Abstract:
Sinusitis, tumors, infections, fractures and other disorders of the paranasal sinuses, are diagnosed and/or treated using minimally invasive approaches. Access devices may be used to facilitate insertion of working devices such catheters, balloon catheters, dilation catheters, tissue cutting or remodeling devices, suction or irrigation devices and biopsy devices.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of Provisional Application Ser. No. 61/290,341, filed Dec. 28, 2009 and Provisional Application Ser. No. 61/298,800, filed Jan. 27, 2010, the contents of which are incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to medical devices, systems and methods and more particularly to minimally invasive devices, systems and methods for performing therapies within the paranasal sinuses. 
       BACKGROUND 
       [0003]    Chronic sinusitis is a widespread and debilitating medical condition that effects over thirty million people annually in the U.S. Ear, nose and throat (ENT) doctors typically treat sinusitis with nasal steroids and/or antibiotics, but oftentimes these medications to not work and patients must then decide to simply endure their symptoms or undergo painful surgery. The symptoms of chronic sinusitis, include headaches, difficulty breathing, feelings of intense pressure in the head and face, toothache, congestion, and runny nose and often significantly reduce a sufferer&#39;s quality of life. 
         [0004]    Functional endoscopic sinus surgery (FESS) is currently the most common type of surgery used to treat chronic sinusitis. In a typical FESS procedure, a rigid endoscope is inserted into the nostril along with one or more rigid surgical instruments, and the instruments are used to remove bone and mucosal tissue in the nasal cavity and the openings into the paranasal sinuses, to enlarge such openings and thus hopefully improving sinus drainage and mitigating sinusitis symptoms. In most FESS procedures, the natural ostium (e.g., opening) of at least one paranasal sinus is surgically enlarged to improve drainage from the sinus cavity. FESS procedures can be effective in the treatment of sinusitis and for the removal of tumors, polyps and other aberrant growths from the nose, however, removing significant amounts of tissue from the nasal cavities causes bleeding and post-operative pain and scarring and typically necessitates nasal packing and painful debridement (scar removal), all of which is difficult for the patient and requires additional physician visits. 
         [0005]    FESS procedures usually include the surgical removal or modification of normal anatomical structures, in order to access the openings into one or more paranasal sinus. For example, in many FESS procedures, a total uncinectomy (e.g., removal of the uncinate process in the nasal canal) is performed at the beginning of the procedure to allow visualization and access of the maxillary sinus ostium and/or ethmoid bulla. In general, as more tissue is removed, post-operative recovery for the patient becomes more longer and more painful. At the same time, it may sometimes be advantageous to remove some tissue, such as polyps or bony growths, when performing a sinus surgery. 
         [0006]    More recently, new devices, systems and methods have been devised to enable a less invasive procedure for dilating openings into paranasal sinuses to mitigate or alleviate chronic sinusitis. In one example, a balloon dilation catheter is advanced into and expanded within a natural paranasal sinus ostium to dilate the ostium. A system for performing such a Balloon Sinuplasty™ procedure is provided by Acclarent, Inc., of Menlo, Calif. (www.acclarent.com). Examples of this and other methods, devices and systems are described, for example, in U.S. patent application Ser. Nos. 10/829,917, entitled Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat; 10/944,270, entitled Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures; 11/116,118, entitled Methods and Devices for Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses; and 11/150,847, entitled Devices, Systems And Methods Useable For Treating Sinusitus, all of which are hereby incorporated fully by reference. 
         [0007]    In some cases, ENT physicians both remove tissue as in a traditional FESS procedure and also perform one or more balloon dilations in the same patient. Ideally, such a combined tissue-removal/balloon-dilation procedure would remove a minimal amount of tissue while still providing a desired outcome for the patient. Also ideally, such a procedure would be relatively straightforward for the physician. At least some of these objectives will be met by the present invention. 
       SUMMARY 
       [0008]    The present disclosure describes methods, devices and systems for treating the paranasal sinuses. In various embodiments, the paranasal sinus (or sinuses) treated may include one or more of the maxillary, frontal, ethmoid and/or sphenoid sinuses. Also in various embodiments, methods, devices and systems of the present disclosure may involve removal of tissue and/or substances from one or more sinuses and/or the nasal cavity, dilation of one or more openings into one or more paranasal sinuses, dilation of other areas/structures within the nasal cavity, or any suitable combination of these procedures. In embodiments where an opening to a paranasal sinus is dilated, this opening may be either a natural paranasal sinus ostium or a manmade opening. In some embodiments, a natural paranasal sinus ostium of one sinus and a manmade opening of another sinus may be dilated using the same system. In some embodiments, an area such as but not limited to the frontal sinus outflow tract, the osteomeatal complex or the like may be dilated. Any suitable combination of these or other procedural steps described herein is contemplated. 
         [0009]    In one aspect of the present invention, a method for treating a paranasal sinus in a patient may involve: advancing a dilating device along a guide device into the patient&#39;s head; dilating an opening into the paranasal sinus, using the dilating device; removing the dilating device from the head while leaving the guide in the patient&#39;s head; advancing a tissue removal device along the guide into the paranasal sinus; and removing tissue from at least one of the paranasal sinus, a different paranasal sinus, or a nasal cavity of the patient using the tissue removal device. In various embodiments, the guide device may be a guide catheter with a lumen, a guidewire, or a combination of a guide catheter and a guidewire. In one embodiment, the dilating device is a balloon catheter. 
         [0010]    In one embodiment of the method, removing the tissue involves suctioning the tissue into the tissue removal device and cutting off the suctioned tissue using a cutter of the tissue removal device. In various embodiments, removing the tissue may involve removing tissue from the opening into the paranasal sinus, removing tissue from within the paranasal sinus, or a combination of both. 
         [0011]    In one embodiment, dilating the opening involves dilating at least one of a frontal sinus ostium and a frontal sinus outflow tract, and removing the tissue involves removing tissue from the frontal sinus outflow tract. In one embodiment, dilating the opening involves dilating a natural paranasal sinus ostium of the paranasal sinus, and removing the tissue involves removing bone fragments. In another embodiment, dilating the opening involves dilating a natural paranasal sinus ostium of the paranasal sinus, and removing the tissue involves removing at least part of an ethmoid sinus. Any suitable type of tissue may be removed using this method, including but not limited to polyps, mucosal tissue, cysts, bone fragments, bone and/or mucocysts. Similarly, in removing the tissue any suitable apparatus may be employed, including but not limited to a morcellator, a snare, a combined snare/cutter, a filter, a radiofrequency cutting and/or coagulating device, a contractable mesh device, a balloon configured with blades, a bone cutter assembly, a tube with openings in combination with a cutter, a high pressure spray device, and/or a forceps-grasper assembly. 
