U.S. patent application number 13/222414 was filed with the patent office on 2012-03-22 for methods and apparatus for treating disorders of the sinuses.
Invention is credited to John Y. Chang, Mina W.B. Chow, Isidro M. Gandionco, Eric A. Goldfarb, Michael J. Gottesman, Jessica M. Liberatore, Serena Swei Loh, Joshua Makower, Mei Y. Pader, Radit Tantisira, Hung Vo, John W. White.
Application Number | 20120071857 13/222414 |
Document ID | / |
Family ID | 45818398 |
Filed Date | 2012-03-22 |
United States Patent
Application |
20120071857 |
Kind Code |
A1 |
Goldfarb; Eric A. ; et
al. |
March 22, 2012 |
METHODS AND APPARATUS FOR TREATING DISORDERS OF THE SINUSES
Abstract
A medical device for the treatment of a sinus opening includes a
handle, a grooming sheath, a rail, a guide wire, a balloon catheter
and a balloon catheter movement mechanism. A method for treating a
sinus opening includes inserting a medical device for the treatment
of a sinus opening partially into a patient's anatomy, positioning
a guide wire operatively extending from a rail of the medical
device into a sinus opening of the patient, advancing a balloon
catheter from an annular lumen of the medical device and along both
the rail of the medical device and the guide wire with a balloon
catheter movement mechanism, and inflating the balloon
catheter.
Inventors: |
Goldfarb; Eric A.; (Belmont,
CA) ; Chow; Mina W.B.; (Campbell, CA) ; White;
John W.; (San Francisco, CA) ; Chang; John Y.;
(Los Altos, CA) ; Pader; Mei Y.; (Fremont, CA)
; Liberatore; Jessica M.; (Union City, CA) ;
Tantisira; Radit; (Menlo Park, CA) ; Loh; Serena
Swei; (San Carlos, CA) ; Makower; Joshua; (Los
Altos, CA) ; Vo; Hung; (Sunnyvale, CA) ;
Gandionco; Isidro M.; (Fremont, CA) ; Gottesman;
Michael J.; (Redwood City, CA) |
Family ID: |
45818398 |
Appl. No.: |
13/222414 |
Filed: |
August 31, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61385250 |
Sep 22, 2010 |
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61385263 |
Sep 22, 2010 |
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61385591 |
Sep 23, 2010 |
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61511237 |
Jul 25, 2011 |
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61511290 |
Jul 25, 2011 |
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Current U.S.
Class: |
604/514 ;
604/103.05 |
Current CPC
Class: |
A61B 17/320016 20130101;
A61B 1/00147 20130101; A61M 29/02 20130101; A61M 25/09041 20130101;
A61M 25/0113 20130101; A61M 2025/0681 20130101; A61B 2017/22042
20130101; A61B 2017/22069 20130101; A61B 17/24 20130101; A61B
2017/00331 20130101; A61B 17/3207 20130101; A61M 2025/09125
20130101 |
Class at
Publication: |
604/514 ;
604/103.05 |
International
Class: |
A61M 25/10 20060101
A61M025/10; A61M 25/09 20060101 A61M025/09 |
Claims
1. A medical device for the treatment of a sinus opening, the
medical device comprising: a handle with: a proximal end; a distal
end; and a longitudinal axis along the length of the handle; a
grooming sheath with a distal end and a proximal end, the proximal
end of the grooming sheath attached to the distal end of the
handle; a first rail with a distal end and a proximal end and
disposed partially within the grooming sheath such that an annular
lumen is defined between the rail and the grooming sheath, the
distal end of the rail having an first angled shape, the rail being
rotatable relative to the longitudinal axis; a guide wire
operatively extending from the distal end of the rail; a balloon
catheter disposed at least partially in the handle and annular
lumen; and a balloon catheter movement mechanism operatively
disposed on the handle; wherein the balloon catheter movement
mechanism is configured for advancement and retraction of the
balloon catheter through the handle and annular lumen and along the
rail and guide wire by user operation of the balloon catheter
movement mechanism.
2. The medical device of claim 1 wherein the distal end of the
grooming sheath is expandable to facilitate advancement and
retraction of the balloon catheter.
3. The medical device of claim 2 wherein the distal end of the
grooming sheath comprises expandable slits.
4. The medical device of claim 1 wherein the guide wire is attached
to the distal end of the rail and extends beyond the distal end of
the rail a predetermined fixed length.
5. The medical device of claim 1 further including: a guide wire
movement mechanism operatively disposed on the handle; and wherein
the rail has a rail lumen, and wherein the guide wire is disposed
at least partially in the handle and the rail lumen; and wherein
the guide wire movement mechanism and the guide wire are configured
for advancement and retraction of the guide wire through the handle
and rail lumen by user operation of the guide wire movement
mechanism.
6. The medical device of claim 5 further including a guide wire
locking and rotation mechanism.
7. The medical device of claim 1 wherein the guide wire has: a
proximal end; a distal end; and an atraumatic tip attached to the
guide wire distal end;
8. The medical device of claim 1 wherein the grooming sheath is
configured to collapse a deflated balloon catheter during
retraction of the balloon catheter into the annular lumen.
9. The medical device of claim 1 wherein the balloon catheter has a
working segment.
10. The medical device of claim 9 wherein the working segment
further comprises a distal extension.
11. The medical device of claim 9 wherein the balloon catheter,
rail and guide wire are configured such that the balloon catheter
can be advanced from the annular lumen in a manner that the working
segment is positioned entirely over the guide wire for inflation of
the balloon catheter.
12. The medical device of claim 9 wherein the balloon catheter,
rail and guide wire are configured such that the balloon catheter
can be advanced from the annular opening in a manner that the
working segment is positioned partially over the guide wire and
partially over the rail for inflation of the balloon catheter.
13. The medical device of claim 9 wherein the balloon catheter,
rail and guide wire are configured such that the balloon catheter
can be advanced from the annular opening in a manner that that the
working segment is at least partially extended beyond the end of
the guide wire rail inflation of the balloon catheter.
14. The medical device of claim 1 wherein at least a portion of the
rail is formed of a malleable material such that the shape of the
rail can be manipulated by a user.
15. The medical device of claim 1 wherein the first rail may be
removed and replaced with a second rail having a second angled
shape.
16. The medical device of claim 1 wherein the rail includes an
endoscopic visible marking.
17. The medical device of claim 1 wherein the distal end of the
grooming sheath includes an atraumatic tip.
18. A method for treating a sinus opening, the method comprising:
inserting a medical device for the treatment of a sinus opening
partially into a patient's anatomy; positioning a guide wire
operatively extending from a rail of a medical device into a sinus
opening of the patient; advancing a balloon catheter of the medical
device from an annular lumen of the medical device and along both
the rail of the medical device and the guide wire; and treating the
sinus opening via inflation of the balloon catheter, wherein the
annular lumen is between the rail and a grooming sheath of the
medical device, and wherein the advancing is accomplished via user
operation of a balloon catheter movement mechanism of the medical
device.
19. The method of claim 18 further comprising: deflating the
balloon catheter; retracting the balloon catheter into the grooming
sheath; and removing the medical device from the patient's
anatomy.
20. The method of claim 18 wherein the positioning includes
advancing the guide wire from a rail lumen of the rail via a
sliding movement of a guide wire movement mechanism of the medical
device along a handle of the medical device.
21. The method of claim 20 further comprising: deflating the
balloon catheter; retracting the balloon catheter into the grooming
sheath and retracting the guide wire into the rail lumen; and
removing the medical device from the patient's anatomy.
22. The method of claim 18 wherein the patient's anatomy is a
nostril.
23. The method of claim 18 wherein the rail is formed of a
malleable material and the method further comprises: configuring
the malleable rail into a shape appropriate for the sinus opening
to be treated prior to the inserting step.
