Abstract:
Systems and methods for determining fallopian tube occlusion are disclosed which may provide and more convenient manner of determining fallopian tube occlusion, particularly in relation to transcervical hysteroscopic sterilization with implantable inserts. In accordance with some embodiments, uterine pressure may be measured to determine occlusion with a fluid delivery system including a reservoir and a pressure monitoring device to measure a fluid pressure downstream from the reservoir.

Description:
BACKGROUND 
       [0001]    Embodiments of the present invention relate to the field of determining fallopian tube occlusion and in particular in relation to transcervical hysteroscopic sterilization. 
         [0002]    Female contraception and sterilization may be effected by transervically introducing an object into a fallopian tube to inhibit conception. Devices, systems and methods for such a contraceptive approach have been described in various patents and patent applications assigned to the present assignee. For example, U.S. Pat. No. 6,526,979, U.S. Pat. No. 6,634,361, U.S. patent application Ser. No. 11/165,733 published as U.S. Publication No. 2006/0293560 and U.S. patent application Ser. No. 12/605,304 describe transcervically inserting an insert (also referred to as implant and device) into an ostium of a fallopian tube and mechanically anchoring the insert within the fallopian tube. One example of such an assembly is known as “Essure”® from Conceptus, Inc. of Mountain View, Calif. Tissue in-growth into the “Essure”® insert provides long-term contraception and/or permanent sterilization without the need for surgical procedures. 
         [0003]    Several months after placement of the inserts within the fallopian tubes, a hysterosalpingography HSG procedure is typically utilized to determine whether the inserts have been properly positioned and whether the fallopian tubes have been occluded. During the HSG procedure a radiopaque contrast agent is injected into the uterine cavity in order to visually determine positioning of the inserts and occlusion of the fallopian tubes. HSG procedures are typically performed without controlling the injection pressure of the radiopaque contrast agent. 
       SUMMARY 
       [0004]    Embodiments of the present invention generally provide systems and methods for determining fallopian tube occlusion. In one embodiment, a dual lumen catheter fluid delivery system is described which may include a handle, a reservoir connected with the handle, an elongated shaft which houses a first and second lumens extending distally from the handle, and a pressure monitoring device to measure a fluid pressure downstream from the reservoir. For example, downstream fluid pressure may correspond to fluid pressure in the first or second lumens of fluid exiting the reservoir or fluid back pressure. The first lumen may be in operable communication with an inflatable balloon to deliver a fluid from the reservoir and into the inflatable balloon, and the second lumen may be in operable communication with an injection port distal to the inflatable balloon to deliver the fluid from the reservoir and through the injection port. The inflatable balloon may be used to form a seal against a cervix. Fluid delivered through the injection port may be used to pressurize a uterine cavity and determine whether the fallopian tubes are occluded. 
         [0005]    A selector may be provided on the handle in order to place either the first or second lumens in operable communication with the reservoir. For example, the selector may be moveable between a first position and second position, where the first position places the first lumen (to the inflatable balloon) in operable communication with the reservoir, and the second position places the second lumen (to the injection port) in operable communication with the reservoir. In an embodiment, the reservoir has a first and second ports, and the selector is rotatable to align one of the first or second lumens with one of the first or second ports to place the first or second lumen in operable communication with the reservoir. In another embodiment, the selector comprises a manifold and a selector rod including a T-valve which can be rotated to place the first or second lumen in operable communication with the reservoir. 
         [0006]    In accordance with embodiments of the present invention, fallopian tube occlusion may be easily and quickly determined with a hand held dual lumen catheter, where the handle and selector are sized and shaped to be gripped and operated by hand. The pressure monitoring device can measure the fluid pressure in the first lumen when the selector is in the first position. In this position, the pressure monitoring device may measure the balloon inflation pressure. The pressure monitoring device can also measure the fluid pressure in the second lumen when the selector is in the second position. In this position, the pressure monitoring device may measure the pressure in the uterine cavity. In some embodiments, the pressure monitoring device includes an analog dial display. Where the pressure monitoring device is utilized for measuring pressure in the second lumen, which corresponds to the uterine pressure, the analog dial display may include marked ranges to provide the operator with information. For example, the analog dial display can include a marked tubal occlusion pressure range, or a marked tubal perforation pressure range. The pressure monitoring device can also include a digital display. Similar to the analog dial, the digital display can include a tubal occlusion display message, or a tubal perforation display message. 
