by a single operator. While several systems and
methods have been made and used to inflate an inflatable member
such as a dilation balloon, it is believed that no one prior to the
inventors has made or used the invention described in the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] 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:
[0009] FIG. 1 depicts a side elevational view of an exemplary
dilation catheter system;
[0010] FIG. 2A depicts a side elevational view of an exemplary
illuminating guidewire of the dilation catheter system of FIG.
1;
[0011] FIG. 2B depicts a side elevational view of an exemplary
guide catheter of the dilation catheter system of FIG. 1;
[0012] FIG. 2C depicts a side elevational view of an exemplary
dilation catheter of the dilation catheter system of FIG. 1;
[0013] FIG. 3 depicts a detailed side elevational view of the
illuminating guide wire of FIG. 2A;
[0014] FIG. 4 depicts a detailed side cross-sectional view of the
illuminating guidewire of FIG. 2A;
[0015] FIG. 5 depicts a perspective view of an exemplary endoscope
suitable for use with the dilation catheter system of FIG. 1;
[0016] FIG. 6 depicts a side elevational view of the distal end of
the endoscope of FIG. 5, showing an exemplary range of viewing
angles;
[0017] FIG. 7A depicts a front view of the guide catheter of FIG.
2B positioned adjacent an ostium of the maxillary sinus;
[0018] FIG. 7B depicts a front view of the guide catheter of FIG.
2B positioned adjacent an ostium of the maxillary sinus, with the
dilation catheter of FIG. 2C and the illuminating guidewire of FIG.
2A positioned in the guide catheter and a distal portion of the
guidewire positioned in the maxillary sinus;
[0019] FIG. 7C depicts a front view of the guide catheter of FIG.
2B positioned adjacent an ostium of the maxillary sinus, with the
illuminating guidewire of FIG. 2A translated further distally
relative to the guide catheter and into the maxillary sinus;
[0020] FIG. 7D depicts a front view of the guide catheter of FIG.
2B positioned adjacent an ostium of the maxillary sinus, with the
dilation catheter of FIG. 2C translated distally relative to the
guide catheter along the illuminating guidewire of FIG. 2A so as to
position a balloon of the dilation catheter within the ostium;
[0021] FIG. 7E depicts a front view of an ostium of the maxillary
sinus, with the ostium having been enlarged by inflation of the
balloon of FIG. 7D;
[0022] FIG. 8 depicts a schematic perspective view of an exemplary
image-guided surgery navigation system;
[0023] FIG. 9 depicts a perspective view of a frame component of
the image-guided surgery navigation system of FIG. 8;
[0024] FIG. 10 depicts a perspective view of an exemplary medical
procedure chair, with the frame component of the image-guided
surgery navigation system of FIG. 12 mounted to the chair;
[0025] FIG. 11 depicts a perspective view of a patient seated in
the medical procedure chair of FIG. 10, with the image-guided
surgery navigation system of FIG. 8 being used to perform a
procedure on the patient while seated in the chair;
[0026] FIG. 12 depicts an elevational side view of an alternative
dilation catheter;
[0027] FIG. 13 depicts a cross-sectional view of the dilation
catheter of FIG. 12, taken along line 13-13 of FIG. 12;
[0028] FIG. 14 depicts a cross-sectional view of the dilation
catheter of FIG. 12, taken along line 14-14 of FIG. 12;
[0029] FIG. 15 depicts an elevational side view of an alternative
guidewire having an integral expandable dilator;
[0030] FIG. 16 depicts a cross-sectional view of the guidewire of
FIG. 15, taken along line 16-16 of FIG. 15;
[0031] FIGS. 17 depicts a detailed side cross-sectional view of the
guidewire of FIG. 15;
[0032] FIG. 18A depicts an elevational side view of an alternative
dilation catheter, where a slider is in a first position and a
distally extending fixed guidewire is in a straight
configuration;
[0033] FIG. 18B depicts an elevational side view of the dilation
catheter of FIG. 18A, where the slider is in a second position and
the distally extending fixed guidewire is in a bent
configuration;
[0034] FIG. 19 depicts a cross-sectional view of the dilation
catheter of FIG. 18A, taken along line 19-19 of FIG. 18A; and
[0035] FIG. 20 depicts a cross-sectional view of the dilation
catheter of FIG. 18A, taken along line 20-20 of FIG. 18A.
[0036] 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
[0037] 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. For example, while various. Accordingly, the drawings
and descriptions should be regarded as illustrative in nature and
not restrictive.
[0038] 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.
[0039] 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.
[0040] I. Overview of Exemplary Dilation Catheter System
[0041] FIG. 1 shows an exemplary dilation catheter system (10) that
may be used to dilate the ostium of a paranasal sinus; or to dilate
some other anatomical passageway (e.g., within the ear, nose, or
throat, etc.). Dilation catheter system (10) of this example
comprises a dilation catheter (20), a guide catheter (30), an
inflator (40), and a guidewire (50). By way of example only,
dilation catheter system (10) may be configured in accordance with
at least some of the teachings of U.S. Patent Pub. No.
2011/0004057, the disclosure of which is incorporated by reference
herein. In some versions, at least part of dilation catheter system
(10) is configured similar to the Relieva.RTM. Spin Balloon
Sinuplasty.TM. System by Acclarent, Inc. of Irvine, Calif.
[0042] As best seen in FIG. 2C, the distal end (DE) of dilation
catheter (20) includes an inflatable dilator (22). The proximal end
(PE) of dilation catheter (20) includes a grip (24), which has a
lateral port (26) and an open proximal end (28). A hollow-elongate
shaft (18) extends distally from grip (24). Dilation catheter (20)
includes a first lumen (not shown) formed within shaft (18) that
provides fluid communication between lateral port (26) and the
interior of dilator (22). Dilator catheter (20) also includes a
second lumen (not shown) formed within shaft (18) that extends from
open proximal end (28) to an open distal end that is distal to
dilator (22). This second lumen is configured to slidably receive
guidewire (50). The first and second lumens of dilator catheter
(20) are fluidly isolated from each other. Thus, dilator (22) may
be selectively inflated and deflated by communicating fluid along
the first lumen via lateral port (26) while guidewire (50) is
positioned within the second lumen. In some versions, dilator
catheter (20) is configured similar to the Relieva Ultirra.TM.
Sinus Balloon Catheter by Acclarent, Inc. of Irvine, Calif. In some
other versions, dilator catheter (20) is configured similar to the
Relieva Solo Pro.TM. Sinus Balloon Catheter by Acclarent, Inc. of
Irvine, Calif. Other suitable forms that dilator catheter (20) may
take will be apparent to those of ordinary skill in the art in view
of the teachings herein.
[0043] As best seen in FIG. 2B, guide catheter (30) of the present
example includes a bent distal portion (32) at its distal end (DE)
and a grip (34) at its proximal end (PE). Grip (34) has an open
proximal end (36). Guide catheter (30) defines a lumen that is
configured to slidably receive dilation catheter (20), such that
guide catheter (30) may guide dilator (22) out through bent distal
end (32). In some versions, guide catheter (30) is configured
similar to the Relieva Flex.TM. Sinus Guide Catheter by Acclarent,
Inc. of Irvine, Calif. Other suitable forms that guide catheter
(30) may take will be apparent to those of ordinary skill in the
art in view of the teachings herein.