24. The method of claim 18 wherein the treating step includes
inflating a working segment of the balloon catheter that is
disposed entirely over the guide wire.
25. The method of claim 18 wherein the treating step includes
inflating a working segment of the balloon catheter that is
disposed partially over the guide wire and partially over the
rail.
26. The method of claim 18 wherein the treating step includes
inflating a working portion of the balloon catheter that extends
beyond a distal end of the guide wire.
27. The method of claim 18 further comprising suctioning the sinus
opening.
28. The method of claim 18 further comprising irrigating the sinus
opening.
Description
RELATED APPLICATIONS
[0001] This application claims priority pursuant to 35 U.S.C.
.sctn.119 to U.S. Provisional Patent Application Ser. No.
61/385,250, entitled "Medical Device for Treatment of a Sinus
Opening" filed on Sep. 22, 2010, to U.S. Provisional Patent
Application Ser. No. 61/385,263, entitled "Method for Treating a
Sinus Opening" filed on Sep. 22, 2010, to U.S. Provisional Patent
Application Ser. No. 61/385,591, entitled "Methods and Apparatus
for Treating Disorders of the Ear, Nose and Throat" filed on Sep.
23, 2010, to U.S. Provisional Patent Application Ser. No.
61/511,237, entitled "Medical Device and Method for Treatment of a
Sinus Opening" filed on Jul. 25, 2011, and U.S. Provisional Patent
Application Ser. No. 61/511,290, entitled "Methods and Apparatus
for Treating Disorders of the Sinuses" filed on Jul. 25, 2011, the
entirety of these applications being incorporated herein by
reference thereto.
FIELD OF THE INVENTION
[0002] The present invention relates, in general, to medical
devices and, in particular, to medical devices and related methods
for the treatment of sinus conditions.
BACKGROUND OF THE INVENTION
[0003] The paranasal sinuses are hollow cavities in the skull
connected by small openings, known as ostia, to the nasal canal.
Each ostium between a paranasal sinus and the nasal cavity is
formed by a bone covered by a layer of mucosal tissue. Normally,
air passes into and out of the paranasal sinuses through the ostia.
Also, mucus is continually formed by the mucosal lining of the
sinuses and drains through the ostia and into the nasal canal.
[0004] Sinusitis is a general term that refers to inflammation in
one or more of the paranasal sinuses. Acute sinusitis can be
associated with upper respiratory infections or allergic
conditions, which may cause tissue swelling and temporarily impede
normal trans-ostial drainage and ventilation of the sinuses,
thereby resulting in some collection of mucus and possibly
infection within the sinus cavities. Chronic sinusitis is a long
term condition characterized by persistent narrowing or blockage of
one or more sinus ostia, resulting in chronic infection and
inflammation of the sinuses. Chronic sinusitis is often associated
with longstanding respiratory allergies, nasal polyps, hypertrophic
nasal turbinates and/or deviated internasal septum. While acute
sinusitis is typically caused by infection with a single pathogen
(e.g., one type of bacteria, one type of virus, one type of fungus,
etc.), chronic sinusitis is often associated with multiple pathogen
infections (e.g., more than one type of bacteria or more than one
genus of micro-organism).
[0005] Chronic sinusitis, if left untreated, can result in
irreparable damage to the tissues and/or bony structures of the
paranasal anatomy. The initial treatment of chronic sinusitis
usually involves the use of drugs such as decongestants, steroid
nasal sprays and antibiotics (if the infection is bacterial). In
cases where drug treatment alone fails to provide permanent relief,
surgical intervention may be indicated.
[0006] The most common surgical procedure for treating chronic
sinusitis is functional endoscopic sinus surgery (FESS). FESS is
commonly performed using an endoscope and various rigid instruments
inserted through the patient's nostril. The endoscope is used to
visualize the positioning and use of various rigid instruments used
for removing tissue from the nasal cavity and sinus ostia in an
attempt to improve sinus drainage.
[0007] A technique known as the Balloon Sinuplasty.TM. procedure
and a system for performing the procedure has been developed by
Acclarent Inc, of Menlo Park, Calif. for treatment of sinusitis. A
number of US patents and patent applications including U.S. Pat.
Nos. 7,645,272, 7,654,997, and 7,803,150 and Publications
2008/0097154 and 2008/0281156 each of which is hereby incorporated
in full by reference, describe various embodiments of the Balloon
Sinuplasty.TM. procedure as well as various devices useable in the
performance of such procedure. In the Balloon Sinuplasty.TM.
procedure, a guide catheter is inserted into the nose and
positioned within or adjacent to the ostium of the affected
paranasal sinus. A guidewire is then advanced through the guide
catheter and into the affected paranasal sinus. Thereafter, a
dilation catheter having an expandable dilator (e.g. an inflatable
balloon) is advanced over the guidewire to a position where the
dilator is positioned within the ostium of the affected paranasal
sinus. The dilator is then expanded, causing dilation of the ostium
and remodelling of bone adjacent to the ostium, without required
incision of the mucosa or removal of any bone. The catheters and
guidewire are then removed and the dilated ostium allows for
improved drainage from and ventilation of the affected paranasal
sinus. There is a continuing need for improved methods and devices
for treating the paranasal sinus.
[0008] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings, in which like numerals
indicate like elements.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a simplified side view depiction of a medical
device according to an embodiment of the present invention.
[0010] FIG. 2 is a simplified cross-sectional depiction of the
medical device of FIG. 1.
[0011] FIG. 3 is a simplified side view of the medical device of
FIG. 1 with a guide wire of the medical device extended;
[0012] FIG. 4 is a simplified perspective depiction of the guide
wire, rail and grooming sheath of the medical device of FIG. 3;
[0013] FIG. 5 is a simplified side depiction of the medical device
of FIG. 1 with the guide wire and balloon catheter of the medical
device extended and the balloon catheter inflated over the guide
wire;
[0014] FIG. 6 is a simplified perspective depiction of the guide
wire, balloon catheter, and grooming sheath of the medical device
of FIG. 5;
[0015] FIG. 7 is a flow diagram depicting stages in a method for
treating a sinus opening according to an embodiment of the present
invention;
[0016] FIG. 8 is a simplified side view depiction of the medical
device of FIG. 1 with the guide wire and balloon catheter of the
medical device extended and the balloon catheter inflated over the
rail;
[0017] FIG. 9 is a simplified side cross-sectional depiction of the
medical device of FIG. 8;
[0018] FIG. 10 is a simplified side cross-sectional depiction of a
portion of the medical device of FIG. 8;
[0019] FIG. 11 is another simplified side cross-sectional depiction
of a portion of the medical device of FIG. 8;
[0020] FIG. 12 is a combined side view and multi-cross-sectional
view of the medical device of FIG. 3;
[0021] FIG. 13 is a simplified depiction of a balloon catheter
sub-assembly as can be employed in embodiments of the present
invention;
[0022] FIGS. 14A and 14B are simplified side and cross-sectional
views of the balloon catheter sub-assembly of FIG. 13;
[0023] FIG. 15 is a simplified depiction of another balloon
catheter sub-assembly as can be employed in embodiments of the
present invention;
[0024] FIG. 16 is a simplified cross-sectional view of a portion of
the balloon catheter sub-assembly of FIG. 15;
[0025] FIGS. 17A and 17B are combined side views and
multi-cross-sectional views of balloon catheters as can be employed
in embodiments of the present invention.
[0026] FIG. 18 is an embodiment of the device according to the
invention showing a side view of an alternative handle design.
[0027] FIG. 19 is an embodiment of the device according to the
invention showing a side view of the device with a further handle
design.
[0028] FIG. 20 is an embodiment of the device according to the
invention showing a side view of another alternative handle
design.
[0029] FIG. 21 is a side view of the distal end of a grooming
sheath according to the present invention.
[0030] FIG. 22 is a side view of the distal end of the rail of the
device according to the present invention.
