System and method for minimally invasive tubal sterilization

Abstract

A tubal sterilization system is described. The system includes a catheter having a first lumen and a second lumen, a footplate or plug deployable from the first lumen, and an adhesive deployable from the second lumen. Also described is a method of tubal sterilization. The method includes the steps of positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a fallopian tube of a subject, deploying a footplate or plug from the first lumen of the catheter to a long segment of the fallopian tube, and deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug. Also described is a method of sterilization for a male subject.

Description

Atorney docket # 206030-0287-00WQSYSTEM AND METHOD FOR MINIMALLY INVASIVE TUBAL STERILIZATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 606,503 filed on December 5, 2023, incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION

[0002] Female sterilization is obtained by almost one-third of women 35-44 years of age in the United States, with approximately 643,000 female tubal sterilizations performed annually. Tubal ligation is the most popular method of female sterilization, and research shows that more than 50% of women over 40 years old have had a surgical tubal ligation. While these procedures have the potential for surgical risks and anesthesia complications, research shows that women are willing to undergo the surgical risk, postoperative discomfort, and the expense of the procedure because tubal ligation is reliable and has a cumulative failure rate of only 1.9%. The majority of procedures are performed under general anesthesia, which has associated risks, particularly in those with medical co-morbidities. Some women may not be ideal surgical candidates for laparoscopy or mini-laparotomy because of prior surgeries or pelvic inflammatory disease resulting in adhesions.

[0003] Tubal ligation surgery is the current standard of care for women desiring permanent tubal sterilization. A study investigating complications after laparoscopic tubal ligation found that 0.35% of patients experienced complications, with uterine injury the most common minor complication and blood loss greater than 500mL the most common major complication. While this rate is very low, many women may be poor surgical or anesthesia candidates or simply prefer a less invasive approach. Given the rising costs of healthcare and the large number of women undergoing tubal sterilization every year, a cost-effective method of accomplishing this goal would be ideal. One study found that placement of the no-longer-available Essure device (placed trans-cervically in a minimally invasive fashion) with moderate sedation had aAttorney docket # 206030-0287-00WO statistically significant cost savings compared to laparoscopic tubal ligation under anesthesia; it stands to reason that a similar cost savings would be observed for a proposed trans-cervical tubal embolization procedure. Given the risks of surgical tubal sterilization and the large number of women undergoing permanent sterilization procedures, further investigation into less invasive, but reliable methods of permanent tubal sterilization that are cost effective is warranted.

[0004] A safe, inexpensive method of tubal occlusion is advantageous given escalating costs of medical care, and a minimally invasive method of tubal occlusion requiring only moderate sedation could increase access to this crucial service. The importance of access to methods of family planning is even more profound in the current political climate, with many women in the United States now unable to access abortion services in their local communities. Some women may have contraindications to general anesthesia or surgery, such as obesity, other comorbidities, pelvic adhesions, or prior pelvic inflammatory disease. A study in 2019 found that of a cohort of women desiring post-partum sterilization in New York, <50% underwent the procedure. Barriers to access included obesity and logistical issues such as operating room availability; 22.8% of women who were not treated subsequently became pregnant. Another study found that of women that desired but did not undergo sterilization, 9.5% had cancellation of their procedure because of intra-operative difficulties, and 4.8% were considered too obese to perform the procedure. Some members of this patient population may be better served by a minimally invasive, image-guided intervention.

[0005] Thus, there is a need in the art for improved systems and methods for tubal sterilization. The present invention meets this need.SUMMARY OF THE INVENTION

[0006] A tubal sterilization system is described. The system includes a catheter having a first lumen and a second lumen, a footplate or plug deployable from the first lumen, and an adhesive deployable from the second lumen. In some embodiments, the system further includes a sheath enclosing at least a portion of the catheter, wherein the catheter may extend out of and retract into the sheath. In some embodiments, the catheter is soft and hydrophilic.Attorney docket # 206030-0287-00WQ

[0007] In some embodiments, the footplate or plug is cone-shaped. In some embodiments, the cone-shaped footplate or plug is oriented with the base of the cone facing in a distal direction. In some embodiments, the footplate or plug is bioabsorbable. In some embodiments, the footplate or plug is expandable. In some embodiments, the footplate or plug is deployable with retention suture for traction. In some embodiments, the adhesive comprises one or more embolizing agents. In some embodiments, the adhesive comprises n-butyl-cyanoacrylate. In some embodiments, the adhesive comprises n-butyl-cyanoacrylate + lipiodol. In some embodiments, the catheter ranges between 1-5 French in size.

