Abstract:
A method for treating a natural drainage passageway in a subject includes forming a cannulated artificial passageway into a subject&#39;s sinus cavity through the canine fossa region with a piercing member, the piercing member containing a hollow cannula thereon, the cannula comprising an elongate flexible member having a lumen passing therethrough. The piercing member is removed so as to leave the cannula in place. A balloon dilation catheter is then advanced within the lumen of the cannula so as to place the dilation balloon at least partially across the natural drainage passage in the sinus cavity. The dilation balloon is dilated so as to at least partially expand the natural drainage passageway.

Description:
RELATED APPLICATIONS 
   This Application is a continuation of U.S. application Ser. No. 11/379,691 filed on Apr. 21, 2006, now issued as U.S. Pat. No. 7,520,876. Priority is claimed pursuant to 35 U.S.C. §120 and all other applicable statues. U.S. application Ser. No. 11/379,691 is incorporated by reference as if set forth fully herein. 

   FIELD OF THE INVENTION 
   The field of the invention generally relates to devices and methods for the treatment or amelioration 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. These paired cavities are located in the skull behind the face, as is depicted in  FIGS. 1 ,  2 , and  3 A. 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 an opening into the nasal passage called an ostium. When the mucosa of one or more of the ostia or regions near the ostia become inflamed, the egress of mucous is interrupted, setting the stage for an infection of the sinus cavity, i.e., sinusitis. Infections of the maxillary and/or ethmoid sinuses make up the vast majority of cases of sinusitis, with far fewer cases involving the sphenoids and frontals. 
   Though many instances of sinusitis may be treatable with antibiotics, in some cases sinusitis persists for months, a condition called chronic sinusitis. Some patients are also prone to multiple episodes of sinusitis in a given period of time, a condition called recurrent sinusitis. 
   Currently, patients experiencing chronic sinusitis are eligible to have a surgical procedure called functional endoscopic sinus surgery (FESS). In this procedure, which almost always done in an operating room setting with the patient under general anesthesia, surgical cutting instruments are guided with an endoscopic visualization tool to the various sinus ostia and adjacent regions. Inflamed mucosa and underlying bony tissue are cut away in an effort to widen the outlet of the sinuses of interest. Once opened, the infected sinuses are able to drain and return to a relatively normal state. 
   While this procedure is generally effective, it is a relatively invasive procedure to the nasal cavity and sinuses. There can be significant post-operative pain for the patient, and sometimes there are bleeding complications that require packing to be placed in the nasal cavity. Subsequent removal of this packing can be quite painful. Also, since the nasal and sinus tissue are significantly traumatized, it may take several days to weeks to know whether the surgery was successful. This is especially true if various healing agents such as MeroGel® (Medtronic/Xomed) were placed at the surgical site, as these often block the sinus drainage until they are flushed away or degrade away after several days. 
   Additionally, in certain patients, the ostial regions of the surgically-treated sinuses can become re-obstructed with excess growth of scar tissue as a result of the tissue trauma. When the advantages and disadvantages of the surgery are considered for a patient with sinusitis, there are many patients in whom the surgery may not be appropriate. For example, their condition may not be considered “chronic enough” or extensive enough to warrant FESS surgery. In other situations, the patient may be fearful of the pain or other aspects of having FESS performed. Alternatively, the FESS procedure may be too costly for a particular patient. 
   For these and other reasons, there is a clear need for better methods and devices for the treatment of sinusitis. 
   SUMMARY OF THE INVENTION 
   In one aspect of the invention, a method for treating a natural drainage passageway in a subject includes forming a cannulated artificial passageway into a subject&#39;s sinus cavity through the canine fossa region with a piercing member, the piercing member containing a hollow cannula thereon, the cannula comprising an elongate flexible member having a lumen passing therethrough. The piercing member is removed so as to leave the cannula in place. A balloon dilation catheter is then advanced within the lumen of the cannula so as to place the dilation balloon at least partially across the natural drainage passage in the sinus cavity. The dilation balloon is dilated so as to at least partially expand the natural drainage passageway. 
   Further features and advantages will become apparent upon review of the following drawings and description of the preferred embodiments. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  illustrates is a schematic view illustrating the paranasal sinuses in relation to the face. 
       FIG. 2  is a coronal section of the human skull, showing the paranasal sinuses. 
       FIGS. 3A-3C  are of a sagittal view of the lateral nasal wall, illustrating various anatomical features thereof. 
       FIG. 4  illustrates one embodiment of the current invention showing a balloon dilation catheter in the ostial region of a paranasal sinus. 
       FIG. 5A  illustrates one embodiment of a guide catheter according to the invention. 
       FIG. 5B  is a cross-sectional view of the embodiment shown in  FIG. 5A . 
       FIG. 5C  is a cross-sectional view of an alternative embodiment of a guide catheter. 
       FIG. 5D  is an alternative embodiment of a guide catheter. 
       FIG. 5E  shows the guide catheter of the embodiment illustrated in  FIG. 5D  being positioned within the nasal cavity. 
       FIG. 5F  is a cross-sectional view of an alternative embodiment of a guide catheter. 
       FIG. 6A  illustrates an embodiment of a balloon dilation catheter according to one embodiment of the invention. 
       FIG. 6B  is a longitudinal sectional view of a portion of the distal shaft of the embodiment of  FIG. 6A . 
       FIG. 6C  is a cross-section of the distal shaft of the embodiment of  FIG. 6A . 
       FIG. 7A  illustrates an alternative embodiment of a balloon dilation catheter according to one embodiment. 
       FIG. 7B  is a longitudinal sectional view of a portion of the distal shaft of the embodiment of  FIG. 7A . 
       FIG. 7C  is a cross-sectional view of the distal shaft of the embodiment of  FIG. 7A . 
       FIG. 8  illustrates an embodiment of a stabilization device according to one aspect of the invention. 
       FIG. 9  illustrates an alternative embodiment of a stabilization device according to another aspect of the invention. 
       FIG. 10A  illustrates a further alternative embodiment of a stabilization device according to another aspect of the invention. 
       FIG. 10B  is a partially exploded top view of the stabilization device of  FIG. 10A . 
       FIG. 10C  is a partially exploded front view of the stabilization device of  FIG. 10A . 
       FIG. 10D  is an assembled front view of the stabilization device of  FIG. 10A . 
       FIG. 11A  illustrates an embodiment of a wire movement guide according to one aspect of the invention. 
       FIG. 11B  is a cross-sectional view of the wire movement guide of  FIG. 11A . 
       FIG. 11C  is an assembly drawing of the wire movement guide of  FIG. 11A  attached to a guide catheter. 
       FIG. 11D  illustrates a method for placement of a wire guide in a sinus ostium according to one aspect of the invention. 
       FIG. 12  illustrates a method and device for confirming the placement of a wire guide in a sinus according to one aspect of the invention. 
       FIG. 13  illustrates an alternative method and device for confirming the placement of a wire guide, according to another aspect of the invention. 
       FIG. 14  illustrates methods and devices for accessing a sinus according to one aspect of the invention. 
       FIG. 15  shows additional methods and devices for accessing a sinus, according to another aspect of the invention. 
       FIG. 16A  shows additional methods and devices for accessing a sinus according to another aspect of the invention. 
       FIG. 16B  shows a flexible visualization scope as used in connection with  FIG. 16A . 
       FIG. 16C  is a cross-sectional view of the flexible visualization scope of  FIG. 16B . 
       FIG. 17A  shows additional methods and devices for accessing a sinus according to one of the invention. 
