U.S. patent application number 13/465757 was filed with the patent office on 2013-01-03 for swing prism endoscope.
This patent application is currently assigned to ACCLARENT, INC.. Invention is credited to Scott J. Baron, Dominick L. Gatto, Eric Goldfarb, Thomas R. Jenkins.
Application Number | 20130006055 13/465757 |
Document ID | / |
Family ID | 47391310 |
Filed Date | 2013-01-03 |
United States Patent
Application |
20130006055 |
Kind Code |
A1 |
Goldfarb; Eric ; et
al. |
January 3, 2013 |
SWING PRISM ENDOSCOPE
Abstract
A variable direction of view endoscope is positionable at
desired locations within the ear, nose, throat, paranasal sinuses
or cranium to accomplish visualization. A method of use includes
introducing the variable direction of view endoscope into a nasal
cavity with the endoscope adjusted to a first direction of view
between about 0 degrees and about 15 degrees relative to a
longitudinal axis of the endoscope. A therapeutic device is
introduced into the nasal cavity and the endoscope is adjusted to a
second direction of view directed toward the sinus opening or
passageway. The method also includes advancing the therapeutic
device into or through the sinus opening and viewing at least one
of the sinus opening or passageway or the therapeutic device using
the endoscope adjusted to the second direction of view.
Inventors: |
Goldfarb; Eric; (Belmont,
CA) ; Gatto; Dominick L.; (Fairfield, CT) ;
Jenkins; Thomas R.; (Alameda, CA) ; Baron; Scott
J.; (Menlo Park, CA) |
Assignee: |
ACCLARENT, INC.
Menlo Park
CA
|
Family ID: |
47391310 |
Appl. No.: |
13/465757 |
Filed: |
May 7, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13464180 |
May 4, 2012 |
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13465757 |
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12502101 |
Jul 13, 2009 |
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13464180 |
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61084949 |
Jul 30, 2008 |
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Current U.S.
Class: |
600/137 ;
600/160; 600/163; 600/173 |
Current CPC
Class: |
A61B 1/00066 20130101;
A61B 1/00039 20130101; A61B 1/00096 20130101; A61B 17/24 20130101;
A61B 1/00183 20130101; A61B 1/126 20130101; A61B 1/233 20130101;
A61M 29/02 20130101 |
Class at
Publication: |
600/137 ;
600/160; 600/173; 600/163 |
International
Class: |
A61B 1/233 20060101
A61B001/233; A61M 29/02 20060101 A61M029/02; A61M 25/09 20060101
A61M025/09; A61B 1/06 20060101 A61B001/06 |
Claims
1. A method for advancing a therapeutic device into or through an
opening or passageway into a paranasal sinus, the method
comprising: introducing a variable direction of view endoscope into
a nasal cavity with the endoscope adjusted to a first direction of
view between about 0 degrees and about 15 degrees relative to a
longitudinal axis of the endoscope; introducing a therapeutic
device into the nasal cavity; adjusting the endoscope to a second
direction of view directed toward the sinus opening or passageway;
advancing the therapeutic device into or through the sinus opening;
and viewing at least one of the sinus opening or passageway or the
therapeutic device using the endoscope adjusted to the second
direction of view.
2. The method of claim 1, wherein the therapeutic device comprises
a balloon dilation catheter and wherein the method further
comprises dilating a balloon of the catheter to expand the opening
or passageway into the paranasal sinus.
3. The method of claim 1, further comprising introducing a guide
catheter into the nasal cavity, wherein the therapeutic device
comprises a flexible device and advancing the therapeutic device
comprises advancing the device through a lumen of the guide
catheter into or through the paranasal sinus opening.
4. The method of claim 3, wherein the flexible device comprises a
balloon dilation catheter.
5. The method of claim 4, further comprising advancing a guidewire
through the lumen of the guide catheter and into the paranasal
sinus before advancing the balloon catheter over the guidewire and
through the guide catheter to position a balloon of the catheter in
the sinus opening.
6. The method of claim 5, wherein the guidewire comprises a lighted
guidewire having an illuminating distal end, and wherein the method
further comprises transilluminating the paranasal sinus while the
illuminating distal end is located in the sinus.
7. The method of claim 1, wherein the therapeutic device comprises
an irrigation catheter, and wherein the method further comprises
irrigating the paranasal sinus using the irrigation catheter,
wherein at least one aperture of the irrigation catheter is located
within the sinus.
8. The method of claim 1, wherein the therapeutic device comprises
a drug delivery reservoir that is implanted in at least one of the
sinus or the opening or passageway into the sinus.
9. The method of claim 1, wherein the paranasal sinus opening
comprises a maxillary sinus ostium.
10. The method of claim 1, wherein the paranasal sinus opening
comprises at least one of a frontal sinus ostium or a frontal sinus
outflow tract.
11. The method of claim 1, wherein the paranasal sinus opening
comprises a sphenoid sinus ostium.
12. The method of claim 1, wherein the paranasal sinus opening
comprises a natural or man made opening of an ethmoid sinus.
13. The method of claim 1, further comprising adjusting the
endoscope to the first direction of view or to a third direction of
view to view at least one of the therapeutic device or anatomy of
the nasal cavity.
14. A method for advancing a flexible device into an opening or
passageway into a paranasal sinus, the method comprising:
introducing a variable direction of view endoscope into a nasal
cavity with the endoscope adjusted to a first direction of view
between about 0 degrees and about 15 degrees relative to a
longitudinal axis of the endoscope; introducing a guide catheter
into the nasal cavity to position a distal tip of the catheter
within or near a paranasal sinus opening or passageway; adjusting
the endoscope to a second direction of view directed toward the
sinus opening or passageway; advancing a flexible device through a
lumen of the guide catheter and into or through the sinus opening;
and viewing at least one of the sinus opening or passageway or the
flexible device using the endoscope adjusted to the second
direction of view.
15. The method of claim 14, wherein the endoscope comprises a swing
prism endoscope, and wherein adjusting the direction of view
comprises rotating a prism of the endoscope.
16. The method of claim 14, wherein the guide catheter is
introduced before the direction of view of the endoscope is
adjusted.
17. The method of claim 14, wherein direction of view of the
endoscope is adjusted before the guide catheter is introduced.
18. The method of claim 14, wherein advancing the flexible device
comprises advancing a guidewire through a paranasal sinus ostium
into the paranasal sinus.
19. The method of claim 18, further comprising: advancing a balloon
catheter over the guidewire to position a balloon of the balloon
catheter at least partially within the sinus ostium; and expanding
the balloon to dilate the sinus ostium.
20. The method of claim 14, wherein advancing the flexible device
comprises advancing an irrigation catheter through the opening into
the paranasal sinus, the method further comprising irrigating the
paranasal sinus using the irrigation catheter.
21. The method of claim 14, wherein advancing the flexible device
comprises advancing an illuminating wire through the opening into
the paranasal sinus, the method further comprising: transmitting
light from a distal end of the illuminating wire disposed in the
paranasal sinus; and viewing the transmitted light from outside the
sinus.
22. A method for viewing anatomy in a head of a human or animal
subject, the method comprising: introducing a variable degree of
view endoscope into the subject's head with the endoscope adjusted
to a first degree of view; viewing anatomy in the head using the
endoscope with the first degree of view; rotating a first portion
of a handle of the endoscope about a longitudinal axis of the
endoscope to adjust the endoscope to a second degree of view,
wherein the first portion of the handle rotates relative to a shaft
of the endoscope; and viewing anatomy in the head using the
endoscope with the second degree of view.
23. The method of claim 22, further comprising rotating a second
portion of the handle about the longitudinal axis to rotate the
shaft of the endoscope without rotating the rest of the handle.
24. The method of claim 23, further comprising rotating the first
portion of the handle to adjust the endoscope to the first degree
of view or to a third degree of view.
25. The method of claim 22, wherein introducing the endoscope
comprises passing the endoscope into a nasal cavity, and wherein
the viewed anatomy is selected from the group consisting of nasal
cavity anatomy, an opening or passageway into a paranasal sinus
ostium, a paranasal sinus, a Eustachian tube opening, an oral
cavity, a nasopharynx, a throat, a larynx, and a trachea.
