Patent Publication Number: US-2017348516-A1

Title: Apparatus and methods for dilating and modifying ostia of paranasal sinuses and other intranasal or paranasal structures

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 14/566,845, entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures,” filed on Dec. 11, 2014, issued as U.S. Pat. No. 9,713,700, which is a continuation of U.S. patent application Ser. No. 12/768,963, entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures,” filed on Apr. 28, 2010, issued as U.S. Pat. No. 8,945,088, which is a continuation of U.S. patent application Ser. No. 11/928,346, entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures,” filed on Oct. 30, 2007, issued as U.S. Pat. No. 8,172,828, which is a continuation of U.S. patent application Ser. No. 10/944,270, entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures,” filed on Sep. 17, 2004, published as U.S. Patent Publication No. 2006/0004323, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 10/829,917, entitled “Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat,” filed on Apr. 21, 2004, issued as U.S. Pat. No. 7,654,997 the entire disclosure of which is expressly incorporated herein by reference. 
    
    
     BACKGROUND 
     The present invention relates generally to medical devices and methods and more particularly to minimally invasive, devices, systems and methods for treating sinusitis and other ear, nose &amp; throat disorders. 
     The nose is responsible for warming, humidifying and filtering inspired air and for conserving heat and moisture from expired air. The nose is formed mainly of cartilage, bone, mucous membranes and skin. 
     The bones in the nose contain a series of cavities known as paranasal sinuses that are connected by passageways. The paranasal sinuses include frontal sinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses. The paranasal sinuses are lined with mucous-producing epithelial tissue and ultimately opening into the nasal cavity. Normally, mucous produced by the epithelial tissue slowly drains out of each sinus through an opening known as an ostium. If the epithelial tissue of one of these passageways becomes inflamed for any reason, the cavities which drain through that passageway can become blocked. This blockage can be periodic (resulting in episodes of pain) or chronic. This interference with drainage of mucous (e.g., occlusion of a sinus ostium) can result in mucosal congestion within the paranasal sinuses. Chronic mucosal congestion of the sinuses can cause damage to the epithelium that lines the sinus with subsequent decreased oxygen tension and microbial growth (e.g., a sinus infection) 
     Sinusitis: 
     The term “sinusitis” refers generally to any inflammation or infection of the paranasal sinuses caused by bacteria, viruses, fungi (molds), allergies or combinations thereof. It has been estimated that chronic sinusitis (e.g., lasting more than 3 months or so) results in 18 million to 22 million physician office visits per year in the United States. 
     Patients who suffer from sinusitis typically experience at least some of the following symptoms:
     headaches or facial pain   nasal congestion or post-nasal drainage   difficulty breathing through one or both nostrils   bad breath   pain in the upper teeth   

