Abstract:
A medical attachment for use on the free end of a suction catheter extending into the middle ear of a patient is disclosed. The attachment can be part of a kit of plural attachments, each attachment being configured for accomplishing a different task. Each attachment includes a proximal base portion and an angularly extending distal portion terminating in a working tip. The working tip can be a foam member, a spade shaped member, or a pointed member. The base portion serves to releasably mount the attachment on the free end of the suction catheter. Also disclosed is a specially constructed suction catheter including a tip in the form of a foam member, a spade shaped member, or a pointed tip member.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This utility application claims the benefit under 35 U.S.C. §119(e) of Provisional Application Ser. No. 62/169,149 filed on Jun. 1, 2015, entitled MIDDLE EAR SURGICAL ATTACHMENTS FOR SUCTION CATHETERS AND SUCTION CATHETERS INCLUDING THE SAME. The entire disclosure of that provisional application is incorporated by reference herein. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISK 
       [0003]    Not Applicable 
       FIELD OF THE INVENTION 
       [0004]    The disclosed invention relates to medical devices and more particularly to otological surgical devices for middle ear surgery. 
       BACKGROUND OF THE INVENTION 
       [0005]    The surgical treatment of conditions in the middle ear is typically accomplished by lifting the eardrum out of the natural groove in which it sits. That process involves making an incision in the skin of the ear canal and basically dissecting the layer between the skin and the underlying bone to lift the eardrum out of its anatomical location and enter the space beyond the eardrum that is known as the middle ear. The otological instruments that are typically used for this process are quite small and have various types of tips, such as spades, points, etc., on the distal end thereof. 
         [0006]    Currently middle ear dissection procedures are visualized by the surgeon using either an endoscope extending into the ear canal or by use of a microscope. If the surgeon is using a microscope he/she can make use of both of his/her hands to effect the surgical procedure. If, however, the procedure is to be accomplished endoscopically, that typically requires that the surgeon use one of his/her hands to hold the endoscope (unless it is held by some mechanical support). 
         [0007]    In any case the surgical procedure, e.g., tissue dissection, in the middle ear is typically accomplished by the surgeon holding a small cutting or scraping instrument in his/her dominant hand to cut or scrape the tissue while holding a suction catheter, such as a Baron catheter, in the non-dominant hand. This enables the surgeon to use the suction catheter to remove blood and retract and/or elevate tissue during the dissection procedure. That technique makes endoscopic surgery challenging since it necessitates the surgeon using both hands, one for the instrument and the other for the suction catheter. In particular, the surgeon typically places the endoscope in his/her non-dominant hand, while holding the small surgical instrument in his/her dominant hand. As such, the surgeon no longer has suction to clear the field of blood and maintain visualization. Accordingly, the surgeon has to pause from time to time to use the suction catheter to clear the field of blood and to improve visualization. 
         [0008]    While endoscope holders are available to hold the endoscope during surgical procedures, and thus eliminate the holding problem an additional problem exists. In particular, the ear canal is too small to accommodate an endoscope, a surgical instrument and a suction catheter while enabling the effective manipulation of all three. This is particularly true if the procedure is to be accomplished on a child, whose ear canal is significantly smaller than an adult&#39;s ear canal. 
         [0009]    Thus, a need exists for surgical devices to overcome these problems. The subject invention does that by combining the suction instrument and the cutting/scraping instrument into a single instrument that can be used by one hand. 
       SUMMARY OF THE INVENTION 
       [0010]    In accordance with one aspect of this invention there is provided a medical attachment for use on the free end of a suction catheter extending into the middle ear of a patient, with an endoscope extending into the associated ear canal of the patient. The medical attachment comprises a proximal base portion and an angularly extending distal portion. The angularly extending distal portion terminates in a working tip. The working tip is selected from the group consisting of a foam member, a spade shaped member, and a pointed tip member. The base portion is configured for releasably mounting the medical attachment on the free end of the suction catheter. The working tip is configured to be brought into engagement with tissue in the middle ear to perform a medical procedure thereon by a user manipulating the suction catheter with one hand, with the other hand of the user being free to manipulate the endoscope to permit the viewing of the medical procedure. 
