Patent Publication Number: US-2016228287-A1

Title: Systems and methods for permanent female contraception

Description:
CROSS-REFERENCE To RELATED APPLICATIONS 
     This application claims benefit of priority to U.S. Provisional Application No. 62/113,321, filed Feb. 6, 2015, the content of which is incorporated by reference herein in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to medical devices and methods for treating and occluding a female patient&#39;s fallopian tubes to provide birth control or sterilization where the duration can be long term or permanent. 
     BACKGROUND 
     Female sterilization typically involves occluding a patient&#39;s fallopian tubes, with various procedures using laparoscopic or minimally invasive trans-cervical approaches. One procedure involves placing flexible coil-like devices into the fallopian tithes which are made of polyester fibers and metal wires. Tissue in-growth into the implanted devices can block the fallopian tubes. However, such implants are worrisome due to potential unknown long term effects. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to catheter systems and implants together with methods of using such systems and device for occluding reproductive body lumens such as a female&#39;s fallopian tubes. 
     The present disclosure includes methods and devices for accessing a fallopian tube. In one variation, the method includes trans-cervically introducing an elongate device into a patient&#39;s uterine cavity, the elongate device including, a flexible guide sleeve having a guide channel with an open distal end; expanding an expandable member in the uterine cavity to open the uterine cavity and align the guide channel with a fallopian tube. 
     The method can include inflating the expandable member with a liquid or gas. In some variations, the expandable member is shaped to conform to the anatomy, such as the triangular shape of the uterine cavity. In such a case, the expandable member has a triangular shape and the distal termination is proximate an apex of said triangular shape. 
     The method can include advancing a catheter through the guide channel and into the fallopian tube. Another variation also includes that the open distal end of the guide channel opens on a first lateral side of the expandable member. In additional variations, the expandable member comprises a triangular shape and the guide channel opens on a distal apex of the triangular shape. 
     In another variation, the methods and devices can include a second flexible guide sleeve having a second guide channel with a second open distal end, where the second open distal end of the second guide channel opens on a second lateral side of the expandable member that is opposite to the first lateral side of the expandable member. 
     The method can also include adjusting an alignment of the guide channel by deflecting an orientation of the flexible guide sleeve within the expandable member. 
     In another example, the devices described herein to access a fallopian tube can comprise an expandable member comprising a triangular shape having a distal base with a first apex and a second apex on either end of the distal base, and a proximal base opposite to the distal base; a flexible guide sleeve having a passageway extending therethrough, the flexible guide sleeve extending through the expandable member from the proximal base through to the first apex along the distal base such that the passageway opens at the first apex on a lateral side of the distal base. 
     Variations of the device can further comprise an external sleeve exterior to the flexible guide sleeve where the external sleeve and flexible guide sleeve are moveable relative to each other. 
     In an additional variation, the access device can include a distal end of the flexible guide sleeve that is affixed to the expandable member such that a profile of the flexible guide sleeve within the expandable member can be adjusted h relative movement of the flexible guide sleeve to the expandable member. 
     In a further variation, the device can include a second flexible guide sleeve having a second passageway that opens at a second apex on a side of the distal base opposite to the first apex 
     The tubal occlusion procedure described herein can be a minimally invasive procedure in which a device is introduced into the patient&#39;s uterine cavity trans-cervically. In one aspect RF energy is used to ablate a thin layer of tissue in a segment of a fallopian tube which can be performed very rapidly, for example in 5 to 60 seconds. A second step of the method involves cutting or damaging tissue within the segment to cause bleeding and a subsequent adhesion formation across the coagulated blood. The wound healing response and adhesion of the walls in the segment can close the fallopian tube. The occlusion caused by the wound healing response can be permanent or have an extended duration in which passage through the segment is blocked. 
     The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. 
     The features of the invention including various novel details of construction and combinations of parts, and other advantages, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular method and device embodying the invention are shown by way of illustration and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a sectional view of a patients uterus and fallopian tubes showing a system of the invention for occluding a fallopian tube, wherein the system includes a catheter carrying an implant and  FIG. 1A  illustrates an initial step in a method corresponding to the invention wherein a hysteroscope is introduced transcervically into the uterine cavity and the catheter is advanced toward the opening of a fallopian tube. 
         FIG. 1B  is an enlarged view of a portion of the uterus and fallopian tube of  FIG. 1A  illustrating another step in a method of the invention wherein a guidewire is advanced through the catheter and into the fallopian tube. 
         FIG. 1C  is a view similar to that of  FIG. 1B  illustrating another step in the method wherein the catheter and implant are advanced over the guidewire to a targeted site in the fallopian tube. 