         [0007]    A syringe may be incorporated into the handle to deliver from or store the fluid in the reservoir. In an embodiment, the handle includes a pressure syringe with a piston that is moveable in and out of the handle to reduce and expand a volume of the reservoir. For example, the piston can be moved by pushing/sliding, or by rotating/screwing the piston. 
         [0008]    In accordance with embodiments of the present invention, a dual lumen catheter with pressure monitoring device may be operated with a modified HSG procedure. A speculum is inserted into a vagina, and the dual lumen catheter is inserted into the uterus through the cervix. The inflatable balloon of the dual lumen catheter is then inflated to hold the dual lumen catheter in place. A distention fluid is then injected through the injection port of the dual lumen catheter and into the uterine cavity as the fluid pressure is measured with the pressure monitoring device in order to determine whether the fallopian tubes have been occluded. It is not required for the distention fluid to contain a contrast agent. In one embodiment, the distention fluid is saline. Accordingly, the modified procedure may take place in an office setting, and it is not required to perform the modified procedure in an x-ray department of a hospital or large clinic. 
         [0009]    Operation of the dual lumen catheter may be performed by manipulating a piston and selector knob to place the first and second lumens of the dual lumen catheter in operable communication with a reservoir for storing the distention fluid. In an embodiment, the dual lumen catheter may be operated by advancing the piston to reduce the volume of the reservoir and push the distention fluid through the first lumen to inflate the inflatable balloon. After sealing the cervix with the inflatable balloon the selector knob may be moved from the first position to a second position to place the reservoir in operable communication with the second lumen. Then the piston may be advanced again to reduce the volume of the reservoir and push the distention fluid through the second lumen. The operator can then monitor the fluid pressure measured by the pressure monitoring device as the distention fluid is injected into the uterine cavity. For example, the measured fluid pressure can be monitored to determine whether the pair of fallopian tubes adjacent the uterine cavity have been occluded by deposited inserts. Occlusion may be determined by both analog and digital displays on the pressure monitoring device. Where the display is analog, the occlusion may be determined where the pressure needle on the analog display maintains a constant position within a prescribed pressure range on the analog pressure gauge. Where the display is digital, the occlusion may be determined where the digital display displays a message indicating occlusion on a digital display. 
         [0010]    In an embodiment, prior to inflating the inflatable balloon, a distal end of elongated catheter shaft may be submerged in distention fluid within a container other than the reservoir. The piston is then withdrawn to enlarge a volume of the reservoir and draw the distention fluid through the second lumen and into the reservoir. The selector is them moved to the first position to place the reservoir in operable communication with the first lumen. The piston may then be advanced to reduce the volume of the reservoir and push the distention fluid through the first lumen to inflate the inflatable balloon. In accordance with some embodiments of the invention, moving the selection knob to place the first or second lumens in operable communication with the reservoir also places the first or second lumens in operable communication with the pressure monitoring device so that the pressure monitoring device measures the fluid pressure within the lumen that is in operable communication with the reservoir. In this manner, the fluid pressure may be measured during both inflation of the inflatable balloon and during injection of the distention fluid into the uterine cavity. Alternatively, the fluid pressure is only measured during injection of the distention fluid into the uterine cavity. It is to be appreciated that fluid pressure can be measured in the first or second lumens when dispensing fluid from the reservoir as well as back pressure of the fluid in the first or second lumens when fluid is not being dispensed from the reservoir. 
         [0011]    Embodiments of the present invention are not limited to a dual lumen catheter fluid delivery system, and other fluid delivery systems are described. In one embodiment, a multi-lumen catheter fluid delivery system is described in which, in addition to the features of the dual lumen catheter, may include a third and fourth lumens housed within the elongated shaft extending distally from the handle. The third lumen may be in operable communication with an inflatable uterine balloon, and the second and fourth lumens may be in operable communication with injection ports which are configured to be placed near left and right corneal regions of a uterine cavity upon inflation of the inflatable uterine balloon. 
         [0012]    In accordance with other embodiments of the invention, a fluid delivery system including a reservoir and pressure monitoring device may be separate from and connectable to a conventional HSG balloon catheter or metal HSG cannula. In an embodiment, the separate fluid delivery system includes a reservoir, a fluid delivery shaft connected to the reservoir at a proximal end of the fluid delivery shaft and connected to a luer lock at a distal end of the fluid delivery shaft, a pressure monitoring device which measures the fluid pressure downstream from the reservoir, and a pressure display gauge. For example, downstream fluid pressure may correspond to fluid pressure in the fluid delivery shaft exiting the reservoir or fluid back pressure. The pressure display gauge can be analog or digital. When the pressure gauge is analog, the analog display gauge includes a marked pressure range which indicates that the fallopian tubes are occluded. When the pressure display gauge is digital, a display is provided which indicates fallopian tube occlusion on a digital display. 
