Abstract:
An apparatus for creating an accessory maxillary ostium for purposes of ventilation, irrigation, or procedural work within the maxillary antrum. An introducer having a ventilation tube and grommet is provided to create and then provide access through the accessory maxillary ostium. An irrigation catheter may be advanced through the ventilation tube in order to irrigate or express the contents of the sinus cavities. A secondary irrigation catheter or a balloon catheter may be advanced through an outer irrigation catheter, deeply into the sinus cavity, in order to irrigate or express the contents of the sinus cavities. Moreover, the balloon catheter may alternatively or additionally be employed to for dilation of the natural ostium. Still further, a device for delivering drugs, fluids or the like, may be coupled to the ventilation tube for delivery of same.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/092,269, filed Aug. 27, 2008, the entirety of which is hereby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates, in general, to functional endoscopic techniques and, more particularly, to apparatus, systems and methods for ventilating the paranasal sinuses. 
         [0004]    2. General Background of the Invention 
         [0005]    There has been resurgence of interest among otolaryngologists in the morphological features of the lateral wall of nasal cavity with the advent of endonasal endoscopic sinus surgery. Functional endoscopic techniques, being minimally traumatic, have become increasingly popular in diagnostic and therapeutic aspects of nasal and sinus problems. 
         [0006]    The area termed the “ostiomeatal complex” of the middle meatus has not only the primary maxillary ostia (“PMO”) opening in the hiatus semilunaris (“HS”) but also of-times, other “holes” or accessory maxillary ostium (AMO). It has been estimated that anywhere between 5-30% of the normal population has an AMO located in the maxillary fontanelle (anterior or posterior). 
         [0007]    AMO is invariably solitary but occasionally multiple, either congenital or secondary to disease process. A possible mechanism of formation of accessory ostia is obstruction of the main ostium by maxillary sinusitis or due to anatomic and pathologic factors in the middle meatus resulting in the rupture of membranous areas known as fontanelle (certain regions in the middle meatus located below the uncinate process and above the inferior turbinate, covered by nasal mucous membrane medially and mucosa of maxillary sinus laterally with connective tissue sandwiched between the two). 
         [0008]    In the past, a naso-antral window procedure was performed for purposes of ventilation and drainage of the maxillary sinus cavity. However, the naso-antral window procedure has the disadvantage of requiring one or more punctures through bony tissues. 
         [0009]    Accordingly, it is an object of the present invention to provide apparatuses and methods for ventilation, irrigation, or procedural work within the maxillary antrum. 
         [0010]    It is another object of the present invention to provide apparatuses and methods for the creation of an AMO to facilitate such ventilation, irrigation, or procedural work within the maxillary antrum. 
         [0011]    It is another object of the present invention to provide an apparatus and method which may be used in connection with the sinuses, including the paranasal, ethmoid, and sphenoid sinuses. 
         [0012]    It is yet another object of the present invention to provide apparatuses and methods for the creation of an AMO to facilitate such ventilation, irrigation, or procedural work within the maxillary antrum, without the requirement to puncture bony tissues, as in the prior naso-antral window procedure. 
