(19)

*EP004321119A2*
(11) EP 4 321 119 A2
(12) EUROPEAN PATENT APPLICATION

(43) Date of publication: (51) International Patent Classification (IPC):

14.02.2024 Bulletin 2024/07 A61B 34/20 (2016.01)

(21) Application number: 23220602.9 (52) Cooperative Patent Classification (CPC):

A61M 29/02; A61B 17/24; A61B 34/20
(22) Date of filing: 04.06.2010

(84) Designated Contracting States: (72) Inventors:

AL AT BE BG CH CY CZ DE DK EE ES FI FR GB • DRONTLE, John R.
GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO Buffalo, MN 55313 (US)
PL PT RO SE SI SK SM TR • HANSON, Anthony J.
Chaska, MN 55318 (US)
(30) Priority: 05.06.2009 US 47952109
(74) Representative: Schott, Jakob Valentin
(62) Document number(s) of the earlier application(s) in Wuesthoff & Wuesthoff
accordance with Art. 76 EPC: Patentanwälte PartG mbB
21191615.0 / 3 936 183 Schweigerstraße 2
19189716.4 / 3 583 975 81541 München (DE)
15184180.6 / 2 977 073
10784199.1 / 2 437 843 Remarks:
This application was filed on 28.12.2023 as a
(71) Applicant: Entellus Medical, Inc. divisional application to the application mentioned
Plymouth, MN 55447 (US) under INID code 62.

(54) FRONTAL SINUS DILATION CATHETER

(57) Disclosed is a guide member (14) for placement can be placed therethrough, wherein the guide member
of a guide wire (64), the guide member (14) extending (14) is formed as a hypotube, has a wall thickness be-
from a distal end (20) to a proximal end (21) and having tween about 0.2032 mm (0.008 inch) to about 0.3048
a length of about 17.78 cm (7 inches) to about 27.94 cm mm (0.012 inch) and has a degree of malleability such
(11 inches) from the distal end (20) to the proximal end that a user may bend or impart some desired shape or
(21), wherein the guide member (14) comprises a lumen configuration to the distal end (20) of the guide member
(18) that extends the length of the guide member (14), (14).
the lumen (18) configured such that the guide wire (64)
EP 4 321 119 A2

Processed by Luminess, 75001 PARIS (FR)

 1 EP 4 321 119 A2 2

Description ample, U.S. Patent Application Publication No.

2008-0097295 discloses a frontal sinus guide catheter
Field of the Invention (FIG. 6B) and method of treating the frontal sinuses (e.g.,
FIGS. 8B-8C). U.S. Patent Application Publication No.
[0001] The field of the invention generally relates to 5 2008-0125626 discloses another guide device (e.g.,
balloon inflation devices and methods. More particularly, FIGS. 10C and 10C) for transnasal access to the frontal
the field of the invention relates to balloon dilation devices sinuses for treatment.
and methods for the treatment of sinusitis.
Summary of the Invention
Background of the Invention 10
[0006] In a first embodiment of the invention, a balloon
[0002] Sinusitis is a condition affecting over 35 million dilation catheter includes a substantially rigid inner guide
Americans, and similarly large populations in the rest of member and a movable shaft coupled to a balloon that
the developed world. Sinusitis occurs when one or more is slidably mounted on the substantially rigid inner guide
of the four paired sinus cavities (i.e., maxillary, ethmoid, 15 member. To treat a drainage pathway of a sinus cavity
frontal, sphenoid) becomes obstructed, or otherwise has (e.g., frontal sinus cavity) of a subject using the balloon
compromised drainage. Normally the sinus cavities, dilation catheter, the substantially rigid inner guide mem-
each of which are lined by mucosa, produce mucous ber is advanced into a drainage pathway of the subject
which is then moved by beating cilia from the sinus cavity via a nasal passageway. The shaft and balloon are then
out to the nasal cavity and down the throat. The combined 20 advanced in a distal direction over the substantially rigid
sinuses produce approximately one liter of mucous daily, inner guide member to place the balloon in the drainage
so the effective transport of this mucous is important to pathway. This enables the balloon to track over the inner
sinus health. guide member. The balloon is inflated to expand or oth-
[0003] Each sinus cavity has a drainage pathway or erwise remodel the drainage pathway. Where the sinus
outflow tract opening into the nasal passage. This drain- 25 cavity is the frontal sinus cavity the drainage pathway is
age passageway can include an ostium, as well as a the frontal recess.
"transition space" in the region of the ostia, such as the [0007] In another aspect of the invention, a device for
"frontal recess," in the case of the frontal sinus, or an dilating the outflow tract of a sinus cavity includes a sub-
"ethmoidal infundibulum," in the case of the maxillary si- stantially rigid inner guide member having a proximal end
nus. When the mucosa of one or more of the ostia or 30 and a distal end and a shaft coupled to a balloon, the
regions near the ostia become inflamed, the egress of shaft having a first lumen along at least a portion thereof
mucous is interrupted, setting the stage for an infection containing the substantially rigid inner guide member,
and/or inflammation of the sinus cavity, i.e., sinusitis. the shaft having a second lumen operatively coupled to
Though many instances of sinusitis may be treatable with the interior of the balloon. A handle is disposed along a
appropriate medicates, in some cases sinusitis persists 35 proximal portion of the substantially rigid inner guide
for months or more, a condition called chronic sinusitis, member, the handle including a moveable knob opera-
and may not respond to medical therapy. Some patients tively coupled to the shaft, wherein distal advancement
are also prone to multiple episodes of sinusitis in a given of the knob advances the shaft and balloon over the sub-
period of time, a condition called recurrent sinusitis. stantially rigid inner guide in a distal direction.
[0004] Balloon dilation has been applied to treat con- 40 [0008] The following items are also disclosed:
stricted sinus passageways for the treatment of sinusitis.
These balloon dilation devices typically involve the use 1. A device for dilating the outflow tract of a sinus
of an inflatable balloon located at the distal end of a cath- cavity comprising: a metallic inner member having a
eter such as a balloon catheter. Generally, the inflatable proximal end and a distal end; a shaft coupled to a
balloon is inserted into the constricted sinus passageway 45 balloon, the shaft having a first lumen along at least
in a deflated state. The balloon is then expanded to open a portion thereof containing the metallic inner mem-
or reduce the degree of constriction in the sinus passage- ber, the shaft having a second lumen operatively
way being treated to facilitate better sinus drainage and coupled to the interior of the balloon; and a handle
ventilation. At the same time most, if not all, of the func- disposed along a proximal portion of the metallic in-
tional mucosal tissue lining of the sinuses and their drain- 50 ner member, the handle comprising a moveable
age passageways are preserved. knob operatively coupled to the shaft, wherein distal
[0005] Exemplary devices and methods particularly advancement of the knob advances the shaft and
suited for the dilation of anatomic structures associated balloon over the metallic inner member in a distal
with the maxillary and anterior ethmoid sinuses are dis- direction.
closed, for example, in U.S. Patent No. 7,520,876 and 55
U.S. Patent Application Publication No. 2008-0172033. 2. The device of item 1, wherein the metallic inner
Other systems have been described for the treatment of member comprises a lumen along a length thereof.
various other sinuses including the frontal sinus. For ex-