     Thus, one of the ways to treat sinusitis is by restoring the lost mucous flow. The initial therapy is drug therapy using anti-inflammatory agents to reduce the inflammation and antibiotics to treat the infection. A large number of patients do not respond to drug therapy. Currently, the gold standard for patients with chronic sinusitis that do not respond to drug therapy is a corrective surgery called Functional Endoscopic Sinus Surgery. 
     Current and Proposed Procedures for Sinus Treatment 
     Functional Endoscopic Sinus Surgery 
     In FESS, an endoscope is inserted into the nose and, under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses. FESS procedures are typically performed with the patient under general anesthesia. 
     Although FESS continues to be the gold standard therapy for surgical treatment of severe sinus disease, FESS does have several shortcomings. For example, FESS can cause significant post-operative pain. Also, some FESS procedures are associated with significant postoperative bleeding and, as a result, nasal packing is frequently placed in the patient&#39;s nose for some period of time following the surgery. Such nasal packing can be uncomfortable and can interfere with normal breathing, eating, drinking etc. Also, some patients remain symptomatic even after multiple FESS surgeries. Additionally, some FESS procedures are associated with risks of iatrogenic orbital, intracranial and sinonasal injury. Many otolaryngologists consider FESS an option only for patients who suffer from severe sinus disease (e.g., those showing significant abnormalities under CT scan). Thus, patients with less severe disease may not be considered candidates for FESS and may be left with no option but drug therapy. One of the reasons why FESS procedures can be bloody and painful relates to the fact that instruments having straight, rigid shafts are used. In order to target deep areas of the anatomy with such straight rigid instrumentation, the physician needs to resect and remove or otherwise manipulate any anatomical structures that may lie in the direct path of the instruments, regardless of whether those anatomical structures are part of the pathology. 
     Balloon Dilation Based Sinus Treatment 
     Methods and devices for sinus intervention using dilating balloons have been disclosed in U.S. Pat. No. 2,525,183 (Robison) and U.S. Patent Publication No. 2004/0064150 A1 (Becker), now U.S. Pat. No. 8,317,816, issued Nov. 27, 2012. For example, U.S. Pat. No. 2,525,183 (Robison) discloses an inflatable pressure device which can be inserted following sinus surgery and inflated within the sinus. The patent does not disclose device designs and methods for flexibly navigating through the complex nasal anatomy to access the natural ostia of the sinuses. The discussion of balloon materials is also fairly limited to thin flexible materials like rubber which are most likely to be inadequate for dilating the bony ostia of the sinus. 
     U.S. patent publication number 2004/0064150 A1, issued as U.S. Pat. No. 8,317,816 (Becker) discloses balloon catheters formed of a stiff hypotube to be pushed into a sinus. The balloon catheters have a stiff hypotube with a fixed pre-set angle that enables them to be pushed into the sinus. In at least some procedures wherein it is desired to position the balloon catheter in the ostium of a paranasal sinus, it is necessary to advance the balloon catheter through complicated or tortuous anatomy in order to properly position the balloon catheter within the desired sinus ostium. Also, there is a degree of individual variation in the intranasal and paranasal anatomy of human beings, thus making it difficult to design a stiff-shaft balloon catheter that is optimally shaped for use in all individuals. Indeed, rigid catheters formed of hypotubes that have pre-set angles cannot be easily adjusted by the physician to different shapes to account for individual variations in the anatomy. In view of this, the Becker patent application describes the necessity of having available a set of balloon catheters, each having a particular fixed angle so that the physician can select the appropriate catheter for the patient&#39;s anatomy. The requirement to test multiple disposable catheters for fit is likely to be very expensive and impractical. Moreover, if such catheter are disposable items (e.g., not sterilizable and reusable) the need to test and discard a number of catheters before finding one that has the ideal bend angle could be rather expensive. 
     Methods and devices for sinus intervention using dilating balloons have been disclosed in U.S. Pat. No. 2,525,183 (Robison) and U.S. Patent Publication No. 2004/0064150 A1 issued as U.S. Pat. No. 8,317,816 (Becker). For example, U.S. Pat. No. 2,525,183 (Robison) discloses an inflatable pressure device which can be inserted following sinus surgery and inflated within the sinus. The patent does not disclose device designs and methods for flexibly navigating through the complex nasal anatomy to access the natural ostia of the sinuses. The discussion of balloon materials is also fairly limited to thin flexible materials like rubber which are most likely to be inadequate for dilating the bony ostia of the sinus. 
     U.S. patent publication number 2004/0064150 A1, issued as U.S. Pat. No. 8,317,816 (Becker) discloses balloon catheters formed of a stiff hypotube to be pushed into a sinus. The balloon catheters have a stiff hypotube with a fixed pre-set angle that enables them to be pushed into the sinus. In at least some procedures wherein it is desired to position the balloon catheter in the ostium of a paranasal sinus, it is necessary to advance the balloon catheter through complicated or tortuous anatomy in order to properly position the balloon catheter within the desired sinus ostium. Also, there is a degree of individual variation in the intranasal and paranasal anatomy of human beings, thus making it difficult to design a stiff-shaft balloon catheter that is optimally shaped for use in all individuals. Indeed, rigid catheters formed of hypotubes that have pre-set angles cannot be easily adjusted by the physician to different shapes to account for individual variations in the anatomy. In view of this, the Becker patent application describes the necessity of having available a set of balloon catheters, each having a particular fixed angle so that the physician can select the appropriate catheter for the patient&#39;s anatomy. The requirement to test multiple disposable catheters for fit is likely to be very expensive and impractical. Moreover, if such catheter are disposable items (e.g., not sterilizable and reusable) the need to test and discard a number of catheters before finding one that has the ideal bend angle could be rather expensive. 
     SUMMARY 
     In general, the present invention provides methods, devices and systems for diagnosing and/or treating sinusitis or other conditions of the ear, nose or throat. 
     In accordance with the present invention, there are provided methods wherein one or more flexible or rigid elongate devices as described herein are inserted in to the nose, nasopharynx, paranasal sinus, middle ear or associated anatomical passageways to perform an interventional or surgical procedure. Examples of procedures that may be performed using these flexible catheters or other flexible elongate devices include but are not limited to: remodeling or changing the shape, size or configuration of a sinus ostium or other anatomical structure that affects drainage from one or more paranasal sinuses; cutting, ablating, debulking, cauterizing, heating, freezing, lasing, forming an osteotomy or trephination in or otherwise modifying bony or cartilaginous tissue within paranasal sinus or elsewhere within the nose; removing puss or aberrant matter from the paranasal sinus or elsewhere within the nose; scraping or otherwise removing cells that line the interior of a paranasal sinus; delivering contrast medium; delivering a therapeutically effective amount of a therapeutic substance; implanting a stent, tissue remodeling device, substance delivery implant or other therapeutic apparatus; cutting, ablating, debulking, cauterizing, heating, freezing, lasing, dilating or otherwise modifying tissue such as nasal polyps, abberant or enlarged tissue, abnormal tissue, etc.; grafting or implanting cells or tissue; reducing, setting, screwing, applying adhesive to, affixing, decompressing or otherwise treating a fracture; delivering a gene or gene therapy preparation; removing all or a portion of a tumor; removing a polyp; delivering histamine, an allergen or another substance that causes secretion of mucous by tissues within a paranasal sinus to permit assessment of drainage from the sinus; implanting a cochlear implant or indwelling hearing aid or amplification device, etc. 
     Still further in accordance with the invention, there are provided devices and systems for performing some or all of the procedures described herein. Introducing devices may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, tissue cutting or remodeling devices, guidewires, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc) into the paranasal sinuses and other structures in the ear, nose or throat. 
     Still further in accordance with the invention, there are provided apparatus and methods for navigation and imaging of the interventional devices within the sinuses using endoscopic including stereo endoscopic, fluoroscopic, ultrasonic, radiofrequency localization, electromagnetic, magnetic and other radiative energy based modalities. These imaging and navigation technologies may also be referenced by computer directly or indirectly to pre-existing or simultaneously created 3-D or 2-D data sets which help the doctor place the devices within the appropriate region of the anatomy. 
     Further aspects, details and embodiments of the present invention will be understood by those of skill in the art upon reading the following detailed description of the invention and the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a schematic diagram of a system for catheter-based minimally invasive sinus surgery of the present invention being used to perform a sinus surgery procedure on a human patient. 
         FIG. 1A  is an enlarged view of portion “ 1 A” of  FIG. 1 . 
         FIGS. 2A through 2D  are partial sagittal sectional views through a human head showing various steps of a method for gaining access to a paranasal sinus using a guide and thereafter dilating or remodeling the ostial opening into the paranasal sinus. 
         FIGS. 2E through 2H  are partial sagittal sectional views through a human head showing various steps of a method for gaining access to a paranasal sinus using a steerable guide. 
         FIGS. 2I through 2L  are partial sagittal sectional views through a human head showing various steps of a method for gaining access to a paranasal sinus using an introducing device in the form of a guidewire with a preset shape. 
         FIGS. 2M through 2O  are partial sagittal sectional views through a human head showing various steps of a method for gaining access to a paranasal sinus using a balloon catheter that has a guide protruding from its distal end. 
         FIGS. 2P through 2X  are partial sagittal sectional views through a human head showing various steps of a method of accessing an ethmoid sinus through a natural or artificially created opening of the ethmoid sinus. 
         FIGS. 2Y through 2AC  are partial coronal sectional views through a human head showing various steps of a method for treating a mucocele in a frontal sinus. 
         FIGS. 3A through 3C  are partial coronal sectional views through a human head showing various steps of a method of accessing a paranasal sinus through an artificially created opening of the paranasal sinus. 
         FIG. 4A  shows a partial longitudinal sectional view of a system for dilating a sinus ostium or other intranasal anatomical structure, such system comprising three progressively larger dilators useable in sequence. 
         FIGS. 4B through 4E  show various steps of a method of dilating a nasal cavity using a working device comprising a balloon catheter with a pressure-expandable stent. 
         FIG. 4F  shows a partial perspective view of a working device that comprises a side suction and/or side cutter. 
         FIG. 4G  shows a partial perspective view of a working device that comprises a rotating cutter to cut away tissue. 
         FIGS. 4H and 4I  show various steps of a method of dilating the ostium of a paranasal sinus or other nasal passageway using a mechanical dilator. 
         FIGS. 4J and 4K  show perspective views of a mechanical dilator comprising a screw mechanism. 
         FIGS. 4L and 4  M show sectional views of a mechanical dilator that comprises a pushable member. 
         FIGS. 4N and 4O  show sectional views of a mechanical dilator that comprises a pullable member. 
         FIGS. 4P and 4Q  show sectional views of a mechanical dilator that comprises a hinged member. 
         FIGS. 4R through 4W  are schematic diagrams of alternative configurations for the distal portions of mechanical dilators of the types shown in  FIGS. 4H through 4Q . 
         FIG. 4S ′ shows a partial perspective view of the outer stationary member of  FIG. 4R . 
         FIG. 4U ′ shows a partial perspective view of the outer hemi-tubular member of  FIG. 4T . 
         FIG. 4W ′ shows a partial perspective view of the outer curved member of  FIG. 4V . 
         FIG. 5A  shows a perspective view of a balloon that comprises a conical proximal portion, a conical distal portion and a cylindrical portion between the conical proximal portion and the conical distal portion. 
         FIG. 5B  shows a perspective view of a conical balloon. 
         FIG. 5C  shows a perspective view of a spherical balloon. 
         FIG. 5D  shows a perspective view of a conical/square long balloon. 
         FIG. 5E  shows a perspective view of a long spherical balloon. 
         FIG. 5F  shows a perspective view of a bi-lobed “dog bone” balloon. 
         FIG. 5G  shows a perspective view of an offset balloon. 
         FIG. 5H  shows a perspective view of a square balloon. 
         FIG. 5I  shows a perspective view of a conical/square balloon. 
         FIG. 5J  shows a perspective view of a conical/spherical long balloon. 
         FIG. 5K  shows a perspective view of an embodiment of a tapered balloon. 
         FIG. 5L  shows a perspective view of a stepped balloon. 
         FIG. 5M  shows a perspective view of a conical/offset balloon. 
         FIG. 5N  shows a perspective view of a curved balloon. 
         FIG. 5O  shows a partial perspective view of a balloon catheter device comprising a balloon for delivering diagnostic or therapeutic substances. 
         FIG. 5P  shows a partial perspective view of a balloon/cutter catheter device comprising a balloon with one or more cutter blades. 
         FIG. 5Q  shows a perspective view of a balloon catheter device comprising a balloon with a reinforcing braid attached on the external surface of the balloon. 
         FIG. 5R  shows a partial sectional view of a balloon catheter wherein inflation ports are located near the distal end of the balloon. 
         FIG. 5S  shows a partial sectional view of an embodiment of a balloon catheter comprising multiple balloons inflated by a single lumen. 
         FIG. 5T  shows a partial sectional view of a balloon catheter comprising multiple balloons inflated by multiple lumens. 
         FIGS. 5U through 5AB  show perspective and sectional views of various embodiments of balloon catheters having sensors mounted thereon or therein. 
         FIG. 6A  shows a partial perspective view of a shaft design useable in the various devices disclosed herein, wherein the shaft comprises an external spiral wire. 
         FIG. 6B  shows a partial perspective view of a shaft design for the various devices disclosed herein, wherein the shaft comprises a stiffening wire. 
         FIG. 6C  shows a partial perspective view of an embodiment of a shaft design for the various devices disclosed herein, wherein the shaft comprises stiffening rings. 
         FIG. 6D  shows a partial perspective view of a shaft design for the various devices disclosed herein, wherein the shaft comprises controllable stiffening elements. 
         FIG. 6E  shows a partial perspective view of a shaft design for the various devices disclosed herein, wherein the shaft comprises a hypotube. 
         FIG. 6F  shows a partial perspective cut-away view of a shaft design for the various devices disclosed herein, wherein the shaft comprises a braid. 
         FIG. 6F ′ is an enlarged side view of the braid of the device of  FIG. 6F . 
         FIG. 6G  shows a partial perspective view of an embodiment of a device comprising a shaft having a plastically deformable region. 
         FIG. 6H  shows a partial perspective view of a device comprising a shaft having a flexible element. 
         FIG. 6I  shows a partial perspective view of a shaft comprising a malleable element. 
         FIG. 6J  shows a partial perspective view of the shaft of  FIG. 6I  in a bent configuration. 
         FIG. 6K  shows a cross sectional view through plane  6 K- 6 K of  FIG. 6I . 
         FIG. 6L  shows a partial sectional view of an embodiment of a controllably deformable shaft. 
         FIG. 6M  shows a partial sectional view of the controllably deformable shaft of  FIG. 6L  in a deformed state. 
         FIG. 6N  shows a perspective view of a balloon catheter comprising a rigid or semi-rigid member. 
         FIGS. 6O through 6Q  show sectional views of a balloon catheter that comprises an insertable and removable element. 
         FIG. 7A  shows a cross sectional view through a balloon catheter shaft comprising two cylindrical lumens. 
         FIG. 7B  shows a cross sectional view through a balloon catheter shaft comprising an inner lumen and an annular outer lumen disposed about the inner lumen. 
         FIG. 7C  shows a cross sectional view through a balloon catheter shaft which comprises a first tubular element with a first lumen, a second tubular element with a second lumen and a jacket surrounding the first and second tubular elements. 
         FIG. 7D  shows a cross sectional view through a balloon catheter shaft comprising three lumens. 
         FIG. 7E  shows a cross sectional view through a balloon catheter shaft comprising a cylindrical element, a tubular element that has a lumen and a jacket surrounding the cylindrical element and the tubular element. 
         FIG. 7F  shows a cross sectional view through a balloon catheter shaft comprising an embedded braid. 
         FIG. 7G  shows a partial perspective view of a catheter shaft comprising a zipper lumen with a guide extending through a portion of the zipper lumen. 
         FIG. 7H  shows a cross sectional view through line  7 H- 7 H of  FIG. 7G . 
         FIG. 7I  shows a partial longitudinal sectional view of a catheter shaft comprising a rapid exchange lumen with a guide extending through the rapid exchange lumen. 
         FIG. 7J  shows a cross sectional view of the catheter shaft of  FIG. 7I  through line  7 J- 7 J. 
         FIG. 7K  shows a cross sectional view of the catheter shaft of  FIG. 7I  through line  7 K- 7 K. 
         FIG. 7L  is a partial perspective view of a balloon catheter device of the present invention comprising a through-lumen and a balloon inflation lumen within the shaft of the catheter. 
         FIG. 7M  is a cross sectional view through line  7 M- 7 M of  FIG. 7L . 
         FIG. 7N  is a cross sectional view through line  7 N- 7 N of  FIG. 7L . 
         FIG. 7O  is a partial perspective view of another balloon catheter device of the present invention comprising a through lumen within the shaft of the catheter and a balloon inflation tube disposed next to and optionally attached to the catheter shaft. 
         FIG. 7P  is a cross sectional view through line  7 P- 7 P of  FIG. 7O . 
         FIG. 7Q  is a cross sectional view through line  7 O- 7 O of  FIG. 7 . 
         FIG. 8A  shows a partial perspective view of a catheter shaft comprising distance markers. 
         FIG. 8B  shows a partial perspective view of a catheter shaft comprising one type of radiopaque markers. 
         FIG. 8C  shows a partial perspective view of a catheter shaft comprising another type of radiopaque markers. 
         FIG. 8D  shows a partial perspective view of a balloon catheter comprising an array of radiopaque markers arranged on the outer surface of the balloon. 
         FIG. 8E  shows a partial perspective view of a balloon catheter comprising an array of radiopaque markers arranged on an inner surface of the balloon. 
         FIG. 8E ′ is a longitudinal sectional view of  FIG. 8E . 
     
