Sinus dilation catheter

A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

FIELD OF THE INVENTION

The field of the invention generally relates to balloon inflation devices and methods. More particularly, the field of the invention relates to balloon dilation devices and methods for the treatment of sinusitis.

BACKGROUND OF THE INVENTION

Sinusitis is a condition affecting over 35 million Americans, and similarly large populations in the rest of the developed world. Sinusitis occurs when one or more of the four paired sinus cavities (i.e., maxillary, ethmoid, frontal, sphenoid) becomes obstructed, or otherwise has compromised drainage. Normally the sinus cavities, each of which are lined by mucosa, produce mucous which is then moved by beating cilia from the sinus cavity out to the nasal cavity and down the throat. The combined sinuses produce approximately one liter of mucous daily, so the effective transport of this mucous is important to sinus health.

Each sinus cavity has a drainage pathway or outflow tract opening into the nasal passage. This drainage passageway can include an ostium, as well as a “transition space” in the region of the ostia, such as the “frontal recess,” in the case of the frontal sinus, or an “ethmoidal infundibulum,” in the case of the maxillary sinus. When the mucosa of one or more of the ostia or regions near the ostia become inflamed, the egress of mucous is interrupted, setting the stage for an infection and/or inflammation of the sinus cavity, i.e., sinusitis. Though many instances of sinusitis may be treatable with appropriate medicates, in some cases sinusitis persists for months or more, a condition called chronic sinusitis, and may not respond to medical therapy. Some patients are also prone to multiple episodes of sinusitis in a given period of time, a condition called recurrent sinusitis.

Balloon dilation has been applied to treat constricted sinus passageways for the treatment of sinusitis. These balloon dilation devices typically involve the use of an inflatable balloon located at the distal end of a catheter such as a balloon catheter. Generally, the inflatable balloon is inserted into the constricted sinus passageway in a deflated state. The balloon is then expanded to open or reduce the degree of constriction in the sinus passageway being treated to facilitate better sinus drainage and ventilation. At the same time most, if not all, of the functional mucosal tissue lining of the sinuses and their drainage passageways are preserved.

Exemplary devices and methods particularly suited for the dilation of anatomic structures associated with the maxillary and anterior ethmoid sinuses are disclosed, for example, in U.S. Pat. No. 7,520,876 and U.S. Patent Application Publication No. 2008-0172033. Other systems have been described for the treatment of various other sinuses including the frontal sinus. For example, U.S. Patent Application Publication No. 2008-0097295 discloses a frontal sinus guide catheter (FIG. 6B) and method of treating the frontal sinuses (e.g., FIGS. 8B-8C). U.S. Patent Application Publication No. 2008-0125626 discloses another guide device (e.g., FIGS. 10C and 10C′) for transnasal access to the frontal sinuses for treatment.

SUMMARY OF THE INVENTION

In a first embodiment of the invention, a balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a drainage pathway of a sinus cavity (e.g., frontal sinus cavity) of a subject using the balloon dilation catheter, the substantially rigid inner guide member is advanced into a drainage pathway of the subject via a nasal passageway. The shaft and balloon are then advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. This enables the balloon to track over the inner guide member. The balloon is inflated to expand or otherwise remodel the drainage pathway. Where the sinus cavity is the frontal sinus cavity the drainage pathway is the frontal recess.

In another aspect of the invention, a device for dilating the outflow tract of a sinus cavity includes a substantially rigid inner guide member having a proximal end and a distal end and a shaft coupled to a balloon, the shaft having a first lumen along at least a portion thereof containing the substantially rigid inner guide member, the shaft having a second lumen operatively coupled to the interior of the balloon. A handle is disposed along a proximal portion of the substantially rigid inner guide member, the handle including a moveable knob operatively coupled to the shaft, wherein distal advancement of the knob advances the shaft and balloon over the substantially rigid inner guide in a distal direction.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIG. 1illustrates one embodiment of a balloon dilation catheter10that is particularly suited for treatment of the outflow tract (frontal sinus ostium and frontal recess) of the frontal sinus of a subject. The balloon dilation catheter10includes a handle12that is configured to be gripped or otherwise manipulated by the operator. An elongate-shaped inner guide member14extends longitudinally from the handle12in a distal direction. The inner guide member14is formed of a suitably rigid material such as stainless steel hypotube. The inner guide member14projects or otherwise extends distally from the handle12for a pre-determined distance. The inner guide member14may be pre-shaped to have a curved distal portion16as is illustrated inFIGS. 1,2A,2B,3A,3B,6A,6B,7,8, and9. For example, the nature and degree of the curved distal portion16may be configured to match with the frontal sinus outflow tract or frontal recess.

