U.S. patent application number 16/437668 was filed with the patent office on 2019-11-28 for system and method to map structures of nasal cavity.
The applicant listed for this patent is Acclarent, Inc.. Invention is credited to Rohit Girotra, Thomas R. Jenkins, Randy J. Kesten, Arthur M. Lin, Kathryn Olson, Sandra W. Ruggles, Meera L. Sankaran.
Application Number | 20190357806 16/437668 |
Document ID | / |
Family ID | 55949085 |
Filed Date | 2019-11-28 |
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United States Patent
Application |
20190357806 |
Kind Code |
A1 |
Kesten; Randy J. ; et
al. |
November 28, 2019 |
SYSTEM AND METHOD TO MAP STRUCTURES OF NASAL CAVITY
Abstract
An apparatus includes a handle assembly, a guide tube, and a
wire. The handle assembly includes a body and an actuator. The
guide tube extends distally from the handle assembly and includes a
distal end. The wire is slidably disposed in the guide tube. The
wire has a distal end including a sensor. The sensor is configured
to cooperate with a navigation system to generate a map of
anatomical structures within a patient. The wire is coupled with
the actuator. The actuator is movable relative to the body to move
the wire relative to the guide tube.
Inventors: |
Kesten; Randy J.; (Mountain
View, CA) ; Lin; Arthur M.; (Fremont, CA) ;
Jenkins; Thomas R.; (Alameda, CA) ; Girotra;
Rohit; (Mountain View, CA) ; Ruggles; Sandra W.;
(Sunnyvale, CA) ; Sankaran; Meera L.; (Cupertino,
CA) ; Olson; Kathryn; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Acclarent, Inc. |
Irvine |
CA |
US |
|
|
Family ID: |
55949085 |
Appl. No.: |
16/437668 |
Filed: |
June 11, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14825551 |
Aug 13, 2015 |
10362965 |
|
|
16437668 |
|
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|
|
62150912 |
Apr 22, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/055 20130101;
A61B 8/0841 20130101; A61B 5/066 20130101; A61B 2017/0046 20130101;
A61B 2217/005 20130101; A61B 2034/2051 20160201; A61B 17/3415
20130101; A61B 17/24 20130101; A61B 17/3421 20130101; A61B
2017/00946 20130101; A61B 34/20 20160201; A61B 2017/00367 20130101;
A61B 2090/0811 20160201; A61B 5/6851 20130101 |
International
Class: |
A61B 5/06 20060101
A61B005/06; A61B 5/00 20060101 A61B005/00; A61B 17/34 20060101
A61B017/34; A61B 34/20 20060101 A61B034/20; A61B 8/08 20060101
A61B008/08; A61B 5/055 20060101 A61B005/055; A61B 17/24 20060101
A61B017/24 |
Claims
1.-20. (canceled)
21. An apparatus comprising: (a) a handle assembly, wherein the
handle assembly comprises: (i) a body, and (ii) an actuator; (b) a
guide tube assembly extending distally from the handle assembly,
wherein the guide tube assembly comprises a rigid member and a
malleable member; and (c) a wire slidably disposed in the guide
tube assembly, wherein the wire has a distal end including at least
one sensor, wherein the sensor is configured to cooperate with a
navigation system to provide image guided navigation of anatomical
structures within a patient, wherein the wire is coupled with the
actuator, wherein the actuator is movable relative to the body to
move the wire relative to the guide tube assembly.
22. The apparatus of claim 21, wherein the at least one sensor
includes a position sensor.
23. The apparatus of claim 22, wherein the position sensor includes
a coil, wherein the coil is responsive to movement of the distal
end of the wire in an electromagnetic field.
24. The apparatus of claim 21, wherein the at least one sensor
includes an ultrasound sensor.
25. The apparatus of claim 21, wherein the at least one sensor
includes both a position sensor and an ultrasound sensor.
26. The apparatus of claim 21, wherein the distal end of the wire
has a ball tip, wherein the at least one sensor is integrated into
the ball tip.
27. The apparatus of claim 21, wherein the malleable member
comprises an inner tube, wherein the rigid member comprises an
outer sheath.
28. The apparatus of claim 27, wherein the inner tube defines a
plurality of lumens, wherein a first lumen of the plurality of
lumens is configured to guide the wire along a length of the guide
tube assembly as the wire translates within and relative to the
inner tube.
29. The apparatus of claim 28, wherein the body comprises a luer
port in fluid communication with a suction source and a second
lumen of the plurality of lumens, wherein the second lumen is
configured to provide suction to the distal end of the inner
tube.
30. The apparatus of claim 29, wherein the body further includes a
suction port that is in fluid communication with the second lumen,
wherein the suction port is located at a position that enables an
operator to selectively cover and uncover the suction port while
simultaneously operating the actuator with the same hand that is
used to selectively cover and uncover the suction port.
31. The apparatus of claim 21, wherein the rigid member includes a
preformed rigid bend.
32. The apparatus of claim 21, wherein the actuator is configured
to drive the wire between a proximal position relative to the guide
tube assembly and a distal position relative to the guide tube
assembly, wherein the distal end of the wire is flush with a distal
end of the guide tube assembly when the wire is in the proximal
position, wherein the distal end of the wire is distal to the
distal end of the guide tube assembly when the wire is in the
distal position.
33. The apparatus of claim 32, wherein the actuator comprises a
rotatable member operable to rotate the wire within the guide tube
assembly.
34. The apparatus of claim 32, wherein the handle assembly includes
a plurality of position indicators, wherein the position indicators
comprise a first indicator and a second indicator, wherein the
first indicator is associated with the proximal position, wherein
the second indicator is associated with the distal position.
35. The apparatus of claim 34, wherein the first and second
indicators comprise at least one of visual indicators or tactile
feedback features.
36. An apparatus comprising: (a) a handle assembly, wherein the
handle assembly comprises: (i) a body, and (ii) an actuator; (b) a
guide tube assembly extending distally from the handle assembly,
wherein the guide tube assembly comprises a rigid member and a
malleable member wherein the malleable member extends distally from
the rigid member, wherein the malleable member defines at least
first and second lumens; and (c) a wire slidably disposed in the
first lumen of the malleable member, wherein the wire has a distal
end that includes a position sensor, wherein the position sensor is
configured to cooperate with a navigation system to provide image
guided navigation of anatomical structures within a patient,
wherein the wire is coupled with the actuator, wherein the actuator
is movable relative to the body to move the wire relative to the
guide tube assembly to a position that is distally past a distal
end of the malleable member.
37. The apparatus of claim 36, wherein the handle assembly provides
a plurality of position indicators, wherein the position indicators
comprise a first position indicator and a second position
indicator, wherein the first position indicator is associated with
a proximal position, wherein the second position indicator is
associated with a distal position.
38. The apparatus of claim 37, wherein the plurality of position
indicators further comprises a third position indicator, wherein
the third position indicator is associated with the actuator and
the wire being located in an intermediate position, wherein the
intermediate position is positioned between the distal position and
the proximal position.
39. The apparatus of claim 38, wherein the body includes a suction
port that is in fluid communication with the second lumen of the
malleable member, wherein the suction port is located at a position
that enables an operator to selectively cover and uncover the
suction port while simultaneously operating the actuator with the
same hand that is used to selectively cover and uncover the suction
port.
40. A method of using an apparatus, wherein the apparatus
comprises: (a) a handle assembly, wherein the handle assembly
comprises: (i) a body, and (ii) an actuator; and (b) a guide tube
extending distally from the handle assembly, wherein the guide tube
has a distal end; and a wire slidably disposed in the guide tube,
wherein the wire has a distal end including a sensor, wherein the
sensor is configured to cooperate with a navigation system to
generate a map of anatomical structures within a patient, wherein
the wire is coupled with the actuator, wherein the actuator is
movable relative to the body to move the wire relative to the guide
tube, the method comprising: (a) inserting a distal end of the
guide tube through a nostril of a patient; (b) actuating the
actuator to drive the wire relative to the guide tube such that the
distal end of the wire is located distal to the distal end of the
guide tube; and (c) using the distal end of the wire in conjunction
with a navigation system to map anatomical structures within a
nasal cavity of the patient.
Description
PRIORITY
[0001] This application claims priority to U.S. Provisional Patent
App. No. 62/150,912, entitled "System and Method to Map Structures
of Nasal Cavity," filed Apr. 22, 2015, the disclosure of which is
incorporated by reference herein.
BACKGROUND
[0002] Image-guided surgery (IGS) is a technique wherein 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 Mill, 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) 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.
[0003] 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, Calif.; systems available from Surgical
Navigation Technologies, Inc., of Louisville, Colo.; and systems
available from Calypso Medical Technologies, Inc., of Seattle,
Wash.
