Abstract:
The invention is directed to a system and method for a less invasive surgical tool and operation to correct sinus disease called balloon sinuplasty. The reusable sinus dilation instrument has a guide seeker constructed from a sterilizable material with a bended terminal end offset from an attachment terminal end and a central grip intermediate of the terminal ends. The instrument also includes a removable handle capable of being attached to the attachment terminal end at a predetermined orientation relative to the bended terminal end of the guide seeker depending upon if the instrument is a frontal sinus guide seeker, a maxillary sinus guide seeker or a sphenoid sinus guide seeker. The bended terminal end of the guide seeker can be selectively angled so that the guide seeker is a frontal sinus guide seeker, a maxillary sinus guide seeker or a sphenoid sinus guide seeker.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/915,791, filed Dec. 13, 2013, which is incorporated herein by reference in its entirety. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable. 
       NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not Applicable. 
       REFERENCE TO A SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX 
       [0004]    Not Applicable. 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of the Invention 
         [0006]    This invention relates generally to a reusable sinus dilation instrument and method of use, and more particularly to a reusable sinus dilation instrument having a guide seeker constructed from a sterilizable material with a bended terminal end offset from an attachment terminal end and a central grip intermediate of the terminal ends, and having a removable handle capable of being attached to the attachment terminal end at a predetermined orientation relative to the bended terminal end of the guide seeker. 
         [0007]    2. Description of the Related Art 
         [0008]    Sinus disease often occurs because of blockage. The blockage traps mucous in a warm, moist environment and can produce infection. Blockage also allows pressure to build which can cause pain and pressure over the sinus cavities. Balloon sinuplasty is a newer less invasive operation to correct sinus disease. During the procedure, no mucosal tissue is removed, rather the ostia or opening on the sinus is enlarged by inserting a balloon that is inflated. The opening then heals in the open position. Balloon sinuplasty overcomes the infection, pain, and pressure by keeping the sinus ostia open. 
         [0009]    Current medical-grade instruments used in balloon sinuplasty have a high cost because most of the parts are intended for one time only use. There are less expensive instruments, but those instruments have problems with bulk and awkward angles, which make these instruments very difficult to use and can cause more tissue trauma, which may lead to more scarring and revisions. 
         [0010]    It is therefore desirable to provide an improved reusable sinus dilation instrument and method of use. 
         [0011]    It is further desirable to provide a reusable sinus dilation instrument that can be safely sterilized, has better angles for finding the sinus, and has less profile so as to cause less tissue trauma. 
         [0012]    It is still further desirable to provide a reusable sinus dilation instrument having a guide seeker and a disposable balloon capable of being slipped over the guide seeker. 
         [0013]    It is yet further desirable to provide a reusable sinus dilation instrument having a guide seeker with a bended terminal end offset from an attachment terminal end and a central grip intermediate of the terminal ends. 
         [0014]    It is still yet further desirable to provide a reusable sinus dilation instrument having a removable handle capable of being attached to an attachment terminal end at a predetermined orientation relative to a bended terminal end of a guide seeker of the instrument. 
         [0015]    It is yet further desirable to provide a reusable sinus dilation instrument where the angle of the terminal bend varies depending on the sinus being treated, e.g., about 45 degrees for frontal, about 95 degrees for maxillary, and about 10 degrees for sphenoid sinus. 
         [0016]    It is still yet further desirable to provide a reusable sinus dilation instrument having a fiber optic cable in the center of the guide seeker. 
         [0017]    It is still yet further desirable to provide a reusable sinus dilation instrument made of sterilizable material, e.g. stainless steel. 
         [0018]    It is still yet further desirable to provide a reusable sinus dilation instrument having a removable handle capable of being attached to the instrument using a luer taper fitting, a threaded attachment or other attachment means. 
         [0019]    Other advantages and features will be apparent from the following description and from the claims. 