         FIG. 1D  is a view similar to that of  FIG. 1C  illustrating another step in the method wherein a retaining sleeve carried by the catheter is retracted to expose the implant in the targeted site in the fallopian tube, and  FIG. 1C  also illustrates a subsequent step of delivering ablative energy to walls of the fallopian, and another step of causing bleeding in the site as further shown in  FIG. 2A . 
         FIG. 1E  is a view similar to that of  FIG. 1D  illustrating another step in the method wherein the guidewire is withdrawn from the implant and the resilient implant moves to its non-tensioned configuration to flatten the fallopian tube. 
         FIG. 2A  is an isometric view of an occluding device or implant carries by the catheter of  FIGS. 1A-1D , with the implant body being maintained in a tensioned linear shape by the guidewire in a passageway of the implant, with  FIG. 2A  further illustrating a blade element that can be extended from the implant to cause bleeding in the targeted site in the step of  FIG. 1D . 
         FIG. 2B  is another view of the implant of  FIG. 2A  with the implant body in a non-tensioned shape having multiple curves with the guidewire withdrawn from the implant, and further illustrating the blade element extended from the implant for causing bleeding in the targeted site, for example, in the step of  FIG. 1E . 
         FIG. 3  is a graphic representation of the fallopian tube with the tube walls approximated which corresponds to the method step shown in  FIG. 1E . 
         FIG. 4A  is a sectional view of the fallopian tube of  FIG. 3  taken along line  4 A- 4 A which again corresponds to the method step shown in  FIG. 1F  wherein blood accumulates and is trapped in the fallopian tube. 
         FIG. 4B  is a sectional similar to that of  FIG. 4A  after the passage of time wherein an adhesion has formed across the lumen of the fallopian tube and further depicting the bin-absorption of the implant body. 
         FIG. 5  is a perspective view of another variation of occluding device or implant that includes the functionality of the system and implant of  FIGS. 1A-4B . 
         FIG. 6A  is a perspective view of another variation of occluding device or implant in a collapsed or non-extended position. 
         FIG. 6B  is a view of the implant of  FIG. 6A  in an extended position. 
         FIG. 7A  is a perspective view of another variation of occluding device or implant in collapsed or non-extended position. 
         FIG. 7B  is a view of the implant of  FIG. 7A  in an extended position. 
         FIG. 8  is a perspective view of another variation of occluding device or implant in an actuated position. 
         FIG. 9A  is a perspective view of another variation of occluding device or implant in an insertion configuration. 
         FIG. 98  is a view of the implant of  FIG. 9A  is a deployed configuration. 
         FIG. 9C  is a view of the implant of  FIG. 9B  deployed in a fallopian tube to thereby flatten the tube. 
         FIG. 10A  is a perspective view of another variation of occluding device or implant in an insertion configuration. 
         FIG. 10B  is a view of the implant of  FIG. 10A  is a deployed configuration. 
         FIG. 11A  is a perspective view of another variation of implant in an insertion configuration. 
         FIG. 11B  is a view of the implant of  FIG. 11A  is a deployed configuration. 
         FIG. 12A  is a perspective view of another variation of implant in an insertion configuration. 
         FIG. 12B  is a view of the implant of  FIG. 12A  is a deployed configuration. 
         FIG. 13A  illustrates accessing a fallopian tithe wherein an introducer and guide sleeve are advanced trans-cervically into the patient&#39;s uterine cavity 
         FIG. 13B  illustrates a subsequent procedure to that of  FIG. 13A  wherein the introducer sleeve is retracted and the exposed expandable structure in then expanded. 
         FIG. 14  is a cut-away view of the expandable structure of  FIG. 13B  showing advancement of an articulating endoscope and treatment catheter through the guide sleeve. 
         FIG. 15  is a cut-away view of another variation of the access device with first and second guide sleeves carried within an expandable structure for accessing both fallopian tubes. 
         FIG. 16  is a cut-away view of another variation of the access device with multiple inflation chambers in an expandable structure for adjusting the orientation of the guide sleeve. 
     
    
    
     DETAILED DESCRIPTION THE INVENTION 
       FIG. 1A  illustrates a patient&#39;s uterus  100  and fallopian tubes  102  or oviducts, which are paired, tubular conduits that extend from the cornua  104  of the uterine cavity  105  us toward the ovaries  106 . Each fallopian is about 7 cm to 14 cm in length and is defined by three different sections: the intramural segment  108 , the isthmus segment  110  and the ampulla  112  ( FIGS. 1A-1B ). The intramural or interstitial segment  108  of the tube continues from the corium  104  to the isthmus  110  and is about 1 cm in length with a 1 mm lumen diameter. The isthmus  108  is a round cord-like structure which constitutes the medial one-third of the fallopian tube with a 2 mm to 10 mm outer diameter. The lumen of the fallopian tube is lined with a layer of mucous membrane that can have many folds and papillae. The wall of the fallopian tube includes layers of muscle tissue. The innermost layer has spirally arranged fibers, the middle layer has circular fibers, and an outer layer has longitudinal muscle fibers. These muscle fibers provide for peristalsis and antiperistalsis in the fallopian tubes. 