[0031] FIGS. 23A and 23B are side and perspective views,
respectively and FIGS. 23C and 23D are front views of the distal
portion of the device according to the present invention.
[0032] FIG. 24 is an enlarged side view of the guide wire movement
mechanism according to the present invention.
[0033] FIG. 25 is a simplified side view of an alternative guide
wire movement mechanism and guide wire of the medical device
according to the invention.
[0034] FIG. 26 is a simplified cross-sectional view of the guide
wire movement mechanism and guide wire of FIG. 25 in a locked
position.
[0035] FIG. 27 is a simplified cross-sectional view of the guide
wire movement mechanism and guide wire of FIG. 25 in an unlocked
position.
[0036] FIG. 28 is a simplified transparent view of the guide wire
movement mechanism and guide wire of FIG. 25 in the absence of the
barrel of the guide wire movement mechanism.
[0037] FIG. 29 is an enlarged perspective view of the guide wire
movement mechanism of FIG. 24.
SUMMARY OF THE INVENTION
[0038] The present invention provides devices and methods for
treating a sinus opening.
[0039] In one aspect, a medical device is provided for the
treatment of a sinus opening. The medical device includes a handle
with a proximal end, a distal end, and a longitudinal axis along
the length of the handle. The medical device further includes a
grooming sheath with a distal end and a proximal end, the proximal
end of the grooming sheath attached to the distal end of the handle
and a rail with a distal end and a proximal end and disposed
partially within the grooming sheath such that an annular lumen is
defined between the rail and the grooming sheath, the distal end of
the rail having an angled shape with an angle appropriate for a
particular sinus, the rail being rotatable relative to the
longitudinal axis. The guide wire operatively extends from the
distal end of the rail, a balloon catheter is disposed at least
partially in the handle and annular lumen, and a balloon catheter
movement mechanism is operatively disposed on the handle. The
balloon catheter movement mechanism is configured for advancement
and retraction of the balloon catheter through the handle and
annular lumen and along the rail and guide wire by user operation
of the balloon catheter movement mechanism.
[0040] In one embodiment, the distal end of the grooming sheath is
expandable to facilitate advancement and retraction of the balloon
catheter. In a further embodiment, the expandable grooming sheath
includes expandable slits.
[0041] In another embodiment, the guide wire is attached to the
distal end of the rail and extends beyond the distal end of the
rail a predetermined fixed length.
[0042] In a further embodiment, the medical device includes a guide
wire movement mechanism operatively disposed on the handle. The
rail has a rail lumen, the guide wire is disposed at least
partially in the handle and the rail lumen, and wherein the guide
wire movement mechanism and the guide wire are configured for
advancement and retraction of the guide wire through the handle and
rail lumen by user operation of the guide wire movement
mechanism.
[0043] In another embodiment the guide medical device includes a
guide wire locking and rotation mechanism.
[0044] In another embodiment the guide wire has a proximal end, a
distal end and an atraumatic tip attached to the guide wire distal
end.
[0045] In a further embodiment, the grooming sheath is configured
to collapse a deflated balloon catheter during retraction of the
balloon catheter into the annular lumen.
[0046] In another embodiment, the balloon catheter has a working
segment. In one embodiment, the working segment has a distal
extension. In another embodiment, the balloon catheter, rail and
guide wire are configured such that the balloon catheter can be
advanced from the annular opening in a manner that the working
segment is positioned entirely over the guide wire, partially over
the guide wire and partially over the rail, at least partially
extended beyond the end of the guide wire for inflation of the
balloon catheter.
[0047] In a further embodiment at least a portion of the rail is
formed of a malleable material such that the shape of the rail can
be manipulated by a user.
[0048] In another embodiment, the first rail may be removed and
replaced with a second rail having a second angled shape.
[0049] In still another embodiment the rail includes an endoscopic
visible marking.
[0050] In another embodiment the distal end of the grooming sheath
includes an atraumatic tip.
[0051] In another aspect, a method is provided for treating a sinus
opening, the method includes inserting a medical device for the
treatment of a sinus opening partially into a patient's anatomy,
positioning a guide wire operatively extending from a rail of a
medical device into a sinus opening of the patient, advancing a
balloon catheter of the medical device from an annular lumen of the
medical device and along both the rail of the medical device and
the guide wire, and treating the sinus opening is accomplished via
inflation of the balloon catheter. The annular lumen is between the
rail and a grooming sheath of the medical device, and the advancing
is accomplished via user operation of a balloon catheter movement
mechanism of the medical device.
[0052] In a further embodiment, the method includes deflating the
balloon catheter, retracting the balloon catheter into the grooming
sheath, optionally retracting the guide wire into the rail lumen
and removing the medical device from the patient's anatomy.
[0053] In another embodiment the positioning includes advancing the
guide wire from a rail lumen of the rail via a sliding movement of
a guide wire movement mechanism of the medical device along a
handle of the medical device.
[0054] In another embodiment, the patient's anatomy is a
nostril.
[0055] In yet a further embodiment, the rail is formed of a
malleable material and the method further includes configuring the
malleable rail into a shape appropriate for the sinus opening to be
treated prior to the inserting step.
[0056] In another embodiment, the treating step includes inflating
a working segment of the balloon catheter that is disposed entirely
over the guide wire, or partially over the guide wire and partially
over the rail, or that extends beyond a distal end of the guide
wire.
[0057] In a further embodiment, the method includes suctioning the
sinus opening.
[0058] In yet another embodiment, the method includes irrigating
the sinus opening.
DETAILED DESCRIPTION
[0059] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are identically numbered. The drawings, which are not
necessarily to scale, depict exemplary embodiments for the purpose
of explanation only and are not intended to limit the scope of the
invention. The detailed description illustrates by way of example,
not by way of limitation, the principles of the invention. This
description will clearly enable one skilled in the art to make and
use the invention, and describes several embodiments, adaptations,
variations, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0060] As used herein, the terms "about" or "approximately" for any
numerical values or ranges indicate a suitable dimensional
tolerance that allows the part or collection of components to
function for its intended purpose as described herein.
[0061] In general, medical devices for the treatment of a sinus
opening according to embodiments of the present invention include a
handle, a grooming sheath, a rail, a guide wire, a balloon catheter
and a balloon catheter movement mechanism. The handle has a
proximal end, a distal end and a longitudinal axis along the length
of the handle, while the grooming sheath has a distal end and a
proximal end with the proximal end of the grooming sheath being
attached to the distal end of the handle. The rail of medical
devices according to embodiments of the present invention has a
distal end and a proximal end and is disposed partially within the
grooming sheath to define an annular lumen between the rail and the
grooming sheath. The guide wire operatively extends from the distal
end of the rail and the balloon catheter of the medical device is
disposed at least partially in the handle and annular lumen. The
balloon catheter movement mechanism of the medical devices is
operatively disposed on the handle and configured for advancement
and retraction of the balloon catheter through both the handle and
the annular lumen and along both the rail and guide wire by user
operation of the balloon catheter movement mechanism via, for
example, longitudinal sliding of the balloon catheter movement
mechanism along the handle.
[0062] Medical devices according to embodiments of the present
invention are beneficial in that, for example, their configuration
provides for a particularly efficient preparation and treatment of
a patient's sinus opening and is mechanically simple. Moreover, the
simplicity of the medical devices provides for them to be
manufactured in a cost effective manner. In addition, the rail of
medical devices according to embodiments of the present invention
is sufficiently stiff that it can be beneficially employed to seek
and access sinus anatomy followed by a convenient advancement and
inflation of a balloon catheter there along using, for example,
only one hand of the user. The medical devices are also beneficial
in that the balloon catheter is advanced over the stiff rail
resulting in the balloon catheter being well supported and
advancing (tracking) smoothly through the sinus anatomy. Although
described with regard to the sinus opening, the inventions
described herein may also be useful for the treatment of the
Eustachian tube, repair of endo-cranial fractures, airway
procedures such as subglottic stenosis dilation and other
procedures of the ear, nose or throat.