2
 3 EP 4 321 119 A2 4

3. The device of item 2, further comprising a flexible FIG. 2B illustrates a cross-sectional view of the bal-
wire dimensioned for slidable movement within the loon dilation catheter of FIG. 2A.
lumen of the metallic inner member.
FIG. 3A illustrates a side view of a balloon dilation
4. The device of item 1, wherein the distal end of the 5 catheter of FIG. 1. The advancer knob is illustrated
metallic inner member comprises a curved portion. in the advanced, distal position.

5. The device of item 4, wherein the distal end of the FIG. 3B illustrates a cross-sectional view of the bal-
curved portion terminates in a straight segment. loon dilation catheter of FIG. 3A.
10
6. The device of item 4, wherein the curved portion FIG. 4 is a cross-sectional view of the handle portion
has a radius of curvature of between 0.25 inches and (dashed line portion) of FIG. 3B.
1.5 inches.
FIG. 5A is a cross-sectional view of the balloon di-
7. The device of item 1, wherein the distal end of the 15 lation catheter taken along the line A-A’ of FIG. 2B.
metallic inner member comprises a bulbous tip.
FIG. 5B is a cross-sectional view of the balloon di-
8. The device of item 1, wherein the distal end of the lation catheter taken along the line B-B’ of FIG. 4.
metallic inner member comprises a malleable por-
tion. 20 FIG. 6A is a side view of an inner guide member
according to one embodiment.
9. The device of item 1, wherein the shaft is helically
wrapped about a length of the metallic inner member FIG. 6B is a side view of an inner guide member
along a portion of the handle. according to another embodiment.
25
10. The device of item 1, further comprising at least FIG. 6C is a side view of an inner guide member
one tracking element disposed at the handle. according to another embodiment.

11. The device of item 1, wherein the metallic inner FIG. 7 illustrates a perspective view of a balloon di-
member is replaceable within the handle. 30 lation catheter according to another embodiment.

12. The device of item 1, wherein the handle includes FIG. 8 illustrates a cross-sectional view of the frontal
a slot and a portion of the knob is slidably disposed sinus of a subject with the inner guide member of
within the slot. the balloon dilation catheter being advanced into the
35 subject’s frontal recess.
13. The device of item 12, wherein the slot is between
1 and 2 inches in length. FIG. 9 illustrates a cross-sectional view of the frontal
sinus of a subject with the inner guide member of
14. The device of item 1, wherein the handle includes the balloon dilation catheter being positioned in the
a stop. 40 subject’s frontal recess. A guide wire is shown ad-
vanced through the catheter and into the subject’s
15. The device of item 1, wherein the metallic inner frontal sinus cavity. FIG. 10 illustrates a cross-sec-
member is a stainless steel tube having an inner di- tional view of the frontal sinus of a subject with the
ameter in the range of between 0.020 inches and balloon (in a deflated state) and shaft being ad-
0.050 inches and a wall thickness in the range of 45 vanced into the subject’s frontal recess.
between 0.005 inches and 0.020 inches.
FIG. 1 1 illustrates a cross-sectional view of the fron-
Brief Description of the Drawings tal sinus of a subject with the balloon of

[0009] 50 FIG. 10 in an inflated state to thereby widen and re-

model the frontal recess.
FIG. 1 illustrates a perspective view of a balloon di-
lation catheter according to one embodiment. FIG. 12 illustrates a cross-sectional view of the fron-
tal sinus of a subject after the frontal sinus has been
FIG. 2A illustrates a side view of a balloon dilation 55 widened and the balloon inflation catheter with-
catheter of FIG. 1. The advancer knob is illustrated drawn.
in the retracted, proximal position.