       FIGS. 1A-1E and 2A-2B  illustrate a system  120  that includes an elongate catheter  122  that carries a releasable occluding device or implant  125  ( FIG. 2A ) which is adapted to occlude a patient&#39;s reproductive lumen such as fallopian tube  102 . The catheter  122  can have any suitable length for extending through the working, channel  128  of a hysteroscope or endoscope  140 . In one embodiment shown in  FIGS. 1A-1D , the hysteroscope  140  is an articulating scope that can be articulated in the uterine cavity  105  to view the entry to the fallopian tubes  102  and direct the catheter into a fallopian tube  102 . In another variation, a straight rigid endoscope could be used with an appropriate viewing angle of 5° to 30° together with a catheter or catheter sleeve that can be articulated to assist in directing a catheter working end into a fallopian tube. 
     In one variation of implant  125  shown in  FIGS. 2A-2B , the body  144  of the implant comprises a polymeric material with a passageway  145  to allow it advancement over a guidewire  148 . In general, the variations of catheter working end  150  and implant  125  disclosed herein are adapted to provide functionality in more than one aspect which thus enables the system to effectively occlude fallopian tubes to provide permanent contraception. In one aspect and function, the system and/or implant provide a mechanism to deliver energy to the catheter working end or implant to ablate tissue in the fallopian tube lumen  152  over an elongated segment. As will be described further below, the ablation of endothelial tissue over an elongated segment prevents that rapid re-epithelialization of the lumen, and ablation of underlying muscle layers prevents peristalsis which otherwise could move or disrupt coagulum described next. In a second aspect, the system and/or implant provide means for causing bleeding with a targeted segment of a fallopian tube. As will be described further below, bleeding and coagulum at the targeted site will optimize conditions for fibrosis and adhesion formation in the targeted site for permanent occlusion. In a third aspect, as will be described further below, the implant  150  provides a ‘dam ’ for preventing displacement of the coagulum following bleeding to allow time for the adhesion to fully develop across to coagulum. In a fourth aspect, as will be described further below, the implant  150  provides a means for approximating fallopian tube walls to lessen or eliminate the adhesion dimension between the walls to accelerate the time required for adhesion formation. In a fifth aspect, as will be described further below, the implant  150  had a very flexible body  144  to allow its insertion into a tortuous path of a fallopian tube over a flexible guidewire. In a sixth aspect, as will be described further below, the implant  125  provides a means for resisting movement of the implant within the fallopian tube  102  which can be the overall shape of the implant or barb-like features on the implant or adhesives carried by the implant for engaging tissue. In a seventh aspect, as will be described further below, the implant  125  can be fabricated at least partly of micro-porous polymeric material that allows for tissue in-growth in a scaffold-like implant body. In an eighth aspect, as will be described further below, the implant  125  can be fabricated at least partly of bio-absorbable or bio-degradable material which will lessen its bulk following absorption or degradation. 
       FIGS. 1A-1F  provide an overview of the steps in a method corresponding to the invention, and further functional details of the system  120  and implant  125  in each of the steps follow this overview. 
     In  FIG. 1A , an articulating hysteroscope  140  is introduced transcervically and articulated to view in the direction of a fallopian tube  102 . The catheter  122  together with a guidewire  148  is then introduced through the working channel  128  of the hysteroscope. 
       FIG. 18  illustrates a subsequent step wherein the physician introduces guidewire  148  into and through the lumen of the fallopian tube  102  to at least the isthmus segment  110 . FIG. IC then shows another step in which the catheter working end  150  is advanced over the guidewire  148  into the fallopian tube  102 . 
       FIG. 1C  illustrates one embodiment of implant  125  which is carried by the catheter working end within a thin-wall sheath  158  that can be retracted to expose the implant  125 . 
       FIG. 1D  next shows another step in which the sheath  158  is retracted to expose and deploy the implant  125  in the intramural and or isthmus segment of the fallopian tube  102 . At this step, the system and implant can be actuated to cause bleeding in the targeted segment of the fallopian tube. Also at this step, the implant  125  is still operatively coupled to the catheter to allow energy delivery from a remote energy source to the implant as will be described below. 