26. The method of claim 22, further comprising viewing a direction
of view indicator on the endoscope indicating the direction of view
in which the endoscope is pointing.
27. The method of claim 22, further comprising viewing at least one
medical or surgical device introduced into the subject's head.
28. A variable direction of view endoscope configured to pass into
a head of a human or animal subject, the endoscope comprising: an
elongate shaft having a proximal end, a distal end, and an outer
diameter of no more than approximately 5 mm; a viewing window
disposed along the shaft at or near its distal end; a pivotable
prism disposed in the shaft near the distal end to change a
direction of view of the endoscope; and a self-focusing lens
disposed in the shaft, configured to automatically focus the view
acquired through the viewing window as the prism pivots.
29. The endoscope of claim 28, wherein the viewing window extends
from the distal end of the shaft proximally along one side of the
shaft.
30. The endoscope of claim 28, wherein a field of view of the
endoscope is between approximately 60 degrees and approximately 70
degrees.
31. The endoscope of claim 28, wherein the endoscope is compatible
with 300 Watt Xenon light sources.
32. A variable direction of view endoscope configured to pass into
a head of a human or animal subject, the endoscope comprising: an
elongate shaft having a proximal end, a distal end, and an outer
diameter of no more than approximately 5 mm; a viewing window
disposed along the shaft at or near its distal end; a pivotable
prism disposed in the shaft near the distal end to change a
direction of view of the endoscope; and a handle coupled with the
proximal end of the elongate shaft, wherein the handle comprises a
first rotating dial for adjusting the viewing angle of the
endoscope by pivoting the prism, wherein the first rotating dial
rotates about a longitudinal axis of the shaft.
33. The endoscope of claim 32, wherein the handle further comprises
a second rotating dial for rotating the shaft of the endoscope
without rotating the rest of the handle.
34. The endoscope of claim 33, wherein the first and second dials
are sealed to allow the endoscope to be sterilized in an autoclave
without damaging the endoscope.
35. The endoscope of claim 32, further comprising a self-focusing
lens disposed in the shaft, configured to automatically focus the
view acquired through the viewing window as the prism pivots.
36. The endoscope of claim 32, wherein the viewing window extends
from the distal end of the shaft proximally along one side of the
shaft.
37. The endoscope of claim 32, wherein a field of view of the
endoscope is between approximately 60 degrees and approximately 70
degrees.
38. The endoscope of claim 32, wherein a direction of view of the
endoscope ranges from between about 0 degrees to about 120
degrees.
39. The endoscope of claim 38, wherein a field of view of the
endoscope ranges from between about 5 degrees to about 100
degrees.
40. The endoscope of claim 32, wherein the endoscope is compatible
with 300 Watt Xenon light sources.
41. The endoscope of claim 32, further comprising a handle
attachment for facilitating holding the handle.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of application
Ser. No. 13/464,180, filed May 4, 2012, which is a
continuation-in-part of application Ser. No. 12/502,101, filed Jul.
13, 2009, now abandoned, which claims the benefit of Provisional
Application Ser. No. 61/084,949, filed Jul. 30, 2008, the contents
of which are incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical apparatus
and methods and more particularly to devices and methods to
facilitate endoscopic viewing within the ear, nose, throat,
paranasal sinuses or cranium.
BACKGROUND
[0003] Functional endoscopic sinus surgery (FESS) is currently the
most common type of surgery used to treat chronic sinusitis. In a
typical FESS procedure, an endoscope is inserted into the nostril
along with one or more surgical instruments. The surgical
instruments are then used to cut tissue and/or bone, cauterize,
suction, etc. In most FESS procedures, the natural ostium (e.g.,
opening) of at least one paranasal sinus is surgically enlarged to
improve drainage from the sinus cavity. The endoscope provides a
direct line-of-sight view whereby the surgeon is typically able to
visualize some but not all anatomical structures within the
surgical field. Under visualization through the endoscope, the
surgeon may remove diseased or hypertrophic tissue or bone and may
enlarge the ostia of the sinuses to restore normal drainage of the
sinuses. FESS procedures can be effective in the treatment of
sinusitis and for the removal of tumors, polyps and other aberrant
growths from the nose.
[0004] The surgical instruments used in prior art FESS procedures
have included applicators, chisels, curettes, elevators, forceps,
gouges, hooks, knives, saws, mallets, morselizers, needle holders,
osteotomes, ostium seekers, probes, punches, backbiters, rasps,
retractors, rongeurs, scissors, snares, specula, suction cannulae
and trocars. The majority of such instruments are of substantially
rigid design.
[0005] In order to adequately view the operative field through the
endoscope and/or to allow insertion and use of rigid instruments,
many FESS procedures of the prior art have included the surgical
removal or modification of normal anatomical structures. For
example, in many prior art FESS procedures, a total uncinectomy
(e.g., removal of the uncinate process) is performed at the
beginning of the procedure to allow visualization and access of the
maxilary sinus ostium and/or ethmoid bulla and to permit the
subsequent insertion of the rigid surgical instruments. Indeed, in
most traditional FESS procedures, if the uncinate process is
allowed to remain, such can interfere with endoscopic visualization
of the maxillary sinus ostium and ethmoid bulla, as well as
subsequent dissection of deep structures using the available rigid
instrumentation.
[0006] More recently, new devices, systems and methods have been
devised to enable the performance of FESS procedures and other ENT
surgeries with minimal or no removal or modification of normal
anatomical structures. Such new methods include, but are not
limited to, uncinate-sparing procedures using Balloon
Sinuplasty.TM. tools and uncinate-sparing ethmoidectomy procedures
using catheters, non-rigid instruments and advanced imaging
techniques (Acclarent, Inc., Menlo Park, Calif.). Examples of these
new devices, systems and methods are described in incorporated U.S.
patent application Ser. Nos. 10/829,917, entitled Devices, Systems
and Methods for Diagnosing and Treating Sinusitis and Other
Disorders of the Ears, Nose and/or Throat; 10/944,270, entitled
Apparatus and Methods for Dilating and Modifying Ostia of Paranasal
Sinuses and Other Intranasal or Paranasal Structures; 11/116,118,
entitled Methods and Devices for Performing Procedures Within the
Ear, Nose, Throat and Paranasal Sinuses; and 11/150,847, entitled
Devices, Systems and Methods Useable for Treating Sinusitis, each
of which is hereby incorporated herein, in its entirety. Procedures
using Balloon Sinuplasty.TM. tools, such as those described in the
above-noted applications, for example, may be performed using
various types of guidance, including but not limited to C-arm
fluoroscopy, transnasal endoscopy, optical image guidance and/or
electromagnetic image guidance.
[0007] In FESS and Balloon Sinuplasty.TM. procedures, the surgeon
typically holds an endoscope with one hand while using the other
hand to manipulate surgical instruments. Recognizing the
desirability of integrating an endoscope with an operative device
so that both could be moved with a single hand, application Ser.
No. 11/193,020, entitled Methods and Apparatus for Treating
Disorders of the Ear, Nose and Throat (hereby incorporated by
reference) describes a number of transnasally insertable sinus
guides coupled or integrated with endoscopes.
[0008] Currently available endoscopes used in ear, nose and throat
procedures are generally rigid endoscopes that view in only one
direction--i.e., either straight ahead or at a fixed angle. At the
same time, the nasal/paranasal anatomy is one of many folded and
curved structures made of bone covered with soft tissue, thus often
making it very challenging to advance and view anatomy with a rigid
unidirectional endoscope. For example, it may be quite challenging
to advance an endoscope into the nose and around the uncinate
process to view the ostium of the maxillary sinus. In fact, this is
at least one reason why the uncinate process is removed in
traditional FESS procedures. Although angled endoscopes are
available, to view the anatomy as desired a surgeon may often need
to use multiple different endoscopes during a procedure, switching
between endoscopes as different views are desired. This can be
quite awkward and cumbersome as well as expensive.
[0009] Therefore, there is a need for new devices and methodology
to facilitate endoscopic viewing of anatomy, guidewires, catheters
and/or other devices in intracranial procedures, such as ear, nose
and throat procedures like paranasal sinus surgery. Ideally, such
devices and methods would involve direct viewing of anatomy and
surgical tools using an endoscope. Also ideally, such an endoscope
would be easy to manipulate and use and would be compatible with a
variety of surgical tools and systems. At least some of these
objectives will be met by the embodiments of the present
invention.