[0008] Also described is a method of tubal sterilization. The method includes the steps of positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a fallopian tube of a subject, deploying a footplate or plug from the first lumen of the catheter to a long segment of the fallopian tube, and deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug. In some embodiments, the step of deploying a footplate or plug includes moving the footplate or plug proximally into the long segment of the fallopian tube. In some embodiments, the footplate or plug is moved proximally by retracting the catheter into a sheath. In some embodiments, the step of deploying a footplate or plug comprises providing traction to the footplate or plug with retention suture. In some embodiments, the method is image-guided. In some embodiments, the method is transcervical.

[0009] Also described is a method of sterilization. The method includes the steps of positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a vas deferens of a subject, deploying a footplate or plug from the first lumen of the catheter to a long segment of the vas deferens and deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are includedAttorney docket # 206030-0287-00WO to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:FIGs. 1A-1F depict an exemplary system and method of tubal sterilization. FIG. 1A depicts an exemplary system positioned in the fallopian tube of a subject. FIG. IB depicts an exemplary system deploying a footplate or plug from a lumen of a catheter. FIG. 1C depicts an exemplary system retracting a plug to a position at which the plug occludes a portion of the fallopian tube and releasing and affixing the plug. FIG. ID depicts an exemplary system administering a liquid embolic agent or glue proximal to a plug. FIG. IE depicts an exemplary system administering a liquid embolic agent or glue proximal to a plug while retracting the system in a proximal direction. FIG. IF depicts an exemplary system retracting in a proximal direction and ending the administration of a liquid embolic agent or glue.FIGs. 2A-2B are diagrams depicting exemplary methods of tubal sterilization. FIG. 2A is a diagram depicting an exemplary method for tubal sterilization or ligation according to aspects of the present invention. FIG. 2B is a diagram depicting an exemplary method for tubal sterilization or ligation according to aspects of the present invention.FIGs. 3A-3D are a series of images depicting a salpingography for a subject in a disclosed example study (e.g., rabbit #5, right fallopian tube) with a tubal sterilization performed using embodiments of the disclosed system and method. FIG. 3A is an image of an initial salpingography for the subject demonstrating opacification of the fallopian tube (black arrow) with free spillage into the peritoneum (white arrow). The Kumpe catheter (curved black arrow) is engaged in the fallopian tube ostium arising from the end of the right spiral-shaped uterine horn, and the sheath and foley balloon catheter (curved white arrow) are located within the vagina. FIG. 3B is an image showing a microcatheter (black arrow) advanced to the distal fallopian tube and an embolization with glue / lipiodol administered as the microcatheter is withdrawn. FIG. 3C is an image depicting a salpingography immediately after embolization via the Kumpe catheter demonstrating reflux of contrast into the uterine horn (black arrow) and absence of contrast opacification in the fallopian tube, n-butyl-cyanoacrylate (NBCA) is visible within the fallopian tube (white arrow). FIG. 3D is an image depicting follow-up salpingography performed for rabbit 5 at 32 days post-procedure, demonstrating reflux of contrast into the uterine horn (blackAtorney docket # 206030-0287-00WQ arrow), absence of contrast opacification of the fallopian tube, and no free spillage of contrast into the peritoneum. NBCA is again visible within the fallopian tube (white arrow). NBCA and microcoil used for embolization of the contralateral fallopian tube are also captured on this image (curved black arrow). Both fallopian tubes for rabbit 5 were noted to be occluded on follow-up salpingography.FIGs. 4A-4C are a series of images depicting examples of histopathologic findings at the level of tubal embolization. FIG. 4A is an image depicting a section from a central portion of the right fallopian tube of rabbit 5 at the level of embolization, which has been fixed in formalin and stained with hematoxylin and eosin. The lumen of the fallopian tube is distended due to complete occlusion by NBCA (black arrow) and lined by variably attenuated epithelium. The adjacent epithelium and submucosa contain mild inflammation, with scattered individual inflammatory cells, and mild fibrosis. FIG. 4B and FIG. 4C are images showing a section at the level of the embolized portion of the right fallopian tube from rabbit 8 demonstrating a lumen completely occluded by NBCA, with admixed sloughed cells, and protein debris (black arrow). The surrounding epithelium displays small areas of regeneration, and the subjacent, mildly inflamed tissue contains scattered foreign body granulomas (white arrow), and areas of plump fibroblasts with admixed small caliber congested vessels (curved black arrow), indicative of granulation tissue.FIGs. 5A-5B are graphs summarizing the findings of salpingography and histopathologic analysis in the disclosed example. FIG. 5 A shows the 1 -month post-embolization for fallopian tubes embolized with NBCA / lipiodol only. FIG. 5B shows the 1 -month post-embolization for fallopian tubes embolized with NBCA / lipiodol + coil.DETAILED DESCRIPTION

[0011] It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in related systems and methods. Those of ordinary skill in the art may recognize that other elements and / orAttorney docket # 206030-0287-00WQ steps are desirable and / or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

[0012] Unless defined elsewhere, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, exemplary methods and materials are described. As used herein, each of the following terms has the meaning associated with it in this section.