[0044] Referring back to FIG. 1, inflator (40) of the present
example comprises a barrel (42) that is configured to hold fluid
and a plunger (44) that is configured to reciprocate relative to
barrel (42) to selectively discharge fluid from (or draw fluid
into) barrel (42). Barrel (42) is fluidly coupled with lateral port
(26) via a flexible tube (46). Thus, inflator (40) is operable to
add fluid to dilator (22) or withdraw fluid from dilator (22) by
translating plunger (44) relative to barrel (42). In the present
example, the fluid communicated by inflator (40) comprises saline,
though it should be understood that any other suitable fluid may be
used. There are various ways in which inflator (40) may be filled
with fluid (e.g., saline, etc.). By way of example only, before
flexible tube (46) is coupled with lateral port (26), the distal
end of flexible tube (46) may be placed in a reservoir containing
the fluid. Plunger (44) may then be retracted from a distal
position to a proximal position to draw the fluid into barrel (42).
Inflator (40) may then be held in an upright position, with the
distal end of barrel (42) pointing upwardly, and plunger (44) may
then be advanced to an intermediate or slightly distal position to
purge any air from barrel (42). The distal end of flexible tube
(46) may then be coupled with lateral port (26). In some versions,
inflator (40) is constructed and operable in accordance with at
least some of the teachings of U.S. Pub. No. 2014/0074141, entitled
"Inflator for Dilation of Anatomical Passageway," published Mar.
13, 2014, the disclosure of which is incorporated by reference
herein.
[0045] As shown in FIGS. 2A, 3, and 4, guidewire (50) of the
present example comprises a coil (52) positioned about a core wire
(54). An illumination fiber (56) extends along the interior of core
wire (54) and terminates in an atraumatic lens (58). A connector
(55) at the proximal end of guidewire (50) enables optical coupling
between illumination fiber (56) and a light source (not shown).
Illumination fiber (56) may comprise one or more optical fibers.
Lens (58) is configured to project light when illumination fiber
(56) is illuminated by the light source, such that illumination
fiber (56) transmits light from the light source to the lens (58).
In some versions, the distal end of guidewire (50) is more flexible
than the proximal end of guidewire (50). Guidewire (50) has a
length enabling the distal end of guidewire (50) to be positioned
distal to dilator (22) while the proximal end of guidewire (50) is
positioned proximal to grip (24). Guidewire (50) may include
indicia along at least part of its length (e.g., the proximal
portion) to provide the operator with visual feedback indicating
the depth of insertion of guidewire (50) relative to dilation
catheter (20). By way of example only, guidewire (50) may be
configured in accordance with at least some of the teachings of
U.S. Pub. No. 2012/0078118, the disclosure of which is incorporated
by reference herein. In some versions, guidewire (50) is configured
similar to the Relieva Luma Sentry.TM. Sinus Illumination System by
Acclarent, Inc. of Irvine, Calif. Other suitable forms that
guidewire (50) may take will be apparent to those of ordinary skill
in the art in view of the teachings herein.
[0046] II. Overview of Exemplary Endoscope
[0047] As noted above, an endoscope (60) may be used to provide
visualization within an anatomical passageway (e.g., within the
nasal cavity, etc.) during a process of using dilation catheter
system (10). As shown in FIGS. 4-5, endoscope of the present
example comprises a body (62) and a rigid shaft (64) extending
distally from body (62). The distal end of shaft (64) includes a
curved transparent window (66). A plurality of rod lenses and light
transmitting fibers may extend along the length of shaft (64). A
lens is positioned at the distal end of the rod lenses and a swing
prism is positioned between the lens and window (66). The swing
prism is pivotable about an axis that is transverse to the
longitudinal axis of shaft (64). The swing prism defines a line of
sight that pivots with the swing prism. The line of sight defines a
viewing angle relative to the longitudinal axis of shaft (64). This
line of sight may pivot from approximately 0 degrees to
approximately 120 degrees, from approximately 10 degrees to
approximately 90 degrees, or within any other suitable range. The
swing prism and window (66) also provide a field of view spanning
approximately 60 degrees (with the line of sight centered in the
field of view). Thus, the field of view enables a viewing range
spanning approximately 180 degrees, approximately 140 degrees, or
any other range, based on the pivot range of the swing prism. Of
course, all of these values are mere examples.
[0048] Body (62) of the present example includes a light post (70),
an eyepiece (72), a rotation dial (74), and a pivot dial (76).
Light post (70) is in communication with the light transmitting
fibers in shaft (64) and is configured to couple with a source of
light, to thereby illuminate the site in the patient distal to
window (66). Eyepiece (72) is configured to provide visualization
of the view captured through window (66) via the optics of
endoscope (60). It should be understood that a visualization system
(e.g., camera and display screen, etc.) may be coupled with
eyepiece (72) to provide visualization of the view captured through
window (66) via the optics of endoscope (60). Rotation dial (74) is
configured to rotate shaft (64) relative to body (62) about the
longitudinal axis of shaft (64). It should be understood that such
rotation may be carried out even while the swing prism is pivoted
such that the line of sight is non-parallel with the longitudinal
axis of shaft (64). Pivot dial (76) is coupled with the swing prism
and is thereby operable to pivot the swing prism about the
transverse pivot axis. Indicia (78) on body (62) provide visual
feedback indicating the viewing angle. Various suitable components
and arrangements that may be used to couple rotation dial (74) with
the swing prism will be apparent to those of ordinary skill in the
art in view of the teachings herein. By way of example only,
endoscope (60) may be configured in accordance with at least some
of the teachings of U.S. Pub. No. 2010/0030031, the disclosure of
which is incorporated by reference herein. Other suitable forms
that endoscope (60) may take will be apparent to those of ordinary
skill in the art in view of the teachings herein
[0049] III. Exemplary Method for Dilating the Ostium of a Maxillary
Sinus
[0050] FIGS. 7A-7E show an exemplary method for using dilation
catheter system (10) discussed above to dilate a sinus ostium (O)
of a maxillary sinus (MS) of a patient. While the present example
is being provided in the context of dilating a sinus ostium (O) of
a maxillary sinus (MS), it should be understood that dilation
catheter system (10) may be used in various other procedures. By
way of example only, dilation catheter system (10) and variations
thereof may be used to dilate a Eustachian tube, a larynx, a
choana, a sphenoid sinus ostium, one or more openings associated
with one or more ethmoid sinus air cells, the frontal recess,
and/or other passageways associated with paranasal sinuses. Other
suitable ways in which dilation catheter system (10) may be used
will be apparent to those of ordinary skill in the art in view of
the teachings herein.
[0051] In the procedure of the present example, guide catheter (30)
may be inserted transnasally and advanced through the nasal cavity
(NC) to a position within or near the targeted anatomical
passageway to be dilated, the sinus ostium (O), as shown in FIG.
7A. Inflatable dilator (22) and the distal end of guidewire (50)
may be positioned within or proximal to bent distal end (32) of
guide catheter (30) at this stage. This positioning of guide
catheter (30) may be verified endoscopically with an endoscope such
as endoscope (60) described above and/or by direct visualization,
radiography, and/or by any other suitable method. After guide
catheter (30) has been positioned, the operator may advance
guidewire (50) distally through guide catheter (30) such that a
distal portion of the guidewire (50) passes through the ostium (O)
of the maxillary sinus (MS) and into the cavity of the maxillary
sinus (MS) as shown in FIGS. 7B and 7C. The operator may illuminate
illumination fiber (56) and lens (58), which may provide
transcutaneous illumination through the patient's face to enable
the operator to visually confirm positioning of the distal end of
guidewire (50) in the maxillary sinus (MS) with relative ease.