    
    
     DETAILED DESCRIPTION 
     The following detailed description, the accompanying drawings and the above-set-forth Brief Description of the Drawings are intended to describe some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description do not limit the scope of the invention in any way. 
     A number of the drawings in this patent application show anatomical structures of the ear, nose and throat. In general, these anatomical structures are labeled with the following reference letters: 
     
       
         
           
               
               
               
             
               
                   
                   
               
             
            
               
                   
                 Nasal Cavity 
                 NC 
               
               
                   
                 Nasopharynx 
                 NP 
               
               
                   
                 Frontal Sinus 
                 FS 
               
               
                   
                 Ethmoid Sinus 
                 ES 
               
               
                   
                 Ethmoid Air Cells 
                 EAC 
               
               
                   
                 Sphenoid Sinus 
                 SS 
               
               
                   
                 Sphenoid Sinus Ostium 
                 SSO 
               
               
                   
                 Maxillary Sinus 
                 MS 
               
               
                   
                 Mucocele 
                 MC 
               
               
                   
                   
               
            
           
         
       
     
       FIGS. 1 and 1A  provide a general showing of a minimally invasive surgery system of the present invention comprising a C-arm fluoroscope  1000  that is useable to visualize a first introducing device  1002  (e.g., a guide catheter or guide tube), a second introducing device  1004  (e.g., a guidewire or elongate probe) and a working device  1006  (e.g., a balloon catheter, other dilation catheter, debrider, cutter, etc.).  FIGS. 2A-8E ′ show certain non-limiting examples of the introducing devices  1002  (e.g., a guide catheter or guide tube),  1004  (guides, guidewires, elongate probes, etc.) and working devices  1006  (e.g., a balloon catheters, other dilation catheters, debrider, cutters, etc.) that may be useable in accordance with this invention. The devices  1002 ,  1004 ,  1006  may be radiopaque and/or may incorporate radiopaque markers such that C-arm fluoroscope  1000  may be used to image and monitor the positioning of the devices  1002 ,  1004 ,  1006  during the procedure. In addition to or, as an alternative to the use of radiographic imaging, the devices  1002 ,  1004 ,  1006  may incorporate and/or may be used in conjunction with one or more endoscopic devices, such as the typical rigid or flexible endoscopes or stereo endocscopes used by otolaryngologists during FESS procedures. Also, in addition to or as an alternative to radiographic imaging and/or endoscopic visualizations, some embodiments of the devices  1002 ,  1004 ,  1006  may incorporate sensors which enable the devices  1002 ,  1004 ,  1006  to be used in conjunction with image guided surgery systems or other electro-anatomical mapping/guidance systems including but not limited to: VectorVision (BrainLAB AG); HipNav (CASurgica); CBYON Suite (CBYON); InstaTrak, FluoroTrak, ENTrak (GE Medical); StealthStation Treon, iOn (Medtronic); Medivision; Navitrack (Orthosoft); OTS (Radionics); VISLAN (Siemens); Stryker Navigation System (Stryker Leibinger); Voyager, Z-Box (Z-Kat Inc.) and NOGA and CARTO systems (Johnson &amp; Johnson). Commercially available interventional navigation systems can also be used in conjunction with the devices and methods. Further non-fluoroscopic interventional imaging technologies including but not limited to: OrthoPilot (B. Braun Aesculap); PoleStar (Odin Medical Technologies; marketed by Medtronic); SonoDoppler, SonoWand (MISON); CT Guide, US Guide (UltraGuide) etc. may also be used in conjunction with the devices and methods. Guidance under magnetic resonance is also feasible if the catheter is modified to interact with the system appropriately. 
     It is to be appreciated that the devices and methods of the present invention relate to the accessing and dilation or modification of sinus ostia or other passageways within the ear nose and throat. These devices and methods may be used alone or may be used in conjunction with other surgical or non-surgical treatments, including but not limited to the delivery or implantation of devices and drugs or other substances as described in copending U.S. patent application Ser. No. 10/912,578 entitled Implantable Devices and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entire disclosure of which is expressly incorporated herein by reference. 
       FIGS. 2A through 2D  are partial sagittal sectional views through a human head showing various steps of a method of gaining access to a paranasal sinus using a guide catheter. In  FIG. 2A , a first introducing device in the form of a guide catheter  200  is introduced through a nostril and through a nasal cavity NC to a location close to an ostium SSO of a sphenoid sinus SS. The guide catheter  200  may be flexible. Flexible devices are defined as devices with a flexural stiffness less than about 200 pound-force per inch over a device length of one inch. The guide catheter  200  may be straight or it may incorporate one or more preformed curves or bends. In embodiments where the guide catheter  200  is curved or bent, the deflection angle of the curve or bend may be in the range of up to 135°. Examples of specific deflection angles formed by the curved or bent regions of the guide catheter  200  are 0°, 30°, 45°, 60°, 70°, 90°, 120° and 135°. Guide catheter  200  can be constructed from suitable elements like Pebax, Polyimide, Braided Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals like stainless steel and fluoropolymers like PTFE, PFA, FEP and EPTFE. Guide catheter  200  can have a variety of surface coatings e.g. hydrophilic lubricious coatings, hydrophobic lubricious coatings, abrasion resisting coatings, puncture resisting coatings, electrically or thermal conductive coatings, radiopaque coatings, echogenic coatings, thrombogenicity reducing coatings and coatings that release drugs. In  FIG. 2B , a second introduction device comprising a guidewire  202  is introduced through the first introduction device (i.e., the guide catheter  200 ) so that the guidewire  202  enters the sphenoid sinus SS through the ostium SSO. Guidewire  202  may be constructed and coated as is common in the art of cardiology. In  FIG. 2C , a working device  204  for example a balloon catheter is introduced over guidewire  202  into the sphenoid sinus SS. Thereafter, in  FIG. 2D , the working device  204  is used to perform a diagnostic or therapeutic procedure. In this particular example, the procedure is dilation of the sphenoid sinus ostium SSO, as is evident from  FIG. 2D . However, it will be appreciated that the present invention may also be used to dilate or modify any sinus ostium or other man-made or naturally occurring anatomical opening or passageway within the nose, paranasal sinuses, nasopharynx or adjacent areas. After the completion of the procedure, guide catheter  200 , guidewire  202  and working device  204  are withdrawn and removed. As will be appreciated by those of skill in the art, in this or any of the procedures described in this patent application, the operator may additionally advance other types of catheters or of the present invention, a guidewire  202  may be steerable (e.g. torquable, actively deformable) or shapeable or malleable. Guidewire  202  may comprise an embedded endoscope or other navigation or imaging modalities including but not limited to fluoroscopic, X-ray radiographic, ultrasonic, radiofrequency localization, electromagnetic, magnetic, robotic and other radiative energy based modalities. In this regard, some of the figures show optional scopes SC is dotted lines. It is to be appreciated that such optional scopes SC may comprise any suitable types of rigid or flexible endoscopes and such optional scopes SC may be separate from or incorporated into the working devices and/or introduction devices of the present invention. 
       FIGS. 2E through 2H  are partial sagittal sectional views through a human head showing various steps of a method of gaining access to a paranasal sinus using a steerable catheter. In  FIG. 2E , an introducing device in the form of a steerable catheter  206  is introduced through a nostril. Although commercially available devices are neither designed, nor easily usable for this technique in the sinuses, examples of a device which has a steerable tip with functionality similar to that described here include but are not limited to the Naviport™ manufactured by Cardima, Inc. in Fremont, Calif.; Attain Prevail and Attain Deflectable catheters manufactured by Medtronic; Livewire Steerable Catheters manufactured by St. Jude Medical Inc.; Inquiry™ Steerable Diagnostic Catheters manufactured by Boston Scientific; TargetCath™ manufactured by EBI; Safe-Steer Catheter manufactured by Intraluminal Therapeutics, Inc.; Cynosar manufactured by Catheter Research, Inc.; Torque Control Balloon Catheter manufactured by Cordis Corp. and DynamicDeca Steerable Catheter and Dynamic XT Steerable Catheter manufactured by A.M.I. Technologies Ltd, Israel. Steerable catheter  206  comprises a proximal portion, a distal portion and a controllably deformable region between the proximal portion and the distal portion. In  FIG. 2F , the steerable catheter  206  is steered through the nasal anatomy so that the distal portion of steerable catheter  206  is near an ostium SSO of a sphenoid sinus SS. In  FIG. 2G , a working device in the form of a balloon catheter  208  is introduced through steerable catheter  206  so that it enters sphenoid sinus SS through the ostium SSO. Thereafter, balloon catheter  208  is adjusted so that the balloon of the balloon catheter is located in the ostium SSO. In  FIG. 2H , balloon catheter  208  is used to dilate the ostium SSO. After completion of the procedure, steerable catheter  206  and balloon catheter  208  are withdrawn from the nasal anatomy. In this example, only a first introduction device in the form of a steerable catheter  206  is used to effect insertion and operative positioning of the working device (which in this example is balloon catheter  208 ). It will be appreciated, however, in some procedures, a second introduction device (e.g., an elongate guide member, guidewire, elongate probe, etc.) could be advanced through the lumen of the steerable catheter  206  and the working device  208  could then be advanced over such second introduction device to the desired operative location. 
