U.S. patent application number 11/623740 was filed with the patent office on 2008-07-17 for apparatus and method for treatment of sinusitis.
This patent application is currently assigned to ENTELLUS MEDICAL, INC.. Invention is credited to John R. Drontle, Anthony J. Hanson, Peter T. Keith, Joel R. Munsinger, Thomas V. Ressemann, Theodore O. Truitt.
Application Number | 20080172033 11/623740 |
Document ID | / |
Family ID | 39618340 |
Filed Date | 2008-07-17 |
United States Patent
Application |
20080172033 |
Kind Code |
A1 |
Keith; Peter T. ; et
al. |
July 17, 2008 |
APPARATUS AND METHOD FOR TREATMENT OF SINUSITIS
Abstract
A method of treating a constricted sinus passageway of a patient
includes traversing the canine fossa region of the patient so as to
form a passageway in the sinus cavity. A cannula is positioned in
the passageway. A visualization tool such as an endoscope is passed
through a lumen or channel in the cannula to aid in visualization
of the anatomical site of interest. A balloon dilation catheter is
then deployed through or along the cannula so as to place the
balloon within or across the constricted anatomical space (e.g.,
ostium). The balloon is then expanded so as to expand at least a
portion of the constricted anatomical space. Alternative
embodiments include the use of an optional guide wire and
incorporating a endoscope lumen through the balloon dilation
catheter.
Inventors: |
Keith; Peter T.; (St. Paul,
MN) ; Truitt; Theodore O.; (St. Cloud, MN) ;
Ressemann; Thomas V.; (St. Cloud, MN) ; Drontle; John
R.; (Monticello, MN) ; Munsinger; Joel R.;
(Blaine, MN) ; Hanson; Anthony J.; (St. Cloud,
MN) |
Correspondence
Address: |
Vista IP Law Group LLP
2040 MAIN STREET, 9TH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
ENTELLUS MEDICAL, INC.
Maple Grove
MN
|
Family ID: |
39618340 |
Appl. No.: |
11/623740 |
Filed: |
January 16, 2007 |
Current U.S.
Class: |
604/506 ;
604/117; 604/264; 604/96.01 |
Current CPC
Class: |
A61B 1/018 20130101;
A61B 1/01 20130101; A61B 17/24 20130101; A61B 1/126 20130101; A61B
1/233 20130101; A61B 2017/3425 20130101; A61B 17/3496 20130101;
A61B 17/3421 20130101; A61B 1/00154 20130101; A61M 29/02 20130101;
A61B 1/00078 20130101; A61B 2017/246 20130101; A61B 2017/3445
20130101; A61M 2210/0681 20130101; A61B 17/3431 20130101; A61B
1/00135 20130101 |
Class at
Publication: |
604/506 ;
604/96.01; 604/117; 604/264 |
International
Class: |
A61M 31/00 20060101
A61M031/00; A61M 29/02 20060101 A61M029/02; A61M 5/00 20060101
A61M005/00; A61M 25/00 20060101 A61M025/00 |
Claims
1. A method of treating sinusitis in a patient comprising: forming
an artificial access passageway into a sinus cavity of the patient;
positioning a cannula within the access passageway, the cannula
having a first lumen adapted for passage of a balloon dilation
catheter, and a secondary lumen adapted for passage of a
visualization tool; inserting the visualization tool into the
secondary lumen and visualizing an anatomical region of interest;
inserting the balloon dilation catheter into the first lumen and
advancing the same so as to place the dilation balloon in or across
the anatomical region of interest; and dilating the dilation
balloon.
2. The method of claim 1, wherein the access passageway is formed
in the canine fossa region of the patient.
3. The method of claim 1, wherein the sinus cavity is the maxillary
sinus.
4. The method of claim 1, wherein the sinus cavity is the frontal
sinus.
5. The method of claim 1, wherein the cannula includes one or more
curved portions.
6. (canceled)
7. The method of claim 1, wherein the cannula contains a biased
portion that has a pre-formed configuration.
8. The method of claim 1, wherein the cannula includes a distal tip
that is canted.
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. The method of claim 1, wherein the visualization tool comprises
a flexible endoscope.
15. The method of claim 1, wherein the balloon dilation catheter
comprises a distal tip projecting distally with respect to the
dilation balloon.
16. The method of claim 15, wherein the distal tip is curved.
17. (canceled)
18. The method of claim 15, wherein during the advancement of the
dilation balloon across the anatomical region of interest, the
distal tip is positioned in the posterior direction.
19. The method of claim 1, wherein the anatomical region of
interest is an ostium.
20. The method of claim 1, wherein the anatomical region of
interest is an infundibulum.
21. A system for treatment of sinusitis in a patient comprising: a
piercing tool for creating an artificial access passageway to a
sinus cavity of the patient; a cannula having a first lumen adapted
for passage of a balloon dilation catheter, and a secondary lumen
adapted for passage of a visualization tool; and a balloon dilation
catheter having an expandable balloon on a distal region thereof,
the balloon dilation catheter being dimensioned for passage through
the first lumen of the cannula.
22. The system of claim 21, wherein the piercing tool further
comprises a sheath for maintaining an opening in the artificial
access passageway, the sheath being disposed on a shaft of the
piercing tool.
23. The system of claim 22, wherein the sheath is disposed within a
recess on the shaft of the piercing tool.
24. The system of claim 21, wherein the visualization tool
comprises a flexible endoscope.
25. (canceled)
26. The system of claim 21, wherein the cannula includes one or
more curved portions.
27. (canceled)
28. (canceled)
29. (canceled)
30. (canceled)
31. (canceled)
32. (canceled)
33. (canceled)
34. (canceled)
35. The system of claim 21, wherein the balloon dilation catheter
comprises a distal tip projecting distally with respect to the
dilation balloon.
36. The system of claim 21, wherein the piercing tool comprises a
drill.
37. The system of claim 35, wherein the distal tip is curved.
38. (canceled)
39. (canceled)
40. (canceled)
41. (canceled)
42. (canceled)
43. (canceled)
44. A system for treatment of sinusitis in a patient comprising: a
sheath for maintaining a working lumen through an artificial access
passageway to a sinus cavity of the patient; a cannula having a
first lumen adapted for passage of a balloon dilation catheter, and
a secondary lumen adapted for passage of a visualization tool; and
a balloon dilation catheter having an expandable balloon on a
distal region thereof, the balloon dilation catheter being
dimensioned for passage through the first lumen of the cannula.
45-73. (canceled)
74. A method of treating sinusitis in a patient comprising: forming
an artificial access passageway into a sinus cavity of the patient;
positioning a cannula within the access passageway, the cannula
having a lumen adapted for receiving a visualization tool and a
balloon dilation catheter; advancing a balloon dilation catheter
through the lumen of the cannula with the dilation balloon in a
collapsed state; advancing the visualization tool through a lumen
in the balloon dilation catheter and visualizing an anatomical
region of interest with the visualization tool; advancing the
balloon dilation catheter to place the dilation balloon in or
across the anatomical region of interest; and dilating the dilation
balloon.
75. A method of treating sinusitis in a patient comprising: forming
an artificial access passageway into a sinus cavity of the patient;
positioning a cannula within the access passageway, the cannula
having a first lumen adapted for passage of a balloon dilation
catheter, the cannula further including a visualization tool
incorporated therein; visualizing an anatomical region of interest
with the visualization tool; inserting the balloon dilation
catheter into the first lumen and advancing the same so as to place
the dilation balloon in or across the anatomical region of
interest; and dilating the dilation balloon.
76. A system for treatment of sinusitis in a patient comprising: a
piercing tool for creating an artificial access passageway to a
sinus cavity of the patient; a cannula having a first lumen adapted
for passage of a balloon dilation catheter a visualization tool
secured to the cannula; and a balloon dilation catheter having an
expandable balloon on a distal region thereof, the balloon dilation
catheter being dimensioned for passage through the first lumen of
the cannula.
77. A balloon dilation catheter for dilating an anatomical
structure associated with paranasal sinus drainage comprising: an
elongate tubular shaft having a proximal end and a distal end and a
lumen extending therethrough; an inflatable dilation balloon having
a proximal end and a distal end, the proximal and distal ends of
the inflatable dilation balloon being secured to an outer surface
of the shaft, the portion of the shaft contained within the
dilation balloon including at least one or more ports in
communication with the shaft lumen; and a curved tip extending
distally from the distal end of the dilation balloon.
78. The balloon dilation catheter of claim 77, wherein the shaft is
formed from a material having a torsional stiffness such that
rotation of the proximal end of the shaft translates to rotation of
the distal end of the shaft in substantially a 1:1 manner.
79. The balloon dilation catheter of claim 77, wherein the distal
tip includes a bulbous tip.
80. The balloon dilation catheter of claim 77, wherein the dilation
balloon includes a plurality of wings in a deflated state.
81. The balloon dilation catheter of claim 77, wherein the dilation
balloon at least partially extends over the curved distal tip.
82. The balloon dilation catheter of claim 77, wherein the balloon
dilation catheter comprises a shaft having a braided portion.
83. The balloon dilation catheter of claim 77, wherein the balloon
dilation catheter comprises a shaft formed from hypotube having a
plurality of slots formed therein.
84. A method of treating an ostium of a paranasal sinus comprising:
placing a balloon dilation catheter in the paranasal sinus, the
balloon dilation catheter comprising a shaft, an inflatable
dilation balloon disposed on a distal region of the shaft, and a
curved tip extending from a distal end of the dilation balloon;
advancing the balloon dilation catheter into the ostium; rotating
the shaft of the balloon dilation catheter so as to re-orient the
curved tip; further advancing the balloon dilation catheter in the
re-oriented direction; and inflating the inflation dilation balloon
to dilate the ostium.
85. The method of claim 84, wherein the curved tip includes a
bulbous tip.
86. The method of claim 84, wherein the curved tip is advanced into
the ostium in the posterior direction and during the further
advancement of the dilation balloon catheter, the curved tip is
positioned in the medial direction.
87. An access tool for creating an artificial access passageway to
a sinus cavity of the patient comprising: an elongate tissue
penetration member including a shaft and a distal tip, and a recess
disposed in the shaft proximal of the distal tip; and a tubular
sheath removably secured to the shaft in the recess, the tubular
sheath including a flange portion.
88. The access tool according to claim 87, further comprising a
stop removably secured around the tubular sheath, the stop
including a flange portion for engaging with tissue surrounding the
artificial access passageway.
89. The access tool according to claim 87, wherein the tubular
sheath includes a plurality of slots.
90. A cannula for positioning one or more devices within a
paranasal sinus comprising: an elongate tubular shaft having a
proximal end and a distal end and a first lumen extending
therethrough, the elongate tubular shaft further including a second
lumen extending along side at least a portion of the first lumen,
the distal end of the elongate tubular shaft including at least one
curved portion having a curvature between about 5.degree. and
30.degree..
91. The cannula of claim 90, further comprising a flexible
polymeric tip secured to the distal end of the elongate tubular
shaft.
92. The cannula of claim 90, wherein the distal end of the elongate
tubular shaft has a canted distal edge.
93. The cannula of claim 90, wherein the second lumen is formed
from a flexible material such that in the absence of any device in
the second lumen, the second lumen is in a collapsed state.
94. The cannula of claim 90, wherein the secondary lumen is
dimensioned to receive a visualization tool.
95. The cannula of claim 90, wherein the elongate tubular shaft has
a single curved portion.
96. The method of claim 75, wherein the visualization tool is
integrated in the cannula.
97. The method of claim 75, wherein the cannula has a secondary
lumen adapted for passage of the visualization tool.
98. The method of claim 1, wherein the cannula is positioned within
a sheath disposed within the access passageway.
99. The method of claim 16, further comprising orienting the distal
tip by rotating the balloon dilation catheter.
100. The system of claim 21, further comprising a sheath for
maintaining an opening in the artificial passageway.
101. The system of claim 21, wherein the balloon dilation catheter
is configured for rotation within the artificial access
passageway.
102. The system of claim 44, wherein the balloon dilation catheter
comprises a curved distal tip projecting distally with respect to
the dilation balloon.
103. The system of claim 44, wherein the cannula comprises a curved
distal end.
104. The method of claim 74, wherein a distal end of the cannula
comprises a curved portion.
105. The method of claim 74, wherein the cannula is positioned
within a sheath disposed within the access passageway.
106. The method of claim 74, wherein the balloon dilation catheter
comprises a curved distal tip projecting distally with respect to
the dilation balloon.
107. The method of claim 75, wherein a distal end of the cannula
comprises a curved portion.
108. The method of claim 75, wherein the cannula is positioned
within a sheath disposed within the access passageway.
109. The method of claim 75, wherein the balloon dilation catheter
comprises a curved distal tip projecting distally with respect to
the dilation balloon.
110. The system of claim 76, wherein the access passageway is
formed in the canine fossa region of the patient.
111. The system of claim 76, wherein the sinus cavity is the
maxillary sinus.
112. The system of claim 76, wherein the sinus cavity is the
frontal sinus.
113. The system of claim 76, wherein the cannula includes one or
more curved portions.
114. The system of claim 76, wherein the cannula contains a biased
portion that has a pre-formed configuration.
115. The system of claim 76, wherein the cannula includes a distal
tip that is canted.
116. The system of claim 76, wherein the visualization tool
comprises a flexible endoscope.
117. The system of claim 76, wherein the balloon dilation catheter
comprises a distal tip projecting distally with respect to the
dilation balloon.
118. The system of claim 117, wherein the distal tip is curved.
119. The system of claim 117, wherein during the advancement of the
dilation balloon across the anatomical region of interest, the
distal tip is positioned in the posterior direction.
120. The system of claim 117, wherein the anatomical region of
interest is an ostium.
121. The system of claim 120, wherein the anatomical region of
interest is an infundibulum.