       SUMMARY OF THE INVENTION 
       [0020]    In general, the invention relates to a reusable sinus dilation instrument and method of use for less invasive balloon sinuplasty for correction of sinus disease. The instrument may be sterilized and reused, has better angles for finding the sinus and causes less tissue trauma. The instrument includes a guide seeker having a bended terminal end offset from an attachment terminal end and a central grip intermediate of the terminal ends. The instrument also includes a removable handle attachable to the attachment terminal end at a predetermined orientation relative to the bended terminal end of the guide seeker. The bended terminal end may be approximately 2.5 cm length, and has an angle that varies depending on sinus being treated—approximately 45 degrees for frontal, approximately 95 degrees for maxillary, and approximately 10 degrees for sphenoid sinus. In addition, a fiber optic cable may be placed in the center of the guide seeker. The guide seeker may be made of sterilizable material, e.g. stainless steel. The removable handle may be attached to the instrument using a luer taper fitting, a threaded attachment or other attachment means. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  is a top plan view of an example of a reusable sinus dilation instrument having a frontal sinus guide seeker and a removable handle oriented generally coplanar with and parallel to a bended terminal end of the guide seeker in accordance with an illustrative embodiment of the invention disclosed herein; 
           [0022]      FIG. 2  is a side view of the instrument shown in  FIG. 1 ; 
           [0023]      FIG. 3  is an exploded view of the instrument shown in  FIG. 2 ; 
           [0024]      FIG. 4  is an exploded view of area  4  as shown in  FIG. 2 ; 
           [0025]      FIG. 5  is a side view of an example of a reusable sinus dilation instrument having a disposable balloon capable of being slipped over a bended terminal end of a guide seeker in accordance with an illustrative embodiment of the invention disclosed herein; 
           [0026]      FIG. 6  is a side view of another example of a reusable sinus dilation instrument having a disposable balloon capable of being slipped over an attachment terminal end of a guide seeker in accordance with an illustrative embodiment of the invention disclosed herein; 
           [0027]      FIG. 7  is a side view of the reusable sinus dilation instrument shown in  FIGS. 5 and 6  with the disposable balloon seated over the guide seeker; 
           [0028]      FIG. 8  is a side fragmentary view of an example of a maxillary sinus guide seeker in accordance with an illustrative embodiment of the invention disclosed herein; 
           [0029]      FIG. 9  is a side fragmentary view of the maxillary sinus guide seeker shown in  FIG. 8  with a disposable balloon seated on a bended terminal end; 
           [0030]      FIG. 10  is a side fragmentary view of an example of a sphenoid sinus guide seeker in accordance with an illustrative embodiment of the invention disclosed herein; 
           [0031]      FIG. 11  is a side fragmentary view of the sphenoid sinus guide seeker shown in  FIG. 10  with a disposable balloon seated on a bended terminal end; 
           [0032]      FIG. 12  is a side view of another example of a reusable sinus dilation instrument having a removable handle attachable a frontal sinus guide seeker at a predetermined orientation in accordance with an illustrative embodiment of the invention disclosed herein; 
           [0033]      FIG. 13  is a side view of the reusable sinus dilation instrument shown in  FIG. 12  with the removable handle attached to the guide seeker and oriented generally coplanar with and in an opposing parallel direction to a bended terminal end of the frontal sinus guide seeker; and 
           [0034]      FIG. 14  is a perspective view of another example of a reusable sinus dilation instrument having a maxillary sinus guide seeker and a removable handle disposed generally perpendicular to a bended terminal end of the guide seeker in accordance with an illustrative embodiment of the invention disclosed herein. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0035]    The instruments and methods discussed herein are merely illustrative of specific manners in which to make and use this invention and are not to be interpreted as limiting in scope. 
         [0036]    While the invention has been described with a certain degree of particularity, it is to be noted that many modifications may be made in the construction and the arrangement of its components without departing from the scope of the invention. It is understood that the invention is not limited to the embodiments set forth herein for purposes of exemplification. 