       FIGS. 2I through 2L  are partial sagittal sectional views through a human head showing various steps of a method for gaining access to a paranasal sinus using an introducing device in the form of a guidewire with a preset shape. In  FIG. 2I , an introducing device in the form of a guidewire  210  with a preset shape is introduced in a nasal cavity. Guidewire  210  comprises a proximal portion and a distal portion and is shaped such that it can easily navigate through the nasal anatomy. In one embodiment, guidewire  210  is substantially straight. In another embodiment, guidewire  210  comprises an angled, curved or bent region between the proximal portion and the distal portion. Examples of the deflection angle of the angled, curved or bent regions are 0°, 30°, 45°, 60°, 70°, 90°, 120° and 135°. In  FIG. 2J , guidewire  210  is advanced through the nasal anatomy so that the distal tip of guidewire enters a sphenoid sinus SS through an ostium SSO. In  FIG. 2K , a working device in the form of a balloon catheter  212  is advanced along guidewire  210  into the sphenoid sinus SS. Typically, as described more fully herebelow, the working device will have a guidewire lumen extending through or formed in or on at least a portion of the working device  212  to facilitate advancement of the working device  212  over the guidewire  212  in the manner well understood in the art of interventional medicine. Thereafter, the position of balloon catheter  212  is adjusted so that the balloon of the balloon catheter is located in the ostium SSO. As described elsewhere in this application, the balloon catheter  212  may be radiopaque and/or may incorporate one or more visible or imageable markers or sensors. In  FIG. 2L , balloon catheter  212  is used to dilate the ostium SSO. After completion of the procedure, guidewire  210  and balloon catheter  212  are withdrawn from the nasal anatomy. In one embodiment, balloon catheter  212  is shapeable or malleable. 
       FIGS. 2M through 2O  are partial sagittal sectional views through a human head showing various steps of a method of gaining access to a paranasal sinus using a balloon catheter comprising a steering wire at its distal end. In  FIG. 2M , a working device comprising a balloon catheter  214  comprising a proximal portion and distal portion is introduced in a nasal cavity. Balloon catheter  214  comprises a steering wire  216  at its distal end. In  FIG. 2N , balloon catheter  214  is advanced through the nasal anatomy into a sphenoid sinus SS through a sphenoid sinus ostium SSO. Thereafter, the position of balloon catheter  214  is adjusted so that the balloon of the balloon catheter is located in the ostium SSO. In  FIG. 2O , balloon catheter  214  is used to dilate the ostium SSO. After completion of the procedure, balloon catheter  214  is withdrawn from the nasal anatomy. In one embodiment, steering wire  216  can be retracted into or advanced from balloon catheter  214 . The retraction or advancement of steering wire can be controlled by several means like a thumb wheel, a slide, a button hooked up to electronic motor and a trigger. In another embodiment, steering wire  216  may be hollow or may incorporate one or more lumen(s) to enable it to introduce or remove devices or diagnostic or therapeutic agents, examples of which are described in copending U.S. patent application Ser. No. 10/912,578 entitled Implantable Devices and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entire disclosure of which is expressly incorporated herein by reference. 
       FIGS. 2P through 2X  are partial sagittal sectional views through a human head showing various steps of a method for accessing an ethmoid sinus through a natural or artificially created opening of the ethmoid sinus. In  FIG. 2P , an introducing device in the form of a guide catheter  218  is introduced in an ethmoid sinus ES. Ethmoid sinus ES comprises multiple ethmoid air cells EAC. In  FIG. 2Q , a guidewire  220  is introduced through guide catheter into a first EAC. Thereafter, in  FIG. 2R , a balloon catheter  222  is introduced over guidewire  220  into the first EAC. In  FIG. 2S , balloon catheter  222  is inflated to dilate the structures of ES. In  FIG. 2T , guide catheter  218 , guidewire  220  and balloon catheter  222  are withdrawn leaving a first new passage in the ES. The newly created passage in the ES facilitates drainage of the mucous through the ES. Alternatively, in  FIG. 2U , only balloon catheter  222  is withdrawn. The position of guide catheter  218  is adjusted and guidewire  220  is introduced into a second EAC. In  FIG. 2V , balloon catheter  222  is introduced over guidewire  220  into the second EAC. In  FIG. 2W , balloon catheter  222  is inflated to dilate the structures of ES. In  FIG. 2X , guide catheter  218 , guidewire  220  and balloon catheter  222  are withdrawn leaving a second new passage in the ES. The second new passage in the ES further facilitates drainage of the mucous through the ES. This method of dilating the structures of ES can be repeated to create multiple new passages in the ES. 
       FIGS. 2Y through 2AC  are partial coronal sectional views through a human head showing various steps of a method for treating a mucocele in a frontal sinus. In  FIG. 2Y , an introducing device in the form of a guide catheter  224  is introduced in a frontal sinus FS through the nasal cavity NC. Frontal sinus FS has a mucocele MC to be treated. In  FIG. 2Z , a penetrating device  226  comprising a sharp tip  228  is introduced through guide catheter  224  such that penetrating device  226  punctures the MC at least partially. In  FIG. 2AA , a balloon catheter  230  is introduced over penetrating device  226  into the MC. Thereafter, in  FIG. 2AB , balloon catheter  230  is inflated to rupture the MC and allow the drainage of contents of the MC. In  FIG. 2AC , penetrating device  226  and balloon catheter  230  are withdrawn. 
     The methods disclosed herein may also comprise the step of cleaning or lavaging anatomy within the nose, paranasal sinus, nasopharynx or nearby structures including but not limited to irrigating and suctioning. The step of cleaning the target anatomy can be performed before or after a diagnostic or therapeutic procedure. 
     The methods of the present invention may also include one or more preparatory steps for preparing the nose, paranasal sinus, nasopharynx or nearby structures for the procedure, such as spraying or lavaging with a vasoconstricting agent (e.g., 0.025-0.5% phenylephyrine or Oxymetazoline hydrochloride (Neosynephrine or Afrin) to cause shrinkage of the nasal tissues, an antibacterial agent (e.g., provodine iodine (Betadine), etc. to cleanse the tissues, etc. 
       FIGS. 3A through 3C  are partial coronal sectional views through a human head showing various steps of a method of accessing a paranasal sinus through an artificially created opening of the paranasal sinus. In  FIG. 3A , a puncturing device  300  is inserted through a nostril and used to create an artificial opening in a maxillary sinus. There are several puncturing devices well known in the art like needles including needles, needles with bent shafts, dissectors, punches, drills, corers, scalpels, burs, scissors, forceps and cutters. In  FIG. 3B , puncturing device  300  is withdrawn and a working device for example a balloon catheter  302  is introduced through the artificial opening into the maxillary sinus. In  FIG. 3C , balloon catheter  302  is used to dilate the artificially created opening in the maxillary sinus. After this step, the balloon catheter  302  is withdrawn. It will be appreciated that, in some embodiments, the puncturing device  300  may have a lumen through which an introduction device (e.g., a guidewire or other elongate probe or member), may be inserted into the maxillary sinus and the puncturing device  300  may then be removed leaving such introduction device (e.g., a guidewire or other elongate probe or member) in place. In such cases, the working device (e.g., balloon catheter  302 ) may incorporate a lumen or other structure that allows the working device (e.g., balloon catheter  300 ) to be advanced over the previously inserted introduction device (e.g., a guidewire or other elongate probe or member). 
     In the methods illustrated so far, balloon catheters were used only as an example for the several alternate working devices that could be used with this invention.  FIG. 4A  shows a sectional view of an example of a working device comprising a set of three sequential dilators: a first sequential dilator  402 , a second sequential dilator  404  and a third sequential dilator  406 . The D 3  of third sequential dilator  406  is greater than the diameter D 2  of second sequential dilator  404  which in turn is greater than the diameter D 1  of first sequential dilator  402 . The sequential dilators may comprise one or more bent or angled regions. The sequential dilators can be constructed from a variety of biocompatible materials like stainless steel 316. A variety of other metals, polymers and materials can also be used to construct the sequential dilators. 
       FIGS. 4B through 4E  show various steps of a method of dilating a nasal cavity using a working device comprising a balloon catheter with a pressure-expandable stent. In  FIG. 4B , an introducing device e.g. a guidewire  416  is introduced into a nasal cavity e.g. an ostium of a sinus. In  FIG. 4C , a balloon catheter  418  is introduced over guidewire  416  into the nasal cavity. Balloon catheter  418  comprises a pressure-expandable stent  420 . The position of balloon catheter  418  is adjusted so that pressure-expandable stent  420  is located substantially within the target anatomy where the stent is to be deployed. In  FIG. 4D , the balloon of balloon catheter  418  is expanded to deploy pressure-expandable stent  420 . In  FIG. 4E , balloon catheter  418  is withdrawn leaving pressure-expandable stent  420  in the nasal cavity. Several types of stent designs can be used to construct stent  420  like metallic tube designs, polymeric tube designs, chain-linked designs, spiral designs, rolled sheet designs, single wire designs etc. These designs may have an open celled or closed celled structure. A variety of fabrication methods can be used for fabricating stent  420  including but not limited to laser cutting a metal or polymer element, welding metal elements etc. A variety of materials can be used for fabricating stent  420  including but not limited to metals, polymers, foam type materials, plastically deformable materials, super elastic materials etc. Some non-limiting examples of materials that can be used to construct the stent are silicones e.g. silastic, polyurethane, gelfilm and polyethylene. A variety of features can be added to stent  420  including but not limited to radiopaque coatings, drug elution mechanisms etc. 