         [0013]    Fluid can be delivered from the fluid delivery system in different manners. In one embodiment, the reservoir comprises a cartridge containing pressurized fluid, which may be liquid or gas. A button may be provided which releases the pressurized fluid from the reservoir and into the fluid delivery lumen when depressed. In another embodiment, the reservoir is part of a pressure syringe in which a piston is movable to reduce and expand a volume of the reservoir. For example, the piston may be moved by pushing/sliding or rotating/screwing. In some embodiments, the fluid delivery system may further include a selector movable between first and second positions, where the first position places a first extension lumen in operable communication with the reservoir, and the second position places a second extension lumen in operable communication with the reservoir. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIGS. 1A-1B  illustrate isometric views of a dual lumen catheter in accordance with an embodiment of the present invention. 
           [0015]      FIG. 1C  illustrates a cross-sectional view of an elongated shaft taken along line A-A in  FIG. 1A  in accordance with an embodiment of the present invention. 
           [0016]      FIG. 1D  illustrates a dual lumen catheter within an expanded uterine cavity in accordance with an embodiment of the present invention. 
           [0017]      FIG. 2A  illustrates a top view of an analog dial display in accordance with an embodiment of the present invention. 
           [0018]      FIG. 2B  illustrates an isometric view of a glow in the dark analog dial display in accordance with an embodiment of the present invention. 
           [0019]      FIG. 3A  illustrates an isometric view of a handle and digital display in accordance with an embodiment of the present invention. 
           [0020]      FIG. 3B  illustrates front view of a digital display displaying a message indicating tubal occlusion in accordance with an embodiment of the present invention. 
           [0021]      FIG. 3C  illustrates front view of a digital display displaying a message tubal perforation in accordance with an embodiment of the present invention. 
           [0022]      FIG. 4  illustrates a close-up isometric view of a pressure syringe incorporated into a dual lumen catheter in accordance with an embodiment of the present invention. 
           [0023]      FIG. 5  illustrates a close-up isometric view of a handle in accordance with an embodiment of the present invention. 
           [0024]      FIG. 6A  illustrates a close-up side view of a selector in accordance with an embodiment of the present invention. 
           [0025]      FIG. 6B  illustrates a close-up isometric view of selector extension lumens unaligned with reservoir ports in accordance with an embodiment of the present invention. 
           [0026]      FIG. 6C  illustrates a close-up isometric view of a first selector extension lumen aligned with a first reservoir port in accordance with an embodiment of the present invention. 
           [0027]      FIG. 6D  illustrates a close-up isometric view of a second selector extension lumen aligned with a second reservoir port in accordance with an embodiment of the present invention. 
           [0028]      FIG. 7  illustrates an isometric view of a dual lumen catheter including a selector switch in accordance with an embodiment of the present invention. 
           [0029]      FIG. 8A  illustrates a close up front view of a selector switch in a first position in accordance with an embodiment of the present invention. 
           [0030]      FIG. 8B  illustrates a close up front view of a selector switch in a second position in accordance with an embodiment of the present invention. 
           [0031]      FIGS. 9A-9B  illustrates an isometric view of a selector including selector switch and T-valve manifold assembly in accordance with an embodiment of the present invention. 
           [0032]      FIGS. 10A-10D  illustrate side views of a manner of operating a dual lumen catheter in accordance with an embodiment of the present invention. 
           [0033]      FIG. 11A  illustrates a side view of a multi-lumen catheter incorporating a uterine balloon in accordance with an embodiment of the present invention. 
           [0034]      FIG. 11B  illustrates a cross-sectional view of an elongated shaft taken along line A-A in  FIG. 11  A in accordance with an embodiment of the present invention. 
           [0035]      FIG. 11C  illustrates a multi-lumen catheter incorporating an inflatable uterine balloon with within an expanded uterine cavity in accordance with an embodiment of the present invention. 
           [0036]      FIG. 12  illustrates a side view of a fluid delivery system in accordance with an embodiment of the present invention. 