       FIG. 1E  shows the implant  125  in the fallopian tube after being de-coupled from the catheter. As will be described below, the implant when released from the catheter moves from a first more linear shape to a second non-linear shape which is adapted to flatten the fallopian tube to thereby approximate walls of the fallopian tube. 
       FIG. 1F  illustrates the implant  125  in portion of the fallopian tube in its second non-linear shape approximating the walls of the fallopian tube  102 . 
       FIGS. 1G and 1H  depict a portion of the fallopian tube segment following approximation o the walls with the pooling of blood and resulting coagulum in the targeted site, followed by adhesion formation in the site and bio-absorption of the body of the implant  125 . 
     Now turning, to  FIGS. 2A-2B , the implant  125  can be described in more detail, The implant body  144  can be fabricated of a polymeric material that is flexible or the polymer can be more rigid and formed as a slotted tube as is known in the art to provide flexibility. In one variation, the implant can have a diameter ranging between 1 mm to 3 mm with a length ranging between 1 cm to 3 cm. In the variation shown in  FIGS. 2A-2B , the implant has a passageway  145  to allow it to be advanced over guidewire  148 . The guidewire  148  can have a highly flexible tip portion  160  adapted for negotiating through a tortuous path of a fallopian tube and a stiffer portion  162  proximal to the highly flexible portion that can function to straighten the fallopian tube and also maintain the implant in a suitable linear shape as in  2 B. In the variation of  FIGS. 2A-2B , the implant  125  can be maintained in a tensioned shape by guidewire  148  as shown in  FIG. 2A  which allows for introduction into the fallopian as shown in  FIGS. 1C and 1D . 
       FIGS. 2A-2B  further illustrate an energy delivery component of the system wherein the implant  125  carries opposing polarity bi-polar electrodes  165 A and  165 B that are operatively coupled to RF source  170  and controller  175 . The spaced apart electrodes  165 A and  165 B are shown in  FIGS. 2A-2B  in a helical configuration over the length of the implant but it should be appreciated that such electrodes can have any form or pattern, including circular, linear, dotted, fragmented or concentric in an outer implant surface an inner passageway of the implant. In operation, the RF source can be actuated at a suitable power level for about 5 seconds to 1 minute to ablate tissue in the fallopian tube lumen. In one variation, the mucosal layer is ablated over the length of the implant which can be from 1 cm to 3 cm. In this variation, the duty cycle of RF energy delivery can further ablate the underlying circular, longitudinal, and spiral muscle layers, which can be a depth of about 0.25 mm to 1 mm. The ablation of the muscle fibers over an elongated segment then will prevent peristalsis and antiperistalsis and thereby assist in preventing displacement of the implant  125  and blood and/or coagulum. The ablation step typically would be performed with the implant in its tensioned shape with the guidewire straightening the implant. In another variation of the method, the ablation step could be performed following withdrawal of the guidewire  148  with the implant  125  in it non-tensioned configuration. The implant  125  can be a resilient polymer that is pre-formed in a curved or sinuous shape, wherein the inherent spring-ability of the implant body will urge it toward its non-tensioned curved shape. In another variation, the implant&#39;s resiliency to urge its shape toward its curved shape of  FIG. 2B  also be assisted by a metal spring element embedded in the implant body  144 . The implant can have any curved shape that can include 1-10 or more curves or a similar number of angled portions with living hinges. In one variation the curved or angled portions are configured to provide a flat or planar shape when the implant is in its non-tensioned position to flatten the fallopian tube  102  to thereby approximate the walls of the tube. 
       FIGS. 2A-2B  further illustrate a mechanism carried by the catheter and implant  125  that can be actuated to cause bleeding at the site. In one variation shown in  FIG. 2A , it can be seen that a thin flexible blade  180 , for example of ribbon stainless steel as used in razor blade, can be moved axially in slot  182  that extends through the catheter and implant  125  to exit an open slot termination  185  to pierce and cut tissue. The blade  180  can be extended from open termination  185  an extension distance of 1 mm to 5 mm, and usually from 1 mm to 2 mm. In any event, the depth of penetration of blade  180  into tissue is greater than the depth of the ablation to insure bleeding through any ablated layer, in use, with reference to the method steps of  FIGS. 1D and 1E , the catheter and implant  125  can be rotated in either direction, and at various degrees of rotation, the blade  180  can be extended and retracted to cut tissue and cause bleeding. In use, the blade  180  can be extended following the ablation step with the implant  125  in either its tensioned configuration ( FIGS. 1D and 2A ) or non-tensioned configuration ( FIGS. 1E and 2B ). 