         [0012]    In another aspect of the present invention, a method for treating a paranasal sinus in a patient may include: advancing a guide catheter into the patient&#39;s head; advancing a guidewire through the guide catheter and through an opening into the paranasal sinus; advancing a balloon dilation catheter over the guidewire through the guide to position a balloon of the catheter in the opening; dilating the opening by expanding the balloon; removing the balloon, leaving at least the guidewire in place; advancing a tissue removal device over the guidewire into the patient&#39;s head; removing tissue from at least one of the paranasal sinus, a different paranasal sinus and a nasal cavity of the patient with a tissue removal device; and removing the tissue removal device and the guidewire from the patient&#39;s head. 
         [0013]    In another aspect, a method for treating a paranasal sinus in a patient may include: advancing a guide device into the patient&#39;s head; advancing a tissue dilation and removal device along the guide device to position a dilator of the device in an opening into the paranasal sinus; dilating the opening by expanding the dilator; removing tissue from the paranasal sinus using the tissue dilation and removal device; and removing the tissue dilation and removal device and the guide device from the patient&#39;s head. 
         [0014]    In yet another aspect, a system for treating a paranasal sinus in a patient may include: a guide device for guiding one or more devices into the patient&#39;s head to treat the paranasal sinus; a dilation device for dilating an opening into the paranasal sinus and configured for passage along the guide device; and a tissue removal device for removing tissue from inside the paranasal sinus and configured for passage along the guide device. 
         [0015]    As mentioned above, in various embodiments, the guide device may include a guide catheter with a lumen, a guidewire, or both. In one embodiment, the dilating device may be a balloon catheter. In various embodiments, the tissue removal device may include one or more of the following: suction substructure, a cutter, a snare, and/or a radiofrequency energy delivery member. Also in various embodiment, the tissue removal device may be configured to remove tissue such as but not limited to polyps, mucosal tissue, cysts, bone fragments, bone and/or mucocysts. 
         [0016]    In another aspect, a system for treating a paranasal sinus in a patient may include: a guide device for guiding one or more devices into the patient&#39;s head to treat the paranasal sinus; and a combined tissue dilation and removal device for dilating an opening into the paranasal sinus and removing tissue from the paranasal sinus, wherein the tissue dilation and removal device is configured for passage along the guide device. 
         [0017]    Further aspects, details and embodiments are described below and in the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1  shows a schematic diagram of the general working environment of an example of a system for catheter-based minimally invasive sinus surgery being used to perform a sinus surgery on a human patient. 
           [0019]      FIG. 1A  shows a magnified view of region  1 A of  FIG. 1  showing a system for catheter-based minimally invasive sinus surgery of a human patient. 
           [0020]      FIG. 1B  shows a perspective view of a treatment tray for catheter-based minimally invasive sinus surgery of a human patient. 
           [0021]      FIG. 2  shows a perspective view of a guide catheter comprising a plastically deformable (malleable) region. 
           [0022]      FIG. 3  shows perspective view of an embodiment of a guide catheter comprising a straight hypotube. 
           [0023]      FIG. 3A  shows a crossection of the guide catheter of  FIG. 7  through plane  3 A- 3 A. 
           [0024]      FIG. 4A  shows a coronal section of the paranasal anatomy showing a method of accessing a maxillary sinus ostium using the guide catheter of  FIG. 2F . 
           [0025]      FIG. 4B  shows a sagittal section of the paranasal anatomy showing the method of  FIG. 8G  to access a maxillary sinus ostium using the guide catheter of  FIG. 8F . 
           [0026]      FIG. 5  shows a perspective view of a set of devices to dilate or modify ostia or other openings. 
           [0027]      FIG. 6  shows a perspective view of an embodiment of a balloon catheter comprising a sizing balloon and a dilating balloon. 
           [0028]      FIG. 6A  shows a crossectional view through the plane  6 A- 6 A of  FIG. 6 . 
           [0029]      FIGS. 6B-6D  show the various steps of dilating an anatomical opening using the balloon catheter in  FIG. 6 . 
           [0030]      FIG. 7  shows a perspective view of a cutting device comprising cutting jaws. 
           [0031]      FIG. 7A  shows a perspective view of the distal region of the cutting device of  FIG. 7  wherein the cutting jaws are closed as seen from the distal end of the cutting device. 
           [0032]      FIG. 7B  shows a perspective view of one embodiment of the cutting jaws of the cutting device of  FIG. 7 . 
           [0033]      FIG. 7C  shows a crossectional view of the cutting device in  FIG. 7  through cutting plane  7 C- 7 C. 
           [0034]      FIG. 8A  shows a perspective view of an alternate embodiment of a device comprising cutting or gripping jaws. 
           [0035]      FIG. 8B  shows a perspective view of the device of  FIG. 8A  wherein the cutting or gripping jaws of the cutting device are in a closed configuration. 
           [0036]      FIG. 9A  shows a perspective view of an embodiment of an ostium enlarger and/or microshaver. 
           [0037]      FIG. 9B  shows one embodiment of the device of  FIG. 9A  being used to remove tissue or matter. 
           [0038]      FIG. 9C  shown another embodiment of the device of  FIG. 9A  being used to shave tissue or matter. 
           [0039]      FIG. 9D  is an exploded view of the device of  FIG. 9C . 
           [0040]      FIG. 10A-10C  show a suction and snare device and various steps of employing the device to capture and remove biological substances. 
           [0041]      FIGS. 11A-11C  depict a suction and morcellator device and various steps of employing the device to capture and remove biological substances. 
           [0042]      FIGS. 12A-12C  depict a suction grasper device and various steps of employing the device to capture and remove biological substances. 
           [0043]      FIGS. 13A-13C  depict a tissue capture suction device and various steps of employing the device to capture and remove biological substances. 
           [0044]      FIGS. 14A-14C  depict a tissue capture device including a capture vial and various steps of employing the device to capture and remove biological substances. 
           [0045]      FIGS. 15A-15C  depict a capture screen device and various steps of employing the device to capture and remove biological substances. 
           [0046]      FIGS. 16A-16E  depict a capture and cutting balloon device and various steps of employing the device to capture and remove biological substances. 
           [0047]      FIGS. 17A-17D  show a spin cutter device and various steps of employing the device to capture and remove biological substances. 
           [0048]      FIGS. 18A-18C  show a back cutter device and various steps of employing the device to capture and remove biological substances. 
           [0049]      FIGS. 19A-19C  show a balloon and cutter device and various steps of employing the device to capture and remove biological substances. 