[0013] Reference throughout the specification to “one embodiment”, “an embodiment” or “some embodiments” means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the subject matter disclosed.Thus, the appearance of the phrases “in one embodiment”, “in an embodiment” or “in some embodiments” in various places throughout the specification is not necessarily referring to the same embodiment. Further, the particular features, structures or characteristics of “one embodiment”, “an embodiment” or “some embodiments” may be combined in any suitable manner with each other to form additional embodiments of such combinations. Further, it is intended that embodiments of the disclosed subject matter cover modifications and variations thereof.

[0014] As used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context expressly dictates otherwise. That is, unless expressly specified otherwise, as used herein the words “a,” “an,” “the,” and the like carry the meaning of “one or more.” Additionally, it is to be understood that terms such as “left,” “right,” “top,” “bottom,” “front,” “rear,” “side,” “height,” “length,” “width,” “upper,” “lower,” “interior,” “exterior,” “inner,” “outer,” and the like that may be used herein merely describe points of reference and do not necessarily limit embodiments of the present disclosure to any particular orientation or configuration. Furthermore, terms such as “first,” “second,” “third,” etc.,Attorney docket # 206030-0287-00WO merely identify one of a number of portions, components, steps, operations, functions, and / or points of reference as disclosed herein, and likewise do not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.

[0015] Throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6 and any whole and partial increments therebetween. This applies regardless of the breadth of the range.

[0016] “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass the specified value, and variations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value, as such variations are appropriate.

[0017] The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, and in some instances, a human.

[0018] Described herein is a system and method relating to a minimally invasive, image-guided procedure that provides a non-surgical, trans-cervical option for women desiring permanent tubal sterilization. The mechanism of the technique involves the administration of one or more embolizing agents or adhesives, such as, but not limited to / / -butyl -cyanoacrylate (NBCA) via a catheter or microcatheter to a long segment of the fallopian tube. Over time, fibrosis takes place and results in durable occlusion. Experimentally demonstrated herein is that the majority of subjects (i.e., rabbits) undergoing tubal embolization had occlusion at 1 month after the procedure and demonstrated that this system and method is a safe and effective technique for tubal sterilization.Attorney docket # 206030-0287-00WQ

[0019] In some embodiments, a bi oab sorbable, cone-shaped footplate / plug may be deployed at the distal fallopian tube via one of the lumens of a catheter or microcatheter, wherein the plug may be retracted to a point at which it occludes the distal Fallopian tube, likely at the beginning of the infundibular segment, and held in place by traction on an absorbable suture. Through another catheter lumen, glue may be administered to the length of the fallopian tube to provide permanent occlusion as the catheter component is withdrawn by the system. In some embodiments, the suture is then released by the system. The disclosed system with cone-shaped plug keeps the liquid surgical adhesive in place within the fallopian tube preventing flow of the glue into the peritoneum, while not leaving behind a permanent or non-absorbable device.

[0020] Referring now to FIG. 1A, shown is an exemplary system 100 for tubal sterilization according to aspects of the present invention. System 100 generally includes a catheter 100 having a proximal portion or end 102 and a distal portion or end 104, and a length therebetween, the distal end 104 forming an opening 112 with a rim 114, with at least one conduit forming at least one lumen (e.g., lumen 120) positioned within the catheter. Catheter 110 and / or the at least one conduit are sized and configured to perform tubal sterilization or ligation on a subject by administering or delivering plugs, footplates, backstops, or other occlusion devices to the fallopian tube of a subject. Further, the catheter 110 and / or the at least one conduit or lumens thereof are sized and configured for administering, dispensing or providing one or more embolizing agents, liquid embolic agents, adhesives, surgical adhesives, glues, or the like, to portions of the fallopian tube.

