Abstract:
Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1). Field of the Invention 
         [0002]    The field of the invention relates to methods and apparatuses for determining fallopian tube occlusion. 
         [0003]    2). Discussion of Related Art 
         [0004]    Female sterilization prevents pregnancy by occluding or mechanically blocking the fallopian tubes. There are several different occlusion techniques—tubes can be tied or “ligated,” blocked with mechanical devices such as clips or rings, or scarred closed with electric current. 
         [0005]    In partial salpingectomy, the fallopian tubes are cut and tied with suture material. The Pomeroy technique, a widely used version of partial salpingectomy, involves tying a small loop of the tube and cutting off the top segment of the loop. 
         [0006]    Clips are used to block the fallopian tubes by clamping down and cutting off the blood supply to a portion of the tubes, causing a small amount of scarring or fibrosis that prevents fertilization from occurring. The two most common clips are the Filshie clip, made of titanium, and the Wolf clip (also known as the Hulka clip), made of plastic. Clips are simple to use, but each type requires a special applicator. 
         [0007]    Tubal rings, like clips, also block the tubes mechanically. A very small loop of the fallopian tube is pulled through the stretched ring. When the ring is released, it stops the blood supply to that small loop. The resulting scarring blocks passage of the sperm or egg. The Yoon Ring, made of silicone, is widely used. 
         [0008]    Electrocoagulation uses electric current to coagulate or burn a small portion of each fallopian tube. Unipolar coagulation passes current through the forceps applied on the tubes, and the current leaves a woman&#39;s body through an electrode placed under her thigh. In bipolar coagulation, current enters and leaves a woman through two ends of the forceps. 
         [0009]    Occlusion device applied transcervically such as the ESSURE® device manufactured by CONCEPTUS, INC. are also used to permanently block the fallopian tubes. 
         [0010]    Hysterosalpingography (HSG) is a known method for determining whether a fallopian tube has been successfully occluded. In HSG, the uterus is pressurized with a fluoroscopically visual fluid. A radiologist fluoroscopically monitors the fallopian tubes to see if the fluid escapes past the occluded portion. Fluid seen escaping and filling the fallopian tubes, for example near the ovaries would indicate that the fallopian tubes are not occluded and that the patient may still be fertile. HSG is problematic in that it requires a radiologist to be present and also requires the use of specialized equipment. Thus HSG also cannot be performed in a doctor&#39;s office. 
       SUMMARY OF THE DESCRIPTION 
       [0011]    The invention includes in one embodiment a method to detect fallopian tube occlusion, including visually identifying the cornua of a fallopian tube through a transcervical approach, wherein the fallopian tube was subjected to a procedure to attempt to occlude the fallopian tube, coupling a device to a cornua to fluidly separate the cornua from the remainder of the uterus, pressurizing the cornua, and monitoring the pressurization of the cornua to determine if the fallopian tube is occluded. 
         [0012]    The device may be coupled to the cornua by an inflatable member of the device. 
         [0013]    The inflatable member may be coupled to the cornua by applying force against the cornua. 
         [0014]    The inflatable member may be coupled to the cornua by a applying a vacuum between the inflatable member and the cornua. 
         [0015]    The cornua may be inflated to a pressure greater than 500 mmHg. 
         [0016]    The method may be used with no fluoroscopic visualization of the procedure. 
         [0017]    The inflatable member is configured to separate the first cornua and a second cornua from the remainder of the uterus by occupying a uterine cavity. 
         [0018]    The inflatable member has at least one first lumen that is configured to pressurize the first cornua, the at least one first lumen extending through the inflatable member to align with the first fallopian tube. 
         [0019]    The inflatable member has at least one second lumen that is configured to pressurize the second cornua. The at least one second lumen extends through the inflatable member to align with a second fallopian tube and is capable of being activated simultaneously with the at least one first lumen. 
         [0020]    The invention includes in one embodiment a method to determine fallopian tube occlusion, comprising distending a uterus with a first fluid, the uterus including at least one fallopian tube and cornua of the fallopian tube, wherein the fallopian tube was subjected to a procedure to attempt to occlude the fallopian tube, visually identifying the cornua of a fallopian tube through a transcervical approach, coupling a device to the cornua to fluidly separate a sealed portion of the cornua from the remainder of the uterus, applying a vacuum to the sealed portion of the cornua to evacuate a first fluid in the sealed portion of the cornua, pressurizing the cornua with a second fluid, and monitoring the volume of the cornua to determine if the fallopian tube is occluded. 