3
 5 EP 4 321 119 A2 6

Detailed Description of the Illustrated Embodiments 38 located at the proximal end 24 of the handle 12. One
exemplary inflation device that may be used in connec-
[0010] FIG. 1 illustrates one embodiment of a balloon tion with the balloon dilation catheter 10 is described in
dilation catheter 10 that is particularly suited for treatment U.S. Patent Application No. 12/372,691 , which is incor-
of the outflow tract (frontal sinus ostium and frontal re- 5 porated by reference as if set forth fully herein. Of course,
cess) of the frontal sinus of a subject. The balloon dilation other inflation devices may also be used. An inflation lu-
catheter 10 includes a handle 12 that is configured to be men 48 contained within the shaft 30 (described in more
gripped or otherwise manipulated by the operator. An detail below), fluidically couples the port 38 to an interior
elongate-shaped inner guide member 14 extends longi- portion of the balloon 36.
tudinally from the handle 12 in a distal direction. The inner 10 [0012] Still referring to FIG. 1, an optional support
guide member 14 is formed of a suitably rigid material member 40 in the form of a tube may be located about
such as stainless steel hypotube. The inner guide mem- the external periphery of a portion of the shaft 30 to impart
ber 14 projects or otherwise extends distally from the further stiffness to the balloon dilation catheter 10. The
handle 12 for a pre-determined distance. The inner guide particular length of the support member 40 may vary de-
member 14 may be pre-shaped to have a curved distal 15 pending on the application and may extend along some
portion 16 as is illustrated in FIGS. 1 , 2A, 2B, 3A, 3B, or all or the shaft 30. The support member 40 may be
6A, 6B, 7, 8, and 9. For example, the nature and degree made of a metallic material such as stainless steel hy-
of the curved distal portion 16 may be configured to match potube that is secured to the shaft 30. The support mem-
with the frontal sinus outflow tract or frontal recess. ber 40 may be welded or bonded along a length of the
[0011] Alternatively, the inner guide member 14 may 20 shaft 30. Generally, the support member 40 does not
have some degree of malleability such that the user may cover the helical portion (described in detail below) of the
bend or impart some desired shape or configuration to shaft 30 that is contained within the handle 12.
the distal end of the inner guide member 14. As explained [0013] FIGS. 2A and 2B illustrate, respectively, side
herein in more detail, the inner guide member 14 may and cross-sectional views of the balloon dilation catheter
include an optional lumen 18 (best illustrated in FIG. 5A) 25 10 with the advancer knob 32 and thus balloon 36 in the
that extends the length of the inner guide member 14. In proximal position. In actual use, as explained herein, the
particular, the inner guide member 14 and the contained balloon 36 is typically in a deflated state when the ad-
lumen 18 may extend from a distal end 20 to a proximal vancer knob 32 is the proximal position as illustrated in
end 21 (best seen in FIGS. 2B and 3B) that interfaces FIGS. 2A and 2B. As best seen in FIG. 1 , the advancer
with a sealed arrangement with a port 22 disposed at a 30 knob 32 is slidably disposed along a length of the handle
proximal end 24 of the handle 12. The port 22 may be 12 inside a slot 42. The advancer knob 32 is thus able
configured with a conventional interface such as a Luer to slide back and forth in the distal/proximal direction
connector. The port 22 may be used as an aspiration port along the length of the slot 42. The slot 42 may incorpo-
or a delivery port for fluids and/or medicaments, or for rate a stop or the like (not shown) to prevent the balloon
introduction of a guide wire. Still referring to FIG. 1 , a 35 36 from being advance too far along the length of the
shaft 30 is mounted about the periphery of the inner guide inner guide member 14. The length of the slot 42 may be
member 14. In particular, the shaft 30 is dimensioned to varied in different devices to adjust the length at which
slide over the inner guide member 14 in response to ac- the balloon 36 may be advanced. Generally, the slot 42
tuation of an advancer knob 32 located on the handle 12. has a length within the range of about 1 inch to about 2
The advancer knob 32 is moveable along a slot 42 con- 40 inches although other dimensions may fall within the
tained in a surface of the handle 12. A distal end 34 of scope of the invention.
the shaft 30 includes a balloon 36 that is configured to [0014] As seen in FIG. 2B, the advancer knob 32 may
be selectively inflated or deflated as explained herein. be directly coupled to the support member 40 that is
During use, the inner guide member 14 is manipulated mounted on the shaft 30. Alternatively, the advancer
and advanced across or into the anatomical space of 45 knob 32 may be coupled directly to the shaft 30. The
interest. The shaft 30 as well as the attached balloon 36 advancer knob 32 may be configured or otherwise
is illustrated in a retracted state in FIG. 1. While FIG. 1 shaped to enable a finger of the user (e.g., index finger
illustrates the balloon 36 in an inflated state for better or thumb) to easily advance or retract the knob 32 along
illustration, the balloon 36 is typically in a deflated state the slot 42 contained in the handle 12.
when the shaft 30 is in the proximal position as illustrated 50 [0015] FIGS. 3A and 3B illustrate, respectively, side
in FIGS. 2A and 2B. After the inner guide member 14 is and cross-sectional views of the balloon dilation catheter
properly positioned, the user actuates the advancer knob 10 with the advancer knob 32 and thus balloon 36 in the
32 by sliding the same in the distal direction which, in distal position. Thus, unlike the configurations of FIGS.
turn, advances the shaft 30 and balloon 36 in a distal 2A and 2B, the advancer knob 32 is located at or near
direction over the pre-placed inner guide member 14. 55 the distal end 26 of the handle 12. Advancement of the
Once the balloon 36 is properly placed, the balloon 36 is advancer knob 32 also slides the shaft 30 and attached
inflated. Inflation of the balloon 36 is accomplished using balloon 36 in a distal direction (arrow A in FIG. 3A) along
an inflation device (not shown) that is coupled to a port the inner guide member 14. The balloon 36 thus is posi-