[0004] Still other examples of methods, devices, and/or systems
that may be modified for use in accordance with the teachings
herein include but are not limited to those disclosed in 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.
[0005] Still further examples of methods, devices, and/or systems
that may be modified for use in accordance with the teachings
herein include but are not limited to those disclosed in 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. Pub. No. 2012/0245456, entitled
"Adapter for Attaching Electromagnetic Image Guidance Components to
a Medical Device," published Sep. 27, 2012, 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. Pub. No. 2008/0281156,
entitled "Methods and Apparatus for Treating Disorders of the Ear
Nose and Throat," published Nov. 13, 2008, 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.
[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, especially in cases where normal anatomical
landmarks are not present or are difficult to visualize
endoscopically.
[0007] There remains a need in the art for the development of
improved sensor equipped instruments and devices for use in image
guided ENT procedures. While several systems and methods have been
made and used to provide image guidance in medical procedures, 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 perspective view of an exemplary mapping
and navigation device;
[0010] FIG. 2 depicts a perspective view of an exemplary single-use
cartridge of the device of FIG. 1;
[0011] FIG. 3 depicts a perspective view of an exemplary flexible
wire and actuator of the cartridge of FIG. 2;
[0012] FIG. 4 depicts a perspective view of a distal end of another
exemplary flexible wire that may be incorporated into the cartridge
of FIG. 2;
[0013] FIG. 5 depicts a perspective view of a distal end of yet
another exemplary flexible wire that may be incorporated into the
cartridge of FIG. 2;
[0014] FIG. 6A depicts a side elevational view of the device of
FIG. 1, with the cartridge of FIG. 2 spaced from a handle of the
device;
[0015] FIG. 6B depicts a side elevational view of the device of
FIG. 1, with the cartridge of FIG. 2 moved toward the handle of the
device, with a distal portion of the flexible wire of FIG. 3
positioned within a guide tube of the device, and with a proximal
portion of the flexible wire coupled with a cable of the
device;
[0016] FIG. 6C depicts a side elevational view of the device of
FIG. 1, with the cartridge of FIG. 2 coupled with the handle of the
device, and with the flexible wire of FIG. 3 in a first
longitudinal position;
[0017] FIG. 6D depicts a side elevational view of the device of
FIG. 1, with the cartridge of FIG. 2 coupled with the handle of the
device, and with the flexible wire of FIG. 3 moved to a second
longitudinal position;
[0018] FIG. 6E depicts a side elevational view of the device of
FIG. 1, with the cartridge of FIG. 2 coupled with the handle of the
device, and with the flexible wire of FIG. 3 moved to a third
longitudinal position;
[0019] FIG. 7 depicts a schematic, pictorial illustration of a
system for sinus mapping and imaging using the device of FIG.
1;
[0020] FIG. 8A depicts a front view of the device of FIG. 1
positioned adjacent an ostium of the maxillary sinus, with the
flexible wire of FIG. 3 in the first longitudinal position of FIG.
6C;
[0021] FIG. 8B depicts a front view of the device of FIG. 1
positioned adjacent an ostium of the maxillary sinus, with the
flexible wire of FIG. 3 moved to the second longitudinal position
of FIG. 6D;
[0022] FIG. 8C depicts a front view of the device of FIG. 1
positioned adjacent an ostium of the maxillary sinus, with the
flexible wire of FIG. 3 moved to the third longitudinal position of
FIG. 6E;
[0023] FIG. 9 depicts a flow chart that schematically illustrates a
method for sinus mapping and imaging;
[0024] FIG. 10 depicts a perspective view of another exemplary
mapping and navigation device;
[0025] FIG. 11 depicts a side elevational view of the device of
FIG. 10;
[0026] FIG. 12 depicts a perspective view of yet another exemplary
mapping and navigation device;
[0027] FIG. 13 depicts a side elevational view of the device of
FIG. 12;
[0028] FIG. 14 depicts a detailed perspective view of a handle
assembly of the device of FIG. 10;
[0029] FIG. 15 depicts a detailed perspective view of a distal end
of a guide tube of the device of FIG. 10;
[0030] FIG. 16 depicts a detailed side cross-sectional view of the
handle assembly of FIG. 14;
[0031] FIG. 17 depicts another detailed perspective view of the
handle assembly of FIG. 14;
[0032] FIG. 18A depicts a perspective view of the device of FIG.
10, with a flexible wire of the device in a first longitudinal
position;
[0033] FIG. 18B depicts a perspective view of the device of FIG.
10, with the flexible wire of FIG. 18A moved to a second
longitudinal position; and
[0034] FIG. 18C depicts a perspective view of the device of FIG.
10, with the flexible wire of FIG. 18A moved to a third
longitudinal position.
[0035] 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
[0036] 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.
[0037] 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.
[0038] 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.
[0039] I. Exemplary Mapping and Navigational Device
[0040] FIG. 1 shows an exemplary mapping and navigational device
(10) that may be used to map and/or navigate the nasal cavity of a
patient, passageways associated with the nasal cavity of a patient
(e.g., paranasal sinus ostia and cavities, the frontal recess, the
Eustachian tube, etc.), and/or other anatomical passageways (e.g.,
within the ear, nose, or throat, etc.). Mapping and navigational
device (10) of the present example comprises a handle (20), a guide
tube (30), and a cartridge assembly (100). In the present example,
handle (20) is formed of stainless steel, though it should be
understood that any other suitable material(s) may be used. In some
instances, the combination of handle (20) and guide tube (30) is
provided as a reusable device (e.g., multi-patient, sterilizable);
while cartridge assembly (100) is provided as a disposable device
(e.g., single patient only, non-sterilizable). Handle (20) of the
present example may be grasped like a pencil by a user.
Alternatively, various other suitable configurations and gripping
techniques may be used, including but not limited to a pistol grip
configuration or a power grip technique. Guide tube (30) extends
distally from handle (20).
[0041] All or a portion (e.g., between 0.3 cm and 2 inches) of
guide tube (30) may comprise a material having a low magnetic
permeability, including by not limited to 316 stainless steel,
nitinol, cobalt chromium, tungsten, PEEK, and polycarbonate, such
that guide tube (30) will not interfere with any signals from wire
(130). In some versions, only the distal portion of guide tube (30)
is non-ferromagnetic or otherwise has low magnetic permeability.
Guide tube (30) of the present example includes a bent distal
portion (32) at its distal end (DE). In some versions, guide tube
(30) is configured similar to the Relieva Flex.TM. Sinus Guide
Catheter by Acclarent, Inc. of Menlo Park, Calif. By way of example
only, bent distal portion (32) may provide a bend angle of
approximately 20.degree.. Alternatively, any other suitable bend
angle may be used. In the present example, guide tube (30) is
rigid. In some other versions, guide tube (30) is malleable such
that the operator may deform guide tube (30) to any desired bend
angle and guide tube (30) may maintain the selected bend angle
during subsequent use. Other suitable forms that guide tube (30)
may take will be apparent to those of ordinary skill in the art in
view of the teachings herein.
[0042] FIG. 2 shows cartridge assembly (100). As will be described
in more detail below, cartridge assembly (100) is configured for
receipt in an opening (22) of handle (20) to thereby couple with
handle (20). In some alternative versions, the features and
functionality of cartridge assembly (100) are fully integrated into
handle (20). Cartridge assembly (100) comprises a housing (110), a
manual actuator (120), and a flexible wire (130). Housing (110)
includes a longitudinal slot (112) formed in a top surface (114) of
housing (110). A sled (121) of actuator (120) is slidably disposed
within slot (112) of housing (110) via a pair of longitudinal
channels (123) (FIG. 3) formed in opposing sides of sled (121) such
that, as will be described in more detail below, actuator (120) is
configured to translate within slot (112) between a proximal
longitudinal position (FIG. 6C), an intermediate longitudinal
position (FIG. 6D), and a distal longitudinal position (FIG. 6E).
Top surface (114) of housing (110) includes a series of visible
markers (115A, 115B 115C) positioned adjacent slot (112). Markers
(115A, 115B 115C) correspond to the proximal longitudinal position,
the intermediate longitudinal position, and the distal longitudinal
position of actuator (120), respectively. Actuator (120) includes a
visible marker (125) that is configured to align with markers
(115A, 115B 115C) of housing (110) to visually indicate that
actuator (120) has reached each corresponding longitudinal
position. Additionally or alternatively, housing (110) and/or
actuator (120) may further include features (e.g. mechanical
detents) that are configured to provide tactile and/or audible
feedback to the operator as actuator (120) reaches each
longitudinal position.