           [0037]      FIGS. 13A-13B  illustrate isometric views of a fluid delivery system in accordance with an embodiment of the present invention. 
           [0038]      FIGS. 14A-14C  illustrate isometric views of a fluid delivery system in accordance with an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0039]    Embodiments of the present invention generally provide fluid delivery systems and manners for use thereof. More specifically, some embodiments provide fluid delivery systems with pressure monitoring devices and methods for determining fallopian tube occlusion. 
         [0040]    Various embodiments and aspects will be described with reference to details discussed below and the accompanying drawings will illustrate the various embodiments. The following description and drawings are illustrative of the invention and are not to be construed as limiting the invention. Numerous specific details are described to provide a thorough understanding of various embodiments of the present invention. However, in certain instances, well-known or conventional details are not described in order to provide a concise discussion of embodiments of the present invention. In accordance with embodiments of the present invention, various fluid delivery systems described and illustrated may share substantially similar features. For clarity and conciseness, similar notation is provided in the figures where substantial similarities may exist amongst features of the various fluid delivery systems. For example, selector  114  initially described with regard to a dual lumen catheter fluid delivery system  100  may share common and substantially similar features as selectors  214  and  314  described with regard to multi-lumen catheter fluid delivery system  200  and fluid delivery system  300 . 
         [0041]      FIGS. 1A-1B  illustrate isometric views of a dual lumen catheter in accordance with an embodiment of the present invention.  FIG. 1C  illustrates a cross-sectional view of the elongated shaft  106  taken along line A-A in  FIG. 1A . As illustrated in  FIGS. 1A-1C , dual lumen catheter  100  may include a handle  102 , a reservoir  104  connected with or integrated into the handle, an elongated shaft  106  which houses a first and second lumens  132 ,  134  extending distally from the handle  102 , a pressure monitoring device  112  to measure a fluid pressure downstream from the reservoir  104 , and selectors  114 ,  115  which can be manipulated to change the operability of the dual lumen catheter  100 . For example, downstream fluid pressure may correspond to fluid pressure in the first or second lumens of fluid exiting the reservoir or fluid back pressure. The handle  102  and selectors  114 ,  115  may be sized and shaped to be gripped and operated by hand. The first lumen  132  may be in operable communication with an inflatable balloon  108  to deliver a fluid from the reservoir and into the inflatable balloon  108 . The second lumen  134  may be in operable communication with an injection port  110  distal to the inflatable balloon to deliver the fluid from the reservoir  104  and through the injection port  110 . In this manner the fluid stored in the reservoir  104  of the dual lumen catheter may be used to both inflate the inflatable balloon  108  to form a seal against a cervix, and to pressurize a uterine cavity as illustrated in  FIG. 1D  to determine whether the adjacent fallopian tubes are occluded, for example by inserts  123  such as the Essure® insert. 
         [0042]    In accordance with embodiments of the present invention fallopian tube occlusion may be easily and quickly determined with the hand held dual lumen catheter, where the handle and selectors are sized and shaped to be gripped and operated by hand. As described in further detail with regard to  FIGS. 5-9B , selector  114  may be provided on the handle  102  in order to place either the first or second lumen  132 ,  134  in operable communication with the reservoir  104 . When the first lumen  132  is placed in operable communication with the reservoir  104  the pressure monitoring device  112  may measure the fluid pressure in the first lumen  132 . In this position, the pressure monitoring device  11  may measure the balloon  108  inflation pressure. When the second lumen  134  is placed in operable communication with reservoir  104  the pressure monitoring device  112  may measure the fluid pressure in the second lumen  134 . In this position, the pressure monitoring device  112  may measure the pressure in the uterine cavity. The measured pressure can be displayed with both analog and digital displays in accordance with embodiments of the invention. In another embodiment, the pressure monitoring device  112  only measures pressure in the second lumen  134  for measuring pressure in the uterine cavity, and the pressure monitoring device does not switch which lumen pressure is being measured when switching which lumen is in operable communication with the reservoir. 