       BRIEF SUMMARY OF THE INVENTION 
       [0013]    The present invention involves the creation of an AMO for purposes of ventilation, irrigation, or procedural work within the maxillary antrum. In particular, an introducer having a ventilation tube and grommet is provided to create and then provide access through the AMO. The irrigation catheter or balloon catheter may then be advanced through the ventilation tube in order to irrigate, or express the contents, of the sinus cavities. The balloon catheter may further be employed to dilate the natural ostium. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0014]      FIG. 1  of the drawings is a sectional view of a human skull showing, in particular, the lateral nasal wall and the orientation of the introducer and ventilation tube; 
           [0015]      FIG. 2A  of the drawings is an enlarged view of a portion of the antrum, or maxillary sinus showing, in particular, the creation of an AMO using the introducer, and the placement of the ventilation tube through the AMO; 
           [0016]      FIG. 2B  of the drawings is an enlarged view of the antrum showing, in particular, an alternative embodiment of the ventilation tube; 
           [0017]      FIG. 3  of the drawings is an enlarged view of the portion of the atrium showing, in particular, the obturator disposed through the introducer and the ventilation tube; 
           [0018]      FIG. 4  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the ventilation tube in place after removal of the introducer; 
           [0019]      FIG. 5  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the use of an irrigation catheter in association with the ventilation tube; 
           [0020]      FIG. 6  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the use of a second, smaller diameter irrigation catheter within an outer irrigation catheter in association with the ventilation tube; 
           [0021]      FIG. 7  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the second irrigation catheter extended deeply into the sinus cavity; 
           [0022]      FIG. 8  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the use of a balloon catheter within the sinus cavity; 
           [0023]      FIG. 9  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the placement of a balloon catheter within the natural ostium; 
           [0024]      FIG. 10  of the drawings is an enlarged view of a portion of the lateral nasal wall showing, in particular, the expansion of the balloon catheter for dilation of the natural ostium; 
           [0025]      FIG. 11  of the drawings shows a perspective view of another embodiment of the introducer of the present invention; 
           [0026]      FIG. 12  of the drawings shows a perspective view of the introducer taken along lines  12 - 12  of  FIG. 11 . 
           [0027]      FIG. 13A  is a perspective view of the ventilation tube in accordance with the present invention. 
           [0028]      FIG. 13B  is a perspective view another embodiment of the ventilation tube in accordance with the present invention. 
           [0029]      FIG. 14  is another embodiment of the catheter of the present invention, for delivering drugs and pharmaceuticals. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0030]    The present nasal ventilation system  10  is shown in  FIG. 1  as comprising ventilation tube  20  and elongated introducer  30 , suitable for creating an AMO within lateral nasal wall  70  (shown with the middle turbinate and uncinate removed to allow visualization of the natural ostium), proximate maxillary ostium  71 , maxillary fontanelle  72 , and inferior turbinate  73 . A distal tip of introducer  30  is insertable through a central channel of ventilation tube  20 , is releasably attachable to ventilation tube  20 , and includes a sharp, removable cutting obturator at the distal tip. 
         [0031]    As shown in  FIGS. 1 and 3 , in operation, introducer  30  with ventilation tube  20  at its distal end are introduced into the middle meatus in the region of the fontanelle (anterior or posterior) under endoscopic assistance, facilitated by the obturator  100 . Referring to  FIG. 3 , obturator  100  includes proximal flexible shaft  101  and sharp distal cutting tip  102 . Once the membraneous fontanelle or other targeted area is identified, obturator  100  is advanced through introducer  30  and ventilation tube  20  until cutting tip  102  extends beyond ventilation tube  20 , and cutting tip  102  and ventilation tube  20  are pushed through the fontanelle. Obturator  100  and introducer  30  are then removed. An endoscope is preferably employed to provide visualization during this procedure. 
         [0032]    Ventilation tube  20  and introducer  30  are shown in further detail in  FIG. 2A . Ventilation tube  20  include grommet-like member or proximal flange  21 , retaining member or distal flange  22 , and channel  23  extending through ventilation tube  20 , terminating in opposing apertures extending through grommet-like member  21 , retaining member  22  of ventilation tube  20 . As shown in  FIG. 2A , upon placement of ventilation tube  20 , grommet-like member  21  and conical or frusto-conical retaining member  22  are disposed on opposing sides of the AMO extending through lateral nasal wall  70 , and serve to maintain ventilation tube  20  in place. As indicated by the phantom lines of FIG.  2 A, introducer  30  is preferably constructed of a relatively flexible material to permit the introducer  30  to be readily advanced through the paranasal sinus passages to the desired site of the AMO. 
         [0033]    Ventilation tube  20  may be constructed of a variety of plastic-like materials commonly used in medical devices, including materials commonly employed in middle ear ventilation tubes. Moreover, ventilation tube  20  may be constructed of a drug eluting material, and may include compounds such as steroids or minerals/elements to decrease viral contamination, inflammatory reactions, and bacterial colonization. Furthermore, ventilation tube  20  may be constructed of a resorbable material, similar to those used in bio-absorbable sutures, and capable of dissolving in situ over time. 
