Abstract:
An improved catheter for delivery of a saline solution to a fallopian tube to be examined by ultrasonic energy and for filling the uterus with a saline solution simultaneously in a sealed position. The device uses first and second expandable balloon sealing elements, one for the fallopian tube opening, the other for the cervix opening to completely seal the fallopian tube and the uterus. The distance between the balloons is adjustable, and a catheterization tip is insertable through a lumen into the fallopian tube. Liquid is provided to the balloons through separate lumens that include cutoff valves for holding the liquid in the balloons. The method employed involves inserting the distal end of the device into the uterus opening while positioning the balloon within the cervical opening and positioning a second balloon in the fallopian tube. The method then includes expanding both balloons so that the cervix and then the fallopian tube are sealed tightly. The catheterization wire can include an echogenic tip for improved ultrasonic testing.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to an improved catheter for dispensing fluid within a fallopian tube and uterus in conjunction with expandable balloons for sealing the entrance to the fallopian tube and uterus to allow the injection of a saline fluid for improving uterine and fallopian tube ultrasonic examination and to provide for corrective procedures such as catheterization of blockages. 
     2. Description of the Background Art 
     Using present day state of the art equipment, surgeons can perform medical procedures to open a closed or blocked fallopian tube. Sonograms and ultrasonics are employed to locate the entrance to the fallopian tube and the blockage in the fallopian tube, in conjunction with a saline fluid that is used to fill the uterus to aid in the ultrasonic locating process. The primary objective is to guide or aid, through the use of ultrasonics, the surgeon in locating obstructions in the fallopian tube. The use of ultrasonics is a desired method, but requires skill on the part of the surgeon to ultimately locate blockages within the fallopian tube. Saline fluid in the fallopian tube and the uterus is essential for proper ultrasonic examination results. Instruments may be utilized for catheterization of blockages in a fallopian tube once the obstruction is located. 
     The use of balloon catheters which allow for inflation of a balloon around the outside of the catheter and injection of a fluid or liquid while simultaneously placing the balloon against the walls of an opening has been used for filling the uterus with a saline solution. 
     Devices are known in the prior art for introducing fluids into the uterine cavity and, ultimately, into the fallopian tubes. U.S. Pat. No. 3,948,259, issued Apr. 6, 1976 to Bolduc et al., describes a dispensing instrument for placing a material in the uterine cavity and moving the material from the uterine cavity through the canals of the fallopian tubes of a female. U.S. Pat. No. 5,188,595, issued Feb. 23, 1993 to Jocobi, discloses a method for enhanced retention of a balloon catheter in a body cavity which uses a pair of inflatable balloons which have a device for forming a suction between them to act to positively retain the catheter in position in a body cavity. U.S. Pat. No. 5,104,377, issued Apr. 14, 1992 to Levine, describes a uterine access device with an automatic cervical adjustment. The device includes expandable distal and proximate members to secure a shaft to the uterus by adjusting to the length of the cervical canal. 
     None of the prior art references describe a catheter to assist in inspection of the fallopian tubes using ultrasonics through the introduction of liquids into the fallopian tubes, as described in the present invention. The present invention may also be used for catheterization of blockages found in the fallopian tubes. 
     SUMMARY OF THE INVENTION 
     The present invention provides an improved catheter that permits diagnostic and therapeutic examination of the uterus and fallopian tubes using ultrasonics and can provide delivery and retention of a predetermined necessary liquid, such as saline, into the fallopian tube and the uterus for proper ultrasonic examinations. 
     Infertility in women is often the result of fallopian tube blockage. Blockage in the fallopian tube prevents the ova from reaching the uterus. It is therefore necessary for a physician or surgeon to determine whether or not there is any blockage occurring in the fallopian tube. One method of determining blockage is through the use of ultrasonics or ultrasound in the form of sonograms, which can provide imaging on a visual display that shows various physiological conditions present in the uterus and in the fallopian areas. In order to get a good sonogram or ultrasonic picture, it is essential that the areas in question contain the proper density of liquid, such as a saline solution, for best results. 
     The catheter in accordance with the present invention is comprised of a plurality of lumens joined together as a single unit having first and second expandable balloons adjustable between strategically determined locations relative to the proximal and distal ends of the lumens. Each expandable balloon is connected to a separate lumen that provides for liquid under pressure through a syringe piston disposed at the proximal end of the device. 