[0052] As shown in FIG. 7C, with guide catheter (30) and guidewire
(50) suitably positioned, dilation catheter (20) is advanced along
guidewire (50) and through bent distal end (32) of guide catheter
(30), with dilator (22) in a non-dilated state until dilator (22)
is positioned within the ostium (0) of the maxillary sinus (MS) (or
some other targeted anatomical passageway). After dilator (22) has
been positioned within the ostium (O), dilator (22) may be
inflated, thereby dilating the ostium (O), as shown in FIG. 7D. To
inflate dilator (22), plunger (44) may be actuated to push saline
from barrel (42) of inflator (40) through dilation catheter (20)
into dilator (22). The transfer of fluid expands dilator (22) to an
expanded state to open or dilate the ostium (O), such as by
remodeling the bone, etc., forming ostium (O). By way of example
only, dilator (22) may be inflated to a volume sized to achieve
about 10 to about 12 atmospheres. Dilator (22) may be held at this
volume for a few seconds to sufficiently open the ostium (O) (or
other targeted anatomical passageway). Dilator (22) may then be
returned to a non-expanded state by reversing plunger (44) of
inflator (40) to bring the saline back to inflator (40). Dilator
(22) may be repeatedly inflated and deflated in different ostia
and/or other targeted anatomical passageways. Thereafter, dilation
catheter (20), guidewire (50), and guide catheter (30) may be
removed from the patient as shown in FIG. 7E.
[0053] In some instances, it may be desirable to irrigate the sinus
and paranasal cavity after dilation catheter (20) has been used to
dilate the ostium (O). Such irrigation may be performed to flush
out blood, etc. that may be present after the dilation procedure.
For example, in some cases, guide catheter (30) may be allowed to
remain in place after removal of guidewire (50) and dilation
catheter (20) and a lavage fluid, other substance, or one or more
other devices (e.g., lavage catheters, balloon catheters, cutting
balloons, cutters, chompers, rotating cutters, rotating drills,
rotating blades, sequential dilators, tapered dilators, punches,
dissectors, burs, non-inflating mechanically expandable members,
high frequency mechanical vibrators, dilating stents and
radiofrequency ablation devices, microwave ablation devices, laser
devices, snares, biopsy tools, scopes, and devices that deliver
diagnostic or therapeutic agents) may be passed through guide
catheter (30) for further treatment of the condition. By way of
example only, irrigation may be carried out in accordance with at
least some of the teachings of U.S. Pat. No. 7,630,676, entitled
"Methods, Devices and Systems for Treatment and/or Diagnosis of
Disorders of the Ear, Nose and Throat," issued Dec. 8, 2009, the
disclosure of which is incorporated by reference herein. An example
of an irrigation catheter that may be fed through guide catheter
(30) to reach the irrigation site after removal of dilation
catheter (20) is the Relieva Vortex.RTM. Sinus Irrigation Catheter
by Acclarent, Inc. of Irvine, Calif. Another example of an
irrigation catheter that may be fed through guide catheter (30) to
reach the irrigation site after removal of dilation catheter (20)
is the Relieva Ultirra.RTM. Sinus Irrigation Catheter by Acclarent,
Inc. of Irvine, Calif. Of course, irrigation may be provided in the
absence of a dilation procedure; and a dilation procedure may be
completed without also including irrigation.
[0054] IV. Exemplary Image Guided Surgery Navigation System
[0055] FIGS. 8 and 9 show an exemplary image-guided surgery (IGS)
navigation system (600) configured to performed a Eustachian tube
(ET) treatment procedure on a patient (P). As described in greater
detail below, IGS navigation system (600) includes a computer used
to obtain a real-time correlation of the location of an instrument
that has been inserted into the patient's body, such as a balloon
dilation catheter (200) that may be substantially similar to
dilation catheter (20) described above, to a set of preoperatively
obtained images (e.g., a CT or MRI scan, 3-D map, etc.) so as to
superimpose the current location of the instrument on the
preoperatively obtained images. In some instances, a digital
tomographic scan (e.g., CT or MRI, 3-D map, etc.) of the operative
field is obtained prior to surgery. A specially programmed computer
is then used to convert the digital tomographic scan data into a
digital map. During surgery, an instrument having one or more
sensors (e.g., electromagnetic coils that emit electromagnetic
fields and/or are responsive to externally generated
electromagnetic fields) mounted thereon is used to perform the
procedure while the sensors send data to the computer, indicating
the current position of the surgical instrument. The computer
correlates the data it receives from the instrument-mounted sensors
with the digital map that was created from the preoperative
tomographic scan. The tomographic scan images are displayed on a
video monitor along with an indicator (e.g., cross hairs or an
illuminated dot, etc.) showing the real-time position of the
surgical instrument relative to the anatomical structures shown in
the scan images. In this manner, the surgeon is able to know the
precise position of the sensor-equipped instrument by viewing the
video monitor, even if the surgeon is unable to directly visualize
the instrument itself at its current location within the body.
[0056] IGS navigation system (600) incorporates balloon dilation
catheter (200) described above, and may further incorporate a
suitable guide catheter (100) that may be substantially similar to
guide catheter (30) described above. As described in greater detail
below, IGS navigation system (600) is configured to implement a
navigation sensor (not shown) at the distal end of dilation
catheter (200) to provide real-time location tracking of the distal
end of dilation catheter (200) within the patient (P) during a
surgical procedure, and thereby facilitate accurate positioning of
dilation catheter (200) within the patient (P). While IGS
navigation system (600) is described below in connection with the
positioning of balloon dilation catheter (200) and variations
thereof within the ostium (0) of the maxilary sinus (MS), it will
be appreciated that IGS navigation system (600) may also be
employed in procedures for accessing and treating various other
anatomical passageways of a patient with dilation catheter (200)
and the variations thereof.
[0057] IGS navigation system (600) of the present example includes
a set of magnetic field generators (602). Before a surgical
procedure begins, field generators (602) are positioned about the
head of the patient (P). As best shown in FIG. 9, in the present
example field generators (602) arranged integrally within a frame
(604) having a horseshoe-like shape and configured to be positioned
about the patient's head. In the example of FIG. 8, patient (P) is
positioned on a medical procedure table (620), and frame (604) is
positioned above table (620) and about the patient's head. Frame
(604) may be mounted to any suitable support structure (not shown),
which may be coupled directly to medical procedure table (620) or
provided independently from table (620), such as a floor-mounted
stand. In other examples, frame (604) may be secured directly to
the head of patient (P). It should be understood that field
generators (602) may be positioned at various other suitable
locations relative to patient (P), and on various other suitable
structures.
[0058] FIGS. 10 and 11 show another exemplary implementation of IGS
navigation system (600), in which patient (P) is seated in a
medical procedure chair (630). Frame (604) is mounted to a headrest
(632) of chair (630) such that frame (604) extends about the head
of patient (P) when seated in chair (630). Medical procedure chair
(630) may be configured according to one or more teachings of U.S.
patent application Ser. No. 62/555,824, entitled "Apparatus to
Secure Field Generating Device to Chair," filed Sep. 8, 2017, the
disclosure of which is incorporated by reference herein.
[0059] Field generators (602) of IGS navigation system (600) are
operable to transmit alternating magnetic fields of different
frequencies into a region in proximity to frame (604), and thereby
generate an electromagnetic field in the region. In the present
example, field generators (602) and frame (604) are arranged
relative to the patient (P) such that the resulting electromagnetic
field is formed about the patient's head. In other examples, field
generators (602) and frame (604) may be suitably arranged in
various other manners so as to generate an electromagnetic field
about various other portions of the patient's body. Various
suitable components that may be used to form and drive field
generators (602) will be apparent to those of ordinary skill in the
art in view of the teachings herein.