       FIG. 17B  shows an embodiment of a directable endoscope sheath as used in connection with  FIG. 17A . 
       FIG. 17C  is a cross-sectional view of the directable endoscope sheath of  FIG. 17B . 
       FIG. 18A  illustrates methods and devices for accessing a sinus from an external location according to one aspect of the invention. 
       FIG. 18B  illustrates additional methods and devices for accessing a sinus ostium from an external location according to one aspect of the invention. 
       FIG. 18C  illustrates further additional methods and devices for accessing a sinus ostium from an external location according to another aspect of the invention. 
       FIGS. 19A-19C  are cross-sectional images depicting various arrangements of devices used in accessing a sinus ostium in connection with  FIG. 18B . 
       FIG. 20  illustrates methods and devices for treating a sinus ostium in one aspect of the invention. 
       FIG. 21  shows an embodiment of a trocar in accordance with one aspect of the invention. 
       FIG. 22  shows another embodiment of a trocar according to another aspect of the invention. 
       FIGS. 23A and 23B  show additional methods and devices for accessing a sinus ostium from an external location according to one aspect of the invention. 
       FIG. 24  shows additional methods and devices for accessing a sinus ostium from an external location according to another aspect of the invention. 
       FIG. 25A  is a coronal view showing anatomical features of the maxillary sinus. 
       FIG. 25B  is a sagittal view showing the anatomical features of  FIG. 25A . 
       FIG. 26A  is a coronal view illustrating methods and devices for the treatment of the uncinate process in accordance with one aspect of the invention. 
       FIG. 26B  is a sagittal view illustrating methods and devices for the treatment of the uncinate process in accordance with one aspect of the invention. 
       FIG. 27A  is a top view of an embodiment of a shim member in accordance with one aspect of the invention. 
       FIG. 27B  is an isometric view of the shim member of  FIG. 27A . 
       FIG. 28  is an embodiment of a shim member delivery device in accordance with one aspect of the invention. 
       FIG. 29  illustrates a method and device for widening the infundibulum in accordance with another aspect of the invention. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1  illustrates a frontal anatomical representation (parallel to the coronal plane) showing the sinuses FS, ES, MS located within a patient&#39;s head H. Above and behind the eyebrows are the frontal sinuses FS. Between the eyes are the ethmoid sinuses ES. Note that unlike the other sinuses, the ethmoids are typically formed as a “honeycombed” structure consisting of several individual air cells. Located behind the cheeks are the maxillary sinuses MS. The sphenoid sinuses are not shown in  FIG. 1 , but are located further posterior to the ethmoid sinuses. 
     FIG. 2  is another frontal view of the sinuses located within the skull bone SK showing additional features. The nasal septum NS divides the nasal cavity into left and right sides. Because the following described structures are generally symmetrical bilaterally, only one of the paired structures is illustrated for sake of convenience. Within the nasal cavity are the middle turbinate MT and the inferior turbinate IT. The middle turbinate MT is connected to the base of the skull SK, while the inferior turbinate IT is connected to the lateral wall of the sinus cavity. The turbinates MT, IT have an underlying bony structure, but are covered with a thick mucosa lining. When this lining swells (rhinitis), it can inhibit breathing through the nose, particularly the inferior turbinate IT. The ethmoid sinuses ES are depicted by a single air cell in  FIG. 2 . The uncinate process UP is a complex three-dimensional structure, projecting off of the lateral wall like a crescent shaped leaf (better seen in  FIGS. 3B and 25B ) The curved aspect of the medial bone defining the ethmoid sinuses ES is called the ethmoid bulla EB. The passageway between the ethmoid bulla EB and the uncinate process UP is referred to as the infundibulum I. The drainage path of the maxillary MS, frontal FS, and some of the ethmoid ES air cells runs into the infundibulum I. At the most inferior part of the maxillary sinus is a thin portion of skull bone referred to as the canine fossa CF. Though this is not a true opening, it is a relatively thin bone region, just above the root of the outer aspect of the canine teeth, inside the mouth. The relationship of the sinuses to the orbit O of the eye can also be seen. Note also that all of the sinus cavities have a mucosa lining (ML) disposed over the bone. 
     FIG. 3A  is a side view parallel to the sagittal plane, looking at the right lateral nasal wall. The right nostril N is seen. The sphenoid sinus SS and frontal sinus FS may also be seen in this view. The flap-like structures illustrated in  FIG. 3A  are the inferior turbinate IT and middle turbinate MT. Other structures of the nasal cavity have been left out for clarification, e.g., the superior turbinate. Located underneath the middle turbinate MT (shown in a “lifted” state in  FIG. 3B  and removed in  FIG. 25B ) are the structures of the lateral nasal wall. As seen in  FIG. 3B , the ethmoid bulla EB is a rounded projection of the bony wall of the nasal cavity. Behind the wall of the ethmoid bulla EB are one or more of the individual air cells of the ethmoid sinus ES (not shown in  FIGS. 3B and 25B ). Anterior and inferior of the ethmoid bulla is the uncinate process UP. The uncinate process UP has essentially two edges to it including a free edge FE and a connected edge CE. The free edge FE stands out from the nasal wall, while the connected edge CE connects the structure to the nasal wall. The narrow space between the ethmoid bulla EB and the uncinate process UP is the infundibulum I. Thus, it can be appreciated the complexity of the anatomy involving the maxillary and ethmoid sinus structures MS, ES. 
     FIG. 3C  illustrates the structure beneath or underneath the uncinate process UP. In  FIG. 3C , the uncinate process UP has been removed for clarity purposes, leaving only the connected edge CE. Two ostia can be seen including the maxillary sinus ostium MO, and the frontal sinus ostium FO. Drainage from the frontal sinuses FS and maxillary sinuses MS emerges into the infundibulum I through the maxillary sinus ostium MO and the frontal sinus ostium FO. Also, some of the ethmoid air cells ES drain into the infundibulum I, but they are not shown as they are substantially smaller than the frontal and maxillary ostia FO, MO. Drainage problems can arise and/or extend from the ostia of one or more of these sinuses to the infundibulum I or vise versa. Consequently, conventional FESS surgical treatment of sinusitis typically involves widening one or more of the ostia FO, MO, as well as complete removal of the uncinate process UP. Incidentally, removal of the uncinate process UP is usually required even to just allow visualization of these sinus ostia FO, MO for the proper placement of the various surgical cutting instruments. Ethmoids are often treated with the FESS procedure by removing some of the wall of the ethmoid bulla EB and some of the “honeycomb” structure between the individual air cells. 
     FIG. 4  illustrates a generic therapeutic approach contemplated by one embodiment of the invention. Rather than remove obstructing tissue associated with the sinus ostia FO, MO, a dilation balloon  10  is positioned in the narrowed region to dilate open the structure. Generally, the dilation balloon is carried on a distal end or region of elongate member  12  such as a balloon catheter. The balloon catheter  12  may include a proximal hub  14  that includes an inflation port  16  that is used inflate (and deflate) the dilation balloon  10 . For example, the inflation port  16  may connect to a syringe or the like (not shown) using, for instance, a Leur lock connection. The balloon catheter  12  may be disposed within a central lumen of a guide catheter  18 . The guide catheter  18  may include a flexible tip portion  18   b  as well as a curved portion  20  that is used to navigate the tortuous pathway around the uncinate process UP. The proximal end of the guide catheter  18  may include a hub  22 . 