       FIG. 4F  shows a partial perspective view of an embodiment of a working device comprising a side suction and/or cutting device  422  comprising a device body  424  having a side opening  426 . Cutting device  422  is advanced into a passageway such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. and positioned so that side opening  426  is adjacent to matter (e.g., a polyp, lesion, piece of debris, tissue, blood clot, etc.) that is to be removed. Cutting device  422  is rotated to cut tissue that has been positioned in the side opening  426 . Cutting device  422  may incorporate a deflectable tip or a curved distal end which may force side opening  426  against the tissue of interest. Further, this cutting device  422  may have an optional stabilizing balloon incorporated on one side of cutting device  422  to press it against the tissue of interest and may also contain one or more on-board imaging modalities such as ultrasound, fiber or digital optics, OCT, RF or electro-magnetic sensors or emitters, etc. 
       FIG. 4G  shows a partial perspective view of an embodiment of a working device comprising a rotating cutter device to cut away tissue. Rotating cutter device  428  comprises a rotating member  430  enclosed in an introducing device  432 . Rotating member  430  comprises a rotating blade  434  located near the distal region of rotating member  430 . Rotating blade  434  may be retractable into rotating member  430 . Rotating cutter device  428  is inserted in a passageway  436  such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. and positioned so that rotating blade  434  is adjacent to matter (e.g., a polyp, lesion, piece of debris, tissue, blood clot, etc.) that is to be removed. Thereafter, rotating member  430  is rotated to cause rotating blade  434  to remove tissue. In one embodiment, rotating member  430  can be retracted into introducing device  432 . In another embodiment, rotating cutter device  428  may comprise a mechanism for suction or irrigation near the distal end of rotating cutter device  428 . 
       FIGS. 4H and 4I  show various steps of a method of dilating a nasal cavity using a working device comprising a mechanical dilator  408 . Mechanical dilator  408  comprises an outer member  410 , an inner member  412  and one or more elongate bendable members  414 . Inner member  412  can slide within outer member  410 . The proximal ends of bendable members  414  are attached to distal end of outer member  410  and the distal ends of bendable members  414  are attached to distal end of inner member  412 . In  FIG. 4H , mechanical dilator  408  is inserted into an opening in the nasal anatomy e.g. an ostium of a sinus. Mechanical dilator  408  is positioned in the opening such that bendable members  414  are within the opening in the nasal anatomy. In  FIG. 4I , relative motion of outer member  410  and inner member  412  causes the distal end of outer member  410  to come closer to the distal end of inner member  412 . This causes bendable members  414  to bend such that the diameter of the distal region of mechanical dilator  408  increases. This causes bendable members  414  to come into contact with the opening in the nasal anatomy and exert an outward pressure to dilate the opening. Various components of mechanical dilator  408  like outer member  410 , inner member  412  and bendable members  414  can be constructed from suitable biocompatible materials like stainless steel 316. A variety of other metals, polymers and materials can also be used to construct the various components of mechanical dilator  408 . In one embodiment, outer member  410  is substantially rigid and inner member  412  is flexible. Outer member  410  can be substantially straight or may comprise one or more bent or angled regions. Inner member  412  may comprise one or more lumens. 
       FIGS. 4J and 4K  illustrate a perspective view of a design of a mechanical dilator comprising a screw mechanism.  FIG. 4J  shows the mechanical dilator comprising an outer member  438  and an inner screw member  440 . Inner screw member  440  is connected to outer member  438  through a first pivot  442  located on the distal end of outer member  438 . The distal end of inner screw member  440  is connected to a second pivot  444 . The mechanical dilator further comprises one or more bendable members  446 . The distal end of bendable members  446  is attached to second pivot  444  and the proximal end of bendable members  446  is attached to first pivot  442 . In  FIG. 4K , inner screw member  440  is rotated in one direction. This causes second pivot  444  to come closer to first pivot  442 . This causes bendable members  446  to bend in the radial direction exerting an outward radial force. This force can be used to dilate or displace portions of the anatomy. Outer member  438  can be substantially straight or may comprise one or more bent or angled regions. Inner screw member  440  may comprise one or more lumens. 
       FIGS. 4L and 4  M illustrate sectional views of a design of a mechanical dilator comprising a pushable member.  FIG. 4L  shows the mechanical dilator comprising an outer member  448  comprising one or more bendable regions  449  on the distal end of outer member  448 . Mechanical dilator further comprises an inner pushable member  450  comprising an enlarged region  452  on the distal end of inner pushable member  450 . In  FIG. 4M , inner pushable member  450  is pushed in the distal direction. This exerts an outward force on bendable regions  449  causing bendable regions  449  to bend in a radial direction exerting an outward force. This force can be used to dilate or displace portions of the anatomy. Outer member  448  can be substantially straight or may comprise one or more bent or angled regions. Inner pushable member  450  may comprise one or more lumens. 
       FIGS. 4N and 4O  illustrate sectional views of a design of a mechanical dilator comprising a pullable member.  FIG. 4N  shows the mechanical dilator comprising an outer member  454  comprising one or more bendable regions  456  on the distal end of outer member  454 . Mechanical dilator further comprises an inner pullable member  458  comprising an enlarged region  460  on the distal end of inner pullable member  458 . In  FIG. 4O , inner pullable member  458  is pulled in the proximal direction. This exerts an outward force on bendable regions  456  causing bendable regions  456  to bend in a radial direction exerting an outward force. This force can be used to dilate or displace portions of the anatomy. Outer member  454  can be substantially straight or may comprise one or more bent or angled regions. Inner pullable member  458  may comprise one or more lumens. 
       FIGS. 4P and 4Q  illustrate sectional views of a design of a mechanical dilator comprising a hinged member.  FIG. 4P  shows the mechanical dilator comprising an outer member  462  comprising one or more bendable regions  464  located on the distal end of outer member  462 . The mechanical dilator also comprises an inner member  466  located within outer member  462 . In one embodiment, inner member  466  is tubular. The distal end of inner member  466  comprises one or more first hinges  468 . First hinges  468  are hinged to the proximal ends of one or more moving elements  470 . Distal ends of moving elements  470  are hinged to one or more second hinges  472  located on the inner surface of outer member  462 . In  FIG. 4Q , inner member  466  is pushed in the distal direction. This causes moving elements  470  to exert an outward radial force on bendable regions  464  causing bendable regions  464  to bend in an outward radial direction with an outward force. This outward force can be used to dilate or displace portions of the anatomy. Outer member  462  can be substantially straight or may comprise one or more bent or angled regions. Inner member  466  may comprise one or more lumens. 
       FIGS. 4R through 4W  illustrate examples of configurations of mechanical dilators in  FIGS. 4H through 4Q .  FIG. 4R  shows a sectional view of a mechanical dilator comprising an inner member  474 , an outer stationary member  476  and an outer bendable member  478 . In  FIG. 4S , movement of inner member  474  displaces outer bendable member  478  in the radial direction with a force. This force can be used to dilate or displace portions of the anatomy. This configuration is useful to exert force in a particular radial direction.  FIG. 4S ′ shows a partial perspective view of the outer stationary member  476  of  FIG. 4R .  FIG. 4T  shows a sectional view of a mechanical dilator comprising an inner member  480 , a first outer hemi-tubular member  482  and a second outer hemi-tubular member  484 . In  FIG. 4U , movement of inner member  480  displaces first outer hemi-tubular member  482  and second outer hemi-tubular member  484  in the radial direction with a force. This force can be used to dilate or displace portions of the anatomy. This configuration is useful to exert force in two diametrically opposite regions.  FIG. 4U ′ shows a partial perspective view of the first outer hemi-tubular member  482  and the second outer hemi-tubular member  484  of  FIG. 4T .  FIG. 4V  shows a sectional view of a mechanical dilator comprising an inner member  486 , a first outer curved member  488  and a second outer curved member  490 . In  FIG. 4W , movement of inner member  486  displaces first outer curved member  488  and second outer curved member  490  in the radial direction with a force. This force can be used to dilate or displace portions of the anatomy. This configuration is useful to exert force over smaller areas in two diametrically opposite regions.  FIG. 4W ′ shows a partial perspective view of the first outer curved member  488  and the second outer curved member  490  of  FIG. 4V . Similar designs for mechanical dilators in  FIGS. 4H through 4Q  are possible using three or more displaceable members. The inner member in the mechanical dilators disclosed herein may be replaced by a balloon for displacing the outer members to exert an outward radial force. 
     Several other designs of the working device may also be used including but not limited to cutters, chompers, rotating drills, rotating blades, tapered dilators, punches, dissectors, burs, non-inflating mechanically expandable members, high frequency mechanical vibrators, radiofrequency ablation devices, microwave ablation devices, laser devices (e.g. CO2, Argon, potassium titanyl phosphate, Holmium:YAG and Nd:YAG laser devices), snares, biopsy tools, scopes and devices that introduce diagnostic or therapeutic agents. 
       FIG. 5A  shows a perspective view of an embodiment of a balloon comprising a conical proximal portion, a conical distal portion and a cylindrical portion between the conical proximal portion and the conical distal portion.  FIGS. 5B to 5N  show perspective views of several alternate embodiments of the balloon.  FIG. 5B  shows a conical balloon,  FIG. 5C  shows a spherical balloon,  FIG. 5D  shows a conical/square long balloon,  FIG. 5E  shows a long spherical balloon,  FIG. 5F  shows a dog bone balloon,  FIG. 5G  shows a offset balloon,  FIG. 5H  shows a square balloon,  FIG. 5I  shows a conical/square balloon,  FIG. 5J  shows a conical/spherical long balloon,  FIG. 5K  shows a tapered balloon,  FIG. 5L  shows a stepped balloon,  FIG. 5M  shows a conical/offset balloon and  FIG. 5N  shows a curved balloon. 