122. The system of claim 76, further comprising a sheath for
maintaining an opening in the artificial passageway.
123. The cannula of claim 90, wherein the curved portion is located
at a distal end of the elongate tubular shaft.
124. A system for treatment of sinusitis in a patient comprising: a
sheath for maintaining a working lumen through an artificial access
passageway to a sinus cavity of the patient; a cannula having a
lumen adapted for passage of a balloon dilation catheter, the
cannula further including a visualization tool incorporated
therein; and a balloon dilation catheter having an expandable
balloon on a distal region thereof, the balloon dilation catheter
being dimensioned for passage through the lumen of the cannula.
125. The system of claim 124, wherein a distal end of the cannula
comprises a curved portion.
126. The system of claim 124, wherein the balloon dilation catheter
comprises a curved distal tip projecting distally with respect to
the dilation balloon.
Description
FIELD OF THE INVENTION
[0001] The field of the invention generally relates to devices and
methods for the treatment or amelioration of sinusitis.
BACKGROUND OF THE INVENTION
[0002] Sinusitis is a condition affecting over 35 million
Americans, and similarly large populations in the rest of the
developed world. Sinusitis occurs when one or more of the four
paired sinus cavities (i.e., maxillary, ethmoid, frontal, sphenoid)
becomes obstructed. Normally the sinus cavities, each of which are
lined by mucosa, produce mucous which is then moved by beating
cilia from the sinus cavity out to the nasal cavity and down the
throat. The combined sinuses produce approximately one liter of
mucous daily, so the effective transport of this mucous is
important to sinus health.
[0003] Each sinus cavity has an opening into the nasal passage
called an ostium. When the mucosa of one or more of the ostia or
regions near the ostia become inflamed, the egress of mucous is
interrupted, setting the stage for an infection of the sinus
cavity, i.e., sinusitis. Infections of the maxillary and/or ethmoid
sinuses make up the vast majority of cases of sinusitis, with far
fewer cases involving the sphenoids and frontals.
[0004] Though many instances of sinusitis may be treatable with
antibiotics, in some cases sinusitis persists for months, a
condition called chronic sinusitis. Some patients are also prone to
multiple episodes of sinusitis in a given period of time, a
condition called recurrent sinusitis.
[0005] Currently, patients experiencing chronic sinusitis are
eligible to have a surgical procedure called functional endoscopic
sinus surgery (FESS). In this procedure, which almost always done
in an operating room setting with the patient under general
anesthesia, surgical cutting instruments are guided with an
endoscopic visualization tool to the various sinus ostia and
adjacent regions. Inflamed mucosa and underlying bony tissue are
cut away in an effort to widen the outlet of the sinuses of
interest. Once opened, the infected sinuses are able to drain and
return to a relatively normal state.
[0006] While this procedure is generally effective, it is a
relatively invasive procedure to the nasal cavity and sinuses.
There can be significant post-operative pain for the patient, and
sometimes there are bleeding complications that require packing to
be placed in the nasal cavity. Subsequent removal of this packing
can be quite painful. Also, since the nasal and sinus tissue are
significantly traumatized, it may take several days to weeks to
know whether the surgery was successful.
[0007] Additionally, in certain patients, the ostial regions of the
surgically-treated sinuses can become re-obstructed with excess
growth of scar tissue as a result of the tissue trauma. When the
advantages and disadvantages of the surgery are considered for a
patient with sinusitis, there are many patients in whom the surgery
may not be appropriate. For example, their condition may not be
considered severe enough or extensive enough to warrant FESS
surgery. In other situations, the patient may have "recurrent
acute" sinusitis, rather than "chronic" sinusitis, and FESS surgery
may not be warranted. In still other situations, the patient may be
fearful of the pain or other aspects of having FESS performed.
Alternatively, the FESS procedure may be too costly for a
particular patient.
[0008] For these and other reasons, there is a clear need for
better methods and devices for the treatment of sinusitis.
SUMMARY OF THE INVENTION
[0009] In a first aspect of the invention, a method of treating
sinusitis in a patient includes forming an artificial access
passageway into a sinus cavity of the patient. A cannula is then
positioned within the access passageway, the cannula having a first
lumen adapted for passage of a balloon dilation catheter, and a
secondary lumen adapted for passage of a visualization tool. The
visualization tool is inserted into the secondary lumen and the
anatomical region of interest is visualized. Next, the balloon
dilation catheter is inserted into the first lumen and advanced so
as to place the dilation balloon in or across the anatomical region
of interest. The dilation balloon is then dilated.
[0010] In another aspect of the invention, a system for treatment
of sinusitis in a patient includes a piercing tool for creating an
artificial access passageway to a sinus cavity of the patient. The
system further includes a cannula having a first lumen adapted for
passage of a balloon dilation catheter, and a secondary lumen
adapted for passage of a visualization tool. The system also
includes a balloon dilation catheter having an expandable balloon
on a distal region thereof, the balloon dilation catheter being
dimensioned for passage through the first lumen of the cannula. The
system may be sold as a kit or, alternatively, one or more
sub-components of the overall system may be sold separately or in
combination.
[0011] In still another embodiment, a system for treatment of
sinusitis in a patient includes a sheath for maintaining a working
lumen through an artificial access passageway to a sinus cavity of
the patient. The system further includes a cannula having a first
lumen adapted for passage of a balloon dilation catheter, and a
secondary lumen adapted for passage of a visualization tool. The
system includes a balloon dilation catheter having an expandable
balloon on a distal region thereof, the balloon dilation catheter
being dimensioned for passage through the first lumen of the
cannula. As with the prior embodiment, the system may be sold as a
kit or, alternatively, one or more sub-components of the overall
system may be sold separately or in combination.
[0012] In another embodiment, a system for treatment of sinusitis
in a patient includes a piercing tool for creating an artificial
access passageway to a sinus cavity of the patient. A cannula is
also provided that has a lumen adapted for passage of a
visualization tool and a balloon dilation catheter at the same
time. The balloon dilation catheter has an expandable balloon on a
distal region thereof and a lumen adapted for receiving the
visualization tool. The system may be sold as a kit or in one or
more sub-components or combinations as described herein.
[0013] In still another embodiment, a method of treating sinusitis
in a patient includes forming an artificial access passageway into
a sinus cavity of the patient. A cannula is positioned within the
access passageway, the cannula having a lumen adapted for receiving
a visualization tool and a balloon dilation catheter. A balloon
dilation catheter is then advanced through the lumen of the cannula
with the dilation balloon in a collapsed state. The visualization
tool is advanced through a lumen in the balloon dilation catheter
and an anatomical region of interest is then visualized with the
visualization tool. The balloon dilation catheter is then advanced
to place the dilation balloon in or across the anatomical region of
interest and the dilation balloon is dilated (e.g., inflated).
[0014] In still another embodiment, a method of treating sinusitis
in a patient includes forming an artificial access passageway into
a sinus cavity of the patient and positioning a cannula within the
access passageway. The cannula has a first lumen adapted for
passage of a balloon dilation catheter and also includes an
integrated visualization tool. An anatomical region of interest is
then visualized with the visualization tool. The balloon dilation
catheter is then inserted into the first lumen and advanced so as
to place the dilation balloon in or across the anatomical region of
interest. The dilation balloon is then dilated.
[0015] In yet another embodiment, a system for treatment of
sinusitis in a patient includes a piercing tool for creating an
artificial access passageway to a sinus cavity of the patient. The
system also includes a cannula having a first lumen adapted for
passage of a balloon dilation catheter. A visualization tool is
also secured to the cannula. The system includes a balloon dilation
catheter having an expandable balloon on a distal region thereof,
the balloon dilation catheter being dimensioned for passage through
the first lumen of the cannula.
[0016] A balloon dilation catheter for dilating an anatomical
structure associated with paranasal sinus drainage including an
elongate tubular shaft having a proximal end and a distal end and a
lumen extending therethrough. The balloon dilation catheter
includes an inflatable dilation balloon having a proximal end and a
distal end, the proximal and distal ends of the inflatable dilation
balloon being secured to an outer surface of the shaft, the portion
of the shaft contained within the dilation balloon including at
least one or more ports in communication with the shaft lumen. The
balloon dilation catheter includes a curved tip extending distally
from the distal end of the dilation balloon.
[0017] In still another embodiment, a method of treating an ostium
of a paranasal sinus includes placing a balloon dilation catheter
in the paranasal sinus, the balloon dilation catheter comprising a
shaft, an inflatable dilation balloon disposed on a distal region
of the shaft, and a curved tip extending from a distal end of the
dilation balloon. The balloon dilation catheter is then advanced
into the ostium. The shaft of the balloon dilation catheter is
rotated so as to re-orient the curved tip. The balloon dilation
catheter is then further advanced in the re-oriented direction. The
inflation dilation balloon can then be inflated to dilate the
ostium.
[0018] In yet another embodiment, an access tool for creating an
artificial access passageway to a sinus cavity of the patient
includes an elongate tissue penetration member including a shaft
and a distal tip, and a recess disposed in the shaft proximal of
the distal tip. The tool further includes a tubular sheath
removably secured to the shaft in the recess, the tubular sheath
including a flange portion.
[0019] In still another embodiment, a cannula for positioning one
or more devices within a paranasal sinus includes an elongate
tubular shaft having a proximal end and a distal end and a first
lumen extending therethrough, the elongate tubular shaft further
including a second lumen extending along side at least a portion of
the first lumen, the distal end of the elongate tubular shaft
including at least one curved portion having a curvature between
about 5.degree. and 30.degree..
[0020] Further features and advantages will become apparent upon
review of the following drawings and description of the preferred
embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1A illustrates various sub-components, some of which
are optional, of an apparatus for treating sinusitis. The
sub-components include a cannula or guide catheter, a visualization
tool such as an endoscope, a guide wire, and a catheter having an
expandable member (e.g., balloon) located on a distal end
thereof.
[0022] FIG. 1B illustrates a trocar or piercing member along with a
stop, sheath, and yet another version of a cannula having a
secondary lumen sized for receiving an endoscope.
[0023] FIGS. 2A-2G illustrate side views of various embodiments of
a cannula or guide catheter.
[0024] FIGS. 2H-2O illustrate cross-sectional views of the shaft of
a cannula according to various embodiments.
[0025] FIG. 2P illustrates a side view of a cannula according to
another embodiment. The cannula includes a handle, a secondary
lumen, and a bent or curved tip.
[0026] FIG. 2Q illustrates a side view of another embodiment of a
cannula.
[0027] FIG. 2R illustrates a side view of cannula of the type shown
in FIG. 2Q with an endoscope slidably disposed inside the secondary
lumen. The field of view of the endoscope is shown at the distal
end of the secondary lumen.
[0028] FIG. 2S illustrates still another embodiment of a cannula.
The cannula is shown in a straight configuration after a rigid
obturator is passed through a central lumen or passage.
[0029] FIG. 2T illustrates the cannula of FIG. 2S with the
obturator removed.
[0030] FIG. 3A illustrates a magnified, partial cross-sectional
view of a cannula according to one embodiment. A cleaning structure
is present in the secondary lumen.
[0031] FIG. 3B illustrates another magnified, partial
cross-sectional view of a cannula according to one embodiment. A
cleaning tool is shown disposed in the main lumen or channel of the
cannula.
[0032] FIG. 4A illustrates a plan view of a balloon dilation
catheter according to one embodiment.
[0033] FIG. 4B illustrates a cross-sectional view of the balloon
dilation catheter taken along the line B-B' of FIG. 4A.
[0034] FIG. 4C illustrates a cross-sectional view of the balloon
dilation catheter taken along the line C-C' of FIG. 4A.
[0035] FIG. 4D illustrates a cross-sectional view of the balloon
dilation catheter taken along the line D-D' of FIG. 4A.
[0036] FIG. 5 illustrates a cross-sectional and partial side view
of a balloon dilation catheter according to another embodiment.
[0037] FIGS. 6A-6C illustrate cross-sectional views of a catheter
taken along the lines B-B', C-C', and D-D', respectively.
[0038] FIG. 7A illustrates a plan view of a balloon dilation
catheter according to another embodiment.
[0039] FIG. 7B illustrates a cross-sectional view the balloon
dilation catheter of FIG. 7A taken along the line B-B'.
[0040] FIG. 7C illustrates a cross-sectional view the balloon
dilation catheter of FIG. 7A taken along the line C-C'.
[0041] FIG. 7D illustrates a plan view of a balloon dilation
catheter according to another embodiment.
[0042] FIG. 8A illustrates a plan view of a balloon dilation
catheter according to another embodiment.
[0043] FIG. 8B illustrates a cross-sectional view the balloon
dilation catheter of FIG. 8A taken along the line B-B'.
[0044] FIG. 8C illustrates a cross-sectional view the balloon
dilation catheter of FIG. 8A taken along the line C-C'.
[0045] FIG. 8D illustrates a plan view of a balloon dilation
catheter according to another embodiment.
[0046] FIG. 8E illustrates a cross-sectional view the balloon
dilation catheter of FIG. 8D taken along the line E-E'.
[0047] FIG. 8F illustrates a cross-sectional view the balloon
dilation catheter of FIG. 8D taken along the line F-F'.
[0048] FIG. 9A illustrates a plan view of a balloon dilation
catheter according to another embodiment.
[0049] FIG. 9B illustrates a plan view of a balloon dilation
catheter of FIG. 9A with the balloon in an expanded state.
[0050] FIG. 10A illustrates a plan view of a balloon dilation
catheter according to another embodiment. The shaft of the balloon
dilation catheter is partially transparent illustrating a braid
structure.
[0051] FIG. 10B illustrates a cross-sectional view the balloon
dilation catheter of FIG. 10A taken along the line B-B'.
[0052] FIG. 10C illustrates a cross-sectional view the balloon
dilation catheter of FIG. 10A taken along the line C-C'.