   Still referring to  FIG. 4 , a wire guide  24  is located within a central lumen in the balloon catheter  12 . The wire guide  24  in  FIG. 4  is introduced into the maxillary sinus MS with the aid of the guide catheter  18  and a steering device  26 . The wire guide  24  preferably has a curved tip  24   b  such as a “J” bend located at or adjacent to a distal tip  24   a  of the wire guide  24 . The steering device  26  connects to a proximal end of the wire guide  24  to allow rotation of the wire guide  24 , and subsequent rotation of the curved tip  24   b  to steer and direct the wire guide  24 . As can be seen in  FIG. 4 , there is a relatively sharp bend that the wire guide  24  and balloon catheter  12  must traverse to enter into the maxillary ostial MO region. It is contemplated that a guide catheter  18  may not be utilized at the time that the balloon catheter  12  is positioned in the ostium of interest, but rather the guide catheter  18  would be utilized just for placement of the wire guide  24 . In this case, the balloon catheter  12  would be advanced over the wire guide  24 . This helps to minimize the size of the “hardware” that is present in the nasal cavity at any one time by allowing use of a smaller diameter guide catheter  18 , and minimizes the amount of distortion required on various structures in the nasal cavity, such as the middle turbinate MT. 
   Still referring to  FIG. 4 , dilation of the maxillary ostial MO region is accomplished by inflation of the balloon  10  via the inflation port  16  with an inflation apparatus (not shown) which may included, for example, a syringe. It is contemplated that a combination of remodeling the soft tissues as well as fracturing/crushing bony tissues will result in a more open drainage path for the sinus(es) being treated. While  FIG. 4  shows a balloon catheter  12  positioned in the maxillary sinus ostium (MO), it is contemplated that the balloon  10  could be positioned in any of the sinus ostia, either naturally occurring ostia, or ostia created intra-procedurally. In particular, treatment of the ethmoid air cells ES may be accomplished by creating one or more small passageways in the walls surrounding the air cells, for example with a needle, followed up by a dilation process using the dilation balloon catheter  12 . Moreover, reference to a particular ostium does not necessarily mean an opening or passageway per se. Rather, reference to ostium may include the general region or anatomical area surrounding or adjacent to the ostium of interest and is not limited to a single, discrete structure or location. 
   Access to the maxillary sinus ostium MO from within the nasal cavity is particularly challenging due in part to the anatomy of the uncinate process UP and infundibulum I.  FIGS. 5A and 5B  illustrate various embodiments of a guide catheter  18  used to facilitate access to the maxillary sinus from the nasal cavity. In  FIG. 5A , the guide catheter  18  has a relatively tight curved portion  20  near the tip  18   b , with a preferred inside radius of curvature between about 0.5 mm and about 10 mm, and more preferably between about 1 mm and about 5 mm. Such a radius of curvature will assist in the tip  18   b  of the guide catheter “hooking” around the uncinate process UP, to help direct the wire guide  24  and subsequently the balloon catheter  12  into the maxillary sinus ostium MO. The degree of bend of the curved portion of the guide catheter  18  is preferably between 90 degrees and 180 degrees from the longitudinal axis of the hub  22 , and more preferably between 120 and 160 degrees. 
   In one preferred aspect of the invention, the guide catheter  18  includes a shaft portion  18   a  and a flexible tip portion  18   b . The tip portion  18   b  is preferably of a softer material than the shaft portion  18   a . Tip portion  18   b  may formed of a polymer such as PEBAX (Arkema), polyurethane, NYLON (DuPont), HYTREL (DuPont), or silicone.  FIG. 5B  illustrates a cross-sectional view of one preferred embodiment of the shaft portion  18   b . As seen in  FIG. 5B , a liner  34  of a lubricious material such as PTFE defines a central lumen  36 . The liner  34  is surrounded by a wire braid  32 . The wire braid  32  is encased in a polymeric material such as PEBAX (Arkema), polyurethane (DuPont), NYLON (DuPont), HYTREL (DuPont), or silicone. The wire braid  32  adds torsional strength to the shaft  18 , allowing the curved tip portion  18   b  to be controlled and directed by manipulations near the hub  22 . The tip portion  18   b  may be pre-formed by a suitable process such as heat forming. 
   Alternatively, as shown in  5 C, the guide catheter  18  shaft portion  18   a  and/or tip portion  18   b  may incorporate a shaping element  38 , such as a removable wire. The wire  38  is preferably axially slidable within a lumen  40  formed in the guide catheter  18 . For example, different pre-shaped wires  38  may be axially slid within the lumen  40  to impart the desired shape or bend in the guide catheter  18 . Alternatively, shaping element  38  could be a ductile non-removable wire that could be shaped and re-shaped to fit to a particular patient&#39;s anatomy. This feature advantageously allows the tip curvature or the curvature of any portion of the guide catheter  18  to be customized by the user prior to or during a procedure. 
   Alternatively, the shaft portion  18   b  of the guide catheter  18  can be formed of a metallic tube rather than the braid and jacket construction. This embodiment is illustrated in  FIG. 5F . Preferably a liner  34  is inside the metallic tube. Such a construction would allow the shaft portion  18   b  to be shaped and reshaped to suit any particular anatomy. 
   The diameter of the guide catheter  18  is determined by the size of the devices that might pass through it. For example, if the guide catheter  18  is used only for the placement of a wire guide  24  of 0.014 inch diameter, then the guide catheter  18  may have an inner diameter of between 0.016 and 0.025 inches, and a total wall thickness of between 0.004 and 0.020 inches. However if the guide catheter  18  is used to assist in placement of a dilation balloon catheter  12 , the inner diameter is preferably between 0.040 and 0.100 inches, with a total wall thickness of between 0.005 and 0.030 inches. The outer diameter of the guide catheter shaft  18   a  and tip  18   b  is preferably uniform in diameter. The length of the guide catheter  18  is preferably between about 8 and about 25 cm, and more preferably between about 10 and about 20 cm. 
     FIG. 5D  illustrates another embodiment of a guide catheter  18  that is particularly useful for cannulating the maxillary sinus ostium MO. In this embodiment, the curved portion  42  is of a substantially larger radius of curvature compared to the embodiment shown in  FIG. 5A . Rather than take a “direct” path up to and around the uncinate process UP, the embodiment shown in  FIG. 5D  makes use of the significant anterior-posterior space in the nasal passage NP. The curvature  42  of the guide catheter  18  may be formed using a shaping element  38  of the type disclosed in  FIG. 5C . 
     FIG. 5E  illustrates how the guide catheter  18  shown in  FIG. 5D  makes a more gradual sweeping turn in the nasal cavity to reach towards the maxillary sinus ostium MO. By possessing a larger radius of curvature, any devices used inside this guide catheter  18  are not forced to negotiate such a tight bend. In a preferred embodiment, the inside radius of curvature is preferably between about 1 cm and about 3 cm, and more preferably between about 1.5 and about 2.5 cm. 