[0060] Field generators (602) enable tracking of the position of
navigation sensor (not shown), and thus the distal end of balloon
dilation catheter (200) when navigation sensor (not shown) moves
through the electromagnetic field generated by field generators
(602). In particular, as described in greater detail below,
electromagnetic navigation sensor (not shown) of balloon dilation
catheter (200) is configured to interact with the electromagnetic
field and generate an electric signal in response to movement of
sensor (not shown) through the electromagnetic field. Navigation
sensor (not shown) then communicates this signal to a processor
(606) of IGS navigation system (600). Processor (606), in turn,
receives the signal and determines the three-dimensional location
of navigation sensor (not shown), and the distal end of balloon
dilation cathter (200) at which sensor (not shown) is arranged,
within the electromagnetic field and thus the patient. While in the
current example navigation sensor (not shown) is implemented at the
distal end of dilation catheter (200), it should be understood that
navigation sensor (not shown) may alternatively or additionally be
implemented at the distal end of guidewire (50), the distal end of
guide catheter (30, 100), or in any other suitable location within
a suitable instrument as would be apparent to one having ordinary
skill in the art in view of the teachings herein.
[0061] Processor (606) of IGS navigation system (600) comprises a
processing unit that communicates with one or more memories, and is
configured to control field generators (602) and other elements of
IGS navigation system (600). In the present example, processor
(606) is mounted in a console (608), which comprises operating
controls (610) that include a keypad and/or a pointing device such
as a mouse or trackball. A physician uses operating controls (610)
to interact with processor (606) while performing the surgical
procedure. Processor (606) uses software stored in a memory of
processor (606) to calibrate and operate system (600). Such
operation includes driving field generators (602), processing data
received from navigation sensor (not shown), processing data from
operating controls (610), and driving display screen (612). The
software may be downloaded to processor (606) in electronic form,
over a network, for example, or it may, alternatively or
additionally, be provided and/or stored on non-transitory tangible
media, such as magnetic, optical, or electronic memory.
[0062] Processor (606) is further operable to provide video in real
time via display screen (612), showing the position of the distal
end of balloon dilation catheter (200) in relation to a video
camera image of the patient's head, a CT scan image of the
patient's head, and/or a computer generated three-dimensional model
of the anatomy within and adjacent to the patient's nasal cavity.
Display screen (612) may display such images simultaneously and/or
superimposed on each other. Moreover, display screen (612) may
display such images during the surgical procedure. Such displayed
images may also include graphical representations of instruments
that are inserted in the patient's head, such as dilation catheter
(200), such that the physician may view the virtual rendering of
the instrument at its actual location in real time. Such graphical
representations may look like the instrument or may be a much
simpler representation such as a dot, crosshairs, etc. By way of
example only, display screen (612) may provide images in accordance
with at least some of the teachings of U.S. Pat. Pub. No.
2016/0008083, entitled "Guidewire Navigation for Sinuplasty,"
published Jan. 14, 2016, the disclosure of which is incorporated by
reference herein. In the event that the physician is simultaneously
using an endoscope, such as endoscope (60) described above, the
endoscopic image may also be provided on display screen (612). The
images provided through display screen (612) may assist the
physician in maneuvering and otherwise manipulating instruments
within the patient's head.
[0063] Any suitable device may be used to generate a
three-dimensional model of the internal anatomy of the portion of
the patient's body (e.g., head) about which the electromagnetic
field is generated and into which balloon dilation catheter (200)
is to be inserted for conducting a treatment procedure. By way of
example only, such a model may be generated in accordance with at
least some of the teachings of U.S. Pat. Pub. No. 2016/0310042,
entitled "System and Method to Map Structures of Nasal Cavity,"
published Oct. 27, 2016, the disclosure of which is incorporated by
reference herein. Still other suitable ways in which a
three-dimensional anatomical model may be generated will be
apparent to those of ordinary skill in the art in view of the
teachings herein. It should also be understood that, regardless of
how or where the three-dimensional model is generated, the model
may be stored on console (608). Console (608) may thus render
images of at least a portion of the model via display screen (612),
and further render real-time video images of the position of the
distal end of dilation catheter (200) in relation to the model via
display screen (612).
[0064] In addition to connecting with processor (606) and operating
controls (610), console (608) may also connect with other elements
of IGS navigation system (600). For instance, as shown in FIG. 8, a
communication unit (614) may be coupled with balloon dilation
catheter (200) via wire (152), shown in FIG. 6. Communication unit
(614) of this example is configured to provide wireless
communication of data and other signals between console (608) and
navigation sensor (not shown) of dilation catheter (200). In some
versions, communication unit (614) simply communicates data or
other signals from navigation sensor (not shown) to console (608)
uni-directionally, without also communicating data or other signals
from console (608). In some other versions, communication unit
(614) provides bi-directional communication of data or other
signals between navigation sensor (not shown) and console (608).
While communication unit (614) of the present example couples with
console (608) wirelessly, some other versions may provide wired
coupling between communication unit (614) and console (608).
Various other suitable features and functionality that may be
incorporated into communication unit (614) will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0065] In addition to, or in lieu of, having the components and
operability described herein, IGS navigation system (600) may be
constructed and operable in accordance with at least some of the
teachings of U.S. Pat. No. 8,702,626, entitled "Guidewires for
Performing Image Guided Procedures," issued Apr. 22, 2014, the
disclosure of which is incorporated by reference herein; U.S. Pat.
No. 8,320,711, entitled "Anatomical Modeling from a 3-D Image and a
Surface Mapping," issued Nov. 27, 2012, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 8,190,389, entitled
"Adapter for Attaching Electromagnetic Image Guidance Components to
a Medical Device," issued May 29, 2012, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 8,123,722, entitled
"Devices, Systems and Methods for Treating Disorders of the Ear,
Nose and Throat," issued Feb. 28, 2012, the disclosure of which is
incorporated by reference herein; and U.S. Pat. No. 7,720,521,
entitled "Methods and Devices for Performing Procedures within the
Ear, Nose, Throat and Paranasal Sinuses," issued May 18, 2010, the
disclosure of which is incorporated by reference herein.
[0066] Similarly, in addition to or in lieu of having the
components and operability described herein, IGS navigation system
(600) may be constructed and operable in accordance with at least
some of the teachings of U.S. Pat. Pub. No. 2014/0364725, entitled
"Systems and Methods for Performing Image Guided Procedures within
the Ear, Nose, Throat and Paranasal Sinuses," published Dec. 11,
2014, the disclosure of which is incorporated by reference herein;
U.S. Pat. Pub. No. 2014/0200444, entitled "Guidewires for
Performing Image Guided Procedures," published Jul. 17, 2014, the
disclosure of which is incorporated by reference herein; U.S. Pat.
No. 9,198,736, entitled "Adapter for Attaching Electromagnetic
Image Guidance Components to a Medical Device," issued Dec. 1,
2015, the disclosure of which is incorporated by reference herein;
U.S. Pat. Pub. No. 2011/0060214, entitled "Systems and Methods for
Performing Image Guided Procedures within the Ear, Nose, Throat and
Paranasal Sinuses," published Mar. 10, 2011, the disclosure of
which is incorporated by reference herein; U.S. Pat. No. 9,167,961,
entitled "Methods and Apparatus for Treating Disorders of the Ear
Nose and Throat," issued Oct. 27, 2015, the disclosure of which is
incorporated by reference herein; and U.S. Pat. Pub. No.
2007/0208252, entitled "Systems and Methods for Performing Image
Guided Procedures within the Ear, Nose, Throat and Paranasal
Sinuses," published Sep. 6, 2007, the disclosure of which is
incorporated by reference herein.