     Disposed adjacent each expandable balloon is a liquid orifice which is the termination of a particular lumen that provides for the proper fluid distribution from a piston or other fluid dispensing device that transmits fluid through the lumen for expulsion at the particular lumen orifice. 
     The present invention may also include a separate lumen having a probe with a distal end tip made of an echogenic material for improved visual display guidance using the sonogram. The echogenic tip will be more visible on the sonic display relative to the catheter probe end and the body tissue. The catheter may also provide for tissue catheterization with the echogenically tipped probe to remove blockage tissue or other undesirable tissue. 
     A syringe can be connected at the proximal end of each lumen for the delivery of saline liquid to the appropriate location. Each syringe is conventional and includes a piston and an on/off locking valve at its end to retain the liquid in the particular lumen once it has been filled. 
     In one embodiment, two syringes can be utilized each having a three position valve to connect one syringe to either the lumen feeding the first balloon or the lumen feeding the first liquid orifice, and the other syringe to either the lumen feeding the second balloon or the lumen feeding the second liquid orifice. 
     In the preferred embodiment, the distance is adjustable between each of the expandable balloons to accommodate the distance of various sized women or various distances between the cervix and the fallopian tube opening, such as to custom fit the more distal balloon within a fallopian tube while the proximal balloon is positioned in the cervical opening. Upon inflation, the cervix opening is blocked with the first balloon to prevent fluid leakage outside the uterus. When the fallopian tube balloon is inflated, saline fluid can be injected into the fallopian tube that is being examined. 
     In an alternative embodiment, the distance is fixed between the cervix opening balloon and the fallopian tube balloon to fit an average woman&#39;s body or for a typical distance between the cervical opening and the fallopian tube. 
     The catheter device can include a flexible, precurved distal end section having memory that, upon insertion of the distal end, is directed by longitudinal insertion predisposed toward either one fallopian tube opening or the other, because the fallopian tube openings are offset relative to the cervix and uterus. The curved end directs the entire catheter distal end in a preferred direction toward the selected fallopian tube opening, reducing the amount of manipulation required by the surgeon to position the balloon in the fallopian tube opening. 
     In the preferred embodiment, a three position valve can be provided to connect a first syringe to either a lumen leading to the first balloon or a lumen leading to the first liquid orifice. The third valve position is an “off” position effectively sealing off the lumens and the syringe. When filled with fluid from the first syringe, the first balloon seals the entrance to the uterus permitting fluid flowing from the first syringe to the first liquid orifice to fill the uterus. 
     A second three position valve can be provided to connected a second syringe to either a lumen leading to the second balloon or a lumen leading to the second liquid orifice. The third valve position being an “off” position effectively sealing off the lumens and the second syringe. 
     The preferred embodiment of the catheter includes a first and second lumen set side by side in the catheter tube. The first lumen supplies fluid to the first balloon and contains a conduit having a third lumen to supply fluid to the first liquid orifice. The second lumen slidably receives a conduit having a fourth lumen to supply fluid to the second balloon and contains a conduit having a fifth lumen to supply fluid to the second liquid orifice. 
     The conduit within the second lumen and containing the lumens leading to the second balloon and second liquid orifice slides in relation to the lumens leading to the first balloon and first liquid orifice. This allows for adjustability in the distance between the second balloon and second liquid orifice for the fallopian tubes, and the first balloon and first liquid orifice for the uterus. 
     The catheter may also include, at the most distal end, an echogenic probe tip and wire that can extend back through the second three position valve for manual manipulation of the probe tip. The conduit within the second lumen may contain a second conduit having a sixth lumen to slidably receive the probe wire. The wire at the proximal end can include a handle grip and may have a plastic body portion extending at least partially between the proximal end and the distal end. At the distal end, the probe tip can be covered with a plastic portion to protect tissue from damage upon insertion, but that may perform physiological operations, such as catheterization. 
     To use the present invention, the physician or surgeon would manipulate the catheter and its distal end toward the uterus. The catheter is preferably rigid but flexible to permit manipulation and positioning by the physician. When the first balloon is positioned within the cervical opening to the uterus, the first three position valve is turned from the first “off” position to a second position to inflate the first balloon. The first syringe can then inflate the balloon causing a seal around the cervical opening into the uterus. The uterus can then be filled with liquid dispensed by turning the first three position valve to a third position and injecting fluid from the first syringe to the first liquid orifice adjacent the first balloon. The first three position valve can then be turned back to the first (off) position. 