         [0011]    In accordance with another aspect of the invention there is provided a kit of medical attachments for use on the free end of a suction catheter extending into the middle ear of a patient, with an endoscope extending into the associated ear canal of the patient. The kit comprises a plurality of medical attachments, each of which comprises a proximal base portion and an angularly extending distal portion. The angularly extending distal portion of each attachment terminates in a working tip. The working tip of one of the attachments comprises a foam member. The working tip of another of the attachments comprises a spade shaped member. The working tip of still another of the attachments comprises a pointed tip member. The base portion of each of the medical attachments is configured for releasably mounting the medical attachment on the free end of the suction catheter. The working tip is configured to be brought into engagement with tissue in the middle ear to perform a medical procedure thereon by a user manipulating the suction catheter with one hand, with the other hand of the user being free to manipulate the endoscope to permit the viewing of the medical procedure. 
         [0012]    In accordance with another aspect of the invention there is provided a suction catheter having a free end configured to be extended into the middle ear of a patient, with an endoscope extending into the associated ear canal of the patient. The free end of the suction catheter comprises an integral angularly extending working tip. The working tip is selected from the group consisting of a foam member, a spade shaped member, and a pointed tip member. The working tip is configured to be brought into engagement with tissue in the middle ear to perform a medical procedure thereon by a user manipulating the suction catheter with one hand, with the other hand of the user being free to manipulate the endoscope to permit the viewing of the medical procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
         [0013]      FIG. 1  is an isometric view of a conventional otological suction catheter, e.g., a Baron catheter, on which one exemplary embodiment of a surgical tip, e.g., a sponge tip, constructed in accordance with this invention is mounted; 
           [0014]      FIG. 2  is an enlarged side elevation view of the distal end of the suction catheter shown in  FIG. 1  with the exemplary surgical tip mounted thereon; 
           [0015]      FIG. 3  is a slightly enlarged end view taken along line  3 - 3  of  FIG. 2 ; 
           [0016]      FIG. 4  is a slightly enlarged cross-sectional view taken along line  4 - 4  of  FIG. 2 ; 
           [0017]      FIG. 5  is a side elevation view, similar to  FIG. 2 , but showing an alternative exemplary embodiment of a surgical tip, e.g., a spade tip, constructed in accordance with this invention; 
           [0018]      FIG. 6  is top plan view taken along line  6 - 6  of  FIG. 5 ; 
           [0019]      FIG. 7  is a slightly enlarged end view taken along line  7 - 7  of  FIG. 5 ; 
           [0020]      FIG. 8  is a side elevation view, similar to  FIGS. 2 and 5 , but showing still another alternative exemplary embodiment of a surgical tip, e.g., a pointed or pick tip, constructed in accordance with this invention; 
           [0021]      FIG. 9  is top plan view taken along line  9 - 9  of  FIG. 8 ; and 
           [0022]      FIG. 10  is a slightly enlarged end view taken along line  10 - 10  of  FIG. 8 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0023]    Referring now to the drawings wherein like characters refer to like parts, there is shown in  FIG. 1  an exemplary embodiment of a conventional suction catheter  10 , e.g., a Baron catheter, on which one exemplary medical attachment  20 A constructed in accordance with this invention is mounted. Before describing the medical attachment  20 A, a brief description of the catheter  10  is in order. To that end, as can be seen in  FIG. 1 , the catheter  10  basically comprises an elongated tubular body  12  having a distal end  14  and a proximal end  16 . The proximal end  16  includes a handle to enable the suction catheter to be held by a surgeon or other operating personnel. The tubular body is hollow and thus includes a central lumen or passageway  18  ( FIG. 4 ) through which suction is applied from a suction source (not shown) to the distal end  14  of the catheter. 