     FIGS. 6A ,  6 B, and  6 C show a preferred embodiment of a dilation balloon catheter  12  for dilation of a sinus ostium, particularly a maxillary sinus ostium MO. The balloon catheter  12  includes a balloon  10 , distal shaft portion  12   a , proximal shaft portion  12   b , and a hub  14  with an inflation port  16  for inflation of the balloon  10 . The balloon catheter  12  is formed using an inner tube  50  coaxially arranged within an outer tube  52  (described in more detail below). An inflation lumen  56  is formed between the inner tube  50  and the outer tube  52 . The balloon catheter  12  terminates at a distal tip  12   c  that projects distally from the balloon  10 . The balloon catheter  12  may be formed as an “over the wire” design (as shown in  FIGS. 6A-6C ), but it is contemplated that it could be a “fixed wire” design or a “monorail” design, as is known in the balloon catheter art, particularly the coronary angioplasty art. However, the length of the balloon catheter  12  shown is relatively short in comparison, preferably from about 10 to about 30 cm, and more preferably between about 15 and about 25 cm. The expanded diameter of the balloon  10  would depend on the initial and final desired size of the sinus ostium to be dilated. Preferred diameters would be from about 2 mm to about 10 mm, and most preferably from about 3 to about 7 mm. A preferred “set” of balloon catheters  12  would include a series of catheters having inflated balloon diameters of 2, 4, 6, and 8 mm. Alternatively, a series of catheters  12  having 3, 5, and, 7 mm expanded balloon diameters could be provided. The balloon  10  is preferably from about 5 mm to 40 mm in length (not including the conical portions), and more preferably from about 10 mm to about 20 mm in length. 
   With particular reference to  FIG. 6B , the distal shaft portion  12   a  of the balloon catheter  12  is preferably of a coaxial construction, with an inner tube  50  located inside of an outer tube  52 . The inner tube defines the wire guide lumen  54  for passage of the wire guide  24  (not shown in  FIG. 6B ). The annular space formed between the inner and outer tubes  50 ,  52  defines an inflation lumen  56 . The inflation lumen  56  may hold a fluid which is used to inflate the balloon  10 . In the embodiment of  FIG. 6B , lumens  54 ,  56  are coaxially arranged. However it is contemplated that a single tube with two side-by-side lumens  54 ,  56  could be utilized as well. 
   Because of the anatomic challenge of accessing the maxillary sinus ostium MO, a preferred embodiment of the balloon catheter  12  includes a kink-resisting structure in the shaft, particularly in the distal shaft portion  12   a , as this is the portion of the catheter  12  that may be exposed to a particularly tight bend as it is advanced around the uncinate process UP. The kink resisting structure is preferably a coil  58 ,  60  or braid (not shown) that is incorporated into the inner tube  50  and/or the outer tube  52 .  FIG. 6B  illustrates coils  58 ,  60  incorporated in both the inner and outer tubes  50 ,  52 , respectively. If a coil  58  is incorporated in the inner tube  50 , it is preferably included in the entire distal portion  12   a , including that portion that traverses the balloon  10 . It is contemplated that for other constructions such as “fixed wire” or “rapid exchange” that the kink resisting structure could also be incorporated. 
   Inner and outer tubes  50 ,  52  are preferably formed of a suitable material such as polyethylene, PEBAX (Arkema), PTFE, NYLON (DuPont), HYTREL (DuPont), or a combination thereof. Proximal shaft portion  12   b  may be more rigid than distal portion  12   b , and may further incorporate a metallic tube (not shown) for either the inner tube  50  or the outer tube  52  of the proximal shaft region. 
   To assist in positioning of the balloon catheter  12  to a target site, one or more shaft markers  62  may be provided at one or more locations along the shaft of the balloon catheter. Preferably, the markers  62  are positioned in uniform increments (e.g., 1 cm increments) along the full length of the shaft (proximal region  12   b  and distal region  12   a ). Additionally, one or more markers  64  on the balloon  10  may be provided. Both the shaft markers  62  and the balloon markers  64  are useful in positioning the balloon  10  relative to the wire guide  24  and/or guide catheter  18 , together with prior or continuous optical visualization using a visualization tool such as an endoscope. Although not shown, the wire guide  24  could also include markers spaced at predefined increments. Balloon markers  64 , shaft markers  62 , and/or wire guide markers (not shown) could make use of a color-coding system or some other recognizable pattern to facilitate endoscopic imaging. For instance, a certain color of marker could pertain to a certain distance from a particular location, such as the tip of the wire guide  24  or the center of the dilation balloon  10 . Alternatively, one or more radiopaque markers (not shown) could be provided on the shaft underneath the balloon  10  if fluoroscopic imaging is utilized. 
     FIGS. 7A ,  7 B, and  7 C show an alternative embodiment for a sinus ostium dilation balloon catheter  12 . In addition to the structures associated with the catheter shown in  FIGS. 6A and 6B , this embodiment further incorporates structure to facilitate the infusion and delivery of one or more therapeutic and/or diagnostic agents at the site of the dilation balloon  10 . In a preferred embodiment, a portion of the balloon catheter  12  that extends proximally and distally with respect to the balloon  10  includes an outer membrane  70  with one or more perforations  72  in the membrane wall. The space between the balloon  10  and the membrane  70  is in fluid communication with an infusion lumen  74  (shown in  FIG. 7B ) formed in the shaft of the balloon catheter  12 . The infusion lumen  74  could be formed by the addition of an infusion tube  76  located on the outside of the outer tube  52 . An infusion port  76  located in the proximal hub  14  is in fluid communication with the infusion lumen  74 . 
   The balloon catheter  12  illustrated in  FIGS. 7A-7C  may be particularly useful for the delivery of an adhesion preventing substance such as MeroGel (Medtronic/Xomed) or Sepragel® (Genzyme Biosurgical/Gyrus ENT) prior to, during, or following the dilation process. This would result in a coating or “sleeve” of the agent being disposed on the contacted tissue region. The fact that the coating or “sleeve” would have an open passageway would provide for immediate ventilation and drainage of the treated sinus. 
     FIGS. 8 ,  9 , and  10  shows various embodiments of a stabilizing device  80  for use with the device and methods disclosed herein. The stabilizing device  80  is used to assist in holding and stabilizing one or more of the various tools used in the treatment of a sinus ostium. Since at times many devices may be in use, it may be difficult for the physician to manage all such devices. Use of a stabilizing device can free the hands to manage fewer devices at any given time. For example, the stabilizing device  80  may be used to stabilize a guide catheter  18  (as shown in  FIG. 8 ), a balloon catheter  12 , and/or an endoscope  82 . 
   The embodiment shown in  FIG. 8  utilizes a base member  84  which secures to various portions of the head H, such as the ears and/or top of the nose. Preferably, two ear hooks  86  wrap around the ear in a similar way as eyeglasses. The base member  84  also rests on the nose with a nose bridge  88 . A support arm  90  is secured to the base member  84 . In one aspect of the invention, the support arm  90 , can preferably be manipulated or formed into any desired shape. For example, the support arm  90  may be formed from a flexible material. A securing member  92  such as a clamp is located on the free end of the support arm  90 . The securing member  92  may be removable and/or interchangeable via a tightening member. Support arm  90  and securing member  92  are held fast by a tightening member  94  such as a tightening nut. In this figure, a clamp  92  is shown stabilizing a guide catheter  18 , which allows the physician to use his or her hands on the endoscope  82  and the wire guide  24 , while the position of the guide catheter  18  is maintained. This may be helpful while the physician tries to advance the wire guide  24  into the desired sinus. It is contemplated that more than one securing member  92  and/or more than one support arm  90  could be mounted to the base member  84  to stabilize more than one device. 
   The embodiment illustrated in  FIG. 9 , a stabilizing element  100  stabilizes a device against an interior surface of the nostril. As shown in  FIG. 9 , the stabilizing element is stabilizing a guide catheter  18 . In one preferred embodiment, the stabilizing element  100  is formed as an expandable tubular structure, such as a self-expanding tubular braid. In the expanded state, the tubular structure includes a lumen or passageway through which one or more devices may be placed. The expandable tube  100  is positioned in the nostril next to the device(s) to be stabilized. Friction holds the device(s) in place, while maintaining a passageway for additional devices such as an endoscope (not shown in  FIG. 9 ) to be introduced into the nasal cavity. More than one expandable tube  100  could be used, either next to another, or in a nesting relationship. 