     Next the slidable conduit within the second lumen is manually slid, relative to the first balloon&#39;s seal in the cervical opening, toward one of the fallopian tubes. The interface between the slidable conduit and the second lumen contains a conventional seal, such as an o-ring seal, so fluid within the uterus does not leak out around the conduit and through the second lumen. 
     The slidable conduit can be somewhat rigid but flexible, and can be provided with a permanent curve such that the distal end automatically tends toward one or the other fallopian tubes during longitudinal insertion. The direction of the curve in the conduit can be controlled by manual rotation during insertion thus directing the distal end toward one or the other desired fallopian tubes. 
     Once the second balloon is in position within, or near, the ostial opening of the fallopian tube, the second three position valve is turned from the first “off” position to the second position and the second balloon is inflated from the second syringe. Once the selected fallopian tube balloon has been expanded to form a seal around the inside of the fallopian tube opening, the second three position valve is turned to the third position and fluid is dispensed from the second syringe through the second liquid orifice adjacent the second balloon, filling the fallopian tube with the desired liquid. 
     If so equipped, the echogenic probe tip can then be inserted into the fallopian tube through the sixth lumen to further enhance the ultrasonic examination, and to catheterize any blockage found therein. The interface between the wire and the sixth lumen can include a seal to prevent fluid within the fallopian tube from leaking back through the sixth lumen. 
     Using the present invention, important saline liquids or other desirable liquids necessary for more accurate ultrasonic investigation and displays can be quickly and easily sealed and trapped in desired body cavities. 
     It is an object of this invention to provide an improved catheter for providing necessary liquids in a sealed relationship in a fallopian tube and in a uterus for ultrasonic examinations. 
     It is another object of this invention to provide an adjustable catheter for diagnostic and therapeutic examination of the fallopian tubes. 
     But yet another object of this invention, in an alternative embodiment, provides two expandable balloons that could be adjusted in distance to provide the proper spacing between the cervical opening to seal the uterus for fluid introduction, while sealing the fallopian tube for fluid introduction by manipulation from the surgeon. 
     Still another object of this invention is to provide an adjustable echogenic probe tip for catheterization of tissue within the fallopian tubes. 
     In accordance with these and other objects which will become apparent hereinafter, the instant invention will now be described with particular reference to the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a schematic representation of the present invention in a top view, representative of the uterine and fallopian portions of the body, in use. 
     FIG. 2 is a cross-sectional view of the present invention. 
     FIG. 3 is a perspective view of the distal probe end of the device in accordance with the present invention. 
     FIG. 4 is a view taken along line  4 — 4  of FIG.  1 . 
     FIG. 5 is a schematic top view of the present invention as disposed in portion at the cervical opening to the uterus. 
     FIG. 6 is a schematic top view of the present invention as disposed in portion at a fallopian tube. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now to the drawings, and in particular to FIG. 1, the present invention is shown generally at  10 , comprised of an extended lumen housing  12  connected at one end to an enlarged handle portion  14  and  14   a,  and which extends at the proximate end to three position valve  16 . Lumen housing  12  slidably receives conduit  18  which extends at the proximate end to three position valve  20 . 
     In the preferred embodiment, the device utilizes two syringes  22 , and  24 . Syringe  22  is connected to three position valve  16  and syringe  24  is connected to three position valve  20 . Three position valves  16  and  20  are manually turned on and off. 
     Syringes  22  and  24 , through the use of plungers  26  and  28 , provide fluid, such as saline solution, into lumens within lumen housing  12  and conduit  18  to inflate elastic balloons  48  and  52 , and to provide fluid through orifices  50  and  54 , as fully described herein below. 
     The overall purpose of the invention is to fill the uterus  44   a  by expelling saline fluid from an orifice  50 , while expanding balloon  48  to seal off the cervical opening  44 , so that fluid is retained in the uterus cavity  44   a.  Simultaneously, it is desirable to fill the fallopian tube  46  with a saline solution and seal it with an inflated, elastic balloon  52 . 
     The filling of the uterus  44   a  and the fallopian tube  46  with saline solution is to enhance the use of ultrasonics or sonograms to determine whether or not there is any blockage in the fallopian tube  46 . 
     At the distal end of conduit  18 , a probe  35  with a sonogenic tip  72  may be utilized for enhancing ultrasonic examination and performing therapeutic opening or catheterization within the fallopian tube if it is blocked. 