     The balloons disclosed herein can be fabricated from biocompatible materials including but not limited to polyethylene terephthalate, Nylon, polyurethane, polyvinyl chloride, crosslinked polyethylene, polyolefins, HPTFE, HPE, HDPE, LDPE, EPTFE, block copolymers, latex and silicone. The balloons disclosed herein can be fabricated by a variety of fabrication methods including but not limited to molding, blow molding, dipping, extruding etc. 
     The balloons disclosed herein can be inflated with a variety of inflation media including but not limited to saline, water, air, radiographic contrast materials, diagnostic or therapeutic substances, ultrasound echogenic materials and fluids that conduct heat, cold or electricity. 
     The balloons in this invention can also be modified to deliver diagnostic or therapeutic substances to the target anatomy. For example,  FIG. 5O  shows a partial perspective view of an embodiment of a balloon catheter device  500  comprising a balloon for delivering diagnostic or therapeutic substances. Balloon catheter device  500  comprises a flexible catheter  502  having a balloon  504  thereon. The catheter device  500  is advanced, with balloon  504  deflated, into a passageway such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. and positioned with the deflated balloon  504  situated within an ostium, passageway or adjacent to tissue or matter that is to be dilated, expanded or compressed (e.g., to apply pressure for hemostasis, etc.). Thereafter, the balloon  504  may be inflated to dilate, expand or compress the ostium, passageway, tissue or matter. Thereafter the balloon  504  may be deflated and the device  500  may be removed. This balloon  504  may also be coated, impregnated or otherwise provided with a medicament or substance that will elute from the balloon into the adjacent tissue (e.g., bathing the adjacent tissue with drug or radiating the tissue with thermal or other energy to shrink the tissues in contact with the balloon  504 ). Alternatively, in some embodiments, the balloon may have a plurality of apertures or openings through which a substance may be delivered, sometimes under pressure, to cause the substance to bathe or diffuse into the tissues adjacent to the balloon. Alternatively, in some embodiments, radioactive seeds, threads, ribbons, gas or liquid, etc. may be advanced into the catheter shaft  502  or balloon  504  or a completely separate catheter body for some period of time to expose the adjacent tissue and to achieve a desired diagnostic or therapeutic effect (e.g. tissue shrinkage, etc.). 
     The balloons in this invention can have a variety of surface features to enhance the diagnostic or therapeutic effects of a procedure. For example,  FIG. 5P  shows a partial perspective view of an embodiment of a balloon/cutter catheter device  506  comprising a flexible catheter  508  having a balloon  510  with one or more cutter blades  512  formed thereon. The device  506  is advanced, with balloon  510  deflated, into a passageway such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. and positioned with the deflated balloon  510  situated within an ostium, passageway or adjacent to tissue or matter that is to be dilated, expanded or compressed and in which it is desired to make one or more cuts or scores (e.g. to control the fracturing of tissue during expansion and minimize tissue trauma etc. Thereafter, the balloon  510  is inflated to dilate, expand or compress the ostium, passageway, tissue or matter and causing the cutter blade(s)  512  to make cut(s) in the adjacent tissue or matter. Thereafter the balloon  510  is deflated and the device  506  is removed. The blade may be energized with mono or bi-polar RF energy or otherwise heated such that it will cut the tissues while also causing hemostasis and/or to cause thermal contraction of collagen fibers or other connective tissue proteins, remodeling or softening of cartilage, etc. 
     The balloons in this invention can have a variety of reinforcing means to enhance the balloon properties. For example,  FIGS. 5Q and 6F  show perspective views of an embodiment of a balloon catheter device  514  comprising a flexible catheter  516  having a balloon  518  with one or more reinforcing means  520  thereon. In this example, reinforcing means  520  is a braid attached on the external surface of balloon  518 . The reinforcing braid can be constructed from suitable materials like polymer filaments (e.g. PET or Kevlar filaments), metallic filaments (e.g. SS316 or Nitinol filaments) and metallic or non-metallic meshes or sheets. A variety of other reinforcing means can be used including but not limited to reinforcing coatings, external or internal reinforcing coils, reinforcing fabric, reinforcing meshes and reinforcing wires, reinforcing rings, filaments embedded in balloon materials etc.  FIG. 6F ′ shows a perspective view of a reinforcing braid that can be used with the balloon catheter device in  FIGS. 5Q and 6F . 
     The balloons in this invention can have a variety of inflation means to enhance the balloon properties.  FIG. 5R  shows a partial sectional view of an embodiment of a balloon catheter  522  comprising a shaft  524  and a balloon  526 . Shaft  524  comprises a balloon inflation lumen. The distal portion of balloon inflation lumen terminates in inflation ports  528  located near the distal end of balloon  526 . Thus, when balloon catheter  522  is inserted in an orifice and balloon  526  is inflated, the distal portion of balloon  526  inflates earlier than the proximal portion of balloon  526 . This prevents balloon  526  from slipping back out of the orifice. 
       FIGS. 5S through 5T  illustrate designs of balloon catheters comprising multiple balloons.  FIG. 5S  shows a partial sectional view of an embodiment of a balloon catheter  530  comprising a shaft  532  with a lumen  533 . Lumen  533  opens into three orifices located on shaft  532  namely a first orifice  534 , a second orifice  536  and a third orifice  538 . The three orifices are used to inflate three balloons. First orifice  534  inflates a first balloon  540 , second orifice  536  inflates a second balloon  542  and third orifice  538  inflates third balloon  544 . In one embodiment, first balloon  540  and third balloon  544  are inflated with a single lumen and second balloon  542  is inflated with a different lumen. In another embodiment, first balloon  540 , second balloon  542  and third balloon  544  interconnected and are inflated with a single lumen. A valve mechanism allows first balloon and second balloon to inflate before allowing second balloon to inflate. 
     Alternatively, the balloons can be inflated by separate lumens.  FIG. 5T  shows a partial sectional view of an embodiment of a balloon catheter  546  comprising a shaft  548  comprising a first inflation lumen  550 , a second inflation lumen  552  and a third inflation lumen  554 . The three inflation lumens are used to inflate three non-connected balloons. First inflation lumen  550  inflates a first balloon  556 , second inflation lumen  552  inflates a second balloon  558  and third inflation lumen  554  inflates a third balloon  560 . 
     The devices disclosed herein may comprise one or more navigation or visualization modalities.  FIGS. 5U through 5AB  illustrate perspective and sectional views of various embodiments of a balloon catheter comprising sensors.  FIG. 5U  shows a partial perspective view of a balloon catheter comprising an outer member  562 , an inner member  564  and a balloon  566  attached to distal region of outer member  562  and distal region of inner member  564 . The balloon catheter further comprises a first sensor  568  located on the distal region of outer member  562  and a second sensor  570  located on the distal region of inner member  564 .  FIG. 5V  shows a crossection through plane  5 V-  5 V in  FIG. 5U . Outer member  562  comprises a first sensor lumen  572  to receive the lead from first sensor  568 . Inner member  564  comprises a second sensor lumen  574  to receive the lead from second sensor  570 . Inner member  564  further comprises a circular lumen  576 . Outer member  562  and inner member  564  enclose an annular lumen  578 . In one embodiment, annular lumen  578  is a balloon inflation lumen. 
       FIG. 5W  shows a partial perspective view of a balloon catheter comprising an outer member  580 , an inner member  582  and a balloon  584  attached to distal region of outer member  580  and distal region of inner member  582 . The balloon catheter further comprises a first sensor  586  located on the distal region of inner member  582  and a second sensor  588  located on the distal region of inner member  582  distal to first sensor  586 .  FIG. 5X  shows a cross section through plane  5 X- 5 X in  FIG. 5W . Inner member  582  comprises a first sensor lumen  590  to receive the lead from first sensor  586  and a second sensor lumen  592  to receive the lead from second sensor  588 . Inner member  582  further comprises a circular lumen  594 . Outer member  580  and inner member  582  enclose an annular lumen  596 . In one embodiment, annular lumen  596  is a balloon inflation lumen. 
       FIG. 5Y  shows a partial perspective view of a balloon catheter comprising an outer member  598 , an inner member  600  and a balloon  602  attached to distal region of outer member  598  and distal region of inner member  600 . The balloon catheter further comprises a first sensor  604  located on the distal region of outer member  598  and a second sensor  606  located on the distal region of outer member  598  distal to first sensor  604 .  FIG. 5Z  shows a cross section through plane  5 Z- 5 Z in  FIG. 5Y . Outer member  598  comprises a first sensor lumen  608  to receive the lead from first sensor  604  and a second sensor lumen  610  to receive the lead from second sensor  606 . Inner member  600  comprises a circular lumen  612 . Outer member  598  and inner member  600  enclose an annular lumen  614 . In one embodiment, annular lumen  614  is a balloon inflation lumen. 
     The leads from the sensors may be attached on the surface of an element of the balloon catheter without being enclosed in a lumen.  FIG. 5AA  shows a partial perspective view of a balloon catheter comprising an outer member  616 , an inner member  618  and a balloon  620  attached to distal region of outer member  616  and distal region of inner member  618 . The balloon catheter further comprises a first sensor  624  located on the distal region of outer member  616  and a second sensor  626  located on the distal region of inner member  618 . Second sensor  626  comprises a lead  628 .  FIG. 5AB  shows a cross section through plane  5 AB- 5 AB in  FIG. 5AA . Outer member  616  comprises a first sensor lumen  630  to receive the lead from first sensor  624 . Inner member  618  comprises a circular lumen  632 . Lead  628  from second sensor  626  is attached on the outer surface of inner member  618  and is oriented parallel to inner member  618 . Outer member  616  and inner member  618  enclose an annular lumen  634 . In one embodiment, annular lumen  634  is a balloon inflation lumen. The sensors mentioned in  FIGS. 5U through 5AB  can be electromagnetic sensors or sensors including but not limited to location sensors, magnetic sensors, electromagnetic coils, RF transmitters, mini-transponders, ultrasound sensitive or emitting crystals, wire-matrices, micro-silicon chips, fiber-optic sensors, etc. 