     In another aspect of the method step shown in  FIGS. 1D and 1E , a negative pressure source  190  can be actuated contemporaneous with or subsequent to the cutting step to draw blood from the cut tissue into the site. As can be understood from  FIGS. 2A-2B , the negative pressure source  190  can be actuated manually or by controller  175  in unison with the ablative energy, or automatically timed to follow the actuation of ablative energy. The negative pressure or suction can communicate with the targeted site through the guidewire passageway  148  in the catheter and implant  125 , and/or the slot  182  for blade  180  that extends through the catheter and implant. In  FIGS. 2A-2B , the guidewire passageway  148  communicates with the negative pressure source  190  to thereby apply suction forces through a plurality of ports  192  in the implant  125 . In one variation, the suction forces are pulsed to sustain bleeding into the site.  FIGS. 1F-1G  show that the blade  180  along with the guidewire  148  can be withdrawn from the implant  125 . 
     In one variation, the implant  125  is releasably carries by the catheter within the retractable sheath  158 . Thus, after the sheath is withdrawn as illustrated in  FIG. 1D , the implant  125  is free from the catheter shaft but still stabilized in place by the guidewire  148 . In other variation, the implant can be released from the catheter shaft by means known in the art, such as (i) a tear-away connection that is broken by retraction of the guidewire  148  or blade  180 , (ii) a mechanical mechanism such as a latching collar; (iii) a meltable polymer connection that can be melted by RF or resistive heating; (iv) a frangible connector actuated and broken by a heated NiTi element; or (v) an electrolytic detaching mechanism as known in the art of detachable embolic coils. 
     Now turning to  FIGS. 1F-1H , it can be seen how the implant  125  is adapted to trap blood  200  and coagulum in the site. In  FIG. 1F , the guide wire has been withdrawn and the implant  125  is urged toward its non-tensioned shape to flatten the fallopian tube  102  wherein the approximated walls of the fallopian tube  102  will allow for more rapid adhesion formation between the opposing walls as shown in  FIG. 1G . 
       FIG. 1G  illustrates blood  200  pooling in the flattened segment of the fallopian tube  102 . The blood also migrates into the guidewire passageway  148  through ports  192  and into the blade slot  182  through open termination  185 . 
     Of particular interest, it can be understood from  FIG. 1E  that the curved shape of implant  125  will help lock it in place in the fallopian tube  102  to resist any peristaltic forces that might otherwise dislodge the implant. Also of particular interest, the curve or curves of the implant body as shown in  FIG. 1F  are adapted to function as a dam to prevent the blood and subsequent coagulum from being displaced. 
       FIG. 1H  illustrates the fallopian tube  102  being occluded with adhesion  210  which can form rapidly in a few days as the trapped blood/coagulum ( FIG. 1G ) functions as an optimal scaffold for fibrosis across and between the walls of the fallopian tube  102 .  FIGS. 1G-1H  also show the flattening of the fallopian tube  102  which allows a more rapid formation of the adhesion  110  due to the reduced thickness dimension between the approximated walls of the fallopian tube  102 . 
       FIG. 1H  also is a graphic representation of one variation of the device and method wherein the implant  125  is bio-absorbable and  FIG. 1H  illustrates that the implant  125  has been resorbed and replaced with the adhesion  110 . 
       FIG. 5  illustrates another variation of implant  225  that can be used to occlude a fallopian tube using, in general, the same methods as described in  FIGS. 1A-4B . The body  226  of implant  225  can comprise a slotted polymer tube having interior lumen  228  in which the slots  240  can have selected dimensions to allow a rigid polymer tube to be flexible to follow a guidewire  248  within a tortuous path. The slots can be formed to provide flexibility in 360° as is known in the art. In this respect, the polymer sleeve can comprise a bio-absorbable or bio-degradable material that is substantially rigid but made flexible by the slots  240 . 
     Still referring to  FIG. 5 , the ablation functionality of the implant can again be provided by an RF source and spaced apart opposing polarity electrodes can be printed on the surface of the implant body  226 . In another variation, the surface of the implant body  226  can have electroless plating of gold or another conductive metal to provide a first electrode and the guidewire  248  can comprise a second opposing polarity electrode. 
     Still referring to  FIG. 5 , the mechanism to cause bleeding associated with the implant  225  comprises a cutting element or blade  250  that extends through lumen  228  and can be actuated from the handle of the catheter and can be manually operated or motor driven. The blade  250  can be a rotatable thin linear member of a ribbon stainless steel as shown in  FIG. 5 , but also can be a helical sharp edged element or an abrasive wire that can be moved rotational, axially or in both rotational and axial directions. An additional advantage of the variation of  FIG. 5  is that the negative pressure source  190  can suction tissue into lumen  228  and the tissue can be cut and captured in the lumen  228 . The cutting depth is sufficient to cut through the ablated tissue layer. The implant  225  can be moved slightly both axially and rotationally while actuating the blade to resect the entire surface layers of the fallopian tube lumen  152 . As a result, bleeding, is caused and further, the approximated walls or the fallopian tube  102  will be raw tissue, instead of ablated layers with cuts therein as shown in the embodiment in  FIGS. 1A-4B . It is believed that adhesions will form more quickly with the exposed cut tissue interfacing the coagulum in the targeted site (cf.  FIGS. 3-4B ). 