SUMMARY
[0010] Various embodiments are directed to a variable direction of
view, swing prism endoscope for use in ear, nose, throat and
possibly other intracranial procedures. Such an endoscope is useful
when the axis of movement is at an angle with respect to the
working or interventional site. The scope allows the user to view
anatomy, such as a paranasal sinus ostium, without using/exchanging
multiple endoscopes during a procedure or removing tissue as may be
required in a traditional FESS procedure. Such a scope may also
allow a physician to view anatomy and surgical tools without using
fluoroscopy or image guidance systems, or at least with limited use
of such systems, so that a procedure might be performed in a clinic
or procedure room setting rather than in an operating room.
Eliminating the use of fluoroscopy during a Balloon Sinuplasty.TM.
or other ear, nose and throat procedure makes such a procedure more
convenient for the physician, as a C-arm fluoroscope is not
required in the operating room or procedure room. Eliminating or
reducing the use of fluoroscopy may also be advantageous for
physician and patient because they both receive less (or no)
radiation dose.
[0011] One embodiment includes a method for advancing a therapeutic
device into or through an opening or passageway into a paranasal
sinus. The paranasal sinus opening may include a maxillary sinus
ostium, at least one of a frontal sinus ostium or a frontal sinus
outflow tract, a sphenoid sinus ostium, or a natural or man made
opening of an ethmoid sinus. The method includes introducing a
variable direction of view endoscope into a nasal cavity with the
endoscope adjusted to a first direction of view between about 0
degrees and about 15 degrees relative to a longitudinal axis of the
endoscope. A therapeutic device is introduced into the nasal cavity
and the endoscope is adjusted to a second direction of view
directed toward the sinus opening or passageway. The method also
includes advancing the therapeutic device into or through the sinus
opening and viewing at least one of the sinus opening or passageway
or the therapeutic device using the endoscope adjusted to the
second direction of view.
[0012] In one embodiment, the therapeutic device used in this
procedure includes a balloon dilation catheter and a balloon of the
catheter is dilated to expand the opening or passageway into the
paranasal sinus. The method may also include introducing a guide
catheter into the nasal cavity. Introduction of the guide catheter
may occur before the direction of view of the endoscope is
adjusted. However, the direction of view of the endoscope may be
adjusted before the guide catheter is introduced.
[0013] The therapeutic device may include a flexible device.
Further, the therapeutic device may be advanced through a lumen of
the guide catheter into or through the paranasal sinus opening. A
guidewire may also be advanced through the lumen of the guide
catheter and into the paranasal sinus before advancing the balloon
catheter over the guidewire and through the guide catheter to
position a balloon of the catheter in the sinus opening. In one
embodiment, the guidewire may be a lighted guidewire having an
illuminating distal end, and the lighted guidewire is used for
transilluminating the paranasal sinus while the illuminating distal
end is located in the sinus.
[0014] In one embodiment of the method for treating a paranasal
sinus, the therapeutic device includes an irrigation catheter, and
the paranasal sinus is irrigated using the irrigation catheter when
at least one aperture of the irrigation catheter is located within
the sinus. The therapeutic device may also include a drug delivery
reservoir that is implanted in at least one of the sinus or the
opening or passageway into the sinus.
[0015] Further, during the procedure, the endoscope may be adjusted
to the first direction of view or to a third direction of view to
view at least one of the therapeutic device or anatomy of the nasal
cavity.
[0016] In another embodiment, the endoscope includes a swing prism
endoscope. In this embodiment, adjusting the direction of view
includes rotating a prism of the endoscope.
[0017] Another embodiment includes a method for viewing anatomy in
a head of a human or animal subject by introducing a variable
degree of view endoscope into the subject's head with the endoscope
adjusted to a first degree of view. Also, the anatomy in the head
is viewed using the endoscope with the first degree of view, and a
first portion of a handle of the endoscope is rotated about a
longitudinal axis of the endoscope to adjust the endoscope to a
second degree of view. The first portion of the handle rotates
relative to a shaft of the endoscope. Also, the anatomy in the head
is viewed using the endoscope with the second degree of view. The
method may include rotating a second portion of the handle about
the longitudinal axis to rotate the shaft of the endoscope without
rotating the rest of the handle. Also, rotating the first portion
of the handle adjusts the endoscope to the first degree of view or
to a third degree of view.
[0018] In one embodiment, the step of introducing the endoscope
includes passing the endoscope into a nasal cavity. Once the
endoscope has been introduced into the nasal cavity, the viewed
anatomy may consist of the nasal cavity anatomy, an opening or
passageway into a paranasal sinus ostium, a paranasal sinus, a
Eustachian tube opening, an oral cavity, a nasopharynx, a throat, a
larynx, and a trachea.
[0019] A physician or user may view a direction of view indicator
on the endoscope indicating the direction of view in which the
endoscope is pointing. The user may also view at least one medical
or surgical device introduced into the subject's head with the
endoscope.
[0020] One embodiment of a variable direction of view endoscope
configured to pass into a head of a human or animal subject is also
disclosed. The endoscope includes an elongate shaft having a
proximal end, a distal end, and an outer diameter of no more than
approximately 5 mm. A viewing window is disposed along the shaft at
or near the endoscope's distal end, and a pivotable prism is
disposed in the shaft near the distal end to change a direction of
view of the endoscope. The viewing window extends from the distal
end of the shaft proximally along one side of the shaft. There may
also be a handle coupled with the proximal end of the elongate
shaft. The handle includes a first rotating dial for adjusting the
viewing angle of the endoscope by pivoting the prism, and the first
rotating dial rotates about a longitudinal axis of the shaft. The
handle may further include a second rotating dial for rotating the
shaft of the endoscope without rotating the rest of the handle. In
certain embodiments, the first and second dials are sealed to allow
the endoscope to be sterilized in an autoclave without damaging the
endoscope.
[0021] Also, the endoscope may include a self-focusing lens
disposed in the shaft, configured to automatically focus the view
acquired through the viewing window as the prism pivots.
[0022] A field of view of the endoscope is between approximately 60
degrees and approximately 70 degrees or from about 5 degrees to
about 100 degrees. Also, a direction of view of the endoscope
ranges from between about 0 degrees to about 120 degrees. In use,
the endoscope is compatible with 300 Watt Xenon light sources.
Also, the endoscope may include a handle attachment attached to the
handle for facilitating holding the handle.