[0067] V. Exemplary Devices having Guidewires with Integral
Expandable Dilators
[0068] In some instances, it may be desirable to combine various
features of guidewire (50, 130) with various features of dilation
catheter (20). Combining various features of dilation catheter (20)
and guidewire (50, 130) into a single device may eliminate the need
to actuate inflatable dilator (20) and guidewire (50, 130)
separately relative to guide catheter (30) during exemplary use,
thereby simplifying use. In addition to combining various features
of dilation catheter (20) and guidewire (50, 130) into a single
device, it may also be desirable to selectively steer (i.e.
deflect) a distal end of the device during a procedure to assist an
operator in locating and inserting the distal end of the device
into the correct sinus passageway.
[0069] A. Exemplary Dilation Catheter with Integral Fixed Angled
Guidewire
[0070] FIGS. 10-12 show an exemplary alternative dilation catheter
(202) that may be readily incorporated into either dilation
catheter system (10) or IGS navigation system (600) described
above. In particular, dilation catheter (202) may be incorporated
into dilation catheter system (10) in replacement of both dilation
catheter (20) and guidewire (50); while dilation catheter (202) may
be incorporated into IGS navigation system (600) in replacement of
dilation catheter (200).
[0071] As best seen in FIG. 12, dilation catheter (202) includes an
inflatable dilator (222), a grip (224), a hollow-elongate shaft
(218), and a distally extending fixed guidewire (250). Inflatable
dilator (222), grip (224), and hollow-elongate shaft (218) may be
substantially similar to inflatable dilator (22), grip (24) and
hollow-elongate shaft (18) described above, respectively, with
differences elaborated below. While in the current example an
inflatable dilator (222) is used, any other suitable dilator may be
used as would be apparent to one having ordinary skill in the art
in view of the teachings herein. For example, a mechanical dilator
may be used. As will be described in greater detail below, distally
extending fixed guidewire (250) is fixedly attached to the rest of
dilation catheter (200) via at least one fixed location (255) such
that guidewire (250) may actuate with the rest of dilation catheter
(200). In other words, guidewire (250) and dilation catheter (200)
together form a unitary construction.
[0072] Grip (224) includes a lateral port (226) and an open
proximal end (228). Shaft (218) defines a first lumen (230) and a
second lumen (232) that are fluidly isolated from each other.
Hollow-elongate shaft (218) extends distally from grip (224) into
inflatable dilator (222). Hollow-elongate shaft (218) is
resiliently flexible such that shaft (218) may deform if actuated
through bent distal portion (32) of guide catheter (30), but also
such that shaft (218) may retain its straight configuration when no
longer constrained within bent distal portion (32).
[0073] First lumen (230) is in fluid communication with both
lateral port (226) and the interior of inflatable dilator (222).
Thus, lateral port (226) may fluidly couple with inflator (40) such
that inflator (40) may add or withdraw fluid to/from dilator (222)
via first lumen (230) in order to selectively inflate and deflate
dilator (222). Second lumen (232) extends from open proximal end
(228) of grip (224) all the way to an open distal end of inflatable
dilator (222). However, unlike second lumen (now shown) of hollow
elongated shaft (18), second lumen (232) does not slidably receive
guidewire (250). Instead, distally extending fixed guidewire (250)
is attached to the open distal end of inflatable dilator (222) at
fixed location (255). Therefore, while distally extending fixed
guidewire (250) may flex relative to inflatable dilator (222) and
the rest of dilation catheter (200), guidewire (250) may not
longitudinally translate relative to inflatable dilator (222).
Therefore, an operator may actuate alternative dilation catheter
(200) by pushing or pulling grip (224) in order to actuate both
inflatable dilator (222) and guidewire (250).
[0074] As best seen in FIGS. 12 and 14, distally extending fixed
guidewire (250) includes a coil a (252) and a core wire (254),
which are substantially similar to coil (52) and core wire (54)
described above, with differences elaborated herein. Additionally,
distally extending fixed guidewire (250) includes a bent distal end
(256). Bent distal end (256) is resiliently biased toward a pre-set
bent angle such that bent distal end (256) may deflect relative to
the rest of guidewire (250). Therefore, bent distal end (256) may
deflect from the pre-set bent angle when under an external force,
and then may return to the pre-set bent angle when no longer under
an external force. While in the current example, distally extending
fixed guidewire (250) is attached to inflatable dilator (222) at a
fixed location (255) that is distal to shaft (218), coil (252) and
or core wire (254) may extend at least partially into second lumen
(232), thereby placing fixed location (255) within shaft (218).
Additionally, core wire (254) and coil (252) may be fixed at
different longitudinal locations to either shaft (218) or
inflatable dilator (222), thereby providing multiple fixed
locations (255) in which guidewire (250) is attached to either
inflatable dilator (222), hollow elongate shaft (218), or grip
(224).
[0075] As best seen in FIGS. 10-12, dilation catheter (200) also
includes an elongated connecting member (258). Elongated connecting
member (258) extends from a coupling unit (260), through open
proximal end (228) of grip (224), through second lumen (232),
through inflatable dilator (222), and through the interior of
guidewire (250) all the way to the tip of bent distal end (256).
Coupling unit (260) may be directly attached to grip (224) such
that coupling unit (260) and open proximal end (228) act as a
second port. Elongated connecting member (258) and coupling unit
(260) may be configured to adapt dilation catheter (200) for use
with either dilation catheter system (10) or IGS navigation system
(600).
[0076] For instance, if elongated connecting member (258) and
coupling unit (260) are configured to adapt dilation catheter (200)
with dilation catheter system (10), connecting member (258) and
coupling unit (260) may be substantially similar to illumination
fibers (56) and connector (55), respectively. Therefore, coupling
unit (260) may be configured to couple with a light source while
elongated connecting member (258) may be configured to communicate
light from light source to the tip of bent distal end (256) for
purposes of transillumination. Alternatively, elongated connecting
member (258) and coupling unit (260) may be configured to adapt for
use with IGS navigation system (600). Therefore, coupling unit
(260) may be substantially similar to communication unit (614)
described above. Additionally, elongated connecting member (258)
may be substantially similar to wire (152) described above, such
that connecting member (258) is connected to the tip of bent distal
end (256), while the tip of bent distal end (256) acts as a
navigation sensor similar to navigation sensor of dilation catheter
(200). Therefore, when the sensing element of the tip of bent
distal end (256) is positioned within an electromagnetic field
generated by field generators (602), movement of the sensing
element of bent distal end (256) within that magnetic field may
generate electrical current within the tip of bent distal end
(256), and this electrical current may be communicated along the
electrical conduit(s) in elongated connecting member (258) and
further to processor (606) via coupling unit (260). Of course,
connecting member (258), coupling unit (260), as well as second
lumen (232) are entirely optional.
[0077] B. Exemplary Guidewire Assembly with Integral Expandable
Dilator
[0078] FIGS. 15-17 show an exemplary guidewire assembly (300) that
may be readily incorporated into either dilation catheter system
(10) or IGS navigation system (600) described above. In particular,
guidewire assembly (300) may be incorporated into dilation catheter
system (10) in replacement of both dilation catheter (20) and
guidewire (50); while guidewire assembly (300) may be incorporated
into IGS navigation system (600) in replacement of dilation
catheter (200).
[0079] Guidewire assembly (300) includes a coil (352), a core wire
(354), and an elongated connecting member (358) extending from a
coupling unit (360) and terminating at a bent distal end (356).
Coil (352) and core wire (354) may be substantially similar to coil
(52) and core wire (54) described above, respectively, with
differences elaborated below. Coil (352) defines an interior (352)
that houses core wire (354) and elongated connecting member (358).
Bent distal end (356) is resiliently biased toward a pre-set bent
angle such that bent distal end (356) may deflect relative to the
rest of guidewire assembly (300). Therefore, bent distal end (356)
may deflect from the pre-set bent angle when under an external
force, and then may return to the pre-set bent angle when no longer
under an external force.