[0021] In some embodiments, catheter 110 forms a first lumen (e.g., lumen 120) for delivering and releasing an occlusion or embolizing device (e.g., plug 130) and a second lumen configured for administering the embolizing agent or adhesive. In some embodiments, the second lumen is formed by an additional conduit in catheter 110, or is formed by the lumen extending through catheter 110. In some embodiments, lumen 120 may be configured to move, slide, or at least partially extend out of distal end 104 of catheter 110 in order to deploy a plug or other occlusion device. However, in some embodiments, catheter 110 and the at least one conduit are fixedly attached and substantially aligned at their distal ends. It should be appreciated that system 100 may be formed of a single unit or structure that extends from the fallopian tube and out of the subject, or may be fixedly and removably attached to the distal end of any dual-lumened surgicalAttorney docket # 206030-0287-00WO catheter. Further, it should be appreciated that system 100 may be connected to various pumps, fluid supplies, glue reservoirs or supplies, and may have actuating means for controlling the pumps and supplies, as well as means for extending and retracting the catheter from a sheath, and / or means for deploying and releasing the occlusion devices or plugs from the system.

[0022] In some embodiments, catheter 110 is slidably inserted into a sheath 160, wherein the catheter 110 may extend or retract from sheath 160 to aid in positioning and use of the system. For example, extending and retracting catheter 110 aids in the positioning and release of plugs, devices and / or embolizing agents from system 100 into one or more portions of a fallopian tube. In some embodiments, system 100 is inserted or positioned within the fallopian tube of a subject with the ends of catheter 110 and sheath 160 substantially aligned, and catheter 110 then extends further distally into a distal portion of the fallopian tube while the sheath 160 remains positioned in a proximal portion of the fallopian tube. Referring now to FIG. IB, system 100 may be configured to deploy, position and / or affix one or more embolizing or occlusion devices such as plugs (e.g., plug 130), coils, microcoils, anchors, fallopian tube anchors, or the like, and any combinations thereof. In some embodiments, system 100 provides traction to plug 130 with a retention suture, one or more expandable portions or regions on the plug, and / or a compression or interference fit for the plug in the fallopian tube. In some embodiments, plug 130 is formed of a compressible material that expands when deployed from lumen 120.

[0023] Referring now to FIGs. 1A-1F, the series of images depicts an exemplary system and method for tubal sterilization or ligation of a fallopian tube according to aspects of the present invention. FIG. 1A depicts system 100 positioned in the fallopian tube of a subject. FIG. IB depicts system 100 deploying a plug 130 from lumen 120. FIG. 1C depicts system 100 retracting or moving proximally plug 130 to a point or position at which the plug occludes a portion of the fallopian tube. In some embodiments, plug 130 is retracted or moved proximally by retracting catheter 110 into sheath 160 in order to position or affix the plug with the aid of a retention suture, and / or compression or interference fit. In some embodiments, system 100 affixes plug 130 with a retention suture and / or traction on the device to fixedly position the plug in the fallopian tube. In some embodiments, embolizing agent, adhesive or glue 140 is administered to plug 130 while catheter 110 is moved in a proximal direction to position the plug. In some embodiments, some glue is applied to a distal portion of the plug, or distal to the plug, prior toAttorney docket # 206030-0287-00WQ moving catheter 110 in a proximal direction. In some embodiments, system 100 releases plug 130 in a position within the fallopian tube, wherein the plug 130 occludes some or all of the fallopian tube. The embolizing device (e.g., plug 130) may be deployed from lumen 120 with fluid pressure, a microcatheter, a wire, a pushrod, actuated means, or the like. FIG. ID depicts system 100 administering an embolizing agent (e.g., liquid embolic agent) or glue 140 proximal to plug 130 through catheter 110. In some embodiments, while glue 140 is administered, distal end 104 is held near plug 130 in order to fill the space between distal end 104 and plug 130 with glue. FIG. IE depicts system 100 administering a liquid embolic agent or glue 140 proximal to plug 130 while also retracting catheter 110 in a proximal direction. FIG. IF depicts system 100 ending or terminating the administration of glue and catheter 110 fully retracted into sheath 160.