         [0043]      FIG. 2A  is an illustration of an analog dial display  118  in accordance with an embodiment. As illustrated, the analog dial display  118  may include a needle  120  and marked pressure ranges  122 ,  124  to provide the operator with information. For example, the analog dial display  118  can include a marked tubal occlusion pressure range  122 , or a marked tubal perforation pressure range  124 . Analog dial display  118  may also include a marked pressure range corresponding to a preferred balloon inflation pressure. As illustrated in  FIG. 2B , the marked pressure ranges  122 ,  124  may glow in the dark to accommodate use of the dual lumen catheter in a dimly lit room. As illustrated in  FIGS. 3A-3C , the pressure monitoring device  112  may include a digital display  126 , which depending upon the measured pressure over time can display a message  128  corresponding to tubal occlusion as illustrated in  FIG. 3B , or a message  130  corresponding to tubal perforation as illustrated in  FIG. 3C . Digital display  126  can also display a message corresponding to preferred balloon inflation pressure. The digital display may likewise be configured to be visible in dim lighting. 
         [0044]    Referring now to  FIG. 4  a pressure syringe may be incorporated into the dual lumen catheter to store the fluid in the reservoir and to expel the fluid from the reservoir. As illustrated, the handle  102  includes a pressure syringe with a piston  116  that is moveable in and out of the handle  102  to reduce and expand a volume of the reservoir, and consequently the amount of fluid contained within the reservoir and delivered through the first or second lumen in operable communication with the reservoir. For example, the piston  116  can be moved by pushing/sliding, by rotating/screwing the piston, or any other suitable mechanism. Piston  116  may include a knob  117  at a proximal end thereof which is sized and shaped to be gripped by hand. 
         [0045]    A selector  115  may be included on the handle  102  in order to select from a plurality of mechanisms for moving the piston  116 . As illustrated, selector  115  may be a knob which is rotatable between two positions  111 ,  119 . In an embodiment, position  111  corresponds to a pushing or sliding mechanism for moving the piston  116 , and position  119  corresponds to a rotating or screwing mechanism for moving the piston  116 . In such an embodiment, pushing or sliding may be used for dispensing large quantities of fluid from the reservoir, and rotating or screwing may be used to obtain greater control on the amount of piston  116  displacement for dispensing smaller quantities of fluid from the reservoir. 
         [0046]    Referring now to  FIG. 5 , a selector  114  may be provided on the handle  102  in order to place either the first or second lumen in operable communication with the reservoir. As illustrated, selector  114  may be a knob which is rotatable between first and second positions. For example, the first position may correspond to a balloon pressure position where the first lumen  132  is placed in operable communication with the reservoir so that the inflatable balloon  108  may be inflated with the fluid stored in the reservoir. The second position may correspond to a uterine pressure position where the second lumen  134  is placed in operable communication with the reservoir so that the fluid stored in the reservoir may be injected through the injection port  110  and into a uterine cavity. The second position may also correspond to a reservoir fill position where fluid can be withdrawn into injection port  110  to fill the reservoir. 
         [0047]    It is to be appreciated that while the foregoing description of selectors  114 ,  115  has been with regard to rotatable knobs, that embodiments are not limited to such and that other suitable selectors may be utilized such as, but not limited to, push buttons and switch levers. For example,  FIGS. 6A-6D  illustrate exemplary embodiments in which selector  114  includes a rotatable knob, and  FIGS. 7-9B  illustrate exemplary embodiments in which selector includes a switch lever. 
         [0048]    Referring now to  FIG. 6A , a selector  114  is illustrated as including a rotatable knob which houses a first and second extension lumens  136 ,  138  which are connected to the first and second lumens  132 ,  134  that extend through the elongated shaft  106 . The first and second extension lumens  136 ,  138  are configured so that the selector  114  can be rotated between a first position where the first extension lumen  136  aligns with a first reservoir port  140 , and a second position where the second extension lumen  138  aligns with a second reservoir port  142 .  FIG. 6B  is an illustration of the relative positions of the first and second extension lumens  136 ,  138  and first and second reservoir ports  140  with the selector at an intermediate position between the first and second positions. In this intermediate position, neither of the first or second extension lumens  136 ,  138  is in alignment with either of the first or second reservoir ports  140 ,  142 .  FIG. 6C  is an illustration of the relative positions of the first and second extension lumens  136 ,  138  and first and second reservoir ports  140 ,  142  with the selector at the first position. As illustrated, in the first position the first extension lumen  136  is in alignment with the first reservoir port  140 , while the second extension lumen  138  and second reservoir port  142  are misaligned. In the first position, the first lumen  132  (to the inflatable balloon  108 ) is in operable communication with the reservoir.  FIG. 6D  is an illustration of the relative positions of the first and second extension lumens  136 ,  138  and first and second reservoir ports  140 ,  142  with the selector at the second position. As illustrated, in the second position the second extension lumen  138  is in alignment with the second reservoir port  142 , while the first extension lumen  136  and first reservoir port  140  are misaligned. In the second position, the second lumen  134  (to the injection port  110 ) is in operable communication with the reservoir. 
