Abstract:
A method for visualization and/or administration of medication of and into the sphenopalatine/pterygopalatine recess of a patient is provided. The method includes providing a sphenocath and inserting a guidewire into the nostril of a patient to a target area proximate the sphenopalatine/pterygopalatine recess of the patient. The sphenocath is advanced over the guidewire and a catheter hub of the sphenocath is rotated relative to a sheath hub to conform to an anatomy of the patient&#39;s sphenopalatine/pterygopalatine recess, such that the distal end of the catheter tube is proximal to the target area. The sphenocath is then advanced relative to a sheath assembly so that the distal end of a sphenocath catheter tube extends from a sphenocath sheath tube distal end and bends along the guidewire. The guidewire is removed and contrast media, fluids, and/or medication is administered to the patient&#39;s sphenopalatine/pterygopalatine ganglion disposed within the sphenopalatine recess of the patient.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 14/548,860, filed on Nov. 20, 2014; which claims the benefit of U.S. provisional patent application serial no. 61/907,328, filed on Nov. 21, 2013, the entireties of which are hereby incorporated by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to an apparatus and method for facilitating intranasal guidance. More particularly, the invention relates an apparatus and method for positioning the tip of a catheter adjacent to a patient&#39;s sphenopalatine/pterygopalatine recess. 
     BACKGROUND OF THE INVENTION 
     U.S. Pat. No. 8,388,600, incorporated herein by reference, describes a device and method of positioning a catheter tip within a patient&#39;s nasal cavity in order to deliver an anesthetic to create a nerve block. As explained in U.S. Pat. No. 8,388,600,  FIG. 1  depicts a cutaway view of the anatomical features of a typical human nasal cavity. One skilled in the art will recognize that certain anatomical features and structures of the human nasal cavity have been omitted to avoid obscuring the structures relevant to the practice of the current invention. To help orient the reader, the mouth  106  is illustrated with teeth  108  and tongue  110 . The anatomical structures relevant to the practice of the current invention include the palate  100  which separates the oral cavity  102  from the nasal cavity  104 , the inferior sinus turbinate  112 , the middle sinus turbinate  114  and the superior sinus turbinate  116  as well as the nasal bone  122 . The middle sinus turbinate  114  and superior sinus turbinate  116  define the sphenopalatine/pterygopalatine recess  118 . Deep within the sphenopalatine/pterygopalatine recess  118  at the posterior  124  of the sphenopalatine/pterygopalatine recess  118  lies the sphenopalatine/pterygopalatine ganglia  120 . 
     One skilled in the art will recognize that the medical community is not uniform in the terminology with regard to the sphenopalatine or pterygopalatine ganglia. Certain practitioners use sphenopalatine while others use pterygopalatine. Therefore, the present description will refer to the ganglia labeled  120  as the sphenopalatine/pterygopalatine ganglia  120 . Similarly, the recess labeled  118  will be referred to as the sphenopalatine/pterygopalatine recess  118 . However, this terminology is in no way limiting on the structure for which the present invention is intended. Where practitioners or scientist differentiate between the sphenopalatine ganglia or the pterygopalatine ganglia, the present disclosure will be understood to apply to either structure. 
     As is evident from  FIG. 1 , the structure of the nasal cavity makes it difficult to deliver a catheter tip to the sphenopalatine/pterygopalatine recess  118 . While U.S. Pat. No. 8,388,600 describes a device and method of positioning a catheter tip, such may not be sufficiently accurate and/or may be complicated in use. 
     SUMMARY OF THE INVENTION 
     In at least one aspect, the present invention provides an apparatus, system, and method for facilitating intranasal fluoroscopic guidance, visualization, administration of radiopaque substances, fluids, and medication to a patient&#39;s nasal sinus including the sphenopalatine/pterygopalatine recess. The apparatus includes a wire in which the internal catheter tracks over the wire into the desired location, and a catheter having a lumen disposed therethrough, the catheter comprising an intrinsic curvature, soft straight proximal end, or a shape memory curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end of the catheter lies in a second plane, wherein the catheter smoothly transitions between the wire, the first plane and the second plane, the intrinsic curvature conforming to the wire and the patients nasal anatomy such that the catheter may be inserted into a sphenopalatine/pterygopalatine recess. The external catheter assists the delivery of the catheter by adding stability and pushability to the overall system allowing the internal catheter to be softer and more comfortable to the patient. 