[0024] In some embodiments, system 100 comprises a flexible catheter component (e.g., catheter 110) with 2 lumens (e.g., lumen 120, and the lumen formed by catheter 110) (approximately 1-5 French size) that may be advanced over a wire to the distal fallopian tube. In some embodiments, the flexible catheter component may be attached to the end of any dual lumen catheter known by one or ordinary level of skill in the art. In some embodiments, a bioabsorbable footpl ate / plug (e.g., plug 130) may be deployed at the distal fallopian tube via one of the lumens (e.g., at least one lumen 120), which may be retracted to a point at which it occludes the distal Fallopian tube, and held in place by traction on an absorbable or resorbable suture (e.g., a retention suture). Through the other lumen, glue or adhesive may be administered to all or a portion of the length of the fallopian tube to provide permanent occlusion as the catheter component is withdrawn by the system. In some embodiments, the resorbable suture used for traction on the plug is then released. Ultimately, glue within the fallopian tube is all that remains after the other components resorb. The traction on the plug or footplate may ensure a tight seal so that glue does not exit the distal fallopian tube into the peritoneum. It may also keep more of the glue in the desired location, aiding in occlusion of the tube. The glue polymerizes quickly, so once the suture is released, it will have solidified adequately. In some embodiments, the glue is cured with a solidifying agent, an activator, and / or a light source (e.g., for a photoactive agent or glue). In some embodiments, the glue is a two-part glue (e.g., a glue and activator), delivered by separate lumens in catheter 110 (e.g., deployed from second and third lumens). In some embodiments, a first plug is delivered, followed by delivery of glue or adhesive, with a second plug delivered after the adhesive, meant to enclose a portion of the fallopian tube and fill it with glue. It shouldAttorney docket # 206030-0287-00WQ be appreciated that the plugs and glue may be deployed in order while the catheter 1 10 is moved proximally at a predetermined speed in order to maximize the amount of glue in the enclosed portion, and prevent egress of glue past the plugs.

[0025] In some embodiments, system 100 comprises a flexible catheter (e.g., catheter 110) with two or more lumens running therethrough (e.g. approximately 1-5 French in size) that may be advanced over a wire to the distal fallopian tube. In some embodiments, catheter 110 is soft or flexible. In some embodiments, catheter 110 is hydrophilic or comprises one or more coatings (e g., a hydrophilic coating, a lubricant). In some embodiments, system 100 comprises a 20 French Foley balloon catheter (e.g., catheter 110) that is placed into the vagina of the subject and reinforced with a 7 French 45 cm sheath (e.g., sheath 160). In some embodiments, the cervix is accessed using a 5 French Kumpe catheter and guidewire up to the ostium of the fallopian tube. In some embodiments, system 100 comprises a 2.4 Fr microcatheter-microwire system that is advanced to the distal fallopian tube. In some embodiments, the one or more embolizing agents or glue is administered through a microcatheter. In some embodiments, the one or more embolizing agents or glue comprise zz-butyl-cyanoacrylate (NBCA), or NBCA + lipiodol.

[0026] Aspects of the present invention relate to a method of tubal sterilization or ligation. Referring now to FIG. 2A, shown is an exemplary method 200 of tubal sterilization. In some embodiments, method 200 comprises the steps of: 202 positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a fallopian tube of a subject; 204 deploying a footplate or plug from the first lumen of the catheter to a long segment of the fallopian tube; and 206 deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug. Referring now to FIG. 2B, shown is an exemplary method 210 for tubal sterilization or ligation. In some embodiments, method 210 comprises the steps of: 212 accessing the fallopian tubes through the cervix using a catheter, without a surgical incision; 214 advancing a microcatheter to the end of the fallopian tube; 216 administering a surgical glue into the fallopian tube as the microcatheter is withdrawn; and optionally, 218 confirming complete closure of the fallopian tube with contrast injection after the tube is occluded. In some embodiments, any disclosed method may include the use or deployment of a resorbable fallopian tube anchor and / or occlusion device and suture or other affixing means for applying traction to the anchor or device. In some embodiments, the system isAttorney docket # 206030-0287-00WQ hysteroscopically deployed or is deployed using one or more medical imaging systems such as laparoscopes or ultrasound.

[0027] The end user of this medical device is physicians, specifically interventional radiologists, who perform minimally invasive, image guided procedures. These include trans-cervical procedures to evaluate for fallopian tubal occlusion in women suffering from infertility (hysterosalpingogram), and to treat fallopian tubal occlusion by crossing the obstructed tube with a wire or microcatheter (fallopian tube recanalization). These physicians would be ideally positioned to utilize this device to treat women who no longer desire fertility. The procedure could be performed in the outpatient setting in any standard angiography suite, with moderate sedation, which is utilized in many interventional radiology procedures.