         [0021]    The device may be coupled to the cornua by an inflatable member of the device. 
         [0022]    The inflatable member may be coupled to the cornua by applying force against the cornua. 
         [0023]    The inflatable member may be coupled to the cornua by a applying a vacuum between the inflatable member and the cornua. 
         [0024]    The cornua may be inflated to a pressure greater than 500 mmHg. 
         [0025]    The second fluid may be visually differentiated from the first fluid. 
         [0026]    The method may additionally include visually confirming that the second fluid does not leak into the first fluid past the device, 
         [0027]    The first fluid removed from the cornua portion may be measured. 
         [0028]    The fallopian tube may be determined to be permanently occluded by the implanted occlusion device by determining if there is more of the second fluid inserted in the evacuated portion of the cornua than of the first fluid removed from the evacuated portion of the cornua. 
         [0029]    The second fluid may be non-soluble with the first fluid. 
         [0030]    The method may be used with no fluoroscopic visualization of the procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0031]    The invention is further described by way of example(s) with reference to the accompanying drawings, wherein: 
           [0032]      FIG. 1  is a cross section of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device. 
           [0033]      FIGS. 2A-2C  show cross sections of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device and a method to determine if the fallopian tube is fully occluded. 
           [0034]      FIGS. 3A and 3B  show cross sections of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device and a method to determine if the fallopian tube is fully occluded. 
           [0035]      FIGS. 4A-4C  show cross sections of devices which may be used to determine if a fallopian tube is fully occluded. 
           [0036]      FIGS. 5A-5D  show cross sections of a uterus including a utero-tubal junction and cornua, and a method to determine if the fallopian tube is fully occluded, according to another embodiment. 
           [0037]      FIGS. 6A and 6B  show cross sections of a uterus including a utero-tubal junction and cornua, and a method to determine if the fallopian tube is fully occluded, according to another embodiment. 
           [0038]      FIG. 7  shows a pump for providing pressure, according to one embodiment. 
           [0039]      FIGS. 8A and 8B  show cross sections of various embodiments of devices which may be used to determine if a fallopian tube is fully occluded. 
           [0040]      FIGS. 9A-9D  show catheter cross sections of various embodiments used to determine if a fallopian tube is fully occluded. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]      FIG. 1  shows a cross section  100  of an ostium or cornua  102  of a uterus. The ostium or cornua  102  is considered to be the flower like opening of a fallopian tube and lies between the greater uterus and the utero-tubal junction  104  (hereinafter, “UTJ”). A previously placed implant  106  is shown placed in the UTJ. The function of the implant is to serve as a platform for encouraging tissue growth occlusion, as shown by the cross-hatched area. When the UTJ has been fully occluded by tissue growth, typically 3 months after implantation, the fallopian tube will no longer be viable for fertilization. The fallopian tube may also be sealed by other known operations, such as partial salpingectomy, electro-cauterization, or clips or rings applied externally to the fallopian tube. The methods and apparatuses described herein apply equally to all forms of tubal ligation. 
         [0042]    The implant  106  includes a proximal portion that extends into the ostium or cornua  102 . The proximal portion of the implant  106  serves as a visual indicator of the placement of the implant  106 . Devices such as the ESSURE® device manufactured by CONCEPTUS, INC. include tail like visual indicators. Not all fallopian tube implants include such indicators. Even with a visual indicator, which shows only positive placement, the device may not fully occlude the utero-tubal junction  104 . 
         [0043]      FIG. 2A  illustrates one embodiment of the invention for determining whether a fallopian tube is occluded. The fallopian tube shows a previously placed occlusion device  106 . A device  200  is shown coupled to the ostium or cornua  102  of a uterus. The device  200  may be delivered to the ostium or cornua  102  by a hysteroscope which is transcervically approached through the vagina of the patient. The uterus is also typically distended with a working fluid, such as saline. The cornua  102  is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor. 
         [0044]    As shown, the device  200  includes an a sealing member  210  to fluidly seal and separate a portion of the ostium or cornua  102  from the remainder of the uterus to create a sealed region. The sealing member  210  is preferably inflatable, although this is not a requirement of this embodiment of the invention. Force is applied by the operator of the device  200  to seal the sealing member  210  against the ostium or cornua  102 . In one embodiment, the sealing member  210  has an inflated diameter of the cornua  102  so that a sealed region is created regardless of the expansion and contractions of the cornua  102 . 