     Conduit  18  is slidable relative to lumen housing  12 , as fully described herein below, to provide adjustable distance between the sealing elastic balloons  48  and  52  to position balloon  48  within the cervical opening  44  and balloon  52  within fallopian tube  46 . 
     In an alternate embodiment, the distance between the sealing, elastic balloons  48  and  52  is predetermined to be the distance that would accommodate an average woman, so that balloon  52  can seal the fallopian tube opening  46 , while at the same time balloon  48  will reside in the cervix opening to seal the uterus chamber. In this manner, a plurality of catheters having various fixed distances between balloons  48  and  52  could be made to accommodate women of various sizes. For example, small, medium, and large size catheters could be made each having a different distance between balloon  48  and balloon  52 . 
     Referring to FIG. 2, lumen housing  12  contains lumens  1  and  2 . Lumen  1  connects fluid flowing from syringe  22  to balloon  48 , through three position valve  16 . Lumen  1  also contains conduit  30 . Conduit  30  includes lumen  3  which connects fluid flowing from syringe  22  to liquid orifice  50 , through three position valve  16 . Liquid orifice  50  can be alternately positioned in lumen housing  12 , such as axially, as long as liquid orifice  50  is distal to balloon  48 . 
     Lumen  2  slidably receives conduit  18 . The interface between lumen  2  and conduit  18  includes at least one conventional seal  31  at the proximal end and/or the distal end. Seal(s)  31  prevent fluid from leaking back from the uterus  44   a  around conduit  18  and through lumen  2 . 
     Conduit  18  contains lumen  4  which connects fluid flowing from syringe  24  to balloon  52 , through three position valve  20 . Lumen  4  also contains conduit  32  which contains lumen  5  which connects fluid flowing from syringe  24  to liquid orifice  54 , through three position valve  20 . Liquid orifice  54  can be alternately positioned in conduit  18 , such as axially, as long as liquid orifice  54  is distal to balloon  52 . 
     Lumen  4  can also contain conduit  34  which includes lumen  6 . Lumen  6  contains probe  35  which can have a handle portion  36  at the proximal end and a sonogenic tip  72  at the distal end. A sonogenic or echogenic tip is made of known material that enhances the echo received from ultrasonic testing. Sonogenic tip  72  can include a protective end portion or cap  73  which prevents tissue damage during insertion but can still be used to catheterize blockages found, as described herein below. Probe  35 , between handle  36  and sonogenic tip  72 , can be made of metal such as a wire, or can be plastic, or can include a portion that is plastic and a portion that is metal. Protective end cap  73  can be made of plastic or similar material. 
     The interface between lumen  6  and probe  35  can include a seal  33  at the distal end, and/or proximate end (not shown) to prevent liquid from leaking back into lumen  6  from the fallopian tube  46 . 
     Each of the lumens  1  through  5  provide separate and independent passages for the transfer and delivery of the saline liquid to inflate the elastic balloons  48  and  52  and deliver fluid to liquid orifices  50  and  54 . 
     The lumen housing  12 , and the conduit utilized in the invention, may be made of suitable plastics as known in the art, such as polypropylenes, polyesters, polyvinyl chloride, or other suitable conduit material for the transport of saline liquids. The device may be extruded or formed together as a series of tubes. 
     The balloons  48  and  52  are essentially thin sheets of latex that are adhered in conventional manner, such as glued, to the corresponding supply tubes in such a way as to inflate circumferentially through the injection of liquid through lumens  1  and  4 , causing the elastic latex balloon to inflate outwardly circumferentially, forming a seal across the fallopian and cervical openings. Valves  16  and  20  can be turned on and off so that once fluid is injected, inflating the balloon, the valves  16  and  20  are shut off, holding the balloon in a filled or expanded position. 
     FIG. 3 shows the distal end of conduit  18  having aperture  54  through which the saline fluid is injected and delivered to the fallopian tube  46 . Balloon  52  is shown in a collapsed position, but is a latex band that can be expanded by providing liquid through lumen  4 . Probe  35 , sonogenic tip  72 , and protective cap  73  are illustrated extending through seal  33 . 
     FIG. 4 is a cross-sectional view of the preferred embodiment of lumen housing  12  illustrating the relationship between lumen  1 - 6 , conduit  18 ,  30 ,  32 , and  34 , and probe  35 . 