[0028] For women desiring permanent sterilization, the only options currently available to them are surgical in nature. Surgical options for sterilization include hysterectomy, salpingectomy, tubal ligation, tubal fulguration, and the application of tubal clips. Intrauterine devices are also widely utilized for long-term birth control, but this is not permanent, and many women experience side effects related to these devices. The Essure device was the only device that offered non-surgical permanent sterilization, but a number of complications resulted in it being pulled from the market by Bayer in 2018. Currently, the only competitor is the standard of care, which is primarily surgical tubal ligation. The Essure device was an implant containing a nickeltitanium alloy outer coil wrapped in a layer of fibers that induce tubal fibrosis. Although originally envisioned for deployment into the fallopian tubes (through the cervix) under fluoroscopic observation, it was approved for placement using hysteroscopy as well. Because of thousands of reports of complications, some of which may have been related to inappropriate placement under hysteroscopy, the device is no longer sold in the United States. No other minimally invasive device for tubal sterilization that can be placed trans-cervically is currently on the market in the United States. Many women who prefer a less invasive method of tubal sterilization, have medical conditions that would make surgery challenging, or have limited ability to undergo a surgery due to access to care would find a minimally invasive method appealing, giving this device a definite competitive advantage. The present invention makes it possible to provide an optimized version of a novel procedure, which is performed through theAtorney docket # 206030-0287-00WO cervix, without surgical incisions, and without general anaesthesia, unlike other options currently available to women.

[0029] The system and method allows for the administration of glue to a long segment of the fallopian tube while avoiding egress of glue into the peritoneum. In some embodiments, the system is soft enough to traverse tortuous fallopian tubes, and also deploy a resorbable backstop via one of the lumens with a retention suture. In some embodiments, the device deploys a resorbable or non-resorbable microvascular plug via a microcatheter.

[0030] In some embodiments, the device and system may be utilized to provide permanent sterilization for men who are no longer interested in fertility by a similar mechanism of action. In some embodiments, the system and method provide a glue embolization of the vas deferens in male subject. For example, a method of sterilization, comprising the steps of positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a vas deferens of a subject, deploying a footplate or plug from the first lumen of the catheter to a long segment of the vas deferens, and deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug. It should be appreciated that any aspects of system 100 and / or any previously disclosed methods may be applied to the method for tubal sterilization for a male subject.EXPERIMENTAL EXAMPLES

[0031] The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein.

[0032] Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the system and method of the present invention. The following working examples therefore, specificallyAtorney docket # 206030-0287-00WQ point out the exemplary embodiments of the present invention, and are not to be construed as limiting in any way the remainder of the disclosure.Fallopian Tube Embolization via Selective Catheterization in a Rabbit Model

[0033] The purpose of this study is to determine whether fallopian tube embolization with n- butyl-2-cyanoacrylate (NBCA) administered via a microcatheter in a rabbit model is technically feasible and resulted in short-term tubal occlusion. In 10 female New Zealand white rabbits, the two cervices were cannulated using a 5 Fr catheter and hydrophilic guidewire transvaginally. Salpingography confirmed tubal patency bilaterally. A 2.4 Fr microcatheter was advanced to the distal fallopian tube, and NBCA / ethiodized oil was administered as the microcatheter was withdrawn to fill the length of the tube. A metallic coil was deployed prior to NBCA administration in half of the fallopian tubes. Rabbits were evaluated for tubal occlusion with salpingography at 1 month, followed by euthanasia and histopathologic analysis. Inflammation and fibrosis were graded from 0 (normal) to 3 (severe). Fallopian tube embolization was technically successful in 17 / 20 fallopian tubes (85%). 13 / 17 (76%) embolized fallopian tubes were occluded at 1 month on salpingography (7 / 9 NBCA only, 6 / 8 NBCA and coil). On histopathologic analysis, direct or indirect evidence of occlusion was observed in 14 / 17 fallopian tubes (82%). Mild or early fibrosis was observed in 65% of the tubes. The mean inflammation and fibrosis scores for the embolized tubes were 0.62 and 0.94, respectively. This study found that embolization of the fallopian tubes using NBCA administered via a microcatheter is technically feasible and results in occlusion of most fallopian tubes in the short term with minimal inflammation.

[0034] H-butyl-2-cyanoacrylate (NBCA) is commonly used for vascular embolotherapy, but is also utilized in non-vascular applications, such as thoracic duct embolization and as tissue adhesive for traumatic lacerations. NBCA is typically delivered using a microcatheter for vascular embolization. Prior studies performed in sheep and rabbit models indicate that this substance has the potential for effective fallopian tubal occlusion with minimal inflammation when administered to the proximal fallopian tube via hysteroscopy. However, hypertrophy of the distal fallopian tube muscular layer and tube dilatation occurred, which could place the plug at risk for eventual expulsion, or other complications related to increased tube diameter.Atorney docket # 206030-0287-00WOInterventional radiologists could embolize a longer segment of the tube, extending distally into the tortuous fallopian tube, using a microcatheter, which is not possible with hysteroscopy. This may help to prevent these architectural changes and decrease the risk of failure due to expulsion. Embolization under fluoroscopy allows for the embolic to be delivered at the desired location and intra-procedural confirmation of occlusion. Complications associated with maldeployment of the Essure device under hysteroscopy underscore the importance of verifying appropriate administration of tubal embolic agents for the purpose of sterilization.