           [0050]      FIGS. 20A-20C  show a spinning shaped cutter device and various steps of employing the device to capture and remove biological substances. 
           [0051]      FIGS. 21A-21C  show a high pressure flushing device and various steps of employing the device to capture and remove biological substances. 
           [0052]      FIGS. 22A-22C  depict an ultrasonic agitation device and various steps of employing the device to capture and remove biological substances. 
           [0053]      FIGS. 23A-23D  depict a forceps grasper device and various steps of employing the device to capture and remove biological substances. 
           [0054]      FIGS. 24A-24E  show various devices for scrubbing and swabbing devices. 
           [0055]      FIGS. 25A-25E  depict an approach for treating a paranasal sinus. 
       
    
    
     DETAILED DESCRIPTION 
       [0056]    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, the accompanying drawings and the Brief Description of the Drawings do not limit the scope of the invention in any way. 
         [0057]    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   Frontal Sinus Ostium FSO   Ethmoid Sinus ES   Ethmoid Air Cells EAC   Sphenoid Sinus SS   Sphenoid Sinus Ostium SSO   Maxillary Sinus MS   Maxillary sinus ostium MSO   Mucocyst MC   Eustachian tube ET   Cochlea   Tympanic cavity TC   Middle turbinate MT   Inferior turbinate IT   Uncinate UN       
 
         [0075]      FIG. 1  shows a schematic diagram of the general working environment of an example of a system for catheter-based minimally invasive sinus surgery being used to perform a sinus surgery on a human patient. The human patient is treated by a working device  10 . Working device  10  may be connected to one or more auxiliary devices located on a treatment tray  12 . A C-arm fluoroscope  14  provides fluoroscopic visualization of anatomical regions during the procedure. An instrument console  16  comprising one or more functional modules  18  may also be present. Examples of functional modules that can be used with the invention are: 
         [0076]    1. Suction pump for delivering a controlled amount of negative pressure or vacuum to a suction device, 
         [0077]    2. Irrigation pump to deliver saline, antibiotic solution or other suitable irrigation medium, 
         [0078]    3. Power module to supply power to drills or other electrical devices, 
         [0079]    4. Storage modules for storing instruments, medications etc., 
         [0080]    5. Energy delivery module to provide radiofrequency, laser, ultrasound or other therapeutic energy to a surgical device, 
         [0081]    6. Fluoroscope, MRI, CT, Video, Endoscope or Camera or other imaging modules to connect or interact with devices used during various diagnostic or therapeutic procedures, 
         [0082]    7. Display module e.g. a LCD, CRT or Holographic screen to display data from various modules such as an endoscope, fluoroscope or other data or imaging module, 
         [0083]    8. Remote control module to enable an operator to control one or more parameters of one or more functional modules  18 , 
         [0084]    9. Programmable Microprocessor that can store one or more operation settings for one or more functional modules  18  etc., and 
         [0085]    10. Stabilization device for holding various apparatuses during the procedure which may include a stabilization arm, table, clip, intranasal or extranasal inflatable support or robotically controlled apparatus, 
         [0086]    11. Rotary drive module for rotating rotatable device such as a drill or auger (e.g., a motor having a rotation drive shaft or drive cable attached thereto. 
         [0087]    One or more functional modules  18  may be connected to the working device  10 . Instrument console module  16  can be controlled by console control means  20 , e.g. a foot pedal controller, a remote controller etc. Instrument console  16  may be fitted with wheels to enable an operator to change the position of the instrument console  16  in an operating area. In one embodiment, instrument console module  16  and C-arm fluoroscope  14  are integrated in a single unit. 
         [0088]      FIG. 1A  shows a magnified view of region  1 A of  FIG. 1  showing a system for catheter-based minimally invasive sinus surgery of a human patient. In  FIG. 1A , a balloon catheter is used as an example of working device  10 . Working device  10  has attachments for a variety of auxiliary devices such as a balloon inflation syringe  22 , a guidewire  24  and a suction or irrigation tube  26 . Working device  10  and the auxiliary devices may be detachably attached to treatment tray  12 . Treatment tray  12  may comprise one or more treatment tray controllers  28  to control one or more treatment parameters. Treatment tray  12  may comprise one or more storage modules to store devices used during a surgery e.g. irrigation bottles, swabs etc. 
         [0089]      FIG. 1B  shows a perspective view of a treatment tray for catheter-based minimally invasive sinus surgery of a human patient. Treatment tray  12  comprises one or more device holders  30  to detachably hold devices during the surgery. In one embodiment, device holders  30  are detachably attached to device holder slots  32  on treatment tray  12 . Thus the position of device holders  30  on treatment tray  12  can be changed by removing a device holder  30  from a device holder slot  32  and transferring to a new device holder slot  32 . 
         [0090]    Any diagnostic or therapeutic device disclosed herein may comprise one or more malleable regions. For example,  FIG. 2  shows a perspective view of a guide catheter comprising a plastically deformable (malleable) region. Such a guide catheter  100  can be employed to place a tissue or biological substance removal device at a target site in a paranasal sinus. Guide catheter  100  comprises a shaft  102  comprising a malleable region  104  located on distal region of shaft  102 . Shaft  102  may comprise stiffening elements e.g. a braid, hypotube etc. Malleable region  104  may comprise malleable metallic tubes, rods (e.g. rods embedded in shaft  102  etc.), wires etc. Examples of metals that can be used for constructing malleable region  104  are malleable stainless steel, fully annealed stainless steel, copper, aluminum etc. Guide catheter  100  further comprises a threaded luer  106  located on proximal end of shaft  102 . In this example, malleable region  104  is located on distal end of guide catheter  100 . Malleable region  104  can also be located on proximal region or any other intermediate region on shaft  102 . Shaft  102  may also comprise more than one malleable regions. Such a design comprising one or more malleable regions can be used for any of the devices mentioned herein such as 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 or other diagnostic or therapeutic devices. 