[0023] Further aspects, elements and advantages of the present
invention will be described in further detail below in reference to
the attached drawing figures. Although the various embodiments will
typically be described in the context of paranasal sinus surgical
procedures, in many embodiments the devices, systems and method
described herein may be used in other ear, nose and throat
procedures and/or in other intracranial procedures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 depicts a perspective view of a swing prism endoscope
according to one embodiment of the present invention;
[0025] FIG. 2 depicts a side view, depicting viewing ranges of an
endoscope equipped with a swing prism, according to one embodiment
of the present invention;
[0026] FIG. 3 depicts a cross-sectional view of a distal end of a
swing prism endoscope, according to one embodiment of the present
invention;
[0027] FIG. 4 depicts a cross-sectional view of a distal end of a
swing prism endoscope, according to one embodiment of the present
invention;
[0028] FIG. 5 is a cross-sectional view of a distal end of a swing
prism endoscope, according to yet another embodiment of the present
invention;
[0029] FIG. 6 depicts a side view of a proximal body member or
handle of a swing prism endoscope equipped with turning dials to
control the rotation of the endoscope shaft and rotation of the
swing prism;
[0030] FIGS. 7-9 depict three different embodiments of a handle
that can be attached to the handle of the swing prism
endoscope;
[0031] FIG. 10 depicts a cross-sectional view of the handle of a
swing prism endoscope showing a sealed chamber and a driving
mechanism using bellows to control the rotation of the swing
prism;
[0032] FIGS. 11 and 12 depict a washing system disposed over a
swing prism endoscope in a resting state;
[0033] FIG. 13 depicts the washing system shown in FIGS. 11 and 12
in a forward position or activated state;
[0034] FIG. 14 depicts viewing angles of a typical endoscope having
a flexible or steerable shaft;
[0035] FIG. 15 depicts viewing angles of a swing prism endoscope
having a flexible or steerable shaft;
[0036] FIG. 16 depicts a reduced number of optical fibers that
lapped at various angles to create a wider illuminating field;
[0037] FIG. 17 depicts a divergent lens positioned at a distal end
of optical fibers to create a wider illuminating beam;
[0038] FIG. 18 depicts a partial view of a miniaturized endoscope
having first and second prisms and a divergent lens to increase the
field of view;
[0039] FIG. 19 depicts a partial view of a miniaturized endoscope
having a first prism and a divergent lens to increase the field of
view;
[0040] FIG. 20 depicts a partial view of a miniaturized endoscope
having first and second prisms and using a divergent lens in
combination with a concave lens to increase the field of return
image capture;
[0041] FIG. 21 depicts a partial view of a miniaturized endoscope
having a first prism and using a divergent lens in combination with
two concave lenses to increase the field of return image
capture;
[0042] FIG. 22A depicts an embodiment of an endoscope having a
handle with an open configuration;
[0043] FIG. 22B depicts an embodiment of an endoscope without a
light post on a handle;
[0044] FIG. 23 depicts a cross-sectional view of handle of an
endoscope that includes ferric fluid seals;
[0045] FIG. 24A depicts a swing prism endoscope introduced into a
nostril of a human or animal subject, according to one embodiment
of the present invention;
[0046] FIG. 24B depicts the endoscope of FIG. 24A advanced farther
into the paranasal anatomy, with the swing prism adjusted to view
at an angle relative to the longitudinal axis of the swing prism
scope;
[0047] FIG. 25A-25D depict partial sagittal sectional views through
a human head showing various steps of a method of using a swing
prism scope to view and facilitate accessing a paranasal sinus
using a sinus guide, according to one embodiment of the present
invention;
[0048] FIG. 26 depicts a perspective view of one embodiment of a
guide system;
[0049] FIG. 27 depicts a perspective view of the guide system in
use on a human subject;
[0050] FIG. 28A depicts a side view of the guide catheter of the
system of FIG. 26.
[0051] FIG. 28B depicts a cross sectional view through line 28B-28B
of FIG. 28A;
[0052] FIG. 28C depicts a cross sectional view through line 28C-28C
of FIG. 28A; and
[0053] FIG. 29 depicts a side view of the connector/camera/light
cable assembly of the system of FIG. 26.
DETAILED DESCRIPTION
[0054] In the following description, where a range of values is
provided, each intervening value, to the tenth of the unit of the
lower limit unless the context clearly dictates otherwise, between
the upper and lower limits of that range is also specifically
disclosed. Each smaller range between any stated value or
intervening value in a stated range and any other stated or
intervening value in that stated range is encompassed within the
invention. The upper and lower limits of these smaller ranges may
independently be included or excluded in the range, and each range
where either, neither or both limits are included in the smaller
ranges is also encompassed within the invention, subject to any
specifically excluded limit in the stated range. Where the stated
range includes one or both of the limits, ranges excluding either
or both of those included limits are also included in the
invention.
[0055] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this disclosure belongs.
Although any methods and materials similar or equivalent to those
described herein can be used in the practice or testing of the
present disclosure, the preferred methods and materials are now
described. All publications mentioned herein are incorporated
herein by reference to disclose and describe the methods and/or
materials in connection with which the publications are cited.
[0056] As used herein and in the appended claims, the singular
forms "a", "an", and "the" include plural referents unless the
context clearly dictates otherwise. Thus, for example, reference to
"a channel" includes a plurality of such channels and reference to
"the endoscope" includes reference to one or more endoscopes and
equivalents thereof, and so forth.
[0057] The publications discussed herein are provided solely for
their disclosure prior to the filing date of the present
application. Nothing herein is to be construed as an admission that
the present disclosure is not entitled to antedate such publication
by virtue of prior invention. Further, the dates of publication
provided may be different from the actual publication dates which
may need to be independently confirmed.
[0058] The following detailed description, the accompanying
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 disclosure. The contents of this detailed
description do not limit the scope of the disclosure in any
way.
[0059] FIG. 1 shows a variable degree of view endoscope 10
according to one embodiment. The endoscope 10 may include an
elongate shaft 30 with a distal end 70 and a proximal end 71, the
latter being attached to a proximal body member or handle 52 that
can be adapted to engage and attach to the adjustable scope/lock
extension, and a swing prism (not shown, but described in relation
to FIG. 3 et seq. below) for adjusting the viewing angle of the
endoscope 10. The shaft 30 may house an image fiber bundle or optic
fibers 54 that extends coaxially through its center, with light
transmitting fibers 56 disposed about the periphery. In one
embodiment, the shaft 30 may be a braided polyimide sheathing that
has a maximum outer diameter of 0.0375 inches and a length of two
feet. Preferably, the image fiber bundle is made up of 10,000 thin
image fibers, and the light transmitting fibers are illumination
fibers with a diameter of between about 0.008 and 0.020 inches,
with a minimum lux of about 10,000. In another embodiment, the
endoscope 10 may use rod lens technology instead of using image
fiber bundles.
[0060] Referring now to FIG. 2, the distal end 70 of the endoscope
shaft 30 is shown with angular measurements according to one
embodiment. In describing FIG. 2, "field of view" means the angular
width/height viewed at any one time via the endoscope, "direction
of view" means the direction in which the center of view is
pointing at any one time (also can be called the "degree of view"
as in "variable degree of view endoscope") and "total range of
view" means the total angular distance across which the endoscope
can view when the swing prism is moved from one extreme direction
of view to the opposite extreme direction of view. The angles
referred to are in relation to the longitudinal axis of the
endoscope shaft 30, which is the zero angle.
[0061] In some embodiments, for example, the endoscope 10 may have
a range of directions of view from about -5.degree. to about
150.degree. and more likely from about 0.degree. to about
120.degree. or from about 5.degree. to about 100.degree.. In some
embodiments, the endoscope may have a field of view from about
50.degree. to about 100.degree. or more likely from about
60.degree. to about 70.degree.. From the ranges of the directions
of view and the fields of view, the total ranges of view may be
determined. For example, in one embodiment the endoscope 10 may
have directions of view ranging from about 5.degree. to about
100.degree. and may have a field of view of about 60.degree.. In
this embodiment, the total range of view would be from about
-25.degree. to about 130.degree.. If the ranges of directions of
view were instead from about 0.degree. to about 120.degree. and the
field of view were about 60.degree., then the total range of view
would be from about -30.degree. to about 150.degree.. In various
embodiments, the endoscope 10 may have any of a number of different
combinations and ranges of directions of view, fields of view and
total ranges of view.
[0062] Referring now to FIGS. 3-5, various configurations distal
portions 70 of the variable degree of view endoscope 10 are shown,
each having different configurations of a swing prism 72 and/or
mechanisms for mounting a swing prism 72. In a first approach, the
swing prism 72 is mounted for rotation between a biasing spring 76
and an actuator 78. Here, the actuator 78 can come in the form of a
wire which extends from the distal portion 70 of the endoscope 10
to a proximal portion which is conveniently accessible and
manipulatable by an operator. In this regard, the actuator can be
attached to a sliding member or configured to be taken up by a
rotating dial (not shown). As so configured, images can be captured
and received through a window 75 and transmitted through the swing
prism 72 and self-focusing lens 74 to the image fiber bundle 54.
The swing prism 72 provides the desired seventy degree field of
view throughout a viewing range of zero degrees to ninety five
degrees by manipulating the actuator 78.
[0063] In another approach shown in FIG. 4, the swing prism 72 can
be mounted in a housing 82 placed in operative association with a
rotatable shaft 84 which extends proximally to an operator. A
distal portion of the shaft 84 is provided with threaded structure
86 arranged to engage teeth 88 formed on the housing 82. Rotating
the shaft accomplishes positioning the swing prism 72 as desired.
Again, these components can be arranged to provide a one hundred
sixty five degree range of viewing.