[0080] Guidewire assembly (300) also includes an inflatable dilator
(322) attached to an exterior portion of coil (352). Therefore,
inflatable dilator (322) may actuate with the rest of guidewire
assembly (300), such that dilator (322) is a unitary feature of
guidewire assembly (300). As best seen in FIGS. 17, an inflation
tube (324) is in fluid communication with both inflatable dilator
(322) and an inflation port (326). In particular, inflation tube
(324) extends from inflation port (326), through a channel (362)
defined by coupling unit (362), within interior (355) defined by
coil (352), and through a gap defined by coil (352) to fluidly
couple with inflatable dilator (322). In other words, inflation
tube (324) extends from interior (355) of coil (352) to an exterior
of coil (352) adjacent to inflatable dilator (322) in order to
establish fluid communication with inflatable dilator (322).
Inflation port (326) may fluidly couple with inflator (40) such
that inflator (40) may add or withdraw fluid to/from dilator (222)
via inflation tube (324) in order to selectively inflate and
deflate dilator (322). Since inflatable dilator (322) is attached
to coil (352), guidewire assembly (300) may serve as both a
guidewire and a dilator.
[0081] Guidewire assembly (300) also includes an elongated
connecting member (358).
[0082] Elongated connecting member (358) extends from coupling unit
(360), through interior (355) of guidewire (250) all the way to the
tip (350) of bent distal end (356). Elongated connecting member
(358) and coupling unit (360) may be configured to adapt guidewire
assembly (300) for use with either dilation catheter system (10) or
IGS navigation system (600).
[0083] For instance, if elongated connecting member (358) and
coupling unit (360) are configured to adapt guidewire assembly
(300) with dilation catheter system (10), connecting member (358)
and coupling unit (360) may be substantially similar to
illumination fibers (56) and connector (55), respectively.
Therefore, coupling unit (360) may be configured to couple with a
light source while elongated connecting member (358) may be
configured to communicate light from light source to tip (350) of
bent distal end (356) for purposes of trans illumination.
Alternatively, elongated connecting member (358) and coupling unit
(360) may be configured to adapt for use with IGS navigation system
(600). Therefore, coupling unit (360) may be substantially similar
to communication unit (614) described above. Additionally,
elongated connecting member (358) may be substantially similar to
wire (152) described above, such that connecting member (358) is
connected to the tip of bent distal end (356), while the tip of
bent distal end (356) acts as a navigation sensor similar to
navigation sensor of dilation catheter (200). Therefore, when the
sensing element of the tip of bent distal end (356) is positioned
within an electromagnetic field generated by field generators
(602), movement of the sensing element of bent distal end (356)
within that magnetic field may generate electrical current in the
one or more coils, and this electrical current may be communicated
along the electrical conduit(s) in elongated connecting member
(358) and further to processor (110) via coupling unit (360). Of
course, connecting member (358) and coupling unit (360) are
entirely optional.
[0084] C. Exemplary Alternative Dilation Catheter and Integral
Guidewire Having Selective Steerability
[0085] FIGS. 18A-20 show an exemplary alternative dilation catheter
(400) that may be readily incorporated into either dilation
catheter system (10) or IGS navigation system (600) described
above. In particular, dilation catheter (400) may be incorporated
into dilation catheter system (10) in replacement of both dilation
catheter (20) and guidewire (50); while dilation catheter (400) may
be incorporated into IGS navigation system (600) in replacement of
dilation cathter (200).
[0086] As best seen in FIGS. 18A-18B, dilation catheter (400)
includes an inflatable dilator (422), a grip (424), a
hollow-elongate shaft (418), and a distally extending fixed
guidewire (450); which may be substantially similar to inflatable
dilator (222), grip (224), hollow-elongate shaft (218), and
distally extending fixed guidewire (250) described above,
respectively, with differences described below. As will be
described in greater detail below, dilation catheter (400) includes
a slide (410) and a pull wire (412) configured to selectively steer
(i.e. deflect) distally extending fixed guidewire (450) during a
procedure.
[0087] Distally extending fixed guidewire (450) is fixedly attached
to the rest of dilation catheter (400) via at least one fixed
location (455) such that guidewire (450) may actuate with the rest
of dilation catheter (400). In other words, guidewire (450) and
dilation catheter (400) together form a unitary construction. While
in the current example an inflatable dilator (222) is used, any
other suitable dilator may be used as would be apparent to one
having ordinary skill in the art in view of the teachings herein.
For example, a mechanical dilator may be used.
[0088] Grip (424) includes a lateral port (426) and an open
proximal end (428). Shaft (418) defines a first lumen (430), a
second lumen (432), and a third lumen (434) that are fluidly
isolated from each other. While in the current example, second
lumen (432) And third lumen (434) are fluidly isolated from each
other, this is merely optional. In fact, second lumen (432) and
third lumen (434) may together form a single lumen, rather than two
separate lumens. Hollow-elongate shaft (418) extends distally from
grip (424) into inflatable dilator (422). Hollow-elongate shaft
(418) is resiliently flexible such that shaft (418) may deform if
actuated through bent distal portion (32) of guide catheter (30),
but also such that shaft (418) may retain its straight
configuration when no longer constrained within bent distal portion
(32).
[0089] First lumen (430) is in fluid communication with both
lateral port (426) and the interior of inflatable dilator (422).
Thus, lateral port (426) may fluidly couple with inflator (40) such
that inflator (40) may add or withdraw fluid to/from dilator (422)
via first lumen (430) in order to selectively inflate and deflate
dilator (422). Second lumen (232) extends from open proximal end
(228) of grip (224) all the way to an open distal end of inflatable
dilator (222). Distally extending fixed guidewire (450) is attached
to the open distal end of inflatable dilator (422) at fixed
location (455). Therefore, while distally extending fixed guidewire
(450) may flex relative to inflatable dilator (422) and the rest of
dilation catheter (400), guidewire (450) may not longitudinally
translate relative to inflatable dilator (422). Therefore, an
operator may actuate alternative dilation catheter (400) by pushing
or pulling grip (424) in order to actuate both inflatable dilator
(422) and guidewire (450).
[0090] Distally extending fixed guidewire (450) includes a coil a
(452) and a core wire (454). While not shown, distally extending
fixed guidewire (450) may also include a bent distal end
substantially similar to bent distal end (256) decried above. While
in the current example, distally extending fixed guidewire (450) is
attached to inflatable dilator (422) at a fixed location (455) that
is distal to shaft (418), coil (452) and or core wire (454) may
extend at least partially into second lumen (432), thereby placing
fixed location (245) within shaft (418). Additionally, core wire
(454) and coil (452) may be fixed at different longitudinal
locations to either shaft (418) or inflatable dilator (422),
thereby providing multiple fixed locations (455) in which guidewire
(450) is attached to either inflatable dilator (422), hollow
elongate shaft (418), or grip (424).
[0091] Dilation catheter (400) also includes an elongated
connecting member (458). Elongated connecting member (458) extends
from a coupling unit (460), through open proximal end (428) of grip
(424), through second lumen (432), through inflatable dilator
(222), and through the interior of guidewire (450) all the way to
the distal end of guidewire (450). Coupling unit (460) may be
directly attached to grip (424) such that coupling unit (460) and
open proximal end (428) act as a second port. Elongated connecting
member (458) and coupling unit (240) may be configured to adapt
dilation catheter (400) for use with either dilation catheter
system (10) or IGS navigation system (600).