Alternatively, the inner guide member14may have some degree of malleability such that the user may bend or impart some desired shape or configuration to the distal end of the inner guide member14. As explained herein in more detail, the inner guide member14may include an optional lumen18(best illustrated inFIG. 5A) that extends the length of the inner guide member14. In particular, the inner guide member14and the contained lumen18may extend from a distal end20to a proximal end21(best seen inFIGS. 2B and 3B) that interfaces with a sealed arrangement with a port22disposed at a proximal end24of the handle12. The port22may be configured with a conventional interface such as a Luer connector. The port22may be used as an aspiration port or a delivery port for fluids and/or medicaments, or for introduction of a guide wire.

Still referring toFIG. 1, a shaft30is mounted about the periphery of the inner guide member14. In particular, the shaft30is dimensioned to slide over the inner guide member14in response to actuation of an advancer knob32located on the handle12. The advancer knob32is moveable along a slot42contained in a surface of the handle12. A distal end34of the shaft30includes a balloon36that is configured to be selectively inflated or deflated as explained herein. During use, the inner guide member14is manipulated and advanced across or into the anatomical space of interest. The shaft30as well as the attached balloon36is illustrated in a retracted state inFIG. 1. WhileFIG. 1illustrates the balloon36in an inflated state for better illustration, the balloon36is typically in a deflated state when the shaft30is in the proximal position as illustrated inFIGS. 2A and 2B. After the inner guide member14is properly positioned, the user actuates the advancer knob32by sliding the same in the distal direction which, in turn, advances the shaft30and balloon36in a distal direction over the pre-placed inner guide member14. Once the balloon36is properly placed, the balloon36is inflated. Inflation of the balloon36is accomplished using an inflation device (not shown) that is coupled to a port38located at the proximal end24of the handle12. One exemplary inflation device that may be used in connection with the balloon dilation catheter10is described in U.S. patent application Ser. No. 12/372,691, which is incorporated by reference as if set forth fully herein. Of course, other inflation devices may also be used. An inflation lumen48contained within the shaft30(described in more detail below), fluidically couples the port38to an interior portion of the balloon36.

Still referring toFIG. 1, an optional support member40in the form of a tube may be located about the external periphery of a portion of the shaft30to impart further stiffness to the balloon dilation catheter10. The particular length of the support member40may vary depending on the application and may extend along some or all or the shaft30. The support member40may be made of a metallic material such as stainless steel hypotube that is secured to the shaft30. The support member40may be welded or bonded along a length of the shaft30. Generally, the support member40does not cover the helical portion (described in detail below) of the shaft30that is contained within the handle12.

FIGS. 2A and 2Billustrate, respectively, side and cross-sectional views of the balloon dilation catheter10with the advancer knob32and thus balloon36in the proximal position. In actual use, as explained herein, the balloon36is typically in a deflated state when the advancer knob32is the proximal position as illustrated inFIGS. 2A and 2B. As best seen inFIG. 1, the advancer knob32is slidably disposed along a length of the handle12inside a slot42. The advancer knob32is thus able to slide back and forth in the distal/proximal direction along the length of the slot42. The slot42may incorporate a stop or the like (not shown) to prevent the balloon36from being advance too far along the length of the inner guide member14. The length of the slot42may be varied in different devices to adjust the length at which the balloon36may be advanced. Generally, the slot42has a length within the range of about 1 inch to about 2 inches although other dimensions may fall within the scope of the invention.

As seen inFIG. 2B, the advancer knob32may be directly coupled to the support member40that is mounted on the shaft30. Alternatively, the advancer knob32may be coupled directly to the shaft30. The advancer knob32may be configured or otherwise shaped to enable a finger of the user (e.g., index finger or thumb) to easily advance or retract the knob32along the slot42contained in the handle12.

