U.S. patent application number 14/464948 was filed with the patent office on 2014-12-11 for systems and methods for performing image guided procedures within the ear, nose, throat and paranasal sinuses.
The applicant listed for this patent is Acclarent, Inc.. Invention is credited to Joshua Makower.
Application Number | 20140364725 14/464948 |
Document ID | / |
Family ID | 38723784 |
Filed Date | 2014-12-11 |
United States Patent
Application |
20140364725 |
Kind Code |
A1 |
Makower; Joshua |
December 11, 2014 |
SYSTEMS AND METHODS FOR PERFORMING IMAGE GUIDED PROCEDURES WITHIN
THE EAR, NOSE, THROAT AND PARANASAL SINUSES
Abstract
Devices, systems and methods for performing image guided
interventional and surgical procedures, including various
procedures to treat sinusitis and other disorders of the paranasal
sinuses, ears, nose or throat.
Inventors: |
Makower; Joshua; (Los Altos,
CA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Acclarent, Inc. |
Menlo Park |
CA |
US |
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Family ID: |
38723784 |
Appl. No.: |
14/464948 |
Filed: |
August 21, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11436892 |
May 17, 2006 |
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14464948 |
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11116118 |
Apr 26, 2005 |
7720521 |
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11436892 |
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11037548 |
Jan 18, 2005 |
7462175 |
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11116118 |
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10944270 |
Sep 17, 2004 |
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11037548 |
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10944270 |
Sep 17, 2004 |
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11116118 |
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10912578 |
Aug 4, 2004 |
7361168 |
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10944270 |
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10829917 |
Apr 21, 2004 |
7654997 |
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10912578 |
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Current U.S.
Class: |
600/424 |
Current CPC
Class: |
A61M 2029/025 20130101;
A61M 25/09 20130101; A61B 90/36 20160201; A61B 2034/107 20160201;
A61M 2210/0681 20130101; A61B 50/13 20160201; A61B 5/062 20130101;
A61B 18/20 20130101; A61B 6/463 20130101; A61B 2034/2074 20160201;
A61B 2034/2055 20160201; A61B 2034/2065 20160201; A61B 1/233
20130101; A61B 2034/105 20160201; A61M 29/02 20130101; A61B 18/02
20130101; A61B 6/032 20130101; A61B 2090/3983 20160201; A61B 90/361
20160201; A61B 90/16 20160201; A61B 6/037 20130101; A61B 34/20
20160201; A61B 2017/00787 20130101; A61B 2034/2051 20160201; A61B
2090/365 20160201; A61B 2034/2048 20160201; A61B 5/6851
20130101 |
Class at
Publication: |
600/424 |
International
Class: |
A61B 5/06 20060101
A61B005/06; A61B 6/03 20060101 A61B006/03; A61B 6/00 20060101
A61B006/00; A61M 29/02 20060101 A61M029/02 |
Claims
1.-23. (canceled)
24. A method for image guided performance of a treatment procedure
to treat a paranasal sinus in a human or animal subject, said
method comprising the steps of: (a) providing a working device,
wherein at least a portion of said working device is insertable
into a paranasal sinus of the subject and is useable to carry out
or facilitate at least a portion of said treatment procedure,
wherein the working device has a proximal end and a distal end,
wherein the working device further includes a sensor; (b) providing
an image guidance system that is useable to determine the location
of the working device within the paranasal sinus of the subject on
the basis of signals received from the sensor; (c) inserting the
working device such that the distal end of the working device is
within an ear, nose, throat, or paranasal sinus of the subject; and
(d) using the image guidance system to detect the position of the
distal end of the working device within the paranasal sinus of the
subject; wherein the working device comprises an elongate member
having an expandable dilator thereon; wherein the expandable
dilator is sized and constructed to be positioned within the ostium
of a paranasal sinus while in a non-expanded state and the
thereafter be expanded to an expanded state, thereby enlarging the
ostium; wherein the ostium in which the expandable dilator is to be
positioned comprises a bone that underlies mucous membrane and
wherein the expandable dilator is further constructed to exert
sufficient force against the ostium to break bone that underlies
the mucous membrane; wherein the location at which the sensor is
positioned is in known relationship to the distal end of the
working device such that the location of the sensor detected by the
image guidance system will enable the operator to determine the
position of the distal end of the working device within an ear,
nose, throat, or paranasal sinus of the subject.
25. A method according to claim 24, wherein the sensor is located
near the proximal end of the working device.
26. A method according to claim 24, wherein the sensor comprises an
electromagnetic coil.
27. A method according to claim 24, wherein the location at which
the sensor is positioned is in known relationship to the position
of the expandable dilator such that the location of the sensor
detected by the image guidance system will enable the operator to
determine the position of the dilator within an ear, nose, throat
or paranasal sinus of the subject.
28. A method according to claim 24, wherein the expandable dilator
comprises a balloon.
29. A method according to claim 24, wherein the image guidance
system comprises: (i) a computer, (ii) a video monitor, (iii) a
localizer, and (iv) a sensor tracking system.
30. A method according to claim 29, wherein anatomical image data
has been obtained from the subject prior to performance of
inserting the working device and using the image guidance system to
detect the position of the distal end of the working device within
a paranasal sinus of the subject, wherein prior to or during
performance of using the image guidance system to detect the
position of the sensor within a paranasal sinus of the subject, the
localizer is used to register the anatomical image data with the
physical positioning of the subject's body.
31. A method according to claim 30, wherein using the image
guidance system to detect the position of the sensor within a
paranasal sinus of the subject comprises causing the anatomical
image data to be received by the computer, wherein the computer
causes the video monitor to display an anatomical image from the
anatomical data along with an indicator indicating the location of
the working device in relation to the anatomical image.
32. A method according to claim 30, wherein the computer i)
receives working device location data from the sensor tracking
system, ii) integrates the working device location data with the
anatomical image data, and iii) causes the video monitor to display
an anatomical image along with an indicator indicating the position
of the working device relative to the displayed anatomical
image.
33. A method according to claim 30, wherein the anatomical image
data comprises one or more of the following: tomographic image
data, data obtained by CT or fluoroscopic CT scan, or data obtained
by PET scan.
34. A method according to claim 30, wherein the anatomical image
data includes data providing a plurality of orthogonal views of the
subject's anatomy.
35. A method according to claim 24, wherein the image guidance
system comprises a transmitter that transmits a signal that is
sensed by the sensor on the working device.
36. A method according to claim 24, wherein the image guidance
system comprises an electromagnetic tracking system, wherein the
sensor on the working device comprises an electromagnetic
sensor.
37. A method according to claim 24, wherein the image guidance
system receives a video image from an endoscope or endonasal camera
positioned within an ear, nose, throat, or paranasal sinus of the
subject and displays that video image on a video monitor along with
an indication of the location of the working device.
38. A method according to claim 24, wherein the treatment procedure
includes the transnasal insertion and advancement of the distal end
of the working device into or through the ostium of a maxillary
sinus without removing or causing substantial trauma to the
uncinate process.
39. A method according to claim 24, wherein the treatment procedure
includes the transnasal insertion and advancement of the distal end
of the working device into or through the ostium of a sphenoid
sinus without removing, altering or causing substantial trauma to
the ethmoid air cells, middle turbinate, superior turbinate, or
supreme turbinate.
40. A method according to claim 24, wherein the treatment procedure
includes the transnasal insertion and advancement of the distal end
of the working device into or through the ostium of a frontal sinus
without removing or causing substantial trauma to the process,
ethmoid bulla, or middle turbinate.
41. A method according to claim 24, wherein the treatment procedure
includes the transnasal insertion and advancement of the distal end
of the working device into or through an ethmoid bulla without
removing or causing substantial trauma to the uncinate process.
42. A method for image guided performance of a treatment procedure
to treat a human or animal subject, said method comprising the
steps of: (a) providing a working device, wherein the working
device comprises: (i) an elongate member having a proximal end and
a distal end, wherein the distal end includes a rigid curved
section, (ii) an expandable dilator positioned on the elongate
member, wherein the expandable dilator is sized and constructed to
be positioned within a drainage passageway of a paranasal sinus
while in a non-expanded state and the thereafter be expanded to an
expanded state, thereby enlarging the drainage passageway, and
(iii) a sensor; (b) providing an image guidance system that is
useable to determine the location of the working device in relation
to the paranasal sinus of the subject on the basis of signals
associated with the sensor; (c) inserting the working device such
that the distal end of the working device is within a nose or
paranasal sinus of the subject; and (d) using the image guidance
system to detect the position of the distal end of the working
device in the subject; wherein the location at which the sensor is
positioned is in known relationship to the distal end of the
working device such that the location of the sensor detected by the
image guidance system will enable the operator to determine the
position of the distal end of the working device within a nose or
paranasal sinus of the subject.
43. A method for image guided performance of a treatment procedure
to treat a human or animal subject, said method comprising the
steps of: (a) providing a working device, wherein the working
device comprises: (i) an elongate member having a proximal end and
a distal end, (ii) an expandable dilator positioned on the elongate
member, wherein the expandable dilator is sized and constructed to
be positioned within a drainage passageway of a paranasal sinus
while in a non-expanded state and the thereafter be expanded to an
expanded state, thereby enlarging the drainage passageway, and
(iii) a sensor positioned near the proximal end of the elongate
member; (b) providing an image guidance system that is useable to
determine the location of the working device in relation to the
paranasal sinus of the subject on the basis of signals associated
with the sensor; (c) inserting the working device such that the
distal end of the working device is within a nose or paranasal
sinus of the subject; and (d) using the image guidance system to
detect the position of the distal end of the working device in the
subject; wherein the location at which the sensor is positioned is
in known relationship to the distal end of the working device such
that the location of the sensor detected by the image guidance
system will enable the operator to determine the position of the
distal end of the working device within a nose or paranasal sinus
of the subject.
Description
RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 11/116,118 entitled "Methods And Devices For
Performing Image Guided Procedures Within The Ear, Nose, Throat And
Paranasal Sinuses" filed Apr. 26, 2005 which is a continuation in
part of four earlier-filed applications, namely 1) U.S. patent
application Ser. No. 10/829,917 entitled "Devices, Systems and
Methods for Diagnosing and Treating Sinusitis and Other Disorders
of the Ears, Nose and/or Throat" filed on Apr. 21, 2004, 2) U.S.
patent application Ser. No. 10/912,578 entitled "Implantable Device
and Methods for Delivering Drugs and Other Substances to Treat
Sinusitis and Other Disorders" filed on Aug. 4, 2004, 3) U.S.
patent application Ser. No. 10/944,270 entitled "Apparatus and
Methods for Dilating and Modifying Ostia of Paranasal Sinuses and
Other Intranasal or Paranasal Structures" filed on Sep. 17, 2004
and 4) U.S. patent application Ser. No. 11/037,548 entitled
"Devices, Systems and Methods For Treating Disorders of the Ear,
Nose and Throat" filed Jan. 17, 2005, the entireties of each such
parent application being expressly incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices,
systems and methods and more particularly to methods and devices
for performing image guided interventional procedures to treat
disorders of the paranasal sinuses, ears, nose or throat (ENT).
BACKGROUND OF THE INVENTION
[0003] A. Recent Advancements in the Treatment of ENT Disorders
[0004] New devices, systems and techniques are being developed for
the treatment of sinusitis and other disorders of the ear, nose,
throat and paranasal sinuses. For example, various catheters,
guidewires and other devices useable to perform minimally invasive,
minimally traumatic ear, nose and throat surgery have been
described in U.S. patent application Ser. No. 10/829,917 entitled
"Devices, Systems and Methods for Diagnosing and Treating Sinusitis
and Other Disorders of the Ears, Nose and/or Throat," Ser. No.
10/912,578 entitled "Implantable Device and Methods for Delivering
Drugs and Other Substances to Treat Sinusitis and Other Disorders,"
Ser. No. 10/944,270 entitled "Apparatus and Methods for Dilating
and Modifying Ostia of Paranasal Sinuses and Other Intranasal or
Paranasal Structures" and Ser. No. 11/037,548 entitled "Devices,
Systems and Methods For Treating Disorders of the Ear, Nose and
Throat." Many of these new devices, systems and techniques are
useable in conjunction with endoscopic, radiographic and/or
electronic assistance to facilitate precise positioning and
movement of catheters, guidwires and other devices within the ear,
nose, throat and paranasal sinuses and to avoid undesirable trauma
or damage to critical anatomical structures such as the eyes,
facial nerves and brain.
[0005] For example, in one new procedure (referred to in this
patent application as a "Flexible Transnasal Sinus Intervention" or
FTSI), a dilation catheter (e.g., a balloon catheter or other type
of dilator) is advanced through the nose to a position within the
ostium of a paranasal sinus or other location, without requiring
removal or surgical alteration of other intranasal anatomical
structures. The dilation catheter is then used to dilate the ostium
or other anatomical structures to facilitate natural drainage from
the sinus cavity. In some cases, a tubular guide may be initially
inserted through the nose and advanced to a position near the sinus
ostium and a guidewire may then be advanced through the tubular
guide and into the affected paranasal sinus. The dilation catheter
may then be advanced over the guidewire and through the tubular
guide to a position where its dilator (e.g., balloon) is positioned
within the sinus ostium. The dilator (e.g., balloon) is then
expanded causing the ostium to dilate. In some cases, such dilation
of the ostium may fracture, move or remodel bony structures that
surround or are adjacent to the ostium. Optionally, in some
procedures, irrigation solution and/or therapeutic agents may be
infused through a lumen of the dilation catheter and/or other
working devices (e.g., guidewires, catheters, cannula, tubes,
dilators, balloons, substance injectors, needles, penetrators,
cutters, debriders, microdebriders, hemostatic devices, cautery
devices, cryosurgical devices, heaters, coolers, scopes,
endoscopes, light guides, phototherapy devices, drills, rasps,
saws, etc.) may be advanced through the tubular guide and/or over
the guidewire to deliver other therapy to the sinus or adjacent
tissues during the same procedure in which the FTSI is carried out.
It is to be understood that, in FTSI procedures, structures and
passageways other than sinus ostia may be dilated using the tools
described above, tissue may be resected or ablated, bone may be
restructured, drugs or drug delivery systems may be deployed, etc.,
as described in the documents incorporated here by reference. Thus,
for the purposes of this application the term FTSI will generally
used to refer broadly to all of those procedures, not just dilation
of sinus ostia.
[0006] B. Prior Uses of Image Guided Surgery in the Treatment of
ENT Disorders
[0007] Image guided surgery (IGS) procedures (sometimes referred to
as "computer assisted surgery") were first developed for use in
neurosurgery and have now been adapted for use in certain ENT
surgeries, including sinus surgeries. See, Kingdom T. T., Orlandi
R. R., Image-Guided Surgery of the Sinuses: Current Technology and
Applications, Otolaryngol. Clin. North Am. 37(2):381-400 (April
2004). Generally speaking, in a typical IGS procedure, a digital
tomographic scan (e.g., a CT or MRI scan) of the operative field
(e.g., the nasal cavities and paranasal sinuses) 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, sensors mounted on the surgical instruments send data to
the computer indicating the position of each surgical instrument.
The computer correlates the data received from the
instrument-mounted sensors with the digital map that was created
from the preoperative tomographic scan. One or more image(s) is/are
then displayed on a monitor showing the tomographic scan along with
an indicator (e.g., cross hairs or an illuminated dot) of the real
time position of each surgical instrument. In this manner, the
surgeon is able to view the precise position of each
sensor-equipped instrument relative to the surrounding anatomical
structures shown on the tomographic scan.