[0063] FIG. 1 is a simplified side view depiction of a medical
device 100 for the treatment of a sinus opening according to an
embodiment of the present invention. FIG. 2 is a simplified
cross-sectional depiction of medical device 100. FIG. 3 is a
simplified side view of the medical device 100 with a guide wire of
the medical device extended. FIG. 4 is a simplified perspective
depiction of the guide wire, rail and grooming sheath of medical
device 100. FIG. 5 is a simplified side depiction of the medical
device 100 with the guide wire and balloon catheter of the medical
device fully extended and the balloon catheter inflated. FIG. 6 is
a simplified perspective depiction of the guide wire, balloon
catheter, and grooming sheath of medical device 100.
[0064] Referring to FIGS. 1 through 5, medical device 100 includes
a handle 102, a grooming sheath 104, a rail 106, a guide wire 108,
a balloon catheter 110, a balloon catheter movement mechanism 112
and a guide wire movement mechanism 114.
[0065] Handle 102 has a proximal end 116, a distal end 118, a
longitudinal axis 120 (the extension of which is marked by dashed
lines in FIG. 2 to avoid obscuring other components of the medical
device) along the length of handle 102, and finger anchoring pegs
122a and 122b. The anchoring pegs 122a and 122b may be stationary
or may be rotatable around the handle for a more comfortable,
personsalizable grip.
[0066] Handle 102 can be formed of any suitable material including,
for example, polycarbonate and ABS (acetonitrile butadiene styrene)
and can be manufactured using any suitable technique including, for
example, injection molding of two clam shell handle halves. The two
clam shell handle halves can be closed using any suitable
manufacturing technique including, for example, adhesive bonding,
screw fastening, clip-based fastening using clips molded as
integral portions of the handle halves, or pins press fitted into
the handle halves.
[0067] Alternative handle designs for the devices of the invention
are shown in FIGS. 18, 19 and 20. In these embodiments, the finger
anchoring pegs shown in FIGS. 1 through 5 have been replaced with
grips 800, 810 and 820 to keep the device in hand in the absence of
active grasping. The grip 800 shown in FIG. 18 comprises a wrap
around band 802 designed to fit around the user's hand or fingers
and allows the user to relax the hand for periods of time without
the fear of the device falling out of the hand. The grip 810 shown
in FIG. 19 comprises an open hook 812 designed for engagement of
the handle 102 by the user with freedom of motion at the distal end
118 of the handle. The grip 820 shown in FIG. 20 comprises a t-leg
822 and finger-loops 824 designed for engagement of the handle 102.
A non-linear actuation track 826 would allow the motion of the
movement mechanisms 112 and 114 to be more naturally along the arc
of the user's thumb path. In the embodiments shown in FIGS. 18 and
19, rounded projections 804 and 814 are added to the handles to
provide easy finger placement.
[0068] Grooming sheath 104 has a distal end 124, a proximal end 126
and an atraumatic tip 128 (see FIG. 4 in particular) at distal end
124. Proximal end 126 of grooming sheath 104 is attached to distal
end 118 of handle 102 (see FIG. 3 in particular). Grooming sheath
104 can be attached to handle 102 using any suitable technique
including, for example, mechanical adaptors known to one skilled in
the art.
[0069] Grooming sheath 104 is configured to collapse and otherwise
groom a balloon catheter 110 during retraction of the balloon
catheter into the grooming sheath. Grooming sheath 104 can also, if
desired, be configured to provide additional stiffness to rail 106.
Grooming sheaths according to embodiments of the present invention
are particularly useful in that deflating a balloon catheter via
application of vacuum can be sub-optimal in terms of collapsing the
balloon catheter into a beneficially small profile. However,
retracting a deflated balloon catheter into a grooming sheath may
collapse the balloon catheter into a beneficially small profile.
Such a small profile provides the beneficial ability to re-advance
and re-inflate the balloon in another sinus opening, particularly
another sinus opening that the collapsed balloon catheter is
accessing through a narrow sinus structure.
[0070] Grooming sheath 104 can be constructed of any suitable
material or materials including for example, a stainless steel tube
with or without a polymer lining (e.g., a Nylon, PTFE or Pebax
lining). In the embodiment of FIGS. 1-6, the polymer lining
includes an extension 104' that extends slightly from the stainless
steel tube at the distal end of the grooming sheath (see FIG. 4 in
particular). Atraumatic tip 128 of grooming sheath 104 can be
formed, for example, of a low durometer polymer fused with polymer
extension 104' or in an alternative embodiment, it may be formed of
a low durometer polymer that is thermally fused and attached with a
lap joint to the stainless steel tube. The polymer may be colored
for endoscopic visualization. The grooming sheath tip 840 may
further be tapered down in diameter at the distal region (see FIG.
21) and it may be expandable. This tapered tip 840 provides a
transition between the outer diameter of the rail 106 and the inner
diameter of the grooming sheath 104, providing a ramp for advancing
through tissue to slide past. Two slits 842a and 842b, positioned
180.degree. apart (or alternatively 4 slits positioned 90.degree.
apart) are designed for expansion as the balloon passes through the
tip 840 and therefore allow for the balloon to exit and re-enter
back into the grooming sheath 104 with low friction. The most
proximal ends of the slits 842a and 842b (there may be four
circular features if there are four slits) have circular features
844a and 844b which are designed to prevent tearing and further
proximal propagation of the slits. The sheath 104 of FIG. 18 is
shown as ending a distance proximal to the rail curved section 136,
but in particular embodiments, it may be extended over close to the
rail curved section 136 so that the balloon has less distance to
travel when it is advanced out of the sheath.
[0071] As shown in FIG. 2, rail 106 has a distal end 130, a
proximal end 132 and a rail lumen 133 (see FIG. 12 described below)
and is disposed partially within grooming sheath 104 such that an
annular lumen 135 is defined between rail 106 and grooming sheath
104. Proximal end 132 of rail 106 is attached to handle 102 (see
FIG. 2).
[0072] Rail 106 is configured to serve as (i) a probe for finding
an access path to the target sinus ostium (also referred to as
sinus opening), (ii) to provide a shaped rail to guide the balloon
catheter into the sinus ostium, and (iii) to provide a luminal path
(i.e., rail lumen 133) for guide wire movement. If desired, the
guide wire lumen of the rail can be made with adequate space such
that irrigation or suction can be applied via the guide wire lumen
during use of the medical device.
[0073] Rail 106 can be formed of any suitable material including,
for example, 304 stainless steel or 316 stainless steel. In
addition, distal end 130 of rail 106 can be manufactured with a
predetermined shape that is appropriate for the treatment of a
given sinus opening in the range of between about 0 degrees and 125
degrees and the appropriate rail 106 chosen for treatment of a
particular sinus. For example, for Frontal sinus access, the
predetermined shape can be an angled shape with an angle (bend) in
the range of 65 degrees and 85 degrees or of about 75 degrees. For
Sphenoid sinus access, the predetermined angled shape can be in the
range of about 0 degrees and 30 degrees or approximately
horizontal. For maxillary access, the predetermined angled shape
can be in the range of about 85 degrees and 125 degrees or of about
100 degrees. For treatment of more than one sinus, the rail 106 can
be removed from the handle 102 and replaced with one shaped for a
different sinus.
[0074] If desired, distal end 130 of rail 106 can be formed of a
malleable material that enables a user to configure the shape of
distal end 130 prior to inserting medical device 100 into a
patient's anatomy. In this circumstance, distal end 130 can be
formed of any suitable malleable material known to one skilled in
the art. An exemplary but non-limiting malleable material is heat
treated (e.g., annealed) stainless steel. A formed feature in a
thermoform tray would allow a user to shape the distal end 130
directly in the tray, would aid in the proper shaping of the distal
end 130 and prevent the user from using their hands or other
instrument with the likely result of damaging the distal end
130.