[0043] Wire (130) of the present example comprises a flexible
stacked-coil design. Wire (130) extends completely through housing
(110) such that a proximal portion (P) of wire (130) extends
proximally from housing (110) and such that a distal portion (D) of
wire (130) extends distally from housing (110). Proximal portion
(P) of wire (130) is fixedly secured within an opening (116) formed
in a proximal surface (117) of housing (110) such that proximal
portion (P) is configured to remain stationary relative to housing
(110). Various suitable structures and techniques that may be used
to fixedly secure proximal portion (P) of wire (130) in opening
(116) will be apparent to those of ordinary skill in the art in
view of the teachings herein. As will be described in more detail
below, proximal portion (P) includes an adapter (131). Adapter
(131) is configured to couple wire (130) of cartridge assembly
(100) with a cable (24) of handle (20). In some versions, adapter
(131) is replaced with one or more pins, one or more exposed
electrical contacts, one or more sockets, and/or one or more other
features that are configured to mate with complementary features in
handle (20) when cartridge assembly (100) is coupled with handle
(20). These alternative mating features of cartridge assembly (100)
and handle (20) may provide electrical communication between wire
(130) and cable (24) when cartridge assembly (100) is coupled with
handle (20). Various suitable forms that such mating features may
take will be apparent to those of ordinary skill in the art in view
of the teachings herein.
[0044] A strain relief (28) is provided at the point where cable
(24) exits handle (20). Cable (24) may be coupled with a console
(210) as will be described in greater detail below. Also as will be
described in more detail below, distal portion (D) of wire (130) is
slidably disposed within an opening (not shown) formed in a distal
surface (not shown) of housing (110) such that distal portion (D)
is configured to translate relative to housing (110). Wire (130)
includes a service loop (S) disposed between proximal portion (P)
and distal portion (D). Service loop (S) is positioned within
housing (110) and is configured to provide freedom of movement to
distal portion (D) so as to accommodate translation of distal
portion (D) relative to housing (110) while proximal portion (P)
remains fixed relative to housing (110).
[0045] As best seen in FIG. 3, wire (130) is positioned within a
longitudinal channel (126) formed in a bottom surface of sled (121)
of actuator (120). Wire (130) is secured within channel (126) such
that translation of actuator (120) within slot (112) of housing
(110) causes concurrent translation of wire (130). In particular,
actuator (120) is coupled with distal portion (D) of wire (130),
distally of service loop (S), such that translation of actuator
(120) within slot (112) causes concurrent translation of distal
portion (D) of wire (130). As mentioned above, service loop (S) is
configured to provide freedom of movement to distal portion (D) so
as to accommodate translation of distal portion (D) relative to
housing (110) while proximal portion (P) remains fixed relative to
housing (110).
[0046] As will be described in more detail below, with cartridge
assembly (100) coupled within handle (20), distal portion (D) of
wire (130) is configured to be slidably received within a bore (26)
of handle (20) and within guide tube (30) such that wire (130) is
configured to translate within bore (26) and guide tube (30) in
response to translation of actuator (120) relative to housing
(110). This translation of wire (130) causes translation of a
distal end (132) of wire (130) relative to guide tube (30) as
actuator (120) translates between the proximal longitudinal
position, the intermediate longitudinal position, and the distal
longitudinal position as described above and as will be described
in more detail below. Guide tube (30) defines a lumen that is
configured to slidably receive wire (130), such that guide tube
(30) may guide wire (130) out through bent distal end (32). In some
versions of cartridge assembly (100), guide tube (30) may be an
integral component of cartridge assembly (100).
[0047] Actuator (120) of the present example further comprises a
rotatable member (128) rotatably disposed within an upper portion
of sled (121). Rotatable member (128) of the present example is
rotatable within and relative to sled (121). A portion of rotatable
member (128) is exposed relative to sled (121) such that the
operator may directly engage rotatable member (128) with a finger
or thumb to thereby cause rotation of rotatable member (128).
Rotatable member (128) is mechanically coupled with wire (130) such
that rotation of rotatable member (128) about the longitudinal axis
of rotatable member (128) causes concurrent rotation of wire (130)
about the longitudinal axis of wire (130). In particular, rotatable
member (128) may be mechanically associated with the portion of
wire (130) that is secured within channel (126) of sled (121) such
that rotation of rotatable member (128) is configured to cause
concurrent rotation of wire (130). By way of example only,
rotatable member (128) and wire (130) may be coupled via gears, one
or more cables, one or more belts, and/or any other components that
are operable to provide rotation of wire (130) in response to
rotation of rotatable member (128). Wire (130) has sufficient
strength against torsion such that rotation of wire (130) by
rotatable member (128) is communicated to distal end (132) of wire
(130). In some alternative versions, rotatable member (128) is
omitted.
[0048] As shown in FIG. 3, distal end (132) of wire (130) of the
present example is substantially straight and includes an
atraumatic distal tip. As shown in FIGS. 4 and 5, the distal end of
wire (130) may include a preformed bend (FIG. 4), a preformed curve
(FIG. 5), or any other appropriate configuration. It should
therefore be appreciated that rotation of wire (130) may result in
realignment or reorientation of distal end (132). It should also be
understood that the tip of distal end (132) may have any suitable
configuration, including but not limited to a dome shape, a ball
shape, a blueberry shape, or any other suitable shape.
[0049] As shown schematically in FIGS. 2-3 and 6A-6E, distal end
(132) of wire (130) of the present example comprises a position
sensor (135) and an ultrasound sensor (136). As will be described
in more detail below, sensors (135, 136) enable distal end (132) of
wire (130) to be used to provide mapping and/or navigation of the
nasal cavity of a patient, passageways associated with the nasal
cavity of a patient (e.g., paranasal sinus ostia and cavities, the
frontal recess, the Eustachian tube, etc.), and/or other anatomical
passageways (e.g., within the ear, nose, or throat, etc.). It
should be understood that some variations of wire (130) may include
position sensor (135) and omit ultrasound sensor (136). Some other
variations of wire (130) may include ultrasound sensor (136) and
omit position sensor (135). In addition to or in lieu of having
position sensor (135) and/or ultrasound sensor (136), distal end
(132) of wire (130) may include a camera that is configured to
provide real-time visualization of a surgical field.
[0050] In the present example, position sensor (135) includes a
coil that is embedded within distal end (132) of wire (130) and
that is in communication with one or more electrical conduits that
extend along the length of wire (130). When position sensor (135)
is positioned within an electromagnetic field, movement of position
sensor (135) within that magnetic field may generate electrical
current in the coil, and this electrical current may be
communicated along wire (132) and further along cable (24). This
phenomenon may enable a system (200) to determine the location of
distal end (132) within a three dimensional space as will be
described in greater detail below.
[0051] By way of example only, position sensor (135) and/or other
components of wire (130) may be constructed and operable in
accordance with at least some of the teachings of U.S. Pat. No.
8,702,626, the disclosure of which is incorporated by reference
herein; U.S. Pat. No. 8,320,711, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 8,190,389, the
disclosure of which is incorporated by reference herein; U.S. Pat.
No. 8,123,722, the disclosure of which is incorporated by reference
herein; U.S. Pat. No. 7,720,521, the disclosure of which is
incorporated by reference herein; U.S. Pat. Pub. No. 2014/0364725,
the disclosure of which is incorporated by reference herein; U.S.
Pat. Pub. No. 2014/0200444, the disclosure of which is incorporated
by reference herein; U.S. Pat. Pub. No. 2012/0245456, the
disclosure of which is incorporated by reference herein; U.S. Pat.
Pub. No. 2011/0060214, the disclosure of which is incorporated by
reference herein; U.S. Pat. Pub. No. 2008/0281156, the disclosure
of which is incorporated by reference herein; and/or U.S. Pat. Pub.
No. 2007/0208252, the disclosure of which is incorporated by
reference herein. As another merely illustrative example, wire
(130) may be constructed and operable in accordance with at least
some of the teachings of U.S. Provisional Pat. App. No. [ATTORNEY
DOCKET NO. ACC5103USPSP.0626027], entitled "Guidewire with
Navigation Sensor," filed on even date herewith, the disclosure of
which is incorporated by reference herein. Other suitable ways in
which wire (130) may be constructed and operable will be apparent
to those of ordinary skill in the art in view of the teachings
herein.
[0052] FIGS. 6A-6E show an exemplary method of assembly and
operation of device (10). FIG. 6A shows cartridge assembly (100)
spaced apart from handle (20). As shown in FIG. 6B, as cartridge
assembly (100) is moved toward handle (20), adapter (131) of
proximal portion (P) of wire (130) is coupled with cable (24) of
handle (20) and distal portion (D) of wire (130) is positioned
within bore (26) of handle (20) and within the lumen of guide tube
(30). FIG. 6C shows cartridge assembly (100) coupled within opening
(22) of handle (20). Cartridge assembly (100) may couple within
opening (22) of handle (20) in a snap-fit manner, interference-fit
manner, friction-fit manner, or any other appropriate method.