         [0045]    In one embodiment, the sealing member  210  includes a biocompatible adhesive  212  capable of creating a seal between the sealing member  210  and the endometrium of the uterus. In one embodiment, the biocompatible adhesive  212  is located along an outer circumference of the sealing member  210  between the sealing member  210  and endometrial layer. It is understood that the adhesive  212  may be strategically applied in specific locations around the sealing member  210  circumference to ensure the sealing member  210  engages with the endometrium. It is also understood that the biocompatible adhesive  212  can be any known adhesive such as wet adhesives, synthetic, natural, bio-adhesives, hydrogels, resins or any other adhesive suitable for application in the uterus. 
         [0046]    In one embodiment, the adhesive  212  is a temporary adhesive application and may remove a portion of the endometrium upon removal of the sealing member  210 . However, the adhesive  212  should not cause the removal of any portion of the myometrium upon removal of the sealing member  210 . 
         [0047]      FIG. 2B  shows the device  200  applying a positive pressure through lumen  210 , as shown by the “+” marks, within a sealed portion of the cornua  102 . A pressure monitor, such as a pressure gauge, is also coupled to the lumen  210 . Pressure is applied for a set amount of time, for example 30 seconds to 3 minutes, to determine if the sealed portion will hold pressure. If the sealed portion is able to maintain a desired amount of pressure for a predetermined amount of time, one may be able to positively determine whether the fallopian tube is fully occluded. A pressure drop will show that the fallopian tube is not fully occluded. 
         [0048]    The amount of pressure applied must be large enough to determine whether the fallopian tube is positively occluded. The fallopian tube may also be naturally and temporarily blocked. Past tests have determined that as much as 500 mmHg is required to remove a temporary blockage from a fallopian tube. In another embodiment, a minimum pressure is about 50 mmHg while a maximum pressure is about 350 mmHg. In one embodiment, an ideal range of pressure is about 90-120 mmHg. Care should be taken such that enough pressure is applied to the cornua  102  to determine whether the fallopian tube is positively occluded while preserving the temporarily blocked fallopian tube. Pressures greater than 500 mmHg may be applied in order to determine intentional fallopian tube occlusion, for example 700-2000 mmHg. 
         [0049]    This method is advantageous over previous method of determining whether a fallopian tube is occluded by previously implanted occlusion devices. Previous methods required pressurization of the entire uterus with a fluoroscopically visible fluid, known as Hysterosalpingography (HSG). A radiologist monitored the fallopian tubes via an x-ray device to determine if the fluoroscopically visible fluid leaks past the previously implanted occlusion devices. This prior art procedure is costly, because it requires the presence of a radiologist and specialized x-ray equipment. The current invention does not require fluoroscopic visualization of the procedure, and may be performed with a less specialized environment, such as a doctor&#39;s office. The sealing member  210  may also include an adhesive as previously described above. 
         [0050]      FIG. 2C  shows an alternative embodiment of a method for determining whether a fallopian tube is occluded. The fallopian tube shows a previously placed occlusion device  106 . A device  220  is shown coupled to the ostium or cornua  102  of a uterus. The device  220  may be delivered to the ostium or cornua  102  by a hysteroscope which is transcervically approached through the vagina of the patient. The uterus is also typically distended with a working fluid, such as saline. The cornua is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor. 
         [0051]    As shown, the device  220  includes an a sealing member  230  to fluidly seal and separate a portion of the cornua from the remainder of the uterus. The sealing member  230  is preferably inflatable, although this is not a requirement of this embodiment of the invention. The sealing member  230  features sealing chambers  240  circumferentially surrounding the sealing member  230 . The sealing member may be defined by two prominent sections of the sealing member  230 . A vacuum is applied through vacuum lumens  250  to positively seal the sealing member to the cornua  102 . A vacuum source (not shown) as known to one commonly skilled in the art, such as a pump, is also coupled to the vacuum lumens  250 . 
         [0052]      FIG. 2C  shows the device  200  applying a positive pressure through lumen  260 , as shown by the “+” marks, with in sealed portion of the cornua. A pressure monitor (not shown) as commonly known to ones skilled in the art, such as a pressure gauge, is also coupled to the lumen  260 . Pressure is applied for a set amount of time, for example 30 seconds to 3 minutes, to determine if the sealed portion will hold pressure. If the sealed portion is able to maintain a desired amount of pressure for a predetermined amount of time, one may be able to positively determine whether the fallopian tube is fully occluded. A pressure drop will show that the fallopian tube is not fully occluded. 