[0075] If desired, distal end 130 of rail 106 can include
endoscopic visible markers (not shown in the FIGs.) and/or an
atraumatic tip (also not shown in the FIGs.). Such an atraumatic
tip can be formed, for example, from a soft polymer material or
consist of an appropriately polished and sintered distal end. Such
endoscopic visible markers can, for example, be placed on the
surface of distal end 130 and be configured to indicate the
distance away from the furthermost distal point of the rail. In one
embodiment the endoscopic visible markers are configured as thin
circumferential bands, with the number of bands corresponding to
the number of centimeters the marked location is from the
furthermost distal point. For example, if the marked location is 3
cm from the furthermost distal point, the endoscopic visible mark
would consist of three thin bands. Such endoscopic visible marks
beneficially provide a user with a sense of the location of the tip
of the rail and, thus, its extension into a sinus.
[0076] In the embodiment of FIGS. 1-6, distal end 130 of rail 106
includes a proximal straight section 134 (such as, for example, a 7
cm straight section), a curved section 136 (e.g., for example, a 3
cm curved section), and a relatively short distal straight section
138 (see FIG. 1) of, for example, 5 mm to 50 mm in length. Typical,
but non-limiting, rail inner and outer diameters are 0.038 inches
and 0.052 inches, respectively. Such a configuration, along with an
extendable guide wire, has been determined to provide for ease of
access to sinus openings during treatment thereof.
[0077] For optimal sinus access, precise dimensions have been
determined for rail 106. In order to ensure an appropriate range of
motion during probing of the maxillary sinus, a tip envelope 830
(see FIG. 22) of between about 0.10 inches and 0.50 inches is
desirable, or between about 0.20 and 0.40 inches and often about
0.30 inches. Further, to ensure easy access of the maxillary sinus
by the guide wire 108 after manipulating the distal end of the
device 100 into position, a tip trajectory 832 of between about 85
degrees and 125 degrees is desirable, or between about 90 degrees
and 110 degrees and often about 100 degrees. The distal tip may be
beveled to provide support to the distal ball, to allow for
directionally anterior advancement of the curved guide wire and
facilitate retraction of the balloon. To ensure easy access of the
frontal sinus by the guide wire 108 after manipulating the distal
end of the device 100 into position, a tip envelope 830 of between
about 0.40 inches and 0.80 inches is desirable, or between about
0.50 inches and 0.70 inches often about 0.60 inches and a tip
trajectory 832 of between about 55 degrees and 85 degrees is
desirable, or between about 60 degrees and 80 degrees and often
about 70 degrees. The distal tip may be squared or beveled. To
ensure easy access of the sphenoid sinus by the guide wire 108
after manipulating the distal end of the device 100 into position,
a tip trajectory 832 of between about 0 degrees and 30 degrees is
desirable, or between about 0 degrees and 10 degrees and often
approximately horizontal.
[0078] The distal end 130 of rail 106 must further be positioned to
allow for the comfort of the user. A right handed user will
position the rail differently than a left handed user. Accordingly,
the ability to rotate the rail relative to the longitudinal axis of
the handle 102 enables the user to orient the rail geometry, the
balloon catheter movement mechanism 112 and the guide wire movement
mechanism 114 on the handle 102. The mechanism to rotate the rail
has five key elements as shown in FIGS. 23A, 23B, 23C and 23D the
rail switch 920, the rail switch post 922, the front collar 926,
the collar stop 928 and the spring. Referring to FIGS. 23A and 23B,
the distal end 118 of the handle 102 is shown. The first element of
the mechanism to rotate the rail 106 is the rail switch 920, a
molded part that provides a bearing surface for the rail switch
post 922. The post 922 extends through the rail switch 920 and
through the distal end 118 of the handle 102 and terminates in a
channel 924 defined between the front collar 926 and the handle
102. The rail switch post 922 is made of a rigid material, in this
case stainless steel, and is welded to the rail 106 through the
rail switch 920. The front collar 926 provides a channel 924 for
the rail switch post 922. As the front collar 926 is rotated, the
rail switch post 922 is moved clockwise or counter clockwise within
the keyway 930 as required for appropriate rail orientation. The
collar stop 928 locks the rail switch post 922 in a first front
collar slot 932. A spring (not shown) provides force against the
front collar 926 to hold the rail switch post 922 in a forward
position. In order to change positions, the collar 926 is pulled
toward the user and twisted so that the rail switch post 922 is
pulled out of the first slot 932 in the keyway 930 and can rotate.
Once the rail switch post 922 reaches a second slot 934 in the
keyway 930 (in the case shown, the second slot 934 is 90 degrees
offset from the original slot, but the slots may be 45, 90, 135, or
180 degrees offset or anywhere therebetween, either clockwise of
counter clockwise from the first slot 932 and there may be 2, 4, 6,
8 or any number of key slots less than or equal to 12), the spring
pulls the post 922 into the second slot 934. Because the rail
switch post 922 rotates about a line that is offset from the center
of the collar 926, the rail switch post 922 telescopes up and down
in the slots 932 and 934.
[0079] As shown in FIGS. 1-4, the guide wire 108 operatively
extends from the distal end of the rail 106 following the
orientation of the rail 106 described above. Guide wire 108 can be
either (i) attached to the distal end of the rail and extend beyond
the distal end of the rail a predetermined fixed length, or (ii)
disposed at least partially in handle 102 and the rail lumen with
medical device 100 being configured for advancement and retraction
of the guide wire through the handle and rail lumen by longitudinal
sliding of guide wire movement mechanism 114 along the handle 102
(compare, for example, FIGS. 2 and 3 which illustrate different
guide wire extensions). For the latter configuration, the guide
wire can be attached to a guide wire movement mechanism such as
element 114 in FIGS. 1-3 and 5.
[0080] In the embodiment of FIGS. 1-6, guide wire 108 includes an
essentially spherical atraumatic tip 140 (see FIGS. 4 and 6 in
particular). Such a spherical atraumatic tip can have, for example,
a diameter in the range of approximately the same diameter as the
guide wire (e.g., 0.032 inches) to 0.080 inches. The upper limit of
the spherical atraumatic tip diameter is chosen such that the tip
does not unduly prevent the guide wire from tracking in a tight
sinus access path. In one embodiment, the rail has a diameter of
approximately 0.050 inches and the spherical atraumatic tip of the
guide wire has a diameter of 0.060 inches such that the spherical
tip shields the furthermost distal edge of the rail from contact
with sinus or other tissue of the patient's anatomy during use of
the medical device. Alternatively, the spherical tip of the guide
wire can be sized such that the balloon catheter can extend beyond
the spherical tip.
[0081] The tip of guide wire 108 can, if desired, be lighted in a
manner that enables a user to confirm successful access to a sinus
opening. Such tip may be formed as a molded component that will be
adhesively bonded to the guide wire 108, but it must be translucent
to allow full light output to transmit through the tip.
[0082] Guide wire 108 can be formed of any suitable material known
to one skilled in the art including, for example, stainless steel,
Nitinol and combinations thereof and of any suitable stiffness or
graded stiffness. In addition, guide wire 108 can be configured in
any suitable manner including, for example, a stainless steel wound
coil, a coil wound around a central core wire (including a core
wire of varying diameter that provides a varying stiffness down the
length of the guide wire), a configuration with an angled distal
end (e.g., a 5-30 degree angle end with a length of 2.0 to 10 mm),
and configurations that include the incorporation of one or more
light transmitting fibers that provide for a lighted guide wire
distal end and/or tip formed of light transmitting material and one
or more stiffening materials (such as a hypotube) that prevent
buckling of the guide wire in the device of in the patient's
anatomy. Other configurations may include a sensor on the tip for
tracking (for example, a coil that is energized that creates a
magnetic field), or a lens on the tip for greater dispersion of
light from the tip. Suitable lighted guide wires that may be
incorporated in the current device are described, for example, in
US 2008/0228085 which is herein incorporated by reference in its
entirety.