[0053] FIG. 10D illustrates a plan view of a balloon dilation
catheter according to another embodiment. The shaft of the balloon
dilation catheter is partially transparent illustrating an internal
core wire.
[0054] FIG. 10E illustrates a cross-sectional view the balloon
dilation catheter of FIG. 10D taken along the line E-E'.
[0055] FIG. 10F illustrates a cross-sectional view the balloon
dilation catheter of FIG. 10D taken along the line F-F'.
[0056] FIG. 11A illustrates a plan view of a balloon dilation
catheter according to another embodiment. The shaft of the balloon
dilation catheter is partially transparent illustrating a braid
structure.
[0057] FIG. 11B illustrates a cross-sectional view the balloon
dilation catheter of FIG. 11A taken along the line B-B'.
[0058] FIG. 11C illustrates a cross-sectional view the balloon
dilation catheter of FIG. 11A taken along the line C-C'.
[0059] FIG. 11D illustrates a plan view of a balloon dilation
catheter according to another embodiment. The shaft of the balloon
dilation catheter is partially transparent illustrating an internal
core wire along with a braid structure.
[0060] FIG. 11E illustrates a cross-sectional view the balloon
dilation catheter of FIG. 11D taken along the line E-E'.
[0061] FIG. 11F illustrates a cross-sectional view the balloon
dilation catheter of FIG. 11D taken along the line F-F'.
[0062] FIG. 12A illustrates a plan view of a balloon dilation
catheter according to another embodiment. The shaft of the balloon
dilation catheter is partially transparent illustrating a braid
structure.
[0063] FIG. 12B illustrates a cross-sectional view the balloon
dilation catheter of FIG. 12A taken along the line B-B'.
[0064] FIG. 12C illustrates a cross-sectional view the balloon
dilation catheter of FIG. 12A taken along the line C-C'.
[0065] FIG. 12D illustrates a plan view of a balloon dilation
catheter according to another embodiment. The shaft of the balloon
dilation catheter is partially transparent illustrating a tubular
(e.g., hypotube) shaft.
[0066] FIG. 12E illustrates a cross-sectional view the balloon
dilation catheter of FIG. 12D taken along the line E-E'.
[0067] FIG. 12F illustrates a cross-sectional view the balloon
dilation catheter of FIG. 12D taken along the line F-F'.
[0068] FIGS. 13A-C illustrate a piercing tool such as a trocar
along with a sheath and stop being used to form an artificial
opening or passageway into a sinus cavity via the canine fossa.
[0069] FIG. 14 illustrates a sagittal cross-sectional view of a
portion of a patient's skull illustrating various anatomical
features of the nasal cavity.
[0070] FIG. 15 illustrates a sagittal cross-sectional view of a
portion of a patient's skull illustrating various anatomical
features of the nasal cavity. The middle turbinate is lifted to
reveal, among other structures, the uncinate process. Also shown
are three different directions extending from the maxillary sinus
cavity through the ostium infundibulum and nasal cavity.
[0071] FIGS. 16 and 17 illustrates a sagittal cross-sectional view
of a portion of a patient's skull like that shown in FIG. 15 with
the middle turbinate removed. Also illustrated is a balloon
dilation catheter being positioned across the ostium and other
anatomical features for dilation. FIG. 17 illustrates a different
embodiment of the balloon dilation catheter.
[0072] FIG. 18 illustrates a sagittal cross-sectional view of a
portion of a patient's skull like that shown in FIG. 15 with the
middle turbinate removed. Another embodiment of a balloon dilation
catheter is shown crossing the ostium and other anatomical
features.
[0073] FIG. 19 illustrates a coronal partial cross-sectional view
of the maxillary sinus of a patient or subject with a cannula or
guide catheter that is positioned at least partially within the
maxillary sinus cavity via an access point (e.g., canine fossa). A
guide wire and a visualization tool (e.g., endoscope) are shown
passing through the cannula or guide catheter to view the
ostium.
[0074] FIG. 20 illustrates the partial cross-sectional view of FIG.
19 wherein the guide catheter is fixed relative to the patient. In
addition, the guide wire is shown in an advanced state wherein the
guide wire has advanced in the distal direction across the ostium
and into the nasal cavity.
[0075] FIG. 21 illustrates the partial cross-sectional view of FIG.
20 wherein the endoscope has been removed.
[0076] FIG. 22 illustrates the partial cross-sectional view of FIG.
21 wherein a balloon dilation catheter has been advanced over the
guide wire and the balloon has been dilated within the ostium.
[0077] FIG. 23 illustrates a coronal cross-sectional view of the
body structure of the skull defining the sinus cavities. A cannula
and endoscope are shown accessing the maxillary sinus via the
canine fossa region.
[0078] FIG. 24 illustrates a cross-sectional view of the body
structure of the skull defining the sinus cavities of FIG. 23. A
balloon dilation catheter is advanced through the cannula. The
balloon on the distal portion of the dilation catheter is in a
deflated state.
[0079] FIG. 25 illustrates the same view of FIG. 24 but with the
balloon of the dilation catheter in an inflated state.
[0080] FIG. 26 illustrates one embodiment of an endoscope that is
used in connection with one or more dilation procedures described
herein.
[0081] FIG. 27A illustrates an endoscope coupled to the proximal
end or hub of a secondary lumen or channel of a cannula.
[0082] FIG. 27B illustrates a protective sleeve that can be placed
over the main, flexible portion of the endoscope for protective
purposes.
[0083] FIG. 28A illustrates a cross-sectional view of the nesting
tubes of the protective sleeve according to one embodiment. The
configuration shown in FIG. 28A illustrates the protective sleeve
in a collapsed state.
[0084] FIG. 28B illustrates a cross-sectional view of the nesting
tubes of the protective sleeve according to one embodiment. The
configuration shown in FIG. 28B illustrates the protective sleeve
in an extended state.
[0085] FIG. 29 illustrates one embodiment of a protective sleeve
using a coil-embedded structure.
[0086] FIG. 30 illustrates another embodiment of a protective
sleeve that uses a corrugated structure.
[0087] FIG. 31 illustrates a coronal cross-section view of the body
structure of the skull defining the sinus cavities with an
alternative embodiment of a balloon catheter, endoscope and cannula
accessing the ostium of a sinus cavity via the canine fossa.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0088] FIG. 1A illustrates an apparatus 10 for the treatment of
sinusitis according to one embodiment. The apparatus 10 may include
a number of sub-components as is shown in FIGS. 1A and 1B. In this
regard, the apparatus 10 may be sold or offered as a kit or the
like that includes all the necessary sub-components necessary to
form the complete apparatus or system 10. However, in an
alternative aspect of the invention, the apparatus 10 may be sold
or offered with fewer than all the sub-components illustrated in
FIGS. 1A and 1B. For example, the guide wire or endoscope may, in
some instances, be off-the-shelf components existing at the
physician's office or hospital that can be utilized with the
remaining sub-components of the apparatus 10. In still other
instances, the complete apparatus 10 does not need certain
sub-components to operate. For example, as explained herein, in
certain aspects of the invention, there is not need for a separate
guide wire.
[0089] As seen in FIG. 1A, the apparatus 10 includes a cannula 20
that is used to provide an access passageway to one or more sinus
cavities of the patient. The cannula 20 includes at least one lumen
22 therein. FIG. 1A illustrates a single lumen 22 passing through a
central portion of the cannula 20. In other embodiments, as
described in more detail herein, there may be multiple, separate
lumens or channels 22 contained with the cannula 20. These lumens
22 may located centrally within the cannula 20, incorporated into
the wall or exterior of the cannula 20, or even located externally
to the main body of the cannula 20.
[0090] The cannula 20 is generally made a rigid material such as a
rigid polymeric or metallic material such that the cannula 20
maintains its generally elongate shape. However, as explained
below, in some alternative embodiments, one or more regions of the
cannula 20 may include flexible regions that assist in
visualization of the anatomical region of interest in the sinus
and/or placement of the expandable member within the anatomical
region of interest. Further, the cannula 20 may include an optional
Luer fitting or other type of fitting known to those skilled in the
art that are associated with one or more lumens 22.
[0091] The cannula 20 generally includes an elongate shaft 24 that
terminates at a distal end or tip 26 and a proximal end 28. As
explained below, the cannula 20 is used with a balloon dilation
catheter or other expandable member to aid in the delivery and/or
placement of the balloon or expandable member adjacent to or across
an anatomical region of interest. For example, the cannula 20 may
be dimensioned to permit placement of the balloon dilation catheter
in the maxillary sinus ostium and infundibulum via the canine fossa
region. As will be explained below, in certain embodiments, the
cannula 20 is dimensioned to pass through an artificial passageway
or hole created at or in the vicinity of the canine fossa region.
The overall length of the cannula 20 depends on the clinical
application but for a trans-canine fossa approach that accesses the
maxillary sinus ostium, a preferred length is between about 5 cm
and about 20 cm. Of course, the length may be shorter or longer
than this range depending on, for example, the anatomical nature of
the sinus cavity.
[0092] As explained above, the cannula 20 may have one or more
lumens 22 for passage of various devices. For example, with
reference to the lumen 22 of FIG. 1A, the lumen 22 extending along
the entire length permits passage of a catheter having an
expandable member (e.g., balloon dilation catheter), visualization
tool (e.g., endoscope), suction catheter, aspiration catheter,
guide wire, and the like. For example, a single lumen 22 cannula 20
like that disclosed in FIG. 1A may be used for delivery of a
balloon catheter (described in more detail below) having preferred
balloon inflation sizes of between 3 and 7 mm. To accommodate the
various devices within the lumen 22, the internal diameter of the
cannula lumen 22 may be between about 0.040 inches to about 0.120
inches or even between about 0.060 inches and about 0.090 inches.
In general, a smaller diameter cannula 20 will necessitate less
tissue trauma at the access site.
[0093] Referring back to FIG. 1A, the apparatus 10 includes an
imaging tool 40. The imaging tool 40 may include a flexible or
semi-flexible endoscope 42 as is shown in FIG. 1A. The endoscope 42
includes a proximal end 44, an elongate shaft portion 46, and a
distal tip 48. The proximal end 44 of the endoscope 42 may include
a hub 50 or the like that includes an eyepiece 52 that is used
visualize the placement and positioning of the apparatus 10 within
the patient's sinus cavity and related anatomy. The hub 50 may
include a connector 54 that connects to a light source for
illuminating the anatomical space. In addition, in certain
embodiments, the endoscope 42 may be coupled to a monitor or the
like such that the anatomical working space may be visualized
better during the procedure. Such attachments and couplings are
known to those skilled in the art and are not described herein.
[0094] As seen in FIG. 1A, the endoscope 42 may include an optional
lumen 56 therein for passage of, for example, a guide wire
(described below). In this regard, the endoscope 42 can be used in
an "over-the-wire" configuration. In other embodiments, however,
there is no need for guide wire lumen. The endoscope 42 is
preferably flexible to permit the distal end 48 thereof containing
the lens and other optical components to be placed in the desired
location within the patient's sinus cavity. The shaft portion 46 is
preferably dimensioned so that the same can be slidably disposed
within the lumen 22 of the cannula 20. For example, in one aspect
of the invention, the endoscope 42 may be placed inside the cannula
20 during placement of a guide wire. The endoscope 42 may then be
withdrawn from the cannula 20 and a balloon dilation catheter
(described below) can be fed over the guide wire. The exterior of
the shaft 46 may be coated with or otherwise contain a lubricous
coating to aid in slidability within the cannula 20.
[0095] Referring still to FIG. 1A, in certain embodiments the
apparatus 10 includes a guide wire 60. In still other embodiments,
however, the guide wire 60 may be eliminated entirely. In those
embodiments using a guide wire 60, it includes proximal end 62, a
central portion 64, and a distal end 66. The guide wire 60 may have
a conventional construction for guide wires used in other
applications. For example, the guide wire 60 may include a tapered
core wire and outer jacket, coating, or coil extending along some
or all of the length of the core wire. The guide wire 60 is
semi-flexible, preferably with increasing flexibility towards the
distal end, to permit passage through the cannula 20, which in
certain configurations, may include one or more bent or curved
sections. The guide wire 60 also has sufficient columnar strength
to prevent buckling when the guide wire 60 is positioned through or
across an anatomical space that is to be dilated (e.g., ostium).
The guide wire 60 may be coated with or otherwise contain a
lubricous coating to aid in pushability through the various lumens
(e.g., lumen 22) through which it can be passed. As seen in FIG.
1A, the distal end 66 of the guide wire 60 may be pre-formed or
pre-shaped with a j-shaped bend. The distal end 66 (with the
optional j-shaped bend) may be manipulated by moving the proximal
end 62. For example, the distal end 66 may be moved axially by
pushing or pulling the guide wire 60. Similarly, the distal end 66
may be rotated or steered about an axis by rotation of the guide
wire's proximal end 62. Such "steerability" facilitates passage of
the guide wire 60 through the anatomical structures of the sinus
and nasal cavities.
[0096] The guide wire 60 may include one or more visible markers
68a, 68b, 70a, 70b that are used to aid the user in placing the
guide wire 60 in the proper location. For example, as seen in FIG.
1A, a distal marker 68a is placed that may be visually identified
by, for instance, its color. A corresponding marker 68b is located
proximally on the guide wire 60 and may be colored with the same
color. FIG. 1A further shows an additional set of distally placed
markers 70a. These markers are distinguished from the marker 68a
because there are two (2) markers or bands. The proximal portion of
the guide wire 60 includes corresponding markers 70b which also
comprises two (2) marker bands. As an alternative, the two (2)
markers 70a, 70b could be replaced by a single maker that is a
different color than markers 68a, 68b. The makers on the distal
68a, 70a and proximal ends 68b, 70b are separated by the same
distance such that the physician can correlate axial movement of
the distal end 66 of the guide wire 60 with movement of the
proximal end 62.