         [0053]    This method is particularly advantageous because it allows an operator remove his hands from device  220 , while simultaneously maintaining a positive seal against the cornua. In one embodiment, a bio-adhesive  262  may located on circumferential portions of the prominent sections of the sealing member  230  to ensure a sealed engagement between the sealing member  230  and the endometrium. 
         [0054]      FIG. 3A  illustrates one embodiment of the invention for determining whether a fallopian tube is occluded. The fallopian tube shows a previously placed occlusion device  106 . A device  300  is shown coupled to the cornua  102  of a uterus. The device  300  may be delivered to the cornua by a hysteroscope which is transcervically approached through the vagina of the patient. The uterus is also typically distended with a working fluid, such as saline. The cornua is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor. 
         [0055]    As shown, the device  300  includes a sealing member  310  to fluidly seal and separate a portion of the cornua from the remainder of the uterus. The sealing member  310  is preferably inflatable, although this is not a requirement of this embodiment invention. Force is applied by the operator of the device  300  to seal the sealing member  310  against the cornua  102 . Alternatively the device  300  may use a vacuum to seal the sealing member  310  against the cornua such as shown in  FIG. 2C . 
         [0056]      FIG. 3A  shows the device  200  applying a negative pressure through a first lumen  320 , as shown by the “−” marks, within the sealed portion of the cornua. Distension fluid is then evacuated from the sealed portion and measured using a measuring device as known to one commonly skilled in the art, such as a marked syringe. The amount of fluid evacuated will typically be small, for example 1 cc or less, given that the volume of the sealed cornua is small. 
         [0057]      FIG. 3B  shows a second lumen  330  supplying a second fluid to replace the distension fluid. The second fluid is pressurized in a device as described in  FIGS. 2A-2C , however it is not necessary to monitor the pressure. The pressure may be mechanically set by a pressure source as known to one commonly skilled in the art, such as a syringe or pump coupled to a lockable leur, which is in turn coupled to lumen  330 . 
         [0058]    The volume of the second fluid applied is measured to determine if it is greater than the amount of distension fluid removed. If the volumes are equal or close, for example within 10%, then the fallopian tube is determined to be positively occluded by the occlusion device I. 
         [0059]    If the volume of the second fluid is significantly greater than the amount removed, for example more than 20%, then the second fluid likely leaked past the utero-tubal junction and occlusion device  106 . Thus it follows that the occlusion device is not fully occluding the utero-tubal junction. The volume of the lumen  330  should be considered when calculating the volume of the second fluid applied into the evacuated portion of the cornua. 
         [0060]    The second fluid may be visually differentiated from the distension fluid, for example colored with a green dye. This aids in visually determining if any leaks exist between the sealing member  310  and cornua. The second fluid may also be non-soluble along with the distension fluid, for example bio-compatible vegetable or mineral oil. In that case, both the distension fluid and second fluid may be measured using the same container, e.g. a single syringe, without intermixing between the fluids. 
         [0061]    This method is advantageous over previous method of determining whether a fallopian tube is occluded by previously implanted occlusion devices. Previous methods required pressurization of the entire uterus with a fluoroscopically visible fluid, known as Hysterosalpingography (HSG). This embodiment does not require fluoroscopic visualization of the procedure, and may be performed with a less specialized environment, such as a doctor&#39;s office. 
         [0062]      FIG. 4A  shows one embodiment of a catheter  400  for use in methods described herein. The catheter includes an inflatable member  410 , and a lumen  420  for pressurizing a cornua of a fallopian tube. The inflatable member  410  may be characterized as a circular shaped balloon. Balloon catheters, materials, and methods of construction are well known in the art, for example as shown in U.S. Patents: U.S. Pat. No. 5,522,961, U.S. Pat. No. 6,585,687, and U.S. Pat. No. 6,024,722, all of which are respectively incorporated herein by reference in their respective entirety. Appropriate coupling devices, such as leurs (not shown) are coupled to the proximal portion of the catheter  400  for adding suitable pressures or vacuums to inflatable member  440  and the remaining lumens. The catheter is of a suitable working length for use in a transcervical environment, for example 400 mm. 