[0035] The female rabbit model has been used extensively to evaluate the technical feasibility and clinical success of surgical and minimally invasive techniques for tubal sterilization and has been validated as a reproducible and clinically relevant animal model prior to in-human clinical trials. This example investigates the technical feasibility of embolization of the fallopian tube using NBCA administered via a microcatheter in a rabbit model, to determine the rate of successful short-term tubal occlusion, and evaluate histopathologic changes following embolization.

[0036] Animal Model: The experimental procedures were performed after protocol approval by the institutional animal care and use committee. 11 female New Zealand White rabbits weighing between 3.0-4.0 kg were utilized. They were fed a standard rabbit diet and housed in the institutional animal facility. The animals were allowed to acclimate to the facility for at least 2 days before the procedures. One rabbit was used for technique optimization and was sacrificed after 1 week.

[0037] Pre-procedural preparation: The veterinary team induced general anesthesia in each rabbit. Xylazine 2-5 mg / kg intramuscular and Ketamine 20-50 mg / kg intramuscular were used for initial sedation. Isoflurane 0.25-4% inhaled continuously after intubation was used for general anesthesia. Carprofen 2-4 mg / kg or Meloxicam 0.1-0.3 mg / kg was administered subcutaneously for pre-emptive analgesia.

[0038] The groin and lower abdomen were shaved and prepped with 70% Alcohol, 3x, followed by betadine scrub. The operators donned appropriate operative attire and practiced sterile technique; sterile drapes, supplies, and instruments were utilized.Attorney docket # 206030-0287-00WO

[0039] Fallopian Tube Embolization Technique: An attending interventional radiologist performed the procedures under fluoroscopic guidance. Using a modification of the technique described by Thurmond et al., [Thurmond AS. Fallopian tube catheterization. Semin Intervent Radiol 2013; 30:381-387] a 20 french Foley balloon catheter, reinforced with a 7 french 45 cm Ansel sheath (Cook Medical, Bloomington, IN), was placed into the vagina with the aid of lubricating jelly. Following inflation of the balloon, iohexol contrast medium (Omnipaque) and / or air was injected through the sheath into the distal vaginal vault to identify the two cervices. The cervix was accessed using a 5 french Kumpe catheter (Cook Medical, Bloomington, IN) and Glidewire (Terumo Medical Corporation, Somerset, NJ). The catheter was advanced to the ostium of the fallopian tube arising from the distal uterine horn. Salpingography was performed to visualize the course of the tube and confirm patency (free spillage of contrast into the peritoneal cavity). A 2.4 french Progreat microcatheter (Terumo Medical Corporation, Somerset, NJ) was then advanced as distally as possible within the tortuous fallopian tube, optimally to the level of the infundibulum, with the aid of a microwire (GT glidewire, Terumo Medical Corporation, Somerset, NJ). After flushing the microcatheter with dextrose, NBCA (Histoacryl Flexible, B. Braun, Melsungen, Germany) mixed with lipiodol (Guerbet, Villepinte, France) was administered through the microcatheter, as it was withdrawn, to fill the length of the fallopian tube. The entire traversed length of the fallopian tube was embolized back to the tubal ostium. For half of the embolized tubes, a 3-2 Tornado microcoil (Cook Medical, Bloomington, IN) was deployed within the distal fallopian tube prior to glue embolization. The microcatheter was then removed and flushed with dextrose. Post-embolization salpingogram was performed via the Kumpe catheter to confirm occlusion. Technical success was defined as successful embolization, with glue seen within several centimeters of the tortuous fallopian tube, with evidence of occlusion on salpingography following embolization. The process was repeated for the fallopian tube arising from the contralateral uterine horn. In the event of visualized perforation of the small, tortuous uterine horns or distal vagina, as evidenced by contrast spillage into the peritoneum prior to catheterization of the fallopian tube, the procedure was aborted, antibiotics were administered, and the rabbit was permitted to recover.