         [0091]      FIG. 3  shows perspective view of an embodiment of a guide catheter comprising a straight hypotube. This structure can also be used to place a tissue or substance removal device within a sinus cavity for accomplishing desired therapies. Guide catheter  110  comprises a tubular element  112  and a hypotube  114  attached to the external surface of tubular element  112 . Suitable materials for constructing hypotube  114  are Stainless Steel 304, Nitinol etc. In one embodiment, hypotube  114  is annealed to the external surface of tubular element  112 . Tubular element  112  can be made from a variety of materials including Pebax, HDPE etc. Tubular element  112  may comprise a braid or a jacket. In an embodiment, tubular element  112  comprises a lubricious coating  115  on its inner surface. The lubricious coating  115  can be made of suitable lubricious materials such as Teflon. In an embodiment, tubular element  112  comprises a bent or angled region near the distal end of tubular element  112 . The bent or angled region may enclose an angle from 0 degrees to 180 degrees. Further this bent or angled region may be further bent out of plane to present a compound three-dimension end shape. Hypotube  114  can be malleable or substantially stiff. A malleable hypotube can be used in situations where the guide catheter  110  has to be bent or distorted to optimize its shape to conform to a patient&#39;s anatomy. Examples of materials that can be used to make a malleable hypotube are malleable stainless steel, fully annealed stainless steel, copper, aluminum etc. A substantially stiff hypotube can be used in situations where extra support is needed for introduction or removal or devices through guide catheter  110 . Examples of materials that can be used to make a substantially stiff hypotube are Stainless Steel 304, Nitinol etc. Hypotube  114  may be bent to a two-dimensional or three-dimensional shape. Distal tip of tubular element  112  may comprise a radio-opaque marker  111  e.g. a standard radio-opaque marker band. The proximal region of tubular element  112  comprises a threaded luer. 
         [0092]      FIG. 3A  shows a crossectional view of guide catheter  110  of  FIG. 7  through plane  3 A- 3 A. The crossection of guide catheter  110  shows an outer hypotube  114  enclosing a tubular member  112  which in turn comprises a lubricious coating  115  located on the inner surface of tubular member  112 . 
         [0093]      FIG. 4A  depicts a coronal section of the paranasal anatomy showing a method of accessing a maxillary sinus ostium using guide catheter  100  of  FIG. 2 . Guide catheter  100  is introduced through a nostril and advanced in the paranasal anatomy such that atraumatic tip  104  is located inside or adjacent to a maxillary sinus ostium MSO. Proximal bent, curved or angled region  102  allows guide catheter  100  to be positioned around the inferior turbinate IT. Similarly, distal bent, curved or angled region  104  allows guide catheter  100  to be positioned around the middle turbinate MT. A guidewire or a suitable diagnostic or therapeutic device may then be introduced through the lumen of guide catheter  100  into the maxillary sinus MS.  FIG. 8B  shows a sagittal section of the paranasal anatomy showing the method of  FIG. 8G  to access a maxillary sinus ostium using guide catheter  100  of  FIG. 2 . 
         [0094]      FIG. 5  shows a perspective view of a set of devices to dilate or modify ostia or other openings in the sinuses or other body cavities. Guide catheter  200  comprises a shaft  202  comprising a threaded luer  204  at proximal end of shaft  202 . Distal end of shaft  202  comprises a radio-opaque marker band MB to enable the physician to identify the tip of shaft  202  in a fluoroscopic image. The distal end of shaft  202  may be substantially straight or may comprise one or more bent or angled regions. One or more distance markings DM may also be located on the shaft  202 . An optional subselective catheter  806  may also be present in the set of devices. Subselective catheter  206  comprises a shaft  208  comprising a threaded luer  210  at the proximal end of shaft  208 . Inner diameter of shaft  208  is smaller than inner diameter of shaft  202 . Distal end of the shaft  208  comprises a radio-opaque marker band MB to enable the physician to identify the tip of shaft  208  in a fluoroscopic image. Distal end of shaft  208  may be substantially straight or may comprise one or more bent or angled regions. One or more distance markings DM may also be located on the shaft  208 . Working device  212  comprises a shaft  214  comprising a working element  216  located on distal region of shaft  214  and a threaded luer  218  located on proximal end of shaft  214 . The working element  216  can be a dilating balloon or can be one or more of a combination of suction or irrigation devices, needles, polypectomy tools, brushes, brushes, energy emitting devices such as ablation devices, laser devices, image-guided devices containing sensors or transmitters, endoscopes, tissue modifying devices such as cutters, biopsy devices, devices for injecting diagnostic or therapeutic agents, drug delivery devices such as substance eluting devices, substance delivery implants etc. 
         [0095]    In one embodiment of a method, the guide catheter  200  is introduced into a patient&#39;s body so that distal end of guide catheter  200  is in the vicinity of an anatomical opening (e.g. an ostium) of an anatomical region (e.g. a paranasal sinus). Thereafter, the guidewire  220  is introduced through guide catheter  200  into the anatomical region e.g. the paranasal sinus. If necessary, guide catheter  200  may be removed and the smaller subselective catheter  206  may be introduced over guide wire  220  into the paranasal sinus. Thereafter, working device  212  is introduced over guidewire  220  into the paranasal sinus and a diagnostic or therapeutic procedure is performed by the working device  212 . In another embodiment of a method using the abovementioned set of devices, subselective catheter  206  is omitted from the procedure. Additionally, in yet another approach, larger guide catheter  200  can be introduced over guide wire  220 . The working device  212  is then introduced over guidewire  220  into the paranasal sinus and a diagnostic or therapeutic procedure is performed by working device  212 . This method embodiment enables a user to introduce larger working device  212  in the anatomical region. 
         [0096]      FIG. 6  shows a perspective view of an embodiment of a balloon catheter comprising a sizing balloon and a dilating balloon. The balloon catheter can be used as a treatment modality in combination with tissue or biological substance removal. A portion of the sizing balloon has been removed to show the dilating balloon underneath the sizing balloon. Balloon catheter  250  comprises a shaft  252  and a dilating balloon  254  located on distal region of shaft  252 . Dilating balloon  254  can be made of suitable non-compliant materials e.g. polyethylene terephthalate, Nylon etc. Dilating balloon  254  is inflated through a first balloon inflation opening  255 . Balloon catheter  250  further comprises a sizing balloon  256  located around dilating balloon  254 . Sizing balloon  256  is made from a compliant or semi-compliant material such as crosslinked polyethylene or other polyolefins, polyurethane, flexible polyvinylchloride, Nylon etc. Sizing balloon  256  is inflated through a second balloon inflation opening  257 . Dilating balloon  254  and sizing balloon  256  enclose an inter-balloon volume  258 .  FIG. 6A  shows a crossection of the balloon catheter in  FIG. 6  through plane  6 A- 6 A. Shaft  252  comprises a guidewire lumen  260 , a first inflation lumen  262  that terminates distally in first balloon inflation opening  255  of  FIG. 14 , and a second inflation lumen  264  that terminates distally in second balloon inflation opening  257  of  FIG. 6 . 