         [0034]    An alternative construction of the ventilation tube, namely ventilation tube  20 ′, is shown in  FIG. 2B . In this alternative embodiment, the retaining member comprises expandable feet  22 ′ serving, in cooperation with grommet-like member  21 , to retain ventilation tube  20  in place though the membranous fontanelle. 
         [0035]    As shown in  FIG. 4 , once ventilation tube  20  is placed and seated through lateral nasal wall  70  proximate frontal sinus  75 , ehtnoid sinus  76 , sphenoid sinus  78  and Eustachian tube  78 , introducer  30  and its associated obturator are separated from ventilation tube  20  and removed. Next, as shown in  FIG. 5 , irrigation catheter  40  may be placed, by inserting distal tip  41  of irrigation catheter  40  into, or entirely through, channel  23  of ventilation tube  20 . Irrigation fluid  80  may then be injected into irrigation catheter  40  and thus introduced into the desired treatment area to flush the contents of the sinus cavity. The contents of the sinus cavity can then be pushed through the principal or main maxillary ostium to un-block the natural ostium. As indicated by the phantom lines of  FIG. 5 , irrigation catheter  40  is preferably constructed of a relatively flexible material to permit distal tip  41  of irrigation catheter to be advanced into the paranasal sinuses and placed through ventilation tube  20 . 
         [0036]    As shown in  FIG. 6 , a separate, smaller diameter secondary irrigation catheter  50  may be used in conjunction with irrigation catheter  40 . Distal tip  51  of secondary catheter  50  is inserted through an opening at proximal end  42  of irrigation catheter  40 , and is advanced beyond distal tip  41  of irrigation catheter  40  and into the targeted sinus cavity. Irrigation fluid  80  is then injected into secondary irrigation catheter  50  and is thus introduced to the desired treatment area to flush the contents of the sinus cavity. Moreover, and as shown in  FIG. 7 , distal tip  51  of secondary catheter  50  may be inserted more deeply into the targeted sinus cavity to deeply instill liquids within the antrum, by further advancing secondary catheter  50  through irrigation catheter  40 . 
         [0037]    Alternatively, and as shown in  FIG. 8 , balloon catheter  60  may be employed in place of secondary irrigation catheter  50 . Balloon catheter  60  includes distal tip  61 , and expansile member  62  surrounding a distal portion of the main lumen of the balloon catheter  60 . As shown in  FIG. 8 , distal tip  61  may be placed through irrigation catheter  40  and advanced deeply into the targeted sinus cavity. Expansile member  62  is then inflated. This, in turn, causes the contents of the sinus cavity, such as mucous or purulent debris  90 , to be expressed through the natural PMO  71 . 
         [0038]    As shown in  FIG. 9 , distal tip  61  of balloon catheter  60  may alternative or additionally be advanced through irrigation catheter  40  and the sinus cavity to extend through the natural PMO  71 . Next, as shown in  FIG. 10 , expansile member  62  is inflated, in order to dilate the natural PMO  71 . 
         [0039]      FIG. 11  is a view of another embodiment of an elongated introducer  100 . The introducer  100  includes a proximal end  102  and a distal end  104 . A tube or shaft  106  extends between the proximal end  102  and distal end  104 . A rod  108  extends within the tube  106 . The rod  108  includes a proximal end  110  extending out of tube  106  and a distal end (not shown) located at the distal end  104  of the introducer  100 . An obturator  112  is located at the distal end  104 . In one embodiment, the obturator  112  is secured to the distal end of the rod  108 .  FIG. 12  is a view of the elongated introducer  100  taken along line  12 - 12  of  FIG. 11 .  FIG. 12  shows the obturator  112  includes a shaft  114 , a flange  116  and a sharp, distal cutting tip  118 . The shaft  114  may be cylindrical or conical shaped, for example. The elongated introducer  100  may be coupled to a myringotomy apparatus or handle (not shown), such as will be understood in the art. Such an apparatus typically includes a mechanism to secure the tube  106  in a stationary manner with respect to the apparatus. The rod  108  may be coupled to a trigger mechanism for slidingly activating and controlling the rod  108  with respect to the tube  106 . Thus, activation of the trigger of the apparatus controls movement of the obturator  112 . The tube  106  of the introducer  100  may be made of a flexible or malleable material to permit the introducer  100  to be readily advanced through the paranasal sinus passages to the desired site of the AMO. 