4
 7 EP 4 321 119 A2 8

tioned at or adjacent to the distal end 20 of the inner guide erally, any technique known to those skilled in the art
member 14. The balloon dilation catheter 10 may be de- may be used to secure to the balloon 36 to the shaft 30.
signed such that the advancer knob 32 may be positioned Given that the balloon 36 is secured directly to the shaft
at either the proximal or distal extremes as illustrated in 30, both structures are slidably mounted over the inner
FIGS. 2A, 2B, 3A, 3B. Alternatively, the advancer knob 5 guide member 14. The balloon 36 generally takes on a
32 may be positioned somewhere in between the two cylindrical- shape when inflated. While not limited to spe-
extremes. For example, the optimal position of the bal- cific dimensions, the inflated balloon 36 has a diameter
loon 36 may be accomplished by sliding the advancer within the range of about 3 mm to about 9 mm, and more
knob 32 some fraction (e.g., 3/4) of the full distance of preferably a diameter within the range of about 5 to about
the slot 42. 10 7 mm when inflated. The length of the balloon 36 may
[0016] Referring to FIGS. 2B and 3B, the inner guide generally fall within the range of about 10 mm to 25 mm
member 14 of the balloon dilation catheter 10 extends although other lengths may be used. Both the shaft 30
from a distal end 20 to a proximal end 21 that terminates and the balloon 36 are preferably formed of high strength
in a sealed interface with a port 22 disposed at a proximal but flexible polymeric materials such as polyamides (e.g.,
end 24 of the handle 12. The inner guide member 14 15 Nylon), PEBAX or the like. The balloon 36 may be "blow
optionally includes a lumen 18 disposed therein that may molded" to a relatively thin wall thickness, and capable
be used to provide aspiration functionality via an aspira- of holding relatively high pressures from about 6 atmos-
tion device (not shown) coupled to port 22. Aspiration pheres to about 20 atmospheres of inflation pressure.
functionality permits the removal of blood and other se- The balloon 36 is inflated using a fluid which is typically
cretions. This makes it easier to visualize the placement 20 a liquid such as water or saline.
of the balloon dilation catheter 10. The inner guide mem- [0020] Referring now to FIG. 4, a magnified, cross-sec-
ber 14 is advantageously rigid to enable the balloon di- tional view of a portion of the handle 12 is illustrated. At
lation catheter 10 to be positioned without the need of a the proximal end 24 of the handle 12 are located ports
separate guiding catheter or guide wire in most, if not all, 22, 38. The port 22 may be configured with a conventional
instances. 25 interface such as a Luer connector or any other connector
[0017] The inner guide member 14 may have a length known to those skilled in the art. The port 22 may be
of about 7 inches to about 1 1 inches from the distal end integrally formed with the handle 12 or, alternatively, the
20 to the proximal end 21 when loaded into the handle port 22 may be a separate structure that is secured to
12, although other dimensions may be used. The inner the handle 12 during assembly. As seen in FIG. 4, the
guide member 14 may be formed from stainless steel 30 proximal end 21 of the inner guide member 14 forms a
hypotube having an inner diameter in the range of about sealing arrangement with the port 22. As explained here-
0.020 inch to about 0.050 inch, and more preferably be- in, the port 22 may be used as an aspiration port or a
tween about 0.036 inch and 0.040 inch, with a wall thick- delivery port for fluids and/or medicaments.
ness within the range of about 0.005 inch to about 0.020 [0021] FIG. 4 also illustrates port 38 which may be con-
inch, and more preferably between about 0.008 inch to 35 structed in the same or similar manner as port 22 as
about 0.012 inch. The curved distal portion 16 of the inner described above. The port 38 is fluidically coupled to the
guide member 14 may be formed right to the distal end inflation lumen 48 in the shaft 30. In this regard, inflation
20 and may have a radius of curvature of about 0.25 inch fluid from an inflation device (not shown) is able to pass
to about 1.5 inch, and more preferably about 0.75 to about through the port 38 and into the inflation lumen 48 of the
1 .25 inch. 40 shaft 30. The port 38 may be configured with a conven-
[0018] The length of the inner guide member 14 that tional interface such as a Luer connector. The fluid then
projects distally from the distal-most portion of the balloon is able to travel along the length of the shaft 30 via the
36 is about 0.5 inch to about 2.0 inch, and more prefer- lumen 48 where the fluid enters the interior of the balloon
ably, about 0.8 inch to about 1.2 inch when the balloon 36. The inflation fluid is thus able to inflate the balloon
36 is in the fully retracted state (e.g., illustrated in FIGS. 45 36 upon actuation of the inflation device.
2A and 2B). As seen in FIGS. 1 , 2A, 2B, 3A, 3B, 6A-6C, [0022] As best seen in FIG. 4, a portion of the handle
7-11 , the distal end 20 of the inner guide member 14 12 includes a recessed region 50 that receives both the
may incorporate an optional bulbous tip 44 in order to inner guide member 14 and the shaft 30. In the recessed
make the distal end 20 more atraumatic. The bulbous tip region 50 of the handle 12, the shaft 30 is helically
44 further serves to limit forward movement of the balloon 50 wrapped around the outer periphery of the inner guide
36 and attached shaft 30 when they are advanced dis- member 14 forming a helical portion 52. The helical por-
tally. The outer diameter of the tip 44 is preferably be- tion 52 facilitates the distal advancement and proximal
tween about 1 mm and about 3 mm. retraction of the shaft 30 and attached balloon 36 along
[0019] The balloon 36 is mounted on the shaft 30 so the inner guide member 14 yet still maintains fluid com-
as to form a fluidic seal between the two components. 55 munication with the port 38. The helical portion 52 of the
The balloon 36 may be bonded to the shaft using a weld, shaft 30, which is located proximal to the advancer knob
adhesive, or the like. Alternately, the balloon 36 may be 32 is in the shape of a helix that wraps around the inner
secured to the shaft using a mechanical connection. Gen- guide member 14 and is configured to elongate and con-