   With reference now to  FIGS. 10A ,  10 B,  10 C, and  10 D, a stabilizing device  110  makes use of the patient&#39;s mouth M. A mouth piece  112  is connected coupled to a support arm  114 , which is connected to a securing member  116  such as a clamp to stabilize the position of a device such as a guide catheter  18 . The support arm  114  and clamp  116  can be positioned, e.g. by rotating around pivot points, to bring the clamp  116  to any desired position.  FIG. 10B  shows a top view of the stabilizing device  110  in a partially exploded view. The mouth piece  112  is configured to engage the upper and/or lower jaw of the patient. The support arm  114  is connected to the mouth piece  112 , preferably by a lockable pivot point  118 . The clamp  116  is likewise connected to the support arm  114 . A series of securing members  120  such as locking screws or nuts locks the clamp  116  position relative to the mouth M. 
     FIG. 10C  is a partially exploded frontal view of the stabilizing device  110  of  FIG. 10B .  FIG. 10D  shows the stabilizing  110  device in the fully assembled state. Again, one or more support arms and/or one or more clamps  116  could be used to stabilize multiple devices such as guide catheters  18 , wire guides  24 , endoscopes  82 , or other instruments used by the physician. 
     FIGS. 11A ,  11 B, and  11 C illustrate a wire movement guide  130  that is used to facilitate one-handed movement of both the wire guide  24  and guide catheter  18 . The wire movement guide  130  may be formed as a recessed handle or the like. As seen in  FIG. 11C , during operation of the guide catheter  18 , a steering device  26  is secured to the wire guide  24 . The steering device  26  is able to slide axially and rotate in the movement path (as shown by arrows A and B in  FIG. 11C ). In a preferred embodiment, the recessed handle  130  includes a hub recess  132  that is sized to receive the hub  22  of the guide catheter  18 . For example, the hub recess  132  may be sized to frictionally secure the hub  22  within the same. Alternatively, one or more detents, tabs, or the like may be positioned on the hub recess  132  and/or hub  22  to releasably secure wire movement guide to the hub  22  of the guide catheter  18 . The wire movement guide  130  also includes a recess  134  for receiving the steering device  26 . The recess  134  is dimensioned to permit axial and rotational movement of the steering device  26  as is shown in  FIG. 11C . The wire movement guide  130  may also include a wire recess  136  for receiving the wire guide  24 . The wire recess  136  may be interposed between the two recesses  132 ,  134 . In addition, a wire recess  136  may be located at a proximal end of the wire movement guide  130  to permit the wire guide  24  to exit the proximal end of the wire movement guide  130 .  FIG. 11B  illustrates a cross-sectional view of the wire movement guide  130 . 
   In an alternative aspect of the invention, the wire movement guide  130  could be formed integrally with the hub  22  or simply formed integrally on the proximal end of the guide catheter  18 . 
   With the use of a wire movement guide  130 , the physician can move the guide catheter  18  into a desired position (preferably with the use of endoscopic imaging, as depicted in  FIG. 11D ), while simultaneously advancing and/or rotating the wire guide  24  with a single hand. For example, the fingers could be manipulating the wire movement guide  130  and therefore the guide catheter  18 , while the thumb is able to manipulate the wire guide  24  to a desired position in the nasal cavity or sinus. A portion of the exterior surface of the steering device  26  may be scored, roughened, or otherwise textured to aid the physician in manipulating the steering device  26 . The wire movement guide  130  advantageously permits the physician to use his or her other hand to independently manipulate another tool such as, for example, an endoscope  82 . 
   One preferred embodiment for positioning a wire guide  24  into the maxillary sinus ostium MO is depicted in  FIG. 11D . In this embodiment, the guide catheter  18 , wire movement guide  130 , and wire guide  24  are manipulated under endoscopic visualization. Here, the endoscope  82  is a “rigid” endoscope, a standard tool in nasal surgery. The rigid endoscope generally has a forward looking viewing field α which may or may not be offset, a light port  82   a , and a viewing port  82   b  through which an image is obtained (indicated with an eyeball symbol). The endoscope  82  is used to help identify the uncinate process UP, and the guide catheter  18  is “hooked” around the uncinate process UP. Additional tools such as a sinus “seeker” (not shown) can be utilized to help pull the uncinate process UP away from the opposite wall and make room for the tip  18   b  of the guide catheter  18 . Once the guide catheter tip  18   b  is positioned, the wire guide  24  is manipulated by tactile feedback until it is felt to have passed into the maxillary sinus ostium MO and into the maxillary sinus MS.  FIG. 11D  illustrates a simplified obstruction  138  located adjacent the uncinate process UP and maxillary sinus ostium MO. This obstruction  138  may include mucous, inflamed mucosa, scar tissue, abnormal bony structure, or other substances. In this manner, only conventional endoscopic imaging is utilized—without the need for fluoroscopic imaging and/or other specialized “image guidance” technology. This same technique could be utilized for the other sinuses and their ostia as well. In addition, one or more of the stabilization devices  80 ,  100 ,  110  previously described could be utilized as would be useful in this or any of the subsequently described methods. 
   During operation of the device, it may be desirable to have a way to independently confirm that the distal tip  24   a  of the wire guide  24  has been positioned in the desired sinus, and not inadvertently passed through some other structure, such as the orbital wall. Since the sinuses are difficult if not impossible to image with the standard rigid endoscopes, endoscopic imaging is not readily amenable for this confirmation. One such confirmation approach is illustrated in  FIG. 12 . As seen in  FIG. 12 , after the wire guide  24  has been positioned in what is believed to be the desired location (maxillary sinus MS), a fiber optic catheter  140  is positioned over the wire guide  24  and advanced distally towards the tip of the wire guide  24 . The fiber optic catheter  140  may be positioned using a guide catheter  18  of the type illustrated in  FIG. 12 . The distal tip  140   a  of the fiber optic catheter  140  emits light  142  that is input into the fiber optic catheter  140  via a light port  144 . In one aspect of the invention, the emitted light  142  is bright enough such that it lights up or illuminates the sinus cavity and can be visualized externally. In this regard, the surrounding environment (e.g., physicians office) may need to have the level of ambient light reduced or turned off completely to aid in the visualization process. 
   If a structure other than the desired sinus is illuminated, the physician or other operator knows that the wire guide  24  has been improperly positioned and can subsequently be repositioned into the proper location. Once the position of the wire guide  24  has been confirmed to be in the desired position, a balloon catheter  12  can then be confidently placed into the sinus ostium (e.g., MO) and dilated. 
     FIG. 13  illustrates an alternative embodiment for confirming the position of a wire guide  24 . In this embodiment, the wire guide  24  is fitted with a detection element  150  at or near the distal tip  24   a . In one aspect, the detection element  150  can be made of a magnetic material. A magnetic detection device (not shown) which could be as simple as a floating magnetic needle such as a compass needle may then be positioned outside the patient&#39;s face near the sinus to confirm the position of the wire tip  24   a . For example, in this case, the deflection of the magnetic needle would indicate the presence of the detection element  150  (and thus the distal tip  24   a  of the wire guide  24 ) within the desired sinus cavity. 