         [0040]      FIG. 13A  shows another embodiment of the ventilation tube  130 . The ventilation tube  130  includes the conical or frusto-conical retaining member  132 , a shoulder  134 , grommet-like member  136  having flat side edges  138 , and a central channel or bore  140  extending through the ventilation tube  130 . 
         [0041]    As understood from the above description, the obturator  112  receives the ventilation tube  130 . In particular, the shaft  114  is designed to be received by the central channel  140 . The shaft  114  and channel  140  may be designed to provide a releasable locking engagement, such as an interference press fit or a snap-fit engagement. The shaft  114  may be cylindrical or conical, for example, with the central channel  140  similarly shaped for a mating engagement. With the obturator  112  inserted into the ventilation tube  130 , the flange  116  and grommet-like member  136  limit the depth in which the obturator  11  is inserted within the central channel  140 . With the flange  116  engaging the grommet-like member  136 , the sharp distal cutting tip  118  projects beyond the conical retaining member  132 . Thus, the combined introducer  100  and ventilation tube  130  are adaptable for piercing the tissue and forcing the ventilation tube  130  in place, with the shoulder on one side of the wall and the grommet-like member on the other side of the wall. 
         [0042]    In another embodiment, the ventilation tube may take other forms such as omitting the distal flange. In  FIG. 13B , another embodiment of the ventilation tube is shown. In particular, ventilation tube  170  shows a neck portion or sleeve  172  having a proximal end  174  with a proximal flange  176 . As an example, the flange may be tab shaped as shown in  FIG. 13B  or annular shaped. The distal end  178  includes a beveled edge  180  which provides a sharp cutting tip  182 . The ventilation tube  170  shown in  FIG. 13B  is more readily inserted by use of forceps (not shown). For example, the forceps may grip the proximal flange or tab  176 . The forceps will be used to guide the tube in place, urging the sharp cutting tip  182  through the sinus wall, and wherein the tab will also limit the insertion depth of the ventilation tube. It will be appreciated that an obturator is not required for inserting the tube  170  into the wall. 
         [0043]    In addition, it will be appreciated that the forceps may be used instead of the introducer described above. However, when the term “introducer” is used herein, it is intended to include forceps. 
         [0044]      FIG. 14  shows another embodiment of a catheter used utilized for delivering a pharmaceutical drug, fluid or the like to the sinus cavity. The catheter  150  is a graphical representation. The catheter  150  includes a hollow shaft  152 . The shaft  152  may be of a malleable material or flexible material to permit the catheter to be readily advanced through the sinus passages to the desired site of the AMO, and in particular to the location of the ventilation tube. It will be appreciated that the shaft  152  will be proportionally longer than that shown in  FIG. 14 . The distal end  154  of the catheter  150  includes an irrigation tip  156 . The irrigation tip  156  may be generally conical in shape. The conical shape more readily accommodates insertion of the tip  156  into the ventilation tube  130 . The irrigation tip  156  may be hollow to provide for fluid and drug flow from the shaft. The irrigation tip  156  may include a delivery opening  158  at the distal end  154 . In addition, the wall of the irrigation tip  156  may include micro pore perforations  160 . The delivery openings  158  and micro pore perforations  160  provide delivery of the drug or fluid. A flange  162  is provided to limit the insertion depth of the catheter  150 . The flange  162  will engage the grommet-like member to limit the insertion of the catheter. 
         [0045]    It will be appreciated that the ventilation tube of the present invention may be used to deliver topical fluids, drugs, anti-inflammatory medications, such as steroids, gene treatments, etc., drug delivery substances, and drug impregnated coils, and beads through simple insertion or via powered pulsation. For example, a device for delivering such items, such as the catheter  150  for example, may be guided toward the inserted ventilation tube, whereupon the desired item may be delivered directly to the sinus, or in a manner consistent with the description herein. In one embodiment, the delivery device may be adapted for insertion into the first catheter, to assist in guiding the delivery device to the ventilation tube.