Cartridge assembly (100) and/or handle (20) may include latches,
clasps, clamps, and/or any other suitable features to releasably
secure cartridge assembly (100) relative to handle (20).
[0053] With actuator (120) in the proximal longitudinal position as
shown in FIG. 6C, the tip of distal end (132) of wire (130) is
positioned flush with the distal edge (34) of guide tube (30). As
actuator (120) is translated distally to the intermediate
longitudinal position as shown in FIG. 6D, distal end (132) of wire
(130) extends from the distal end (DE) of guide tube (30), such
that at least a portion of distal end (132) is distal to distal
edge (34) of guide tube (30). In some versions, the length of wire
(130) that extends distally past distal edge (34) of guide tube
(30) at this stage is between 3 mm and 8 mm, or more particularly 5
mm. Alternatively, any other suitable length of wire (130) may
extend distally past distal edge (34) of guide tube (30) at this
stage. As actuator (120) is translated further distally to the
distal longitudinal position as shown in FIG. 6E, distal end (132)
of wire (130) extends further from the distal end (DE) of guide
tube (30). In some versions, the length of wire (130) that extends
distally past distal edge (34) of guide tube (30) at this stage is
between 10 mm and 25 mm. Alternatively, any other suitable length
of wire (130) may extend distally past distal edge (34) of guide
tube (30) at this stage.
[0054] As will be described in more detail below, during use of
device (10) in a patient, distal end (132) of wire (130) may
contact one or more anatomical structures associated with the
patient's paranasal sinuses and/or other anatomical structures
(e.g., within the ear, nose, or throat, etc.). Wire (130) may have
sufficient column strength to withstand buckling in response to
longitudinally oriented forces when such contact occurs, at least
when actuator (120) and wire (130) are in the intermediate
longitudinal position shown in FIG. 6D. Wire (130) may additionally
or alternatively be configured to buckle when such contact exceeds
a threshold load. For instance, wire (130) may be configured to
buckle when exposed to loads exceeding 7 Newtons of force, or any
other appropriate force. It should also be understood that when
actuator (120) and wire (130) are in the intermediate longitudinal
position shown in FIG. 6D or in the distal longitudinal position
shown in FIG. 6E, the length of wire (130) that is extended
distally of distal edge (34) allows distal end (132) to deflect
laterally when distal end (132) contacts one or more anatomical
structures associated with the patient's paranasal sinuses and/or
other anatomical structures. This may be useful when distal end
(132) contacts a particularly fragile anatomical structure. In
other words, the flexibility provided by wire (130) may prevent
distal end (132) from inadvertently fracturing a fragile anatomical
structure as distal end (132) is pushed against the fragile
anatomical structure during a process of mapping or navigation as
described herein.
[0055] It should be understood from the foregoing that device (10)
may be provided in three different modes based on the longitudinal
position of actuator (120) and wire (130). When actuator (120) and
wire (130) are in the proximal position shown in FIG. 6C, device
(10) is in a rigid mode. In the rigid mode, wire (130) does not
provide any flexibility as distal end (132) contacts anatomical
structures. When actuator (120) and wire (130) are in the
intermediate position shown in FIG. 6D, device (10) is in a
flexible mode. In the flexible mode, wire (130) provides an
intermediate amount of "give" or flexibility as distal end (132)
contacts anatomical structures. When actuator (120) and wire (130)
are in the distal position shown in FIG. 6E, device (10) is in an
extended mode. In the extended mode, wire (130) provides the most
"give" or flexibility as distal end (132) contacts anatomical
structures.
[0056] After device (10) is used in a patient, the operator may
remove and discard cartridge assembly (100). The remaining
components of device (10) may be sterilized for further use. After
sterilization, another new cartridge assembly (100) may replace the
discarded cartridge assembly (100) and device (10) may be used once
again. Thus, in some versions of device (10), cartridge assembly
(100) may be single-use.
[0057] II. Exemplary Mapping and Imaging System and Method
[0058] An operator may wish to use device (10) to provide a 3-D
image of a targeted anatomical structure. FIG. 7 is a schematic,
pictorial illustration of an exemplary system (200) for imaging and
mapping a target structure, such as the maxillary sinus (MS) of a
patient. By way of example only, system (200) may be configured and
operable in accordance with at least some of the teachings of 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. System (200) comprises
device (10), which is inserted transnasally and advanced through
the nasal cavity (NC) to position the distal end (DE) of guide tube
(30) within or near the maxillary sinus (MS) as shown in FIG. 8A.
After device (10) has been positioned, the operator advances wire
(130) distally through guide tube (30) by translating actuator
(120) distally such that distal end (132) of the wire (130) passes
through the ostium (O) of the maxillary sinus (MS) and into the
cavity of the maxillary sinus (MS) as shown in FIG. 8B (actuator
(120) in the intermediate longitudinal position) and 8C (actuator
(120) in the distal longitudinal position). It should be understood
that the maxillary sinus (MS) is shown in the present example
merely for illustrative purposes.
[0059] A positioning sub-system of system (200) comprises a set of
external field generating coils (202). Field generating coils (202)
are configured to generate electromagnetic fields in accordance
with components and techniques known in the art. The locations of
field generating coils (202) are defined in a fixed coordinate
space of the positioning sub-system. In the present example, and as
shown in FIG. 7, field generating coils (202) are located near the
patient's head such that the patient's head is positioned in the
electromagnetic field generated by field generating coils
(202).
[0060] As mentioned above, distal end (132) of wire (130) of the
present example comprises a position sensor (135). Based on the
fields generated by coils (202), position sensor (135) generates
position-related signals and transmits these signals to a console
(210). A positioning processor (212) in console (210) calculates
location coordinates of the distal end (132) of wire (130) from the
position-related signals of position sensor (135). Distal end (132)
of the wire (130) may be brought into contact with one or more
locations on an inner surface of the maxillary sinus (MS), and the
coordinates at each location are determined and stored in the
console (210) as a matrix of points. The stored matrix is referred
to hereinbelow as an anatomical map.
[0061] Distal end (132) of wire (130) may further comprise an
ultrasound sensor (136) comprising a transducer that generates
ultrasound energy and receives reflected ultrasound echoes. Based
on the reflected echoes, ultrasound sensor (136) transmits
ultrasound-related signals to an image processor (214) in console
(210). Image processor (214) may receive these ultrasound-related
signals from multiple positions and orientations of the ultrasound
sensor (136), and processes these signals to construct a 3-D
ultrasound image in a 3-D space, comprising a set of voxels (i.e.,
3-D pixels). Image processor (214) may be configured to perform
other functions such as contour delineation. Using 3-D
visualization techniques, image processor (214) also displays 3-D
objects (such as delineated contours) on a display (216) of console
(210).
[0062] Console (210) may be interactive, enabling the operator to
control displayed items using a pointing device, such as a
track-ball or mouse (218), and/or to enter commands with a keyboard
(220). In some instances, the operator may use mouse (218) and/or
keyboard (220) to mark and/or annotate certain anatomical features
or regions within the image displayed through display (216).
[0063] In the present example, the functions of the positioning
processor (212) and image processor (214) are implemented using a
general-purpose computer that is programmed in software to carry
out the functions described herein. The software may be downloaded
to the computer in electronic form, over a network, for example, or
it may alternatively be supplied to the computer on tangible media,
such as CD or DVD, etc. The positioning processor (212) and image
processor (214) may be implemented using separate computers or
using a single computer, or may be integrated with other computing
functions of system (200). Additionally or alternatively, at least
some of the positioning and image processing functions may be
performed using dedicated hardware.
[0064] FIG. 9 is a flow chart that schematically illustrates an
exemplary process (250) for mapping and imaging of a target
structure, such as the maxillary sinus (MS) of a patient. At a data
acquisition step (252), a user manipulates device (10) within the
maxillary sinus (MS) to acquire ultrasound image data and
anatomical map data of a target structure via position sensor (135)
and ultrasonic sensor (136). The anatomical map data may be
delineated by a user of system (200). Additionally or
alternatively, the anatomical map data may be acquired by contact
mapping, such as electro-anatomical mapping, in which distal end
(132) of wire (130) is brought into contact with multiple points on
the inner surface of the maxillary sinus (MS).
[0065] At a seed generation step (254), image processor (214)
automatically generates, from the anatomical map data, one or more
seed points. A seed point may be a particular point comprised in
the map, or may be determined by interpolation and/or extrapolation
from several measured points. In some instances, a surface may be
generated by a polynomial least-squares fit of points in the
anatomical map, and a single seed point is determined as a midpoint
of the surface. Alternatively, the seed point may be chosen by an
operator of system (200).