[0083] For additional tactile feedback for the user for accessing
the sinus, a number of additional features may be incorporated into
the handle 102 as will be further described with regard to FIG. 24.
In this embodiment, in order to prevent buckling of the guide wire
108 between the rail 106 and the distal portion of the guide wire
movement mechanism 114, a hypotube 900 may be soldered or welded to
the guide wire 108 and a fin 902 soldered or welded to the hypotube
to connect the guide wire movement mechanism 114 to the hypotube
900. Alternatively, rather than a fin 902, a tube or bushing may be
placed around the hypotube, a post with a through hole for the
hypotube, a split leg fin welded on either side of the hypotube, or
a glue connection directly to the guide wire movement mechanism may
be useful to connect the guide wire movement mechanism to the
hypotube. In this way, the force that is applied to the guide wire
movement mechanism to advance it along the handle 102 directly
translates into movement of the guide wire 108 into the sinus
anatomy. When an obstacle is encountered, the guide wire movement
mechanism 114 will no longer advance and the user will know that
there is an obstacle. Alternatively, rather than a hypotube, it may
be desirable to increase the diameter of the internal core wire of
the guide wire 108 or to add a stiffening member to provide
stiffness to the guide wire 108 between the rail 106 and the guide
wire movement mechanism 114. In addition, when the rail 106 is
rotated for advancement into the right or left maxillary sinus or
for appropriate orientation for a right or left handed user, the
tube or bushing placed around hypotube 900 will allow for rotation
of the guidewire 108 with the rail 106 so that it too will be
appropriately positioned for the sinus and/or the handedness of the
user.
[0084] Guide wire 108 serves to provide additional reach, beyond
the reach of the rail, into target anatomy in a safe manner. For a
guide wire of predetermined fixed length, the length can be, for
example, in the range of 5 mm to 30 mm. For a medical device
configured with an extendable guide wire, the configuration can be
such that a user can extend the guide wire from the rail for a
distance of, for example, 1 mm to 50 mm.
[0085] Balloon catheter 110 is disposed at least partially in
handle 102 and the annular lumen between the rail 106 and the
grooming sheath 104 (see, for example, FIG. 12 described below).
Moreover, balloon catheter 110 is operatively connected with
balloon catheter movement mechanism 112. In this regard, balloon
catheter movement mechanism 112 is configured for advancement and
retraction of the balloon catheter 110 through the handle 102 and
annular lumen 135 and along the rail 106 and guide wire 108 by
longitudinal sliding of the balloon catheter movement mechanism 112
along the handle 102. However, once apprised of the present
disclosure, one skilled in the art will recognize that balloon
catheter movement mechanisms employed in medical devices (and
methods) according to the present invention are not limited to
those that are user operated via longitudinal sliding along the
length of the handle. Rather, user operation of the balloon
catheter movement mechanism can be any suitable operation that
results in operable movement of the balloon catheter by, for
example, translation of the balloon catheter movement mechanism
relative to the handle or rotation of a balloon catheter movement
mechanism component. In this regard, the configuration of the
balloon catheter mechanism would support such user operation via
suitable rack and pinion mechanism, gear-based mechanisms, threaded
mechanism and/or electromechanical means.
[0086] A suitable rack and pinion mechanism can be incorporated
into devices according to embodiments of the present invention by,
for example, employing a configuration wherein a balloon catheter
shaft disposed within the handle is attached to a rack gear. Such a
rack gear can be configured for longitudinal movement by engagement
with a roller gear that is operated (i.e., rotated) by a user.
Between the roller gear and the rack gear, there can be a gear
train that includes various combinations of gear ratios providing a
reduction in the force required to be exerted by a user at the
roller and/or increasing travel distance for the rack with a small
rotation actuated at the roller.
[0087] A suitable threaded mechanism can be incorporated, for
example, by attaching the balloon catheter to a cylindrical
component with external threads with the cylindrical component
being constrained to move longitudinally without rotation. A roller
with internal threads can be configured to engage with the external
threads of the cylindrical component. In such a configuration, user
operation via rotation of the roller causes the cylindrical
component and the balloon catheter to move longitudinally. The
thread design of such an embodiment can be configured with threads
of a predetermined pitch or type (e.g., 3 start thread) to provide
greater travel distance by the catheter for a lesser rotation of
the roller.
[0088] Balloon catheter 110 can be any suitable balloon catheter
known to one skilled in the art including, for example, dual shaft
balloon catheters with a braided inner shaft formed of Nylon, PET
and Pebax. A braided inner shaft provides for stiffness so that the
balloon remains in line with the curve of the rail when advanced
distal to the rail and inflated. As shown in FIG. 9, a soft tapered
balloon tip 142 on the distal extension 144 to the braided inner
shaft provides for a smooth profile transition to the smaller guide
wire 108 and allows for advancement of the balloon around the curve
of the rail and placement into the target anatomy. The balloon
catheter can also, if desired, include a lubricity layer to reduce
friction between the rail and the catheter balloon. The balloon
catheter may be any size catheter including but not limited to 3.5
mm to 7 mm in diameter (when inflated) and 12 mm to 24 mm in
working length (for example 3.5 mm.times.12 mm, 5 mm.times.16 mm, 5
mm.times.24 mm, 6 mm.times.16 mm, 6 mm.times.20 mm, 6 mm.times.24
mm, 7 mm.times.16 mm and 7 mm.times.24 mm. In one embodiment for
the maxillary sinus, the dimensions of the working portion of the
balloon catheter are 6 mm in diameter (when inflated) and 24 mm in
working length. The balloon catheter 110 further may have a
conformable distal tip such that it is flush with the outer
diameter of the guidewire 108 when it is expanded distally over the
distal end of rail 106. Materials useful for such purpose include
but are not limited to stainless steel, nitinol, a coil, or laser
cut tubing, of a tip conformation similar to that of the grooming
sheath described above, with two slits spaced 180 degrees apart (or
four slits 90 degrees apart).
[0089] Prior to use of the medical device, the balloon catheter 110
is retracted within the grooming sheath 104 and handle 102. When
extended, part or the entirety of the balloon working length of the
balloon catheter extends distal to the tip rail over the guide
wire. In one embodiment, the balloon catheter does not extend
beyond the tip of the guide wire. If the tip of the guide wire is
of a sufficient diameter and the guide wire is not fully extended
when the balloon catheter is extended, extension of the balloon
catheter can carry the guide wire with it. In another embodiment,
the guide wire tip is smaller than a lumen of the balloon catheter.
In this embodiment, the balloon catheter can extend beyond the tip
of the guide wire.
[0090] Guide wire movement mechanism 114 is configured for
advancement and retraction of the guide wire through the handle 102
and rail lumen 133 by longitudinal sliding of the guide wire
movement mechanism 114 along the handle 102. However, once apprised
of the present disclosure, one skilled in the art will recognize
that guide wire movement mechanisms employed in medical devices
(and methods) according to the present invention are not limited to
those that are user operated via sliding along the length of the
handle. Rather, user operation of the guide wire movement mechanism
can be any suitable operation that results in operable movement of
the guide wire by, for example, translation (i.e., movement that
changes the position of an object) of the guide wire movement
mechanism relative to the handle or rotation of a guide wire
movement mechanism component. In this regard, the configuration of
the guide wire movement mechanism would support such user operation
via, for example, a suitable rack and pinion mechanism, gears,
and/or electromechanical means.