5
 9 EP 4 321 119 A2 10

tract upon movement of the advancer knob 32. FIG. 4 and turns back on itself in the shape of a "U" in which the
illustrates the state of the helical portion 52 after the ad- distal end 20 turns back in retrograde fashion. This em-
vancer knob 32 has been advanced distally. Thus, in the bodiment may be useful to treat hard to reach ostia or
extended state, the length of the helical portion 52 other structures, e.g., the maxillary ostium or the in-
traverses much if not all of the recessed region 50. Con- 5 fundibulum via a transnasal route, if the nasal anatomy
trast this with FIG. 2B which illustrates the helical portion will allow for a trans-nasal approach. While FIG. 6A illus-
52 compressed to the proximal portion of the recessed trates a "U" shaped curve, other degrees of curvature
region 50 because the advancer knob 32 is the in prox- are contemplated. FIG. 6B illustrates an inner guide
imal position. Thus, the helical portion 52 is thus able to member 14 according to another embodiment. In this em-
expand or compress much in the way that a spring does 10 bodiment, the curved distal portion 16 also terminates in
in response to a tensile or compressive load. One or both a straight segment 46 although the radius of curvature
of the inner guide member 14 and the helical portion 52 is less pronounced. In this embodiment, the straight seg-
of the shaft 30 may be optionally coated or lined with a ment 46 may have a length within the range of about 8
lubricious coating to prevent the contact surfaces from mm to about 10 mm although other lengths may be used.
any unwanted fhctional binding or the like. 15 It is believed that this embodiment is particularly suited
[0023] The helical portion 52 of the shaft 30 may be for most frontal recess anatomy. FIG. 6C illustrates an
formed by "skiving" away a portion of the shaft 30. FIG. embodiment in which the inner guide member 14 is sub-
5A illustrates a cross-sectional view of the shaft 30, inner stantially straight. This later embodiment may be partic-
support guide 14, and support member 40 along the line ularly suited for treating the sphenoids of the subject, or
A-A’ of FIG. 2B. As seen in FIG. 2B, this area is distal to 20 straightforward frontal recess anatomy.
where the helical portion 52 of the shaft 30 is located. [0026] FIG. 7 illustrates a balloon dilation catheter 10
Referring now to FIG. 5A, the shaft 30 includes a rider according to another embodiment. In this embodiment,
lumen 54 that is dimensioned to have a diameter that is a tracking element 60 is located on the handle 12 of the
slightly larger than the outer diameter of the inner support balloon dilation catheter 10. The tracking element 60 may
guide 14. The rider lumen 54 thus enables the shaft 30 25 include an antenna, transmitter, optical reflectors, or the
to advance and retract over the inner support guide 14 like that communicates a wireless signal that is then re-
in a close-fit arrangement. The outer diameter of the shaft ceived and processed to determine the orientation and/or
30 may generally fall within the range of about .050 inch positioning of the balloon dilation catheter 10. In certain
to about .1 10 inch or within the range of about .070 inch embodiments, more than one tracking element 60 may
to about .100 inch. One or both of the exterior surface of 30 be disposed on the balloon dilation catheter 10. Data
the inner guide member 14 and the interior surface of the regarding the orientation and/or positioning of the balloon
rider lumen 54 may be optionally coated with a lubricious dilation catheter 10 may then be processed and dis-
coating to reduce fhctional contact forces. FIG. 5B illus- played on the display for viewing by the physician. For
trates a cross-sectional view of the inner support guide example, image guided surgery is becoming increasingly
14 and the helical portion 52 of the shaft 30 taken along 35 commonplace, permitting physicians to review real time
the line B-B’ of FIG. 4. As seen in FIG. 5B, a portion of actual or virtual images of a particular device within a
the shaft 30 that includes the rider lumen 54 is skived subject during a surgical procedure.
away. The result is that a single lumen (inflation lumen [0027] For example, U.S. Patent Nos. 5,391 ,199 and
48) remains in the shaft 30 that is helically wrapped about 5,443,489, which are incorporated by reference, de-
the inner support guide 14. 40 scribe a system wherein coordinates of an intrabody
[0024] FIGS. 6A-6C illustrate various embodiments of probe are determined using one or more field sensors
an inner guide member 14. The inner guide member 14 such as, Hall effect devices, coils, or antennas that are
may have a variety of shapes and configurations depend- carried on the probe. U.S. Patent Application Publication
ing on the particular application or patient. The different No. 2002-0065455, which is also incorporated by refer-
shapes of the inner guide member 14 may be factory- 45 ence, describes a system that is capable of generating
formed in a particular shape and offered as a different a six-dimensional position and orientation representation
model as fully assembled or, alternatively, the inner guide of the tip of a catheter using a combination of sensor and
member 14 may be replaceable or modular elements that radiation coils. U.S. Patent Application Publication No.
could slide inside the rider lumen 54 and inserted into 2008-0269596, which is also incorporated by reference,
the port 22 in a press-fit type sealing arrangement. In yet 50 describes yet another monitoring system that has partic-
another alternative, the shapes could represent desirable ular applications in orthopedic procedures. Commercial
shapes that a malleable inner guide member 14 could systems such as the LANDMARX Element (Medtronic
be formed into by the user to better fit a particular appli- Xomed Products, Inc., Jacksonville, FL) are available for
cation or subject’s anatomy. use in conjunction with ENT procedures.
[0025] FIG. 6A illustrates an inner guide member 14 55 [0028] In the embodiment of FIG. 7, the tracking ele-
that includes a curved distal portion 16 that terminates ment 60 permits accurate tracking of the distal end 20 of
in a straight segment 46. In the embodiment of FIG. 6A, the balloon dilation catheter 10 such that an image of
the curve in the curved distal portion 16 is pronounced distal portion of the balloon dilation catheter 10 may be