[0092] For instance, if elongated connecting member (458) and
coupling unit (460) are configured to adapt dilation catheter (400)
with dilation catheter system (10), connecting member (458) and
coupling unit (460) may be substantially similar to illumination
fibers (56) and connector (55), respectively. Therefore, coupling
unit (460) may be configured to couple with a light source while
elongated connecting member (458) may be configured to communicate
light from light source to the distal end of guidewire (450) for
purposes of transillumination. Alternatively, elongated connecting
member (458) and coupling unit (460) may be configured to adapt for
use with IGS navigation system (600). Therefore, coupling unit
(460) may be substantially similar to communication unit (614)
described above. Additionally, elongated connecting member (458)
may be substantially similar to wire (152) described above, such
that connecting member (458) is connected to the tip of guidewire
(450), while the tip of guidewire (400) acts as a navigation sensor
similar to navigation sensor of dilation catheter (200). Therefore,
when the sensing element of the tip of guidewire (450) is are
positioned within an electromagnetic field generated by field
generators (602), movement of the one or more coils within that
magnetic field may generate electrical current within the tip of
guidewire (450), and this electrical current may be communicated
along the electrical conduit(s) in elongated connecting member
(458) and further to processor (606) via coupling unit (460). Of
course, connecting member (458), coupling unit (460), as well as
second lumen (432) are entirely optional.
[0093] As mentioned above, it may be desirable to assist an
operator in locating and inserting the distal end of the device
into the correct sinus passageway during a procedure. As also
mentioned above, and as will be described in greater detail below,
dilation catheter (400) includes a slide (410) and a pull wire
(412) configured to selectively steer (i.e. deflect) distally
extending fixed guidewire (450) during a procedure.
[0094] Slide (410) is slidably coupled to grip (424) such that
slide (410) may longitudinally actuate along the profile of grip
(424). Slide (410) is coupled with pull wire (412) such that
actuation of slide (410) relative to grip (424) actuates pull wire
(412) relative to grip (424). Pull wire (412) is slidably housed
within third lumen (434) of shaft (418). Additionally, pull wire
(412) extends distally past shaft (418) along the exterior of coil
(452). In the current example, a distal tip of pull wire (412) is
fixed to a distal tip of guidewire (450). However, pull wire (412)
may be fixed along any suitable portion of guidewire (450) as would
be apparent to one having ordinary skill in the art in view of the
teachings herein.
[0095] As best shown between FIGS. 18A-18B, an operator may actuate
slide (410) proximally relative to grip (424) such that pull wire
(412) slides proximally relative to grip (424) and within third
lumen (434). Because the distal tip of pull wire (412) is fixed to
the distal tip of guidewire (450), guidewire (450) deflects away
from the longitudinal axis defined by shaft (418). It should be
understood that since guidewire (450) is coupled to inflatable
dilator (422), inflatable dilator (422) may also deflect away from
the longitudinal axis defined by shaft (418). Therefore, an
operator may utilize slide (410) and pull wire (412) in order to
steer/deflect guidewire (450) into a desired position for inserting
guidewire (450) into a targeted passageway.
[0096] Pull wire (412) is resiliently biased toward the straight
configuration as shown in
[0097] FIG. 18A. Therefore, if an operator desires to deflect guide
wire (450) back toward the straight configuration as shown in FIG.
18A, an operator may distally actuate slide (410) relative to grip
(424) such that pull wire (314) slides distally relative to grip
(424) and within third lumen (434). The resilient nature of pull
wire (412) may straighten pull wire (412) and guidewire (450).
[0098] Slide (410) may be able to selectively lock its own
longitudinal position relative to grip (424) such that an operator
may help maintain the deflection at which guidewire (450) is
deviated from the longitudinal axis of shaft (418). Various types
of locking mechanism will be apparent to one having ordinary skill
in the art in view of the teachings herein. For instance, slide
(410) may be resiliently biased into frictional engagement with
grip (424), such that an operator would have to overcome the bias
to reduce the frictional breaking force between slide (410) and
grip (424) in order to actuate slide (424) relative to grip
(424).
[0099] While in the current example, a slide (410) is used in order
to actuate pull wire (314). Various types of actuating mechanisms
will be apparent to one having ordinary skill in the art in view of
the teachings herein. For instance, a thumb wheel may be pivotally
coupled with grip (424), such that rotation of thumb wheel may
actuate pull wire (412) relative to grip (424) and shaft (418).
[0100] While in the current example, slide (410) and pull wire
(412) are incorporated into a dilation catheter (400), slide (410)
and pull wire (412) may be incorporated into guide wire assembly
(300) having inflatable dilator (322). In examples where guidewire
(450) includes a bent distal end, pull wire (412) may be fixed at a
proximal end of the bent distal end. Alternatively, pull wire (412)
may also be fixed at the distal end of the bent distal end, or any
lactation between the distal end and proximal end of the bend
distal end.
[0101] VI. Exemplary Combinations
[0102] The following examples relate to various non-exhaustive ways
in which the teachings herein may be combined or applied. It should
be understood that the following examples are not intended to
restrict the coverage of any claims that may be presented at any
time in this application or in subsequent filings of this
application. No disclaimer is intended. The following examples are
being provided for nothing more than merely illustrative purposes.
It is contemplated that the various teachings herein may be
arranged and applied in numerous other ways. It is also
contemplated that some variations may omit certain features
referred to in the below examples. Therefore, none of the aspects
or features referred to below should be deemed critical unless
otherwise explicitly indicated as such at a later date by the
inventors or by a successor in interest to the inventors. If any
claims are presented in this application or in subsequent filings
related to this application that include additional features beyond
those referred to below, those additional features shall not be
presumed to have been added for any reason relating to
patentability.
Example 1
[0103] A dilation apparatus, the dilation apparatus comprising: (a)
a handle assembly; (b) a dilator configured to transition between
an unexpanded state and an expanded state, wherein the dilator is
connected to the handle assembly; (c) a guidewire extending
distally from the dilator, wherein the guidewire is longitudinally
fixed relative to the dilator, wherein the guidewire comprises a
distal end; and (d) a steering assembly configured to laterally
deflect at least a portion of the guidewire relative to the handle
assembly, wherein the steering assembly comprises: (i) an actuator
coupled with the handle assembly, and (ii) a pull wire extending
between the actuator and guidewire, wherein a portion of the pull
wire is attached to the guidewire, wherein the actuator is
configured to move the pull wire relative to the handle assembly in
order to laterally deflect the at least a portion of the
guidewire.
Example 2
[0104] The dilation apparatus of Example 1, wherein the dilator
comprises an inflatable dilator.
Example 3
[0105] The dilation apparatus of Example 2, further comprising a
hollow-elongate shaft extending from the handle assembly to the
inflatable dilator.
Example 4
[0106] The dilation apparatus of Example 3, wherein the
hollow-elongate shaft defines a pull wire lumen, wherein the pull
wire lumen slidably houses a portion of the pull wire.
Example 5
[0107] The dilation apparatus of Example 4, wherein the
hollow-elongate shaft defines a first lumen in fluid communication
with the inflatable dilator in order to transition the inflatable
dilator from the unexpanded state to the expanded state.
Example 6
[0108] The dilation apparatus of Example 5, wherein the
hollow-elongate shaft defines a second lumen housing an elongated
connecting member, wherein the elongated connecting member extends
from the handle assembly to the distal end of the guide wire.
Example 7
[0109] The dilation apparatus of Example 6, wherein the elongated
connecting member is attached to a coupling unit.
Example 8
[0110] The dilation apparatus of Example 7, wherein the elongated
connecting member comprises an illumination fiber.
Example 9
[0111] The dilation apparatus of any one or more of Examples 7
through 8, wherein the elongated connecting member comprises a
coil, wherein the coil and the coupling unit are configured for use
with an IGS navigation system.