FIGS. 3A and 3Billustrate, respectively, side and cross-sectional views of the balloon dilation catheter10with the advancer knob32and thus balloon36in the distal position. Thus, unlike the configurations ofFIGS. 2A and 2B, the advancer knob32is located at or near the distal end26of the handle12. Advancement of the advancer knob32also slides the shaft30and attached balloon36in a distal direction (arrow A inFIG. 3A) along the inner guide member14. The balloon36thus is positioned at or adjacent to the distal end20of the inner guide member14. The balloon dilation catheter10may be designed such that the advancer knob32may be positioned at either the proximal or distal extremes as illustrated inFIGS. 2A,2B,3A,3B. Alternatively, the advancer knob32may be positioned somewhere in between the two extremes. For example, the optimal position of the balloon36may be accomplished by sliding the advancer knob32some fraction (e.g., %) of the full distance of the slot42.

Referring toFIGS. 2B and 3B, the inner guide member14of the balloon dilation catheter10extends from a distal end20to a proximal end21that terminates in a sealed interface with a port22disposed at a proximal end24of the handle12. The inner guide member14optionally includes a lumen18disposed therein that may be used to provide aspiration functionality via an aspiration device (not shown) coupled to port22. Aspiration functionality permits the removal of blood and other secretions. This makes it easier to visualize the placement of the balloon dilation catheter10. The inner guide member14is advantageously rigid to enable the balloon dilation catheter10to be positioned without the need of a separate guiding catheter or guide wire in most, if not all, instances.

The inner guide member14may have a length of about 7 inches to about 11 inches from the distal end20to the proximal end21when loaded into the handle12, although other dimensions may be used. The inner guide member14may be formed from stainless steel hypotube having an inner diameter in the range of about 0.020 inch to about 0.050 inch, and more preferably between about 0.036 inch and 0.040 inch, with a wall thickness within the range of about 0.005 inch to about 0.020 inch, and more preferably between about 0.008 inch to about 0.012 inch. The curved distal portion16of the inner guide member14may be formed right to the distal end20and may have a radius of curvature of about 0.25 inch to about 1.5 inch, and more preferably about 0.75 to about 1.25 inch.

The length of the inner guide member14that projects distally from the distal-most portion of the balloon36is about 0.5 inch to about 2.0 inch, and more preferably, about 0.8 inch to about 1.2 inch when the balloon36is in the fully retracted state (e.g., illustrated inFIGS. 2A and 2B). As seen inFIGS. 1,2A,2B,3A,3B,6A-6C,7-11, the distal end20of the inner guide member14may incorporate an optional bulbous tip44in order to make the distal end20more atraumatic. The bulbous tip44further serves to limit forward movement of the balloon36and attached shaft30when they are advanced distally. The outer diameter of the tip44is preferably between about 1 mm and about 3 mm.

The balloon36is mounted on the shaft30so as to form a fluidic seal between the two components. The balloon36may be bonded to the shaft using a weld, adhesive, or the like. Alternately, the balloon36may be secured to the shaft using a mechanical connection. Generally, any technique known to those skilled in the art may be used to secure to the balloon36to the shaft30. Given that the balloon36is secured directly to the shaft30, both structures are slidably mounted over the inner guide member14. The balloon36generally takes on a cylindrical-shape when inflated. While not limited to specific dimensions, the inflated balloon36has a diameter within the range of about 3 mm to about 9 mm, and more preferably a diameter within the range of about 5 to about 7 mm when inflated. The length of the balloon36may generally fall within the range of about 10 mm to 25 mm although other lengths may be used. Both the shaft30and the balloon36are preferably formed of high strength but flexible polymeric materials such as polyamides (e.g., Nylon), PEBAX or the like. The balloon36may be “blow molded” to a relatively thin wall thickness, and capable of holding relatively high pressures from about 6 atmospheres to about 20 atmospheres of inflation pressure. The balloon36is inflated using a fluid which is typically a liquid such as water or saline.

Referring now toFIG. 4, a magnified, cross-sectional view of a portion of the handle12is illustrated. At the proximal end24of the handle12are located ports22,38. The port22may be configured with a conventional interface such as a Luer connector or any other connector known to those skilled in the art. The port22may be integrally formed with the handle12or, alternatively, the port22may be a separate structure that is secured to the handle12during assembly. As seen inFIG. 4, the proximal end21of the inner guide member14forms a sealing arrangement with the port22. As explained herein, the port22may be used as an aspiration port or a delivery port for fluids and/or medicaments.