6
 11 EP 4 321 119 A2 12

superimposed on a patient’s anatomical imagery. For ex- vance into the frontal sinus cavity 104, the balloon dilation
ample, a previously conducted computed tomography catheter 10 is re-positioned and confirmation is subse-
(CT) scan of the patient may be used to generate a visual quently attempted. As an alternative to a fluoroscopically
image of the patient’s anatomical regions of interest. visible guide wire 64, the guide wire 64 could be a light
Based on the location of the tracking element 60, an im- 5 emitting guide wire such as that disclosed in U.S. Patent
age guided surgery (IGS) system can then superimpose Application Publication No. 2007-0249896, which is in-
an image of the balloon dilation catheter 10 onto the im- corporated by reference herein. Of course, the guide wire
age to better enable the physician to manipulate and ori- 64 is optional as the inner guide member 14 may be
ent the balloon dilation catheter 10. placed without the aid or need for the same. Alternatively,
[0029] Other commercial systems may also be used 10 the guide wire 64 could be positioned in the frontal sinus
in connection with the balloon dilation catheter 10 illus- initially, prior to placement of the balloon catheter 10.
trated in FIG. 7. For example, the INSTATRAK 3500 Plus [0032] Now referring to FIG. 10, once the curved por-
- ENT from GE Healthcare, Chalfont St. Giles, United tion 16 of the inner guide member 14 is properly posi-
Kingdom may be integrated and/or used with the balloon tioned, the advancer knob 32 is advanced in the distal
dilation catheter 10. The use of CT guidance to position 15 direction (arrow A of FIG. 3A) thereby advancing the shaft
the balloon dilation catheter 10 is preferred because the 30 and attached balloon 36 into the frontal recess 102.
device may be positioned by the operator with just a sin- This is illustrated in FIG. 10. After the balloon 36 is posi-
gle hand, while viewing the CT image interface (e.g., dis- tioned in the frontal recess 102, the balloon 36 is inflated
play) at the same time the handle 12 is manipulated. Op- as illustrated in FIG. 1 1. Inflation is accomplished by
tionally, the balloon dilation catheter 10 may be initially 20 coupling an inflation device (not shown) to the port 38.
positioned using and endoscope or other visualization The inflation device may include a syringe or the like that
tool. For instance, a conventional "Hopkins rod" endo- is depressed to infuse a fluid into the inflation lumen 48
scope (not shown) may be manipulated alongside the which then passes into the interior of the balloon 36 to
balloon dilation catheter 10 to aid in placement. effectuate expansion of the balloon 36 to the state illus-
[0030] FIGS. 8-12 illustrate various cross-sectional 25 trated in FIG. 1 1. Pressures typically used to accomplish
views (sagittal plane) of the frontal sinus of a subject un- widening or remodeling of the frontal recess 102 are with-
dergoing treatment with a balloon dilation catheter 10. in the range of about 3 atmospheres to about 12 atmos-
The cross-sectional views illustrate the nasal passage- pheres. The balloon 36 may be inflated only a single time
way 100, the frontal recess 102, and the frontal sinus or, alternatively, the balloon 36 may be inflated, deflated,
cavity 104. Referring to FIG. 8, the balloon dilation cath- 30 and inflated again a plurality of times in order to achieve
eter 10 is inserted into the nasal passageway 100 with the desired degree of widening. Each inflation step may
the advancer knob 32 in the retracted position (e.g., as be performed after positioning the balloon 36 in a different
illustrated in FIG. 1 , 2A, 2B) such that the shaft 30 and position within the frontal recess 102.
balloon 36 are also retracted proximally. In addition, the [0033] After the frontal recess 102 has been widened
balloon 36 is in a deflated state as seen in FIG. 8. The 35 or otherwise remodeled, the balloon 36 is deflated and
curved portion 16 of the inner guide member 14 is then removed as illustrated in FIG. 12. The widened frontal
positioned within the frontal recess 102 of the subject as recess 102 illustrated in FIG. 12 is believed to restore
seen in FIG. 8. This positioning of the inner guide member the drainage and aeration function and health of the fron-
14 may be accomplished under endoscopic visualization tal sinus cavity 104. Deflation of the balloon 36 is accom-
using a conventional endoscope such as a Hopkins rod- 40 plished by reducing the fluid pressure within the interior
type endoscope that is positioned alongside the balloon of the balloon 36. For example, the plunger of a syringe
dilation catheter 10. Alternatively, the inner guide mem- or the like that is fluidically coupled to the port 38 may be
ber 14 may be positioned using IGS techniques that track withdrawn to remove fluid from the interior of the balloon
the position of the balloon dilation catheter 10 using one 36. The balloon dilation catheter 10 can then be with-
or more tracking elements 60 as illustrated, for instance, 45 drawn proximally from the nasal passageway 100.
in the embodiment of FIG. 7. For instance, the inner guide [0034] In certain patients, treatment of one or both fron-
member 14 may be advanced under guidance from CT tal sinuses 104 as described above may be adequate.
imaging. In other patients, additional sinuses may need to be treat-
[0031] Referring now to FIG. 9, confirmation of accu- ed, particularly the maxillary and/or anterior ethmoid si-
rate positioning of the inner guide member 14 within the 50 nuses. In such patients, a combination procedure may
frontal recess 102 may be accomplished by placement be well suited. The maxillary and/or anterior ethmoid si-
of a fluoroscopically visible guide wire 64 through the nuses can be treated with a system such as described
lumen 18 of the inner guide member 14. The guide wire in U.S. Patent No. 7,520,876 and U.S. Patent Application
64 may be inserted into the lumen 18 via the port 22. Publication No. 2008-0172033, commercially available
Under fluoroscopic visualization, the guide wire 64 can 55 as the FinESS system by Entellus Medical, Inc. of Maple
be seen to advance into the frontal sinus cavity 104 once Grove, MN. Alternatively, other sinuses could be treated
the inner guide member 14 is positioned properly within more conventionally using surgical techniques such as,
the frontal recess 102. If the guide wire 64 does not ad- for instance, functional endoscopic sinus surgery

7
 13 EP 4 321 119 A2 14

(FESS). (30) is in a fully retracted position.