[0008] A typical IGS surgery system of the prior art includes a) a
computer work station, b) a video monitor, c) one or more surgical
instruments having sensors mounted thereon, d) a localizer and e) a
sensor tracking system. The sensor(s) mounted on the surgical
instruments and the corresponding tracing system may be optical,
electromagnetic or electromechanical. The localizer functions to
localize or "register" the preoperative tomographic image data with
the real time physical positioning of the patient's body during
surgery. The sensor tracking system serves to track the position of
each sensor equipped surgical instrument during the surgery and to
communicate such information to the computer workstation.
[0009] In IGS systems that employ optical sensors/tracking systems,
optical navigation elements (e.g., infrared light emitting LEDs or
passive markers) are placed on the surgical instruments and on a
localizer frame worn by the patient. Camera(s) is/are positioned to
receive light emitted or reflected from the navigation elements.
One example of an optical IGS system that is useable in ENT and
sinus surgery is the LandmarX Evolution.RTM. ENT II Image Guidance
System available from Medtronic Xomed Surgical Products, Inc.,
Jacksonville, Fla. Other optical IGS systems useable in ENT surgery
include the VectorVision.RTM. system and Kolibri.RTM. system
available from BrainLAB, Inc., Westchester, Ill. In the
VectorVision.RTM. system and Kolibri.RTM. systems a sensor
assembly, known as a STARLINK.TM. Universal Instrument Adapter, is
attached to a portion of an instrument that remains outside of the
patients body. A plurality of passive markers in the nature of
reflective members is positioned at spaced apart locations on the
navigation element assembly. An infrared light source and cameras
are positioned to receive light reflected from the passive markers
located on the navigation element assembly. A computer then
receives input from the cameras and uses software tracking
algorithms to determine the real time position of the instrument
within the subject's body based on the relative spatial positions
of the passive markers. The instrument's current position is then
displayed on a monitor along with stored tomographic images,
thereby enabling the operator to monitor the position and movement
of the instrument relative to anatomical structures of
interest.
[0010] In IGS systems that employ electromagnetic sensors/tracking
systems, radiofrequency electromagnetic sensors (e.g.,
electromagnetic coils) are placed on the surgical instruments and
on a localizer frame worn by the patient. A transmitter is
positioned near the operative field. The transmitter transmits
signals that are received by the instrument-mounted sensors. The
tracking system detects variations in the electromagnetic field
caused by the movement of the instrument-mounted sensors relative
to the transmitter. Examples of commercially available
electromagnetic IGS systems that have been used in ENT and sinus
surgery include the ENTrak Plus.TM. and 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 invention include
but are not limited to those available from Surgical Navigation
Technologies, Inc., Louiville, Colo., Biosense-Webster, Inc.,
Diamond Bar, Calif. and Calypso Medical Technologies, Inc.,
Seattle, Wash.
[0011] In IGS systems that employ electromechanical
sensors/tracking systems, a multi-jointed articulating mechanical
arm is attached to the surgical instrument and sensors to measure
movements of the joints. The computer determines the location of
the instrument based on signals received from the sensors.
Electromechanical systems have not been widely used in ENT or sinus
surgery.
[0012] In any IGS system used in sinus surgery or other ENT
applications, it is imperative that the localization system provide
accurate "registration."Registration is the process of matching two
sets of data (i.e., the preoperative tomographic scan data and the
intraoperative patient body position data) so that the image
displayed on the monitor will accurately show the position(s) of
the surgical instrument(s) relative to the locations of anatomical
structures shown on the tomographic scan. A number of different
registration strategies have been used, including intrinsic
strategies as well as extrinsic strategies.
[0013] The registration strategy most widely used in sinus surgery
and other ENT procedures is an intrinsic registration strategy
known as anatomical fiducial registration. A number of fiducial
markers are placed at specific anatomical locations on the
patient's body during the preoperative tomographic scan and during
the surgical procedure. These fiducial markers are typically
positioned on the patient's head or face at locations that
correspond to specific anatomical landmarks within the ears, nose
and/or throat. The fiducial markers may be mounted on a head set or
frame that is worn by the patient or the fiducial markers may be
affixed directly to the patient's body (e.g., by adhesive
attachment to the skin, anchoring into bone, etc.).
[0014] Once the registration process has been completed, the sinus
surgery or other ENT procedure is performed. To correlate head
position with the tracking system, the fiducial markers must remain
in fixed position on or in the patient's body until after the
surgery has been completed. Unlike neurosurgical procedures that
require the patient's head to be fixed in a rigid stereotactic
frame, IGS systems that use fiducial markers mounted on or in the
patient's body allow for free movement and repositioning of the
patient's head during surgery.
[0015] When applied to functional endoscopic sinus surgery (FESS)
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, two
dimensional, line-of-sight view. The use of image guidance systems
provides a real time, three dimensional view of all of the anatomy
surrounding the operative field, not just that which is actually
visible in the spatially limited, two dimensional, direct
line-of-sight endoscopic view.
[0016] One shortcoming of the prior art IGS systems used in sinus
surgery and other ENT procedures is that the sensors have been
mounted on proximal portions of the instruments (e.g., on the
handpiece of the instrument) such that the sensors remain outside
of the patient's body during the surgical procedure. Because these
prior art surgical instruments were of rigid, pre-shaped
construction, the proximally mounted sensors could be used to
accurately indicate to real time position of the distal tip of the
instrument. However, in the new FTSI procedures and other new ENT
procedures that use flexible and/or malleable catheters and
instruments, it is no longer suitable to mount the sensors on
proximal portions of the surgical instruments such that the sensors
remain outside of the body. Rather, it will be necessary to mount
or integrate the sensors at the distal tips of the instruments
and/or at other locations on portions of the instruments that are
actually inserted into the patient's body, thereby allowing for
flexibility or malleability of the instrument shaft.
[0017] The present invention provides new sensor-equipped devices
that are useable to perform image guided FTSI procedures as well as
a variety of other image guided ENT procedures. Additionally, the
present invention provides improvements and modifications to the
prior art IGS systems and methods to facilitate the performance of
image guided FTSI and other image ENT procedures with minimal or
less iatrogenic trauma to and/or alteration of anatomical
structures that are not involved in the disorder being treated.
SUMMARY OF THE INVENTION
[0018] The present invention generally provides methods, systems
and devices for performing image guided FTSI procedures as well as
other image guided procedures for the treatment of sinusitis and
other disorders of the paranasal sinuses, ears, nose and/or
throat.
[0019] In accordance with the invention, there is provided a method
and system for performing an image guided treatment procedure to
treat a disease or disorder of an ear, nose, throat or a paranasal
sinus in a human or animal subject. In this method and system, a
working device (e.g., guidewires, catheters, cannula, tubes,
dilators, balloons, substance injectors, needles, penetrators,
cutters, debriders, microdebriders, hemostatic devices, cautery
devices, cryosurgical devices, heaters, coolers, scopes,
endoscopes, light guides, phototherapy devices, drills, rasps,
saws, etc.) is inserted into an ear, nose, throat or paranasal
sinus of the subject and used to carry out or facilitate at least a
portion of the treatment procedure. A sensor is positioned on or in
the portion of the working device that becomes inserted into the
ear, nose, throat or paranasal sinus of the subject. An image
guidance system is used to determine the location of the sensor
when the sensor is positioned within an ear, nose, throat or
paranasal sinus of the subject, thereby providing a real time
indication of the positioning and movement of the working device
during the treatment procedure. In some applications, a
preoperative tomographic scan (e.g., a CT scan, MRI scan, PET scan,
3 dimensional fluoroscopy such as FluoroCT, etc.) may be obtained
and the image guidance system may be programmed to display the
tomographic images on a video monitor along with a real time
indication (e.g., cross hairs, an illuminated dot, etc.) of the
location of the working device relative to the anatomical
structures shown on the tomographic image. In some embodiments, an
endoscope or intranasal camera may additionally be used to provide
a direct line-of-sight video image through the nasal cavity. Such
direct line-of-sight video image may be displayed on a separate
monitor or may be integrated with the tomographic image data to
provide a single monitor display combining 1) the real time
line-of-sight video image, 2) indicia (e.g., dotted lines)
depicting anatomical structures that are hidden from view on the
real time line-of-sight video image and 3) indicia of instrument
position provided by the image guidance system. In some
applications, the indicia of instrument position may consist of a
single indicator (e.g., cross hairs or a dot) indicating the
current position of the working device within the subject's body.
In other applications, the indicia of instrument position may
consist of a series of marks (e.g., a sharp dot followed by a
series of phantom dots) indicating the path of prior or future
advancement or movement of the working device. Also, in some
applications, the working device may optionally include a rotation
indicator (e.g., an accelerometer) and the image guidance system
may be further programmed to sense and indicate the rotational
orientation of the working device within the subject's body.
[0020] Further in accordance with the invention, there are provided
sensor-equipped working devices (e.g., guidewires, catheters,
cannula, tubes, dilators, balloons, substance injectors, needles,
penetrators, cutters, debriders, microdebriders, hemostatic
devices, cautery devices, cryosurgical devices, heaters, coolers,
scopes, endoscopes, light guides, phototherapy devices, drills,
rasps, saws, etc.) useable to perform image guided FTSI procedures
or other image guided ENT procedures. These image guided working
devices of the present invention generally comprise an elongate
shaft that is insertable through the nose to a location within a
paranasal sinus, ear, nose or throat of the subject and one or more
sensor(s) is/are positioned on or in the device at a location that
becomes inserted into the subject's body during the procedure. In
some embodiments, a sensor may be located at the distal tip of the
device. Additionally or alternatively, sensor(s) may be located at
other locations on the shaft of the device, such as at the location
of a particular working element (e.g., a dilator, balloon,
substance injector, needle, penetrator, cutter, debrider,
microdebrider, hemostatic device, cautery device, cryosurgical
device, heater, cooler, scope, lense, port, endoscope, light guide,
phototherapy device, drill, rasp, saw, etc.). In some embodiments,
the shaft of the working device proximal to the sensor(s) may be
flexible or malleable. Such flexibility or malleability may allow
the working device to be advanced though tortuous regions of the
intra nasal anatomy and/or to be positioned behind obstructive
anatomical structure(s) (e.g., behind the uncinate process) without
traumatizing or requiring removal or surgical modification of the
obstructive anatomical structure(s).
[0021] Still further in accordance with the present invention,
there is provided a system of working devices specifically useable
to perform an image guided FTSI procedure. Such system generally
comprises a flexible guidewire that is advanceable into the ostium
of a paranasal sinus and a dilation catheter that is advanceable
over the guidewire and useable to dilate the ostium of the
paranasal sinus. A sensor is located on a portion of the guidewire
and/or dilation catheter that becomes positioned within the
subject's body. The sensor communicates with the image guidance
system to provide real time indicia of the position of the
guidewire and/or dilation catheter such that the operator may
precisely position the dilator within the desired sinus ostium
without the need for obtaining direct line-of-sight endoscope view
of that sinus ostium. Optionally, the system may additionally
comprise a tubular guide through which the guidewire and/or
dilation catheter may be advanced. The tubular guide may be rigid,
flexible or malleable and may be specifically configured to be
advanced through the nose to a position within or near the ostium
of the affected paranasal sinus.
[0022] Still further in accordance with the present invention,
there are provided fiducial marker devices that may be precisely
and reproducibly positioned within the mouth of a human subject. In
some embodiments, these fiducial marker devices may incorporate
brackets, projection of other configurational attributes for
mounting of a transmitter useable in conjunction with an
electromagnetic image guidance system.
[0023] Still further in accordance with the present invention there
are provided methods and systems for image guided procedures
wherein a single sensor is mounted on a working device that is
inserted into the body (e.g., into a paranasal sinus, and a
plurality of transmitters are positioned outside of the subject's
body such that the device-mounted sensor will receive signals from
at least 3 transmitters, thereby enabling a computer within the
image guidance system to compute (e.g., triangulate) the three
dimensional position of the sensor within the subject's body.
[0024] Still further in accordance with the present invention there
is provided a system that is useable to perform a procedure in
which a working device is inserted to a position within an ear,
nose, throat or paranasal sinus of a human or animal subject. In
general, such system comprises a) a working device that has a
proximal end and a distal end, said working device being insertable
into an ear, nose, throat or paranasal sinus of a human or animal
subject and useable to facilitate performance of a diagnostic or
therapeutic procedure; b) an extender that is attachable to the
proximal end of the working device; c) a marker assembly that is
attachable to or part of the extender, said marker assembly
comprising a plurality of active or passive markers; and d) an
image guidance system that is adapted to receive signals from the
sensors and to determine, on the basis of said signals, the current
position of the working device within the subject's body. In some
embodiments, the working device may have a lumen through which a
second working device may be inserted or through which a fluid or
substance may be infused. In such embodiments, the extender may
also have a lumen that becomes substantially continuous with the
working device lumen to facilitate delivery of such second working
device or substance. In some embodiments, the marker assembly may
be attachable to and detachable from the extender by way of a clamp
or other connector apparatus. Still further in accordance with the
invention, there is provided a method for image guided performance
of a treatment procedure to treat a disease or disorder of an ear,
nose, throat or a paranasal sinus in a human or animal subject.
Such method generally comprises the steps of a) providing a working
device that is useable to carry out or facilitate at least a
portion of said treatment procedure, said working device having a
distal end that becomes inserted into the subject's body and a
proximal end that remains outside of the subjects body; b)
providing an extension member that is attachable to the proximal
end of the working device; c) providing a marker assembly that
comprises a plurality of markers, said marker assembly being
attachable to the extension member; c) providing an image guidance
system that is useable to determine the location of the working
device within the ear, nose, throat or paranasal sinus of the
subject on the basis of signals received from the markers of the
marker assembly; d) attaching the extension member to the proximal
end of the working device; e) attaching the marker assembly to the
extension member; g) inserting the distal end of the working device
into the subject's body; and h) using the image guidance system to
detect the position of the working device within the subject's body
on the basis of signals received from the markers of the marker
assembly.
[0025] Further aspects, details and embodiments of the present
invention will be understood by those of skill in the art upon
reading the following detailed description of the invention and the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a side view of a sensor-equipped guidewire of the
present invention.
[0027] FIG. 1A is an enlarged cut-away view of the distal end of
the sensor-equipped guidewire of FIG. 1.
[0028] FIG. 2A is a perspective view of a sensor-equipped guide
tube of the present invention.
[0029] FIG. 2B is a perspective view of another sensor-equipped
guide tube of the present invention.
[0030] FIG. 3 is a schematic perspective view of a sensor-equipped
working device useable to perform a therapeutic or diagnostic
procedure within an ear, nose, throat or paranasal sinus.
[0031] FIG. 4 is a perspective view of a sensor-equipped dilation
catheter of the present invention.
[0032] FIG. 4A is a partial cut away view of a first embodiment of
a sensor equipped balloon dilation catheter of the present
invention.
[0033] FIG. 4B is a cross sectional view through line 4B-4B of FIG.
4A.
[0034] FIG. 4C is a partial cut away view of a second embodiment of
a sensor equipped balloon dilation catheter of the present
invention.
[0035] FIG. 4D is a cross sectional view through line 4D-4D of FIG.
4C.