         [0063]    In one embodiment, a back portion  482  of the inflatable member  410  is a concave shape. In another embodiment, the back portion  484  of the inflatable member  410  is a convex shape. A specific concave or convex shape can be selected depending on the curvature of the cornua. 
         [0064]      FIG. 4B  shows one embodiment of a catheter  430  for use in methods described herein. The catheter includes an inflatable member  440 , and a lumen  450  for pressurizing a cornua of a fallopian tube. It is understood that the lumen  450  can also include a first and second lumen, as shown in  FIG. 4C . The inflatable member  440 , may be characterized as a circular shaped balloon with at least two prominent sections  440   a  and  440   b.  A vacuum space exists between sections  440   a  and  440   b  for application of a vacuum by lumens  460  for sealing the inflatable member to a cornua of a fallopian tube. Appropriate coupling devices, such as leurs (not shown) are coupled to the proximal portion of the catheter  430  for adding suitable pressures or vacuums to inflatable member  440  and the remaining lumens. The catheter is of a suitable working length for use in a transcervical environment, for example 400 mm. 
         [0065]      FIG. 4C  shows one embodiment of a catheter  470 , and a first  476  and second  478  lumen, similar to the embodiment shown in  FIG. 3A . Again, the inflatable member  472  is characterized by a circular shape and two prominent radial portions  472   a,    472   b  extending in a perpendicular direction transverse to the longitudinal axis of the first  476  and second lumen  478 . The first  472   a  and second  472   b  prominent portions form a circular vacuum space  474  which will engage the cornual wall, as already described. A vacuum suction is created within the vacuum space  474  through the vacuum lumen  480 . The same fluid distension technique can be applied to the catheter  470  through the first  476  and second  478  lumen, as already described in  FIGS. 3A and 3B . 
         [0066]      FIG. 5A  shows an arrangement  500  having an outer catheter or sheath  502  with a proximal end and a distal end being inserted into a uterus  510  with previously occluded portions  514 . The sheath  502  is made from a material such as stainless steel, Teflon, silicone, or other known materials and may be flexible or rigid. In one embodiment, the sheath  502  can have a length in a range of about 12 cm to about 25 cm and a diameter in a range of 0.4 cm to about 0.8 cm. 
         [0067]    The sheath  502  contains two inner catheters  504 . The two inner catheters  504  are shown in a collapsed position within the outer sheath  502  with respective balloon end portions  506  located near the distal end of the sheath  502 . As shown, the balloon end portions  506  are not inflated when located within the outer catheter or sheath  502 . 
         [0068]    In addition, an outer sheath balloon  508  is connected with the outer sheath  502 . The outer sheath balloon  508  remains in a deflated configuration upon insertion of the outer sheath  502  into the cervix. 
         [0069]      FIG. 5B  shows the outer sheath  502  being inserted into the uterus so that a distal portion of the outer sheath  502  is located near the fundus region  512  of the uterus  510 . The inner catheters  504  are exposed by either advancing the inner catheters  504  or by retracting the outer sheath  502 . The balloon end portions  506  are in a deflated configuration when the inner catheters  504  are in a collapsed position. Upon reaching a desired position,  FIG. 5B  illustrates the outer sheath balloon  508  being inflated to engage the walls of the cervical canal to create a sealed upper region of the uterus  510 . The engagement of the outer sheath balloon  508  prevents unwanted movement during subsequent procedures. The outer sheath balloon  508  is connected with a first air or fluid source  516  for inflating the outer sheath balloon  508 . The sheath  502  is also connected with a second air or fluid source  520  and a vacuum source  526  as will be discussed in further detail. 
         [0070]      FIG. 5C  shows the inner catheters  504  being moved from a collapsed position to an open and extended Y-shaped position. The first catheter  504   a  is movable to seal a first cornua  518   a  and the second catheter  504   b  is movable to seal a second cornua  518   b.  The inner catheters  504  can be configured to create pressure within a respective cornua region  518  according to any of the embodiments previously described. Moreover, the inner catheters  504  can be configured to apply a fluid distension technique according to any of the embodiments already described. 