[0091] In an alternative embodiment shown in FIG. 25, guide wire
movement mechanism 610 may include an integrated guide wire locking
and rotation mechanism 640 configured for rotation of guide wire
606 and for securely locking and unlocking the guide wire to the
guide wire movement mechanism 610, a rail 642, and a nosepiece 644.
Rail 642 is configured for slidably attaching guide wire movement
mechanism 610 to handle 102. Nosepiece 644 is configured to direct
guide wire 606 into handle 102 and rail lumen 133 of rail 106 as
described above.
[0092] Integrated guide wire locking and rotation mechanism 640
includes a barrel 646 and a collet axle 648 (see FIGS. 25-29 in
particular). The locking/unlocking capability of integrated guide
wire locking and rotation mechanism 640 enables a user to adjust
the length of the guide wire extending (distally) beyond the guide
wire movement mechanism 610.
[0093] Collet axle 648 is configured to function both as a collet
and as an axle and has a longitudinal opening through which the
guide wire 606 passes (see FIG. 27 in particular). In the
embodiment of FIGS. 25 through 29, collet axle 648 is essentially
cylindrical in overall shape, and when locked onto the guide wire
(see FIG. 26 where the depicted overlap of the barrel and the
collet axle serves to illustrate that the barrel is compressing the
collet axle onto the guide wire), rotates with the guide wire 606.
Collet axle 648 rotates within bearing surfaces 650 of the guide
wire movement mechanism 610 (see FIG. 27). The collet axle has a
plurality of alternating protrusions 652 and slots 654 (see FIG.
27) configured to lock (close) onto the guide wire, thereby linking
rotation of the guide wire with rotation of the collet axle. Collet
axle 648 exerts a strong clamping force on the guide wire when the
collet axle is tightened via longitudinal movement of barrel 646
(as is evident from a comparison of FIG. 25 where the collet axle
is locked into the guide wire and FIG. 26 where the collet axle is
unlocked from the guide wire).
[0094] Barrel 646 has an essentially cylindrical cross-section and
an opening therethrough, in which collet axle 648 is disposed. The
contour of the barrel's opening is designed to receive the collet
axle and has at least one focal point configured to collapse the
collet axle onto the guide wire (see FIG. 25 in particular). The
exterior of barrel 646 has grip features shown in the embodiment of
FIGS. 25-26 as a macroscopic surface feature (i.e., ridges).
However, such grip features could alternatively be microscopic in
nature or based on frictional material properties such as a
rubberized surface. Such grip features provide traction for the
user to rotate or translate the barrel via operation with, for
example, the user's thumb. The distal and proximal ends of the
barrel have a raised ring feature 656, which provides traction for
the user to translate the guide wire movement mechanism when the
collet axle is in a locked position or provide a gripping feature
to move the barrel 646 relative to the remainder of the guide wire
movement mechanism 610 to lock and unlock the axle 648.
[0095] The guide wire movement mechanism 610 is shown in detail in
FIG. 29 and allows for advancing, retracting and rotating the guide
wire 606. The mechanism 610 integrates a guide wire locking and
rotation mechanism 640 configured for rotation of the guide wire
606 and for securely locking and unlocking the guide wire 606 to
the guide wire movement mechanism 610 as further described with
regard to guide wire locking and rotation mechanism 640 above.
Included in FIG. 29 is clicker 658 that interacts with the fins of
barrel 646 to provide audible and tactile feedback of rotation of
the locking and rotation mechanism 640 and the resultant rotation
of the guide wire 606. A representative guide wire 606 incorporated
in the device 100 of the invention is the Relieva Luma Sentry.TM.
Sinus Illumination System manufactured by Acclarent, Inc., Menlo
Park, Calif., a guide wire system that can be connected to a light
source for transillumination, illumination and subsequent
transcutaneous visualization of the sinus cavity.
[0096] Once apprised of the present disclosure, one skilled in the
art will recognize that guide wire locking and rotation mechanisms
employed in medical devices according to the present invention can
take any suitable form in addition to the barrel and collet axle
configurations shown in, for example, FIGS. 25 through 29. For
example, the barrel could be shaped essentially as a sphere,
cylinder or other suitable shape.
[0097] In general, methods for treating a sinus opening according
to embodiments of the present invention include inserting a medical
device for the treatment of a sinus opening partially into a
patient's anatomy (e.g., a patient's nostril) and subsequently
positioning a guide wire operatively extending from a rail of a
medical device into a sinus opening of the patient. The methods
also include advancing a balloon catheter from an annular lumen of
the medical device and along both the rail of the medical device
and the guide wire. In the methods, the annular lumen is between
the rail and a grooming sheath of the medical device and the
advancing is accomplished via sliding movement of a balloon
catheter movement mechanism of the medical device along a handle of
the medical device. The method also includes treating the sinus
opening via inflation of the balloon catheter.
[0098] Methods according to embodiments of the present invention
are beneficial in that they are, for example, particularly
efficient with respect to positioning the balloon catheter for
treatment of the sinus opening and retracting the balloon catheter
into the medical device. Moreover, the methods provide for the
entire method to be conveniently and efficiently conducted using a
single medical device and may be performed in hospital operating
room setting or in a medical office.
[0099] Referring to FIG. 7, method 200 for treating a sinus opening
according to an embodiment of the present invention includes
inserting a medical device for the treatment of a sinus opening
partially into a patient's anatomy (see step 210 of FIG. 7).
[0100] At step 220, a guide wire operatively extending from a rail
of a medical device is positioned into a sinus opening of the
patient.
[0101] Subsequently and as noted in step 230 of FIG. 7, a balloon
catheter of the medical device is advanced from an annular lumen of
the medical device along both the rail of the medical device and
the guide wire. Alternatively, the balloon catheter can be advanced
solely over the rail and, in a future step, inflated solely over
the rail as described below. It is noted that the annular lumen
referenced in step 230 is between the rail and a grooming sheath of
the medical device. Moreover, in step 230 the advancing is
accomplished via sliding movement of a balloon catheter movement
mechanism of the medical device along a handle of the medical
device.
[0102] Method 200 also includes, at step 240, treating the sinus
opening via inflation of the balloon catheter. The balloon working
segment of the (also referred to as a working portion) balloon
catheter can be inflated, as appropriate depending on the
positioning of the rail and guide wire, solely over the rail,
partially over the rail and partially over the guide wire, solely
over the guide wire, or extending beyond the guide wire. Following
treatment, the balloon catheter is deflated (step 250), and
retracted into the grooming sheath of the medical device (see step
260). At step 270, the medical device is removed from the patient's
anatomy.
[0103] Once apprised of the present disclosure, one skilled in the
art will recognize that method 200 can be readily modified to
incorporate any of the techniques, benefits and characteristics of
medical devices according to embodiments of the present invention
and described herein. For example, methods according to embodiments
of the present invention can also include, as part of the
positioning step, advancing the guide wire from a rail lumen of the
rail via a sliding movement of a guide wire movement mechanism of
the medical device along a handle of the medical device. Such a
method could also include, following the treating step, retracting
the balloon catheter into the grooming sheath and retracting the
guide wire into the rail lumen. Moreover, one skilled in the art
will also recognize that methods according to embodiments of the
present invention, including method 200, can be modified to
incorporate suitable sinus opening treatment techniques and steps
known to one skilled in the art including suitable techniques and
steps described in U.S. Pat. Nos. 7,462,175, 7,500,971, and
7,645,272, and U.S. Patent Application Publications 2008/0281156,
and 2010/0030113, each of which is hereby incorporated in full by
reference.
[0104] Referring again to medical device 100, FIG. 8 is a
simplified side view depiction of the medical device 100 with the
guide wire and balloon catheter of the medical device extended and
the balloon catheter inflated over the rail. FIG. 9 is a simplified
side cross-sectional depiction of the medical device 100. FIG. 10
is a simplified side cross-sectional depiction of a portion of
medical device 100. FIG. 11 is another simplified side
cross-sectional depiction of a portion of medical device 100 and
FIG. 12 is a combination of a side view and multiple
cross-sectional views taken along various lines of the side view of
medical device 100.