[0036] FIG. 4E is a partial cut away view of a third embodiment of
a sensor equipped balloon dilation catheter of the present
invention.
[0037] FIG. 4F is a cross sectional view through line 4F-4F of FIG.
4E.
[0038] FIG. 4G is a partial cut away view of a fourth embodiment of
a sensor equipped balloon dilation catheter of the present
invention.
[0039] FIG. 4H is a cross sectional view through line 4H-4H of FIG.
4G.
[0040] FIG. 4I is a partial cut away view of a fifth embodiment of
a sensor equipped balloon dilation catheter of the present
invention.
[0041] FIG. 4J is a cross sectional view through line 4J-4J of FIG.
4I.
[0042] FIG. 5 is a perspective view of a sensor-equipped
sub-selective sheath of the present invention.
[0043] FIG. 5A is a cross sectional view through line 5A-5A of FIG.
5.
[0044] FIG. 6 is a side view of a sensor equipped penetrator of the
present invention.
[0045] FIG. 7A shows a human subject undergoing a preoperative
tomographic scan while wearing a head frame having fiducial
anatomical markers thereon.
[0046] FIG. 7B is a schematic showing of data from the preoperative
tomographic scan being loaded into the computer workstation of the
image guidance system in accordance with this invention.
[0047] FIG. 7C shows an example of the image guidance system being
used to provide a single image display (which may or may not
incorporate superimposed data or indicia from multiple
sources).
[0048] FIG. 7D an example of the image guidance system being used
to provide separate displays of multiple images.
[0049] FIG. 7E shows the human subject positioned on the operating
table and wearing the head frame having fiducial anatomical markers
and a transmitter thereon.
[0050] FIG. 8 is a schematic depiction of an electromagnetic field
having a sensor equipped working device of the present invention
positioned therein.
[0051] FIG. 8A is a perspective view of one embodiment of a
localizer apparatus mountable transmitter having one or more
transmitter locations.
[0052] FIG. 8B is a perspective view of another embodiment of a
localizer apparatus mountable transmitter having three transmitter
locations.
[0053] FIG. 8C is a perspective view of another embodiment of a
localizer apparatus mountable transmitter having three transmitter
locations.
[0054] FIG. 9 shows the human subject positioned on the operating
table during performance of an image guided interventional
procedures using sensor equipped device(s) of the present
invention.
[0055] FIG. 9A is a schematic showing of a video monitor displaying
indicia of the path of advancement or movement of a sensor equipped
working device in accordance with the present invention.
[0056] FIG. 10A shows a first orthogonal view of an anatomical
image with indicators of the current position of the distal tip of
a working device and indicia of the path of advancement of that
working device, as seen on a video monitor screen during
performance of a procedure according to this invention.
[0057] FIG. 10B shows a second orthogonal view of the procedure
shown in FIG. 10A as viewed on a separate video monitor screen
during performance of a procedure according to this invention.
[0058] FIGS. 11A-11C show examples of direct line-of-sight
endoscopic images with superimposed indicia indicating the
positions of anatomical structure(s) and/or apparatus that are
hidden from view on the line-of-sight endoscopic images, as viewed
on video monitors during performance of procedures according to
this invention.
[0059] FIG. 12 shows a sensor-equipped working device of the
present invention that is additionally equipped with a rotation
sensor to indicate the rotational orientation of the device while
it is positioned within a subject's body.
[0060] FIGS. 13A and 13B are schematic showings of examples of
anatomical images viewed on a video monitor with indicia of the
current position and prior path of advancement of an image guided
working device shown in relation to a) adjacent anatomical
structures and b) "keep in" and/or "keep out" zones that have been
delineated to assist the operator in safely and correctly
performing the procedure.
[0061] FIG. 14A is a top perspective view of a first embodiment of
a fiducial marker mouthpiece according to the present
invention.
[0062] FIG. 14B is a side perspective view of the fiducial marker
mouthpiece of FIG. 14 A.
[0063] FIG. 15A is a top perspective view of a second embodiment of
a fiducial marker mouthpiece according to the present
invention.
[0064] FIG. 15B is a side perspective view of the fiducial marker
mouthpiece of FIG. 15 A.
[0065] FIG. 15C is a front view of the mouth of a human subject
having the fiducial marker mouthpiece of FIGS. 15A and 15B in its
operative position.
[0066] FIG. 16 is a partial cut-away side view of a sensor equipped
guidewire of the present invention attached to a cable/connector
assembly of the present invention.
[0067] FIG. 17 is a partial cut-away side view of a sensor equipped
working device of the present invention having a cable/connector
assembly of the present invention attached thereto.
[0068] FIG. 18 is an exploded view of a system of the present
invention that includes a tubular guide working device, an
extension that is attachable to the proximal end of the tubular
guide working device and a navigation elements assembly that is
attachable to the extender to facilitate tracking of the working
device by an IGS system.
[0069] FIG. 19 is a fully assembled view of the device of FIG. 18
along with an IGS system useable therewith.
DETAILED DESCRIPTION
[0070] The following detailed description, the drawings and the
above-set-forth Brief Description of the Drawings are intended to
describe some, but not necessarily all, examples or embodiments of
the invention. The contents of this detailed description, the
accompanying drawings and the above-set-forth brief descriptions of
the drawings do not limit the scope of the invention or the scope
of the following claims, in any way.
[0071] In this invention, various types of working devices are
equipped with sensors and are used to perform interventional
procedures within the paranasal sinuses, ears, noses and throats of
human or animal subjects, while an image guidance system is used to
track the location of the sensor(s) and, hence, the location(s) of
the working device(s). FIGS. 1-6 and 11 show examples of sensor
equipped working devices of the present invention. FIGS. 7A-17 show
various components and operational aspects of an image guidance
system of the present invention and its use in conjunction with the
sensor equipped working devices of the present invention.
[0072] FIGS. 1 and 1A show a sensor equipped guidewire 10 that may
be inserted through a nostril (with or without a guide tube or
guide catheter) and advanced to a desired location within a
paransal sinus, ear, nose or throat. This sensor-equipped guidewire
10 comprises an elongate flexible body 12 having a proximal end PE
and a distal end DE. As shown in the cut-away view of FIG. 1A, the
elongate body 12 comprises a core member 19 which may be solid or
tubular. In the particular example shown, the core member 19 is
tubular and comprises stainless steel hypotube. Optionally, an
outer member 18 such as a helical strand or wire may be wound or
otherwise disposed about the core member 19, as is well known in
the art of guidewire manufacturing. In the particular example
shown, a distal tip member 15 formed of electrically insulating
material (e.g., plastic) is received within and/or affixed to the
distal end of the core member 19 by any appropriate means such as
adhesive (e.g., epoxy), mechanical innerlocking, frictional fit,
etc. An electromagnetic sensor 16 (e.g., an electromagnetic coil)
is disposed (e.g., coiled) about the mid-region of the
non-conductive distal tip member 15. Optionally, an electrically
insulating cylindrical cover 17 (e.g. a plastic sheath, plastic
shrink wrap, etc) may be disposed about the electromagnetic sensor
16. The outer surface of such cover 17, if present, may be
substantially flush with the adjacent outer surface of the outer
member 18, if present, as shown in FIG. 1A. In embodiments where
the come member 19 is hollow (e.g., hypotube) sensor leads 14 may
extend from the electromagnetic sensor coil 16, through the lumen
of the core member 19 and to or out of the proximal end PE of the
guidewire 10. In some embodiments, a connector 21 (e.g., a jack)
located on the proximal end PE of the guidewire 10 may be
configured to connect to a corresponding connector 27 (e.g., a
plug) located on one end of a cable 25. A connector 23 on the other
end of the cable 25 is then connectable to an image guidance system
that is programmed for use in combination with such guidewire, as
described more fully herebelow. In some embodiments, the
guidewire's proximal connector 21 may be connected to another types
of cable/connector assembly 400 as shown in FIGS. 16 and 17 and
described herebelow. Also, in some embodiments of devices of this
invention, the sensor 16 may be in wireless communication with an
image guidance system, as explained more fully herebelow.
[0073] It will also be appreciated that the outer helical wire wrap
18 may formed of wire, a plastic strand, a helically cut metal or
plastic tube, or any other suitable material. It will also be
appreciated that the guidewire 10 may be constructed such that at
least a distal portion of the outer member 18 or other outer
material (e.g., helically cut tube) may be made of substantially
nonferromagnetic material and may extend over the sensor 16 such
that the sensor is disposed within a substantially nonferromagnetic
portion of the outer member 18. The sensor leads 14 may then extend
through the outer member 18.
[0074] Furthermore, it is to be appreciated that, in this guidewire
10 or any other sensor equipped device of the present invention,
the sensor 16 need not necessarily be longitudinally aligned with
or disposed about the longitudinal axis of the device. Rather, the
sensor may be disposed transversely within the device or in any
other suitable attitude, position or alignment. For example, in a
guidewire, catheter or other device that has a lumen or cavity
formed therein, a crossmember may extend transversely across such
lumen or cavity and the sensor 16 may be disposed about such
crossmember (e.g., an electromagnetic coil may be wound about the
cross member). Such construction may allow for better selectivity
and control of the magnetic permeability of the material lying
under and/or over the sensor 16 and may allow for a more robust
design and construction of certain devices.
[0075] Examples of commercially available image guidance systems
that may be modified and programmed for use in connection with this
sensor equipped guidewire 10, as well as the other sensor equipped
working devices described in this patent application, include the
ENTrak Plus.TM. and InstaTrak ENT.TM. systems available from GE
Medical Systems, Salt Lake City, Utah as well as systems available
from Surgical Navigation Technologies, Inc., Louisville, Colo.,
Biosense-Webster, Inc., Diamond Bar, Calif. and Calypso Medical
Technologies, Inc., Seattle, Wash.
[0076] As described herebelow, it will often be desirable to
advance catheters or other devices over the guidewire 10 after the
guidewire 10 has been inserted into the subject's body. Thus, the
guidewire body 12 and any proximal connector 21 may be small enough
in diameter to allow the desired catheter(s) and/or other
devices(s) to be advanced over the guidewire body 12 and any
proximal connector 21.
[0077] FIGS. 2A and 2B show examples of sensor equipped tubular
guides 20a, 20b that may be inserted through a nostril (with or
without a guidewire) and advanced to a desired location within a
paranasal sinus, ear, nose or throat. All of portions of tubular
guides of the present invention may be rigid, flexible or
malleable. In the particular examples shown in FIGS. 2A and 2B, the
tubular guides 20a, 20b are substantially rigid and preformed to a
specific shape to facilitate advancement of the tubular guide 20a
or 20b to locations that are immediately adjacent to the ostia of
paranasal sinuses such that working devices such as dilation
catheters and the like may be advanced through the tubular guide
20a or 20b and into or through the adjacent sinus ostium.
[0078] Specifically, FIG. 2A shows an example of a tubular guide
20a that is configured for use in accessing the ostium of a
maxillary sinus of a human subject. This tubular guide 20a
comprises a substantially straight proximal portion 22a and a
curved distal portion 24a. A Luer hub 28a is mounted on the
proximal end PE of the proximal portion 20a. A sensor 16, such as
an n electromagnetic sensor coil, is positioned on the curved
distal portion 24a. Wire leads 14 may extend from the
electromagnetic sensor coil 16, though the proximal portion 22a and
out of the proximal end PE of the tubular guide 20a, as shown, for
attachment of the tubular guide 20a to an image guidance system
that is programmed for use in combination with such guidewire as
described more fully herebelow. Although various types of
construction and materials may be used, in this particular example,
the proximal portion 22a comprises stainless steel hypotube of
approximately 0.040 inch to approximately 0.200 inch outer
diameter. It will be appreciated that in embodiments where
stainless steel or other metal is used, such metal will be
separated from the sensor 16 by insulating material(s) and/or
sufficient distance to avoid any affect that the meal may have on
the accuracy or function of the sensor 16. A plastic tube formed of
rigid plastic (e.g., pebax, polyurethane, etc) is advanced through
the lumen of the hypotube such that a portion of the plastic tube
protrudes out of and beyond the distal end of the hypotube. This
protruding portion of the plastic tube is then plastically deformed
(e.g., thermally formed) to the desired curvature, thereby forming
the curved distal portion 24a of the tubular guide 20a. In this
example, the sensor 16 comprises a coil that is wound about or
positioned about the outer surface of the curved distal portion 24a
of the tube. Optionally, a plastic film or other electrically
insulating cover (e.g, an outer skin) may be heat shrunk or
otherwise disposed and secured about the electromagnetic sensor 16
to provide a smooth outer surface in the area where the
electromagnetic sensor 16 is mounted. The electromagnetic sensor 16
may be mounted at or near the distal tip of the tubular guide 20a
to permit the associated image guidance system to monitor the real
time position of the distal tip of the guide 20a. Wire leads 14 may
extend from the electromagnetic sensor 16, through or along the
distal portion 24a, through or along the proximal portion and out
of the proximal end PE of the tubular guide 20a, as shown. In this
regard, the plastic tube that extends through the metal hypotube
and protrudes thereform to form the curved distal portion 14a may
have a large working lumen as well as one or two additional lumens
through which the wire leads 14 may pass. Alternatively, the wire
leads 14 may pass along the outer surface of the distal portion
24a, the through the lumen of the hupotube, between the outer
surface of the inner plastic tube and inner surface of the outer
hypotube. In this particular example, the distal portion 24a is
substantially rigid and is preformed to a curve of from
approximately 70 degrees through approximately 135 degrees, so as
to be useable for accessing the ostium of a maxillary sinus without
requiring substantial cutting or surgical modification of the
uncinate process or other normal anatomical structures within the
nose. Alternatively, it will be appreciated that the distal portion
24a may be malleable (e.g., a malleable metal, polymer or
metal-polymer composite) so that the operator may shape the distal
portion 24a as desired, depending on the particular sinus ostium or
other location to be accessed, anatomical irregularities of the
subject, etc. So long as the electromagnetic sensor coil 16 is
located distal to any curve(s) introduced in the malleable distal
segment, the introduction of such custom made curve(s) will not
require any recalibration or otherwise hamper the ability of the
image guidance system to sense the position of the distal end of
the tubular guide 20a. In operation, this tubular guide 20a is
inserted through the subject's nostril, either alone, over a
previously inserted guidewire or with a guidewire pre-inserted into
the lumen of the tubular guide 20a. The tubular guide 20a is then
advanced through the medial meatus and rotated to cause the curve
of the distal portion 24a to pass over the uncinate process such
that the open distal end DE of the tubular guide 20a is positioned
adjacent to and in substantial alignment with the ostium of the
maxillary sinus.
[0079] The tubular guide 20b shown in FIG. 2B may be constructed
and used in the same manner as the tubular guide 20a of FIG. 2A
except that the curved distal portion 24b has a less severe
curvature than the distal portion of the 24a of the guide shown in
FIG. 2A. In this particular example, the distal portion 24b is
substantially rigid and is preformed to a curve of from
approximately 30 degrees through approximately 90 degrees, thereby
being useable for accessing the ostia of frontal sinuses.