[0066] Next, at a contour detection step (256), a contour in the
ultrasound image is detected and delineated based on the seed
point(s). The contour may correspond to the inner surface of the
maxillary sinus (MS). Contour detection and delineation is based on
the seed point(s). Detection may include edge detection methods,
correlation methods, motion detection methods and other methods
known in the art. A well-known method of edge detection is the
"Canny" edge detection method, described in F. J. Canny, "A
Computational Approach to Edge Detection," IEEE Trans PAMI,
8(6):679-698, 1986. An improved method, based on the "Canny" edge
detection method, is described in U.S. Pub. No. 2009/0080738,
entitled "Edge Detection In Ultrasound Images," published Mar. 26,
2009, the disclosure of which is incorporate by reference herein.
The output of step (256) is a matrix in three dimensions defining
one or more contours that segment the original ultrasound 3-D image
produced by image processor (214). Alternatively, contours may be
defined using parametric equations. Once a contour is determined
according to the above steps, the contour may be applied in
subsequent steps of visualizing the ultrasound image and the
anatomical map.
[0067] At a map enhancement step (260), the resolution of the
anatomical map acquired at step (252) is enhanced with points
extracted from the contour. Step (260) comprises three sub-steps.
At a sub-step (262), the contour determined at step (256) is
transformed in the 3-D coordinate space to align with the points in
the electro-anatomical map. In one embodiment, the transformation
of the contour is performed based on a least-squares, best-fit
algorithm.
[0068] Subsequently, at a point extraction sub-step (264), contour
points are extracted from the transformed contour and added to the
anatomical map, thereby enhancing the density of the map.
Extraction of contour points may be performed automatically by
projecting a 2-D grid of a given density onto the surface of the
contour and extracting points at grid intersections.
[0069] At a sub-step (266), a picture of the enhanced map,
including coordinates of the extracted contour points, is
displayed. The picture is generally displayed as a 3-D image using
3-D visualization methods, including projection of 3-D data onto
the 2-D plane of display (216). Typically, the displayed image may
be rotated via track-ball or mouse (218) and/or keyboard (220) so
as to be viewed from multiple perspectives.
[0070] At a contour display step (267), the contour determined at
step (256) is displayed, using 3-D visualization methods.
Physiological parameters from the anatomical map may be
interpolated and/or extrapolated over the surface of the contour so
as to display the contour with highlighting indicative of the
parametric values. Highlighting may be indicated by various means,
such as coloring or shading. Similar highlighting of the contour
surface may also be used to display image data (i.e., voxels) from
the 3-D ultrasound image. Each point of the contour surface may be
highlighted according to the value of the voxel at the
corresponding coordinates in the 3-D image. The contour may also be
highlighted based on 3-D image data extracted from other sources,
including MRI, CT, or x-ray imaging. The contour may also be
transformed by a given radial offset, and the 3-D image data
highlighting may be displayed according to the offset coordinates,
analogous to viewing onion skins at various depths.
[0071] In further examples, image processor (214) may generate a
closed volume, rather than a surface, based on the contour. Within
the closed volume, voxels extracted from 3-D image sources may be
displayed with various degrees of transparency, such that voxels
corresponding to unobstructed anatomical structures appear
transparent and voxels corresponding to tissues or other
obstructions appear relatively dark and opaque.
[0072] At a supplemental acquisition step (268), additional map
points are measured with wire (130) and added to the anatomical
map, thereby increasing the map density.
[0073] Process (250) may be performed iteratively, in real-time,
such that images displayed via display (216) of console (210) are
updated based on newly acquired data and subsequent calculations
based on the newly acquired data.
[0074] III. Exemplary Navigating Method
[0075] As noted above, mapping and navigational device (10) may be
used in conjunction with system (200) to provide image-guided
navigation within a patient. Distal end (132) of wire (130) may be
used to gently probe anatomical structures within the patient,
which will allow for identification of anatomic structures that can
be directly visualized in the endoscopic view and anatomical
structures that are outside of the endoscopic view using position
sensor (135). Device (10) could be used to identify any portion of
the anatomy, including structures and spaces within the nasal
anatomy such as the frontal outflow tract and cells within the
frontal recess, ethmoid cells, sinus ostia, the skull base, optic
nerve, carotid artery, etc. via gentle probing to prevent damage to
mucosa and anatomic structures. Distal end (132) of wire (130) may
identify anatomical structures and the navigation software of
system (200) could use this location information to generate a
computer-rendered endoscopic view via display (216), as observed
from distal end (132) of wire (130). This would allow visualization
of a rendered endoscopic view from the distal end (132) of wire
(130) to observe sinus outflow tracts, ostia, and walls of the
sinus cavities, etc. In some versions as will be described in
greater detail below, a modified version of device (10) also
provides suction to remove blood, mucus, and other fluids from the
surgical field. With wire (130) in the retracted position, device
(10) acts as a standard navigable probe and/or, in the variation of
device (10) described below, a suction device.
[0076] After the 3-D map or image has been generated as described
above, the operator may wish to use device (10) as a navigation
tool. As mentioned above, distal end (132) of wire (130) of the
present example comprises a position sensor (135). Based on the
fields generated by coils (202), position sensor (135) generates
position-related signals and transmits these signals to a console
(210). Positioning processor (212) calculates location coordinates
of the distal end (132) of wire (130) from the position-related
signals of position sensor (135). Console (210) correlates the data
it receives from position sensor (135) and positioning processor
(212) with the 3-D image. The 3-D image is displayed on display
(216) along with an indicator (e.g., cross hairs or an illuminated
dot) showing the real time position distal end (132) of wire (130)
relative to the anatomical structures shown in the 3-D image. In
this manner, the operator is able to know the precise position of
distal end (132) by viewing display (216) of console (210), even if
the operator is unable to directly visualize distal end (132) at
its current location within the body.
[0077] In view of the foregoing, it should be understood that wire
(130) may be incorporated into various kinds of instruments in
order to provide navigation of such instruments in relation to 3-D
images or maps that are generated as described herein. Such
alternative instruments may also be used to generate 3-D images or
maps that are generated as described herein. In other words, it is
contemplated that the wire (130) and its associated functionality
may be readily incorporated into various instruments other than
device (10). By way of example only, wire (130) and its associated
functionality may be readily incorporated into otherwise
conventional suction devices, otherwise conventional probe devices,
otherwise conventional seeker devices, etc. Incorporating wire
(130) and its associated functionality into an otherwise
conventional instrument may enhance such an instrument by
facilitating use of the instrument around fragile anatomical
structures such as those found within the nasal cavity, etc. In
other words, the flexibility provided by wire (130) may prevent
distal end (132) from inadvertently fracturing a fragile anatomical
structure as distal end (132) is pushed against the fragile
anatomical structure when the instrument incorporating wire (130)
is used during a process of mapping or navigation as described
herein. In the absence of the flexibility provided by wire (130),
the conventional instrument might otherwise fracture the fragile
anatomical structure. This enhanced usability provided by wire
(130) around fragile anatomical structures may be particularly
beneficial when distal end (132) is located in a region that is
outside of an endoscopic field of view, where the operator would
otherwise be operating the instrument blindly.
[0078] IV. Exemplary Mapping and Navigational Device with Malleable
Guidance Tube and Suction Features
[0079] FIGS. 10 and 11 show another exemplary mapping and
navigational device (300) that may be used in conjunction with
system (200) and in addition to or in lieu of device (10) described
above, to map and/or navigate the nasal cavity of a patient,
passageways associated with the nasal cavity of a patient (e.g.,
paranasal sinus ostia and cavities, the frontal recess, the
Eustachian tube, etc.), and/or other anatomical passageways (e.g.,
within the ear, nose, or throat, etc.). Mapping and navigational
device (300) of the present example comprises a handle assembly
(320) and a guide tube assembly (330). In the present example, the
combination of handle assembly (320) and a guide tube assembly
(330) is provided as a disposable device (e.g., single patient
only, non-sterilizable). In some instances, the combination of
handle assembly (320) and a guide tube assembly (330) is provided
as a reusable device (e.g., multi-patient, sterilizable). Handle
assembly (320) of the present example may be grasped like a pencil
by a user. Alternatively, various other suitable configurations and
gripping techniques may be used, including but not limited to a
pistol grip configuration or a power grip technique.
[0080] Handle assembly (320) comprises a body (322), a manual
actuator (324), and a flexible wire (340). As best seen in FIG. 14,
body (322) includes a longitudinal slot (326) formed in a top
surface (328) of body (322). Actuator (324) is slidably disposed
within slot (326) of body (322) via a pair of longitudinal channels
(not shown) formed in opposing sides of actuator (324) such that,
as will be described in more detail below, actuator (324) is
configured to translate within slot (326) between a proximal
longitudinal position (FIG. 18A), an intermediate longitudinal
position (FIG. 18B), and a distal longitudinal position (FIG. 18C).