[0064] In an approach shown in FIG. 5, the swing prism 72 is
mounted for rotation between a torsion spring 100 and a pull wire
102. The torsion spring can be any spring, such as an extension
spring, leaf spring, or the like. Here, the pull wire 102 may
extend from the distal portion 70 of the endoscope shaft 30 to a
proximal portion which is conveniently accessible and manipulatable
by an operator. In this regard, the pull wire can be attached to a
sliding member or configured to be taken up by a rotating dial.
Images can be captured and received through the window (not shown)
and transmitted through the swing prism 72 and self-focusing lens
74 to the image fiber bundle 54. In this embodiment, there is
always tension on swing prism between the torsion spring and pull
wire, so there is no lag or buckling in the pull wire during
operation. Further, use of the pull wire and torsion spring to move
the swing prism allows the diameter of the endoscope to be
smaller.
[0065] The images collected by the image fiber bundle 54 can be
transmitted to a monitor (described below) to thereby provide the
operator with visual data concerning the particular interventional
procedure being performed. In one embodiment, the endoscope 10 be
compatible with a 300 Watt Xenon source and be configured with a
universal light guide connector, thus making the assembly useable
with conventionally available devices. In one embodiment, the
endoscope shaft 30 may have an outer diameter of approximately 4 mm
and a working length of about 175 mm. Moreover, the endoscope shaft
30 is preferably provided with rounded surfaces thus making the
assembly atraumatic in use. It has also been found useful to
construct the endoscope 10 in a manner and embodying material which
permit the endoscope 10 to be sterilized using an autoclave.
[0066] In certain approaches, it may be useful to configure the
endoscope 10 with indicia indicating the direction of view of the
swing prism and/or a rotational position of the endoscope 10. Thus,
a proximal portion of the actuator 78 of FIG. 3, for example, can
be coupled with a dial which includes markings indicative of the
angle of the swing prism 72. Similarly, a proximal end of the shaft
84 of FIG. 4 can be attached to a dial including indicia providing
information relative to the angle of the swing prism 72. Moreover,
the external surface of the endoscope 10 can include marking
indicators rotational positioning of the overall assembly.
[0067] The swing prism endoscope 10 may be freely advanced within
anatomy along with a sinus guide in order to facilitate endoscopic
viewing of the desired anatomical structures and/or to view, guide
and/or verify the positioning of the sinus guide device or a
working device that has been inserted through the sinus guide. The
ability to advance the tip of the endoscope 10 within anatomy to
view the end of the sinus guide allows the devices to be positioned
closer to anatomy or to reach spaces in the paranasal sinuses that
the devices cannot travel due to size constraints.
[0068] As discussed above with reference to FIGS. 3 through 5, the
rotation of the swing prism may be controlled by a dial. As shown
in FIG. 6, a proximal dial 104 is disposed on the handle 52 of the
endoscope 10 for controlling the rotation of the swing prism. The
proximal dial 104 has a circular configuration and includes ridges
106 that provide leverage for turning the proximal dial or dial to
a desired position. Further, the ridges provide a tactile feel for
the dial location and grooves 108 between the ridges provide an
area for the user's fingers to rest. In one embodiment, there are
eight ridges evenly placed around the proximal dial 104, however,
there may be fewer or more ridges placed around the dial. The
height of the ridges is approximately 0.05 inches, and can be
increased or decreased depending on user preferences. Also, the
spacing between each ridge is approximately 0.228 inches, and can
be increased or decreased depending on the number of ridges
disposed on the dial and the width of the ridges.
[0069] Still referring to FIG. 6, the handle 52 of the endoscope
may include indicia 107 adjacent the proximal dial 104 to provide
information relative to the angle of the swing prism 72. In this
embodiment, there is also a marker 108 on the proximal dial itself
indicating the relative angle of the swing prism 72. As shown, the
indicia 107 adjacent the proximal dial indicate the relative angle
of the swing prism 72 anywhere from 0 degrees to 180 degrees.
[0070] In one embodiment, a distal dial or shaft dial 110 is
disposed on the handle 52 of the endoscope as shown in FIG. 6, and
the shaft dial 110 controls rotation of the endoscope shaft 30. A
marker 112 is shown on the shaft dial 110 to indicate the relative
position of the endoscope shaft 30. More particularly, the marker
112 on the shaft dial indicates the relative position of the window
75 (see FIG. 3) at the distal portion 70 of the endoscope 10. As
shown in FIG. 6, since the marker 112 is on the top side of the
endoscope, the window 75 is also pointing towards the top side of
the endoscope 10, allowing the endoscope 10 to view the
surroundings in the same general direction. Rotating the shaft dial
110 allows the endoscope to view its surroundings in a full
three-hundred and sixty degrees of rotation. Having a rotating
shaft dial 110 that rotates the endoscope shaft 30 without rotating
the entire handle 52 may be advantageous because it allows for
rotation of the endoscope shaft 30 without rotating the light post
109.
[0071] FIG. 7 shows a handle attachment 114 attached to the handle
52 of the endoscope 10. The handle attachment 114 facilitates
turning the dials 104 and 110 while the user is holding the
endoscope 10. The handle attachment 114 is affixed to the handle 52
and/or may be snap fit onto the light post 109 stemming from the
handle 52. A light post portion 116 of the handle attachment 114
snaps onto the light post 109 and shields the user from the heat
radiating from the light post 109. When holding the handle
attachment 114 and endoscope 10, the crook between the user's thumb
and extended index finger is positioned at the curve 118 under the
light post portion 116 of the handle while the palm of the user's
hand rests on the body 120 of the handle attachment 114. The handle
attachment 114 may provide the user with comfort and balance while
holding the endoscope and may also provide additional torque to
turn the dials 104 and 110. Holding the endoscope 10 with the
handle attachment 114 allows the user to turn the proximal dial 104
with the thumb and index fingers, and the distal dial 110 can be
accessed with the ring or pinkie finger.
[0072] Another embodiment of a wrap-around handle attachment 122
that is snap-fit onto the handle 52 of the endoscope is shown in
FIG. 8. The wrap-around handle attachment 122 allows the user to
grip the endoscope tightly without impinging the rotation of the
dials 104 and 110. A handle attachment back 124 is designed to be
relatively long and rounded to fit a variety of positions within
the palm of the user. With a light post cut out 126, the handle
attachment 122 can be moved or positioned around the handle 52
about two hundred and seventy degrees to facilitate a variety of
holds by the user. The handle attachment 122 includes an opening
128 that allows the handle attachment 122 to more than half-way
overlap the dials and handle 52 of the endoscope 10 while still
allowing access to the dials 104 and 110.
[0073] Yet another embodiment of a handle attachment 130, including
legs 132 that snap-fit onto the handle 52 of the endoscope 10, is
shown in FIG. 9. Handle attachment 130 includes a back 134 that
fits against the user's palm and a dial cover 136 that extends over
the proximal dial 104. A light post slot 138 can also be seen in
FIG. 9 to accommodate the light post 109. The user is allowed to
freely engage the dials 104 and 110 with his fingers when holding
the endoscope 10 with the handle 130.
[0074] The optical fibers 54 of the endoscope 10 may be enclosed in
a sealed chamber to allow the endoscope to be autoclaved.
[0075] In another embodiment shown in FIG. 10, a middle bellow
joint 154 is attached to the housing 142 and is controlled in
longitudinal motion by the proximal dial 104 which drives a screw
mechanism. The pin 144 attached to the proximal dial extends into
the handle 52 and through the curved slot disposed in the housing
142. There is also a proximal bellow joint 156 and a distal bellow
joint 158 that are fixed within the endoscope on an inner shield
160, and there are flexible bellows 162 that are disposed between
the bellow joints 154, 156, and 158. As the proximal dial 104 is
turned, the pin moves along the curved slot and moves the housing
142 in a proximal or distal direction along the longitudinal axis
of the endoscope and moves the middle bellow joint. As the middle
bellow joint moves forwards and backwards, it drives the swing
prism by moving the push/pull mechanism 152 that is attached to the
middle bellow joint. The inner shield 160 creates the sealed
chamber 151 for the optical fibers 54. The push/pull mechanism may
be an actuator, pull wire, bar, hypotube, or the like, that is
attached to the swing prism. In this embodiment, the bellow joints
can easily transmit torque for rotation of a hypotube or rotatable
shaft that can be attached to the middle bellow joint 154.