         [0097]      FIGS. 6B-6D  show the various steps of dilating an anatomical opening using the balloon catheter in  FIG. 6 . In  FIG. 6B , balloon catheter  250  is introduced over a guidewire GW into an anatomical opening  266  to be dilated. Examples of the types of anatomical openings  266  that may be dilated by this invention include ostia of paranasal sinuses, Eustachian tubes, ostia of lachrymal ducts, etc. Thereafter, in  FIG. 6C , sizing balloon  256  is inflated using an imageable inflating medium. Examples of suitable imageable inflating media are saline with a radioopaque contrast agent, carbon dioxide gas etc. Distal region of balloon catheter  250  is subsequently imaged using a suitable imaging modality such as fluoroscopy or X-rays. This enables an operator to accurately estimate the size of anatomical opening  266 . Such a balloon catheter is also suited for estimating the diameter of the narrowest region in a tubular anatomical region e.g. a Eustachian tube prior to performing a diagnostic or therapeutic procedure such as balloon dilation. On the basis of information obtained during step  6 C, balloon catheter  250  may be repositioned and step  6 C repeated if necessary. Thereafter, in step  6 D, sizing balloon  256  is deflated. Also in step  6 D, dilating balloon  254  is inflated to dilate a target region in anatomical opening  266 . Thereafter, dilating balloon  254  is deflated and balloon catheter  250  is withdrawn from anatomical opening  266 . In one embodiment, sizing balloon  256  may be reinflated after a balloon dilation procedure to obtain feedback about the performance of the balloon dilation procedure. 
         [0098]    Prior, subsequent or contemporaneously with the implant of a balloon catheter, tissue and/or biological substances can be captured or removed from a treatment site. Such capture and removal devices can be deployed over a guidewire or can embody structure permitting direct placement at the interventional site.  FIG. 21  depicts one approach to a cutting device comprising cutting jaws. Cutting device  300  comprises a shaft  302  comprising an upper jaw  304  and a lower jaw  306  located on the distal end of shaft  302 . Proximal region of shaft  302  comprises a scissor-like device with handles or other suitable control apparatus  308  that is useable to control the movement of upper jaw  304  and/or lower jaw  306 . Upper jaw  304  and lower jaw  306  are hinged together so that they can be opened or closed by scissor handles  308  to bite, grip or cut tissue. In one embodiment, the edges of upper jaw  304  and lower jaw  306  are provided with a series of cutting teeth. Alternately, the edges of upper jaw  304  and lower jaw  306  may be provided with sharp edges, blunt gripping teeth etc. Shaft  302  comprises a lumen  310 . This enables cutting device  300  to be advanced over an access device such as a guidewire to access a target anatomical region. Examples of materials that can be used to construct cutting device  300  are stainless steel 304, stainless steel 316, titanium, titanium alloys etc. 
         [0099]      FIG. 7A  shows a perspective view of the distal region of the cutting device of  FIG. 7  wherein the cutting jaws are closed. 
         [0100]      FIG. 7B  shows a perspective view of one embodiment of the jaws of the cutting device of  FIG. 7 . Upper jaw  304  comprises an upper jaw notch  312 . In one embodiment, upper jaw notch  312  is semicircular in shape. Similarly, lower jaw  306  comprises a lower jaw notch  314 . In one embodiment, lower jaw notch  314  is semicircular in shape. This design enables a guidewire to pass through a gap in the distal end of the cutting device  300  even when upper jaw  304  and lower jaw  306  are closed. In another embodiment, a guidewire passes through an opening located on either upper jaw  304  or lower jaw  306 . Upper jaw  304  and lower jaw  306  can also be square, ovoid, trapezoidal or circular in shape. 
         [0101]      FIG. 7C  shows a crossectional view of the cutting device in  FIG. 7  through plane  7 C- 7 C. Shaft  302  of cutting device  300  comprises a lumen  310  for an access device such as a guidewire. Shaft  302  further comprises one or more pull wires  316  that connect upper jaw  304  and lower jaw  306  to control apparatus  308 . When the control apparatus  308  is moved, pull wires  316  transmit the movement to upper jaw  304  and lower jaw  306  causing them to open or close. 
         [0102]      FIG. 8A  shows a perspective view of an alternate embodiment of a device comprising cutting or gripping jaws. Cutting device  320  comprises a shaft  322 . Distal end of cutting device  320  comprises an upper jaw  324  and a lower jaw  326  that are hinged together at a first hinge  328 . Proximal end of upper jaw  324  comprises a first elongate member  330  and proximal end of second jaw  326  comprises a second elongate member  332 . The proximal end of first elongate member  330  is connected to a second hinge  334  which in turn is connected to a third elongate member  336 . Proximal end of second elongate member  332  is connected to a third hinge  338  which in turn is connected to a fourth elongate member  340 . The proximal ends of third elongate member  336  and fourth elongate member  340  are connected by a fourth hinge  332  to pull wire  344  that passes through shaft  322 .  FIG. 8A  shows cutting device  330  wherein the upper jaw  334  and lower jaw  326  are in an open configuration. When pull wire  344  is pulled in the proximal direction, fourth hinge  342  is pulled inside shaft  322 . This causes the distal ends of third elongate member  336  and fourth elongate member  340  to come closer to each other. This in turn causes the proximal ends of first elongate member  330  and second elongate member  332  to come closer to each other. This in turn causes upper jaw  324  and lower jaw  326  close. Similarly, pushing pull wire  344  in the distal direction causes upper jaw  324  and lower jaw  326  to open. In one embodiment, cutting device  320  comprises a spring mechanism located between pull wire  344  and shaft  322  that biases upper jaw  324  and lower jaw  326  in an open or closed configuration. 
         [0103]      FIG. 8B  shows a perspective view of the device of  FIG. 9A  wherein the jaws of the cutting device are in a closed configuration. 
         [0104]      FIG. 9A  shows a perspective view of an embodiment of a microshaver or ostium enlarger device  350 . Device  350  comprises a proximal portion  352  and a distal portion  353 . Proximal portion  352  is hollow and comprises a proximal cutting surface  354  e.g. sharp cutting teeth etc. located on the distal end of proximal portion  352 . Distal portion  353  comprises a distal cutting surface  356  e.g. sharp cutting teeth etc. located on the proximal end of distal portion  353 . Distal portion  353  is further connected to a pull shaft  358  that encloses a guidewire lumen  360 . Guidewire lumen  360  allows microshaver  350  to be introduced over a guidewire GW into a target anatomy. The region between pull shaft  358  and proximal portion  352  encloses a suction lumen  362 . Suction lumen  362  can be used to remove solid debris or liquids from the target anatomy by suction. Proximal portion  352 , distal portion  353  and pull shaft  358  can be made of suitable biocompatible materials such as stainless steel. 