     Still referring to  FIG. 5 , the implant  225  can flatten the fallopian tube by providing a pull wire in the side of the sleeve to cause a curve in the implant (not shown). In another variation, a heat shrink polymer can be provided on one side of the implant that can be heated to deform the implant. Thus, the implant  225  of  FIG. 5  can provide all the functions as described in the previous embodiment, including: flexibility to follow a tortuous path, an RF electrode arrangement to ablate tissue, a cutting mechanism to cause bleeding in a targeted site, means to flatten the fallopian tube and means to trap the coagulum in the targeted site. 
       FIGS. 6A-6B  illustrate another variation of implant  275  for occluding a fallopian tube that can function to perform the methods as described previously. The body  276  of implant  275  again can comprise polymers with a guidewire lumen  278  to accommodate guidewire  280 . The implant has first and second (outer and inner) elements  282  and  284  that can be actuated to flatten the fallopian tube lumen. The outer element  282  has a flexible medial section that carries an abrasive edge  285  for example of diamond powder. Thus, the outer element  282  can be rotated to abrade and cut tissue to cause bleeding when is a collapsed or partly collapsed position. Further, the inner and outer elements  282  and  284  can be patterned with surface electrodes to perform the ablation step. To actuate the implant to an expanded shape as in  FIG. 6A , the inner element  284  can be pulled proximally to bend the outer element  284  which can be locked in place by a ratchet mechanism, heat actuated melt adhesion of the elements or any suitable mechanical locking, mechanism. Thus, the implant  275  of  FIGS. 6A-6B  can again provide the key functions of previous variations, including: flexibility to follow a tortuous path, an RF electrode arrangement to ablate tissue, a cutting mechanism to cause bleeding in a targeted site, means to flatten the fallopian tube and means to trap the coagulum in the targeted site. 
       FIGS. 7A-7B  depict another variation of implant  325  for use in occluding a fallopian tube that again can function to perform the methods described above. The body  326  of implant  325  has first and second, or respectively, outer and inner polymer sleeve elements  332  and  334  that can be actuated to expand leg elements  335  laterally to flatten the fallopian tube lumen. It can be seen that the outer element has a plurality of slots  340  and the inner element  334  has living-hinged leg elements  335  that can lay flat in the slots  340  in the insertion configuration of  FIG. 7A . The inner sleeve  334  can be moved axially relative to outer sleeve  332  over guidewire  342  as shown in  FIG. 7B  to cause the lea elements  335  to be flexed outwardly. The extended leg elements  335  then will trap blood and coagulum in the site, with the mechanism to cause bleeding described below. 
     In order to perform the step to cause bleeding in the targeted site in a fallopian tube, the outer sleeve element  332  has a surface  345  covered at least in part with abrasive particles, for example diamond particles or powder bonded to the surface  345 . Thus, the outer element  332  can be rotated to abrade and cut tissue to cause bleeding when the implant  325  is in the non expanded position of  FIG. 7A . The implant  325  also allows for negative pressure to be applied to the site through the outer sleeve lumen  350  that accommodates the inner sleeve  334 . In order to provide the ablation step, the outer surface  345  also can comprise a first polarity electrode with the guidewire  342  comprising the second polarity electrode. 
     To actuate the implant  325  to an extended or expanded shape of in  FIG. 7B , the inner element  334  is pulled proximally to outwardly flex the leg elements  335  which can be locked in place by a ratchet mechanism, heat actuated melt adhesion of the elements or any suitable mechanical locking mechanism. Thus, the implant  325  of  FIGS. 7A-7B  can again provide the functionality of previous variations, including: flexibility to follow a tortuous path, an RF electrode arrangement to ablate tissue, an abrasive mechanism to cause bleeding in a targeted site, means to flatten the fallopian tube and means to trap the coagulum in the targeted site. 