         [0071]      FIG. 5C  further shows a first balloon end portion  506   a  being inflated by the first air or fluid source  516 . In one embodiment, the air or fluid source can be a single source that can selectively allow air or fluid to flow to the outer sheath balloon  508  or the end balloon portions  506  through the use of a valve (not shown). It is understood that, in one embodiment, the outer sheath balloon  508  may not be necessary and may be removed or inactivated. In another embodiment, separate air or fluid sources may be used. In one embodiment, a separate air or fluid source  520  is provided to apply pressure or fluid distension to the cornua regions  518   a,    518   b  through lumens within the inner catheters  504  as already described. In one embodiment, the air source  520  is a hand pump with a gauge of pressure. In another embodiment, the fluid source  520  is a syringe. 
         [0072]    In one embodiment, a spring mechanism  522  is biased to expand the inner catheters  504  to an open Y-position. A wire  524  is connected with the spring mechanism  522  to activate or retract the spring mechanism  522  so that the inner catheters  504  can move from an open Y-position to a closed collapsed position. In one embodiment, the user may pull on the wire  524  to cause the spring mechanism  522  to retract causing the inner catheters  504  to collapse. It is understood that a spring mechanism that expands upon pulling of the wire  524  may be provided. 
         [0073]      FIG. 5D  further shows an embodiment  528  similar to  FIG. 5C . However, the end balloon portions  506  have a vacuum cavity as described in  FIGS. 2C ,  4 B, and  4 C. The vacuum cavity engages the cornual walls and creates a sealed region for determining whether a fallopian tube is patent as previously described. A vacuum is created within the vacuum cavity through a vacuum source  526  and lumens within the catheter as previously described. The vacuum source  526  can also be utilized to deflate the outer sheath balloon  508  and end balloon portions  506  to a collapsed position for withdrawal from the uterus. A collapsed withdrawal position would be similar to the insertion configuration shown in  FIG. 5A . 
         [0074]      FIG. 6A  shows another embodiment  600  where a catheter or sheath  602  having similar dimensions as already described is inserted into the uterus  604  having occluded regions  614 . The sheath  602  has a proximal end and a distal end.  FIG. 6A  further shows the proximal end of the catheter including a uterine balloon  606  in a collapsed position. An outer sheath balloon  608  is shown in a collapsed position located at a mid-portion of the sheath  602 . In a collapsed position, the uterus balloon  606  is inserted through the cervix and into the uterus toward the fundus region. The uterine balloon  606  is connected with an air or fluid source  610  through a lumen of the catheter  602 . The uterine balloon  606  is also connected with a vacuum source  612  through a catheter lumen. It is understood that the outer sheath balloon  608  may be connected with the same air or fluid source  610  and vacuum source  612  for selective inflation and collapse. In one embodiment, the outer sheath balloon  608  may be inflated or collapsed independently from the uterine balloon  606 . 
         [0075]      FIG. 6B  shows the same embodiment described in  FIG. 6A  when the uterine balloon  606  and outer sheath balloon  608  are expanded. It is understood that the outer sheath balloon  608  may be removed or inactive, according to one embodiment. However, as shown in  FIG. 6B , the outer sheath balloon  608  is expanded to engage the cervical canal wall while the uterine balloon  606  fills the uterine cavity and engages with the cornual regions of the uterus  604 . In one embodiment, the balloon  606  may not conform or fill the entire uterine cavity but it is configured to provide a full engagement with the cornual regions of the uterus without filling the entire uterine cavity. 
         [0076]    The uterine balloon  606  has a triangular or heart-shaped configuration when inflated. The uterine cavity is expandable so that it may stretch or adjust to the inflated uterine balloon  606  so that two sealed regions  620   a,    620   b  are created. The sealed regions  620   a,    620   b  created are air tight or fluid tight if the occluded areas  614  are not patent. The uterine balloon  606  engages the fundus and the cornua of the uterus to create a sealed region. As mentioned, the uterine balloon  606  is inflatable with air, water, saline solution, or any other known fluid. 
         [0077]    The uterine balloon  606  also includes a first tube  616  and a second tube  618  within the inflated balloon  606 . The first tube  616  extends from a distal end of the catheter  602  to an upper corner region of the uterine balloon  606  to align with the tubal ostia. The first tube  616  includes a distal opening into the first sealed region  620   a  of the uterus  604 . The second tube  618  includes a distal opening into the second sealed region  620   b  of the uterus  604  to align with the tubal ostia. It is understood that the first  616  and second tubes  618  may remain flush with an outer surface of the uterine balloon  606  or may extend beyond the outer surface of the uterine balloon  606  protruding into the sealed regions  620   a,    620   b.  The first  616  and second tube  618  are coupled to lumens within the catheter  602 , as will be described in further detail. 