         [0024]    The exemplary attachment  20 A is configured for releasable mounting on the distal end  14  of the catheter  10  and includes a working end that is shaped to accomplish a particular otological task. As will be seen from the discussion to follow the attachment  20 A is one of several types of attachments that can be constructed in accordance with this invention, with each attachment being configured for a particular otological task. The various attachments can be provided as a kit of replaceable attachments, with each attachment being shaped like a corresponding tip of a typical conventional instrument set. If desired, each attachment may be disposable, so that it can be disposed of after use, or may be non-disposable so that it can be cleaned and disinfected for subsequent reuse. Moreover, it must be pointed out at this juncture, that the subject invention is not limited to attachments for conventional suction catheters, such as that shown in  FIG. 1 . Thus, the subject invention also contemplates a suction catheter that is specially constructed so that its free end includes a tip constructed in accordance with this invention. 
         [0025]    In any case, each of the attachments/tips of this invention (whether replaceable attachments for mounting on a conventional suction catheter, or as an integral tip of a specially constructed suction catheter) includes a working end of a particular construction, shape and size to accomplish a particular otological task. 
         [0026]    For example, in  FIG. 2  there is shown an attachment  20  in the form of a “sponge” tip. This type of attachment is used to draw blood into the suction catheter without drawing in adjacent tissue to thereby protect that tissue while it is being elevated as an initial step in a typical middle ear dissection procedure (to be described later). The sponge tip  20  basically comprises a proximal base portion  22  and an angularly extending distal portion  24 , which are preferably an integral unit and can be formed of any suitable material, e.g., surgical steel. The angularly extending distal portion terminates in a free working end  26 . The proximal base  22  portion is in the form of a hollow tubular hub having a central longitudinal axis  28 . The hollow tubular hub includes a central passageway  22 A that is configured to receive the free end  14  of the suction catheter  10  to releasably mount the attachment  20 A thereon. To that end, the diameter passageway  22 A of the hub is preferably sized to accommodate the distal end of a conventional catheter therein. As is known those catheters come in 5 French, 20 gauge and 24 gauge sizes. Thus, the inside diameter of the hub&#39;s passageway is sized accordingly. The angularly extending distal portion  24  of the attachment  20 A is also a hollow tubular section having a central longitudinal axis  30  and a central passageway  24 A. The outside and inside diameters of the angularly extending portion  24  are preferably the same as the respective outside and inside diameters as the proximal portion  22 , but that need not be the case. Moreover, the angle between the longitudinal axis  28  of the proximal base portion  22  and the longitudinal axis  30  of the angularly extending distal portion  24  is within the range of approximately 160 degrees to approximately 135 degrees, although other angular arrangements are contemplated. Thus, for example the angle between the distal end portion  24  of the tip and its proximal portion  22  may be approximately 160 degrees, or 150 degrees or 135 degrees. Other angles can be used as well. In fact, it is contemplated that the interface between the proximal base portion  22  and an angularly extending distal portion  24  be adjustable so that the angle can be adjusted to any angle desired. 
         [0027]    In any case, the hollow interior of the proximal base portion  22  and the hollow interior of angularly extending distal portion  24  are in fluid communication with each other so that suction can be applied through the body of the attachment to the working end  26 . In accordance with one preferred exemplary embodiment of this invention, the length of the base portion  22  from its proximal end to the point at which it merges with the angularly extending distal portion  24  is approximately 7 mm, and the length of the angularly extending distal portion  24  from that merger point to the distal end of the angularly extending distal portion  24  is approximately 3 mm. The working tip  26  of the attachment  20 A is in the form of a body of open cell foam which is fixedly secured to the distal end of the angularly extending distal portion  24 . Preferably the material making up the foam is polyvinyl acetyl, but other open cell foams can be used, if desired. The length of the body of foam is approximately 1-1.5 mm, but other lengths are contemplated. 