         [0049]    Referring now to  FIG. 7  and  FIGS. 8A-8B , a selector  114  may include a switch lever  144 , which can be moved between first position illustrated in  FIG. 8A  which places the first lumen (to the inflatable balloon) in operable communication with the reservoir, and a second position illustrated in  FIG. 8B  which places the second lumen (to the injection port) in operable communication with the reservoir. In an embodiment, operation of the switch lever  144  may be accomplished with a T-valve manifold assembly as illustrated in  FIGS. 9A-9B . As illustrated, switch lever  144  may extend from a selector rod  145  including a T-valve port  150  which can be rotated between the first and second positions to place either the first or second lumens  132 ,  134  in operable communication with the reservoir  104 . Referring to  FIG. 9A , a shaft  148  extends from the reservoir to a T-valve manifold  146 . First and second extension lumens  136 ,  138  are connected at their distal ends to lumens  132 ,  134  and at their proximal ends to first and second T-valve manifold ports  147 ,  149 .  FIG. 9B  is an illustration of switch lever  144  in the first position, in which the T-valve port  150  is positioned to place the first lumen  132  in operable communication with the reservoir  104 . When the switch lever  144  is moved to the second position, the selector rod  145  may rotate approximately  90  degrees such that the T-valve port  150  is positioned to place the second lumen  134  in operable communication with the reservoir  104 . 
         [0050]    Referring now to  FIGS. 10A-10D  a manner of operating the dual lumen catheter is described in accordance with an embodiment of the present invention. Prior to inflating the balloon  108  the distal end comprising injection port  110  of the elongated catheter shaft  106  may be first submerged in distention fluid within a container (not illustrated) other than the reservoir. With the selection knob  114  in the second position, piston  116  may then be withdrawn as illustrated in  FIG. 10B  to enlarge a volume of the reservoir and draw the distention fluid through the second lumen  134  and into the reservoir. The selection knob  114  may then be moved to the first position to place the reservoir in operable communication with the first lumen  132 . With the reservoir filled with distention fluid, the distal end of the dual lumen catheter may then be inserted into the uterine cavity through the cervix. With the selection knob  114  now in the first position, piston  114  may be advanced as illustrated in  FIG. 10C  to reduce the volume of the reservoir and push the distention fluid through the first lumen  132  to inflate the balloon  108  and seal the cervix. The operator may monitor the fluid pressure being measured by the pressure monitoring device while advancing the piston  114  to monitor the balloon  108  inflation pressure. After sealing the cervix with the inflatable balloon  108  the selector knob  114  may be moved from the first position to the second position to place the reservoir in operable communication with the second lumen  134 . The operator can then monitor the fluid pressure measured by the pressure monitoring device while advancing the piston  114  as illustrated in  FIG. 10D  to reduce to the volume of the reservoir and inject the distention fluid into and pressurize the uterine cavity, as illustrated in  FIG. 1D . In an embodiment, the fluid pressure is monitored while pressurizing the uterine cavity to determine whether the pair of fallopian tubes adjacent the uterine cavity have been occluded, for example by deposited inserts such as the Essure® inserts. Tubal occlusion may be determined by both analog and digital displays on the pressure monitoring device. 
         [0051]    In an embodiment, where the display is analog, tubal occlusion may be determined by injecting the distention fluid into the uterine cavity until the pressure needle  120  on the analog display  118  maintains a constant position within the prescribed tubal occlusion pressure range  122  on the analog display  118  described with regard to  FIG. 2 . During initial injection of fluid into the uterine cavity a spike in fluid pressure within the respective lumen being measured may be observed. Upon stopping injecting of fluid, the pressure monitoring device may measure the back pressure of fluid from the uterine cavity into the respective lumen being measured. If the uterine cavity is not distended then the back pressure may be low. For example, in an embodiment the back pressure can be between 0 mm Hg and 25 mm Hg for a uterus which is not distended. If the back pressure is decreasing or approximately constant in a range  124  lower than the tubal occlusion range  122 , then this may be an indication that the uterine tissue is absorbing the distention fluid or that the uterine muscle is stretching into a larger distended shape. Decreasing pressure or an approximately constant pressure in a range  124  lower than the tubal occlusion range  122  may also be an indication of perfusion such as a leak in the cervical seal with the balloon  108 , a leak down one of the fallopian tubes, or a perforation in the uterus or cervix. For example, a perfusion range  124  may be between 25 mm Hg and 75 mm Hg in an embodiment. In accordance with embodiments of the present invention, observation of an approximately constant higher pressure in a pressure range  122  such as 150 mm Hg to 250 mm Hg may indicate tubal occlusion. It is to be appreciated that an operator may avoid extremely high pressures to ensure that inserts  123  are not moved from their intended locations, and to avoid patient discomfort. 