[0097] Still referring to FIG. 1A, the apparatus 10 includes a
balloon dilation catheter 80. The balloon dilation catheter 80
includes an elongate tubular section 82 (sometimes referred to as a
shaft) that has a proximal hub 84 and a distally-located expandable
member 86 which may take the form of a balloon. The balloon
dilation catheter 80 may also include an optional distal tip 88
which, as explained in more detail below, may take the form of a
number of configurations and shapes. The balloon dilation catheter
80 includes a central lumen 90 or passageway that communicates with
the expandable member 86 and the proximal hub 84. In this regard,
there is a fluidic passageway through which a fluid can pass to
selectively expand and contract the expandable member 86. The
proximal hub 84 may include a connector 92 such as a Luer fitting
or the like which can be coupled to a device for
delivering/extracting the fluid to expand/contract the expandable
member 86. For example, a syringe, or inflation apparatus known to
those skilled in the art (now shown), or the like may be
fluidically coupled to the connector 92 that can be used by the
operator to expand/deflate the expandable member 86 as needed. In
addition, in still other embodiments (not shown in FIG. 1A), the
balloon dilation catheter 80 may contain additional lumens for the
passage of various devices. For example, added lumens may be
dimensioned to provide access for a guide wire 60 or an imaging
tool 40 like an endoscope 42.
[0098] Referring now to FIG. 1B, in some embodiments the apparatus
10 may include additional components as part of kit to provide
access to the patient's sinus cavity of interest. For example, a
piercing tool 100 in the form of a trocar, drill, or the like may
be provided. The piercing tool 100 includes a sharpened distal tip
102 and a proximal hub 104 or handle that can be grasped by the
physician. The piercing tool 100 is used to create an artificial
opening in, for example, the canine fossa region to provide an
access passageway to the sinus cavity of interest. The piercing
tool 100 may include an optional recessed portion 101 that is used
to hold a sheath 108 (described in more detail below) during
placement. An optional stop 106 may also be included that is used
in conjunction with the piercing tool 100 to limit the depth of
penetration of the piercing tool 100. In this regard, the stop 106
acts as a safety device that limits axial movement of the piercing
tool 100 during the process of forming the access passageway. The
stop 106 may include a slit 107 or the like along its length so
that the same can be easily placed over the piercing tool 100
during placement.
[0099] FIG. 1B also illustrates a sheath 108 that may be positioned
within the passageway created by the piercing tool 100. The sheath
108 includes an elongate body portion having a lumen 110 passing
there through. The proximal end of the sheath 108 may include a rim
or flange 111 that is used to secure the sheath 108 in the newly
created artificial opening. FIG. 1B illustrates an alternative
embodiment of the cannula 20 illustrated in FIG. 1A. The cannula 20
of FIG. 1B includes a secondary lumen 30, which in this illustrated
embodiment, is positioned external to the main cannula shaft 24.
The secondary lumen 30 runs substantially the entire length of the
cannula 20 and terminates at a proximal hub 31 and can be used to
guide an imaging tool 40 such as an endoscope 42. The proximal hub
31 may be made of any number of fittings, connectors, or interfaces
that can be used to couple to an imaging tool 40 like an endoscope
42. The cannula 20 illustrated in FIG. 1B may be used, for example,
in those embodiments where the guide wire is eliminated.
[0100] FIGS. 2A-2T illustrate various embodiments of the cannula 20
that may be used in connection with the apparatus 10. The various
features shown may be used individually or in combination. FIG. 2A
illustrates a cannula 20 having a substantially straight shaft 24
and an optional Luer fitting on a proximal hub 32 located at the
proximal end 28 of the cannula 20. As shown in FIG. 2A, the shaft
24 is made from a rigid material such as, for instance, stainless
steel tube. FIG. 2B illustrates a cannula having a single curved
portion at the distal tip 26. The curve or arc created at the
distal tip 26 subtends an angle .alpha.. The sharpness of the curve
is defined by either the inner radius R.sub.i, the outer radius
R.sub.0, or the midline radius R. The span illustrated in FIG. 2B
is the lateral offset of the tip 26 from the centerline of the
cannula 20 along the shaft 24 (proximal to tip 26) and is a
function of the angle .alpha. and the radius of curvature R. In one
preferred embodiment, the cannula has an angle .alpha. from about
1.degree. to about 90.degree. with a radius of curvature R of about
5 mm to about 30 mm. The curved tip 26 may be directed or "pointed"
in any direction within the sinus cavity by rotation of the
proximal end 28 of the cannula 20. The shaft 24 may be formed from
a rigid material such as, for instance, stainless steel tubing.
[0101] FIGS. 2C and 2D illustrate a cannula 20 with two curves 34a,
34b in the shape of a "question mark." In this embodiment, the
distal curve 34a subtends an angle .alpha.1 and has a radius of
curvature R1. The second or more proximal curve 34b subtends an
angle .alpha.2 and has a radius of curvature R2. Having two curves
34a, 34b as such allows for additional degrees of freedom to alter
the tangent direction (as shown in the arrow A of FIG. 2C) of the
distal end 26 of the cannula 20 and the span. It should be
understood that the multiple curves may have a sinusoidal shape
such as an "S" shape. In FIG. 2D, the span can even be a negative
number. Preferred embodiments making use of multiple (e.g., two)
curves result in a tangent direction of preferably about 5.degree.
to about 90.degree. (relative to the main shaft axis) and a span of
about -0.5 cm to about +1.0 cm. Such a curve shape can be
especially useful in certain anatomical configurations of a
patient's nasal and paranasal spaces, for example if the patient
has a pronounced "barrel" shape of their nasal walls.
[0102] FIG. 2E illustrates an embodiment of a cannula 20 with an
optional handle 36. It should be understood that the handle 36 is
contemplated as an option on all embodiments of the cannula 20. The
handle 36 is preferably of a larger diameter than the diameter of
the shaft 24, such as 1 mm to 10 mm or larger. The handle 36 also
may have a circular or non-circular cross section for some or all
of its length. Additional features such as finger grips, bumps,
texturing, or ridges are also contemplated to improve the ergonomic
feel of the handle 36. When used in the canine fossa application,
it is preferable to position the handle 36 proximally on the shaft
24 so as not to interfere with either the access hole of the canine
fossa, or other structures such as the teeth. The distance from the
tip 26 of the cannula 20 to the handle 36 is about 3 cm to about 10
cm, and most preferably about 5 cm to about 7 cm.
[0103] FIG. 2F shows an embodiment of a cannula 20 that includes a
soft distal tip 27. Whereas the shaft 24 of the cannula 20 is
preferably relatively rigid, e.g. formed from stainless steel, the
soft distal tip 27 in this embodiment is preferably made of a more
flexible polymer, such as Pebax, Nylon, Pellethane, PTFE,
polyethylene, or a combination thereof. The soft tip 27 makes the
distal end 26 of the cannula 20 more atraumatic to tissue.
Furthermore, the soft tip 27 facilitates the removal of the balloon
dilation catheter 80, after the balloon 86 has been inflated and
subsequently deflated. The deflated balloon 86 often forms "wings"
which can be difficult to withdraw back inside the catheter lumen
22, particularly if the lumen 22 is defined by a rigid material
such as stainless steel. A soft tip 27 can partially or temporarily
deform and diametrically expand to help ease during retraction of
the deflated balloon 86. Enhancements to the lubricity and/or
radiopacity can also be incorporated or added, such as oxidized
polyethylene, paralene, PTFE, hydrophilic coatings, barium sulfate,
bismuth subcarbonate, or bismuth trioxide. The soft tip 27 may be
attached to the distal end of the shaft 24 by suitable means such
as thermal or adhesive bonding. Additionally, the distal end 26 of
the cannula 20 can have an angled or canted end as shown. The
canted end further enhances the ability to withdraw a deflated
balloon 86 back into the distal end 26 of the cannula 20.
[0104] FIG. 2G illustrates another embodiment of a cannula 20 that
includes an additional or secondary lumen 30. The secondary lumen
30 may be used to position an imaging tool 40 such as a flexible
endoscope 42 within it, and extend to the distal tip 26 of the
cannula 20. The cannula 20 may include one or more optional curved
portions 34a, 34b as described herein. Alternatively, the cannula
20 may be substantially straight as is shown, for instance in FIG.
1B. As shown in FIG. 2G, the cannula 20 includes a soft distal tip
27.
[0105] FIGS. 2H through 20 further illustrate various
configurations for the secondary lumen 30, which will be described
in further detail below. The secondary lumen 30 may take the form
of a lumen or channel through which an imaging tool 40 passes. In
the cannula embodiments incorporating a lumen for the imaging tool
40, these are preferably utilized in the placement of balloon
dilation catheters 80 that do not have a lumen that can pass an
imaging tool 40. Generally, the secondary lumen 30 is sized to
contain a relatively small flexible endoscope 42. For example, in
one embodiment, the secondary lumen 30 is sized to slidably receive
a 0.5 mm flexible endoscope (falloposcope model 11565) made by Karl
Storz Endoscopy--America Inc. (Culver City, Calif.). This endoscope
42 has a flexible main portion that has an outer diameter of about
0.5 mm and is about 100 cm in length.
[0106] FIGS. 2H-2O illustrates various cross-sectional views of a
cannula 20 with a secondary lumen 30 for positioning an imaging
tool 40 such as an endoscope 42. The cross-sectional views are
taken along the line A-A' of FIG. 2G. As seen in FIG. 2H, the
secondary lumen 30 (e.g., lumen or channel for endoscope 42) is
defined by a tube 38 that is positioned inside the main body of the
cannula 20. The tube 38 is preferably bonded to the inside surface
of the main shaft 24 of the cannula 20 by suitable means such as
thermal or adhesive bonding. The tube 38 is preferably formed of a
polymer or a metallic tube, and as mentioned prior, the main tube
is preferably relatively rigid, e.g. stainless steel. The inside of
the tube 38 may be coated with a lubricious coating or the like to
ease slidability of the endoscope 42 through the secondary lumen
30.
[0107] FIG. 21 illustrates an alternative arrangement whereby a
portion of the wall of the main shaft or tube 24 of the cannula 20
is removed, and the tube 38 used to form the secondary lumen 30 is
"nested" into the wall of the main tube 24. This provides for the
ability to maintain a larger lumen 22 through the main body of the
cannula 20. An even larger lumen 22 through the cannula 20 can be
provided, as shown in the embodiment of FIG. 2J. In this
embodiment, the entire wall thickness of a portion of the main tube
of the cannula 20 is removed, and the tube 38 is positioned within
the slot created therein. As seen in FIG. 2J, the outer diameter
OD.sub.1 is greater than the outer diameter OD.sub.2. Preferably
the slot that is created to make room for the tube 38 extends from
the distal tip 26 proximally for at least a portion of the length
of the cannula 20 that is at least as long as the desired length to
be positioned into and beyond the canine fossa. Proximal of that
point, it may be desirable to position the tube 38 on the outer
surface of the cannula. The tube 38 thus forming the secondary
lumen 30 transitions from being at least partially within the main
lumen 22 to being completely external to the main lumen 22 at a
proximally located transition point.
[0108] FIG. 2K illustrates a similar embodiment to that shown in
FIG. 2J except that the main tube or shaft 24 of the cannula 20 is
formed in a generally oval or elliptical cross-sectional shape such
that the two diameters are closer in value. This embodiment
provides for a relatively large cross-sectional area of the lumen
22 of the main shaft 24 of the cannula 20, while keeping the two
diameters equal or relatively similar.
[0109] FIGS. 2L and 2M illustrate additional embodiments where the
tube 38 used for the secondary lumen 30 is capable of transitioning
between a collapsed configuration (FIG. 2L) and an expanded
configuration (FIG. 2M). For example, in the absence of an imaging
tool 40 within the lumen 30 of the tube 38, the tube 38 is in the
collapsed configuration, which helps minimize the outer diameter of
the cannula 20 while also helping to maximize the inner diameter of
the main lumen 22. In this embodiment, the tube 38 is positioned
and secured within a slot in the wall of the main shaft 24.
Optional flanges 39 on each side of the tube 38, as shown in FIGS.
2L and 2M, may assist in securing the tube 38 to the main shaft 24.
The tube 38 for the secondary lumen 30 is preferably formed of a
relatively flexible and resilient material such as Pebax, Nylon, or
PTFE, or a combination thereof. When an endoscope 42 is passed into
the tube 38, the tube 38 expands (FIG. 2M). If the endoscope 42 is
withdrawn, the tube 38 preferably re-collapses entirely or,
alternatively, at least partially. When a device such as a balloon
dilation catheter 80 is advanced or withdrawn through the main
lumen 22, the flexible nature of the tube 38 allows itself to "make
room" for the device, particularly given the relatively larger
profile of the balloon portion 86 of the balloon dilation catheter
80, and especially after it has been inflated and is desired to be
withdrawn back into the cannula 20. The extra room for the balloon
dilation catheter 80 is present both when the endoscope 42 is
disposed in the secondary lumen 30 and also when it is withdrawn
from the secondary lumen 30. However there will naturally be more
room for devices such as a balloon dilation catheter 80 in the main
lumen 22 if the endoscope 42 is not present in the secondary lumen
30.
[0110] FIG. 2N illustrates yet another alternative embodiment of a
cannula 20 with a collapsible tube 38 forming a secondary lumen 30.