     Referring to FIG. 5, aperture  50 , which is formed in lumen housing  12 , allows fluid to be dispensed into the uterus after balloon  48  has been expanded by manually setting three position valve  16  to the appropriate position for inflation, and depressing plunger  26  of syringe  22  (FIGS.  1  and  2 ). Conduit  18  can then be manually inserted through the uterus  44   a  toward the fallopian tube  46 . 
     Referring to FIG. 6, a schematic representation of fallopian tube  46  is shown with an inflated balloon  52  sealing the entrance to the fallopian tube  46 , allowing a liquid to be dispensed through aperture  54 , which would fill the fallopian tube. Once conduit  18  is inserted into the fallopian tube area, the surgeon manually inflates balloon  52  by setting the three position valve  20  to the appropriate position for inflation, and depressing plunger  28  on syringe  24  (FIGS. 1 and 2) to seal the fallopian tube  46 . 
     Referring back to FIG. 1, the overall method used in the present invention is to insert the distal end of the catheter  10  into the cervix opening  44  of the uterus  44   a.  At this time, the distal end of conduit  18  will be essentially at the distal end of catheter  10 . When balloon  48  is in position in the cervical opening  44 , balloon  48  is manually inflated by setting three position valve  16  to the appropriate position for inflation, and depressing plunger  26  of syringe  22 . The inflation position of three position valve  16  connects lumen  1  between syringe  22  and balloon  48  and seals off lumen  3 . 
     Once balloon  48  is inflated sealing the opening to the uterus  44   a,  three position valve  16  is manually set to the fill position, and plunger  26  is depressed in syringe  22  to inject saline fluid through orifice  50  filling uterus  44   a.  The fill position of three position valve  16  connects lumen  3  between syringe  22  and liquid orifice  50 , and seals off lumen  1 . Three position valve  16  can then be manually turned to the off position sealing lumens  1  and  3 . 
     Next, conduit  18  is manually inserted through lumen  2  in lumen housing  12 , and manipulated toward the fallopian tube of interest. Conduit  18  can include a permanent curve  70 , to align the distal end of conduit  18  with one or the other fallopian tubes by rotation of the device by the operating surgeon. 
     Since the distance between balloon  48  and balloon  52  is adjustable, with balloon  48  in the cervical opening, balloon  52  can be properly positioned within the fallopian tube  46  to permit sealing of the fallopian tube when balloon  52  is inflated. Once the positioning has been accomplished, fluid is then introduced to inflate balloon  52  and seal it tightly against the walls of the fallopian tube  46  by manual setting of three position valve  20  to the inflation position and depressing plunger  28  of syringe  24 . The inflation position of three position valve  20  connects lumen  4  between syringe  24  and balloon  52 , and seals off lumen  5 . 
     Once balloon  52  is inflated sealing fallopian tube  46 , three position valve  20  is manually set to the fill position, and plunger  28  is depressed in syringe  24  to inject saline fluid through orifice  54 , filling fallopian tube  46 . The fill position of three position valve  20  connects lumen  5  between syringe  24  and liquid orifice  54 , and seals off lumen  4 . Three position valve  20  can then be manually turned to the off position sealing lumens  4  and  5 . 
     At this point in time, both the fallopian tube cavity and the uterine cavity are filled with saline solution to allow proper ultrasonic examination in both areas. 
     The catheter  10  may also include probe  35  delivered through lumen  6  in conduit  34  which can catheterize detected blockages found beyond the distal end of conduit  18  by insertion of probe  35 . Echogenic tip  72  of probe  35  can be utilized to enhance ultrasonic analysis. Tip  72  can have a protective end cap  73 , which may be plastic, to prevent unwanted damage to surrounding tissue during insertion of conduit  18  and/or probe  35 , but that can still catheterize blockages. 
     Lumen housing  12  can include seal  31 , which can be an o-ring, shaft seal, or other seal to prevent fluid within uterus  44   a  from leaking back into or entering lumen housing  12  at the slidable interface with conduit  18 . Likewise, conduit  34  can include seal  33 , which can be similar to seal  31 , to keep fluid that is within fallopian tube  46  from entering conduit  34  at the slidable interface with probe  35 . 
     The instant invention has been shown and described herein in what is considered to be the most practical and preferred embodiment. It is recognized, however, that departures may be made therefrom within the scope of the invention and that obvious modifications will occur to a person skilled in the art.