         [0037]    The description of the invention is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. In the description, relative terms such as “front,” “rear,” “lower,” “upper,” “horizontal,” “vertical,” “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly” etc.) should be construed to refer to the orientation as then described or as shown in the drawings under discussion. These relative terms are for convenience of description and do not require that the machine be constructed or the method to be operated in a particular orientation. Terms, such as “connected,” “connecting,” “attached,” “attaching,” “join” and “joining” are used interchangeably and refer to one structure or surface being secure to another structure or surface or integrally fabricated in one piece. 
         [0038]    Referring to the figures of the drawings, wherein like numerals of reference designate like elements throughout the several views, and initially to  FIGS. 1 through 7 , a reusable sinus dilation instrument  10  has a guide seeker  12  constructed from a sterilizable material, such as stainless steel. The guide seeker  12  includes a bended terminal end  14  offset from an attachment terminal end  16  and a central grip  18  intermediate of the terminal ends  14 / 16 . The instrument  10  also includes a removable handle  20  capable of being attached to the attachment terminal end  16  at a predetermined orientation relative to the bended terminal end  14  of the guide seeker  12 . 
         [0039]    As exemplified in  FIGS. 1 through 3  and  5  through  7 , the guide seeker  12  is a frontal sinus guide seeker  12  with the removable handle  20  oriented generally coplanar with and parallel to the bended terminal end  14  of the guide seeker  12 . The bended terminal end  14  of the frontal sinus guide seeker  12  may have an angle A of about 45 degrees with a long gentle curve of approximately 2.5 cm in length L 1 . A tip  22  of the curve of the bended terminal end  14  may be approximately 1 mm diameter and progressively enlarge to about 2 mm in diameter over a length L 2  of about 8 cm. The length L 3  of the central grip  18  of the guide seeker  12  continues the diameter of approximately 2 mm to the attachment terminal end  16  of the guide seeker  12 . 
         [0040]    The removable handle  20  of the instrument  10  is capable of being attached to the attachment terminal end  16  at a predetermined orientation relative to the bended terminal end  14  of the guide seeker  12 . The handle  20  of the instrument  10  may increase in diameter to about 5 mm and be about 2 cm in length L 4 . Similarly to the guide seeker  12 , the handle  20  may be constructed of a sterilizable material, such as stainless steel. As depicted in the figures, namely  FIG. 4 , the handle  20  is coupled to the attachment terminal end  16  of the guide seeker  12  using a threaded attachment mechanism  24 ; however, the invention is not so limited as the handle  20  can be attached to the instrument  10  using a luer taper fitting or other suitable attachment means. The handle  20  may include a wing  26  attached to and protrude away from a body  28  of the handle  20 . The wing  26  may be about 2 mm thick, about 3.5 cm long and about 2 cm wide, resulting in the instrument  10  having a length of about 23 cm from the tip  22  of the bended terminal end  14  of the guide seeker  12 . As illustrated in  FIGS. 1 through 3  and  5  through  7 , the handle  20  is oriented generally coplanar with and parallel to the bended terminal end  14  of the front sinus guide seeker  12 . Alternatively as illustrated in  FIGS. 12 and 13 , the handle  20  may be selectively attached to the attachment terminal end  16  of the guide seeker  12  such that the wing  26  of the handle  20  projects in a direction opposite of the curve of the bended terminal end  14  of the guide seeker  12 . 