Top surface (328) of body (322) includes a series of visible
markers (325A, 325B, 325C) positioned along a side surface (329) of
body (322) adjacent slot (326). Markers (325A, 325B, 325C)
correspond to the proximal longitudinal position, the intermediate
longitudinal position, and the distal longitudinal position of
actuator (324), respectively. Actuator (324) includes a visible
marker (327) that is configured to align with markers (325A, 325B,
325C) of body (322) to visually indicate that actuator (324) has
reached each corresponding longitudinal position. Additionally, or
alternatively, body (322) and/or actuator (324) may further include
features (e.g. mechanical detents) that are configured to provide
tactile and/or audible feedback to the operator as actuator (324)
reaches each longitudinal position. Of course, body (322) and/or
actuator (324) may simply lack markers (325A, 325B, 325C, 327)
and/or mechanical detents altogether, as such components are merely
optional and not required. It should also be appreciated that
although not depicted, actuator (324) may include a rotatable
member configured to operate substantially similar to rotatable
member (128) of actuator (120) described above.
[0081] Guide tube assembly (330) extends distally from handle
assembly (320). Guide tube assembly (330) of the present example
includes an outer sheath (332) and an inner tube (334). Inner tube
(334) is positioned within and extends distally from outer sheath
(332) such that a proximal length (351) of inner tube (334) is
encased within outer sheath (332) (FIG. 16) and such that a distal
length (337) of inner tube (334) is exposed relative to outer
sheath (332). In the present example, outer sheath (332) is rigid
such that proximal length (351) of inner tube (334) positioned
within outer sheath (332) conforms to the shape of outer sheath
(332). In some versions of device (300), outer sheath (332) is
substantially straight as shown in FIGS. 10 and 11. Alternatively,
outer sheath (332) may include a preformed bent portion (336) as
shown in FIGS. 12 and 13. By way of example only, bent portion
(336) may provide a bend angle of approximately 20.degree..
Alternatively, any other suitable bend angle may be used.
[0082] In the present example, inner tube (334) is malleable such
that the operator may deform distal length (337) of inner tube
(334) to any desired bend angle and distal length (337) may
maintain the selected bend angle during subsequent use. By way of
example only, distal length (337) may have a length of between
approximately 0.5 inches and approximately 3.0 inches.
Alternatively, any other suitable length may be used. In some
versions, inner tube (334) extends along the full length of device
(300). Regardless of the length of inner tube (334), inner tube
(334) may be reinforced with a metal or plastic braid or coil
positioned about or within inner tube (334). In some versions of
guide tube assembly (330), outer sheath (332) may be omitted
entirely such that the entire length of guide tube assembly (330)
is malleable. In other versions of guide tube assembly (330), outer
sheath (332) may extend the entire length of inner tube (334) or
inner tube (334) may be omitted entirely such that the entire
length of guide tube assembly (330) is rigid. In still other
versions of guide tube assembly (330), guide tube assembly (330) is
configured similar to the Relieva Flex.TM. Sinus Guide Catheter by
Acclarent, Inc. of Menlo Park, Calif. As yet another merely
illustrative example, guide tube assembly (330) may consist of a
single tubular element instead of two tubular elements such as
inner tube (334) and outer sheath (332). For instance, guide tube
assembly (330) may comprise a single tubular element with materials
of disparate stiffness, such that a proximal region of the single
tubular element is rigid while a distal region of the single
tubular element is malleable. As yet another merely illustrative
example of a single tubular element version, the single tubular
element may be formed of a stiff material such as metal with a
distal portion being annealed to make the distal portion of the
single tubular element malleable. Other suitable forms that guide
tube assembly (330) may take will be apparent to those of ordinary
skill in the art in view of the teachings herein.
[0083] As best seen in FIG. 15, inner tube (334) includes a
plurality of lumens (331, 333, 335) formed therein and which extend
the full length of inner tube (334). As will be described in more
detail below, lumen (331) is configured to slidably receive wire
(340) such that lumen (331) is configured to guide wire (340) along
the length of guide tube assembly (330) as wire (340) translates
within and relative to inner tube (334).
[0084] Lumen (333) is configured to receive a malleable member
(350). Malleable member (350) is configured to provide malleability
to inner tube (334). In some versions, the material that forms the
outer region of inner tube (334) (including the material that
defines lumens (331, 333, 335) is flexible and non-malleable, such
that malleability of inner tube (334) is provided solely by
malleable member (350). Malleable member (350) may include a
malleable wire, rod, or tube. Malleable member (350) may
additionally or alternatively include an articulation joint(s). All
or a portion (e.g., between 0.3 cm and 2 inches) of malleable
member (350) may comprise a material having low magnetic
permeability, including by not limited to 316 stainless steel,
nitinol, cobalt chromium, tungsten, PEEK, and polycarbonate, such
that malleable member (350) will not interfere with any signals
from wire (340). Various suitable materials and configurations that
may be used to form malleable member (350) will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0085] Lumen (335) is configured to provide suction to the distal
end of inner tube (334) to remove blood, mucus, and other fluids
from the surgical field. As shown in FIG. 16, lumen (335) is in
fluid communication with a lumen (352) formed within body (322). A
proximal end of lumen (352) of body (322) terminates in a luer port
(354), which is best seen in FIGS. 10-11. A suction/vacuum source
may be coupled with luer port (354) to provide suction to the
distal end of inner tube (334). As best seen in FIGS. 16-17, body
(322) further includes a suction port (356) that is in fluid
communication with lumen (352) of body (322). The operator may
control the suction provided to the distal end of inner tube (334)
via lumen (335) by selectively covering or uncovering port (356)
using his or her finger or thumb while simultaneously maneuvering
device (320) and/or translating actuator (324). For instance, the
operator may use his or her thumb to cover port (356) while
simultaneously using his or her index finger to translate actuator
(324). When port (356) is covered, the suction from the suction
source may be fully delivered to the distal end of inner tube (334)
via lumen (335). When port (356) is uncovered, the suction from
suction source will be communicated through port (356) to the
atmosphere, such that either no suction or just a limited amount of
suction will travel further distally past port (356). In other
words, the distal end of inner tube (334) receives full suction
when port (356) is covered; and the distal end of inner tube (334)
receives either no suction or just limited suction when port (356)
is uncovered.
[0086] While port (356) is shown as being formed in a bottom
surface (353) of body (322), it should be understood that port
(356) may be provided at any other suitable location. For instance,
port (356) may be located on actuator (324). As another merely
illustrative example, port (356) may be located at a position on
body (322) proximal to actuator (324). As yet another illustrative
example, port (356) may be located at on a lateral side of body
(322). Regardless of the particular location chosen for port (356),
port (456) may be located at a position that will enable the
operator to selectively cover/uncover port (356) while
simultaneously operating actuator (324) with the same hand that is
used to selectively cover/uncover port (356). Various suitable
alternative locations and configurations for port (356) will be
apparent to those of ordinary skill in the art in view of the
teachings herein. It should also be understood that port (356) may
be substituted with a footswitch actuated valve that is located
upstream of luer port (354).
[0087] Wire (340) may be configured and operable substantially
identically to wire (130) described above. Wire (340) of the
present example comprises a flexible stacked-coil design. Wire
(340) extends completely through body (322) and lumen (331) of
inner tube (334). As mentioned above, wire (340) is configured to
translate within and relative to inner tube (334) of guide tube
assembly (330). Wire (340) is secured to actuator (324) such that
translation of actuator (324) within slot (326) of body (322)
causes concurrent translation of wire (340) relative to inner tube
(334). This translation of wire (340) causes translation of a
distal end (342) of wire (340) relative to guide tube assembly
(330) as actuator (324) translates between the proximal
longitudinal position, the intermediate longitudinal position, and
the distal longitudinal position as described above and as will be
described in more detail below.
[0088] The distal end (342) of wire (340) may be configured and
operable substantially identically to distal end (132) of wire
(130) described above. Distal end (342) of wire (340) of the
present example is substantially straight and includes an
atraumatic distal tip. As discussed above with reference to wire
(130), distal end (342) of wire (340) may include a preformed bend
(FIG. 4), a preformed curve (FIG. 5), or any other appropriate
configuration. It should also be understood that the tip of distal
end (342) may have any suitable configuration, including but not
limited to a dome shape, a ball shape, a blueberry shape, or any
other suitable shape.
[0089] Distal end (342) of wire (340) of the present example
comprises a position sensor (345) and an ultrasound sensor (346).