FIG. 4also illustrates port38which may be constructed in the same or similar manner as port22as described above. The port38is fluidically coupled to the inflation lumen48in the shaft30. In this regard, inflation fluid from an inflation device (not shown) is able to pass through the port38and into the inflation lumen48of the shaft30. The port38may be configured with a conventional interface such as a Luer connector. The fluid then is able to travel along the length of the shaft30via the lumen48where the fluid enters the interior of the balloon36. The inflation fluid is thus able to inflate the balloon36upon actuation of the inflation device.

As best seen inFIG. 4, a portion of the handle12includes a recessed region50that receives both the inner guide member14and the shaft30. In the recessed region50of the handle12, the shaft30is helically wrapped around the outer periphery of the inner guide member14forming a helical portion52. The helical portion52facilitates the distal advancement and proximal retraction of the shaft30and attached balloon36along the inner guide member14yet still maintains fluid communication with the port38. The helical portion52of the shaft30, which is located proximal to the advancer knob32is in the shape of a helix that wraps around the inner guide member14and is configured to elongate and contract upon movement of the advancer knob32.FIG. 4illustrates the state of the helical portion52after the advancer knob32has been advanced distally. Thus, in the extended state, the length of the helical portion52traverses much if not all of the recessed region50. Contrast this withFIG. 2Bwhich illustrates the helical portion52compressed to the proximal portion of the recessed region50because the advancer knob32is the in proximal position. Thus, the helical portion52is thus able to expand or compress much in the way that a spring does in response to a tensile or compressive load. One or both of the inner guide member14and the helical portion52of the shaft30may be optionally coated or lined with a lubricious coating to prevent the contact surfaces from any unwanted frictional binding or the like.

The helical portion52of the shaft30may be formed by “skiving” away a portion of the shaft30.FIG. 5Aillustrates a cross-sectional view of the shaft30, inner support guide14, and support member40along the line A-A′ ofFIG. 2B. As seen inFIG. 2B, this area is distal to where the helical portion52of the shaft30is located. Referring now toFIG. 5A, the shaft30includes a rider lumen54that is dimensioned to have a diameter that is slightly larger than the outer diameter of the inner support guide14. The rider lumen54thus enables the shaft30to advance and retract over the inner support guide14in a close-fit arrangement. The outer diameter of the shaft30may generally fall within the range of about 0.050 inch to about 0.110 inch or within the range of about 0.070 inch to about 0.100 inch. One or both of the exterior surface of the inner guide member14and the interior surface of the rider lumen54may be optionally coated with a lubricious coating to reduce frictional contact forces.FIG. 5Billustrates a cross-sectional view of the inner support guide14and the helical portion52of the shaft30taken along the line B-B′ ofFIG. 4. As seen inFIG. 5B, a portion of the shaft30that includes the rider lumen54is skived away. The result is that a single lumen (inflation lumen48) remains in the shaft30that is helically wrapped about the inner support guide14.

FIGS. 6A-6Cillustrate various embodiments of an inner guide member14. The inner guide member14may have a variety of shapes and configurations depending on the particular application or patient. The different shapes of the inner guide member14may be factory-formed in a particular shape and offered as a different model as fully assembled or, alternatively, the inner guide member14may be replaceable or modular elements that could slide inside the rider lumen54and inserted into the port22in a press-fit type sealing arrangement. In yet another alternative, the shapes could represent desirable shapes that a malleable inner guide member14could be formed into by the user to better fit a particular application or subject's anatomy.