[0105] Referring to FIGS. 8 through 12, handle 102, grooming sheath
104, rail 106, guide wire 108, balloon catheter 110, balloon
catheter movement mechanism 112 and guide wire movement mechanism
114, and rail lumen 133 are depicted. Balloon catheter 110 of
medical device 100 includes an inner shaft 150 and an outer shaft
152 (see FIG. 12). FIG. 11 depicts how grooming sheath 104 is
attached to the inner diameter (ID) of a bushing 190 of handle 102
and how rail 106 is attached to handle 102 by a fin 192. Rail 106
can be, for example, soldered or welded to fin 192 and fin 192
mechanically fastened or adhesive bonded to the remainder of handle
102.
[0106] FIG. 13 is a simplified depiction of a balloon catheter
sub-assembly 300 as can be employed in embodiments of the present
invention. FIGS. 14A and 14B are simplified side and
cross-sectional views of balloon catheter sub-assembly 300.
[0107] Referring to FIGS. 13, 14A and 14B, balloon catheter
sub-assembly 300 includes a balloon catheter 302, a balloon
catheter movement mechanism 304 and an inflation tube 306. Balloon
catheter 302 includes a balloon working segment 310, distal shaft
portion 312, mid-catheter joint 314, a flat lumen shaft 316, inner
shaft 318, and outer shaft 320.
[0108] Inner shaft 318 and outer shaft 320 are configured such that
a rail lumen 322 and an annular inflation lumen 326 are formed in
distal shaft portion 312 (see cross-section 360 of FIG. 14B taken
along line B-B of FIG. 14A). At mid-catheter joint 314, rail lumen
322 and inflation lumen 328 are in a stacked configuration (see
cross-section 370 of FIG. 14B taken along line C-C of FIG. 14A).
Cross-section 380 of FIG. 14B (taken along line D-D of FIG. 14A)
and cross-section 370 both depict a configuration wherein the flat
lumen shaft 316 defines the inflation lumen. Cross-section 350 of
FIG. 14B (taken along line A-A of FIG. 14A) depicts the
configuration of inner shaft 318 and balloon working segment
310.
[0109] Balloon working segment 310 can be made of any suitable
material including, for example, polymeric materials such as Pebax,
Nylon and PET. The diameter of the balloon working segment can be,
for example, in the range of 3.00 mm to 8.00 mm (inflated) and have
a length in the range of, for example, 5 mm to 30 mm, with a
typical length being in the range of 20 mm to 25 mm. The balloon
catheter inner and outer shafts can be made of any suitable
material including, for example, polymers such as Pebax, Nylon,
Hytrel or high density polyethylene (HDPE). In some embodiments,
the inner shaft may be of braided construction to increased
stiffness such that the balloon remains coaxial with the rail when
advanced distal to the rail and inflated. To reduce friction
between the balloon catheter and a rail, the inner shaft can be
formed, for example, of a polymer impregnated with micro-particles
of PTFE (Polytetrafluoroethylene) or have a PTFE thin liner fused
on the inside of the lumen. The balloon may be attached to the
inner and outer shafts by thermal or laser bonding.
[0110] Inflation lumen shaft 316 can be formed, for example, of
metallic tubular material such as a stainless steel tubular
material. Inflation lumen shaft 316 can be manufactured, for
example, by flattening a round tube of stainless steel. Inflation
lumen shaft 316 serves to (i) provide a lumen for inflation and
deflation of the balloon working segment and (ii) provide a
suitable stiffness to advance and retract the balloon catheter
while resisting buckling. In one embodiment, cross-section of
inflation lumen shaft 316 is flat and can have any suitable ratio
of flat height to flat width (depicted in cross-section 380) with a
particularly beneficial ratio being a ratio of 1:1.
[0111] FIG. 15 is a simplified depiction of another balloon
catheter sub-assembly 400 as can be employed in embodiments of the
present invention. FIG. 16 is a simplified cross-sectional view of
a portion of the balloon catheter sub-assembly of FIG. 15.
[0112] Referring to FIGS. 15 and 16, balloon catheter sub-assembly
400 includes a balloon catheter 402, a balloon catheter movement
mechanism 404 and an inflation tube 406. Balloon catheter 402
includes a balloon working segment 410, distal shaft portion 412,
mid-catheter joint 414 and a flat lumen shaft 416. Flat lumen shaft
416 is assembled into balloon catheter movement mechanism 404 at a
slight downward angle (see FIG. 16). Such a downward angle serves
to prevent buckling since the downward angle biases any buckling
toward the downward direction (which is a direction that can be
reinforced by support from the handle as depicted in the handle of
FIG. 11).
[0113] FIG. 16 depicts the joint between flat lumen shaft 416 and
inflation tube 406 inside of balloon catheter movement mechanism
404. FIG. 16 also depicts a clearance hole 420 for a guide wire,
the angular entry of the flat lumen shaft 416 (which forces the
flat lumen shaft to bend downward under any buckling forces) and
the overlapping joint between the flat lumen shaft 416 and the
inflation tube 406.
[0114] During manufacturing, the flat lumen shaft and inflation
tube are first joined together by techniques such as adhesive or
heat bonding. In such heat bonding, a polymeric shrink tube is
placed over the overlapping joint segment. The assembly is then
placed inside of a heat source (e.g., a hot air, RF energy, or
laser energy heat source) to melt the polymeric shrink tube and
fuse it securely around a metallic flat lumen shaft. The joined
segment is then placed inside the balloon catheter movement
mechanism as shown in FIG. 16. Adhesive is then used to bond the
joined flat lumen shaft and inflation tube inside of the balloon
catheter movement mechanism.
[0115] FIG. 17A is a simplified cross-sectional view of a balloon
catheter 500 as can be employed in embodiments of the present
invention. FIG. 17A shows an exemplary, but non-limiting balloon
catheter 500. A balloon distal inner shaft 502, distal outer shaft
504 and proximal shaft 516 are heat fused together at a
mid-catheter joint 506. The inner shaft 502 comprises a guide wire
lumen 508 and the outer shaft 504 comprises a distal annular lumen
505 which also serves as the inflation lumen. The mid-catheter
joint 506 is formed such that the guide wire can exit from the
catheter and the inflation lumen transitions from a distal annular
lumen 505 (see cross-section 510 taken along line A-A of FIG. 17A)
to a single lumen 507 (see cross-section 512 taken along line C-C
of FIG. 17A). As shown in cross-section 514 taken along B-B in FIG.
17A, in order to allow for the free movement of the balloon
catheter mechanism 112 and the guide wire movement mechanism 114
shown in FIGS. 1-5, the inflation tube (not shown) and attached
proximal balloon shaft 516 must be off center with regard to the
balloon 518 such that the guide wire lumen 508 and inflation lumen
509 are in a dual lumen configuration. In one embodiment, as
described above, the materials may be heat fused together at the
mid-catheter joint 506. In another embodiment, a hypotube ring may
be crimped around the mid-catheter joint 506. In yet another
embodiment shown in FIG. 17B, the mid-catheter joint 550 may
comprise a molded portion in order to consistently maintain
co-axial distal annular lumens, a distal inflation lumen 552 and a
distal guidewire lumen 554 (see cross-section 556 taken along A-A
of FIG. 17B), a single proximal annular lumen, proximal inflation
lumen 558, and an off-set dual lumen mid-catheter joint 550
(cross-section 560 taken along B-B of FIG. 17B), that includes a
mid-catheter inflation lumen 562 and a mid-catheter guide wire
lumen 564. This molded mid-joint connector allows for smooth
advancement and retraction of balloon catheter 566 through the
handle 102 described above.
[0116] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that devices and methods
within the scope of these claims and their equivalents be covered
thereby.
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