[0035] Also, the sphenoid and/or maxillary sinus out-
flow tracts could be dilated with the embodiment of the 3. The balloon dilation catheter (10) of any one of
balloon catheter 10 described above. It is also contem- claims 1-2, wherein a distal portion of the substan-
plated that the balloon catheter 10, particularly the em- 5 tially rigid inner guide member (14) is malleable and
bodiment of FIG. 7 with a suitable IGS device is incorpo- can be shaped by an operator into a desired config-
rated, and with an appropriate shape for the inner support uration and maintain the desired configuration while
member 14, preferably straight as illustrated in FIG. 6C, the shaft (30) is advanced along the substantially
could be used to dilate the maxillary sinus outflow tract rigid inner guide member (14).
via the canine fossa route. Suitable access tools are de- 10
scribed in co-pending U.S. Patent Application No. 4. The balloon dilation catheter (10) of any one of
12/038,719, which is incorporated by reference herein. claims 1-3, wherein the balloon dilation catheter (10)
This could be performed without need for additional en- is configured to prevent the shaft (30) from advanc-
doscopic visualization, permitting treatment through a ing past a predetermined position along the substan-
relatively small diameter access passageway into the si- 15 tially rigid inner guide member (14).
nus cavity in the region of the canine fossa. A small en-
doscope (not shown) could be utilized, if desired, through 5. The balloon dilation catheter (10) of claim 4,
the lumen 18 of the inner support member 14 to further wherein the balloon dilation catheter (10) includes a
aid in visualization of the maxillary sinus outflow tract. stop that prevents the shaft (30) from advancing past
[0036] While embodiments of the present invention 20 the predetermined position along the substantially
have been shown and described, various modifications rigid inner guide member (14).
may be made without departing from the scope of the
present invention. The invention, therefore, should not 6. The balloon dilation catheter (10) of any one of
be limited, except to the following claims, and their equiv- claims 1-5, wherein the balloon dilation catheter (10)
alents. 25 is configured to prevent the balloon (36) from ad-
[0037] The following item refer to embodiments of the vancing past the distal end (20) of the substantially
invention, wherein the term "claim" means "embodi- rigid inner guide member (14).
ment":
7. The balloon dilation catheter (10) of any one of
1. A balloon dilation catheter (10) comprising: 30 claims 1-6, wherein the substantially rigid inner guide
member (14) is sealed to the handle (12).
a handle (12) configured to be gripped by an
operator; 8. The balloon dilation catheter (10) of any one of
a substantially rigid inner guide member (14) ex- claims 1-7, wherein the substantially rigid inner guide
tending longitudinally from the handle (12) in a 35 member (14) is a stainless steel hypotube.
distal direction, the substantially rigid inner
guide member (14) having a proximal end (21), 9. The balloon dilation catheter (10) of any one of
a distal end (20), and a lumen (18) extending claims 1-8, wherein a light emitting guidewire (64)
along a length thereof and terminating at the dis- extends through the lumen (18) of the substantially
tal end (20); and 40 rigid inner guide member (14).
a shaft (30) coupled to a balloon (36), wherein
the shaft (30) includes a first lumen (54) along 10. The balloon dilation catheter (10) of any one of
at least a portion thereof containing the substan- claims 1-9, wherein the distal end (20) of the sub-
tially rigid inner guide member (14), wherein the stantially rigid inner guide member (14) comprises a
shaft (30) includes a second lumen (48) opera- 45 curved portion (16).
tively coupled to an interior of the balloon (36),
and wherein the shaft (30) and the balloon (36) 11. The balloon dilation catheter (10) of claim 10,
are slidably mounted over the substantially rigid wherein a distal end of the curved portion (16) ter-
inner guide member (14) such that the shaft (30) minates in a straight segment.
and the balloon (36) are configured to be ad- 50
vanced distally with respect to the substantially 12. The balloon dilation catheter (10) of any one of
rigid inner guide member (14) and the handle claims 1-11, wherein the shaft (30) is helically
(12). wrapped about a length of the substantially rigid in-
ner guide member (14) along a portion of the handle
2. The balloon dilation catheter (10) of claim 1, 55 (12).
wherein the shaft (30) defines a rider lumen (54) and
the substantially rigid inner guide member (14) ex- 13. The balloon dilation catheter (10) of any one of
tends through the rider lumen (54) when the shaft claims 1-12, further comprising:

8
 15 EP 4 321 119 A2 16

at least one tracking element (60) disposed at the mm (0.012 inch).

handle (12).
19. The balloon dilation catheter (10) of any of claims
14. The balloon dilation catheter (10) of any one of 16 to 18, wherein the inner guide member (14) has
claims 1-13, further comprising: 5 an inner diameter in the range of about 0.508 mm
an advancer knob (32) operatively coupled to the (0.020 inch) to about 1.27 mm (0.050 inch), prefer-
shaft (30), wherein distal advancement of the ad- ably between about 0.9144 mm (0.036 inch) and
vancer knob (32) advances the shaft (30) and the 1.016 mm (0.040 inch).
balloon (36) over the substantially rigid inner guide
member (14) in a distal direction. 10 20. The balloon dilation catheter (10) of any of claims
16 to 19, wherein the inner guide member (14) has
15. The balloon dilation catheter (10) of claim 14, a length of about 17.78 cm (7 inches) to about 27.94
wherein the handle (12) defines a slot (42) extending cm (11 inches) from the distal end (20) to the prox-
along a longitudinal length of the handle (12), and imal end (21).
wherein the advancer knob (32) is configured to 15
translate along the slot (42). 21. The balloon dilation catheter (10) of any one of
claims 16 to 20, wherein the inner guide member
16. A balloon dilation catheter (10) for dilating sinus (14) has a degree of malleability such that a user
drainage pathways, the balloon dilation catheter (10) may bend or impart some desired shape or config-
comprising: 20 uration to the distal end (20) of the guide member
(14).
a handle (12) having a proximal end (24) and a
distal end (26) and a slot (42) contained in a 22. The balloon dilation catheter (10) of any one of
surface of the handle; claims 16 to 21, wherein the guide wire (64) is a light
a substantially rigid inner guide member (14) 25 emitting guide wire (64).
having a proximal end (21), a distal end (20),
and a lumen (18) extending between the distal 23. The balloon dilation catheter (10) of any one of
end (20) and the proximal end (21), wherein the claims 16 to 22, wherein the distal end (20) of the
substantially rigid inner guide member (14) ex- substantially rigid inner guide member (14) compris-
tends longitudinally from the distal end of the 30 es a curved portion (16).
handle (12), and wherein the proximal end of
the substantially rigid inner guide member ter- 24. The balloon dilation catheter (10) of claim 23,
minates within the handle; wherein a distal end of the curved portion (16) ter-
a shaft (30) slidably mounted over the substan- minates in a straight segment.
tially rigid inner guide member (14), wherein the 35
shaft (30) includes an inflation lumen (48) that 25. The balloon dilation catheter (10) of any one of
is fluidically coupled to an inflation port (38), claims 16 to 24, wherein the guide wire (64) extends
wherein a distal portion of the shaft (30) includes through the handle (12) and beyond a distal end (20)
an inflatable balloon (36), and of the substantially rigid inner guide member (14).
an advancer knob (32) that is moveable along 40
the slot (42) disposed in the surface of the handle 26. The balloon dilation catheter (10) of any one of
(12), wherein the advancer knob (32) is coupled claims 16 to 25, further comprising a tubular support
to the shaft (30) such that moving the advancer member (40) located about an external periphery of
knob (32) along the slot (42) slides the shaft (30) a portion of the shaft (30).
over the substantially rigid inner guide member 45
(14); and 27. The balloon dilation catheter (10) of any one of
a guide wire (64) disposed in the lumen (18) of claims 16 to 26, wherein a distal portion of the sub-
the substantially rigid inner guide member (14). stantially rigid inner guide member (14) is malleable.