FIG. 6Aillustrates an inner guide member14that includes a curved distal portion16that terminates in a straight segment46. In the embodiment ofFIG. 6A, the curve in the curved distal portion16is pronounced and turns back on itself in the shape of a “U” in which the distal end20turns back in retrograde fashion. This embodiment may be useful to treat hard to reach ostia or other structures, e.g., the maxillary ostium or the infundibulum via a transnasal route, if the nasal anatomy will allow for a trans-nasal approach. WhileFIG. 6Aillustrates a “U” shaped curve, other degrees of curvature are contemplated.FIG. 6Billustrates an inner guide member14according to another embodiment. In this embodiment, the curved distal portion16also terminates in a straight segment46although the radius of curvature is less pronounced. In this embodiment, the straight segment46may have a length within the range of about 8 mm to about 10 mm although other lengths may be used. It is believed that this embodiment is particularly suited for most frontal recess anatomy.FIG. 6Cillustrates an embodiment in which the inner guide member14is substantially straight. This later embodiment may be particularly suited for treating the sphenoids of the subject, or straightforward frontal recess anatomy.

FIG. 7illustrates a balloon dilation catheter10according to another embodiment. In this embodiment, a tracking element60is located on the handle12of the balloon dilation catheter10. The tracking element60may include an antenna, transmitter, optical reflectors, or the like that communicates a wireless signal that is then received and processed to determine the orientation and/or positioning of the balloon dilation catheter10. In certain embodiments, more than one tracking element60may be disposed on the balloon dilation catheter10. Data regarding the orientation and/or positioning of the balloon dilation catheter10may then be processed and displayed on the display for viewing by the physician. For example, image guided surgery is becoming increasingly commonplace, permitting physicians to review real time actual or virtual images of a particular device within a subject during a surgical procedure.

For example, U.S. Pat. Nos. 5,391,199 and 5,443,489, which are incorporated by reference, describe a system wherein coordinates of an intrabody probe are determined using one or more field sensors such as, Hall effect devices, coils, or antennas that are carried on the probe. U.S. Patent Application Publication No. 2002-0065455, which is also incorporated by reference, describes a system that is capable of generating a six-dimensional position and orientation representation of the tip of a catheter using a combination of sensor and radiation coils. U.S. Patent Application Publication No. 2008-0269596, which is also incorporated by reference, describes yet another monitoring system that has particular applications in orthopedic procedures. Commercial systems such as the LANDMARX Element (Medtronic Xomed Products, Inc., Jacksonville, Fla.) are available for use in conjunction with ENT procedures.

In the embodiment ofFIG. 7, the tracking element60permits accurate tracking of the distal end20of the balloon dilation catheter10such that an image of distal portion of the balloon dilation catheter10may be superimposed on a patient's anatomical imagery. For example, a previously conducted computed tomography (CT) scan of the patient may be used to generate a visual image of the patient's anatomical regions of interest. Based on the location of the tracking element60, an image guided surgery (IGS) system can then superimpose an image of the balloon dilation catheter10onto the image to better enable the physician to manipulate and orient the balloon dilation catheter10.

Other commercial systems may also be used in connection with the balloon dilation catheter10illustrated inFIG. 7. For example, the INSTATRAK 3500 Plus-ENT from GE Healthcare, Chalfont St. Giles, United Kingdom may be integrated and/or used with the balloon dilation catheter10. The use of CT guidance to position the balloon dilation catheter10is preferred because the device may be positioned by the operator with just a single hand, while viewing the CT image interface (e.g., display) at the same time the handle12is manipulated. Optionally, the balloon dilation catheter10may be initially positioned using and endoscope or other visualization tool. For instance, a conventional “Hopkins rod” endoscope (not shown) may be manipulated alongside the balloon dilation catheter10to aid in placement.

FIGS. 8-12illustrate various cross-sectional views (sagittal plane) of the frontal sinus of a subject undergoing treatment with a balloon dilation catheter10. The cross-sectional views illustrate the nasal passageway100, the frontal recess102, and the frontal sinus cavity104. Referring toFIG. 8, the balloon dilation catheter10is inserted into the nasal passageway100with the advancer knob32in the retracted position (e.g., as illustrated inFIGS. 1,2A,2B) such that the shaft30and balloon36are also retracted proximally. In addition, the balloon36is in a deflated state as seen inFIG. 8. The curved portion16of the inner guide member14is then positioned within the frontal recess102of the subject as seen inFIG. 8. This positioning of the inner guide member14may be accomplished under endoscopic visualization using a conventional endoscope such as a Hopkins rod-type endoscope that is positioned alongside the balloon dilation catheter10. Alternatively, the inner guide member14may be positioned using IGS techniques that track the position of the balloon dilation catheter10using one or more tracking elements60as illustrated, for instance, in the embodiment ofFIG. 7. For instance, the inner guide member14may be advanced under guidance from CT imaging.