[0080] It is to be appreciated that the particular curvatures and
shapes of the tubular guides 20a, 20b shown in FIGS. 2A and 2B are
merely examples of the many shapes and configurations in which
tubular guides of the present invention may be configured to
accesses specific locations within the nose, paranasal sinuses,
Eustacian tubes, etc. Additionally, it is to be appreciated that
any of the guidewires 10, tubular guides 20a, 20b or other working
devices 30 of this invention may be steerable, bendable, malleable
or capable of being articulated. FIG. 3 shows a generic example of
a sensor-equipped working device 30 of the present invention. This
device 30 comprises an elongate shaft 32, a sensor 16, a working
element 36 and wires 14 that extend from the sensor 16 through the
shaft 32 and out of the proximal end PE of the device 30. In some
embodiments, the outer diameter of the working device 30 may be
less than the inner diameter of a sensor-equipped tubular guide 20a
or 20b or other tubular guide such that the working device 30 may
be advanced through a tubular guide to a desired location where
treatment is to be applied. Additionally or alternatively, the
working device 30 may have a guidewire lumen extending through or
adjacent to the shaft 32 such that the working device 30 may be
advanced over a sensor-equipped guidewire 10 or other guide member
to a desired location where the treatment is to be applied. In this
example, the sensor 16 comprises a coil that is wound about or
positioned about the outer surface of shaft 32 a known distance
from the distal end DE of the device 30. Provided that any bending,
curving or flexing of the shaft 32 occurs proximal to the sensor
16, the spatial relationship of the sensor 16 to the distal end DE
will remain constant and, thus, the position of the distal end DE
of the device 30 may be determined and displayed on a video screen
on the basis of the sensed location of the sensor 16. In some
embodiments, one or more sensors may be positioned in known spatial
relation to the working element so as to provide the ability to
determine and display the real time location of the working element
on the basis of the sensed location of the sensor(s) 16. In
embodiments where the sensor comprises a wire coil, such coil may
be positioned within or wound about the outer surface of the
elongate shaft 32. Optionally, a plastic film or other electrically
insulating cover (e.g, an outer skin) may be heat shrunk or
otherwise disposed and secured about the sensor 16 to provide a
smooth outer surface in the area where the sensor 16 is mounted.
Wire leads 14 may extend from the sensor 16, through the shaft 32
to facilitate connection of the sensor 16 to an image guidance
console (e.g., a computer workstation) as described herein.
Alternatively, the wire leads 14 may pass along the outer surface
of the shaft 32 and may be secured by adhesive, a surrounding wrap,
sheath or skin, etc. These wire leads 14 or the sensor 16 itself
may be connected directly, indirectly through an intervening
apparatus (e.g., a cable, self-calibrating instrument system or
other intervening apparatus) or by wireless connection to the
console 76 and/or computer 78. In applications where the sensor 16
ro its leads 14 are connected to the console 76 and/or computer 78
by way of a self-calibrating instrument system, such
self-calibrating instrument system may comprise a sensor-equipped
distal instrument attached to a proximal handpiece. The instrument
system would be initially calibrated by touching the
sensor-equipped distal instrument to fiducial markers. Once the
instrument system was calibrated, the sensor-equipped distal
instrument could be exchanged for other sensor-equipped distal
instruments without requiring the user to recalibrate the
instrument system. Instead, the instrument system would self
calibrate by means of the proximal handpiece reading calibration
information embedded electronically in a tag on the distal
instrument.
[0081] The working element 36 may be positioned at a location
between the proximal end PE and distal end DE, as shown in the
example of FIG. 3. Alternatively, the working element 36 may be
positioned at or on the distal end DE of the device 30, depending
on the mode of action and intended use of the working element. The
working element 36 may perform or facilitate any type of
therapeutic or diagnostic function. Examples of working elements 36
that may be used include but are not limited to: dilators,
balloons, substance injectors, needles, penetrators, cutters,
debriders, microdebriders, hemostatic devices, cautery devices,
cryosurgical devices, heaters, coolers, scopes, lenses, ports,
endoscopes, light guides, phototherapy devices, drills, rasps,
saws, etc. Some specific examples of working elements 36 and their
uses in ENT procedures are described in U.S. patent application
Ser. No. 10/829,917 entitled "Devices, Systems and Methods for
Diagnosing and Treating Sinusitis and Other Disorders of the Ears,
Nose and/or Throat," Ser. No. 10/912,578 entitled "Implantable
Device and Methods for Delivering Drugs and Other Substances to
Treat Sinusitis and Other Disorders," Ser. No. 10/944,270 entitled
"Apparatus and Methods for Dilating and Modifying Ostia of
Paranasal Sinuses and Other Intranasal or Paranasal Structures" and
Ser. No. 11/037,548 entitled "Devices, Systems and Methods For
Treating Disorders of the Ear, Nose and Throat," which are
expressly incorporated herein by reference.
[0082] Optionally, any working device 30 of this invention, may
include a guide member 37, such as a flexible, malleable or rigid
wire or other elongate member, that extends from the distal end DE
of the device, as shown in phantom in FIG. 3. This guide member 37
may be tapered or nontapered. The guide member 37 will typically be
smaller in diameter than the body 32 of the working device 30 such
that the guide member may be easily advanced through an ostium of
other anatomical opening, thereby facilitating or "guiding"
placement of the body 32 of the device 30 in a position adjacent to
that ostium or opening and/or thereby facilitating or guiding
further advancement of the body 32 of the device 30 through that
ostium or opening.
[0083] In systems used to perform FTSI procedures, a working device
30 wherein the working element 36 comprises a balloon or other
dilator will be used to dilate the ostium of a paranasal sinus.
FIGS. 4-4J show some specific examples of sensor equipped working
devices in the nature of dilation catheters (e.g., balloon
catheters) for dilation of the ostia of paranasal sinuses or other
anatomical or pathological structures.
[0084] FIGS. 4-4B show an embodiment of a sensor equipped dilation
catheter 40a comprising a shaft 42 comprising a single, multi-lumen
tube, a proximal Luer hub 48, a balloon 46, sensor(s) 16 and sensor
leads 14. While any number of sensors 16 may be used, the example
shown in FIGS. 4-4B incorporates two (2) sensors 16, wherein one
sensor 16 is located near the proximal end of the balloon 46 and
the other sensor 16 is located near the distal end of the balloon
46. A through lumen 94 extends from the bore of the proximal Luer
hub 48, through the shaft 42 and terminates distally in a distal
end opening. This through lumen 94 may be used for fluid
infusion/aspiration and/or for guidewire passage. Lead lumens 98
also extend through the shaft 42 and the sensor leads 14 extend
through such lead lumens 98. An inflation/deflation lumen 96
extends from a sidearm port 49 on the proximal hub 48, through the
shaft 42 and terminates in an aperture 91 within the balloon 46 to
facilitate inflation and deflation of the balloon 46. For
applications intended to dilate the ostia of paranasal sinuses, the
balloon will typically be formed of a relatively non-compliant
material such as polyethylene teraphthalate (PET) or nylon of a
thickness and density that renders the balloon capable of
withstanding inflation pressures of up to approximately 25
atmospheres. The balloon 46 may have a straight cylindrical side
wall with tapered ends, as shown, and if the balloon 46 is so
constructed, the sensors 16 may be positioned directly beneath the
proximal and distal ends of the straight cylindrical mid-portion MP
of the balloon 46 as seen in FIG. 4A. As explained more fully
herebelow, this catheter 40 may be advanced to a position where the
deflated balloon 46 is positioned within a stenotic ostium of a
paranasal sinus with the distal sensor 16 on one side of the ostium
and the proximal sensor 16 on the other side of the ostium. The
balloon 46 may then be inflated one or more times to desired
pressure(s) (e.g., typically pressures ranging from about 10
atmospheres through about 25 atmospheres) to dilate the stenotic
ostium. Thereafter, the balloon 46 may be deflated and the dilation
catheter 40 removed. FIGS. 4C and 4D show another way in which a
sensor equipped dilation catheter 40b may be constructed. In this
example, the catheter 40b differs from that shown in FIGS. 4-4B
because its shaft 104 comprises an outer tube 100 and an inner tube
102. The inner tube 102 extends through the outer tube 100 and
protrudes out of the distal end of the outer tube 100 by a fixed
distance. The sensors 16 are mounted on the outer tube 100 at
spaced apart locations such that one sensor 16 is directly beneath
the proximal end of the straight walled midportion MP of the
balloon 46 and the other sensor 16 is directly beneath the distal
end of the straight walled midportion MP of the balloon 46. The
outer tube 100 has a main through lumen 106 and two lead lumens 108
through which the sensor leads 14 extend. The inner tube 102 has a
through lumen 103 which may be used as a guidewire lumen and/or an
infusion/aspiration lumen or for other purposes. The outer diameter
of the inner tube 102 is smaller than the inner diameter of the
outer tube 100 such that a space exists to allow balloon inflation
fluid to be infused into or removed from the balloon 46 through the
lumen of the outer tube 100. This embodiment of the dilation
catheter 40 shown in FIGS. 4C-4D may be positioned and used to
dilate the ostium of a paranasal sinus in the same manner as that
described above with respect to the embodiment of FIGS. 4-4B.
[0085] FIGS. 4E and 4F show yet another way in which a sensor
equipped dilation catheter 40c may be constructed. In this example,
like the example shown in FIGS. 4C and 4D, the catheter 40c has a
shaft 114 that comprises an outer tube 100a and an inner tube 102a,
wherein the outer tube 100a terminates near the longitudinal
midpoint of the balloon 46 and the inner tube 102a extends through
the outer tube 100a and protrudes out of the distal end of the
outer tube 100a by a fixed distance. In this embodiment of the
catheter 40c, the proximal sensor 16 is positioned on the outer
tube 100a at a location that is directly beneath the proximal end
of the straight walled midportion MP of the balloon 46 and the
other sensor 16 is positioned on the inner tube 102a at a location
that is directly beneath the distal end of the straight walled
midportion MP of the balloon 46. The outer tube 100a has a main
through lumen 106a and one lead lumen 120 through which the sensor
leads 14 from the proximal sensor 16 extend. The inner tube 102a
has a through lumen 103a which may be used as a guidewire lumen
and/or an infusion/aspiration lumen. The outer diameter of the
inner tube 102a is smaller than the inner diameter of the lumen
106a of outer tube 100a such that a space exists to allow balloon
inflation fluid to be infused into or removed from the balloon 46
through the lumen 106a of outer tube 100a.
[0086] In the example of FIGS. 4E and 4F, the sensor leads 14 from
the distal sensor 16 extend along the outer surface of the inner
tube 102a, as shown, and may be secured to the outer surface of the
inner tube 102a by any suitable means such as adhesive, clips,
bands, sheathing, shrink wrapping, etc. It is to be appreciated,
however, that in any of the embodiments, any of the sensor leads 14
may extend outside of, within or through a lumen of any portion of
the catheter shaft, as may be desirable or expedient for
manufacturing or operative purposes and/or to minimize electrical
interference and optimize signal transmission. For example, FIGS.
4G and 4H show another way in which a sensor equipped dilation
catheter 40d may be constructed. In this example, like the example
shown in FIGS. 4E and 4F, the catheter 40d has a shaft 126 that
comprises an outer tube 100b and an inner tube 102b. The outer tube
100b terminates near the longitudinal midpoint of the balloon 46
and the inner tube 102b extends through the outer tube 100b and
protrudes out of the distal end of the outer tube 100b by a fixed
distance. Again, in this embodiment of the catheter 40d, the
proximal sensor 16 is positioned on the outer tube 100b at a
location that is directly beneath the proximal end of the straight
walled midportion MP of the balloon 46 and the other sensor 16 is
positioned on the inner tube 102b at a location that is directly
beneath the distal end of the straight walled midportion MP of the
balloon 46. The outer tube 100b has a main through lumen 106b and
one lead lumen 126 through which the sensor leads 14 from the
proximal sensor 16 extend. The inner tube 102b has a through lumen
103b which may be used as a guidewire lumen and/or an
infusion/aspiration lumen. The outer diameter of the inner tube
102b is smaller than the inner diameter of the outer tube 100b such
that a space exists to allow balloon inflation fluid to be infused
into or removed from the balloon 46 through the lumen 106b of the
outer tube 100b. In this embodiment, a second lead lumen 128 is
formed in the wall of the inner tube 102b and the wire leads 14
from the distal sensor 16 extend through such second lead lumen
128, as shown.
[0087] FIGS. 4I and 4J show yet another way in which a sensor
equipped dilation catheter 40e may be constructed. In this catheter
40e, the shaft 136 comprises an outer tube 100c that terminates
within the proximal region of the balloon 46 and the inner tube
102c extends through the outer tube 100c such that it protrudes out
of the distal end of the outer tube 100c by a fixed distance. In
this embodiment, both the proximal and distal sensors 16 are
positioned on the inner tube 102c. Specifically, the proximal
sensor 16 is positioned on the inner tube 100c at a location that
is directly beneath the proximal end of the straight walled
midportion MP of the balloon 46 and a distal sensor 16 is
positioned on the inner tube 102c at a location that is directly
beneath the distal end of the straight walled midportion MP of the
balloon 46. The outer tube 100c has a main through lumen 106c
through which the inner tube 102c extends. The inner tube 102c has
a through lumen 103c which may be used as a guidewire lumen and/or
an infusion/aspiration lumen and two lead lumens 142, 144 through
which the sensor leads 14 from the proximal and distal sensors 16
extend. The outer diameter of the inner tube 102c is smaller than
the inner diameter of the lumen 106c of outer tube 100c such that a
space exists to allow balloon inflation fluid to be infused into or
removed from the balloon 46 through the lumen 106c of outer tube
100c.
[0088] Although the balloons 46 shown in FIGS. 4-4J are straight
walled cylindrical balloons having tapered ends, it is to be
appreciated that various other shapes and configurations of
balloons may be employed in any embodiments of the dilation
catheter 40. For example, one or more depressions or indentations
(e.g., an annular depression or groove) may be formed in the
midportion MP of each balloon to facilitate positioning of the
balloon and seating of ostial tissue or other anatomical tissue
within such depressions or indentations. Examples of balloons
having such depressions or indentations are described in U.S.
patent application Ser. Nos. 10/829,917, 10/944,270 and 11/037,548,
which are expressly incorporated herein by reference.
[0089] It is to be appreciated that the specific examples shown in
the drawings are merely examples. Indeed, the sensors 16 may be
positioned at many other locations other than those shown in these
examples. For example, in any sensor equipped dilation catheter 40,
sensor(s) may be located in the center of the balloon 46 or other
working element and/or elsewhere on or in the catheter shaft within
the balloon 46 or other working element and/or distal to the
balloon 46 or other working element and/or proximal to the balloon
46 or other dilator and/or within the wall(s) of the balloon 46 or
other dilator.
[0090] Also, in any of the working devices having lumen(s) the
shaft of the device (e.g., the catheter body) need not be of
coaxial (e.g., tube within a tube) design, but alternatively may be
a single catheter body having a plurality of lumens. For example,
in the case of a balloon dilation catheter, a catheter shaft having
four lumens may be used. One lumen may serve as a guidewire/working
lumen, one lumen may serve as a balloon 46 inflation/deflation
lumen and the other two lumens may serve as passageways for the
sensor leads 14. Also, as stated, in any of the sensor equipped
devices 10, 20, 30, 40 a fixed guide tip and/or sensor 16 may be
located at the distal end DE of the device.
[0091] Also, in any embodiment of a sensor equipped dilation
catheter 40, the balloon 46 may be replaced by other types of
dilators or expandable structures, such as expandable mesh cages
and the like.