As will be described in more detail below, sensors (345, 346)
enable distal end (342) of wire (340) to be used to provide mapping
and/or navigation of the nasal cavity of a patient, passageways
associated with the nasal cavity of a patient (e.g., paranasal
sinus ostia and cavities, the frontal recess, the Eustachian tube,
etc.), and/or other anatomical passageways (e.g., within the ear,
nose, or throat, etc.). It should be understood that some
variations of wire (340) may include position sensor (345) and omit
ultrasound sensor (346). Some other variations of wire may include
ultrasound sensor (346) and omit position sensor (345). In addition
to or in lieu of having position sensor (345) and/or ultrasound
sensor (346), distal end (342) of wire (340) may include a camera
that is configured to provide real-time visualization of a surgical
field.
[0090] In the present example, position sensor (345) includes a
coil that is embedded within distal end (342) of wire (340) and
that is in communication with one or more electrical conduits that
extend along the length of wire (340). When position sensor (345)
is positioned within an electromagnetic field (e.g., as generated
by coils (202) of system (200)), movement of position sensor (345)
within that magnetic field may generate electrical current in the
coil, and this electrical current may be communicated along wire
(340). This phenomenon may enable system (200) described above to
determine the location of distal end (342) within a three
dimensional space as will be described in greater detail below.
[0091] By way of example only, position sensor (345) and/or other
components of wire (340) may be constructed and operable in
accordance with at least some of the teachings of U.S. Pat. No.
8,702,626, the disclosure of which is incorporated by reference
herein; U.S. Pat. No. 8,320,711, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 8,190,389, the
disclosure of which is incorporated by reference herein; U.S. Pat.
No. 8,123,722, the disclosure of which is incorporated by reference
herein; U.S. Pat. No. 7,720,521, the disclosure of which is
incorporated by reference herein; U.S. Pat. Pub. No. 2014/0364725,
the disclosure of which is incorporated by reference herein; U.S.
Pat. Pub. No. 2014/0200444, the disclosure of which is incorporated
by reference herein; U.S. Pat. Pub. No. 2012/0245456, the
disclosure of which is incorporated by reference herein; U.S. Pat.
Pub. No. 2011/0060214, the disclosure of which is incorporated by
reference herein; U.S. Pat. Pub. No. 2008/0281156, the disclosure
of which is incorporated by reference herein; and/or U.S. Pat. Pub.
No. 2007/0208252, the disclosure of which is incorporated by
reference herein. As another merely illustrative example, wire
(340) may be constructed and operable in accordance with at least
some of the teachings of U.S. Provisional Pat. App. No. [ATTORNEY
DOCKET NO. ACC5103USPSP.0626027], entitled "Guidewire with
Navigation Sensor," filed on even date herewith, the disclosure of
which is incorporated by reference herein. Other suitable ways in
which wire (340) may be constructed and operable will be apparent
to those of ordinary skill in the art in view of the teachings
herein.
[0092] FIGS. 18A-18C show an exemplary method of operation of
device (300). As shown in FIG. 18A, with actuator (324) in the
proximal longitudinal position, the tip of distal end (342) of wire
(340) is positioned flush with the distal edge (355) of inner tube
(334). As actuator (324) is translated distally to the intermediate
longitudinal position as shown in FIG. 18B, distal end (342) of
wire (340) extends from the distal end of inner tube (334), such
that at least a portion of distal end (342) is distal to distal
edge (355) of inner tube (334). In some versions, the length of
wire (340) that extends distally past distal edge (355) of inner
tube (330) at this stage is between 0.5 cm and 1.5 cm.
Alternatively, any other suitable length of wire (340) may extend
distally past distal edge (355) of inner tube (334) at this stage.
As actuator (324) is translated further distally to the distal
longitudinal position as shown in FIG. 18C, distal end (342) of
wire (340) extends further from the distal end of inner tube (334).
In some versions, the length of wire (340) that extends distally
past distal edge (355) of inner tube (334) at this stage is between
2 cm and 3.5 cm. Alternatively, any other suitable length of wire
(340) may extend distally past distal edge (355) of inner tube
(334) at this stage.
[0093] As described with reference to device (10), during use of
device (300) in a patient, distal end (342) of wire (340) may
contact one or more anatomical structures associated with the
patient's paranasal sinuses and/or other anatomical structures
(e.g., within the ear, nose, or throat, etc.). Wire (340) may have
sufficient column strength to withstand buckling in response to
longitudinally oriented forces when such contact occurs, at least
when actuator (324) and wire (340) are in the intermediate
longitudinal position shown in FIG. 18B. Wire (340) may
additionally or alternatively be configured to buckle when such
contact exceeds a threshold load. For instance, wire (340) may be
configured to buckle when exposed to loads exceeding 7 Newtons of
force, or any other appropriate force. It should also be understood
that when actuator (324) and wire (340) are in the intermediate
longitudinal position shown in FIG. 18B or in the distal
longitudinal position shown in FIG. 18C, the length of wire (340)
that is extended distally of distal edge (355) allows distal end
(342) to deflect laterally when distal end (342) contacts one or
more anatomical structures associated with the patient's paranasal
sinuses and/or other anatomical structures. This may be useful when
distal end (342) contacts a particularly fragile anatomical
structure. In other words, the flexibility provided by wire (340)
may prevent distal end (342) from inadvertently fracturing a
fragile anatomical structure as distal end (342) is pushed against
the fragile anatomical structure during a process of mapping or
navigation as described herein.
[0094] It should be understood from the foregoing that device (300)
may be provided in three different modes based on the longitudinal
position of actuator (324) and wire (340). When actuator (324) and
wire (340) are in the proximal position shown in FIG. 18A, device
(300) is in a rigid mode. In the rigid mode, wire (340) does not
provide any flexibility as distal end (342) contacts anatomical
structures. When actuator (324) and wire (340) are in the
intermediate position shown in FIG. 18B, device (300) is in a
flexible mode. In the flexible mode, wire (340) provides an
intermediate amount of "give" or flexibility as distal end (342)
contacts anatomical structures. In some versions, distal end (342)
of wire (340) is between approximately 0.5 cm and approximately 1.5
cm distal to distal edge (355) of inner tube (334) when device
(300) is in the flexible mode shown in FIG. 18B. When actuator
(324) and wire (340) are in the distal position shown in FIG. 18C,
device (300) is in an extended mode. In the extended mode, wire
(340) provides the most "give" or flexibility as distal end (342)
contacts anatomical structures. By way of example only, wire (340)
may be advanced to a longitudinal position where distal end (342)
is approximately 2.0 cm, approximately 2.5 cm, approximately 3.0
cm, or up to approximately 3.5 cm distal to distal edge (355) of
inner tube (334).
[0095] Device (300) may be used with system (200) described above.
Device (300) would be used to gently probe anatomical structures
with distal end (342) of wire (340). This would allow for
identification of anatomical structures that cannot be directly
visualized endoscopically or anatomical structures that are outside
of an endoscopic view using position sensor (345) and/or ultrasonic
sensor (346) as described above with reference to device (10) and
system (200). Device (300) could be used to identify any portion of
the anatomy, including structures and spaces within the nasal
cavity of a patient (e.g., paranasal sinus ostia and cavities, the
frontal recess, the Eustachian tube, etc.), and/or other anatomical
passageways (e.g., within the ear, nose, or throat, etc.) via
gentle probing to prevent damage any such anatomic structures.
Distal end (342) of wire (340) thus can identify structures and the
navigation software of system (200) could use this location
information to generate a computer-rendered 3-D image via display
(216) as described above. Device (300) may also be used to provide
suction to remove blood, mucus, and other fluids from the surgical
field. With wire (340) in the retracted position, device (300) may
be used as a standard navigable probe and/or as a simple suction
device.
[0096] After device (300) is used in a patient, device (300) may be
sterilized for further use. Alternatively, device (300) may be
discarded after a single use.
[0097] V. Exemplary Combinations
[0098] 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
[0099] An apparatus comprising: (a) a handle assembly, wherein the
handle assembly comprises: (i) a body, and (ii) an actuator; (b) a
guide tube extending distally from the handle assembly, wherein the
guide tube has a distal end; (c) a wire slidably disposed in the
guide tube, wherein the wire has a distal end including a sensor,
wherein the sensor is configured to cooperate with a navigation
system to generate a map of anatomical structures within a patient,
wherein the wire is coupled with the actuator, wherein the actuator
is movable relative to the body to move the wire relative to the
guide tube.
Example 2
[0100] The apparatus of Example 1 or any of the following Examples,
wherein the handle assembly further comprises a cable extending
from the body.
Example 3
[0101] The apparatus of Example 2, wherein the cable is coupled
with a navigation system to communicate signals from the sensor to
the navigation system.