       FIG. 8  illustrates a portion of another variation of implant  425  for occluding a fallopian tube that functions to perform methods described previously and is similar to the implant  325  of  FIGS. 7A-7B . In  FIG. 8 , the body  426  of implant  425  has outer and inner polymer sleeve elements  432  and  434  that are actuated to extend leg elements  435  outwardly. In this variation, the leg elements  435  are hollow and needle-like to penetrate tissue and allow bleeding to flow back to site through ports  444  and  445 . In other respects, the implant  425  is similar to that of  FIGS. 7A-7B  with the leg elements  435  being collapsible into a plurality of slots  455 . The inner sleeve  434  is moved axially relative to outer sleeve  432  over guidewire  460  and the extended legs  435  then will trap blood and coagulum in the site. The mechanism to cause bleeding is described in the previous embodiment. The outer sleeve element  432  has a surface  465  covered at least in part with abrasive diamond particles bonded to the surface  465 . Thus, the outer element  432  can be rotated to abrade and cut tissue to cause bleeding when the implant  425  is in the non-expanded position as in  FIG. 8 . The outer surface  465  can comprise a first polarity electrode as described previously. 
       FIGS. 9A-9C  illustrate another variation of implant  515  for a fallopian tube that comprises a flexible polymer with multiple flex elements  518  that can flex outwardly to flatten a fallopian tube  102 . The flex elements  518  can be resilient, and flex outward as in  FIG. 9B  after retraction of a retaining sheath (cf.  FIG. 1D, 1E and 2B ). Alternatively, the flex elements  518  can be flexed by the pull of an inner sleeve in guidewire lumen  520  as shown in the embodiment of  FIGS. 6A-6B . The implant  515  can have an abrasive surface  522  for causing bleeding as described previously as well as surface electrodes as described in earlier embodiments. 
       FIGS. 10A-10B  illustrate another variation of implant  525  for occluding a fallopian tube that comprises a polymer with hinged elements  528  that can flex outwardly to flatten a fallopian tube. This embodiment includes barbs  540  for penetrating and gripping tissue. It should be appreciated that all of the previous variations can include barb features for engaging the walls of the fallopian tube. In one variation, an implant can have barbs that point in both the proximal and distal directions to assist in resisting dislodgement when subjected to both peristalsis and antiperistalsis The implant  525  can have an abrasive surface  522  for causing bleeding and surface electrodes as described in earlier embodiments. 
       FIGS. 11A-11B  illustrate another variation of implant  555  for occluding a fallopian tube that has resilient polymer barb elements  558  that Ilex outwardly to grip and flatten a fallopian tube.  FIGS. 12A-12B  depict another variation of implant  565  that has resilient flex elements  568  that flex outwardly and have barbs  570  facing both proximal and distal directions to engage and flatten a fallopian tube. The variations of  FIGS. 11A, 11B, 12A and 12B  can include a retractable sheath as described previously as well as surface electrodes as described above. 
     In some embodiments above, the polymer implants are of a bio-absorble material. Such materials are well known in the art and can be described as bio-resorbable, absorbable bio-erodible and can be assimilated by the body at predictable rates. Bio-resorbable or bio-degradable polymers include polylactic acid (PLA) polyglycolic acid (PGA), polydioxanone (PDS), polyhydroxybutyrate (PHB), polyhydroxyvalerate (PHV), polycaprolactone, polycyanocrylates, or polyphosphazenes. As used herein, the term bio-resorbable includes a suitable bio-compatible material, mixture of materials or partial components of materials being degraded into other generally non-toxic materials by an agent present in biological tissue, for example by being biodegradable or being removed by cellular activity, by bulk or surface degradation, or a combination of one or more of bio-degradable, bio-erodable, or bio-resorbable materials. 
       FIGS. 13A-13B  illustrate another variation of accessing, viewing and navigating a treatment catheter to a targeted location in a fallopian tube. In many cases, a woman&#39;s uterus  100  and/or cornua  104  can have an irregular shape or configuration making it difficult to access a fallopian tube  102 . Further, the fallopian tube may have a tortuous lumen or a sharp bend in the intramural segment  108  of the tube.  FIGS. 13A-13B and 14  schematically depict a device  600  corresponding to invention variation of a device that is adapted to assist introducing an endoscope/treatment catheter/guide wire into a fallopian tube  102 . 
     As can be seen in  FIG. 13A , the device  600  includes an introducer sleeve  605  with an optional proximal grip  606  and a lumen  608  that accommodates a guide member  610 .  FIG. 13A  shows the assembly of the sleeve  605  and guide member  610  being introduced through cervical canal  612  into the uterine cavity  105 . The guide member  610  has an elongated shaft assembly  614  with guide passageway  615  therein to receive an articulating endoscope  620  and treatment catheter similar to the system shown in  FIGS. 1A-1E  above. However, any number of devices can be advanced through the passageway  615 . The guide passageway  615  extends through handle  616 , shaft assembly  614  and flexible guide sleeve  622  ( FIG. 13B ) in an expandable structure  625  to an open termination  628  ( FIG. 13B ) that can be adjusted in position and orientation to access the fallopian tube  102  ( FIG. 13B ). In one variation shown in  FIG. 13B , the expandable structure  625  has a triangular shape and can have truncated distal apexes  630   a  and  630   b  in which the open termination  628  is disposed. The guide passageway  615  can be sized as needed (e.g., from 3 mm to 8 mm in diameter) and extends through shaft assembly  614  and flexible guide sleeve  622  to the open termination area  628 . 