   Alternatively, the detection element  150  could be formed from a dense metallic material that can be detected with a metal detector device (not shown). For example, the metal detector device may include a probe or the like that can be manipulated near to patient&#39;s face near the sinus cavity of interest to detect the presence (or absence) of the metallic detection element  150 . In yet another aspect, the detection element  150  may emit a signal (e.g., radiofrequency pulse or the like) that can then be detected externally to confirm the presence or absence of the distal tip  24   a  of the wire guide  24  within the sinus cavity of interest. 
   Independent confirmation methods and devices as described above may not be necessary if more versatile optical imaging techniques and devices are utilized in the placement of the various devices such as wire guides  24 , guide catheters  18 , and/or balloon catheters  12 . For instance,  FIG. 14  illustrates a method for placing a wire guide  24  across a sinus ostium (e.g., maxillary ostium MO) with the aid of a directable or steerable endoscope  152 . Directable endoscopes  152  make use of flexible fiber optic bundles which can be bent or curved to alter the direction of the viewing field  154 . A typical construction of a directable endoscope  152  includes multiple control wires (not shown) connected near the distal tip  152   a  and to a deflection knob  155 . In this method, the directable endoscope  152  is positioned superior to the uncinate process UP and then directed retrograde to allow direct viewing of the viewing field  154  where the guide catheter  18  and wire guide  24  are being manipulated. To further aid in the identification of the maxillary sinus ostium MO, particularly in the case of occlusion  156  associated with sinusitis, the maxillary sinus MO is illuminated with the placement of a small illumination member  158  into the sinus. The illumination member  158  may be formed as an elongate member having a light-emitting distal end  158   a  and a proximal end  158   b  that is typically connected or otherwise coupled to a light source  160 . In one aspect, the illumination member  158  is formed as a fiber optic light based device. 
   The illumination member  158  can be placed into the sinus cavity of interest (e.g., maxillary sinus MS) by using a piercing member  162  such as, for example, an introducer needle  162  that is introduced through the canine fossa CF region. It should be understood that reference to the canine fossa CF refers to the general region or anatomical area surrounding or adjacent to the canine fossa CF and is not limited to a single, discrete structure or location. The introducer needle  162  may include a hollow lumen or the like to permit the passage of the illumination member  158 . The canine fossa CF is a thin portion of the maxillary sinus wall located adjacent the root of the canine teeth. The canine fossa CF has been utilized for other intrasinus procedures. After the formation of a passageway  164  through the canine fossa CF, the illumination member  158  is advanced distally such that the distal tip  158   a  of the illumination member  158  is disposed inside the sinus cavity. The emitted light  162  in the maxillary sinus MS (or other sinus cavity) will be visible through the blockage  156  of the ostium MO using the directable endoscope  152 . This aids the physician or other user to direct the wire guide  24 . 
     FIG. 15  illustrates a similar method to  FIG. 14 , the difference being the use of a rigid retrograde endoscope  170 . A rigid retrograde endoscope  170  is similar to a normal rigid endoscope, but the direction of viewing field  172  is in a retrograde direction. The rigid retrograde endoscope  170  has a substantially rigid shaft portion  173  and a retrograde viewing window  174  located at or near the distal tip  170   a . Retrograde visualization is accomplished through the use of one or more mirrors and/or lenses located at or adjacent to the viewing window  174  to deflect the viewing field  172 . Since the viewing field  172  is retrograde, this endoscope  170  can assist in accessing the sinus ostium in a similar manner as described with respect to the method shown in  FIG. 14 . One difficulty with a rigid retrograde endoscope  170  is that it can be awkward to initially position it, since it cannot be used to see straight ahead. However, this difficulty is overcome by utilizing a normal rigid endoscope (not shown) alongside the retrograde rigid endoscope  170  to get it positioned initially in the nasal cavity. Again, an illumination member  158  in the sinus, placed via the canine fossa CF, can be further utilized to aid in accessing the sinus ostium. 
   Still other alternative methods for accessing the sinus ostium are illustrated in  FIGS. 16A ,  16 B, and  16 C. In these embodiments, a flexible visualization scope  180  is utilized. The flexible visualization scope  180  includes an elongate flexible body  182  that contains a flexible fiber optic bundle  183  (as shown in  FIG. 16C ) for viewing around bends. Although not shown in the figures, the fiber optic bundle  183  includes both “imaging” fibers and “illumination” fibers for lighting up the viewing field  184 . The flexible visualization scope  180  is not directable like the endoscope  152  of  FIG. 14 . Rather, the flexible visualization scope  180  includes a lumen or passageway  185  for the wire guide  24  and follows the wire guide  24  around bends as illustrated in  FIG. 16A . Consequently, in this method, particularly for a maxillary sinus ostium MO, a guide catheter  18  having a curved distal portion  20  is positioned near or around the uncinate process UP. A conventional rigid endoscope (not shown) may be used to assist in this positioning. Next, the wire guide  24  is positioned near the tip  18   b  of the guide catheter  18 . Then the flexible visualization scope  180  is advanced over the wire guide  24 , curving back in a retrograde fashion, allowing the viewing field  184  to be directed towards the sinus ostium (MO in this case). A blockage is shown  186  positioned within the maxillary ostium MO. The wire guide  24  and guide catheter  18  may then be manipulated under visual observation to access the ostium MO. Again, as has been mentioned previously, additional tools or the use of a “seeker” can be used in addition to the visualization scope  180 , guide catheter  18  and wire guide  24 . In addition, the sinus cavity of interest may be illuminated using the canine fossa CF access method described above with respect to  FIGS. 14 and 15 . 
   Another alternative device and method for accessing a sinus ostium is illustrated in  FIGS. 17A ,  17 B, and  17 C. In this embodiment, a directable endoscope sheath  190  is provided that has a deflectable tip  190   a . The directable endoscope sheath  190  is similar to the directable endoscope  152  of  FIG. 14 , but further includes a working channel or lumen  192 , as best seen in  FIG. 16C , together with the deflection wires  194  and optical fibers  196  (which contain both imaging and illuminating fibers). In use, the directable endoscope sheath  190  can be introduced into the nasal cavity relatively straight, so as to see straight ahead. When the directable endoscope sheath  192  is near the uncinate process UP, the tip  190   a  is deflected retrograde using, for instance, a deflection knob  197 , so that the viewing field  198  is directed towards the sinus ostium MO which contains an obstruction  200 . At this point, a wire guide  24  is positioned in the working lumen  192  and the ostium MO is accessed under visual observation. 
   In one preferred embodiment, the directable endoscope sheath  190  has a large enough working channel  192  that a balloon catheter  12  can be advanced into the sheath  190  over the wire  24 . In this manner, a separate guide catheter  18  is not necessary. In yet another preferred embodiment, the working channel  192  is only large enough to accommodate the wire guide  24 . This allows for the sheath  190  to have a reasonably small outer diameter. Once the wire  24  is positioned in the sinus, the directable endoscope sheath  190  is removed from the wire  24 , leaving the wire  24  in position. Thereafter, a balloon catheter  12  can be installed over the wire  24  and into the sinus ostium MO for dilation. 
     FIGS. 18A and 18B  illustrate a device  210  and method for accessing and dilating a sinus ostium (e.g., maxillary sinus ostium MO) via a direct sinus puncture technique, in contrast to a transnasal technique. This approach can generally be done with the frontal sinus FS and the maxillary sinus MS. While a description of the device  210  and process is provided for the maxillary sinus MS, it should be understood that similar access devices  210  can be used with the frontal sinus FS. 