Example 4
[0102] The apparatus of any of Examples 1 through 3, wherein the
handle assembly further comprises a cartridge, wherein the
cartridge is configured to removably couple with the body.
Example 5
[0103] The apparatus of Example 4, wherein the actuator is
integrated into the cartridge such that the actuator is removable
from the body.
Example 6
[0104] The apparatus of any of Examples 4 through 5, wherein the
wire is integral with the cartridge such that the wire is removable
from the guide tube as the cartridge is removed from the body.
Example 7
[0105] The apparatus of any of Examples 1 through 6, wherein the
guide tube is integral with the body.
Example 8
[0106] The apparatus of any of Examples 1 through 7, wherein the
guide tube is rigid.
Example 9
[0107] The apparatus of Example 8, wherein the guide tube has a
distal region with a preformed bend.
Example 10
[0108] The apparatus of any of Examples 1 through 9, wherein at
least a distal portion of the guide tube is malleable.
Example 11
[0109] The apparatus of any of Examples 1 through 10, wherein a
distal portion of the wire includes a preformed bend.
Example 12
[0110] The apparatus of Example 11, wherein the preformed bend
defines an angle with a vertex.
Example 13
[0111] The apparatus of Example 11, wherein the preformed bend
defines a curve.
Example 14
[0112] The apparatus of any of Examples 1 through 13, wherein the
wire has a distal end with a ball tip.
Example 15
[0113] The apparatus of Example 14, wherein the sensor is
integrated into the ball tip.
Example 16
[0114] The apparatus of any of Examples 1 through 15, wherein the
sensor comprises a coil.
Example 17
[0115] The apparatus of Example 16, wherein the coil is responsive
to movement of the distal end of the wire in an electromagnetic
field.
Example 18
[0116] The apparatus of any of Examples 1 through 17, wherein the
actuator is configured to drive the wire between a proximal
position relative to the guide tube and a distal position relative
to the guide tube, wherein the distal end of the wire is flush with
the distal end of the guide tube when the wire is in the proximal
position, wherein the distal end of the wire is distal to the
distal end of the guide tube when the wire is in the distal
position.
Example 19
[0117] The apparatus of Example 18, wherein the handle assembly
provides a plurality of position indicators, wherein the position
indicators comprise a first indicator and a second indicator,
wherein the first indicator is associated with the proximal
position, wherein the second indicator is associated with the
distal position.
Example 20
[0118] The apparatus of Example 19, wherein the indicators comprise
visual indicators.
Example 21
[0119] The apparatus of any of Examples 19 through 20, wherein the
indicators comprise tactile feedback features.
Example 22
[0120] The apparatus of Example 21, wherein the tactile feedback
features comprise detent structures.
Example 23
[0121] The apparatus of Example 19, wherein the indicators further
comprise a third indicator, wherein the third indicator is
associated with the actuator and the wire being located in an
intermediate position, wherein the intermediate position is
positioned between the distal position and the proximal
position.
Example 24
[0122] The apparatus of any of Examples 1 through 23, wherein the
wire forms a service loop within the handle assembly.
Example 25
[0123] The apparatus of Example 24, wherein a proximal portion of
the wire is fixedly secured relative to the handle assembly,
wherein the service loop is configured to permit a distal portion
of the wire to translate relative to the handle assembly while the
proximal portion of the wire remains fixedly secured relative to
the handle assembly.
Example 26
[0124] The apparatus of any of Examples 1 through 25, wherein the
wire is rotatable within the guide tube.
Example 27
[0125] The apparatus of Example 26, wherein the actuator comprises
a rotatable member operable to rotate the wire within the guide
tube.
Example 28
[0126] An apparatus comprising: (a) a handle assembly, wherein the
handle assembly comprises: (i) a body, and (ii) an actuator; (b) a
guide tube assembly extending distally from the handle assembly,
wherein the guide tube assembly comprises a rigid member and a
malleable member; (c) a wire slidably disposed in the guide tube
assembly, wherein the wire has a distal end including a sensor,
wherein the sensor is configured to cooperate with a navigation
system to provide image guided navigation of anatomical structures
within a patient, wherein the wire is coupled with the actuator,
wherein the actuator is movable relative to the body to move the
wire relative to the guide tube.
Example 29
[0127] The apparatus of Example 28, wherein the malleable member
comprises an inner tube, wherein the rigid member comprises an
outer sheath.
Example 30
[0128] The apparatus of any of Examples 28 through 29, wherein the
malleable member extends distally from the rigid member.
Example 31
[0129] The apparatus of any Examples 28 through 30, wherein the
malleable member comprises at least one lumen.
Example 32
[0130] The apparatus of Example 31, wherein the wire is slidably
disposed within a lumen of the at least one lumens of the malleable
member.
Example 33
[0131] The apparatus of any of Examples 31 through 32, wherein the
malleable member comprises a flexible portion and a malleable
portion, wherein the flexible portion defines a lumen of the at
least one lumens of the malleable member, wherein the malleable
portion is disposed the lumen defined by the flexible portion.
Example 34
[0132] The apparatus of any of Examples 31 through 33, wherein a
lumen of the at least one lumens of the malleable member is
configured to provide suction to a distal end of the malleable
member.
Example 35
[0133] The apparatus of Example 34, wherein the body comprises a
luer port in fluid communication with the lumen configured to
provide suction to the distal end of the malleable inner
member.
Example 36
[0134] The apparatus of any of Examples 28 through 35, wherein the
rigid member is substantially straight.
Example 37
[0135] The apparatus of any of Examples 28 through 36, wherein the
rigid member includes a preformed bend.
Example 38
[0136] The apparatus of Example 37, wherein the preformed bend
defines an angle with a vertex.
Example 39
[0137] The apparatus of Example 37, wherein the preformed bend
defines a curve.
Example 40
[0138] The apparatus of any of Examples 28 through 39, wherein the
wire has a distal end with a ball tip.
Example 41
[0139] The apparatus of Example 40, wherein the sensor is
integrated into the ball tip.
Example 42
[0140] The apparatus of any of Examples 28 through 41, wherein the
sensor comprises a coil.
Example 43
[0141] The apparatus of Example 42, wherein the coil is responsive
to movement of the distal end of the wire in an electromagnetic
field.
Example 44
[0142] The apparatus of any Examples 28 through 43, wherein the
actuator is configured to drive the wire between a proximal
position relative to the guide tube assembly and a distal position
relative to the guide tube assembly, wherein the distal end of the
wire is flush with the distal end of the guide tube assembly when
the wire is in the proximal position, wherein the distal end of the
wire is distal to the distal end of the guide tube assembly when
the wire is in the distal position.
Example 45
[0143] The apparatus of Example 44, wherein the handle assembly
provides a plurality of position indicators, wherein the position
indicators comprise a first indicator and a second indicator,
wherein the first indicator is associated with the proximal
position, wherein the second indicator is associated with the
distal position.
Example 46
[0144] The apparatus of Example 45, wherein the indicators comprise
visual indicators.
Example 47
[0145] The apparatus of Example 45, wherein the indicators comprise
tactile feedback features.
Example 48
[0146] The apparatus of Example 47, wherein the tactile feedback
features comprise detent structures.
Example 49
[0147] The apparatus of Example 45, wherein the indicators further
comprise a third indicator, wherein the third indicator is
associated with the actuator and the wire being located in an
intermediate position, wherein the intermediate position is
positioned between the distal position and the proximal
position.
Example 50
[0148] The apparatus of any of Examples 28 through 49, wherein the
actuator comprises a rotatable member operable to rotate the wire
within the guide tube assembly.
Example 51
[0149] A method of using an apparatus, wherein the apparatus
comprises: (a) a handle assembly, wherein the handle assembly
comprises: (i) a body, and (ii) an actuator; (b) a guide tube
extending distally from the handle assembly, wherein the guide tube
has a distal end; and (c) a wire slidably disposed in the guide
tube, wherein the wire has a distal end including a sensor, wherein
the sensor is configured to cooperate with a navigation system to
generate a map of anatomical structures within a patient, wherein
the wire is coupled with the actuator, wherein the actuator is
movable relative to the body to move the wire relative to the guide
tube; wherein the method comprises: (a) inserting a distal end of
the guide tube through a nostril of a patient; (b) actuating the
actuator to drive the wire relative to the guide tube such that the
distal end of the wire is located distal to the distal end of the
guide tube; and (c) using the distal end of the wire in conjunction
with a navigation system to map anatomical structures within the
nasal cavity of the patient.
[0150] VI. Miscellaneous
[0151] 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.
[0152] 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.
[0153] 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.
[0154] 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.
[0155] 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.
[0156] 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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