Referring now toFIG. 9, confirmation of accurate positioning of the inner guide member14within the frontal recess102may be accomplished by placement of a fluoroscopically visible guide wire64through the lumen18of the inner guide member14. The guide wire64may be inserted into the lumen18via the port22. Under fluoroscopic visualization, the guide wire64can be seen to advance into the frontal sinus cavity104once the inner guide member14is positioned properly within the frontal recess102. If the guide wire64does not advance into the frontal sinus cavity104, the balloon dilation catheter10is re-positioned and confirmation is subsequently attempted. As an alternative to a fluoroscopically visible guide wire64, the guide wire64could be a light emitting guide wire such as that disclosed in U.S. Patent Application Publication No. 2007-0249896, which is incorporated by reference herein. Of course, the guide wire64is optional as the inner guide member14may be placed without the aid or need for the same. Alternatively, the guide wire64could be positioned in the frontal sinus initially, prior to placement of the balloon catheter10.

Now referring toFIG. 10, once the curved portion16of the inner guide member14is properly positioned, the advancer knob32is advanced in the distal direction (arrow A ofFIG. 3A) thereby advancing the shaft30and attached balloon36into the frontal recess102. This is illustrated inFIG. 10. After the balloon36is positioned in the frontal recess102, the balloon36is inflated as illustrated inFIG. 11. Inflation is accomplished by coupling an inflation device (not shown) to the port38. The inflation device may include a syringe or the like that is depressed to infuse a fluid into the inflation lumen48which then passes into the interior of the balloon36to effectuate expansion of the balloon36to the state illustrated inFIG. 11. Pressures typically used to accomplish widening or remodeling of the frontal recess102are within the range of about 3 atmospheres to about 12 atmospheres. The balloon36may be inflated only a single time or, alternatively, the balloon36may be inflated, deflated, and inflated again a plurality of times in order to achieve the desired degree of widening. Each inflation step may be performed after positioning the balloon36in a different position within the frontal recess102.

After the frontal recess102has been widened or otherwise remodeled, the balloon36is deflated and removed as illustrated inFIG. 12. The widened frontal recess102illustrated inFIG. 12is believed to restore the drainage and aeration function and health of the frontal sinus cavity104. Deflation of the balloon36is accomplished by reducing the fluid pressure within the interior of the balloon36. For example, the plunger of a syringe or the like that is fluidically coupled to the port38may be withdrawn to remove fluid from the interior of the balloon36. The balloon dilation catheter10can then be withdrawn proximally from the nasal passageway100.

In certain patients, treatment of one or both frontal sinuses104as described above may be adequate. In other patients, additional sinuses may need to be treated, particularly the maxillary and/or anterior ethmoid sinuses. In such patients, a combination procedure may be well suited. The maxillary and/or anterior ethmoid sinuses can be treated with a system such as described in U.S. Pat. No. 7,520,876 and U.S. Patent Application Publication No. 2008-0172033, commercially available as the FinESS system by Entellus Medical, Inc. of Maple Grove, Minn. Alternatively, other sinuses could be treated more conventionally using surgical techniques such as, for instance, functional endoscopic sinus surgery (FESS).

Also, the sphenoid and/or maxillary sinus outflow tracts could be dilated with the embodiment of the balloon catheter10described above. It is also contemplated that the balloon catheter10, particularly the embodiment ofFIG. 7with a suitable IGS device is incorporated, and with an appropriate shape for the inner support member14, preferably straight as illustrated inFIG. 6C, could be used to dilate the maxillary sinus outflow tract via the canine fossa route. Suitable access tools are described in co-pending U.S. patent application Ser. No. 12/038,719, which is incorporated by reference herein. This could be performed without need for additional endoscopic visualization, permitting treatment through a relatively small diameter access passageway into the sinus cavity in the region of the canine fossa. A small endoscope (not shown) could be utilized, if desired, through the lumen18of the inner support member14to further aid in visualization of the maxillary sinus outflow tract.

While embodiments of the present invention have been shown and described, various modifications may be made without departing from the scope of the present invention. The invention, therefore, should not be limited, except to the following claims, and their equivalents.