   In  FIG. 18A , a trocar  212  is shown being advanced into the maxillary sinus MS via the canine fossa CF approach. The trocar  212  includes a hollow cannula  214  and a needle  216  contained within the lumen  218  of the cannula  214 . The needle  216  has a sharp tip  220  for penetrating the thin bone surrounding the sinus. The needle  216  may be a solid piece or having one or more lumens therein. Once the cannula  214  is inside the sinus, the needle  216  is then removed and the cannula  214  serves as a guide catheter for subsequent devices. As an alternative to a needle-cannula type of trocar  212 , a hollow sharpened needle could be used as well. 
   Referring now to  FIG. 18B , once the cannula  214  is in place, a wire guide  24  and an endoscope  222  can be introduced into the sinus. The cannula  214  is pointed towards the ostium MO, which points the viewing field  224  to the ostium MO. Manipulation of the wire guide  24  through use of a steering device  26  then delivers the wire guide  24  across the ostium MO which may contain a blockage  200  as is shown in  FIG. 18B . Optionally, an illumination member  226  can be placed in the nasal cavity to “back-light” the ostium MO and enhance the ability for the ostium MO to be seen, further aiding the ability to direct the wire guide  24  across the ostium MO. Alternatively, a bright light placed at the nostril may be adequate to perform this back-lighting. 
   With the above-described “direct sinus puncture” technique such as through the canine fossa CF, various stabilization devices can be utilized to stabilize one or more of the various tools used for accessing and/or treating the ostium. For example, as shown in  FIG. 18C , a stabilization device  110  is shown stabilizing the cannula  214 . The stabilization device  110  could also be used to stabilize the wire guide  24 , the endoscope  222 , trocar  212 , and/or the balloon catheter  12 . Similarly, any of the previously described stabilization devices can be utilized with the direct sinus puncture techniques. 
     FIGS. 19A ,  19 B, and  19 C illustrate various arrangements and types of endoscopes  222   a ,  222   b ,  222   c  that can be used with this canine fossa CF approach. In  FIG. 19A , the endoscope  222   a  is a flexible visualization scope having a bundle of optical fibers  228 . The endoscope  222   a  further includes a lumen  230  through which the wire guide  24  is fed.  FIG. 19B  shows a rigid endoscope  222   b  used next to the wire guide  24 , inside cannula  214 .  FIG. 19C  illustrates a similar arrangement to that shown in  FIG. 19B , but with an additional dual lumen catheter  232  to better manage the positioning of the wire guide  24  relative to the rigid endoscope  222   c . In all these approaches, the diameter of the endoscope  222   a ,  222   b ,  222   c  used is preferably small, about 0.5 mm to about 4 mm, and most preferably about 1 mm to about 2 mm. This allows for the use of a relatively small trocar and relatively small puncture size. Preferred trocar diameters are from 0.7 mm to 4.2 mm (depending on the size of the devices used with them), and more preferably from about 1 mm to 2.5 mm, and most preferably 1.2 to 2.0 mm. 
     FIG. 20  illustrates the introduction of a balloon dilation catheter  12  into the cannula  214  and into the sinus ostium MO, dilating the ostium MO, and deforming and/or remodeling the uncinate process UP. To aid in the positioning of the balloon  10 , an optional endoscope  240  is placed in the nasal cavity may be used to visualize the catheter tip  12   c  relative to the uncinate process UP. 
   Alternatively, the position of the balloon  10  may not require “real time” visualization with an endoscope, if various markers on the wire guide and/or balloon catheter shaft as described earlier are utilized. For example, if the wire guide  24  includes markers, the marker that is seen at or near the ostium can be noted. Markers on the proximal portion of the wire guide  24  can then be used to determine the “depth” that the wire guide  24  has been advanced to reach the ostium. The balloon catheter  12  can then be advanced a distance over the wire guide  24  a predetermined distance on the wire guide  24 , such that the balloon  10  is positioned at a desired position relative to the noted marker on the wire guide  24 . Markers  62  on the shaft of the balloon catheter  12  can aid in this positioning. With this use of markers  62 , the balloon  10  can be confidently positioned in the desired region of the sinus ostium. The desired length of the balloon can be selected by viewing the computed tomography (CT) scans of the patient, which are part of a standard diagnostic workup of the patient prior to any intervention. 
   Though not shown, once the maxillary ostium MO has been treated, the ethmoids and/or frontal sinuses ES, FS can also be treated by this same canine fossa access. The wire guide  24  can be manipulated into the ethmoids and/or frontals, with subsequent dilation of the ostia of these sinuses. Similar endoscopic visualization techniques as described above can also be utilized to assist in placement of the various devices such as the wire guide  24  to these locations. In the case of the ethmoids, it may be desirable to use a sharpened wire in lieu of a wire guide  24  to puncture into the wall of the ethmoid sinus air cells, followed by balloon dilation of the puncture. 
   As mentioned above, the frontal sinus FS can also be accessed directly from outside the skull, through the wall of the frontal sinus FS to facilitate treatment of the frontal sinus ostium FO. Rather than a trocar, the frontal sinus FS can be directly accessed through a mini trephination through the skin and the sinus wall, as is known in the art. With a mini-trephination, the access is performed with a drill tool. Once accessed, the frontal sinus ostium FO may be directly accessed with a wire guide  24 . A preferred location for accessing the frontal sinus FS is through the floor of the frontal sinus FS. Since the frontal sinus FS is relatively small, and there is only one outflow tract and its position can be approximated relative to the nose, visualization may not be required to pass the wire guide  24  through the frontal sinus ostium FO and into the nasal cavity. Standard endoscopic visualization could be performed in the nasal cavity via the nostrils to observe the wire guide  24  after it passes into the nasal cavity. Subsequent to passing the wire guide  24  into the frontal ostium FO, a balloon dilation catheter  12  can be positioned in the ostium FO to dilate it. 
   Although the maxillary sinus MS is easily accessible via the canine fossa CF, it is important to control the depth of the initial puncture so as to not inadvertently advance the needle  216  too far and potentially into the orbit O or elsewhere.  FIG. 21  illustrates a trocar  212  with a stop  250  secured to a portion of the trocar  212 . The stop  250  prevents the needle  216  from advancing too far into the sinus cavity. In one aspect, the stop  250  is clamped on to either the needle  216  or the cannula  214  at a predetermined position. In a preferred embodiment of the invention, the stop  250  is adjustable and/or removable with respect to the fixation point (e.g., needle  216  or cannula  214 ). For example, the stop  250  may include one or more tightening members  252  such as screws or the like that can be selectively tightened or loosen the stop  250 . Once the trocar  212  is inserted up to the stop  250 , the stop  250  is removed. The cannula  214  can then be advanced with little force, as the puncture site has already been made. 
     FIG. 22  shows an alternative trocar  212  arrangement for improving the control of the puncturing into the canine fossa CF. Here, the needle  216  includes needle threads  216   a  located on an exterior surface thereof. The threads  216   a  of the needle  216  engage with a threaded hub  254  in a threaded interface. The threaded hub  254  may be in the form of a “clamshell” of two treaded pieces or halves  254   a ,  254   b  that surround and engage the needle threads  216   a . The position of the threaded hub  254  may be held fast by attachment to a stabilizing device such as the stabilizing devices  80 ,  110  shown in  FIGS. 8 and 10 . The needle  216  is then advanced into the canine fossa CF by controlled rotation of the needle  216 . Once the needle  216  has penetrated or traveled the desired amount, the threaded hub  254  is removed, and the cannula  214  is advanced to a desired position within the sinus. Alternatively, the threaded hub  254  could be attached to a stabilizing device  80 ,  110  in a manner that allows rotation of the threaded hub  254  about the needle threads  216   a , by utilizing a bearing surface (not shown) with the stabilizing device  80 ,  110 . The threaded hub  254  when rotated would controllably advance the needle  216  into the sinus. In this manner, the needle  216  is not rotated. 