In this embodiment, the tube 38 is a relatively thin walled tube,
preferably formed of PTFE or FEP. Flexible tubes of this material
can be formed very thin, with a preferred wall thickness of from
around 0.0005 inches to around 0.0025 inches (more preferably about
0.0015 inch). The tube 38 is positioned in a formed slot in the
wall of the main shaft 24, and may be secured by heat or adhesive
bonding to a thin tube or jacket 21 of polymer that preferably
extends around the entire circumference of the main shaft 24. This
outer tube or jacket 21 is preferably formed of a heat-shrinkable
or heat-formable tube such as Pebax or Nylon. Chemical etching of
the outer surface of the tube 38 forming the secondary lumen 30 can
further facilitate attachment to the outer tube 21.
[0111] A further refinement of this embodiment is shown in FIG. 20.
Here, an additional thin walled inner tube 23, preferably of PTFE
or other highly lubricious polymer, is positioned inside the main
shaft or tube 24 to serve as an inner liner. This inner tube 23
preferably extends through the entire length of the main shaft 24.
In this embodiment, if a soft tip 27 is provided, the inner tube 23
can serve as a substrate upon which to secure the soft tip 27.
Consequently, in a preferred embodiment, the thin inner tube 23
extends distally beyond the distal end of the main shaft 24, and a
soft tip 27 is secured to the outside of the thin inner tube 23,
and completely embeds the tube 38 forming the secondary lumen 30.
The distal extension is preferably about 0.5 mm to about 3 mm and
more preferably about 1 mm beyond the distal end of the main shaft
or tube 24.
[0112] FIG. 2P illustrates still another embodiment of a cannula
20. In this embodiment, the cannula 20 has a proximal straight
portion A, a curved or elbow portion B, and a relatively straight
distal portion C. With this embodiment, when used through the
canine fossa, the elbow B is preferably positioned right at the
hole created through the bony portion. The straight distal segment
C then extends within the sinus towards the ostium, while the
proximal portion A extends out from the canine fossa opening in a
direction further away from the teeth. This embodiment may be more
suitable in patients where the maxillary sinus ostium is disposed
more anterior vs. posterior in the sinus cavity.
[0113] FIG. 2Q illustrates an embodiment of a cannula 20 with a
relatively short curved portion D located on the distal end 26 of
the cannula 20 and also incorporated into the tube 38 forming the
secondary lumen 30. Preferably the secondary lumen 30 is sized
close to the diameter of the endoscope 42 (not shown in FIG. 2Q).
When the endoscope 42 is positioned at the end of the secondary
lumen 30, the direction of view is influenced by the degree of
curve in the cannula 20. The main lumen 22 (through which a balloon
dilation catheter 80 would be placed) is preferably relatively
larger than the shaft size of the balloon dilation catheter 80.
Therefore, the trajectory or direction that the balloon dilation
catheter 80 takes is less impacted by the curve in the cannula 20.
In this fashion, the cannula 20 behaves more like a straight
cannula vis-a-vis balloon catheter 88 delivery but performs like a
curved cannula 20 with respect to viewing through the endoscope 42.
By altering the viewing direction, the endoscope 42 behaves more
like a conventional angled endoscope, which can be useful for being
able to view more of the sinus cavity if the cannula 20 and
endoscope 42 are rotated. FIG. 2R illustrates a cannula 20 with a
flexible endoscope 42 positioned in the secondary lumen 30 and
emerging at the distal tip 26 of the cannula 20. The solid arrow
represents the centerline of the field of view of the endoscope 42
while the dashed cone represents the field of view of the endoscope
42.
[0114] FIGS. 2S and 2T illustrate still another embodiment of a
cannula 20. In this embodiment, the cannula 20 includes a biased
portion E that is pre-formed and, in its natural state, forms a
curved or sinusoidal shape (e.g., FIG. 2T). The biased portion E is
formed from a relatively flexible material (e.g., polymeric) such
that placement of a relatively rigid obturator 37 or other device
within a lumen (not shown) of the biased portion E, it causes the
curved, biased portion E to straighten out (e.g., FIG. 2S) prior to
placement. After positioning the "straight" cannula 20 into the
desired location (e.g. in the sinus cavity), the biased portion E
re-curves upon retraction of the obturator 37 from the lumen 22 of
the cannula 20. Preferably, the biased portion E is stiff enough
such that other devices placed within it, such as a balloon
dilation catheter 80 or flexible endoscope 42, do not cause the
biased portion E to straighten out (i.e., the state of FIG. 2S).
This embodiment of the cannula 20 is particularly useful if there
are anatomic features that can not be easily negotiated upon
advancement of a curved cannula, but can be negotiated if the
cannula 20 is initially in a straight configuration.
[0115] It should be understood that any combination of the features
described in connection with the cannulas 20 described herein may
be contemplated. For example, any of the various curve, sinusoidal
shapes, soft tips, canted ends, secondary tube lumens, Luer
fittings, handles, linings, materials, etc. described herein may be
substituted or mixed and matched as appropriate into the final
structure of the cannula 20.
[0116] The endoscope 42 or other imaging tool 40 contemplated
herein typically have optical components such as lenses or the like
that are located on the distal end thereof. Because of this, when
using an endoscope 42 with a cannula 20 in a sinus cavity such as
the maxillary sinus or anywhere else in the nasal or paranasal
space, there is a risk of getting the distal end (and thus optics)
of the endoscope dirty. For example, if the endoscope 42
inadvertently touches the mucosa or other tissue it can get smudged
with fluid such as mucous or blood. This can impede or prevent
visualization of the anatomical space. If this happens, the entire
cannula 20 may need to be removed from the patient and the distal
end of the endoscope 42 can be wiped clean. Alternatively, the
endoscope 42 can be removed from the cannula 20, wiped clean, and
repositioned in the cannula 20.
[0117] FIGS. 3A and 3B illustrate two alternative cleaning
structures that can be used to avoid having to retract and manually
clean the distal end of the endoscope 42. FIG. 3A illustrates a
partial, magnified cross-sectional view of the cannula 20 showing
the main lumen 22 along with the secondary lumen 30 containing an
endoscope. A cleaning structure 112 is provided in the secondary
lumen 30 near the distal end. The cleaning structure 112 serves to
wipe the face of the endoscope 42 clean each time it is passed
through it. The cleaning structure 112 can be one or more
"squeegee" portions such as bristles (as shown), absorbent
material, or the like. Multiple bristles are preferred, as they can
be directed in a retrograde fashion to brush across the front
surface of the endoscope 42, assuring that any material on the
optics of the endoscope 42 gets pushed aside or otherwise
removed.
[0118] Alternatively, as shown in FIG. 3B, a cleaning tool 114 can
be positioned in the main lumen 22 of the cannula 20. The cleaning
tool 114 has one or more cleaning members 116, such as a
"squeegee", absorbent material, or bristles located on a portion
thereof. The cleaning tool 114 shown in FIG. 3B has multiple sets
of deformable bristles 116 attached that can be swept across the
face of the scope by rotation of the cleaning tool 114. The
bristles 116 preferably have a retrograde orientation from the
points of attachment. Also, the bristles 116 preferably expand out
to an overall diameter greater than the main lumen 22, such that
the bristles 116 can extend across the full diametric face of the
endoscope 42.
[0119] The cleaning structure 112 and cleaning tool 114 illustrated
in FIGS. 3A and 3B may be omitted if a sheath 108 is used to
maintain or support the artificially created hole or passageway
created in the patient's tissue/boney structure. The sheath 108
generally creates a clean, unobstructed passageway through which
the various devices (including endoscope 42) may pass.
[0120] With reference now to FIGS. 4A through 4D, FIGS. 5, 6A-6C,
7A-7D, 8A-8F, 9A-9B, 10A-10F, 11A-11F, and 12A-12F, various
embodiments of a balloon dilation catheter 80 are illustrated. As
explained with respect to FIG. 1A, in certain embodiments the
balloon dilation catheter 80 may have a distal tip 88 that projects
some distance from the balloon 86. FIG. 4A illustrates one
embodiment of a balloon catheter 88. In this embodiment, the
balloon catheter 88 incorporates a soft distal tip 88 extending
distally of the balloon 86. The elongate tubular member or catheter
shaft 82 as well as the tip 88 includes a lumen 96 (best seen in
FIGS. 4B, 4C, 4C) through which a flexible endoscope 42 can be
positioned. In use, the distal end of the endoscope 42 is
positioned at or near the distal end of the balloon catheter tip
88, which allows for viewing from the balloon catheter tip 88. FIG.
4A illustrates a cone (dashed lines) illustrating the field of view
from an endoscope 42 distally advanced through the balloon catheter
88. The balloon catheter 88 also includes an inflation lumen 90 for
inflating and deflating the expandable member 86 (e.g., balloon).
FIG. 4B illustrates a cross-sectional view taken along the line
B-B' of FIG. 4A showing the endoscope 42 positioned with the lumen
96 in the elongate shaft 82 of the balloon dilation catheter 80.
FIG. 4B also shows the inflation lumen 90 that is used to carry the
inflation medium (e.g., saline fluid or the like). FIG. 4C
illustrates a cross-sectional view taken along the line of C-C' of
FIG. 4A. The balloon 86 in an expanded state is shown about the
periphery of the elongate shaft 82 contained within the balloon 86
(obscured from view in FIG. 4A). FIG. 4D illustrates a
cross-sectional view taken along the distal tip 88 of the balloon
dilation catheter 80 along the line D-D' of FIG. 4A. As best seen
in FIGS. 4A and 4D, the distal tip 88 includes a lumen 96 for the
passage of the endoscope 42. The distal tip 88 may be substantially
straight as is shown in phantom in FIG. 4A or, alternatively, the
distal tip 88 may be curved as shown in FIG. 4A. The curvature of
the distal tip 88 may be formed using a biasing member 98 that may
be positioned within the distal tip 88. The biasing member 98 may
be formed as a wire or the like. The curved distal tip 88 allows
for the catheter tip to naturally be directed away from the ethmoid
bulla to aid in positioning of the distal portion of the balloon
catheter within the nasal cavity. The biasing member 98 may be bent
or preformed prior to placement by the physician. In addition, as
shown in FIG. 4A, the distal end of the distal tip 88 may include a
bulbous end 88a as shown in phantom in FIG. 4A.
[0121] Placement of the endoscope 42 within the balloon dilation
catheter 80 enables the balloon dilation catheter 80 to be
positioned across the ostium and into the anatomy of the nasal
cavity under direct visualization. The distal tip 88 of the balloon
dilation catheter 80 is essentially "flown" through the anatomy in
this embodiment, while the endoscopic image is being viewed by the
operator. The distal tip 88 preferably transitions from a soft
distal end and gets progressively stiffer towards the balloon 86,
enabling the relatively stiffer balloon 86 to be advanced and
tracked through the anatomy of the nasal cavity beyond the ostium
in an atraumatic manner.
[0122] In one embodiment, as shown in FIG. 5, the shaft of the
balloon dilation catheter 80 further incorporates a torsionally
rigid structure such as braid 81 embedded into a polymeric tubular
shaft 82. Such a structure allows the distal tip 88 of the catheter
80 to be rotationally directed via rotational movements of the
catheter shaft 82 at the proximal region or end. If the tip 88 of
the catheter 80 has a bend formed in it, such as shown in FIG. 4A,
then the tip 88 can be rotated to facilitate passage through
various anatomic structures in the nasal and paranasal region, such
as through the ostium of a sinus.
[0123] FIG. 4B also illustrates a balloon dilation catheter 80 that
incorporates a relatively large main lumen 96 large enough for a
flexible endoscope 42 and an optional support tube 41 (as shown in
FIGS. 4B, 6A, and 7B) to surround a portion of the flexible
endoscope 42. In this embodiment, the tip of the endoscope 42 can
be positioned at or near the tip 88. An optional guide wire 60
(seen in FIGS. 6A, 6B, and 6C) can be separately advanced ahead of
the balloon dilation catheter 80 ahead of the catheter tip 88.
FIGS. 6A, 6B, and 6C illustrate cross-sectional views of a catheter
80 taken along the lines B-B', C-C', and D-D', respectively showing
a guide wire 60 positioned within a larger main lumen 96. The main
lumen 96 may include a single large lumen 96 like that in FIG. 5 or
it may include two, merged lumens like that shown in FIGS. 6A, 6B,
and 6C.
[0124] However, in other instances it is desirable to provide a
balloon dilation catheter 80 with a shorter tip or no tip 88. FIG.
7A illustrates one such embodiment where the distal tip 88 is
relatively short, preferably about 1-3 mm in length, extending from
the balloon cone portion (described below). In addition, the distal
balloon "cone" region 94 is also relatively short, by virtue of
having a relatively steep cone angle, preferably from about 45
degrees to about 90 degrees, and most preferably about 60 degrees.
As used herein, the cone angle is the angle between the cone and
the longitudinal axis of the catheter 80. A lumen 96 (best seen in
FIGS. 7B and 7C) may extend through the balloon catheter 88 for
passage of a flexible endoscope 42 and/or a wire guide 60 (not
shown in FIGS. 7B and 7C). FIG. 7A illustrates in phantom (cone
shaped) the field of view from the endoscope 42 located in the
distal tip 88 of the balloon dilation catheter 80.
[0125] FIG. 7D illustrates another embodiment of a balloon dilation
catheter 80 with no distal tip extending beyond the expandable
balloon 86. In this embodiment, the balloon 86 preferably
incorporates a "reverse" distal cone 95 where it is secured to the
shaft 82 of the balloon dilation catheter 80. This embodiment may
be useful in instances where dilation from the balloon 86 is
preferred to extend as distally as possible within an anatomic
structure. In this regard, the distal most portion of the balloon
86 is able to expand to substantially the maximum diameter of the
balloon 86. For example, if the ostium of a sinus to be dilated is
immediately adjacent to another structure just beyond it (e.g., the
ethmoid bulla in the instance of a trans-canine fossa dilation of a
maxillary sinus ostium), then it may be difficult to position the
tip of the balloon dilation catheter 80 into that anatomy beyond
the ostium. Therefore, a balloon dilation catheter 80 of the
embodiment shown in FIG. 7D could be placed completely through the
ostium, without needing to find a place to position a distal
tip.