       FIGS. 6A through 6G  illustrate partial perspective views of several embodiments of shaft designs for the various devices disclosed herein. These shaft designs are especially useful for devices that encounter high torque or high burst pressures or require enhanced pushability, steerability and kink resistance.  FIG. 6A  shows a partial perspective view of an embodiment of a shaft  602  comprising a spiral element  604  wound around the shaft. Spiral element  604  can be made of suitable materials like metals (e.g. SS316L, SS304) and polymers. In one embodiment, spiral element  604  is in the form of round wire of diameter between 0.04 mm to 0.25 mm. In another embodiment, spiral element is in the form of flat wire of cross section dimensions ranging from 0.03 mm×0.08 mm to 0.08 mm×0.25 mm.  FIG. 6B  shows a partial perspective view of an embodiment of a shaft  606  comprising a reinforcing filament  608 . Reinforcing filament  608  is substantially parallel to the axis of shaft  606 . Shaft  606  with reinforcing filament  608  can be covered with a jacketing layer. Reinforcing filament  608  can be made of suitable materials like metals, polymers, glass fiber etc. Reinforcing filament  608  can also have shape memory characteristics. In one embodiment, reinforcing filament  608  is embedded in shaft  606 . In another embodiment, reinforcing filament is introduced through a lumen in shaft  606 . Shaft  606  may comprise more than one reinforcing filament  608 .  FIG. 6C  shows a partial perspective view of an embodiment of a shaft  610  comprising one of more stiffening rings  612  along the length of shaft  610 .  FIG. 6D  shows a partial perspective view of an embodiment of a shaft  614  comprising a series of controllably stiffening elements  616  along the length of the shaft. Shaft  614  further comprises a tension wire  618  that runs through controllably stiffening elements  616  and is attached to the most distal stiffening element. The tension in tension wire  618  causes controllably stiffening elements  616  to come into contact with each other with a force. Friction between controllably stiffening elements  616  causes shaft  614  to have a certain stiffness. Increasing the tension in tension wire  618  increases the force with which controllably stiffening elements  616  come into contact with each other. This increases the friction between controllably stiffening elements  616  which in turn increases the stiffness of shaft  614 . Similarly, reducing the tension in tension wire  618  reduces the stiffness of shaft  614 . Controllably stiffening elements  616  can be made from suitable materials like metal, polymers and composites. In one embodiment, controllably stiffening elements  616  are separated from each other by one or more springs. Tension wire  618  can be made from metals like SS316. Tension wire  618  may also be used to cause the device to actively bend or shorten in response to tension.  FIG. 6E  shows a partial perspective view of an embodiment of a shaft  620  comprising a hypotube  622 . In one embodiment, hypotube  622  is located on the exterior surface of shaft  620 . In another embodiment, hypotube  622  is embedded in shaft  620 . Hypotube  620  can be made of metals like stainless steel 316 or suitable polymers.  FIGS. 6F and 6F ′ show a partial perspective view of an embodiment of a shaft  624  comprising a reinforcing element  626  in the form of a reinforcing braid or mesh located on the outer surface of shaft  624 . Reinforcing element  626  can be made of suitable materials like polymer filaments (e.g. PET or Kevlar filaments), metallic wires e.g. SS316 wires etc. The braid pattern can be regular braid pattern, diamond braid pattern, diamond braid pattern with a half load etc. In one embodiment, the outer surface of reinforcing element  626  is covered with a jacketing layer. 
     The shafts of various devices disclosed herein may be non homogenous along their length. Examples of such shafts are illustrated in  FIGS. 6G through 6H .  FIG. 6G  shows a partial perspective view of an embodiment of a device comprising a shaft  628  comprising a proximal portion  630 , a distal portion  632 , a working element  634  and a plastically deformable region  636  located between the proximal portion  630  and distal portion  632 . Plastically deformable region  636  can be deformed by a physician to adjust the angle between proximal portion  630  and distal portion  632 . This enables the devices to be used for several different anatomical regions of the same patient. Also, such devices can be adjusted for optimal navigation through a patient&#39;s anatomy. In one embodiment, shaft  628  comprises multiple plastically deformable regions. In another embodiment plastically deformable region  636  is located within working element  634 . Such a design comprising one or more plastically deformable regions can be used for any of the devices mentioned herein like catheters with working elements, guide catheters, guide catheters with a pre-set shape, steerable guide catheters, steerable catheters, guidewires, guidewires with a pre-set shape, steerable guidewires, ports, introducers, sheaths etc. 
       FIG. 6H  shows a partial perspective view of an embodiment of a device comprising a shaft with a flexible element. The design is illustrated as a shaft  638  comprising a proximal portion  640 , a distal portion  642  and a working element  644  (e.g. a balloon). Shaft  638  further comprises a flexible element  646  located between proximal portion  640  and distal portion  642 . This design enables proximal portion  640  to bend with respect to distal portion  642  making it easier to navigate through the complex anatomy and deliver working element  644  to the desired location. In one embodiment, shaft  638  comprises multiple flexible elements. In another embodiment, flexible element  646  is located within working element  644 . Such a design comprising one or more flexible elements can be used for any of the devices mentioned herein like catheters with working elements, guide catheters, guide catheters with a pre-set shape, steerable guide catheters, steerable catheters, guidewires, guidewires with a pre-set shape, steerable guidewires, ports, introducers, sheaths etc. 
       FIGS. 6I through 6K  illustrate an example of a shaft comprising a malleable element.  FIG. 6I  shows a partial perspective view of an embodiment of a shaft  648  comprising malleable element  650  and a lumen  652  wherein shaft  648  is in a substantially straight configuration. Malleable element  650  is embedded in shaft  648  such that the axis of malleable element  650  is substantially parallel to the axis of shaft  648 .  FIG. 6J  shows a partial perspective view of the embodiment of  FIG. 6I  in a bent configuration.  FIG. 6K  shows a cross sectional view through plane  6 K- 6 K of  FIG. 6I  showing shaft  648  comprising malleable element  650  and a lumen  652 . In one embodiment, shaft  648  comprises more than one malleable element. 
       FIGS. 6L through 6M  show an embodiment of a controllably deformable shaft.  FIG. 6L  shows a partial sectional view of an embodiment of a controllably deformable shaft  654  comprising a pull wire  656  attached to a pull wire terminator  658  located near the distal end of shaft  654 .  FIG. 6M  shows a partial sectional view of the controllably deformable shaft  654  of  FIG. 6L  in a bent orientation when pull wire  656  is pulled in the proximal direction. The deformation can be varied by varying the location of pull wire terminator  658  and the stiffness of various sections of shaft  658 . The stiffness of a section of shaft  658  can be varied by adding reinforcing coatings, external or internal reinforcing coils, reinforcing fabric, reinforcing meshes and reinforcing wires, hinged elements, embedded filaments, reinforcing rings etc. 
       FIG. 6N  shows a perspective view of a balloon catheter comprising a rigid or semirigid member. The balloon catheter comprises a rigid or semi-rigid member  660  and a balloon  662  located on the distal region of rigid or semi-rigid member  660 . Rigid or semi-rigid member  660  may comprise one or more lumens. Rigid or semi-rigid member  660  may comprise one or more bent, curved or angled regions. Balloon  662  is inflated by a balloon inflation tube  664  comprising a hub  666  at the proximal end of balloon inflation tube  664 . In one embodiment, balloon inflation tube  664  is fully attached along its length to rigid or semi-rigid member  660 . In another embodiment, balloon inflation tube  664  is partially attached along its length to rigid or semi-rigid member  660 . 
       FIGS. 6O through 6Q  illustrate sectional views of a balloon catheter comprising an insertable and removable element.  FIG. 6O  shows a balloon catheter  668  comprising a balloon  670 , a first lumen  672  and a balloon inflation lumen  674  opening into balloon  670  through an inflation port  676 .  FIG. 6P  shows an insertable element  678  having a proximal end  680  and a distal end  682 . In one embodiment, distal end  682  ends in a sharp tip for penetrating tissue. In one embodiment, insertable element  678  comprises one or more bent, angled or curved regions  684 . Insertable element  678  can be fabricated from a variety of materials to obtain properties including but not limited to rigidity, shape memory, elasticity, ability to be plastically deformed etc. In  FIG. 6Q , insertable element  678  is inserted into balloon catheter  668  through first lumen  672 . This combination can be used to perform a diagnostic or therapeutic procedure. Insertable element  678  may be removed during or after the procedure. 