         [0052]    In an embodiment, where the display is digital, a digital display  126  as illustrated in  FIGS. 3A-3C  may display a message  128  corresponding to tubal occlusion if an approximately constant high pressure within the previously described tubal occlusion pressure range is measured, and a message  130  corresponding to a system leak may be displayed if a decreasing or approximately constant pressure in a pressure range lower than the previously described tubal occlusion pressure range is measured. 
         [0053]    In another embodiment, tubal occlusion may be determined utilizing a multi-lumen catheter incorporating a uterine balloon.  FIGS. 11A-11C  illustrate a multi-lumen catheter with substantial similarities to the dual lumen catheter described above. As illustrated, the multi-lumen catheter  200  may include a handle  202 , a reservoir  204  connected with or integrated into the handle, a pressure syringe including a piston  216  and knob  217 , a forked elongated shaft  206  which houses multiple lumens extending distally from the handle  202 , a pressure monitoring device  212  to measure fluid pressure downstream from the reservoir  204 , and selectors  214 ,  215  which can be manipulated to change the operability of the multi-lumen catheter  200 . For example, downstream fluid pressure may correspond to fluid pressure in one of the multiple lumens of fluid exiting the reservoir or fluid back pressure. The handle  202  and selectors  214 ,  215  may be sized and shaped to be gripped and operated by hand. A first lumen  232  may be in operable communication with an inflatable balloon  208  to deliver a fluid from the reservoir and into the inflatable balloon  208 . A second lumen  234  may be in operable communication with an injection port  274  distal to the inflatable uterine balloon  280  to deliver the fluid form the reservoir  204 , through the injection port  274  and into a left fallopian tube. A third lumen  270  may be in operable communication with an inflatable uterine balloon  280  to deliver a fluid from the reservoir and into the inflatable uterine balloon  280 . A fourth lumen  272  may be in operable communication with an injection port  276  distal to the inflatable uterine balloon  280  to deliver the fluid from the reservoir  204 , through the injection port  276  and into a right fallopian tube. In this manner, as illustrated in  FIG. 11C , the fluid stored in the reservoir  204  of the multi-lumen catheter may be used to both inflate the inflatable balloon  208 , to seal the cervical canal, inflate the inflatable uterine balloon  280  to seal the corneal regions of the uterine cavity, and to pressurize the cornual regions of the uterine cavity adjacent the fallopian tubes to determine whether a specific fallopian tube adjacent an injection port  274 ,  276  is occluded, for example by inserts  123  such as the Essure® insert. 
         [0054]    In accordance with embodiments of the invention, pressure monitoring device  212  may operate similarly as pressure monitoring device  112  previously described. Likewise, selector  215  may operate similarly as selector  115  previously described, and selector  214  may operate similarly as selector  114  with any necessary modifications to accommodate additional lumens. 
         [0055]    In other embodiments of the present invention, tubal occlusion may be determined utilizing a fluid delivery system, such as those illustrated in  FIGS. 12-14C , which can be connected to conventional balloon HSG catheters or metal HSG cannulas. Referring to  FIG. 12 , in an embodiment the handle  302  of a fluid delivery system  300  has substantial similarities to the handle  102  of the dual lumen catheter  100  described above. As illustrated, a reservoir  304  and pressure syringe including a piston  316  and knob  317  may be connected with or integrated into the handle  302 . A pressure monitoring device  312  is provided to measure fluid pressure downstream from the reservoir  304 . Selectors  314 ,  315  may be sized and shaped to be gripped and operated by hand, and manipulated to change the operability of the fluid delivery system  300 . Selector  314  may be provided on the handle  302  and moveable between a first and second positions in order to place either a first extension lumen  336  or a second extension lumen  338  in operable communication with the reservoir  304 . In the first position, the first extension lumen  336  is placed in operable communication with the reservoir  304  and the pressure monitoring device  312  may measure pressure in the first extension lumen  336 . In the second position, the second extension lumen  338  is placed in operable communication with the reservoir  304  and the pressure monitoring device  312  may measure pressure in the second extension lumen  338 . Luer locks  364  may be placed on the distal ends of extension lumens  336 ,  338  in order to connect with luer channels  402 ,  404  on a separate balloon HSG catheter  400  or metal HSG cannula. In this manner luer locks  364  of fluid delivery system  300  are connected to luer channels  402 ,  404  of a separate balloon HSG catheter  400  or metal HSG cannula. When selector  314  is in the first position, the reservoir  304  may be in operable communication with a balloon of the HSG catheter  400  and pressure monitoring device  312  may measure the balloon inflation pressure, and when selector  314  is in the second position, the reservoir  304  may be in operable communication with a injection port of the HSG catheter  400  and the pressure monitoring device  312  may measure the pressure in the uterine cavity. The measured pressure can be displayed with both analog and digital displays in accordance with embodiments of the invention. 