[0126] FIGS. 8A through 8F illustrate a balloon dilation catheter
80 having a relatively short curved distal tip 88 extending
distally from the dilation balloon 86. The distal tip 88 may
terminate in an optional bulbous end 88a as illustrated in FIGS. 8A
and 8D. FIG. 8A illustrates the expandable balloon 86 in a
deflated, folded, and wrapped condition. Cross-sectional images
taken along the lines B-B' and C-C' are illustrated, respectively,
in FIGS. 8B and 8C. In one aspect of the embodiment, the balloon 86
has at least two wings or appendages 86a when in a deflated
condition (best seen in FIG. 8C). In the embodiment shown in FIG.
8A, four (4) such wings 86a are shown. Other numbers of wings 86a
are contemplated, e.g., three, five, or more.
[0127] FIGS. 8D through 8F illustrate the balloon 86 in an inflated
state, where the wings 86a unfold and the balloon 86 takes on a
substantially cylindrical configuration. Cross-sectional views
taken along the lines E-E' and F-F', respectively, are shown in
FIGS. 8E and 8F. Preferably folds 86b (shown in FIG. 8F) are formed
in the balloon 86 (e.g., by heat setting, crimping or the like)
such that when the balloon 86 is deflated after an inflation, the
folded wings 86a re-establish themselves, and the deflated balloon
resumes a folded configuration (as shown in FIG. 8C).
Re-establishing a folded configuration with multiple wings 86a on
the balloon 86 as shown in FIG. 8C is helpful if the same balloon
dilation catheter 80 is intended to be used to dilate an
additional, e.g. second, sinus ostium.
[0128] FIGS. 9A and 9B illustrate another embodiment of a balloon
dilation catheter 80 in which the distal region of the balloon 86
extends over a portion of a curved distal tip 88 disposed on the
distal end of the shaft 82. As seen in FIG. 9A, the expandable
balloon 86 includes a plurality of wings 86a although the wings 86a
may be omitted in other embodiments. FIG. 9A shows the balloon 86
in a deflated state while FIG. 9B illustrates the balloon 86 in an
inflated state. This embodiment allows for the balloon dilation
catheter 80 to have a curved distal tip 88 while at the same time
minimizing any added length that projects distally to the main body
of the expandable balloon 86.
[0129] FIGS. 10A through 12F illustrate multiple embodiments of a
balloon dilation catheter 80 having curved distal tips 88 and a
shaft 82 which enables the curved tip 88 to be rotationally
controlled via one or more manipulations on the proximal end (e.g.,
proximal hub 84) of the balloon dilation catheter 80 to facilitate
navigation through the anatomy of the nasal and paranasal spaces,
such as the ostia of the sinuses. Preferably, in both embodiments,
the construction of the shaft 82 permits the distal tip 88 to be
rotated in a substantially 1:1 relationship with rotational
movement of the proximal end of the catheter 80. That is to say, if
the proximal end of the balloon dilation catheter 80 is rotated
through an angle of about 90.degree., the distal tip 88 is also
rotated through an angle of about 90.degree.. The embodiments
illustrated in FIGS. 10A through 12F may include a lumen 96 for
placement of a flexible endoscope, or they may not have such a
lumen. If no such lumen is provided in the balloon dilation
catheter 80, a flexible endoscope 42 may still be utilized to guide
the positioning of the balloon dilation catheter 80, but will
reside in a different component, as will be described later.
[0130] FIG. 10A illustrates a balloon dilation catheter 80 having a
shaft 82 having multiple regions (two as shown in FIGS. 9A-9C)
which includes a proximal region 82a and a distal region 82b. It is
contemplated that further additional regions (e.g., beyond two)
could also be incorporated. In this embodiment, the proximal region
82a is a polymeric tube with an incorporated braid 81.
Incorporation of a braid 81 significantly increases the torsional
rigidity of the shaft 82. A lumen 90 (seen in FIGS. 10B and 10C)
extends inside the shaft 82 for inflation and deflation of the
expandable balloon 86. The distal region 82b of the shaft 82 is an
extension of the proximal tubular member and may be formed by
necking or shrinking the diameter of the tubing utilizing, for
example, a heat forming process. The distal region 82b still
includes the braid 81 albeit it at a reduced diameter. By reducing
the diameter of the distal region 82b, the distal region 82b
becomes more flexible, which facilitates its ability to navigate
tortuous pathways within the nasal and paranasal spaces. One or
more ports or passageways 83 (seen, for example, in FIGS. 8A, 8D,
9A, 9B, 10A and 10B) are disposed in the side wall of the distal
region 82b within the balloon 86 to allow for fluid communication
between the inflation lumen 90 and the balloon 86. As seen in FIG.
10A, the curved distal tip 88 is secured to the distal end of the
braid-incorporated shaft 82 in the distal region 82b, however the
curved distal tip 88 could also be formed as an extension of the
braid-incorporated shaft 82. An optional bulbous tip 88b which may
have an oval or olive-shape, (e.g., "olive tip") may also be
incorporated to make the tip relatively atraumatic to the tissues
it may encounter in the nasal and paranasal spaces. The curved
distal tip 88 can be attached or formed by suitable means such as
thermal bonding, adhesive bonding or thermal forming.
[0131] FIGS. 10D through 10F illustrate an embodiment wherein the
torque is transmitted to the distal tip 88 via an internal core
wire 85. A tubular outer jacket 87 surrounds the core wire 85 and
defines the inflation lumen 90 there between (best seen in FIG.
10F). The tubular outer jacket 87 is preferably formed of a
lubricious material such as high-density polyethylene, Nylon, or
Pebax, and is secured to the proximal end of the balloon 86 by
thermal or adhesive bonding. In this embodiment, the proximal end
of the core wire 85 and the proximal end of the outer jacket 87 are
preferably connected to a Luer fitting (not shown). The distal end
of the core wire 85 is connected to the curved distal tip 88.
[0132] Rotation of the proximal end (e.g., Luer fitting) transmits
rotation to the core wire 85, which in turn, transmits rotation to
the distal tip 88. The core wire 85 may have a varying diameter
along its length, being larger in the proximal region 82a and
smaller in the distal region 82b. The core wire 85 could have one
"step" as shown between the proximal region 82a and the distal
region 82b, or the core wire 85 could have multiple steps in
diameter or gradual changes in diameter. Alternatively, the
transition may be smooth from the larger diameter of the proximal
region 82a to the smaller diameter of the distal region 82b. A
preferred core wire 85 may be formed of highly cold-worked
stainless steel and may have a diameter in the proximal region 82a
of around 0.018 inches to around 0.030 inches, and a diameter in
the distal region 82b of around 0.005 to around 0.015 inches. Both
the proximal region 82a and the distal region 82b could have
multiple steps, or a gradually changing diameter between the above
ranges.
[0133] FIGS. 11A through 11C shows an embodiment of a balloon
dilation catheter 80 having multiple, separate braided shaft
components 81a, 81b connected together, rather than reforming a
single braided shaft 81 configuration into multiple regions having
differing characteristics, as illustrated in the embodiment of
FIGS. 10A-10C. As best seen in FIG. 11A, the balloon dilation
catheter 80 includes a proximal braided tubular shafts 81a and a
distal braided tubular shaft 81b. Preferably, the outer diameter
(OD) of the distal shaft 81b is small enough to be inserted into
the internal diameter (ID) of the proximal shaft 81b to allow for
some overlap between the two braided structures. The two braided
segments 81a, 81b may be secured to each other by any suitable
means such as the use of an adhesive or thermal bonding the two
segments 81a, 81b. Additional polymeric material 103 (shown in FIG.
11A) may be optionally added to "backfill" the junction between the
two segments 81a, 81b. The backfill material 103 may be additional
adhesive or an addition thermoplastic polymer.
[0134] FIGS. 11D through 11F illustrate still another alternative
embodiment of a balloon dilation catheter 80. The embodiment of
FIGS. 11D through 11F makes use of a tubular braided shaft 81a for
the proximal portion 82a of the catheter shaft 82 and a core wire
85 surrounded by a tube or jacket 87 for the distal portion 82b of
the catheter shaft 82. The proximal end of the core wire 85 is
secured to the distal end of the braided shaft 81a by suitable
means such as adhesive 89, while the distal end of the core wire 85
is secured to the distal tip 88. Rotation of the proximal braided
shaft portion 82a transfers rotation to the core wire 85 and,
consequently, to the distal tip 88. In this embodiment, it is also
contemplated that the proximal tubular braided shaft 81a could also
be a solid-walled metal tube such as a stainless steel hypotube (or
other material). The core wire 85 could then be secured to the
distal end of the hypotube component by use of a weld, braze,
solder, or adhesive 89.
[0135] FIGS. 12A through 12C illustrate another alternative
embodiment of a balloon dilation catheter 80. In the embodiment of
FIGS. 12A-12C, the shaft 82 uses one or more tubular braided shaft
components 81a, 81b (either separately formed and secured, or
"reformed" form a single braided tubular shaft component 81) and a
core wire 85, which extends from the distal end of the distal-most
braided shaft 81b structure through the balloon 86 to the distal
tip 88. In this embodiment, rotational movement of the proximal
portion of the catheter shaft 86 is transmitted via the braided
shaft region(s) (81 or 81a and 81b) to the core wire 85 and onto
the distal tip 88. This embodiment is different from that disclosed
in FIGS. 11D-11F in that the braided portion 81 extends further
along the catheter shaft 86 until the proximal end of the balloon
86. Further, the core wire 85 is shorter, traversing across the
interior of the balloon 86 until the distal tip 88. Bonding between
the core wire 85 and braided shaft (e.g., 81 or 81b) may be as
described above with respect to the embodiment of FIGS.
11D-11F.
[0136] FIGS. 12D-12F illustrates still another alternative
embodiment for a balloon dilation catheter 80. The embodiment of
FIGS. 12D-12F uses a hypotube 97 for the shaft 82. The hypotube 97
of the proximal shaft region 82a is solid-walled, whereas the
distal shaft region 82b has a pattern 91 cut into the wall which
greatly increases the flexibility of the distal region, while
maintaining significant torsional stiffness to facilitate
torquing/rotation of the distal tip 88 which may optionally be
curved and include a bulbous end 88b. There are numerous slot
configurations which can accomplish this, including an "interrupted
spiral" pattern 91 (as illustrated in FIG. 12D), or a series of
interconnected rings. The pattern 91 may be formed in any number of
ways known to those skilled in the art. This may include, for
example, using a laser to cut such slots 91 within a tubular
component such as metallic hypotube 97. The hypotube 97 may end at
the connection with the distal tip 88 or, alternatively, the
hyptotube 97 can extend within a polymeric structure to create or
form the curved distal tip 88. The slot pattern 91 may be uniform
along the length of the distal shaft region 82b, or it can vary.
Preferably the slot pattern 91 imparts greater flexibility in a
distal direction along the distal shaft portion 82b. This may be
accomplished, for example, by beginning with a coiled slot of a
longer pitch proximally and becoming shorter in the distal
direction. The proximal portion of the shaft 82a is preferably
covered with a polymeric tube or jacket 93 to build up the diameter
to facilitate hand manipulations. The polymeric tube 93 preferably
extends to the balloon 86 as is shown in FIG. 12D, but is thinner
in the distal portion 82b to facilitate higher flexibility. The
polymeric tube 93 also serves to seal the slots 91 contained in the
hypotube 97 that are located proximal with respect to the balloon
86. The slots in the hypotube 97 within the balloon 86 serve to
conduct the inflation fluid to the balloon 86 for inflation and/or
deflation.
[0137] In the embodiments of the balloon dilation catheter 80
described in FIGS. 10A through 12F, for use in dilating the
maxillary sinus ostium/infundibulum via the canine fossa, the
proximal region 82a may have an ID of around 0.025 inches and an OD
of around 0.055 inches. The distal region 82b may have an ID of
around 0.010 inches and an OD of around 0.030 inches. The length of
the distal tip 88 may be about 3 mm to about 12 mm beyond the body
of the balloon 86, and more preferably from about 7 mm to 10 mm
beyond the body of the balloon 86 and may have between about
25-90.degree. of curvature. If the optional bulbous or "olive tip"
end 88b is used, it may have an OD of around 0.035 inches. The
expandable balloon 86 may have a number of sizes depending on the
application and anatomical peculiarities of the patient. For
example, the balloon 86, when inflated, may have ODs of around 3,
5, and 7 mm.
[0138] If a braid 81 structure is employed, the braid 81 may have
between 50-100 picks per inch and sixteen (16) or thirty-two (32)
wires. The braid wire may be around 0.0005.times.0.002 up to
0.0015.times.0.005 ribbon (all in inches), and formed form
stainless steel. Tubular materials such as that used for jackets
87, 93 may be formed from a polymeric material such as Nylon and
Pebax 35D to 72D. The length of the body of the balloon 86 may vary
from about 15 mm to about 25 mm but is preferably about 20 mm in
length. The balloon 86 may be formed from a number of polymeric
materials including, for example, PET, Nylon 12, Pebax, and may be
blow molded. Bonding between the balloon 86 and the shaft 82 of the
balloon dilation catheter 80 may be accomplished using heat bonding
or adhesive bonding.
[0139] The total length of the balloon dilation catheter 80 may
vary, in part because of the length of the cannula 20, but the
balloon dilation catheter 80 generally has a length within the
range of about 20 to about 40 cm. If a distal shaft portion 82b is
used, it is at least as long as the balloon 86 an may extend
proximally, distally, or both with respect to the ends of the
balloon 86.
[0140] It should be understood that the dimensions and materials
discussed above are exemplary and meant to be illustrative of the
dimensions and materials contemplated to be used in connection of
the apparatus 10. Dimensions and materials falling outside of the
list and ranges mentioned above may still fall within the scope of
the invention.