[0076] In one embodiment, the endoscope 10 is a re-usable
instrument. Conventionally, endoscopes are processed between uses
via steris, autoclave or other known processes. The time required
to process the endoscope can be significant, resulting in delays
between cases or the need to purchase multiple endoscopes for
procedures occurring one after the other. One embodiment includes a
disposable sterile sleeve 164 (see FIG. 1) that is used with the
endoscope 10. The sterile sleeve is low-profile and optically clear
at the distal tip to allow viewing with the prism. The sterile
sleeve spans the full length of the endoscope that is inserted into
the patient for the procedure so that there is no direct contact
between the patient and the endoscope. Also, the sterile sleeve may
cover the proximal end of the endoscope and camera so there is no
direct contact between the user and the endoscope. Once a procedure
is complete, the user simply removes and discards the sterile
sleeve and then inserts a new sterile sleeve over the endoscope for
the next case. Using the sterile sleeve may eliminate the need to
process the endoscope between cases or in the office
environment.
[0077] During case procedures, endoscopes have the tendency to lose
visual clarity because of the debris, blood, and/or mucus adhering
to the distal tip of the endoscope. Conventionally, surgeons or
users remove the endoscope from the patient frequently to clean the
distal tip of the endoscope. Alternatively, some surgeons use scope
washing systems having an open sheath over the endoscope shaft to
deliver fluid and/or vacuum to enable in situ cleaning. Each
washing sheath is specifically designed for the endoscope geometry,
and because endoscope distal tip geometries vary by viewing angles,
there are also multiple cleaning sheaths that must be
correspondingly used. Therefore, when a user wants to change the
scope viewing angle during a procedure, the washing sheath must
also be changed. In one embodiment described below, a washing
system and sheath is used with the endoscope 10. As described
above, the geometry of the endoscope 10 does not change when the
direction of the desired view changes, and therefore, a single
fixed sheath may be used with the swing prism endoscope described
herein.
[0078] A washing system 168 is shown disposed on the endoscope 10
in FIGS. 11 through 13. The washing system includes a button 170
positioned between first and second cones 172 and 174. The first
and second cones 172, 174 are connected together by a spring 176
(FIG. 12). In this embodiment, the first cone 172 is fixed to the
endoscope and the second cone 174 is connected to a wiping sheath
178. A distal end of the wiping sheath includes a cloth 180, which
may be a hydrophilic elastomer. As shown in FIGS. 11 and 12, the
washing system 168 is in its resting state, with the extension
spring 176 in a drawn state and the first and second cones at a
minimum distance from one another. In the resting state, the cloth
180 is positioned proximal to the lens 75 of the endoscope as shown
in FIG. 11.
[0079] To move the washing system 168 forward to clean the lens 75
of the endoscope, the button 170 is pushed, such that it moves off
the central axis of the endoscope in any direction. This movement
of the button causes the second cone 174 to move forward since the
first cone 172 is fixed to the endoscope. Driving the second cone
174 forward or in the distal direction causes the wiping sheath 178
to also move forward and push the cloth 180 over the lens 75 since
it is attached to the second cone. The activated state of the
washing system is shown in FIG. 13. The cloth 180 is elastomeric,
and therefore, it conforms to the shape of the lens 75 and wipes
any debris, mucus, and/or blood off of the lens. The porous
hydrophilic cloth also absorbs any fluid which has collected on the
lens. Once the button 170 is released, the spring recoils and draws
the cloth back over the lens into a position proximal to the
lens.
[0080] In one embodiment, the cloth 180 may have a supporting
structure, such as, rods, mesh, or the like, to prevent the cloth
from bunching or folding up when the cloth is pushed forward in the
distal direction. Also, it has been contemplated that the leading
distal edge of the cloth 180 may be silicone, rubber or some other
hydrophilic material to wipe the fluid forward (distally) from the
lens 75. The leading distal edge of the cloth may also have
multiple slits cut into it to help wipe or push debris off of the
lens.
[0081] In the embodiment described above, the endoscope 10 may have
a relatively rigid shaft. However, it has been contemplated that
the shaft of the endoscope 10 may also be flexible to greatly
enhance the viewing area of the endoscope. As shown in FIG. 14, a
typical endoscope is shown that can visualize a fixed area A or B
at any position within the flexible range of the typical endoscope.
One embodiment of the current invention, shown in FIG. 15, can
visualize a much larger range A' or B' by modifying the flex or
position of the swing prism within the endoscope 10. It is
contemplated that a flexible endoscope can be constructed with
fiber scope or video chip technology. Such flexible endoscope may
be useful for intra nasal, intra sinus, skull bass, laryngeal,
orthopaedic, abdominal and other surgeries where a variable and
large viewing range is desired.
[0082] In one embodiment, the endoscope 10 uses rod lens technology
to acquire and transfer images along the shaft of the endoscope. In
another embodiment, video chip technology as understood in the art
requires rigidity around the distal portion of the endoscope and
the images are transferred over a wire that enables the shaft of
the endoscope to be downsized. Acquisition of the image via video
chip technology may also allow the diameter of the distal portion
of the endoscope to be downsized, without compromising the quality
of the image or the size of the image that is viewed by the user.
Current video chip technology requires the distal end of the
endoscope to have a minimum diameter of about 1.2 mm to about 1.8
mm. With the addition of illumination fibers and mechanics for the
swing prism, an endoscope using video chip technology may be
constructed with a diameter at the distal portion of the endoscope
of less than 4 mm.
[0083] Certain embodiments are disclosed herein that increase the
field of illumination and increase the field of image capture after
miniaturizing an endoscope, such as the swing prism endoscope. When
an endoscope is reduced in size or miniaturized, the number of
optical fibers is decreased, thereby reducing the field of
illumination utilizing such optical fibers. Also, miniaturizing an
endoscope reduces the field of image capture due to the smaller
size of optical components for the return image. As shown in FIG.
16, one embodiment of a miniaturized endoscope includes optical
fibers 182 lapped at various angles from about 0 degrees to about
30 degrees. In this embodiment, the optical fibers can be arranged
with such angles increasing from a chosen interior fiber 182a to
the outer or edge fibers 182b, and thereby, creating a wider
illuminating field A.
[0084] In another embodiment shown in FIG. 17, a diverging lens 184
can be disposed at the end of the optical fibers 182 to create a
wider illuminating beam B. In this embodiment, the optical fibers
are lapped at about 0 degrees; however, the diverging lens can be
combined with lapped optical fibers similar to those shown in FIG.
16 to amplify the divergence of the illuminating beam. The
diverging or expansion lens can be fabricated from a block of glass
with the required curvature for beam divergence and then parted by
using a saw or high pressure water jet to minimize edge defects.
The non-functional sides of the individual diverging lens could be
coated with nickel or gold to reduce optical leakage by creating
internally reflective surfaces. It is noted that the input power to
the optical fibers of a miniaturized endoscope can be increased to
match the illumination intensity of a standard endoscope.
[0085] To maintain or improve the field of view captured by a
return beam through a prism, a divergent lens may be used on a
miniaturized endoscope. As shown in FIG. 18, the miniaturized
endoscope includes a first prism 186 and a second prism 188
contacting the first prism. There is also a divergent lens 184
disposed on the second prism 188 which increases the field of view
C. FIG. 19 shows a miniaturized endoscope with only the first prism
186 being used and the divergent lens 184 disposed near the first
prism. As shown in FIG. 19, O may be optimized for the return beam
relative to the axis of the endoscope.
[0086] In another embodiment, a concave or negative refractive
power lens may be mounted to the distal prism 186 to increase the
field of return image capture for the return optics. As shown in
FIG. 20, a negative refractive power lens or concave lens 190 is
used in combination with the positive refractive power lens or
divergent lens 184 to achieve a wider angle of image capture while
minimizing aberrations on the fiber optics to increase image
quality. In this embodiment, the steering mechanism for the prism
may be eliminated if the range of the wide angle image is
sufficient to cover the target area without steering the prism. In
embodiments where the steering mechanism is eliminated, this will
create more space within the miniaturized endoscope for adding more
illuminating fiber optics to better illuminate the target area and
improve reliability.