[0092] Also, in any embodiment of a sensor equipped dilation
catheter 40, the balloon 46 or other dilator may be coated,
textured, equipped with injection ports or otherwise equipped
and/or constructed to deliver additional treatment(s) in addition
to the primary anatomical dilation. For example, the balloon 46 may
be coated with or may comprise a drug or any other substance (e.g.,
a hemostatic agent or a substance that deters scarring or adhesion
formation) that will transfer onto or into the tissue contacted by
the balloon. Examples of balloons having such additional treatment
delivering capabilities are described in U.S. patent application
Ser. Nos. 10/912,578 and 11/037,548, which are expressly
incorporated herein by reference.
[0093] Additionally, in some embodiments of sensor equipped
dilation catheter 40, a stent or other radially expandable
implantable device may be mounted on the exterior of the balloon 46
or other dilator such that, when the balloon 46 is inflated (or
when any other type of dilator is expanded) the stent or other
radially expandable implantable device will be expanded and will
remain within the body after the balloon has been deflated (or the
other type of dilator contracted) and the dilation catheter 40
removed. Examples of stents and other radially expandable
implantable devices that may be used in conjunction with these
sensor equipped dilation catheters 40 are described in U.S. patent
application Ser. Nos. 10/829,917; 10/912,578; 10/944,270 and
11/037,548, which are expressly incorporated herein by
reference.
[0094] In some applications, it may be desirable to utilize a
sensor equipped subselective sheath 50, such as that shown in FIGS.
5 and 5A. The sheath 50 shown in FIGS. 5 and 5A comprises an
elongate tubular body 52 having a Luer hub 54 on its proximal end
PE and a sensor 16, such as an electromagnetic coil located at some
desired location, such as at or near the distal end DE of the
tubular body 52. A main lumen 216 extends through the tubular body
52 in communication and direct alignment with the bore of the Luer
hub 54. A separate lead lumen 56 also extends through the tubular
body 52. Sensor lead wires 14 extend through such lead lumen 56 and
out of the proximal hub 54 such that the lead wires 14 may be
connected to the computer of an image guidance system as described
more fully herebelow. In some embodiments, the inner diameter D1 of
the sheath lumen 216 will be large enough to allow a guidewire 10
and/or working device 30, 40, 60 to be advanced through the lumen
216 of the subselective sheath 50 and/or the outer diameter D2 of
the tubular body 52 will be small enough to advance through a
tubular guide 20a, 20b. The tubular body 52 of the subselective
sheath 50 may be formed of a polymer such as Pebax, polyimide, high
density polyethylene (HDPE), low density polyethylene (LDPE),
blends of HDPE/LDPE, etc. and may have a wall thickness from
approximately 0.001 inches through approximately 0.050 inches. In
some embodiments, a lubricious liner or coating may be disposed
within the main lumen 216 to facilitate sliding of guidewires or
working devices therethrough.
[0095] Another type of sensor equipped working device of the
present invention is a penetrator 60, as shown in FIG. 6. In the
example shown, the penetrator 60 comprises a solid or hollow
elongate body 62 (e.g., a plastic or stainless steel rod or
hypotube of approximately 14 gage through approximately 27 gage
having a sharp tip 64 at its distal end DE. A sensor 16, such as an
electromagnetic coil, is positioned at a desired location on the
penetrator, such as at or near its distal end DE. In some
embodiments a sensor coil may be wrapped about the elongate body
62. A notch or depression may be formed in the elongate body to
accommodate such coil wrap and a covering, such as a plastic
coating, sleeve, shrink wrap, etc. may be disposed about the coil,
thereby providing a smooth outer surface and deterring direct
contact of the sensor coil with body fluids or tissues. Sensor lead
wires 14 extend through the elongate body 62 exiting near its
proximal end PE such that they may be connected to the computer of
an image guidance system as described more fully herebelow.
[0096] Any of the sensor equipped working devices (e.g.,
guidewires, catheters, cannula, tubes, dilators, balloons,
substance injectos, needles, penetrators, cutters, debriders,
microdebriders, hemostatic devices, cautery devices, cryosurgical
devices, heaters, coolers, scopes, endoscopes, light guides,
phototherapy devices, drills, rasps, saws, etc.) may incorporate
biocompatible outer layers or coatings of lubricious material to
facilitate smooth advancement of the device through the nasal
anatomy, unless the inclusion of such coating would render the
device unusable for its intended purpose.
[0097] Also, any of the sensor equipped working devices may
incorporate a vibrator or other movement imparting apparatus to
cause vibration, reciprocation, vacillation or other movement of
the working device to facilitate passage of the working device
through tight or tortuous anatomical passages, unless the inclusion
of such vibrator or other movement imparting apparatus would render
the device unusable for its intended purpose.
[0098] Also, any of the sensor equipped working devices (e.g.,
guidewires, catheters, cannula, tubes, dilators, balloons,
substance injectors, needles, penetrators, cutters, debriders,
microdebriders, hemostatic devices, cautery devices, cryosurgical
devices, heaters, coolers, scopes, endoscopes, light guides,
phototherapy devices, drills, rasps, saws, etc.) may incorporate
internal guidewire lumens for over-the-wire use or rapid exchange
type guidewire lumens (e.g., tubes, split lumens or rails on that
extend along a portion of the outer wall of the catheter) to
facilitate rapid device and/or guidewire exchange during the
procedure, unless the inclusion of such guidewire lumen would
render the working device unusable for its intended purpose. In
embodiments that incorporate a rapid exchange guidewire lumen
(e.g., tubes, split lumens or rails on that extend along a portion
of the outer wall of the catheter) such rapid exchange guidewire
lumen may have a length of from about 0.5 cm through about 10 cm.
In some embodiments, the guidewire lumen may have a distal aperture
at the distal end of the device and a proximal aperture located
less than 10 cm proximal to the distal aperture. The sensor
equipped working devices of the present invention (e.g.,
guidewires, catheters, cannula, tubes, dilators, balloons,
substance injectors, needles, penetrators, cutters, debriders,
microdebriders, hemostatic devices, cautery devices, cryosurgical
devices, heaters, coolers, scopes, endoscopes, light guides,
phototherapy devices, drills, rasps, saws, etc.) may be used in
conjunction with an image guidance system to perform a variety of
image guided procedures for the treatment of sinusitis or other
disorders of the paranasal sinuses, ears, nose or throat. An
example of an electromagnetic image guidance system is shown in
FIGS. 7-9. This image guidance system comprises a localizer
apparatus 70 and a console 76 that includes a computer workstation
78 and a video monitor 80. As shown in FIGS. 7C and 7D, the video
monitor 80 may be used in a single screen mode 80a to single screen
image or in split screen mode 80b to simultaneously display 2 or
more images.
[0099] The localizer apparatus 70, which in this example comprises
a headset, has positioning projections 71 that are configured to
rest on or to insert within the ear canals and on either side of
the bridge of the subject's nose such that each time the localizer
apparatus 70 is worn by the subject it will remain in the same
substantially fixed position relative to the subject's paranasal
sinuses and intranasal anatomy, even when the subject's head is
turned or moved about. Two or more radiopaque fiducial markers 72
are mounted at fixed locations on either side of the portion of the
localizer apparatus 70 that resides over the subject's forehead, as
shown. Also, as seen in FIGS. 7E and 9, the localizer apparatus 70
is adapted to have a transmitter assembly 75 mounted at a specific
location in the center of the portion of the localizer apparatus 70
that resides over the subject's forehead. As illustrated in FIG. 8,
the transmitter assembly 75 has one or more transmitter locations
or sites 73 which emit electrical signals that are sensed by the
sensor(s) 16 located on the working devices that will later be
inserted into the subjects nose. In some cases, such as that shown
in FIG. 8A, a single transmitter 75a having single or plural (e.g.,
one, two, three or more) transmitter site(s) 73 may be used. If a
single transmitter site 73 is used, the transmitter 71a may emit a
variable signal from the single transmitter site 73 to create a
non-uniform electromagnetic field such that the position of a
single sensor 16 may be determined within that electromagnetic
field. If three (3) or more transmitter sites 73 are used, the
transmitter 75a may emit separate signals through each transmitter
site 73 such that the location of an individual sensor 16 may be
determined by a process of triangulation, similar to the manner in
which GPS technology is used to determine the positions of objects
on the earth's surface. In this regard, FIGS. 8B and 8C show
alternative transmitters 75b, 75c, each of which has three (3)
transmitter sites 73 at spaced apart locations which may be used
for real time triangulation of the position of a single
electromagnetic coil sensor 16 located on a working device 10, 20a,
20b, 30, 40, 60, etc. These transmitters 75a, 75b are constructed
such that the transmission sites 73 are positioned on arm members
79a, 79b that emanate or extend from a central post 77, such arm
members 75a, 75b being configured and positioned so as to provided
the needed signal transmission while not obstructing the surgeon's
access to the operative field.
[0100] Referring to FIG. 7A, in one example of an image guided FTSI
procedure of this invention, the subject is initially placed in a
CT scanner S while wearing the localizer apparatus 70 (without the
transmitter 75 mounted thereon). A pre-procedure CT scan of the
head is obtained using a protocol that Is compatible with the image
guidance system to be used. After the pre-procedure CT scan has
been completed, the CT scan data is down-loaded onto a transfer
disc 82. Also, the pre-procedure CT scan may be used for planning
of the procedure. During such planning, anatomical structures of
interest (e.g., ostia and sinuses) may be identified and flagged,
desired instrument trajectories may be plotted (e.g., the surgeon
may plan the trajectory on which a curved penetrator 60 will be
advanced to create openings in or between the ethmoid air cells)
and "keep out" areas may be defined (e.g., skull base,
posterior/superior wall of sphenoid near pituitary, orbital floor,
facial nerves, etc.)
[0101] As shown in FIG. 7B, before beginning the FTSI procedure,
the CT scan data is uploaded from the transfer disc 82 into the
computer 78 of the image guidance system.
[0102] With reference to FIG. 7E, the localizer apparatus 70 is
again placed on the subject's head and a transmitter 75 is attached
to the localizer apparatus 70. The positioning projections 71 are
placed in the same locations as during the pre-procedure CT scan,
thereby ensuring that the localizer apparatus 70 and its fiducial
markers 72 are in the same positions relative to the subject's head
as they were during the pre-procedure CT scan. The transmitter 75
is connected to the computer 78. In accordance with its
programming, the computer 78 then initiates and performs a
localization protocol to accomplish the "registration" process
whereby the positions of the fiducial markers 72 are used to
correlate the stored CT scan data with the subject's current body
position. Such localization protocol may require the physician to
touch the tip of a sensor equipped working device 30 or a
non-sterile sensor equipped localization wand to each fiducial
marker and signaling to the computer 78 when such is accomplished,
thereby enabling the computer to correlate the current positions of
each fiducial marker 72 within the electromagnetic field with the
position of that fiducial marker 72 on the stored CT scan
images.
[0103] With reference to FIG. 9, the sensor equipped tubular guide
20 may be initially inserted into the subject's nose and the sensor
lead wires 14 of the tubular guide 20 connected to the console 76.
The sensor equipped tubular guide 20, as well as the other sensor
equipped working devices 30, may be pre-calibrated at the point of
manufacture. Calibration details (e.g., length of instrument,
position of sensor relative to distal tip, baseline output from
additional sensors, etc.) may be stored in an electronically
readable medium (e.g., a read-only tag) on or in each working
device 30 such that, when each working device 30 is connected to
the console 76 or a precalibrated handpiece, the computer 78 will
read the calibration tag and will cause the image guidance system
to self-calibrate accordingly. The sensor(s) 16 of the tubular
guide 20 receive signals from the transmitter site(s) 76 and in
turn send signals to the computer 78. The computer 78 uses such
signals to determine the position of the sensor(s) 16 and/or the
position of a desired portion (e.g., the distal tip) of the tubular
guide 20 within the patient's body. The computer 78 also causes an
indicator of the position of the sensor 16 and/or desired portion
of the tubular guide 20 to appear on the video monitor 80 relative
to the CT scan image displayed on the monitor 80. As the tubular
guide 20 is advanced, the computer 78 will cause the displayed CT
scan image to scroll from cross section to cross section, thereby
providing real time monitoring of the anatomical structures in the
area of the sensor 16 and/or desired portion of the tubular guide
20. While viewing the position indicator and CT scan images on the
monitor 80, the physician advances the tubular guide 20 to a
position where its distal tip is adjacent to (and in substantial
alignment with) a sinus ostium or other structure to be treated by
a working device 30.
[0104] A non-sensor equipped or sensor equipped guidewire may then
be advanced through the tubular guide 20 into or through the sinus
ostium or other area to be treated by the working device 30. In
some cases, the guidewire may be initially inserted within the
lumen of the tubular guide 20 and may be advanced along with the
tubular guide 20. In other cases, the tubular guide 20 may be
inserted first and the guidewire may subsequently be advanced
through the lumen of the tubular guide 20. In the particular
example shown in FIG. 9, a sensor equipped guidewire 10 is used.
The sensor lead wires 14 of the sensor equipped guidewire 14 are
attached to the console 76 and the computer 78 performs the
self-calibration in the same manner as described above. After the
self-calibration for the guidewire 10 has been completed, the
guidewire is advanced as the sensor(s) 16 on the guidewire 10
receive signals from the transmitter site(s) 76 and in turn the
sensor(s) 16 send signals to the computer 78. The computer 78 uses
such signals to determine the position of the guidewire's sensor 16
and/or a desired location on the guidewire 10 (e.g., its distal
tip). The computer 78 also causes an indicator of the position of
the sensor 16 and/or desired portion of the guidewire 10 to appear
on the video monitor 80 relative to the CT scan image displayed on
the monitor 80. In some cases, while the tubular guide 20 and
guidewire 10 are both positioned within the subject's body, the
monitor 80 will display indicators of the positions of both the
tubular guide 10 and guidewire 20. In other cases, once the tubular
guide 20 has been advanced to its intended position, the indicator
of tubular guide 20 position may be deactivated so that it no
longer appears on the monitor 80 and the only device position
indicator appearing will then be that of the guidewire 10. In cases
where position indicators for two or more working devices 30 (e.g.
a tubular guide 20 and a guidewire 10 are simultaneously displayed
on the monitor 80, the position indicators may be color coded or
otherwise made to be distinguishable from one another. If more than
one sensor-equipped device is placed in the anatomy, the surgeon
(or system) must choose which device is the "master" (the device
whose movement controls the position of the cross hairs and
therefore which image slices are displayed) and which device is the
"reference" (ie, its relative position is displayed, but movement
of this device does not move the cross hairs or change which image
slices are displayed. In some applications, it may be desirable to
advance the guidewire 10 into a sinus or other cavity such that the
guidewire 10 becomes coiled within that cavity. If the body of the
guidewire is radiodense, such coiling of the guidewire within the
sinus or other cavity may be used as a means to enhance
visualization of the cavity by fluoroscopy or other radiographic
means. In this regard, it is to be appreciated that the guidewire
10 could be equipped with a plurality of sensors 16, such that a
primary sensor 16 is located at or near the distal tip and one or
more secondary sensors are located along the shaft of the guidewire
10. The primary sensor 10 could remain active while the secondary
sensors could be actuated and deactuated on demand. This would
enable the physician to confirm that a sufficient amount of the
guidewire 10 has been advanced into or past a particular anatomical
location (e.g., confirm that enough of the guidewire 10 has been
advanced into and coiled within a paranasal sinus.