         [0056]    Selector  314  may be any suitable selector in accordance with embodiments of the invention. For example, selector  314  comprise a rotatable selector knob similar to that described with regard to  FIGS. 5-6D , or selector  314  may comprise a switch lever  344  similar to that described with regard to  FIGS. 7-9B . 
         [0057]    A selector  315  may be included on the handle  302  in order to select from a plurality of mechanisms for moving a piston  316 . Similar to that described with regard to  FIG. 4 , selector  315  may be a knob which is rotatable between two positions. In an embodiment, one position corresponds to a pushing or sliding mechanism for moving the piston  316 , and another position corresponds to a rotating or screwing mechanism for moving the piston  116 . In such an embodiment, pushing or sliding may be used for dispensing large quantities of fluid from the reservoir, and rotating or screwing may be used to obtain greater control on the amount of piston  316  displacement for dispensing smaller quantities of fluid from the reservoir. 
         [0058]    Referring now to  FIGS. 13A-13B , in an embodiment, tubal occlusion may be determined utilizing a fluid delivery system  400  including a single lumen within elongated shaft  466  which can be connected to a conventional balloon HSG catheter or metal HSG cannula with a luer lock  464 . Fluid delivery system  400  may be substantially similar to the dual lumen catheter described above with one difference being the fluid delivery system  400  comprises a single lumen catheter rather than a dual lumen catheter, and the fluid delivery system  400  does not include a selector  114 . In this manner, pressure monitoring device  412  measures the fluid pressure in the single lumen exiting the reservoir. The single lumen may be placed in operable communication a luer channel of a conventional balloon HSG catheter or metal HSG cannula to measure the pressure in the channel, which may be connected to an inflatable balloon or uterine cavity, for example. Similar to the dual lumen catheter describe above, the fluid delivery system  400  may also incorporate a selector  415  and syringe including a piston  416  and knob  417  into handle  402 . 
         [0059]    Referring now to  FIGS. 14A-14C , in an embodiment, tubal occlusion may be determined utilizing a fluid delivery system  500  including a single lumen within a shaft  566  which can be connected to a conventional balloon HSG catheter or metal HSG cannula with a luer lock  564 . Fluid delivery system  500  may include a pressurized reservoir  504  storing a fluid and an analog dial display  518  in accordance with an embodiment. In an embodiment, the pressurized reservoir  504  includes a cartridge containing the pressurized fluid. The analog dial display  518  may include a needle  520  and marked pressure ranges  522 ,  524  to provide the operator with information. For example, the analog dial display  518  can include a marked tubal occlusion pressure range  522 , or a marked tubal perforation pressure range  524 . Alternatively, fluid delivery system  500  may include a digital display similar to that described with regard to  FIGS. 3A-3C . Fluid delivery system  500  may additionally include a button  562  to dispense the fluid from the pressurized reservoir  504 . Similar to  FIG. 2B , the marked ranges  522 ,  524  and button  562  of analog dial display  518  may glow in the dark to accommodate use of the fluid delivery system  500  in a dimly lit room. In use, an operator may hold fluid delivery system  500  by hand and press button  562  with the same hand to dispense the pressurized fluid from the reservoir and into a uterine cavity or balloon while monitoring the pressure reading as discussed above. 
         [0060]    In the foregoing specification, various embodiments of the invention have been described. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention as set forth in the appended claims. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense. Hence, the scope of the present invention is limited solely by the following claims.