     In another aspect, the invention provides a sphenocath including a sheath assembly including a sheath hub with a sheath tube extending therefrom with a passage extending from a proximal end of the sheath hub to a distal end of the sheath tube; a catheter assembly including a catheter hub with a catheter tube extending therefrom with a passage extending from a proximal end of the catheter hub to a distal end of the catheter tube; wherein the catheter assembly passes through the sheath assembly with a portion of the catheter hub engaging a portion of the sheath hub to limit relative rotation between the hubs while permitting relative axial movement such that in an initial non-extended position the distal end of the catheter tube is proximate to the distal end of the sheath tube. A system further including a guidewire is also provided. 
     In yet another aspect, the invention provides a system including a sphenocath configured to be positioned over and guide into position by a guidewire. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings: 
         FIG. 1  is a schematic cutaway view of an exemplary facial anatomy of a patient. 
         FIG. 2  is a perspective view of a sphenocath in accordance with an exemplary embodiment of the invention in an initial, non-extended position. 
         FIG. 3  is a top plan view of the sphenocath of  FIG. 2 . 
         FIG. 4  is an isometric view of an exemplary catheter assembly of the sphenocath of  FIG. 2 . 
         FIG. 5  is a cross-sectional view along the line  5 - 5  in  FIG. 4 . 
         FIG. 6  is an elevation view along the line  6 - 6  in  FIG. 4 . 
         FIG. 7  is a top plan view of a portion of an exemplary sheath assembly of the sphenocath of  FIG. 2 . 
         FIG. 8  is an elevation view along the line  8 - 8  in  FIG. 7 . 
         FIG. 9  is a cross-sectional view along the line  9 - 9  in  FIG. 7 . 
         FIG. 10  is a perspective view similar to  FIG. 2  illustrating the sphenocath in an extended position. 
         FIG. 11  is a cross-sectional view along the line  11 - 11  in  FIG. 10 . 
         FIG. 12  is an elevation view along the line  12 - 12  in  FIG. 10 . 
         FIG. 13  illustrates the positioning of an exemplary guidewire within the nasal cavity of a patient. 
         FIG. 14  illustrates the positioning of the sphenocath of  FIG. 2  in the initial position as it is positioned along the guidewire. 
         FIG. 15  illustrates extension of the catheter from the sheath with the patient&#39;s nasal cavity. 
         FIG. 16  is a side elevation view of an exemplary catheter distal end. 
         FIG. 17  is an end elevation view of the catheter distal end of  FIG. 16 . 
         FIG. 18  is a side elevation view of another exemplary catheter distal end. 
         FIG. 19  is an end elevation view of the catheter distal end of  FIG. 18 . 
         FIG. 20  is a side elevation view of another exemplary catheter distal end. 
         FIG. 21  is an end elevation view of the catheter distal end of  FIG. 20 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The following describes preferred embodiments of the present invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiments described herein. 
     Referring to  FIGS. 2-12 , a sphenocath  300  in accordance with an exemplary embodiment of the invention will be described. The sphenocath  300  generally comprises a catheter assembly  310  and a sheath assembly  340 . As explained in more detail below, the catheter assembly  310  is configured to be positioned within the sheath assembly  340  and to be moved between an initial, non-extended position as illustrated in  FIG. 2  and an extended position as illustrated in  FIG. 10 . 
     Referring to  FIGS. 4-6 , the exemplary catheter assembly  310  generally includes a catheter tube  330  extending from a catheter hub  312 . The catheter hub  312  has a generally cylindrical body  314  extending between a proximal end  311  and a distal end  313 . A through passage  316  extends through the body  314  from the proximal end  311  to the distal end  313 . The proximal end of the passage  316  may have a larger opening  315  which then tapers at  317  to the diameter of the lumen  332  of the catheter tube  330 . The proximal end  311  of the catheter hub  312  preferably includes a thread  308  or the like for connection of the catheter assembly  310  to a syringe or the like (not shown). The distal end  313  of the catheter hub  312  includes a radial projection  322  configured to guide motion relative to the sheath hub  342  as described hereinafter. The radial projection  322  includes a proximal shoulder  321  and a distal tapered surface  323  which facilitates passage of the catheter hub  312  into the sheath hub  342 . The projection  322  has a width was illustrated in  FIG. 6 . 