         [0041]    As can be seen in  FIGS. 5 through 7 , a disposable balloon  30  may be slipped directly over the guide seeker  12  and does not have to be removed or advanced, although the balloon  30  could be advanced if needed. The balloon  30  may be about 6 mm in diameter and about 18 mm long. The balloon  30  is positioned along the length L 1  of the gentle curve of the bended terminal end  14 , with a leading end  32  positioned about 1 mm from the tip  22  of the bending terminal end  14  and a terminal end  34  positioned along length L 2  of the central grip  18  of the guide seeker  12 . As illustrated in  FIG. 5 , the balloon  30  is slipped over the bended terminal end  14  of the guide seeker  12  while in  FIG. 6  the balloon  30  is slipped over the attachment terminal end  16  of the guide seeker  12 . Once the balloon  30  is seated over the guide seeker  12  as depicted in  FIG. 7 , a suitable air supply (not shown) may be fluidly coupled to an attachment mechanism  36  of the disposable balloon  30 . 
         [0042]    Referring now to  FIGS. 8 ,  9  and  14 , the reusable sinus dilation instrument  10  includes a maxillary sinus guide seeker  12  having the bended terminal end  14  with a rounded approximately 95 degree angle A. Similarly to the front sinus guide seeker discussed above, the bended terminal end  14  of the maxillary sinus seeker  12  may be approximately 8 mm in length L 1  from the central grip  18 . The diameter of the bended terminal end  14  is about 1 mm and progressively increases to about 2 mm in diameter for a length of about 8 cm along the central grip  18  of the guide seeker  12 . The handle  20  is coupled to the attachment terminal end  16  of the guide seeker  12  and increases the diameter to about 5 mm and is about 2 cm in length. The wing  26  of the handle  30  may be about 2 mm in thickness, about 3.5 cm long, about 2 cm wide and about 23 cm from the tip  22  of the bended terminal end  14  of the guide seeker  12 . As shown in  FIG. 14 , the handle  20  is disposed generally perpendicular to the bended terminal end  14  of the guide seeker  12 . Although the handle  20  is exemplified as having a single wing  26  attached to and projecting from the body  28  of the handle  20 , the handle  20  can include two (2) opposing wings  26  affixed to and protruding away from the body  28 , and in such an embodiment, each of the wings  26  would be oriented generally perpendicular to the angle A of the bended terminal end  14  of the guide seeker  12 . 
         [0043]    Referring now to  FIGS. 10 and 11 , the reusable sinus dilation instrument  10  includes a sphenoid sinus guide seeker  12  having the bended terminal end  14  with a gentle curve having an approximately 10 degree angle A. The gentle curve may measure about 1 cm long and about 2 mm at the tip  22  of the bended terminal end  14  of the guide seeker  12 . The diameter can be about 2 mm for a length of about 8 cm, and then increase to about 5 mm in diameter for about 2 cm in length. The wing  26  and the handle  20  of the sphenoid sinus guide seeker  20  may be configured and oriented similarly to the frontal sinus guild seeker  12 , namely, the handle  20  is oriented generally coplanar with the bended terminal end  14  of the front sinus guide seeker  12 . In addition, the handle  20  may be selectively positioned such that the wing  26  of the handle  20  is parallel to the bended terminal end  14  of the front sinus guide seeker  12  or such that the wing  26  of the handle  20  projects in a direction opposite of the curve of the bended terminal end  14  of the guide seeker  12 . 
         [0044]    Additionally, the handle  20  of the reusable sinus dilation instrument  10  may be specifically constructed for left or right sinus cavity procedures, and could be made with one wing  26  or with two (2) opposing wings  26 . The balloon  30  may also have a locking mechanism (not shown) onto the handle  20 , along with smaller wings  26  to allow advancement if needed. 
         [0045]    The reusable sinus dilation instrument  10  may include a fiber optic element (not shown) embedded within a center channel (not shown) of the guide seeker  12  allowing the practitioner to confirm positioning and placement of the balloon  20  in the sinus cavity using transdermal illumination. With embedded fiber optics, the diameter of the tip  22  at the bended terminal end  14  of the guide seeker  12  increase to about 2 mm. 
         [0046]    Whereas, the instruments and methods have been described in relation to the drawings, it should be understood that other and further modifications, apart from those shown or suggested herein, may be made within the scope of this invention.