[0141] FIGS. 13A through 13C illustrate a method of forming and
maintaining an access passageway to the maxillary sinus via the
canine fossa (CF) region of a patient. FIG. 13A illustrates a
piercing tool 100 such as a trocar loaded with the sheath 108 as
well as the stop 106. The piercing tool 100 may be made of a
metallic material such as stainless steel and may have a diameter
at least as large as the cannula 20 that will then be used to
access the anatomy of interest. In FIG. 13A, the sheath 108 is
partially obstructed from view by the stop 106. The piercing tool
100 includes a proximal handle 104 that is grasped by the physician
or other health professional that performs the operation. The
piercing tool 100 further includes a sharpened distal tip 102 that
will be used to tissue the soft tissue/bony structure of the canine
fossa CF region (or other soft tissue/bony structure). The
sharpened distal tip 102 may be a multi-faceted type (e.g., three
facets) as illustrated in FIG. 13A. A multi-faceted tip 102 allows
for the trocar 100 to be introduced into the soft tissue of the
gums until in encounters the bony structure defining the sinus
cavity.
[0142] As seen in FIG. 13A, the piercing tool 100 is advanced in
the direction of arrow A to initially pierce or puncture the gum of
the patient. Once the bony structure of the sinus cavity is
reached, the trocar 100 may be rotated back and forth (e.g.,
clockwise then counter-clockwise or vice versa) while light
pressure in the direction of arrow A is applied. The trocar 100
essentially drills into the bone until it enters the sinus cavity.
As seen in FIG. 13A, the removable stop 106 prevents the trocar 100
from penetrating too deep into the sinus cavity which could
inadvertently puncture the other side of the cavity or other
anatomical spaces. The stop 106 mechanically interacts with the
trocar 100 such that it is prevented from moving proximally along
the trocar 100, as will become clear below. The stop 106 may
include a flange 105 located at one end of the stop 106 that is
large enough to atraumatically prevent the trocar 100 from
advancing too far. For example, the flange 105 may extend about the
periphery of the stop 106 and have an outer diameter that is about
1 mm to about 5 mm larger than the OD of the trocar 100. After
access is made to the sinus cavity, the removable stop 106 may be
removed from the trocar 100 as is shown in FIG. 13B. The
longitudinal slit 107 in the stop 106 permits the stop 106 to be
"peeled off" the trocar 100.
[0143] With reference now to FIG. 13B, once the stop 106 is
removed, the sheath 108 (which is mounted on the shaft of the
trocar 100) is advanced into the access passageway formed in the
canine fossa CF region until a flange 111 on the proximal end of
the sheath 108 abuts the external tissue. The sheath 108 is
preferably formed from a thin-walled tube, which may be polymeric
or metallic. For example, the sheath 108 may be stainless steel or
a nickel titanium alloy (e.g., NITINOL), with a series of slots 109
cut into it to allow for diametric and lateral flexibility. The
sheath 108 may be between 0.002 inches and 0.006 inches thick and
between about 1 cm and about 3 cm long, with an initial outer
diameter equal to or slightly smaller than the outer diameter of
the trocar tip 102. Initially the sheath 108 sits in a recess on
the shaft of the trocar 100. This enables the sheath 108 to be
advanced into the soft tissue and the bone without catching or
hanging on the tissue. The recess is preferably at least as deep as
the wall thickness of the sheath 108, but may also be deeper, such
that when assembled, the outer diameter of the trocar tip 102 is
larger than the outer diameter of the sheath 108. In this manner,
the hole formed by the trocar tip 102 is somewhat larger than the
sheath 108. This diameter difference enables the sheath 108 and
subsequent tools such as the cannula 20 to be more easily
manipulated within the sinus cavity. Also, the proximal ledge of
the recess prevents proximal movement of the sheath 108. The flange
111 on the sheath prevents proximal movement of the stop 106. Once
the sheath 108 is fully inserted, the tip 102 of the trocar 100 is
pulled back from the sheath 100 in the direction of arrow B, as
depicted in FIG. 13C. The sheath 108 is now positioned within the
access passageway and is used to maintain a lumen 110 through which
the various devices may pass during the remainder of the
procedure.
[0144] FIGS. 14-18 illustrate various cross-sectional
representations of the right nasal cavity of a subject. The right
nasal cavity is shown but the description applies equally to the
left side as well. FIGS. 14-18 generally illustrate the teeth 120,
roof of the mouth 122, the palate 124, the nose 126, portions of
the skull 128, the lower part of the right frontal sinus cavity
130, and a portion of the right sphenoid sinus cavity 132. The
dotted circular line 134 is the ostium of the right maxillary
sinus, which sits in a structure lateral to the nasal wall. The
flap-like structure 136 is the middle turbinate. The channel 137
(shown as a dashed line going in the superior or vertical
direction) going up to the right frontal 130 sinus is also
depicted, as it is lateral to the nasal wall. The dashed line D
just above the middle turbinate 136 depicts the site of attachment
(shown as attached to the nasal wall but this can vary in different
patients).
[0145] FIG. 15 illustrates various anatomical structures of the
nasal cavity that are located "underneath" or lateral to the middle
turbinate 136. For illustration purposes, the middle turbinate 136
in FIG. 15 has been lifted up to reveal the uncinate process 138
which is a rim of mucosa covered bone extending medially from the
lateral nasal wall and it is anterior to the hiatus semilunaris
140, the opening between the edge of the uncinate process 138 and
the more posterior ethmoid bulla (not shown). The "pocket"
underneath or lateral to the uncinate process is the ethmoid
infundibulum 142. The ethmoid infundibulum 142 as well as the
ostium 134 and the hiatus semilunaris 140 associated with the
maxillary sinus can all be quite narrowed in a patient with
suspected sinusitis. This narrowing can be a combination of
inflammation of the mucosa, scar tissue, mucous, pus, polypoid
tissue, narrowed underlying bony structure, or other pathology. The
three arrows A, B, C in FIG. 15 indicate the three general
directions extending from the maxillary sinus cavity through the
ostium 134 and nasal cavity. The first direction, represented by
arrow A, is a generally superior direction, towards the frontal
recess and frontal sinus. The second direction, represented by
arrow B in FIG. 15, is a "straight shot" out of the ostium 134 to
and across the ethmoid bulla and towards the attachment point A of
the middle turbinate 136. The third direction, represented by arrow
C in FIG. 15 is posterior, generally running parallel to the
attachment ridge or line of the middle turbinate 136.
[0146] FIG. 16 illustrates in partial phantom the distal end of a
balloon dilation catheter 80 positioned in the maxillary sinus
ostium 134. As shown, the distal tip 88 and the expandable balloon
86 are shown passing through the infundibulum 142, lateral to the
uncinate process 138, and curving in a posterior direction (e.g.,
along path C in FIG. 15). For illustration purposes, the middle
turbinate 136 is shown removed to allow better viewing of the
balloon 86. The posterior placement of the balloon dilation
catheter 80 is a preferred position for purposes of dilating the
maxillary sinus ostium 134, infundibulum 142, and uncinate process
138. The balloon dilation catheter 80 shown here has a distal tip
88 to help facilitate placement of the balloon 86 in the posterior
direction. The previously described embodiments of balloon dilation
catheters 80 with distal tips 88 are preferred for such placement,
and would facilitate such placement.
[0147] FIG. 17 illustrates a balloon dilation catheter 80
positioned in the "straight shot" direction (i.e., direction of
arrow B in FIG. 15) as the balloon 86 emerges from the ostium 134
and infundibulum 142. To facilitate the balloon 86 being positioned
in this direction, it is preferred to utilize a balloon 86 with a
short distal tip 88 (as shown), or no tip. FIG. 18 illustrates a
balloon dilation catheter 80 with the balloon 86 positioned in a
superior direction (i.e., in the direction of arrow A of FIG. 15)
as the balloon 86 emerges from the ostium 134 and infundibulum 138.
To place a balloon dilation catheter 80 in this position, it is
preferred to make use of a balloon dilation catheter 80 with a
curved distal tip 88 as shown in FIG. 18 and described in more
detail herein. More preferably, a balloon dilation catheter 80 is
used that has a "torqueable" curved distal tip 88 that can be
controllably rotated. For example, rotation of the proximal end or
region of the balloon dilation catheter 80 translates into a
rotating or torquing movement of the curved distal tip 88.
[0148] In one aspect, the balloon dilation catheter 80 is initially
placed inside the ostium 134 in the posterior direction. The distal
tip 88 can then be re-oriented by a rotational movement of the
distal tip 88 (e.g., by rotation of the proximal end or region of
the balloon dilation catheter 80) and further advanced in
re-oriented direction (e.g., the medial direction).
[0149] Turning now to FIGS. 19-22, a method of treating sinusitis
is illustrated using a apparatus 10 in which the imaging tool 40
(e.g., endoscope 42) and balloon dilation catheter 80 are
positioned using a guide wire 60. In the method illustrated in
FIGS. 19-22, an access passageway has been made in the canine fossa
region CF using the piercing tool 100 described in more detail
herein (e.g., shown in FIGS. 13A-13C). While access to the
maxillary sinus is made through the CF region, access to the
maxillary sinus or other sinus cavity may be made through a
trephination or the like through which a dilation balloon catheter
80 of the type described herein is placed.
[0150] Initially, FIG. 19 illustrates a cannula 20 positioned
within the artificial opening or passageway formed in the canine
fossa region CF. FIG. 19 omits the sheath 108 but in other
embodiments, the cannula 20 may be passed through a temporary
sheath 108 that is placed in the newly formed opening. The cannula
20 is shown having a curved distal tip 26 to better allow access
toward the ostium 134 and associated infundibulum. An imaging tool
40 such as a flexible endoscope 42 has been placed within that
cannula 20 and over the guide wire 60. In this regard, the
endoscope 42 incorporates a guide wire lumen 56 as shown in FIG. 1A
(hidden from view in FIG. 19) such that the endoscope can be slide
over the guide wire 60.
[0151] FIG. 19 illustrates a curved (e.g., "j" bend or the like)
distal tip 66 of the guide wire 60 projecting from the distal end
of the endoscope 42, the orientation of which can be controlled by
manipulating the proximal end 62 of the guide wire. FIG. 19
illustrates a person such as a physician or the like looking
through the eyepiece 52 of the endoscope 42 to view the ostium 134
and associated infundibulum. Optionally, the eyepiece 52 could be
hooked up to a camera and monitor (not shown). The field of view of
the endoscope 42 is shown (dashed conical region) projecting from
the distal end 48.
[0152] Referring now to FIGS. 19 and 20, the cannula 20 is
manipulated to aim the guide wire 60 to the ostium 134, using the
endoscopic image to guide the manipulation. In FIG. 20, the guide
wire 60 is shown being advanced across the ostium 134 and into the
nasal cavity. The guide wire 60 preferably incorporates a series of
visible markers 72a, 72b, and 72c on the distal portion 66.
Corresponding visible markers 74a, 74b, and 74c are located on the
proximal portion 62 and are spaced a known distance from the
corresponding visible markers 72a, 72b, 72c on the distal end 66.
For example the distal markers 72a, 72b, 72c could be different
colors. Alternatively, the first mark (e.g., most distal mark)
could have one configuration or appearance, e.g. a single mark (as
shown in FIG. 20), and the second marker (from the distal tip)
could be of a different configuration or appearance (e.g., two
marks as shown in FIG. 20). FIG. 20 shows a third marker 72c (from
the distal tip) that is formed from three (3) marks. The distance
between the first mark 72a on the distal portion 66 and the
corresponding first mark 74a on the proximal portion 62 would be
predetermined. The distance between the second mark 72b on the
distal portion 66 would be the same predetermined distance to the
corresponding second mark 74b on the proximal portion 62.
Similarly, the distance between the third mark 72c on the distal
portion 66 would be the same predetermined distance to the
corresponding third mark 74c on the proximal portion 62.
[0153] The particular marker at or near the ostium 134 is noted.
The endoscope 42 is then removed from the guide wire 60, as shown
in FIG. 21, leaving the guide wire 60 in place through the cannula
20 and positioned across the ostium 134. As shown in FIG. 21, the
cannula 20 is kept in a stable position using a stabilizing member
150 to keep its position relative to the ostium 134 constant. For
example, a stabilizing member of the type described in U.S. patent
application Ser. No. 11/379,691 may be used to stabilize the
cannula 20. The '691 application is incorporated by reference as
set forth fully herein. Alternatively, the operator can manually
stabilize the position of the cannula 20 with his/her hands.
[0154] Next with reference to FIG. 22, a balloon dilation catheter
80 is then positioned over the guide wire 60. A reference length on
the balloon dilation catheter 80 corresponds to the distance
between the sets of visible markers on the guide wire 60. For
example the distance between the corresponding distal mark 72c and
proximal mark 74c on the guide wire 60 could be equal to the
distance between the midpoint of the balloon 86 and the proximal
end 84 of the balloon dilation catheter 80. In this manner, the
midpoint of the balloon 86 would be at or near where the previously
noted mark 72c (shown by arrow A in FIG. 22) on the guide wire 60
was located, just as the corresponding mark 74c (shown by arrow B
in FIG. 22) on the proximal portion comes into view behind the
proximal end 84 of the balloon dilation catheter 80.
[0155] FIGS. 23-25 illustrate still other embodiments of treating
sinusitis with the apparatus 10 described herein. FIGS. 23-25
illustrate a method of using a balloon dilation catheter 80 to
dilate the ostium 134 of the maxillary sinus and the infundibulum
space and the uncinate process. Though not illustrated, the same
devices and sub-components described herein could be applied to
other sinuses beyond the maxillary sinus, such as the frontal
sinus, where the access could be made through a trephination of the
frontal sinus to gain access to the cavity, and thereafter dilating
the frontal sinus ostium and frontal recess area via the
trephination access site using a balloon dilation catheter 80 and
delivery system of the type described herein.