17. The balloon dilation catheter (10) of claim 16, 50 28. The balloon dilation catheter (10) of any one of
wherein the substantially rigid inner guide member claims 16 to 27, wherein the distal end (20) of the
(14) is a metallic hypotube. substantially rigid inner guide member (14) compris-
es a bulbous tip.
18. The balloon dilation catheter (10) of claim 16 or
17, wherein the inner guide member (14) has a wall 55 29. The balloon dilation catheter (10) of claim 28,
thickness within the range of about 0.127 mm (0.005 wherein the bulbous tip has an outer diameter be-
inch) to about 0.508 mm (0.020 inch), preferably be- tween 1 mm and 3 mm.
tween about 0.2032 mm (0.008 inch) to about 0.3048

9
 17 EP 4 321 119 A2 18

30. A guide member configured to be used as the 11. The guide member (14) of any one of claims 1 to 10,
inner guide member (14) of the balloon dilation cath- wherein the proximal end (21) is configured to inter-
eter (10) defined in any one of claims 16 to 29. face with a port (22) usable as an aspiration port or
a delivery port for fluids and/or medicaments or for
5 introduction of the guide wire (64).
Claims
12. A ballon dilation catheter (10) for dilating sinus pas-
1. A guide member (14) for placement of a guide wire sage drainways, the balloon dilation catheter (10)
(64), the guide member (14) extending from a distal comprising the guide member (14) according to any
end (20) to a proximal end (21) and having a length 10 one of claims 1 to 11.
of about 17.78 cm (7 inches) to about 27.94 cm (11
inches) from the distal end (20) to the proximal end 13. The balloon dilation catheter of claim 12, further com-
(21), wherein the guide member (14) comprises a prising the guide wire (64) disposed in the lumen
lumen (18) that extends the length of the guide mem- (18).
ber (14), the lumen (18) configured such that the 15
guide wire (64) can be placed therethrough, wherein 14. The balloon dilation catheter (10) of claim 12 or 13,
the guide member (14) is formed as a hypotube, has further comprising a handle (12), wherein the guide
a wall thickness between about 0.2032 mm (0.008 member (14) extends longitudinally from the handle
inch) to about 0.3048 mm (0.012 inch) and has a (12) in a distal direction.
degree of malleability such that a user may bend or 20
impart some desired shape or configuration to the 15. The balloon dilation catheter (10) of claim 14, com-
distal end (20) of the guide member (14). prising the guide member (14) according to claim 11,
wherein the port (22) is disposed at a proximal end
2. The guide member (14) of claim 1, wherein the hy- (24) of the handle (12).
potube has an inner diameter in the range of about 25
0.508 mm (0.02 inch) to about 1.27 mm (0.05 inch).

3. The guide member (14) of claim 1 or 2, formed as a

metallic hypotube.
30
4. The guide member (14) of any one of claims 1 to 3,
formed as a stainless steel hypotube.

5. The guide member (14) of any one of claims 1 to 4,

wherein the guide wire (64) is a light emitting guide 35
wire (64).

6. The guide member (14) of any one of claims 1 to 5,

wherein the distal end (20) comprises a bulbous tip
(44). 40

7. The guide member (14) of claim 6, wherein the bul-

bous tip (44) has an outer diameter between 1 mm
and 3 mm.
45
8. The guide member (14) of any one of claims 1 to 7,
wherein the distal end (20) comprises a curved por-
tion (16).

9. The guide member (14) of claim 8, wherein a distal 50

end of the curved portion (16) terminates in a straight
segment.

10. The guide member (14) of any one of claims 1 to 9,

configured such that the guide wire (64), when 55
placed through the lumen (18), can extend beyond
the distal end (20) of the guide member (14).

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11
EP 4 321 119 A2

12
EP 4 321 119 A2

13
EP 4 321 119 A2

14
EP 4 321 119 A2

15
EP 4 321 119 A2

16
EP 4 321 119 A2

17
EP 4 321 119 A2

18
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 EP 4 321 119 A2

REFERENCES CITED IN THE DESCRIPTION

This list of references cited by the applicant is for the reader’s convenience only. It does not form part of the European
patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be
excluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description

• US 7520876 B [0005] [0034] • US 5443489 A [0027]

• US 20080172033 [0005] [0034] • US 20020065455 [0027]
• US 20080097295 [0005] • US 20080269596 [0027]
• US 20080125626 [0005] • US 20070249896 [0031]
• US 372691 [0011] • US 038719 [0035]
• US 5391199 A [0027]

20