     Between the ends  311 ,  313 , the catheter hub  312  includes one or more annular rings  318  which define a gripping structure of the catheter hub  312 . A distal most ring  318  defines a stop  319  which limits the amount of distal movement of the catheter hub  312  relative to the sheath hub  342 . The catheter hub  312  is preferably manufactured from a generally rigid material, for example, a polymer such as ISOPLAST 2510. 
     The catheter tube  330  extends from a proximal end  331  secured within the hub passage  316  to a free distal end  333 . The catheter tube  330  is manufactured from a flexible material, for example, a polyurethane elastomer such as PELLETHANE. The catheter tube  330  defines a hollow lumen  332  extending from the proximal end  331  to the distal end  333  such that a continuous passage is defined by the catheter hub passage  316  and the lumen  332 . Referring to  FIGS. 10-12 , the distal end  333  of the catheter tube  330  may be formed with a preformed curvature  335 . The curvature  335  is such that an axis DA of the distal end  333  is at an angle relative to the axis PA of the proximal end  331 . The angle is preferably between  30  degrees to  90  degrees and more preferably is between  35  degrees to  55  degrees. The angle is preferably chosen to correspond to the anatomy of the patient&#39;s nasal cavity. 
     Referring to  FIGS. 7-9 , the exemplary sheath assembly  340  will be described. The sheath assembly  340  generally includes a sheath tube  360  extending from a sheath hub  342 . The sheath hub  342  has a generally tubular body  344  extending between a proximal end  341  and a distal end  343 . A through passage  345  extends through the body  344  from the proximal end  341  to the distal end  343 . The proximal end of the passage  345  may have a larger opening  349  while the distal end  343  has a smaller passage  347  which approximates the diameter of the lumen  362  of the sheath tube  360 . The proximal end  341  of the catheter hub  342  preferably includes an annular shoulder  354  about the opening  349  which defines an internal shoulder  356 . 
     A guide slot  346  extends along the top surface of the sheath hub body  344  from the shoulder  356  to the distal end  343 . As illustrated in  FIG. 8 , the guide slot  346  has a width W which is slightly larger than the width w of the catheter hub projection  322 . As illustrated in  FIGS. 11 and 12 , the distal end of the catheter hub  312  is received in the passage  345  such that the projection  322  moves within the guide slot  346 . Referring to  FIG. 14 , contact of the projection proximal shoulder  321  with the internal shoulder  356  limits proximal movement of the catheter hub  312  relative to the sheath hub  342 . 
     Positioning of the projection  322  in the guide slot  346  also controls the relative rotational movement between the hubs  312  and  342 . As illustrated in  FIG. 12 , the larger width W of the guide slot  346  compared to the width w of the projection  322  allows for slight rotation of the catheter tube distal end  333  over a limited range, for example, approximately  10  degrees in each direction. In this way, the orientation of the preformed curvature  335  of the catheter tube distal end  333  cannot be modified relative to the sheath hub  342  beyond the controlled range. 
     Referring again to  FIGS. 7-9 , an indicator member  350  with an arrow head  352  covers a portion of the guide slot  346 , preferably at least over the range of axial movement of the projection  322  within the slot  346 . The indicator member  350  provides an indication of the orientation of the device  300  and more specifically the orientation of the preformed curvature  335 . Since, as explained above, the engagement of the projection  322  in the guide slot  346  limits relative rotation between the hubs  312 ,  342 , the preformed curvature  335  will always be away from the indicator member  350 . As illustrated in  FIGS. 2 and 9 , the indicator member  350  may be formed with a curvature that mimics the preformed curvature  335 , i.e. away from a user looking from above and proximally of the sheath hub  342 . 
     The sheath tube  360  extends from a proximal end  361  secured to the sheath hub  342  to a free distal end  363 . The sheath tube  360  defines a hollow lumen  362  extending from the proximal end  361  to the distal end  363  such that a continuous passage is defined by the sheath hub passage  345  and the lumen  362 . The distal end  363  of the sheath tube  360  preferably has a tapered portion  364  which provides a tapered contact surface during advancement of the sheath tube  360  and also conforms the sheath tube diameter to that of the catheter tube  330  outer diameter. The outer surface of the sheath tube  360 , preferably on the top surface, has a plurality of markers  366  which are spaced a given distance from one another. The markers  366  can be used to illustrate a depth of insertion of the device, for example, the defined depth being a depth equaling a distance between an entrance to a patient&#39;s sphenopalatine recess and an external entrance to the patient&#39;s nostril or a depth relative to a guidewire  370  over which the sphenocath  300  is guided as will be described hereinafter. The sheath tube  360  may also include a radiopaque mark  665  adjacent to the distal end  363  to assist with placement of the sphenocath  300  utilizing x-ray or fluoroscopy. 