[0105] After the guidewire 10 has been advanced to its desired
position (e.g., where the distal portion of the guidewire 10
extends through the sinus ostium or other area to be treated), the
sensor equipped working device 30 is inserted over the guidewire
10. In some cases, the tubular guide 20 may remain in place and the
sensor equipped working device 30 will be inserted over the
guidewire 10 and through the tubular guide 20, as shown in the
example of FIG. 9. In other cases, the tubular guide 20 may be
removed leaving the guidewire 10 in place and the working device 30
may then be inserted over the guidewire 10 alone. The sensor lead
wires 14 of the sensor equipped working device 30 are attached to
the console 76. The computer 78 performs a self-calibration as
described above. After the self-calibration for the sensor equipped
working device 30 has been completed, the sensor equipped working
device 30 is advanced over the guidewire 10. As the working device
30 is advanced, the computer 78 receives signals from the
transmitter site(s) 76 and sensor(s) 16 on the working device 30.
On the basis of such signals, the computer 78 will cause one or
more indicator(s) of the position of the working device 30 to
appear on the video monitor 80 relative to the CT scan image
displayed on the monitor 80. While viewing the video monitor, the
physician may advance the working device 30 to a precise location
within the body where its working element 36 is operatively
positioned within the sinus ostium or other area to be treated. It
will be appreciated that in some embodiments, a one or more
sensor(s) 16 may be positioned on the working device 30 so as to
delineate or mark the location of its working element 36 (e.g.,
sensors may be located at the proximal and distal ends of a
dilation balloon or a single sensor may be positioned a known
distance form the distal tip of a penetrator), thereby facilitating
precise positioning of the working element 36 relative to the sinus
ostium or other anatomical area to be treated by the working
element 36. In some cases where other sensor equipped devices
(e.g., the tubular guide 20 and guidewire 10) remain positioned
within the subject's body along with the working device 30, the
monitor 80 may display indicators of the positions of some or all
of those other devices along with the indicator of the position of
the working device 30. In other cases, the position indicator(s) of
the other devices may be deactivated or caused not to be displayed
on the video monitor 80 so that only the position of the working
device 30 is visible. In other cases, the position indicator for
the working device 30 may be displayed simultaneously with position
indications of the other indwelling sensor equipped devices (e.g.
tubular guide 20 and guidewire 10) and the position indicators for
each of the separate devices may be color coded or otherwise
distinguishable from one another when viewed on the monitor 80.
[0106] In some procedures, more than one working device 30 may be
used. Accordingly, in such procedures, after one working device has
been used to deliver a desired treatment or portion of a treatment
(e.g., a balloon used to dilate the ostium of a paranasal sinus),
that first working device may be removed, leaving the guidewire 30
in place. Thereafter, another working device 30 may then be
advanced over the guidewire 30 and used to deliver another stage of
the treatment to the same location. Or, the guidewire 10 may be
moved to a different location and another working device 30 (or
even the same working device 30) may then be used to deliver a
treatment to a different treatment location. This may be repeated
numerous times with various different types of working devices 30.
For example, in some FTSI procedures, a first working device 30 in
the form of a balloon dilation catheter 40 may be advanced over the
guidewire 10, used to dilate the ostium of a paranasal sinus and
then removed, leaving the guidewire 10 in place. Thereafter, a
second working device in the form of a penetrator 60 may be
advanced over the guidewire 10 into the paranasal sinus and used to
puncture a mucocele, mucocyst or other vesicle located on the wall
of the sinus or elsewhere. The penetrator 60 may then be removed
leaving the guidewire 10 in place. Thereafter, another working
device 30 in the form of a tube or sheath 50 may be advanced over
the guidewire 30 and used to lavage (e.g., wash out) the sinus.
After the lavage is complete, the tube or sheath 50 may be removed,
leaving the guidewire 10 in place, and yet another working device
in the nature of a substance eluting implant delivery catheter may
be advanced over the guidewire 10 and used to place a substance
eluting implant (e.g., a therapeutic implant as described in
incorporated U.S. patent application Ser. Nos. 10/829,917 and
10/912,578) in or near the affected paranasal sinus. After all of
the desired working devices 30 have been inserted and used, the
guidewire 30 (and the tubular guide 20 if it remains at that point)
may be withdrawn and removed from the subject's nasal cavity.
[0107] With reference to FIGS. 9A and 13A-B, the computer 78 may be
programmed to display on the video monitor 80 not only an indicator
94 of the current position of a sensor equipped device 10, 20, 30,
40, 50, 60, 220 but also path indicator(s) 97 (e.g., ghosts, dotted
lines, etc.) indicating the prior positions (e.g., the path of
advancement) of that sensor equipped device 10, 20, 30, 40, 50, 60,
220 such that the device's path of advancement or retraction can be
visualized on the monitor 80. Optionally, some distance measurement
markings 95 (e.g., hash marks) may also be displayed to allow the
physician to easily determine the relative distance by which a
sensor equipped device 10, 20, 30, 40, 50, 60, 220 is advanced or
retracted. Alternatively or additionally, the computer 78 may
optionally be programmed to display path indicator(s) 97 indicating
a planned path of device advancement that is intended to be
followed.
[0108] Also, optionally, the computer 78 may be programmed such
that, as a sensor equipped device 30 is advanced or moved over a
particular path, that path may be converted into a different type
of indicia (e.g., a solid or color coded line) and displayed on the
video monitor 80. In this regard, the tip of a sensor-equipped
working device 30 could be advanced, passed or swept over an
anatomical surface or boundary and the computer 78 could then cause
the monitor 80 to display an indication (e.g., a solid or colored
line) delineating or demarcating that anatomical surface or
boundary. This aspect of the invention could be used, for example,
to provide on the displayed video image an outline of the inner
surface of a paranasal sinus. Also, for example, this aspect of the
invention could be used intraoperatively to provide a current image
of the shape of an anatomical structure that is being modified in
the procedure (e.g., the shape of the nasal septum during a
septoplasty procedure intended to straighten the septum).
Similarly, by changing a setting on the computer, the surgeon could
trace with the distal tip of the sensor-equipped device the
boundary of anatomical structures to be "erased" from the displayed
images.
[0109] It is to be appreciated that, in some procedures of the
present invention, other types of imaging such as fluoroscopy or
x-ray may be used as well as the image guidance system 76. Thus,
the device so the present invention may include one or more
radiopaque markers or radiographically visible region(s) to
facilitate their use with fluoroscopy or x-ray.
[0110] Also, optionally, the computer 78 of the image guidance
system may be programmed to accept operator input as to points or
locations along a path of device advancement that should be tagged
or flagged on the displayed image and/or on a recorded image
maintained as a record of the procedure. These tags can then be
correlated with the image guidance system so that as the physician
reviews the case on the CT, the endoscopic images are linked and
being "flown through" as well.
[0111] Optionally, in some procedures, it may be desirable to also
insert an endoscope 84 within the subject's body to obtain an
endoscopic image that may be viewed separately or concurrently with
the pre-procedure scan images and indicia of device position
indicators 97, 97, 95 provided on the video monitor 80. When so
employed, the endoscope 84 may or may not be equipped with
sensor(s) 16 to allow its position to be monitored by the image
guidance system. Standard endoscopes used during functional
endoscopic sinus surgery (FESS) may be used for this purpose,
including but not limited to the Karl Storz Hopkins II rigid scope
(7210AA) and the Karl Storz Flexible Rhino-Laryngoscope (11101RP)
which are available commercially from Karl Storz
Endoscopy--America, Culver City, Calif. In cases where the
endoscope 84 is equipped with one or more sensor(s) of its own, the
sensor(s) mounted on the endoscope will provide a real time
indication of the position of the endoscope 84 within the subject's
body. In cases where the endoscope 84 is not equipped with
sensor(s) 16, another sensor equipped guidewire 10 or device 30 may
be inserted into the endoscope 84 to provide an indication of the
endoscope's location within the body. For example, a non-sensor
equipped endoscope 84, such as a flexible endoscope (e.g., Karl
Storz Flexible Rhino-Laryngoscope (11101RP), Karl Storz
Endoscopy--America, Culver City, Calif.), may be used and a sensor
equipped guidewire 10 may be inserted into (e.g., "parked" within)
the working lumen of that endoscope 84. In this manner, the
sensor(s) 16 on the guidewire will provide to the computer indicia
of the position of the endoscope 84 as it is navigated through the
anatomy. In this manner, an indicator of the position of an
endoscope 84 (or any other device into which the sensor equipped
guidewire 10 may be inserted) may be displayed on the image
guidance system monitor 80, even though that endoscope 84 (or other
device) is not itself equipped with a sensor 16. A window or signal
transitionable region may be formed in the endoscope to allow the
sensor(s) on the guidewire 10 to receive signals from the
transmitter 75, or the portion of the guidewire 10 on which the
sensor(s) is/are located my protrude out of an opening in the
endoscope to allow the sensor(s) on the guidewire 10 to receive
signals from the transmitter 75. It is to be appreciated that this
procedure is useable not only with endoscopes 84, but also with any
other devices into which a sensor-equipped guidewire 10 may be
inserted. For example, a sensor equipped guidewire 10 may be
inserted into a needle and used to guide the needle to a desired
submucosal position where it is desired to deliver a substance
(e.g., a drug or other therapeutic substance) or implant.
[0112] In some procedures where an endoscope 84 is employed, the
visual image obtained from the endoscope 84 may be displayed on a
monitor that is separate from the image guidance system monitor 80
(e.g., on a separate endoscopic tower commonly used with endoscopes
during FESS). In other instances, the endoscopic image may be
displayed on the image guidance system monitor 80 interchangeably
with the pre-procedure scan images and indicia of device position
indicators 97, 97, 95 (e.g., such that the physician may switch
back and forth between a real time, line-of-sight image provided by
the endoscope 84 and the pre-procedure scan images and device
position indicators 97, 97, 95 provided by the image guidance
system. In other instances, the image guidance system may
incorporate two separate monitors 80, one of which displays a real
time, line-of-sight image provided by the endoscope 84 and the
other of which displays the pre-procedure scan images and device
position indicators 97, 97, 95 provided by the image guidance
system. In still other instances, the image guidance system may
incorporate a single monitor 80 that is operable in split screen
mode such that one portion of the monitor screen displays a real
time, line-of-sight image provided by the endoscope 84 and another
portion of the monitor screen displays the pre-procedure scan
images and device position indicators 97, 97, 95 provided by the
image guidance system. In yet other instances, the computer 78 of
the image guidance system may be programmed to combine or integrate
a real time, line-of-sight image that is received from the
endoscope 84 with the stored pre-procedure scan images or with
computer models that have been derived from the pre-procedure scan
images and loaded into the image guidance system computer 78.
[0113] FIGS. 10A and 10B show one example of the manner in which an
endoscopic image may be used in conjunction with CT scan images to
provide unique displays and images to the physician. In this
example, a standard rigid endoscope is used. Typically, before the
endoscope is inserted, a vasoconstricting agent e.g., cocaine,
ephedrine, etc.) is sprayed into the nose. The endoscope 84 is then
inserted into the nares and positioned to view the medial meatus
MM, which is an open passageway adjacent to the middle turbinate
MT. The uncinate process UP is a rigid structure that protrudes
from the lateral wall of the nose, near the anterior end of the
middle turbinate, preventing the endoscope 84 from viewing
structures that lie behind the uncinate process UP. Such structures
include the ethmoid bulla and an opening called the hiatus
semilunaris as well as the ostium of the maxillary sinus which
drains into the hiatus semilunaris. Thus, in typical FESS
procedures, it is necessary for the physician to surgically incise
or remove the uncinate process UP in order to view or insert rigid
instruments into the ethmoid bulla, hiatus semilunaris or ostium of
the maxillary sinus. However, in the example of FIG. 10A, the
computer 78 of the image guidance system has used the stored CT
scan data to integrate, into the displayed endoscopic image, an
anatomical structure indicator 202 (e.g., a dotted line or other
demarcation) showing the position of an anatomical structure of
interest that is hidden from view of the endoscope 84 by the
protruding uncinate process UP and/or portions of the midal
turbinate MT. In the particular example of FIG. 10A, the anatomical
structure indicator 202 is in the form of a generally circular
dotted line showing the perimeter of the maxillary sinus ostium MO.
A flexible sensor equipped working device 30 is being advanced
through the medial meatus MM, around the intact uncinate process UP
and into the maxillary ostium MO, as indicated by a device position
indicator 94 and advancement path indicators 95.
[0114] As shown in FIG. 10B, in this example a separate video
screen displays a sagital tomographic image of the maxillary ostium
MO based on the pre-procedure CT scan images that are stored in the
computer 78 of the image guidance system. The computer 78 is
programmed to cause an indicator 94b of the position of the distal
end of the working device 30 relative to the maxillary ostium MO.
In this example the indicator 94b is a circle, but any suitable
marking or demarcation may be used. This view shown in FIG. 10B
aids the physician in advancing the distal end of the working
device 30 through the maxillary ostium MO, without having to incise
or remove the uncinate process UP.
[0115] Also, in some embodiments of the invention, the computer 78
may be programmed to use the distal tip of the guidewire 10 or any
other location on any other working device 30 as a "virtual
viewpoint" from which a virtual endoscopic view is created from the
pre-procedure CT scan images and displayed on the monitor 80.
[0116] Also included in the present invention are systems and
methods for performing endoscopic medical or surgical procedures
anywhere in the body of a human or animal subject. For example, an
endoscope 84 having an electromagnetic sensor 16 thereon may be
advanced though a portion fo the subject's body while the image
guidance system computer 78 receives and uses signals received from
the sensor 16 on the endoscope 84 to determine the position of the
endoscope within the subject's body, stores endoscopic images
received from the endoscope and correlates the stored endoscopic
images with locations within the subject's body. Thereafter, the
operator may request an endoscopic image obtained from a specified
location within the subject's body and the computer 78 may display
on the video monitor 84 the stored endiscopic image obtained at the
selected location. In some cases, the selected location may be the
current location of a working device 30 within the subject's body.
In this regard, a working device 30 that has an electromagnetic
sensor 16 thereon may be positioned within the subject's body, the
computer 78 may determine the position of the working device based
on signals received from the sensor on the working device 30 and
the computer 78 may display on the video monitor a stored
endoscopic image that was previously obtained from the current
location of the working device 30. In this manner, the operator is
provided with an endoscopic image of the anatomy near the working
device even though the working device may not be equipped with an
endoscope. In other cases, this system and method may be used to
compare a real time endoscopic image to a previously stored
endoscopic image. For example, an endoscope 84 having a sensor 16
thereon may be positioned within the subject's body and used to
obtain a real time endoscopic image. The computer 78 may use
signals received from the sensor 16 on the endoscope 84 to
determine its real time position and to display a real time
endoscopic image obtained from the endoscope currently positioned
within the body and ii) a stored endoscopic image that was
previously obtained at the same location where the endoscope 84 is
currently positioned. The real time and stored endoscopic images
may be displayed side by side (e.g., on separate screens or using a
split screen on a single monitor 84. This technique may be used,
for example, to compare a postoperative or intra-operative
endoscopic image to a previously obtained pre-operative endoscopic
image for the purpose of assessing efficacy, changes, etc.