[0156] FIG. 23 illustrates the bony structure of the skull defining
the sinus cavities. In this embodiment, a cannula 20 such as the
one described with respect to FIG. 2G (or any above described
cannula 20 with a secondary channel or lumen 30) is positioned in
an access hole or passageway created at or near the canine fossa CF
region and advanced into the maxillary sinus. An optional sheath
108 (not shown in FIGS. 23-25) may be used to maintain an open
passageway and prevent the distal end of the imaging tool 40 from
being obscured from blood or other biological material while it is
advanced into the sinus cavity. In one aspect of the procedure, the
patient is given a local anesthetic (with or without some sedation)
prior to the access and subsequent dilation procedure. This local
anesthesia is preferably applied via standard techniques such as a
needle injection to the canine fossa (CF) region, as well as at
sites near the ostium of interest (preferably via transnasal
injections). The patient may be lying or his or her back or,
alternatively, the patient may be sitting in a chair much like that
found in a dentists office. In yet another aspect, the patient may
be under general anesthesia during the entire procedure.
[0157] Referring to FIG. 23, the cannula 20 has a secondary channel
or lumen 30 through which a flexible endoscope 42 is positioned,
with the distal end 48 advanced to the distal end or tip 26 of the
cannula 20. The cannula 20 may be manipulated by advancing,
rotating and sweeping until the maxillary ostium 134 is in view. In
some instances it may be desirable to irrigate and/or aspirate the
maxillary sinus cavity(s) prior to the dilation procedure. Such a
procedure may be accomplished prior to insertion of the cannula 20,
or alternatively, at the same time the cannula 20 is positioned
within the sinus cavity of interest. For example, an irrigation
and/or aspiration device (not shown) may be advanced through the
main lumen 22 or secondary lumen 30 of the cannula 20, or performed
as a separate procedure following known techniques.
[0158] Next, with reference to FIG. 24, once the ostium 134 is in
view, a balloon dilation catheter 80 is positioned within the
cannula 20. The balloon dilation catheter 80 may include an
embodiment in which the distal tip 88 is curved so that it can be
directed by rotation of the proximal portion 84 of the balloon
dilation catheter 80. Once the distal tip 88 emerges from the main
lumen 22 of the cannula 20, it can be visualized by the operator
via the endoscope 42. Optional color patterns (not shown) can be
provided on the distal tip 88 to aid in imaging. For example, one
or more longitudinal stripes could be provided on the distal tip
88, to help identify it in the field of view of the endoscope 42.
Additionally, the balloon 86 could be provided with a color tint or
texture to help minimize light reflection in the field of view.
Such light reflection may distract from the viewing of the distal
tip 88. The distal tip 88 is manipulated across the ostium 134 by a
combination of manipulations including advancement, rotation,
cannula manipulations, and to-and-fro movements together with
rotations. The objective here is to guide the distal tip 88 to and
through the ostium 134 and infundibulum, and positioning the
balloon 86 across the entire anatomical space (as illustrated in
FIG. 24). Preferably the balloon 86 is long enough such that when
it is inflated, a portion of the distal end of the balloon 86 is
distally positioned past the edge of the uncinate process, and a
portion of the proximal end of the balloon 86 proximally positioned
relative to the maxillary sinus ostium 134. This positioning can be
done via a visible mark placed on the balloon 86 (not shown) which
can be placed at a desired location relative to the anatomy.
[0159] Once the distal tip 88 and balloon 86 are through the sinus
ostium 134, it is preferable to orient the curve of the distal tip
88 in either a posterior or medial direction as opposed to an
anterior, lateral, or superior direction. This is done because
there are anatomical features in the superior/anterior part of the
infundibulum that are desirable to avoid, such as the agger nasi
cell or a recessus terminalus. Also, to position the distal tip 88
and some of the distal balloon 86 beyond the edge of the uncinate
process often requires that the distal tip 88 be oriented medially
to help guide the distal portion of the balloon 86 in the medial
direction. The position of the distal tip 88 can optionally be
confirmed via trans-nasal endoscopic imaging, using know tools and
techniques. Alternatively, one or more radiopaque markers (not
shown) on the balloon dilation catheter 80, within the balloon 86
could be utilized in conjunction with fluoroscopy to confirm the
positioning of the balloon 86 prior to inflation.
[0160] With reference now to FIG. 25, once the balloon 86 is in a
desired position, it is inflated by passing an inflation fluid
through the inflation lumen 90. For example, a syringe or the like
coupled to the proximal hub 84 may be used to forcibly pass
inflation fluid into the interior of the balloon 86 to effectuate
expansion. The inflation may optionally be witnessed by the
endoscope 42. After a sufficient dilation pressure has been
applied, for example, up to between about 4 and about 12
atmospheres of pressure, the balloon 86 is deflated and withdrawn
back (proximally) into the lumen 22 of the cannula 20. The
resulting dilation can then be directly viewed with the endoscope
42 to confirm a successful/unsuccessful dilation of the anatomy of
interest. After viewing the site, the balloon 86 may have to be
re-deployed across the anatomical site of interest for one or more
dilation(s).
[0161] FIG. 26 illustrates an exemplary flexible endoscope 42
(available from Storz as described herein) that may be used in
connection with the dilation methods described herein. The flexible
endoscope 42 may be usable in the primary or main lumen 22 of a
cannula 20 or, alternatively, the flexible endoscope 42 may be
adapted for passage through a secondary lumen 30 contained in or on
a cannula 20. In yet another alternative, the flexible endoscope 42
may be adapted for use through a lumen 96 (as shown, for instance,
in FIGS. 4A-4D, 5, 6A-6D, 7B and 7C) contained inside a balloon
dilation catheter 80. The endoscope 42 may include a connector
portion 160 that is flexible yet robust that connects a main
portion of the endoscope 42 and a remotely located eyepiece 52. The
eyepiece 52 may be viewed directly by a physician or,
alternatively, the eyepiece may be coupled to a camera or imaging
device for visualization on a separate monitor or the like (not
shown in FIG. 26).
[0162] Still referring to FIG. 26, the endoscope 42 may include a
connector 54 adjacent to the eyepiece 52 for coupling to a light
source for illuminating the anatomical site of interest. Multiple
light transmission fibers 162 (e.g., fiber optic fibers) may
surround a fused quartz imaging bundle 164. The distal end 160a of
the connector portion 160 may include a metallic manifold with
multiple (e.g., two) Luer fittings 166, 168. One such fitting 166
surrounds the proximal end of the main endoscope portion 42 and the
other 168 projections laterally which is fluid communication with
the first Luer fitting 166.
[0163] FIG. 27 illustrates the endoscope 42 inserted into a cannula
20 that incorporates a secondary lumen 30 through which the
endoscope 42 may pass. Since the overall length of the cannula 20
is considerably shorter than the length of the main portion of the
endoscope 42, a significant length of "exposed" endoscope 42
extends between the manifold or connector 160 of the endoscope 42
and the proximal end or hub 31 of the secondary lumen 30. The
proximal hub 31 may have a funnel shape such as provided by a
female Luer fitting and an optional Tuohy Borst valve (not shown).
While this arrangement of the endoscope 42 and cannula 20 is
useable, the exposed endoscope 42 is somewhat fragile and
vulnerable to damage or fracture if it is inadvertently kinked,
buckled, or crushed during handling or manipulation.
[0164] Consequently, in order to help protect the endoscope 42
during handling and manipulation, a protective sleeve 180 can be
provided, as shown in FIG. 27B. The protective sleeve 180 is
flexible enough to not interfere with the routine handling of the
endoscope 42 and cannula 20 during the procedure, yet is able to
prevent the main portion of the endoscope 42 from kinking,
buckling, or crushing. The length of the protective sleeve 180 may
be tailored to cover the full length of what would have been
exposed between the manifold 160a of the endoscope 42 and the
proximal hub 31 of the cannula 20, when the endoscope 42 is fully
inserted into the secondary lumen 30 during use.
[0165] In use, the endoscope 42 would first be inserted into the
proximal end 180a of the protective sheath 180. A portion of the
endoscope 42 would emerge and extend distally of the distal end
180b of the protective sheath 180. The proximal end 180a of the
sheath 180 would then be secured to the manifold 160a of the
endoscope, such as via the Luer connector 166 or the like. The
distal portion 180b of the endoscope 180 may then be inserted into
the secondary lumen 30 of the cannula 20. When the distal end 48 of
the endoscope 42 is at the desired position at the distal end of
the secondary lumen 30, the distal end 180b of the protective
sheath is secured to the proximal hub 31, such as by a Luer
connection. In this manner, the full length of the relatively
fragile endoscope 42 is protected for the duration of the
procedure. When the procedure is complete (e.g., after the
patient's sinus ostia have been dilated), the sleeve 180 can be
disconnected from the cannula 20. In general, the endoscope 42 is a
reusable and re-sterilizable device, while the other devices or
sub-components described herein may be disposable, such as the
cannula 20 and the balloon dilation catheter 80. The protective
sleeve 180 may be left in place to keep the majority of the fragile
portion of the endoscope 42 protected during re-sterilization and
storage until it is needed for a next procedure. The endoscope 42
can be re-sterilized with the protective sleeve 180 in place. The
Luer fitting 168 can be utilized to infuse cold sterilant (such as
used in a Steris.TM. device) through the inside of the protective
sleeve 180 and the outside of the endoscope 42.
[0166] FIG. 27B also illustrates a version of the protective sleeve
180 in which the sleeve is formed from nesting halves 180a, 180b.
As seen in FIG. 27B, the distal half 180b is dimensioned to pass
within a lumen or channel of the proximal half 180a. In this
regard, the overall length of the protective sleeve 180 may be
varied. The two halves 180a, 180b may include telescoping nesting
tubes which can be moved axially with respect to one another to
adjust the overall length.
[0167] As seen in FIG. 28A, the proximal half 180a may include an
internal detent or rib 182 that engages with a flange 184 on the
end of the distal half 180b of the protective sleeve 180. The
internal detent or rib 182 limits axial movement of the distal half
180b within the lumen or channel of the proximal half 180a. In
addition, if multiple the detents or ribs 182 are used (as shown in
FIG. 28A) these can be used to lock the protective sleeve 180 in a
collapsed state. In this initial position, the endoscope 42 would
be inserted into the sleeve 180, emerging and extending from the
distal end 180b. Once the endoscope 42 is in a desired position at
the distal end of the secondary lumen 30, the distal end of the
sleeve 180 is secured to the proximal hub 31 of the endoscope 42.
If necessary, the length of the protective sleeve 180 may be
extended to facilitate this connection.
[0168] At the end of the procedure, the sleeve 180 may be removed
from the cannula 20. The sleeve 180 can then be extended to an
extended position, which preferably is at least long enough to
cover the entire length of the fragile portion of the endoscope 42.
One or more detents or ribs 182 on the inner surface at the distal
end of the proximal half of the sleeve 180a prevent the distal
portion of the sleeve 180b from completely separating from the
proximal half 180a. The endoscope 42 together with the protective
sleeve 180 can then be re-sterilized and stored together. At the
start of the next procedure, the protective sleeve 180 may be
contracted in length to allow for insertion of the endoscope 42
into the secondary lumen 30.
[0169] The tube(s) that comprise the protective sleeve 180 may be
flexible yet kink resistant. For example, FIG. 29 illustrates one
embodiment in which the tube 188 forming the protective sleeve 180
is includes a coil-embedded structure, wherein a coil 186 is
embedded into the wall of a flexible polymeric tubular material
188. In another embodiment, as illustrated in FIG. 30, at least one
of the tube(s) 188 that comprise the protective sleeve 180 can also
have a corrugated construction.
[0170] The embodiments described above for a protective sleeve 180
are useful in conjunction with the above-mentioned Storz endoscope
42 (or other flexible endoscopes 42) which have length of
relatively fragile small diameter portion that is longer than the
secondary lumen 30 on or within the cannula 20. The protective
sleeve 180 thus protects the fragile portion of the endoscope 42
that is not within the secondary lumen 30. Alternatively, it is
also possible to tailor the length of the fragile portion of the
endoscope 42 to match the length of the secondary lumen 30. The
manifold 160a on the endoscope 42 can then be directly connected to
the proximal end of the endoscope 42, for instance, by Luer
fittings. Further still, the optical components in the fragile
portion of the endoscope 42 including the light input fibers 162,
fused imaging bundle 164 and lens could be permanently secured and
sealed within the secondary lumen 30 of cannula 20. The cannula 20
together with the endoscope 42 would then preferably be an
integrated reusable and re-sterilizable structure.
[0171] FIG. 31 illustrates another embodiment of treating sinusitis
in which the endoscope 42 is advanced through a lumen 96 (hidden
from view in FIG. 31) contained in the balloon dilation catheter
80. FIG. 31 illustrates a cannula 20 placed in the artificially
created opening or passage in the canine fossa CF region. The
distal tip 88 of the balloon dilation catheter 80 is shown emerging
from the distal tip 26 of the cannula 20. Also, FIG. 31 illustrates
the distal end 48 of the endoscope 42 projecting distally from the
distal tip 88 of the balloon dilation catheter 80. The imaging
field of view is shown by the dashed conical portion extending
toward the patient's ostium 134. As seen in FIG. 31, location and
positioning of the balloon dilation catheter 80 and endoscope 42
may be accomplished by a series of twisting, rotational, and axial
movements of both the cannula 20 and the balloon dilation catheter
80.
[0172] While embodiments of the present invention have been shown
and described, various modifications may be made without departing
from the scope of the present invention. The invention, therefore,
should not be limited, except to the following claims, and their
equivalents.
* * * * *