   Sometimes the desired direction and positioning for placing the trocar  212  in the canine fossa CF does not provide good alignment with the location of the sinus ostium. In this case, a trocar  212  having a flexible tip  260  can be used, as shown in  FIGS. 23A and 23B . In  FIG. 23A , the cannula  214  has a somewhat flexible curved tip  260 , that, in  FIG. 23A , is maintained straight by the presence of the needle  216 . This trocar  212  is advanced into the sinus. Upon removal of the needle  216 , the flexible tip  260  takes on its curved shape, more oriented to the ostium MO. Thereafter a wire guide  24  is advanced across the ostium MO, preferably under the visual guidance of a flexible visualization scope  262  as shown in  FIG. 23B . The visualization scope  262  is preferably dimensioned such that it can be slidably passed through the cannula  214 . The flexible visualization scope  262  includes a lumen or passageway  264  for the wire guide  24 . The flexible visualization scope  262  is able to be oriented to place the visualization field  266  within the vicinity of the ostium MO. Manipulation of the curved tip  260  of the cannula  214  can assist in directing the wire guide  24  to and through the ostium MO. Also as shown, the nasal cavity can be back-lit using an illumination member  268  to aid in seeing the ostium. Also, other tools and methods may be used as desired, such as, for example, the trocar  212  modifications illustrated in  FIGS. 21 and 22 . 
     FIG. 24  illustrates another device and method for accessing the maxillary sinus ostium MO via the canine fossa CF. In this embodiment, two small punctures  270 ,  272  are made, side-by-side in the canine fossa CF region. A puncture device  210  like that disclosed in  FIG. 18A  may be used. For example, a rigid endoscope  274  is positioned in the cannula  214  of the first puncture site  270 . A wire guide  24  is then positioned in the cannula  214  of the second puncture site  272 . One or more of the cannulas  212  may have a curved tip  260  to better access the maxillary sinus ostium MO. The wire guide  24  may then be positioned across the ostium MO under the visualization of the rigid endoscope  274 . A balloon dilation catheter (not shown in  FIG. 24 ) may then be advanced over the wire  24  to dilate the sinus. The ostial region may be back-lit using an illumination member  276 . 
     FIGS. 25A and 25B  illustrate a common anatomical characteristic present in patients with sinusitis associated with the maxillaries, ethmoids, and frontals. The uncinate process UP is shown in close association with the opposite wall, typically on the ethmoid bulla EB. This condition creates a narrow slit-like space called the infundibulum I. The maxillary sinus ostium MO is actually located below (i.e., inferior to) the infundibulum I.  FIG. 25B  more clearly shows the “topography” of the structures of the uncinate process UP and ethmoid bulla EB. It is believed that a narrowed infundibulum I may be part of the condition leading to the patient&#39;s sinusitis, as well as one or more narrowed ostia. In some patents, a narrowed infundibulum I may be the sole anatomical cause leading to sinusitis. 
   The previously described approaches to dilating the maxillary sinus ostium MO may result in a widening of the infundibulum I by deforming or remodeling the uncinate process UP, as well as the widening of the ostium MO itself. However, in some patients, the uncinate process UP may not stay permanently deformed following removal of the dilation catheter  12 . 
   An alternative approach to widening the infundibulum I is illustrated in  FIGS. 26A and 26B . One or more shim members  280  are placed in the gap of the infundibulum I to forcibly spread it away from the ethmoid bulla EB and improve drainage for the maxillary, frontal and portions of the ethmoid sinus. In one preferred aspect of the invention, the one or more shim members  280  are left in place after implantation. The shim members  280  may remain in place for a temporary period of time or permanently. The sinus ostium may still be dilated with the use of a balloon dilation catheter  12 .  FIG. 26B  illustrates three such shim members  280  secured in the infundibulum I. As seen in  FIG. 26B , the gap is widened to expose the maxillary sinus ostium MO. 
     FIGS. 27A and 27B  illustrate one preferred embodiment of a shim member  280 . The shim members  280  may be dimensioned such that one or more sides are longer than the remaining sides. For example, the shim member  280  may be longer than it is wide, with a length dimension preferably about 1 mm to about 6 mm in length, and more preferably about 2 mm to about 4 mm in length. The shim members  280  may include one or more gripping members  282  on all or a portion of an exterior surface. The gripping members  282  may be formed as a serrated surface or even a plurality of teeth or similar projections. As seen in  FIGS. 27A and 27B , the gripping members  282  are located on opposing sides of the shim member  280  to allow for the shim member  280  to be rotated into position and held in place. 
   The shim member  280  may include one or more engagement holes  284  that are used for the delivery of the shim member  280 . For example, the engagement holes  284  may be dimensioned to fit on the distal end of a tool as shown in  FIG. 28 . The shim member  280  may be a permanent implant, or more preferably a degradable bioabsorbable implant. Suitable materials for a degradable shim member  280  include poly-lactic acid, poly-glycolic acid, poly-L-lactic acid or other materials such as those used in degradable sutures. It is believed that after the shim members  280  are implanted in the infundibulum I, the uncinate process UP will remodel over time to maintain a widened infundibulum. 
     FIG. 28  illustrates a delivery tool  290  for use in the delivery of the shim member(s)  280 . The delivery tool  290  includes an elongate torque driver  292  constructed of a multi-layer, multi-filar drive shaft similar to that used in speedometer cables. The torque driver  292  is dimensioned to be positionable within a guide catheter  18  or the like. The shim member  280  is connected to the torque driver  292  at its distal end  292   a . The proximal end  292   b  of the torque driver  292  is coupled to a handle  294  or the like that is used to rotate the torque driver  292  (and attached shim member  280 ) in the direction of the arrows shown in  FIG. 28 . 
   The guide catheter  18  is used to place the shim member  280  over the uncinate process UP and in the narrowed infundibulum I, initially in a narrow or “sideways” orientation. The torque driver  292  is then rotated by rotation of the handle  294 . Rotation of about 60 to about 90 degrees will widen the infundibulum I as shown in  FIG. 26B . The connection between the torque driver  292  and the shim member  280  is disconnected. This could be done, for example, by reversing the rotational direction of the torque handle  294  and causing a weakened portion of the connection to break. Alternatively, the torque driver  292  may be frictionally engaged with the holes  284  of the shim member  280 . Retraction of the torque driver  292  in the proximal direction may disengage the torque driver  292  from the shim member  280 . Once place, the one or more shim members  280  will maintain the infundibulum I in a widened condition, while minimizing the interruption of the mucosa by the presence of the shim member(s)  280 . 
   Alternatively, as shown in  FIG. 29 , the infundibulum I can be widened by delivery of an expandable stent  300 , oriented more or less in the infundibulum I. This stent  300  can be similar to that used in coronary stenting procedures, and can be either “self-expanding” or “balloon expandable.” The geometry of the stent  300  may be tubular as is shown in  FIG. 29 . The stent  300  can be placed in the infundibulum I using a balloon catheter  12  and a wire guide  24 . As one example, the stent  300  may be positioned via a transnasal approach wherein the wire guide  24  is directed along the infundibulum I up towards the frontal sinus ostium FO (as shown in  FIG. 3C ) and then deployed between the uncinate process UP and the ethmoid bulla EB. 
   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.