         [0078]    After the sealed regions  620   a,    620   b  are created, a second air or fluid pressure source  622  creates a pressure within the first tube  616 , second tube  618 , and sealed regions  620   a,    620   b.  In one embodiment, a hand pump provides the necessary pressure. In another embodiment, bio-adhesives (as previously described) may be strategically applied on the outer surface of the uterine balloon  606  to ensure the balloon  606  is engaged with the endometrium to create a sealed region. 
         [0079]      FIG. 7  shows an exemplary hand pump  700  for providing a pressure to the sealed regions  620   a,    620   b.  The hand pump  700  includes a pump handle  702 , a dial  704 , a connecting piece  706 , and a relief valve  708 . The pump handle  702  is made of an elastic material such as rubber or silicone that compresses air when a user closes his or her grip. When a user releases his or her grip, the handle  702  returns to an initial uncompressed state. The dial  704  indicates to the user how much pressure is created within the sealed regions  620   a,    620   b.  In one embodiment, a minimum pressure of 50 mmHg is provided or a maximum of 350 mmHg. An ideal pressure range is 90-120 mmHg to determine whether the fallopian tube is successfully occluded. A check valve  708  is connected with the hand pump  700  to allow excess pressure to escape when a predetermined value is reached. For example, in one embodiment, the check valve can be configured to release pressure above 350 mmHg to opening a fallopian tube or dislodging an implant. Therefore, when the user squeezes the pump handle  702  when the dial is reading 350 mmHg, the check valve releases any excess pressure. The connecting piece  706  is connected to a catheter  710 . The catheter  710  can be of the same configuration and type of any catheter described in this application. Of course, if a fallopian tube is patent, the dial  704  will indicate a pressure drop so the user will know the regions  620   a,    620   b  are not sealed. It is understood that negative or positive pressure can be applied by the hand pump  700  and the pump may be an automatic pump, according to one embodiment. 
         [0080]      FIG. 8A  illustrates an exemplary embodiment of a uterine balloon  800  similar to the one shown in  FIG. 613 . The first  802  and second  804  tubes are shown protruding slightly beyond an outer surface  806  of the uterine balloon  800 . The inner wall  808  of the uterine balloon  800  defines an inflation cavity  810  where the air, water, saline, or other liquid fills the balloon  800  for inflation. The balloon  800  can be made from an elastic material such as silicone, latex, urethane, and other known flexible polymers. In one embodiment, the uterine balloon  800  is slightly larger than a typical uterus size. In one embodiment, the balloon  800  has an inflated width dimension  812  of 1.6-3.0 cm depending on the size of a patient&#39;s uterus. In another embodiment, the inflated width dimension  812  is at least 3.0 cm to ensure the balloon seals and engages with the fundal width. In one embodiment, the balloon  800  has an inflated length dimension  814  of 5-8 cm. In another embodiment, the inflated length dimension  814  is at least 8 cm to ensure the balloon seals and engages the uterus length. In yet another embodiment, the balloon can have an inflated width in a range from about 3-4 cm, a height in a range of about 5-7 cm, and a depth range of about 1-1.5 cm. A pressure of about 150-250 mmHg can be used to inflate the balloon. 
         [0081]    As previously mentioned, the first  802  and second  804  tubes can be individually connected with a pressure source  816  such as the hand pump and gauge described in  FIG. 7 . The advantage of having an individual tube and gauge connection is that each fallopian tube can be verified independently of the other fallopian tube. In one embodiment, a different pressure is provided in the first tube  802  and second tube  804  so that the individual verification of each tube can be easily achieved. In one embodiment, more than one hand pump or gauge  816  can be connected with the balloon  800 . 
         [0082]    The first  802  and second  804  tubes can be made from a material including nylon, Teflon, silicone, tygon, polyethylene, and any other known flexible polymer. In one embodiment, the tubal openings can be in the range of about 0.1-0.3 cm. 
         [0083]      FIG. 8B  illustrates another embodiment of a uterine balloon  818  having the same shape and dimensions as described above. The uterine balloon  818  includes a first pair of tubes  820  and a second pair of tubes  822  extending from a distal end of the catheter  824  to a respective sealed region in alignment with a tubal ostia. The first  820  and second pair of tubes  822  together form a Y-shape as previously described. 