[0117] The computer 78 of the image guidance system may also be
programmed to display on the image guidance system monitor 80
and/or on a separate endoscopic monitor, one or more virtual images
generated from the stored CT scan data and/or the device position
data received from the sensor(s) 16. For example, virtual images of
ostia, bones and portions of devices (e.g., inflated balloons) that
are not visible on a displayed endoscopic image. Examples of this
are shown in FIGS. 11A-11C.
[0118] FIG. 11A shows an image obtained from an endoscope 84
wherein an image guided dilation catheter 40 having a dilation
balloon 46 has been advanced partially through an anatomical
opening 209 and the balloon has been inflated. In this example, the
computer 78 is programmed to use the information received from the
sensor(s) on this balloon dilation catheter 40 to superimpose or
otherwise display on the endoscopic image a virtual image (e.g.,
dotted line) 208 representing the portion of the inflated balloon
46 that is hidden from actual view of the endoscope.
[0119] FIG. 11B shows an image obtained from an endoscope 84
viewing an anatomical structure AS within the body. This particular
anatomical structure AS is made up of bone covered with mucous
membrane or other soft tissue, as is typical of structures located
within the nose and paranasal sinuses. An ostium OS or opening is
formed in the anatomical structure AS, as shown. In this example,
the computer 78 is programmed to use information from the stored
pre-procedure CT scan data to superimpose or otherwise display, on
the endoscopic image, virtual images (e.g., dotted lines) 210
showing the edges of the bones that underlie the anatomical
structure AS and ostium OS being viewed by the endoscope 84.
[0120] FIG. 11C shows an image obtained from an endoscope 84
positioned within the middle meatus MM, anterior to the uncinate
process UP. In this example, the computer 78 is programmed to use
information from the stored pre-procedure CT scan data to
superimpose or otherwise display, on the endoscopic image, virtual
images (e.g., dotted lines) 214 showing the maxillary ostium MO and
openings into the ethmoid air cells EO, which are hidden from the
endoscope's view by the uncinate process UP. The ability to view
virtual images 214 of the maxillary ostium MO and/or openings into
ethmoid air cells EO may enable the physician to advance flexible
or curved devices (e.g., the guidewires, catheters, penetrators and
any other working devices 30) into or through those openings MO, EO
to perform treatment procedures directed at the maxillary sinuses
and/or ethmoid air cells without requiring removal or surgical
modification of the protruding uncinate process UP. An example of a
procedure for dilation the maxillary ostium and/or delivering other
treatment to the maxillary sinus is described above. Various other
procedures may be performed to treat or ablate the ethmoid air
cells. Some examples of the types of procedures that may be
performed to treat and/or ablate the ethmoid air cells include
those described in U.S. patent application Ser. No. 11/037,548
which is incorporated herein by reference.
[0121] Also, any of the working devices 10, 20, 30, 40, 50, 60 of
the present invention may include, in addition to one or more of
the image guidance system sensors 16, one or more other sensors or
movement indicators that may provide further information regarding
the 3 dimensional position and/or orientation of the device 10, 20,
30, 40, 50, 60. The types of other sensors or movement indication
apparatus that may be used include, for example, accelerometers,
strain gages (for flexible instruments), pitch/roll sensors, and
capacitive sensors. FIG. 12 shows one example of a working device
220 (e.g., a guidewire, catheter, cannula, tube, dilator, balloon,
substance injector, needle, penetrator, cutter, debrider,
microdebrider, hemostatic device, cautery device, cryosurgical
device, heater, cooler, scope, endoscope, light guide, phototherapy
device, drill, rasp, saw, etc.) that comprises an elongate shaft
222, a hub member 226 located on the proximal end PE of the shaft,
an image guidance sensor 16 (e.g., an electromagnetic coil) located
on the shaft 222 at a known distance from its distal end DE and a
working element 36 (e.g., a dilator, balloon, injector, light
delivery lens, endoscopic lens, cutter, opening, port, heater,
cooler, probe, or other treatment delivering aparatus or
structure). All or portion(s) of the shaft 222 may be rigid,
flexible or malleable. An accelerometer 228 is mounted on one side
of the hub 226, as shown. This accelerometer 228 sends signals to
the computer 78 indicating rotational movement of the device 220.
The computer 78 is programmed to process those signals and to
provide, on the basis of those signals, an indicator of the current
rotational orientation of the device 220 within the subject's body.
In operation, as the device may be inserted into the subject's
nostril with a specific maker (not shown) or structure (e.g., one
or more wings 227) of the device 220 in specific radial orientation
(e.g., such that the wings 227 on the hub 226 extend vertically up
and down--at the 12 o'clock and 6 o'clock positions). A foot pedal
or button on the console 76 may be depressed to cause the computer
78 to identify the current position of the accelerometer 228 as the
"zero" or starting position. Thereafter, any clockwise or
counterclockwise rotation of the device 220 will cause signals to
be sent from the accelerometer 228 to the computer 78 and the
computer will cause indicia of such rotational movement of the
device 220 to be shown on the monitor 80 or elsewhere.
[0122] The present invention is also useable to aid the operator in
maintaining the operative instruments within predefined areas of
the subject's body (e.g., "keep in zones") and/or to avoid
advancing operative instruments into other predefined areas of the
subject's body (e.g., "keep out zones"). Examples of this are shown
in FIGS. 13A and 13B. As shown, the computer 78 may be programmed
to display indicia (e.g., shaded and unshaded areas) demarcating
keep out zones 90 and a keep in zone 92. The intended keep in
zone(s) and keep out zone(s) may be electronically marked on the CT
scan images during the physician's pre-procedure planning. As shown
in FIG. 13A, as a sensor equipped working device 30 of the present
invention is advanced or moved within the keep in zone 92, device
position indicators 94 and path indicators 95 will appear only
within the keep in zone 92 and no alarm (e.g., visual or audible
alarm) will be provided to the operator. However, as shown in FIG.
13B, if the working device 30 is advanced or moved into either of
the keep out zones 90, the device position indicator 94 will appear
in the keep in zone 92 and, optionally, the computer 78 may be
programmed to cause an alarm (e.g., visual or audible alarm) to be
provided to the operator.
[0123] In some cases, it may be possible to maintain the subject's
head in a substantially fixed position during the procedure. In
those cases, the transmitter assembly 75 need not be mounted on a
localizer apparatus 70 or otherwise affixed to the subject's head.
Instead, in such cases, it may be possible for just the fiducial
markers 72 to be affixed to the subject's body while the
transmitter assembly 75 and fiducial markers 72 may be mounted on
or within the operating table, on a nearby IV pole, on or in a
fluoroscopic c-arm or elsewhere near the subject's body. However,
in many image guided ENT procedures (including many FTSI
procedures), it may be desirable to move or reposition the
subject's head one or more times during the procedure. Also, in
cases where the subject remains unanesthetized, it may be desirable
to allow the subject to make some voluntary head movements during
the procedure. Thus, it will often be desirable for the transmitter
assembly 75 and fiducial markers 72 to be mounted on a localizer
apparatus 70 or otherwise affixed to subject's body such that after
the fiducial markers 72 have been used to perform the initial
localization/registration protocol, the transmitter sites 73 will
subsequently move in fixed spatial relationship to the subject's
head. Certainly, a localizer apparatus 70 as shown in FIGS. 7E and
9 may be used for this purpose. However, such headset may be
uncomfortable for an unanesthetized subject and/or may be an
unwelcome or non-sterile obstacle located near the operative field
during the procedure. Thus, the present invention provides other
head attachment devices that may be used to attach the fiducial
markers 72 and transmitter(s) 75 to the subject's head during the
pre-procedure CT scan and also during the procedure. In some cases
these head attachment devices may comprise adhesive patches that
contain the fiducial markers 72 and to which the transmitter 75 is
attachable. In other cases, a mouthpiece may be used as a head
affixation device. Examples of such mouthpieces 240, 240a are shown
in FIGS. 14A-15C.
[0124] In the embodiment shown in FIGS. 14A and 14B, a dental
mouthpiece 242 is formed of silicon or other plastic. This
mouthpiece 242 may be configured based on an impression of the
subject's teeth such that the positioning of the mouthpiece 242
will be reproducible from wearing to wearing. The methods for
making mouthpieces 242 of this type are well known and such
mouthpieces are sometimes worn by athletes who play contact sports
and by some individuals who tend gnash or grind their teeth during
sleep. Radiopaque fiducial markers 244, such as metal articles, are
mounted at locations on the mouthpiece 242, as shown. These
fiducial markers 72 may be located on the buccal sides of the
mouthpiece 242 so as to be easily accessible during the
localization/registration protocol where it may be necessary for a
sensor equipped device 30 or a sensor equipped wand to be touched
against or placed in juxtaposition to each fiducial marker 72. A
transmitter assembly 75 mounting location is provided on the
mouthpiece such that the transmitter 75 may be attached to the
mouthpiece 242 at a predetermined, reproducible position.
[0125] The embodiment 240a shown in FIGS. 15A-15C is the same as
that shown in FIGS. 14A and 14B except that it includes a
transmitter mounting member 244 that is attached to the front of
the mouthpiece 242. The transmitter assembly 75 may be attached to
this transmitter mounting member 244. Optionally, in some
embodiments, a plurality of transmitter locations or sites 73 may
be at spaced apart locations along the transmitter mounting member
73 to facilitate determination (e.g., by triangulation) of the
position of a single sensor 16 positioned within the subject's
ears, nose, throat or paranasal sinuses.
[0126] FIGS. 16 and 17 show examples of a cable connector assembly
400 that may be used in connection with any of the sensor equipped
devices of the present invention, as well a other sensor equipped
devices, to facilitate transmission of signal(s) between the sensor
equipped device and an image guidance system, console 76 and/or
computer 78. This cable/connector assembly 400 comprises a cable
402 one end of which is connected to the sensor equipped device and
the other end of which terminates in a connector 402. The sensor
leads 14 extend through the cable 402 to connector 404. A
corresponding connector 406 is mounted on the image guidance system
console 76 or computer 78. The connectors 404, 406 may comprise
multi-pin connectors as shown, or any other suitable type of
connector. In some embodiments, the connectors 404, 406 may
transmit ither information or signals in addition to signals from
the sensor(s) mounted on the device. For example, the sensor
equipped device and/or connector 402 may contain a PROM, memory
chip or other storage medium that holds magnetic or digitally
encoded information relating to the device (e.g., calibration
information, information relating the position of a sensor 16 to
the distal end DE of the device, information relating the position
of the sensor 16 to a working element on the device, information
relating to the length, diameter or other sizing of the device,
information as to the type of device (e.g., balloon catheter,
guidewire, penetrator, cutter, tubular guide, etc.) being employed
or numerous other types of information). That other information may
be transmitted through certain prongs, pins, channels or other
contact points in the connectors 404, 406 while the signals form
the sensor(s) is/are transmitted through other prongs, pins,
channels or other contact points in the connectors 404, 406.
transmitted to the image guidance system console 76 and/or computer
78 and the connectors 404, 406.
[0127] With specific reference to FIG. 16, in some cases, an
optional handpiece 408 may be attached to the end of the cable 402
opposite the connector 404. Such handpiece may perform the dual
function of 1) connecting the cable 402 to the sensor equipped
device and 2) providing a handpiece that the operator may use to
manipulate, torque or otherwise move the device. In the particular
example shown in FIG. 16, the proximal end of a sensor equipped
guidewire 10 as shown in FIGS. 1-1A and described above, is
inserted into a bore of the handpiece 408 causing the connector 21
on the proximal end of the guidewire body 12 to engage a
corresponding connector (not seen in FIG. 16) located within the
handpiece 408. In this manner, signals from the guidewire's sensor
16 will travel from the guidewire 10, through cable 402, to cable
connector 404 and into console/computer connector 406, thereby
providing communication between the guidewire 10 and the image
guidance system console 76 and/or computer 78. When it is desired
to advance another device over the guidewire 10, the handpiece may
be disengaged from the proximal end of the guidewire to permit such
advancement of another device over the guidewire.
[0128] With specific reference to FIG. 17, in cases where the
handpiece 408 is not needed or desired, the cable 402 may be
connected directly to the proximal portion of a sensor equipped
device. In the particular example of FIG. 17, the cable 402 is
attached to the proximal hub 38 of a working device 30 that is
equipped with a working element 36 and sensor 16, as shown in FIG.
3 and described hereabove. The attachment of the cable 402 to the
working device 30 may be permanent or disconnectable. In instances
where the cable 402 is disconnectable from the device 30, a plug
and jack arrangement may be used to allow the cable 402 to be
volitionally connected to and disconnected form the device 30.
[0129] In some embodiments of the invention, the image guidance
components (e.g., markers and/or sensors) need not be integrated
into or attached to the device at the time of manufacture. Rather,
in some embodiments, the image guidance components may be
attachable to a working device (e.g., guidewire, guide catheter,
balloon catheter, lavage catheter, needle, electrosurgical probe,
stent delivery catheter, substance eluting implant delivery
catheter, debrider, seeker, cannula, tube, dilator, balloon,
substance injector, penetrator, cutter, debrider, microdebrider,
hemostatic device, cautery device, cryosurgical device, heater,
cooler, scope, endoscope, phototherapy device, drill, rasp, saw,
punch, forceps and laser, etc.) at the time of the procedure. For
example, FIGS. 18-19 show an example wherein an extender 500 is
attached to the proximal end of a working device 502 and an optical
navigation element assembly 506 is attached by way of clamp 504 to
the extender 500. In this manner, an optical IGS system 508, such
as the VectorVision.RTM. ENT image guidance system (available from
BrainLAB AG, Westchester, Ill.) or LandmarX.RTM. image guidance
system (available from Medtronic Xomed Surgical Products, Inc.,
Jacksonville, Fla.), may be used to monitor the position of the
working device within a subject's body.
[0130] More specifically, in the example shown in FIGS. 18 and 19,
the working device 502 comprises a tubular guide having a curved
distal end DE, a female Luer connector 510 on its proximal end and
a lumen extending therethrough. This tubular guide working device
502 is similar to the tubular guides 20a and 20b shown in FIGS. 2A
and 2B, except that this tubular guide working device 502 does not
incorporate any sensor 16 or wire leads 14. Also, in this example,
the extender 500 comprises a substantially cylindrical elongate
body 514 having a lumen that extends longitudinally therethrough, a
male Luer connector 516 on its distal end and a female Luer
connector 518 on its proximal end. The male Luer connector 516 on
the distal end of extender 500 is connectable to the female Luer
connector 510 on the proximal end of the tubular guide working
device 502. In this manner, the lumen of the extender 500 is
substantially continuous with the lumen of the tubular guide
working device 502 such that other working devices (e.g.,
guidewires, balloon catheters, lavage catheters, needles,
electrosurgical probes, stent delivery catheters and substance
eluting implant delivery catheters, debriders, seekers, cannulae,
tubes, dilators, balloons, substance injectors, penetrators,
cutters, debriders, microdebriders, hemostatic devices, cautery
devices, cryosurgical devices, heaters, coolers, scopes,
endoscopes, phototherapy devices, drills, rasps, saws, punches,
forceps and lasers, etc.) may be inserted into the proximal end PE
of the extender 500 and advanced through the extender 500, through
the tubular guide working device 502 and out of its distal end DE.
Although the embodiment of the invention shown in FIGS. 18 and 19
is a tubular device with a cylindrical wall, the extender can also
be a partially cylindrical wall or non-tubular extender. Also, the
extender 500 may perform other optional functions. For example,
prior to or after the clamp 530 has been attached to the extender
500, the extender 500 may be used as a handle to facilitate
grasping and control of the tubular guide working device 502.