         [0028]    Turning now to  FIGS. 5-7 , another exemplary embodiment of an attachment  20 B constructed in accordance with this invention is shown. The attachment  20 B is constructed identically to the sponge attachment  20 A except for the working end, which is in the form of a spade tip. In the interest of brevity, the common features of the attachments  20 A and  20 B will be given the same reference numbers and the details of the construction and operation of those features will not be reiterated. Thus, as can be seen the attachment  20 B includes a proximally located base portion  22 , an angularly extending distal portion  24  and a spade shaped extension or tip  32  projecting distally from the distal end of the angularly extending distal portion  24  adjacent the top thereof. In fact, the spade tip constitutes an extension of the wall of the tube making up the angularly extending distal portion  24 . The spade tip extends over the open end of the angularly extending distal portion  24  and parallel to the central longitudinal axis  30  thereof. In accordance with one exemplary preferred embodiment of a spade attachment  20 B, the tip  32  is approximately 1-1.5 mm long. As can be best seen in  FIG. 6  the free distal end  32 A of the spade tip  32  is wider, e.g., flares outward, from the root  32 B of the spade tip. The amount of flare of the spade tip can be whatever is deemed desirable for a particular otological procedure. As will be appreciated by those skilled in the art, the flared spade tip can be used to elevate either skin or diseased tissue from the surface of the middle ear by scraping the spade along the tissue-bone interface while the suction applied through its passageways  22 A and  24 A removes the blood and debris, thereby improving visualization. 
         [0029]    Another type of attachment constructed in accordance with this invention is a “point or pick” tip attachment  20 C, like shown in  FIGS. 8-10 . The attachment  20 C is used for very fine dissection, e.g., to take off a layer of very delicate tissue by scraping the point along the tissue-bone interface. The attachment  20 C is constructed identically to the spade attachment  20 B except for the working end, which is in the form of a pointed or pick tip. In the interest of brevity, the common features of the attachments  20 B and  20 C will be given the same reference numbers and the details of the construction and operation of those features will not be reiterated. Thus, as can be seen the attachment  20 C includes a proximally located base portion  22  and an angularly extending distal portion  24  and a V-shaped pointed extension or tip  34 . The tip  34  projects distally from the distal end of the angularly extending distal portion  24  adjacent the top thereof. In fact, the pick tip constitutes an extension of the wall of the tube making up the angularly extending distal portion  24  and extends over the open end of the angularly extending distal portion  24  and parallel to the central longitudinal axis  30  thereof. As can be best seen in  FIG. 9  the free distal end  32 A of the spade tip  32  is a point. In particular, the tip  34  tapers inward from the root  34 B of the tip  34  to the point at the free end thereof. The amount of taper of the pick tip can be whatever is deemed desirable for a particular otological procedure. The length of the tip  34  can be any length deemed desirable. In accordance with one exemplary preferred embodiment of a pick tip attachment  20 C the pointed tip is approximately 1-1.5 mm long. 
         [0030]    The following constitutes use of the attachments of the subject invention during a cholesteatoma surgery. As is known a cholesteatoma is a cyst of skin that forms in the middle ear space behind the eardrum which must be excised. The first step is to access the middle ear space, which is medial to the eardrum. Thus, the surgeon makes an incision in the skin of the ear canal and lifts up that skin which will take the surgeon to the edge of the eardrum. This initial cutting can be accomplished by a conventional cutting knife, such as a Rosen knife, or an otological round knife Once that has been accomplished the sponge tip attachment  20 A can be used on the suction catheter  10  to basically scrape in the plane between the skin of the ear canal and the bone of the ear canal. An endoscope (not shown) may be located in the ear canal to provide visualization of this procedure. The endoscope need not extend through the opening produced by the lifting of the skin into the operative space in the middle ear, since that space will be visible from the ear canal. Thus, the endoscope may remain in the ear canal for the entire surgery. 
         [0031]    As the attachment  20 A is pushed along the tissue the sponge body at its free end compresses so that the distal end of underlying cylindrical base portion of the tip scan scrape along that interface to gently elevate the skin of the ear canal. This process is known as the elevation of the tympanomeatal flap and exposes the middle ear. Once the cholesteatoma in the middle ear has been exposed the surgeon can then use the spade attachment  20 B on the suction catheter  10  for coarser dissection, followed by use of the pick attachment  20 C on the suction catheter for finer dissection, alternating as much as desired to remove the cholesteatoma. 
         [0032]    As will be appreciated by those skilled in the art the attachments/tips of this invention can be used for other otologic procedures, than the exemplary middle ear dissection described above. 
         [0033]    Without further elaboration the foregoing will so fully illustrate my invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.