       FIG. 13B  depicts sleeve  605  being retracted in the cervical canal  612  to expose the expandable member  625  carried by the shaft assembly  614 .  FIG. 13B  further depicts the expandable structure  625  being expanded in the uterine cavity  105 . In one variation, the expandable structure  625  is inflatable with a fluid (gas or liquid) delivered by a pump  635  such, for example a syringe or squeeze pump. In one example, the inflation pressure can range from 0.25 psi to 5 psi. The expandable structure  625  has interior chamber  640  ( FIG. 14 ) and is configured to occupy a substantial portion of the uterine cavity  105  to form a stable base for a flexible guide sleeve  622  carried within or about the expandable structure  625 . In certain variation, the expandable structure has a triangular shape with truncated distal apexes in which the open termination  628  of the guide passageway  615  exits the expandable structure. Other shapes that approximate the shape of the body cavity can be used as well. 
     Turning, to  FIG. 14 , a cut-away view of the expandable structure  625  and also shows the guide sleeve  622  in interior chamber  640 , wherein the guide sleeve can be a thin-wall flexible polymeric material. An endoscope  620  tin phantom view) is shown being introduced through guide passageway  615 . As can be understood from  FIG. 14 , the expansion of expandable structure  625  can apply a force as indicated by arrow A and A′ which thereby opens the entrance to the fallopian tube  102 . The inflation pressure can be adjusted between higher and lower levels to open the cornua  104  either more or less. In one variation, the angle or direction D or D′ at which the endoscope  620  and treatment catheter exit the expandable structure  625  can be adjusted by the physician pushing the shaft assembly  614  slightly back and forth in the cervical canal  612  and uterine cavity  105  to thus alter the orientation of the distal end  648  of the guide sleeve between, for example between shape X and X′ (phantom view). By adjusting the inflation pressure of the expandable structure  625 , and by articulating the working end of the endoscope  620 , the working channel of the endoscope and the treatment catheter can be aligned with the entrance to an ‘opened-up’ fallopian tube  102 . The device  600  will then allow for simplified navigation of the treatment catheter within the fallopian tube  102  as be understood from  FIG. 14 . 
     In use, it can be understood that expandable structure  625  can be collapsed and the device can be rotated about its axis by 180° and then expanded to view and access the other fallopian tube  102 ′. 
       FIG. 15  shows another variation of device  600 ′ which includes a first and second flexible guide sleeves  642   a  and  642   b  with guide passageways  644   a  and  644   b  carried within the expandable structure  625 . In one variation, the expandable structure again has a triangular shape with truncated distal apexes  630   a  and  630   b  which are configured with the open terminations  648   a  and  648   b  of the guide passageways  644   a  and  644   b  in the sleeves. The guide sleeves  642   a  and  642   b  can be thin polymer tubes that can be flattened to allow for collapse of the sleeves when the expandable structure is collapsed. In one variation, the physician may direct the articulating endoscope  620  into either guide sleeve  642   a  or  642   b  as the endoscope is navigated through the expandable structure  625 . In another variation, each guide sleeve  642   a  and  642   b  can be coupled to a collapsible sleeve that extends back through handle  616  (see  FIG. 13B ) and thus the physician can then insert the endoscope  620  into either collapsible sleeve at the proximal end of handle  616 . 
       FIG. 16  shows another variation of device  700  that is similar to the device  600  of  FIG. 13B . In this embodiment, the expandable structure  725  has first and second inflatable chambers  726   a  and  726   b  on either side of flexible guide sleeve  622 . In this version, each chamber can be expanded independently allows for adjusting the orientation of the sleeve  622  and opening  628  to align with fallopian tube  102 . It should be appreciated that two or more inflatable structures may be positioned about the guide sleeve to open the cornua  104  and fallopian tube  102  as well as aligning the guide passageway  615  with the fallopian tube. In another variation similar to that of  FIGS. 13A-13B , an elongate sleeve caring the guide passageway  615  can be axially slidable in the shaft assembly  614 , and the elongate sleeve can be moved axially back and forth and torqued from outside the handle  616  to thus flex the sleeve inside the expandable structure to thus align the guide passageway with a fallopian tube. 
     Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.