Example 10
[0112] The dilation apparatus of any one or more of Examples 1
through 9, wherein the actuator comprises a slide.
Example 11
[0113] The dilation apparatus of any one or more of Examples 1
through 10, wherein the guidewire further comprises a bent distal
end.
Example 12
[0114] The dilation apparatus of any one or more of Examples 1
through 11, wherein the pull wire is fixed at the distal end of the
guidewire.
Example 13
[0115] The dilation apparatus of any one or more of Examples 1
through 12, wherein the guidewire extends between the handle
assembly and the dilator.
Example 14
[0116] The dilation apparatus of any one or more of Examples 1
through 13, wherein the guidewire comprises a coil and a core wire,
wherein the core wire defines an interior, wherein the core wire
extends within the interior of the coil.
Example 15
[0117] The dilation apparatus of Example 14, wherein the pull wire
is located on an exterior of the coil.
Example 16
[0118] A dilation apparatus, the dilation apparatus comprising: (a)
a handle assembly; (b) an elongated shaft assembly extending
distally from the handle assembly; (c) a dilator coupled with the
elongated shaft, wherein the dilator is configured to transition
from an unexpanded state to an expanded state; and (d) a guidewire
extending distally from the dilator, wherein the guidewire is
longitudinally fixed relative to the dilator, wherein the guidewire
comprises: (i) a proximal portion defining an axis, and (ii) a
distal portion comprising a bent distal end, wherein the bent
distal end defines an oblique angle with the axis.
Example 17
[0119] The dilation apparatus of Example 16, wherein the bent
distal end of the guidewire is resiliently biased toward the
oblique angle.
Example 18
[0120] The dilation apparatus of any one or more of Examples 16
through 17, wherein the guidewire is fixed to the dilator.
Example 19
[0121] A dilation apparatus, the dilation apparatus comprising: (a)
a guidewire extending from a proximal end to a distal end, wherein
the guidewire comprises: (i) a coil comprising an exterior surface,
wherein the coil defines an interior, and (ii) a core wire
extending within the interior of the coil; (b) a connector coupled
with the proximal end of the guidewire; (c) an inflatable dilator
configured to transition between an inflated state and a deflated
state, wherein the inflatable dilator is longitudinally fixed to
the exterior surface of the coil; and (d) an inflation tube,
wherein the inflation tube extends within the interior of the coil,
wherein a portion of the inflation tube extends from the interior
of the coil toward the exterior surface of the coil encompassed by
the inflatable dilator, wherein the inflation tube is in fluid
communication with the inflatable dilator.
Example 20
[0122] The dilation apparatus of Example 19, wherein the inflation
tube extends through the connector and terminates into an inflation
port.
Example 21
[0123] A method of using a dilation apparatus, the dilation
apparatus comprising: (a) a handle assembly; (b) a dilator
configured to transition between an unexpanded state and an
expanded state, wherein the dilator is connected to the handle
assembly; (c) a guidewire extending distally from the dilator,
wherein the guidewire is longitudinally fixed relative to the
dilator, wherein the guidewire comprises a distal end; and (d) a
steering assembly configured to laterally deflect at least a
portion of the guidewire relative to the handle assembly, wherein
the steering assembly comprises: (i) an actuator coupled with the
handle assembly, and (ii) a pull wire extending between the
actuator and guidewire, wherein a portion of the pull wire is
attached to the guidewire, wherein the actuator is configured to
move the pull wire relative to the handle assembly in order to
laterally deflect the at least a portion of the guidewire; the
method comprising: (a) grasping the handle assembly and inserting
the distal end of the guidewire into a nasal cavity of a patient;
(b) manipulating the steering assembly to laterally deflect the
guidewire relative to the handle assembly such that the distal end
of the guidewire is adjacent to a targeted passageway; and (c)
interesting the guidewire and a portion of the dilator into the
targeted passageway.
Example 22
[0124] The method of Example 21, wherein the method further
comprises transitioning the dilator from the unexpanded state to
the expanded state.
Example 23
[0125] The method of either one of Examples 20 through 21, wherein
manipulating the steering assembly further comprises translating
the actuator relative to the handle assembly.
Example 24
[0126] The method of either one of Examples 20 through 21, wherein
manipulating the steering assembly further comprises rotating the
actuator relative to the handle assembly.
Example 25
[0127] A method of using a dilation apparatus, the dilation
apparatus comprising: (a) a handle assembly; (b) an elongated shaft
assembly extending distally from the handle assembly; (c) a dilator
coupled with the elongated shaft, wherein the dilator is configured
to transition from an unexpanded state to an expanded state; and
(d) a guidewire extending distally from the dilator, wherein the
guidewire is longitudinally fixed relative to the dilator, wherein
the guidewire comprises: (i) a proximal portion defining an axis,
and (ii) a distal portion comprising a bent distal end, wherein the
bent distal end defines an oblique angle with the axis; wherein the
method comprises: (a) grasping the handle assembly and inserting
the bent distal end of the guidewire into a nasal cavity of a
patient; and (b) further inserting at least a portion of the
dilator into the nasal cavity of the patient.
Example 26
[0128] The method of Example 25, further comprising transitioning
the dilator from the unexpanded state to the expanded state.
Example 26
[0129] The method of any one or more of Examples 25 through 26,
wherein inserting the bend distal end of the guidewire into the
nasal cavity of the patient further comprises deflecting the bend
distal end of the guidewire relative to the proximal portion of the
guidewire.
Example 27
[0130] A method of using a dilation apparatus, the dilation
apparatus comprising: (a) a guidewire extending from a proximal end
to a distal end, wherein the guidewire comprises: (i) a coil
comprising an exterior surface, wherein the coil defines an
interior, and (ii) a core wire extending within the interior of the
coil; (b) a connector coupled with the proximal end of the
guidewire; (c) an inflatable dilator configured to transition
between an inflated state and a deflated state, wherein the
inflatable dilator is longitudinally fixed to the exterior surface
of the coil; and (d) an inflation tube, wherein the inflation tube
extends within the interior of the coil, wherein a portion of the
inflation tube extends from the interior of the coil toward the
exterior surface of the coil encompassed by the inflatable dilator,
wherein the inflation tube is in fluid communication with the
inflatable dilator; the method comprising: (a) inserting the distal
end of the guidewire into a nasal cavity of a patient; (b) further
inserting at least a portion of the dilator into the nasal cavity
of the patient; (c) transitioning the inflatable dilator from the
deflated state to the inflated state by transferring fluid to the
inflatable dilator via the inflation tube.
Example 28
[0131] The method of Example 27, further comprising transitioning
the inflatable dilator from the inflated state to the deflate state
by transferring fluid from the inflatable dilator via the inflation
tube.
Example 29
[0132] The method of Example 28, further comprising removing the
guidewire and the inflatable dilator from the nasal cavity of the
patient.
Example 30
[0133] The method of any one or more of Examples 27 through 29,
wherein the dealation apparatus further comprises a connecting
member extending within the interior of the coil.
[0134] VII. Miscellaneous
[0135] It should be understood that any of the examples described
herein may include various other features in addition to or in lieu
of those described above. By way of example only, any of the
examples described herein may also include one or more of the
various features disclosed in any of the various references that
are incorporated by reference herein.
[0136] It should be understood that any one or more of the
teachings, expressions, embodiments, examples, etc. described
herein may be combined with any one or more of the other teachings,
expressions, embodiments, examples, etc. that are described herein.
The above-described teachings, expressions, embodiments, 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.
[0137] 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.
[0138] 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.
[0139] 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.
[0140] 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.
* * * * *