     The sheath tube  360  is manufactured from a semi-flexible material that is more rigid than the catheter tube  330 , but may still have some flexibility. In this way, the sheath tube  360  maintains the preformed curvature  335  straight while within the sheath tube  360 . The sheath tube  360  may also be manufactured from, for example, a polyurethane elastomer such as PELLETHANE, however, it will be a composition that provides the greater rigidity. The sheath tube  360  may be formed with a lubricant blended with the material thereof or may be coated with a lubricant such that the sheath tube  360  has an external lubricious surface that minimizes the need for additional lubricants that may irritate the tracked area. 
     Referring to  FIG. 13 , the system further includes a guidewire  370  over which the sphenocath  300  is guided. The guidewire  370  extends from a proximal end  374  to a distal end  372 . The distal end  372  may be formed with a preformed curvature  376  which approximates the preformed curvature  335  of the catheter tube  330 , however, it is understood that the curvatures may be different. 
     Having described the components of an exemplary system, an exemplary method of insertion of the catheter tube  330  into a patient&#39;s nasal cavity will be described with reference to  FIGS. 13-15 . First, the distal end  372  of the guidewire  370  is inserted into the nostril  202  as illustrated in  FIG. 13 . Such insertion may be done, for example, using fluoroscopic guidance or by physician feel into the sphenopalatine/pterygopalatine recess or targeted location to access. 
     Referring to  FIG. 14 , the proximal end  374  of the guidewire  370  is received into the catheter tube distal end  333  and the sphenocath  300  is advanced over the guidewire  370  as indicated by arrow A. It is noted that at this stage, the catheter hub  312  is in the initial, non-extended position and the distal end  333  of the catheter tube  330  is proximate to the distal end  363  of the sheath tube  360 . The sphenocath  300  is advanced over the guidewire  370  to the desired position and location, for example, with the distal end  363  of the sheath tube  360  proximate the anterior ridge  204  of the middle sinus turbinate  114 . As explained above, the markings  366  may be utilized to help with the depth of insertion and the radiopaque mark  665  may further assist with placement. 
     Referring to  FIG. 15 , the catheter hub  312  is then advanced distally relative to the sheath hub  342  as indicated by arrow B. As such, the distal end  333  of the catheter tube  330  is extended out of the distal end  363  of the sheath tube  360 . The catheter tube distal end  333  follows the path defined by the guidewire distal end  372  as indicated by arrow C. The catheter distal end  333  is advanced into the patient&#39;s sphenopalatine/pterygopalatine recess  118  of the patient or another desired position. 
     Once the catheter distal end  333  is positioned, the guidewire  370  is removed and the catheter assembly  310  is ready for the desired application, with a passage defined from the hub passage  316  and through the lumen  332 . For example, a syringe or the like (not shown) may be connected to the thread  308  and a fluid, for example, contrast media, or medication, may be dispensed to the patient&#39;s sphenopalatine/pterygopalatine ganglion  120  disposed within the sphenopalatine/pterygopalatine recess  118 . 
     Referring to  FIGS. 16 and 17 , the configuration of an exemplary catheter  310  distal end  333 ′ will be described. The distal end  333 ′ has a substantially closed end  336  except for a slotted passage  337  extending across the closed end  336 . The slotted passage  337  will cause fluid expelled from the catheter  310  to fan out and provide a spraying or “painting” of the entire target area.  FIGS. 18 and 19  illustrate another spraying tip wherein the catheter distal end  333 ″ has a similar slotted passage  337 , however, the closed end  336 ″ tapers to the passage  337 , rather than the rounded end in the previous embodiment. In both embodiments, the slotted passage  337  preferably extends horizontally relative to the angle of the catheter distal end  333 .  FIGS. 20 and 21  illustrate another spraying tip wherein the catheter distal end  333 ″&#39; has a substantially closed end  336  except for a series of small openings  338 . The openings  338  will again cause fluid expelled from the catheter  310  to fan out provide a spraying or “painting” of the entire target area. While five openings  338  are illustrated, more or fewer openings may be provided and may be arranged in configurations other than the illustrated configuration. 
     These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as defined in the claims.