       FIGS. 7A through 7K  show cross sectional views of several embodiments of lumen orientation in the devices disclosed herein.  FIG. 7A  shows a cross sectional view of an embodiment of a shaft  702  comprising a first lumen  704  and a second lumen  706 . In one embodiment, first lumen  704  is a guidewire lumen and second lumen  706  is an inflation lumen.  FIG. 7B  shows a cross sectional view of an embodiment of a shaft  708  comprising a first lumen  710  and a annular second lumen  712  such that second annular lumen  712  is substantially coaxial with first lumen  710 . In one embodiment, first lumen  710  is a guidewire lumen and annular second lumen  712  is an inflation lumen.  FIG. 7C  shows a cross sectional view of an embodiment of a shaft  714  comprising a first tubular element  716  comprising a first lumen  718 , a second tubular element  720  comprising a second lumen  722  and a jacket  724  surrounding first tubular element  716  and second tubular element  720 . in one embodiment, first lumen  718  is a guidewire lumen and second lumen  722  is an inflation lumen.  FIG. 7D  shows a cross sectional view of an embodiment of a shaft  726  comprising a first lumen  728 , a second lumen  730  and a third lumen  732 . In one embodiment, first lumen  728  is a guidewire lumen, second lumen  730  is an irrigation/aspiration lumen and third lumen  732  is an inflation lumen.  FIG. 7E  shows a cross sectional view of an embodiment of a shaft  734  comprising a cylindrical element  736 , a tubular element  738  comprising a lumen  740  and a jacket  742  surrounding cylindrical element  736  and tubular element  738 .  FIG. 7F  shows a cross sectional view of an embodiment of a shaft  744  comprising a tubular member  746  comprising a first lumen  748  and a second lumen  750 ; a first coating  752  located on the outer surface of tubular member  746 ; a braid  754  located on the outer surface of first coating  752  and a second coating  756  surrounding braid  754 . First lumen  748  is lined with a suitable coating  758  like hydrophilic lubricious coating, hydrophobic lubricious coating, abrasion resisting coating etc. In one embodiment, first lumen  748  is a guidewire lumen and second lumen  750  is an inflation lumen. The lumens disclosed herein can be lined with suitable coatings like hydrophilic lubricious coatings, hydrophobic lubricious coatings, abrasion resisting coatings, radiopaque coatings, echogenic coatings etc. 
       FIG. 7G  shows a partial perspective view of an embodiment of a shaft  754 * comprising a first lumen  756 * and a zipper lumen  758 *. Zipper lumen  758 * allows a device like a guidewire  760 * to be easily introduced into or removed from shaft  754 *.  FIG. 7H  shows a cross sectional view through plane  7 H- 7 H in  FIG. 7G  showing the orientations of first lumen  756 * and zipper lumen  758 *. 
       FIG. 7I  shows a cross sectional view of an embodiment of a shaft  762  comprising a first lumen  764  and a rapid exchange lumen  766 . Rapid exchange lumen  766  extends from the distal end of shaft  762  to a proximal region. Rapid exchange lumen  766  enables shaft  762  to be easily and quickly introduced or removed over an exchange device like a guidewire  768 .  FIG. 7J  shows a cross sectional view through plane  7 J- 7 J in  FIG. 7I  showing first lumen  764  and rapid exchange lumen  766 .  FIG. 7K  shows a cross sectional view through plane  7 K- 7 K in  FIG. 7I  showing first lumen  764 . 
       FIGS. 7L through 7Q  shows perspective and sectional views of lumens for the devices disclosed herein that are not present throughout the length of the devices.  FIG. 7L  shows a perspective view of a balloon catheter comprising a shaft  770 , a balloon  772  and a lumen  774  that is present throughout shaft  770 . The balloon catheter further comprises a balloon inflation lumen  776  that opens into balloon  772 . The distal end of balloon inflation lumen  776  is plugged with a plug  778 .  FIG. 7M  shows a crossection through plane  7 M- 7 M in  FIG. 7L  showing shaft  770  comprising lumen  774  and balloon inflation lumen  776 .  FIG. 7N  shows a crossection through plane  7 N- 7 N in  FIG. 7L  showing shaft  770  comprising lumen  774  and plug  778 .  FIG. 7O  shows a perspective view of a balloon catheter comprising a shaft  780 , a balloon  782  and a lumen  786  that is present throughout shaft  780 . The balloon catheter further comprises a balloon inflation lumen  784 . The distal end of balloon inflation lumen  784  opens into balloon  782 .  FIG. 7P  shows a crossection through plane  7 P- 7 P in  FIG. 7O  showing shaft  780  comprising lumen  786  and balloon inflation lumen  784 .  FIG. 7Q  shows a crossection through plane  7 Q- 7 Q in  FIG. 7O  showing shaft  780  comprising lumen  786 . 
       FIGS. 8A through 8E  show partial perspective views of several embodiments of markers that may be present on the elements of the devices mentioned herein.  FIG. 8A  shows a partial perspective view of an embodiment of a shaft  800  comprising a plurality of distance markers  802  located along the length of shaft  800 .  FIG. 8B  shows a partial perspective view of an embodiment of a shaft  804  comprising a plurality of radiographic markers  806  located along the length of shaft  804 .  FIG. 8C  shows a partial perspective view of an embodiment of a shaft  808  comprising a plurality of ring shaped radiographic markers  810  located along the length of shaft  808 .  FIG. 8D  shows a partial perspective view of an embodiment of a balloon catheter  812  comprising a shaft  814  and a balloon  816 . Balloon  816  comprises a plurality of radiographic markers  818  located on the outer surface of the balloon  816 . Such markers  818  may be in a linear arrangement, non-linear arrangement or any other configuration that performs the desired marking function (e.g., delineating the length and/or diameter of the balloon, marking the proximal and/or distal ends of the balloon, etc.).  FIGS. 8E and 8E ′ show partial perspective and longitudinal sectional views of an embodiment of a balloon catheter  820  comprising a shaft  822  and a balloon  824 . Balloon  824  comprises a plurality of radiographic markers  826  located on the inner surface of the balloon  824 . Such markers  826  may be in a linear arrangement, non-linear arrangement or any other configuration that performs the desired marking function (e.g., delineating the length and/or diameter of the balloon, marking the proximal and/or distal ends of the balloon, etc.). The devices disclosed herein may also comprise several other types of markers like ultrasound markers, radiofrequency markers and magnetic markers. Similarly, the devices disclosed herein may also comprise one or more sensors like electromagnetic sensors, electrical sensors, magnetic sensors, light sensors and ultrasound sensors. 
     The term “diagnostic or therapeutic substance” as used herein is to be broadly construed to include any feasible drugs, prodrugs, proteins, gene therapy preparations, cells, diagnostic agents, contrast or imaging agents, biologicals, etc. Such substances may be in bound or free form, liquid or solid, colloid or other suspension, solution or may be in the form of a gas or other fluid or nan-fluid. For example, in some applications where it is desired to treat or prevent a microbial infection, the substance delivered may comprise pharmaceutically acceptable salt or dosage form of an antimicrobial agent (e.g., antibiotic, antiviral, antiparasitic, antifungal, etc.), a corticosteroid or other anti-inflammatory (e.g., an NSAID), a decongestant (e.g., vasoconstrictor), a mucous thinning agent (e.g., an expectorant or mucolytic), an agent that prevents of modifies an allergic response (e.g., an antihistamine, cytokine inhibitor, leucotriene inhibitor, IgE inhibitor, immunomodulator), etc. Other non-limiting examples of diagnostic or therapeutic substances that may be useable in this invention are described in copending U.S. patent application Ser. No. 10/912,578 entitled Implantable Devices and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders filed on Aug. 4, 2004, issued as U.S. Pat. No. 7,361,168 on Apr. 22, 2008, the entire disclosure of which is expressly incorporated herein by reference. 
     The term “nasal cavity” used herein to be broadly construed to include any cavity that is present in the anatomical structures of the nasal region including the nostrils and paranasal sinuses. 
     The term “trans-nasal” means through a nostril. 
     Although the methods and devices disclosed herein are illustrated in conjunction with particular paranasal sinuses, it is understood that these methods and devices can be used in other paranasal sinuses as well as other anatomical passageways of the ear, nose or throat. 
     Optionally, any of the working devices and guide catheters described herein may be configured or equipped to receive or be advanced over a guidewire or other guide member (e.g., an elongate probe, strand of suure material, other elongate member) unless to do so would render the device inoperable for its intended purpose. Some of the specific examples described herein include guidewires, but it is to be appreciated that the use of guidewires and the incorporation of guidewire lumens is not limited to only the specific examples in which guidewires or guidewire lumens are shown. The guidewires used in this invention may be constructed and coated as is common in the art of cardiology. This may include the use of coils, tapered or non-tapered core wires, radioopaque tips and/or entire lengths, shaping ribbons, variations of stiffness, PTFE, silicone, hydrophilic coatings, polymer coatings, etc. For the scope of this invention, these wires may possess dimensions of length between 5 and 75 cm and outer diameter between 0.005″ and 0.050″. 
     Several modalities can be used with the devices and methods disclosed herein for navigation and imaging of the devices within the anatomy. For example, the devices disclosed herein may comprise an endoscope for visualization of the target anatomy. The devices may also comprise ultrasound imaging modalities to image the anatomical passageways and other anatomical structures. The devices disclosed herein may comprise one or more magnetic elements especially on the distal end of the devices. Such magnetic elements may be used to navigate through the anatomy by using external magnetic fields. Such navigation may be controlled digitally using a computer interface. The devices disclosed herein may also comprise one or more markers (e.g. infra-red markers). The markers can be used to track the precise position and orientation of the devices using image guidance techniques. Several other imaging or navigating modalities including but not limited to fluoroscopic, radiofrequency localization, electromagnetic, magnetic and other radiative energy based modalities may also be used with the methods and devices disclosed herein. These imaging and navigation technologies may also be referenced by computer directly or indirectly to pre-existing or simultaneously created 3-D or 2D data sets which help the doctor place the devices within the appropriate region of the anatomy. 
     The distal tip of devices mentioned herein may comprise a flexible tip or a soft, atraumatic tip. Also, the shaft of such devices may be designed for enhanced torquability. 
     The embodiments herein have been described primarily in conjunction with minimally invasive procedures, but they can also be used advantageously with existing open surgery or laparoscopic surgery techniques. 
     It is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless to do so would render the embodiment or example unsuitable for its intended use. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.