         [0105]      FIG. 9B  shows a crossection of a paranasal sinus showing one way in which the device  350  of  FIG. 9A  may be used to remove tissue or matter. The device  350  is introduced over a guidewire GW into paranasal sinus  364 . The device  350  is then positioned such that the tissue or matter is located between proximal cutting surface  354  and distal cutting surface  356 . Thereafter, in this embodiment, pull shaft  358  is pulled in the proximal direction. This causes movement of distal region  353  in the proximal direction with respect to proximal portion  352 . This in turn forces cylindrical distal cutter  356  to be retracted into the interior of the cylindrical proximal cutter  354 , thereby cutting off or breaking tissue or matter that is captured therebetween. Optionally, in this embodiment, the cylindrical distal cutter  356  cylindrical proximal cutter  354  may be rotated relative to the other to further cut or shave tissue. Also, optionally in this embodiment, suction lumen  352  can be used to remove any solid debris or liquids generated during the procedure. 
         [0106]      FIGS. 9C and 9D  show an example of another way in which the device  350  may be used—i.e., to shave tissue or matter. Examples of anatomical structures that may be shaved by this device  350  include bone, cartilage and soft tissues of Eustachian tubes, turbinates, lachrymal ducts, anatomical openings such as ostia of paranasal sinuses, ostia of lachrymal ducts, etc. and other regions in the ear, nose, throat or mouth. As shown in  FIG. 9C , in this embodiment, there need not be a proximally moveable pull shaft  358 , but rather the distal cutting surface  356  may remain positioned within the cylindrical proximal cutting surface  354 . The cutting surfaces are positioned adjacent to the tissue or matter to be shaved and the cylindrical distal cutter  356  and/or cylindrical proximal cutter  354  is/are rotated to shave the tissue or matter. Suction may be applied through lumen  362  to draw the tissue or matter into slots  359  such that it will be shaved by the rotating proximal cutter  354 . 
         [0107]    Referring now to  FIGS. 10A-C , in one embodiment a tissue removal device  380  may include an elongate tubular member  382  and a snare  384 . The tissue removal device  380  may be used to remove tissue from the nasal cavity and/or from within a paranasal sinus prior to, subsequent to, or contemporaneous with the use of dilation catheters such as those depicted in  FIG. 6 . In various embodiments, tissue removal device  380  may be used to remove tissue in one or more paranasal sinuses, in the nasal cavity, or both. The elongate tubular member  382  may include a proximal end configured to be attached to a device that creates a negative pressure gradient within the tubular member  382 . In one embodiment, the elongate tubular member  382  may further include a balloon or other expandable member to allow the device  380  to both remove tissue and dilate an opening or other space in the nasal cavity or paranasal sinuses. In one embodiment, the tissue removal device  380  may be advanced over a guidewire and/or through an introducer or guide catheter, such as those described above in reference to shown  FIGS. 2 and 3 . In alternative embodiments, the tissue removal device  382  may be advanced without the use of a guide device. 
         [0108]    The elongate tubular member  382  may include an internal lumen sized and shaped to accept the snare  384 . The snare  384  may be moved longitudinally with respect to the elongate tubular member  380  so that it can be both advanced beyond a distal end of the elongate tubular member  380  and withdrawn completely within the internal lumen of the tubular member  380 . In various embodiments, the snare  384  may be either a simple mechanical loop of material such as a wire or may be equipped to transmit RF energy. In the latter embodiments, a proximal end of the snare  384  may be connected to a RF energy transmitting device. 
         [0109]    As shown in  FIGS. 10B and 10C , the tissue removal device  380  may be advanced into a patient&#39;s nasal cavity  364  (and/or one or more paranasal sinuses) to engage tissue or other biological substances. In these and subsequent sets of figures, devices are shown removing tissue from the nasal cavity for ease of illustration. However, in many if not all embodiments, the devices and methods shown in use in such figures may also be used to remove tissue from within one or more paranasal sinuses. At some point during or after advancement of the device  380 , the snare  384  may be advanced out of the elongate tubular member  382  and manipulated to snare and cut a target tissue or substance. In a purely mechanical approach, the snare  384  can be placed about the target tissue and withdrawn to cut the tissue from the sinus cavity. Alternatively, RF energy can be transmitted to accomplish the severing of tissue. Contemporaneously with this severing action or subsequent thereto, a suction force is applied via the elongate tubular member  382 . The suctioning and withdrawing of the snare  384  then accomplishes the capture of the target substances. The device  380  and severed tissue/substances can then be removed from the interventional site or further severing and collection of material can be performed until the site is cleared as desired. 
         [0110]    With reference now to  FIGS. 11A-11C , in a related approach, a therapy system  400  for removing biological substances from paranasal cavities can include an elongate, tubular, suctioning member  402  having a distal end portion configured with a morcellator  404 . Again, balloon dilation or other dilation of paranasal cavities can be conducted along with targeted tissue removal. Also, the elongate tubular member  402  is intended to be connected to a device that creates a suctioning force within a lumen running a length of the elongate tubular member  402 . The morcellator  404  can define various sub-assemblies designed to break down, sever or cut biological substances found in a patient&#39;s sinuses. In the approach depicted in the drawing figures, the morcellator  404  can include a plurality of blades that rotate about a central hub. A control device can be attached to the morcellator  404  and extend proximally to an operator so that rotation of the morcellator  404  can be effected. 
         [0111]    In use, in combination with or separate from balloon dilation of the paranasal cavity, a distal end of the suction and morcellator assembly  400  can be placed as previously described within a paranasal sinus adjacent substances targeted for removal. Suctioning pressure can then be generated within the elongate tubular member  402  to begin the substance collection process. The morcellator  404  is then activated to sever, cut or chop the targeted substances. The targeted biological substances are then withdrawn within the elongate tubular member  402  and can be removed from the patient&#39;s sinuses. This procedure can be repeated as necessary to clean out a sinus to a desired degree. Further balloon dilation can also be conducted to fully treat the sinuses. 
         [0112]    Now turning to  FIGS. 12A-12C , another embodiment of a suctioning tubular member  420  is disclosed. Independently or along with balloon dilation of a paranasal sinus opening or other nasal/paranasal area, the suctioning tubular member can be used for therapies for treating the sinuses. As before, the suctioning tubular member  420  can further include a balloon or other expandable member for dilating paranasal sinus anatomy, or a separate catheter can be employed for this purpose. A proximal end of the device  420  is again attached to an assembly that generates a suctioning force. In the present approach, a distal end of the suctioning tubular member  420  is configured with a single limb with a plurality of holes  422  formed therein to adhere to tissue reversibly using suction. As shown in the figures, this relatively less traumatic approach to tissue manipulation can be used to capture and remove tissue  365  or other substances from sinus and/or nasal cavity anatomy. 