[0087] In another embodiment shown in FIG. 21, two negative
refractive power lenses are used with a single prism of a
miniaturized endoscope including a prism steering mechanism. As
shown in FIG. 21, a first negative refractive power lens or concave
lens 190a is disposed distally of the prism 186 and a second
negative refractive power lens or concave lens 190b is disposed
proximally of the prism 186. In this embodiment, the first and
second concave lenses can operate in conjunction with one another
or individually as required. Also, the positive refractive power
lens or divergent lens 184 is positioned distally of the first
concave lens 190a. The divergent lens 184 works with the first and
second concave lenses 190a and 190b to reduce optical aberrations
in the lens system and to enhance the image quality.
[0088] Referring now to FIG. 22A, one embodiment of the handle 52
of the endoscope may be open to allow fluid to freely move in and
out of the handle 52. In this way, the handle 52 of the endoscope
may be cleaned and dried while the sealed chamber 151 remains
sealed. In one embodiment the proximal body 52 has an open
configuration by drilling holes 192 into the housing of the handle
52. In another embodiment, a mesh may be used to create an open
handle 52. Without an open configuration, there is a possibility
that fluid may leak into the inner chamber of the handle 52 through
a broken seal. Any fluid that enters the inner chamber of the
handle 52 has the potential of rusting components and allowing
bacterial growth. Therefore, providing the handle 52 with an open
configuration prevents this problem in the inner chamber of the
handle because any fluid entering will more easily evaporate or be
drained through the holes 192.
[0089] Light fiber 194 extends from the light post 193 and into the
sealed chamber 151 or optical chamber. In this embodiment, the
light fiber must be free moving in order to allow the endoscope
shaft to rotate in relation to the light post. In order to maintain
the seal on the sealed chamber 151, a flexible sheath 196 covers
the light fiber 194 and is affixed to the sealed chamber. This
flexible sheath may be formed of silicone or steel. The flexible
sheath 196 allows the light fiber to move and the flexible sheath
protects the light fiber from damage.
[0090] In another embodiment shown in FIG. 22B, the light post has
been removed, and the light fiber 194 within the flexible sheath
196 exits the handle 52. In this embodiment, the light fiber would
be connected to a light cable further away from the endoscope.
Removing the light post prevents heat build up on the handle where
the user holds the endoscope.
[0091] Yet another embodiment of an endoscope is shown in FIG. 23,
where the internal mechanisms of the endoscope are sealed from the
outside environment. FIG. 23 shows a cross-sectional view of the
handle 52 of the endoscope 10 with the internal driving mechanisms
removed for clarity. In this embodiment, ferric fluid, which can be
an oil containing iron particles mixed within, is injected into
spaces 198 between the dials or dials 104 and 110 and the inside
portion of the handle 52. Teeth 199 are formed on the surfaces of
the dials 104 and 110 to trap the ferric fluid as shown in FIG. 23.
It has also been contemplated that teeth can be formed on the
internal surface of the handle. Either the dials 104 and 110 or the
handle 52 can contain a magnet disposed near or forming spaces 198,
and these magnets can attract and bond with the magnetic ferric
fluid. In another embodiment, both the dials and the handle may
contain magnets at the spaces 198. As shown in FIG. 23, the teeth
on the distal dial 110 are formed on a proximal portion of the dial
that is connected with the shaft of the endoscope and positioned
within the internal chamber of the handle. Therefore, the spaces
formed around the internal circumference of the handle become a
fluid seal.
[0092] This bonding between the magnets within the dials 104 and
110 or the handle 52 and the ferric fluid allows the dials to move
in relation to the handle with little or no friction. Also, this
bonding seals the internal chamber of the handle from the outside
environment. These fluidic seals will not wear like a typical
O-ring and they are capable of withstanding high pressures.
[0093] Referring now to FIGS. 24A and 24B, one embodiment of a
method of using a swing prism endoscope in the nasal and paranasal
anatomy is described. For ease of illustration, FIGS. 24A and 24B
show a nostril N, a nasal cavity 1009, and a non-specific paranasal
sinus 1022 with a natural paranasal sinus ostium 1020. In various
embodiments, the endoscope 10 may be used in procedures addressing
the maxillary, frontal, sphenoid and/or ethmoid paranasal sinuses
and their related ostia. FIGS. 25A-25D, for example, show a method
involving dilation of a natural ostium of a sphenoid sinus.
However, it may be even more advantageous to use a swing prism
endoscope of the present application in a procedure involving the
maxillary and/or frontal paranasal sinuses, as the natural openings
into these sinuses are usually difficult to visualize using an
endoscope without removing one or more natural anatomical
structures. Therefore, although FIGS. 24A and 24B show a generic
paranasal sinus, and FIGS. 25A-25D show a sphenoid sinus, the
endoscopes of the present invention may be used in any suitable
procedure involving any paranasal sinus and/or nasal cavity. In
further alternative embodiments, endoscopes of the present
application may be used in procedures involving other portions of
ear, nose or throat anatomy, such as but not limited to Eustachian
tube procedures such as dilation and/or stent placement, repair of
cranio-facial fractures, airway procedures such as subglottic
stenosis dilation, tonsillectomy, adenoidectomy and/or the
like.
[0094] As shown in FIG. 24A, in one embodiment a swing prism
endoscope 10 may be inserted into a nostril N of a human or animal
subject with the viewing angle of the scope adjusted to
approximately 0 degrees (i.e., a straight ahead view), as
demonstrated by the ray lines 1024. In alternative embodiments, the
endoscope 10 may not be capable of viewing at 0 degrees but may be
capable of between about 5 degrees and about 10 degrees as the most
"straight ahead" angle. In either case, the physician may advance
the endoscope 10 through the nasal cavity 1009 using the straight
ahead view, moving toward, for example, a paranasal sinus ostium
1020, such as an ostium of a maxillary, frontal, sphenoid or
ethmoid sinus. FIG. 24B shows endoscope 10 in a more advanced
location. At some point during or after advancing endoscope 10, the
physician may adjust the swing prism of scope 30 to change its
viewing angle, for example to look in the direction of ostium 1020.
In one embodiment, endoscope 10 includes an automatic focusing
element, so that as the swing prism is adjusted and the viewing
angle changed, endoscope 10 automatically refocuses. After viewing
ostium 1020, the physician may decide to leave the viewing angle
the same or make further adjustments to view different anatomy, an
additional device inserted into the paranasal anatomy, and/or the
like. In some embodiments, at any point during a procedure, a
physician may be able to lock the viewing angle of endoscope 10 at
a desired angle. When withdrawing the device from the human or
animal subject's nostril, the physician may again adjust the swing
prism viewing angle back to 0 degrees or may leave the angle as it
was during any part of the procedure. Such a method, or any of a
number of variations thereof, allows a physician to view anatomy of
a nasal cavity 1009, paranasal sinus ostium 1020 and/or paranasal
sinus 1022, as well as one or more surgical devices, during a
procedure without having to switch out multiple different
endoscopes or to remove tissue to look around corners.
[0095] FIGS. 25A through 25D are illustrations of partial sagittal
sectional views through a human head showing various steps of a
method for viewing and treating an ostium of a paranasal sinus,
which in this example is a sphenoid sinus. In FIG. 25A, the swing
prism endoscope 10 is introduced through a N nostril and through a
nasal cavity 1012 to a location close to an ostium 1014 of a
sphenoid sinus 1016. The endoscope is used to view surrounding
anatomy using a first, straight ahead viewing angle (or
approximately straight ahead, such as between about 5 degrees and
about 10 degrees angled from the endoscope longitudinal axis).
[0096] In FIG. 25B, the angle of view of the endoscope 10 is
altered to view an ostium 1014 of a sinus 1016. In an alternative
embodiment, one or more therapeutic or diagnostic devices may be
advanced into the nasal cavity 1012 before the angle of view of the
endoscope 10 is adjusted. In fact, the endoscope 10 may generally
be advanced, adjusted, removed and the like in conjunction with any
additional device(s) in any suitable order or manner as
desired.