[0131] In the example shown, the tubular guide working device 502
has a curve 520 formed near its distal end. The angle A of such
curve may range from 0 to about 110 degrees. Alternatively, all or
part of this tubular guide working device 502 may be made of
plastically deformable or malleable material such that the operator
may customize the shape of this device 502 before or during the
procedure.
[0132] Also in the example of FIGS. 18-19, the navigation element
assembly 506 comprises a hub member 522, a plurality of radiating
arms 524 that extend radially from the hub member 522 and a
plurality of active or passive navigation elements 526 attached to
the radiating arms 524. Examples of active optical navigation
elements include light emitters, such as light emitting diodes
(LEDs). Examples of passive optical navigation elements include
reflective members (e.g., spheres) that reflect light, such as
infrared light emitted from one or more infrared light sources
located in proximity to the device. The bottom end of the hub
member 522 is configured to be received by or otherwise attached to
the clamp 504. In the depicted example, the bottom end of the hub
member 522 is received within an upstanding sleeve portion 528 of
clamp 504 and a locking pin 530 is used to hold the navigation
element assembly 506 in substantially fixed rotational position
relative to the clamp 504. The body portion 532 of clamp 504 is
designed to fit upon and frictionally engage the cylindrical body
514 of the extender 500 such that the clamp 504 and navigation
element assembly 506 will be firmly attached to the extender and,
thus, will be held in substantially fixed position relative to the
extender 500 and the tubular guide working device 502 to which the
extender 500 has been attached. The extender 500 in some
embodiments can have features to enhance the attachment of the
navigation element assembly to the extender in substantially fixed
rotational position such as knurling, indentations, etc. One
commercially available example of a navigation element assembly 506
and clamp 504 having the general configuration shown in FIGS. 18
and 19 is the STARLINK.TM. Universal Instrument Adapter
manufactured by BrainLAB, Inc., Westchester, Ill.
[0133] Although FIGS. 18 and 19 show an embodiment where the
navigation element assembly 506 is attachable to and detachable
from the extender 500, it is to be appreciated that, in some other
embodiments of this invention, the clamp 504 and/or navigation
element assembly 506 may be integrated into or pre-attached to the
extender 500. For example, a clamp or other fitting designed to
receive and attach the navigation element assembly 506 may be
molded into or pre-attached to the extender 500. Or, all or part of
the navigation element assembly 506 (e.g., with or without
inclusion of the active or passive navigation elements 526) may be
molded into or pre-attached to the extender 500.
[0134] The IGS system 508 generally comprises a monitor 534 and one
or more camera(s) 538. Additionally, when the navigation elements
525 are passive (e.g., reflective) rather than active (e.g., light
emitting), the IGS system 508 may further comprise one or more
light emitter(s) 536 (e.g., infrared lamps) which emit light that
is reflected by the passive markers 526. Additionally, the IGS
system incorporates a computing device (e.g., a computer or
microprocessor) that is loaded with software for calibration and
tracking of the distal end DE of tubular guide working device 502
and/or other working devices within the subject's body. A user
interface (e.g., a keypad, keyboard, touch screen, other data entry
apparatus, etc.) may also be provided to enable the user to enter
parameters or information into the system 508. In some embodiments,
the computing device 540 may be programmed with software that
includes a database containing design parameters (e.g., length,
curvature/shape, etc.) for a number of tubular guides and/or other
working devices to which the extender 500 may be attached. In such
embodiments, the user interface device is used to enter or detect
the particular type of working device. Typically, the user enters
the type of guide device 100 (e.g. a maxillary sinus ostium access
guide device) in the surgical navigation system. The software in
the surgical navigation system then calibrates the position and/or
orientation of the distal tip of guide device 100 to navigational
unit 118, and hence to the surgical navigation system.
[0135] In typical operation, the male Luer connector on the distal
end of the extender 500 is firmly attached to the female Luer
connector 510 on the proximal end of the tubular guide working
device 502. The navigation element assembly 506 is attached to the
clamp 504 and the clamp 504 is firmly mounted on the extender 500,
as described above. Stored anatomical images, such as CT scan
images are displayed on the monitor 534 of the IGS system 508. In
some cases, a facemask or other headgear containing fiducial
markers may have been worn by the subject as the CT scan images (or
other anatomical images) are obtained and the locations of the
fiducial markers on the scanned images may then be used for
purposes of registration in accordance with the instructions
provided by the manufacturer of the IGS system. Examples of
headgear containing fiducial markers that may be used for this
purpose include those devices shown in FIGS. 7E, 9 and 14A-15C of
this application as well as those devices commercially available as
the Reference Headband/Reference Star (BrainLAB, Inc., Westchester,
Ill.) and the Framelock.TM. kit (Medtronic Xomed Surgical Products,
Inc., Jacksonville, Fla.) In other cases, the subject may not have
worn fiducial markers during the prior CT scan (or other anatomical
imaging procedure) and, instead, an alternative calibration
technique may be used. For example, the position and/or the
trajectory of the distal end DE of the tubular guide working device
502 may be calibrated to the surgical navigation system using an
anatomical landmark of the patient's body. To facilitate this, a
device such as the Z-Touch.RTM. Registration System (BrainLAB,
Inc., Westchester, Ill.) may be used. Such Z-Touch.RTM.
Registration System is a special laser pointer that allows the
VectorVision.RTM. IGS system to utilize the surface anatomy of the
subject's face and head to calculate an advanced surface-matching
algorithm and calibrate the system to the patient's scan. Or, in
another alternate method embodiment, the position of the distal tip
of guide device 100 may be calibrated to the surgical navigation
system using a calibration device such as VectorVision.RTM. ENT
ICM4 Instrument Calibration Tool (Brainlab, Inc., Westchester,
Ill.) that comprises one or more fiducial markers used for
calibration purposes.
[0136] After any required calibration has been performed, the
distal end DE of the tubular guide working device 502 may be
inserted trans-nasally and advanced to a position where the distal
end DE is in alignment with or adjacent to a desired treatment
sight, such as the ostium of a paranasal sinus. Thereafter, a
second working device (e.g., guidewire, guide catheter, balloon
catheter, lavage catheter, needle, electrosurgical probe, stent
delivery catheter, substance eluting implant delivery catheter,
debrider, seeker, cannula, tube, dilator, balloon, substance
injector, penetrator, cutter, debrider, microdebrider, hemostatic
device, cautery device, cryosurgical device, heater, cooler, scope,
endoscope, phototherapy device, drill, rasp, saw, punch, forceps
and laser, etc.) may be inserted into the proximal end PE of the
extender 500, advanced through the lumen of the extender 500,
through the lumen of the tubular guide working device 502 and out
of its distal end DE to the desired treatment location where such
second working device may be used to perform a desired therapeutic
or diagnostic function. One such therapeutic function would be to
dilate an opening of a paranasal sinus by a) using the IGS system
to position the distal end DE of the tubular guide working device
502 adjacent to or in alignment with the opening of the paranasal
sinus, b) advancing a dilation catheter through the extender 500
and through the tubular guide working device 500 and into the
opening of the paranasal sinus and c) using the dilation catheter
to dilate the opening of the paransal sinus. Additionally or
alternatively, fluids or substances may be infused through the
extender 500 and through the tubular guide working device 502 for
purposes of lavage, imaging or treatment delivery.
[0137] FluoroCT is a relatively new technology in which a C-arm
type three-dimensional (3D) imaging device (e.g., the ISO-C3D
available from Siemens Medical Systems) is used to obtain a
fluoroscopic computed tomogram. Because these C-arm devices may be
mobile, Fluoro CT scans may be obtained intraoperatively and
immediately postoperatively, as well as preoperatively. In some
cases, FluoroCT may be used to obtain the pre-procedure imaging
data stored in the image guidance system computer 78. Additionally,
in some cases, one or more FluoroCT scans may be obtained during or
after the procedure and data sets from such intraoperative or
postoperative FluoroCT scans may be loaded into the computer 78.
The computer 78 may be programmed to use such FluoroCT scan data to
update the previously stored imaging data that has been obtained by
traditional CT, MRI, FluoroCT or other means, thereby adjusting the
stored anatomical image data to show changes to the anatomy that
have occurred subsequent to the pre-operative scan. Additionally or
alternatively, the computer may be programmed 78 to display the
newly added FluoroCT data in addition to or in comparison with
other images based on the preoperative scan, thereby allowing the
surgeon to compare the current (e.g., intraoperative or
postoperative) anatomy to the preoperative anatomy.
[0138] It is to be appreciated that the computer 78 of the image
guidance system may be programmed with a number of optional
programs (e.g., software bundles) to provide additional or
different features. The following are non-limiting examples of some
of the optional capabilities that may be programmed into the
computer 78:
[0139] Device Path Suggestion Feature:
[0140] The computer 78 may, in some embodiments, be programmed to
automatically suggest path(s) of advancement or vector(s) along
which a desired device (e.g., a sensor equipped working device 30)
may be advanced to reach a desired location (e.g., the ostium of a
particular paranasal sinus, the ethnoid air cells, a site of
infection, a bulla, a mucocele, a mucocyst, etc.) The suggested
path(s) of advancement or vector(s) may be selected based on
operator-input criteria (e.g., least complex path, least tortuous
path, least traumatic path, safest path, etc.) After it has
determined the desired path(s) or vector(s) the computer 78 may
cause indicia of such desired path(s) or vector(s) (e.g., dotted
lines) to appear on the video monitor 80 in relation to the
displayed anatomical CT and/or endoscopic images.
[0141] Path Ahead Mode:
[0142] The computer 78 may, in some embodiments, be programmed to
display not only the anatomical structures that are adjacent to or
near the current position of a sensor equipped working device 30,
but also anatomical structures that are located ahead on one or
more path(s) on which the device 30 may be advanced from its
current position to reach its target position. In this regard, the
computer 78 may cause the monitor 80 to display 1) a tomographic
section or other anatomical image of the area in which the working
device 30 is currently located (the "current location image") and
2) one or more other tomographic sections or other images showing
anatomical structures that lie ahead on one or more intended
path(s) of advancement (the "path ahead image(s)). The current
location image and the path ahead image(s) may be displayed
simultaneously (e.g., on separate monitors, on a split screen
monitor or on a single screen where with one image is inset within
a larger image). Alternatively, current location image and the path
ahead image(s) may be displayed one at a time such that the
operator may switch back and forth between the current location
image and the path ahead image(s).
[0143] Pre-Post Comparison Mode:
[0144] The computer 78 may, in some embodiments, be programmed to
take the stored pre-procedure imaging scan data and compare it to
subsequently input a post-procedural or intra-operative imaging
scan data such that the effects or anatomical changes caused by the
procedure may be assessed.
[0145] Turn Cueing Mode:
[0146] The computer 78 may, in some embodiments, be programmed to
provide a turn indicator (e.g., an audible signal or visual
indicator shown on the monitor screen) to indicate the direction
that a guidewire 10 or other sensor equipped working device 30
should be turned to navigate toward a desired target location.
[0147] Treatment Forecasting
[0148] The computer 78 may, in some embodiments, be programmed to
utilize the stored anatomical image data (e.g., CT scan data) to
provides prompts or suggestions of 1) anatomical structures or
pathological lesions that may be amenable to a particular treatment
and/or 2) optimal or suggested locations and/or rotational
orientations in which working device(s) 30 may be placed in order
to effect a particular treatment and/or 3) the optimal or suggested
size or dimensions of the working device(s) 30 to be used (e.g.,
for regions marked in red a 6 mm balloon diameter is suggested and
for regions marked in blue a 7 mm balloon is suggested).
[0149] Simulation of Result
[0150] The computer 78 may, in some embodiments, be programmed to
provide a simulated result of a particular procedure before the
procedure is actually performed. The ability to generate a
simulated result may be particularly advantageous in cases where it
is not feasible for the physician to actually view the area being
treated and, thus, is unable to make a visual assessment of such
area as may be needed to arrive at an accurate prediction of the
likely therapeutic and/or untoward results of a proposed treatment
or maneuver. For example, the console 76 and computer 78 may be
adapted to receive operator input of the particular diameter (or
other dimensions/characteristics) of a dilator balloon that the
physician proposes to use for dilation of a particular passageway.
The computer 78 will be programmed with software that it will use
to provide a simulated view of what that passageway would look like
after it has been dilated by that proposed balloon and what
submucosal, adjacent or hidden anatomical structures would likely
be compressed or otherwise affected by such dilation procedure, if
the procedure were actually performed using a balloon having the
proposed diameter, dimensions and/or characteristics.
[0151] Simulation of Device
[0152] The computer 78 may, in some embodiments, be programmed to
provide a simulated view of a particular device that is positioned
within the subject's body. For example, the computer 78 may be
programmed with device information (e.g., the dimensions, shape and
appearance of the device) and, after tracking the trajectory of a
the sensor 16 mounted on that device through the anatomy, the
computer 78 may generate and display on the monitor 80, a "virtual"
image of the device as it is positioned relative to the adjacent
anatomy. This aspect of the invention may provide to the operator
some "feel" for the relative 3 dimensional size and position of the
device within the body.
[0153] Look Ahead Mode
[0154] The computer 78 may, in some embodiments, be programmed to
provide a simulated view from a vantage point on a device that has
been inserted into the subject's body. For example, the computer 78
may cause the monitor to display a forward looking view from the
distal tip of an advancing guidewire as if the operator were
sitting on the distal tip of the guidewire and looking forward at
the anatomy as the guidewire is advanced.
[0155] Also, it is to be appreciated that any working device 30 may
incorporate endoscopic components (e.g., fiber optic light guide,
fiber optic image transmission bundle, lenses, etc.) as well as
other working elements 36. In this regard, the working device 30
may comprise an on board endoscope that is useable to view some or
all of the procedure wherein that working device 30 is employed.
Alternatively, it is to be appreciated that any working device 30
may be inserted or incorporated into an endoscope such that the
endoscope may be used to view some or all of the procedure wherein
that working device 30 is employed.
[0156] Also, in any device or system described herein, the
locations of the sensor(s) 16 and transmitter(s) 75 or transmitter
sites 73 may be switched. For example, one or more transmitter
sites 73 may be located on a transmitter equipped device (e.g., a
guidewire, tubular guide, sheath, dilation catheter or other device
having a working element as described herein) and one or more
sensors 16 may be located on a localizer apparatus 70 such as a
localizer frame or headset.
[0157] The use of the sensor equipped working devices 30 and
methods of the present invention may serve a number of purposes and
may provide a number of advantages over the prior art. For example,
the use of such image guided devices and methods may permit very
precise positioning and movement of devices within the subject's
body, thereby improving the safety of the procedure, causing less
trauma or unnecessary iatrogenic tissue modification, requiring
less use of fluoroscopy or x-ray and hence less radiation exposure
to the subject or the operator(s), etc.
[0158] It is to be further appreciated that the invention has been
described hereabove with reference to certain examples or
embodiments of the invention but that various additions, deletions,
alterations and modifications may be made to those examples and
embodiments without departing from the intended spirit and scope of
the invention. For example, any element or attribute of one
embodiment or example may be incorporated into or used with another
embodiment or example, unless to do so would render the embodiment
or example unsuitable for its intended use. All reasonable
additions, deletions, modifications and alterations are to be
considered equivalents of the described examples and embodiments
and are to be included within the scope of the following
claims.
* * * * *