         [0113]    In yet another related approach ( FIGS. 13A-13C ), a tissue capture suction device  430  having a generally elongate tubular body structure and a distal end including a cutting edge  432  is contemplated to sever, capture or remove tissue from sinus anatomy. This assembly as well can be advanced over a guidewire and/or within a guide catheter or can itself define a guide catheter. Moreover, this device can be used with or independently from a balloon catheter or other structure for dilating paranasal sinus and/or nasal cavity anatomy, or expandable structure can be incorporated directly into the tubular body. 
         [0114]    As shown, the cutting edge  432 , which extends a full circumference of the tubular body, is defined by a sharp angle between an internal luminal wall of the tubular capture suction device  430  and an outer surface thereof. Various other approaches to cutting surfaces are also contemplated such as sharp edges extending less than a full circumference of the distal tubular portion. The tissue capture suctioning device  430  further includes a filter  434  for registering captured material within the device. 
         [0115]    In use, separate or contemporaneously with balloon or other sinus dilation, the tissue capture suctioning device  430  is placed at the intervention site adjacent substances to be collected. By way of a connection to a suction subassembly, suction force is applied while the cutting edge  432  is manipulated to engage and sever the substances targeted for removal. When the device dislodges the substances target for removal, the suctioning force draws the substance within the elongate tubular member, the filter  434  operating to retain the substance in place. 
         [0116]    Alternatively, as shown in  FIGS. 14A-14C , a tissue capture device  450  can include an elongate tubular member  452  terminating with a cutting surface  454  as well as a capture subassembly  456  with a vial  458  attached to a proximal end of the tubular member  452 . For ease of manipulation, the elongate tubular member  452  can rotate with respect to the capture subassembly  456  to engage and sever targeted biological substances. Although this embodiment shares features with the immediately preceding embodiment both in structure and use, here a filter is configured within the capture subassembly  456  to effect registering captured material. In this way, captured material can be displaced from the interventional site, and a larger volume of material can be collected. 
         [0117]    A capture screen device  470  such as that depicted in  FIGS. 15A-15C  can also be employed to sever and collect biological substances targeted for removal from the paranasal sinuses. As with the previously described embodiments, this device can be used while applying a suctioning force as the capture screen device  470  is used to collect targeted tissues independently of the use of suction. Moreover, as before, this device can incorporate a balloon or other dilation of sinus anatomy and it can form part of a guide catheter and/or be deployable within the same or over a guidewire. The presently contemplated capture screen devices  470  includes an expandable and collapsible screen  472  that is longitudinally translatable within a generally tubular tube  474 . Again, the tube  474  can be attached to a suctioning subassembly as desired. Moreover, a balloon (not shown) can be configured within the screen  472  to aid in expanding the screen or contribute to dilation of sinus anatomy. 
         [0118]    In use, the capture screen device  470  is placed within a nasal cavity or paranasal sinuses at the interventional site. Once placed as desired, the screen device  472  is advanced beyond the distal end of the tubular member  474  and either permitted to self expand or is expanded by way of opposing motion of members defining the screen  472  (such as a pull wire attached to a distal end of the screen, not shown). Material to be severed is captured between crossing struts  476  of the screen structure  472  when the screen  472  is expanded. Both manipulation of the screen  472  and/or the subsequent withdrawal and collapse of the screen within the tubular member  474  accomplishes cutting the targeted biological material from within the sinus and collection of the material within an interior of the screen. The treatment is completed upon removal of the screen loaded with the collected material from the interventional site. Multiple collection steps can be repeated as necessary to complete the desired treatment. 
         [0119]    Turning now to  FIGS. 16A-16E , another approach to therapies involving biological tissue or substance capture and removal is presented. A balloon catheter  490  including a balloon  491  having an outer surface configured with cutting elements is contemplated for this purpose. Such devices can be advanced over a guidewire and within a guide catheter as disclosed above and can further be used along with suctioning or other capture approaches to remove severed tissue along with or independent from independent balloon dilation of the sinus anatomy. In one approach, the cutting balloon  490  can include one or more blades  492  extending longitudinally along the balloon body  491  ( FIG. 16A ). The blades can also assume a scooper design  494  or a helical pattern  496  as shown in  FIGS. 16B and 16C . To provide treatment at an interventional site, the balloon catheter  470  is expanded to fully expose the blades  492 ,  494 ,  496 . Manipulating the balloon  490  so that the blades  492 ,  494 ,  496  engage and sever the targeted tissue  365  results in dislodging the tissue from walls defining the paranasal cavity. The severed tissue  365  can then be subsequently removed by flushing or by employing a suctioning member (not shown). 
         [0120]    In an alternate approach, the severing of target tissue can be achieved employing a spin cutter device  500  (See  FIGS. 17A-17D ). Here as well, the spin cutter device  500  can be employed with a dilation catheter for opening paranasal sinus cavities and the device can be advanced within a guide catheter and/or over a guidewire. As shown, the spin cutter device  500  includes an elongate generally cylindrical member  502  having an external surface configured with cutting blades  504  having a curved, rolled profile defining a tissue retention feature. Once placed as desired within sinus anatomy, the spin cutter  500  is rotated so that the cutting blades  504  both cut and capture tissue within its rolled structure. The device can be reused as necessary and then withdrawn from the site employing a sheath so as to avoid trauma to tissue in the area. 
         [0121]    Yet further approaches to tissue collection and removal are depicted in  FIGS. 18A-18C  and  19 A- 19 C. Such further approaches can be conducted independently from or in combination with one or more of balloon dilation of sinus or nasal cavity anatomy, suctioning pressure, over guidewire advancement and guide catheter introduction. As shown in  FIGS. 18A-18C , a back cutter device  520  can be employed to capture biological substances  365  targeted for removal from sinuses. The back cutter device  520  can include a cone  522  supported on a longitudinal member  524 , each of which are translatable with request to a generally tubular collection sleeve  526 . In one embodiment, the longitudinal member  524  slides within an interior of the sleeve  526  and the cone  522  is sized to be received within a distal end of the sleeve  526 . It is contemplated that one or both of the proximal end of the cone  522  and a distal end of the sleeve  526  can include structure for cutting biological substances typically found within sinuses. In this regard, as before, structure defining both the cone  522  and sleeve  526  can include a sharp angle about the center or a portion of a circumference of the cone  522  and sleeve  526 . To achieve dissection, targeted matter  365  can be arranged between the cone  522  and the sleeve  526  and the longitudinal member  524  can be rotated to cause the cutting surface of the cone  522  to cut the targeted matter  365 . Additionally, the sleeve  526  can also be rotated to cut the targeted matter  365 . Once it is believed that a sufficient dissection has occurred, the longitudinal member  524  can be drawn proximally to capture dissected material between the cone  522  and sleeve  526 . 