         [0084]    The first pair of tubes  820  include a first lumen  820   a  and a second lumen  820   b.  As described in  FIG. 3A , a negative pressure is applied through the first lumen  820   a  within the sealed portion of the cornua. Distension fluid is evacuated from the sealed portion and measured using a measuring device  826  such as a marked syringe. It is understood that a separate syringe may be provided for each individual lumen or the same single syringe may be movable between each lumen. Again, a small amount of fluid can be evacuated such as 1 cc or less. 
         [0085]    The second lumen  820   b  can supply a second fluid to replace the distension fluid. The volume of the second fluid applied is measured to determine if it is greater than the amount of distension fluid removed. As previously mentioned, if the volumes are equal or close (within 10%), the fallopian tube is determined to be positively occluded by the occlusion device. 
         [0086]    On the other hand, if the volume of the second fluid is significantly greater than the amount removed, the second fluid is assumed to have leaked past the utero-tubal junction and occlusion device as previously described. 
         [0087]    The second pair of tubes  822  include a first lumen  822   a  for removing distension fluid and a second lumen  822   b  for replacing the fluid. The second pair of tubes  822  operate in the exact same manner as described above with respect to the first pair of tubes  820 . 
         [0088]      FIGS. 9A-9D  illustrate various catheter cross-sectional views that may be implemented in any of the embodiments previously discussed.  FIG. 9A  illustrates a catheter cross-section embodiment having a first lumen  902 , a second lumen  904  and a third lumen  906  within the outer sheath. In one embodiment, the first lumen  902  is used to deliver air, fluid, saline, or any gas or liquid to inflate an outer sheath balloon  508 ,  608  or end balloon  506 ,  606 . In addition, the first lumen  902  may be used to evacuate or vacuum the air or fluid. In one embodiment, the second  904  and third  906  lumen can be connected to inner catheters  504 ,  616  or the inner catheters can be located within the second and third lumen. 
         [0089]      FIG. 9B  shows another embodiment  908  having a first lumen  910 , a second lumen  912 , a third lumen  914 , a fourth lumen  916 , and a fifth lumen  918 . Again, the first lumen  902  provides air or fluid to the balloons and may also evacuate or vacuum the air or fluid. The second  912  and third  914  lumens operate to evacuate a distension fluid from respective catheters, as previously described. The fourth  916  and fifth  918  lumens allow a replacement fluid to be injected into a sealed region, as previously described. 
         [0090]      FIG. 9C  shows yet another cross-sectional embodiment  920  having a first lumen  922 , a second lumen  924 , a third lumen  926 , a fourth lumen  928 , a fifth lumen  930 , a sixth lumen  932 , and a seventh lumen  934 . The first lumen  922  acts primarily as a vacuum source while the second lumen  924  operates to fill the outer sheath balloon with air or fluid. The third lumen  926  primarily operates to fill the end balloon portions or uterine balloon with air or fluid. The fourth lumen  928  and fifth lumen  930  operate to vacuum or evacuate a distension fluid. The sixth  932  and seventh lumen  934  operate to inject a second fluid into the sealed region as previously described. 
         [0091]      FIG. 9D  shows another embodiment  936  having a first lumen  938 , a second lumen  940 , a third lumen  942 , a fourth lumen  944 , and a fifth lumen  946 . The first  938 , second  940 , and third lumen  942  operate in the same manner as the embodiment described in  FIG. 9C . The fourth  944  and fifth  946  lumen are provided to supply a monitoring pressure to the sealed region to determine if a respective fallopian tube is patent. The fourth lumen  944  correlates to one sealed region and the fifth lumen  946  correlates to a second sealed region of the cornua. 
         [0092]    Although the lumens show are generally a circular shape, it is understood that the lumen passages can be a variety of cross-sectional shapes including semi-circles, squares, rectangles and any other known shape for delivering air or fluid to a cornua for determining whether a fallopian tube is occluded. 
         [0093]    A significant advantage of the embodiments of the present invention is that the fallopian tubes can be tested for patency either individually or simultaneously. Having both cornual regions tested simultaneously results in reduced testing time and minimizes patient discomfort. 
         [0094]    While certain exemplary embodiments have been described and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative and not restrictive of the current invention, and that this invention is not restricted to the specific constructions and arrangements shown and described since modifications may occur to those ordinarily skilled in the art.