[0097] As shown in FIG. 25C, in one embodiment, a guide catheter
212 may next be advanced into the nasal cavity 1012, in some cases
but not necessarily preloaded with a guidewire 110 and/or a balloon
catheter. The guidewire 110 may then be advanced out of the distal
end of the guide catheter 212 such that it passes through the sinus
ostium 1014 and into the sphenoid sinus 1016. A working device
1006, such as a balloon catheter, can be introduced over the
guidewire 110, through the guide catheter, to position an
expandable member 213 such as an inflatable balloon, into the sinus
ostium 1014.
[0098] Thereafter, as shown in FIG. 25D, working device 1006 is
used to perform a diagnostic or therapeutic procedure. In this
particular example, the procedure is dilation of the sphenoid sinus
ostium 1014, where the balloon of device 1006 is expanded to
enlarge the ostium 1014. After completion of the procedure, the
sinus guide catheter 212, guidewire 110 and working device 1006 are
withdrawn and removed. The entire procedure can be observed using
the swing prism endoscope 10.
[0099] The features of the present disclosure may also be used to
dilate or modify any sinus ostium or other man-made or naturally
occurring anatomical opening or passageway within the nose,
paranasal sinuses, nasopharynx or adjacent areas. In this or any of
the procedures described in this patent application, the operator
may additionally advance other types of catheters, and guidewire
110, guide catheter 212 or both may be steerable (e.g. torquable,
actively deformable) or shapeable or malleable. Additionally, in
various alternative embodiments, the endoscope 10 and one or more
other devices, such as a guide catheter 212, may be integrated. In
one embodiment, for example, a guide catheter 212 may include an
endoscope lumen through which the endoscope 10 may pass.
[0100] The scope 30 may be useful to reduce or eliminate the need
for fluoroscopic visualization during placement of a sinus guide
and/or for visualization of the procedure performed by working
device 1006. Being configured with a swing prism providing a one
hundred sixty five degree viewing field, it can provide the
capability to see an opening into a paranasal sinus and possibly
even inside the sinus itself, and thus the endoscope may provide
sufficient visual feedback for use in guiding guidewire 110 into
the desired sinus.
[0101] FIG. 26 shows one embodiment of a sinus guide system 210
which can be used with the swing prism endoscope 10 of the present
disclosure. Sinus guide 212 may be straight, malleable, or it may
incorporate one or more preformed curves or bends as further
described above, as well as in U.S. Patent Publication Nos.
2006/004323; 2006/0063973; and 2006/0095066, for example, each of
which are incorporated herein, in their entireties, by reference
thereto. In embodiments where sinus guide 212 is curved or bent,
the deflection angle of the curve or bend may be in the range of up
to about 135 degrees. This sinus guide system 210 comprises a sinus
guide 212 and a camera/transmission/endoscope assembly 214. This
embodiment of the sinus guide 212 is shown in more detail in FIGS.
28A-28C. As shown, this sinus guide 212 comprises a sinus guide
body 226 and an endoscope channel 228 in generally side-by-side
arrangement. As previously described, the swing prism endoscope 10
may be inserted separately from the sinus guide system 210. In
certain applications, however, the endoscope 10 also can be
inserted through the endoscope channel 228. Accordingly, the system
210 can also lack an endoscope channel 228. In either approach, the
swing prism endoscope can be connected to a camera/transmission
assembly and to a console 234 including a monitor 236 and video
recorder 240.
[0102] The sinus guide body 226 can embody a tube 244 having a
lumen 245 (e.g., see FIG. 28B), such as a polymer tube made of
biocompatible polymeric material. Optionally, a liner 246 (FIG.
28B) may be disposed within the lumen 245 of the tube 244. Such
liner may be formed of lubricious or smooth material such as
polytetrafluoroethylene (PTFE). Also, optionally, a proximal
portion of the tube 244 may be surrounded by an outer tube member
242 formed of material such as stainless steel hypotube. In the
embodiment shown, a distal portion of the tube 244 extends out of
and beyond the distal end of outer tube 242. This protruding distal
portion of the tube 244 may be straight or curved. Also, it may be
pre-formed at the time of manufacture or malleable to a desired
shape at the time of use. When intended for use in accessing the
ostium of a paranasal sinus, the distal portion of tube 244 may be
curved to form an angle A from about 0 degrees to about 120
degrees. For example, a series of sinus guides 212 having angles A
of 0, 30, 70, 90 and 110 degrees may be provided thereby allowing
the physician to select the sinus guide angle A that is most
appropriate for the particular paranasal sinus ostium to be
accessed.
[0103] Additionally, in some embodiments, a rotation grip 260 may
be positioned about a proximal portion of the sinus guide 210, as
seen in FIGS. 26, 28A and 28B. This rotation grip 260 may have a
smooth or textured round outer surface (e.g., it may be a
cylindrical tube) that may be grasped between the fingers of the
operator's hand and easily rotated, thereby facilitating rotation
(e.g., rolling) of the sinus guide 212 as it is being used. Such
rotation of the sinus guide 212 may be desirable for a number of
reasons including but not limited to positioning of the distal end
of the sinus guide 212 at a desired location.
[0104] In the event it is desirable to configure the sinus guide
system with an endoscope channel, it is contemplated that the
channel 228 may comprise any structure (e.g., tube, track, groove,
rail, etc.) capable of guiding the advancement of a flexible
endoscope. In the particular examples shown in these figures, the
endoscope channel 228 comprises a tube (e.g., a polymer tube)
having a lumen 229 extending therethrough. In the embodiment seen
in FIGS. 26-28C, the endoscope channel 228 is attached to and
extends along substantially the entire length of the sinus guide
body 226. In another embodiment, the endoscope channel 228 can be
inside the sinus guide body 226. In other embodiments, the
endoscope channel 228 may be interrupted, non-continuous or may
extend over less than the entire length of the sinus guide body
226. An outer skin 240 may be heat shrunk or otherwise disposed
around the sinus guide body 226 and endoscope channel 228 to hold
the endoscope channel 228 at a desired position on the outer
surface of the sinus guide body 226. Alternatively, the endoscope
channel 228 may be attached to the sinus guide body 226 at one or
more locations by any other suitable attachment substance,
apparatus or technique, including but not limited to adhesive,
soldering, welding, heat fusion, coextrusion, banding, clipping,
etc. The particular circumferential location of the endoscope
channel 228 can be important in some applications, particularly
when the sinus guide body 226 includes a curve formed in its distal
portion 244. In this regard, for some applications, the endoscope
channel 228 may be affixed at a particular circumferential location
on the sinus guide body 226 to allow an endoscope 10 inserted
through the endoscope channel 228 to provide a view from a desired
or optimal vantage point, without obstruction from adjacent
anatomical structures. It is also to be recognized that a second
endoscope (not shown) distinct from the above described swing prism
endoscope and which incorporates a swing prism or otherwise defines
flexible structure can be inserted through the endoscope
channel.
[0105] Again referring to FIGS. 26-28C, a proximal Y connector 241
may be attached to the proximal end of the sinus guide 212. A first
arm 243b of this Y connector comprises a female Luer fitting that
is connected to the lumen 245 of the sinus guide body 226. The
other arm 243a is a female Luer fitting that is connected to the
lumen 229 of the endoscope channel 226.
[0106] A camera/cable/endoscope assembly 214 is attachable to arm
243a. In the particular embodiment shown in FIGS. 26 and 29, the
camera/cable/endoscope assembly 214 comprises an adjustable
scope/lock extension 216, a camera 220 and a monitor cable 224. The
scope body 30 can be advanced through the scope/lock extension 216
and through the lumen 229 of the endoscope channel 228. As shown in
FIG. 27, the light cable 250 and monitor cable 224 may be connected
to console 234 that houses a monitor 236, light source 238 and
video recorder 240. Alternatively, the endoscope 10 can be directly
connected to a console 234 separate from the sinus guide system
212.
[0107] The invention has been described hereabove with reference to
certain examples or embodiments of the invention, but various
additions, deletions, alterations and modifications may be made to
these examples and embodiments and or equivalents may be
substituted 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. In addition, many
modifications may be made to adapt a particular situation,
material, composition of matter, process, process step or steps, to
the objective, spirit and scope of the present invention. All such
modifications are intended to be within the scope of the claims
appended hereto.
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