         [0122]    In a related embodiment ( FIGS. 19A-19C ), a balloon and cutter device  540  is configured to cut and capture biological tissue  365  in paranasal sinuses and/or the nasal cavity. Here, the device  540  includes a distal portion that is configured with both a laterally extending expandable balloon as well as an open window  544  positioned on an opposite side of the device from the balloon  542 . Configured within the window  544  is a cup-shaped cutter  546 , a proximal end of which is connected to a manipulation member  548  extending to an operator. The balloon portion  542  of the device can be employed to open ostia or other spaces within the sinuses or to anchor the device for tissue collection. Tissue collection can occur by placing the window  544  over tissue or other substances to be cut and removed. The cup-shaped cutter  546  can then be rotated and/or advanced against the material to cut and capture the same. The captured material can then be removed from the site by withdrawing the balloon and cutter device from the patient. 
         [0123]    A spinning shaped cutter device  560  such as that depicted in  FIGS. 20A-20C  also can be used as previously described to access and then be placed adjacent tissue identified for removal from the sinuses. This device is provided with a generally tubular body  562  sized to receive a scored, elongate member  564 , the terminal distal end of which includes a shaped cutter  566 . In one approach, the cutter  566  is highly flexible and through the manipulation of the elongate member  564 , the cutter  566  is rotated to cut tissue. The depth of advancement of the shaped cutter  566  is monitored by noting the position of the markings on the elongate member  564  relative to a proximal end of the tubular body  562 . Similar scoring of other embodiments of disclosed therapy devices can be employed to monitor device placement. Additionally, direct or remote viewing technologies such as endoscopy and/or fluoroscopy can be used to aid in tissue dissection and capture. 
         [0124]    Yet another approach to sinus therapy ( FIGS. 21A-21C ) can involve employing a high pressure fluid delivery system  580  to dislodge material from within a patient&#39;s nasal cavity  364  and/or paranasal sinus. The system  580  can also be equipped to suction dislodged material from the therapy site through a tubular body  582  as well as a balloon  584  that can be used to stabilize the system or to dilate ostia or other sinus cavities. 
         [0125]    The therapy device  600  can further be defined by a generally tubular member  602  with a plurality of openings  604  formed therein (See  FIGS. 22A-22C ). In this application, where it has been found to be difficult to cut through hard tissue or bone, a cutter  606  is configured to be responsive to or apply ultrasonic spinning or other oscillary motion to improve cut-ability. That is, motion such as spinning or vibration can induce micromotions that help eliminate friction and further augment cutting ability. The cutter  600  can further be withdrawn as desired to cut tissue adjacent or extending within the holes  604  formed in the device body  602 . 
         [0126]    In still yet another approach ( FIGS. 23A-23D ), in combination with balloon dilation of sinus anatomy, a forceps grasping device  620  is provided to engage and remove tissue from within a paranasal sinus, a paranasal sinus opening and/or a nasal cavity. The device  620  can include a reusable handle  622  and replaceable grasper structure  624 . The device can also be entirely disposable or reusable. Moreover, the forceps grasper  620  device may be sized and shaped to be placed through a guide member (not shown). In any event, proximally located finger receptacles  626  are conveniently placed so that tissue extraction can be accomplished remotely. 
         [0127]    Various approaches to mechanically scrubbing, cleaning and swabbing paranasal cavities are presented in  FIGS. 24A-24E . Thus, rather than using sharp blade-like objects, cotton swabs  630  ( FIG. 24A ), cloth members  632  ( FIG. 24B ) or a fine brush  634  are contemplated for treating paranasal sinuses. Also contemplated is the use of a wire scrubber  636  depicted in  FIG. 24D . For each of these objects, the scrubbing or swabbing members can be advanced through a sheath  640  and permitted to self-expand to a configuration suited for effectively engaging surfaces internal to the paranasal sinuses. Dislodged material can be withdrawn from the therapy site directly by the swabbing/scrubbing device as well as via other disclosed methods (i.e. suctioning). 
         [0128]    The removal device may include any of those described above. In various embodiments, the removal device may be advanced through a guide, as shown, or may be advanced on its own, without using a guide. In various embodiments, an endoscope may be used to view all or some of the procedure. In one embodiment, a variable degree of view endoscope may be used, such as a swing prism endoscope described in U.S. patent application Ser. No. 12/502,101, entitled “Swing Prism Endoscope,” the full disclosure of which is hereby incorporated by reference. 
         [0129]    In some embodiments, the tissue removal device may include a balloon dilation catheter, for example mounted on a catheter shaft that houses a tissue cutter. Thus, in some embodiments, the dilating and tissue removal functions may be achieved by the same device. In some embodiments, this combination device may be advanced over or through a guide, while in alternative embodiments it may not require a guide. 
         [0130]    The method shown in  FIGS. 25A-25E  may also be applied to other paranasal sinuses, such as the maxillary, sphenoid and ethmoid sinuses. Although the ethmoid sinuses typically do not have one discrete, natural opening as the other sinuses do, some combination of dilation and tissue removal may be used in some embodiments to treat the ethmoid sinuses and/or areas of the nasal cavity such as the osteomeatal complex. Here, a balloon catheter  650  is advanced through a guide catheter  652  to within an ostium or outflow tract  653  leading to a frontal sinus  654 . The balloon  656  of the balloon catheter is expanded ( FIG. 25B ) to open the ostium or outflow tract. The balloon catheter  650  is then removed leaving the guide catheter in place ( FIG. 25C ). Bone fragments or other biological substances  660  may remain at the site. Thus, a tissue removal device  670  such as those described above can be advanced to the site through the guide  652  ( FIG. 25D ). Once there, the fragments can be removed to thereby leave an expanded, clear outflow tract and ostium. 
         [0131]    In various alternative embodiments, the devices, systems and methods described above may be used for diagnosing or treating other conditions caused by narrowing or blockage of structures in the ear, nose, throat or mouth. Also in various embodiments, devices described herein such as catheters may comprise one or more lumens such as end-to-end lumens, zipper lumens, rapid exchange lumens, parallel lumens surrounded by a jacket, and the like. 
         [0132]    The above description provides a number of examples and embodiments, but various additions, deletions, alterations and modifications may be made to these examples and embodiments without departing from the intended spirit and scope of the present 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.