[0040] Post-procedural follow-up: The study rabbits underwent repeat salpingography at 1- month post-procedure to evaluate for tubal occlusion, which was performed using a Kumpe catheter to evaluate for evidence of contrast spillage into the peritoneum. Pentobarbital-Atorney docket # 206030-0287-00WO containing euthanasia solution was administered for euthanasia. The uteri and fallopian tubes were harvested by the study veterinarian and fixed in 10% formalin. The peritoneum was examined for evidence of adhesions or NBCA outside the fallopian tubes.

[0041] Histopathologic evaluation: Tissues were embedded in paraffin, sectioned at 4 pm, and stained with hematoxylin and eosin (H&E). Masson’s tri chrome staining, which visualizes collagen, was used for additional evaluation of fibrosis within the fallopian tubes. Histopathologic analysis proximal to, distal to, and containing the embolic was performed by a board-certified veterinary pathologist. Grades of fibrosis and inflammation according to semiquantitative analysis were recorded as outlined by Rivoire. Structural changes and direct and indirect evidence of occlusion were recorded.

[0042] Data Analysis: Descriptive statistics evaluate the study results. The percentage of embolized fallopian tubes occluded on salpingography at 1 -month post-embolization was reported, and embolization techniques were compared using the chi-square test. The degree of inflammation and fibrosis were graded as follows: 0 (absent), 1 (mild), 2 (moderate), and 3 (marked) as outlined in Rivoire and reported as a mean.

[0043] Technical Success: Procedural refinement was performed using Rabbit 1. Embolization of both fallopian tubes was successful (one NBCA / lipiodol, one NBCA / lipiodol plus coil) and both were noted to be occluded on salpingography 1 week later, prior to euthanasia.

[0044] Ten study rabbits were utilized for data generation (rabbits 2-11, Table 1A & Table IB). Technical success was achieved for 17 / 20 fallopian tubes (85%); 8 were embolized with glue and coil and 9 with glue only. 3 fallopian tubes (15%) were unable to be catheterized secondary to perforation of the uterine horn or distal vagina by the Kumpe catheter or guidewire, precluding catheterization of the fallopian tube. The 17 successfully embolized fallopian tubes were noted to be patent on initial salpingography and were occluded on intra-procedural post-embolization salpingography (FIGs. 3A-3D). The amount and ratio of the NBCA / lipiodol utilized to embolize each fallopian tube is listed in Table 1A & Table IB. Because of concern for a small amount of glue entering the peritoneum from the distal fallopian tube in rabbits 2 and 3, the proportion of NBCA in the mixture was increased thereafter.Attorney docket # 206030-0287-00WQ

[0045] FIGs. 3A-3D are a series of images depicting a salpingography for a subject in a disclosed example study (e.g., rabbit #5, right fallopian tube) with a tubal sterilization performed using embodiments of the disclosed system and method. FIG. 3A is an image of an initial salpingography for the subject demonstrating opacification of the fallopian tube (black arrow) with free spillage into the peritoneum (white arrow). The Kumpe catheter (curved black arrow) is engaged in the fallopian tube ostium arising from the end of the right spiral-shaped uterine horn, and the sheath and foley balloon catheter (curved white arrow) are located within the vagina. Contrast opacification of the left uterine horn is also incidentally noted. FIG. 3B is an image showing a microcatheter (black arrow) advanced to the distal fallopian tube and an embolization with glue / lipiodol administered as the microcatheter is withdrawn. FIG. 3C is an image depicting a salpingography immediately after embolization via the Kumpe catheter demonstrating reflux of contrast into the uterine horn (black arrow) and absence of contrast opacification in the fallopian tube, n-butyl-cyanoacrylate (NBCA) is visible within the fallopian tube (white arrow). FIG. 3D is an image depicting follow-up salpingography performed for rabbit 5 at 32 days postprocedure, demonstrating reflux of contrast into the uterine horn (black arrow), absence of contrast opacification of the fallopian tube, and no free spillage of contrast into the peritoneum. NBCA is again visible within the fallopian tube (white arrow). NBCA and microcoil used for embolization of the contralateral fallopian tube are also captured on this image (curved black arrow). Both fallopian tubes for rabbit 5 were noted to be occluded on follow-up salpingography.

[0046] Table 1A. Summary of Fallopian Tube Embolization ProceduresAtorney docket # 206030-0287-00WQ

[0047] Table IB. Continued Summary of Fallopian Tube Embolization Procedures

[0048] Complications: In total, 4 rabbits experienced perforation (20%) of the distal vagina or uterine horns by the 5 French Kumpe catheter. This included 3 rabbits who had one fallopian tube embolized prior to the perforation, rabbits 3, 6, and 8. For rabbit 4, a perforation occurred upon accessing the right uterine horn prior to embolization of either fallopian tube. The procedure was aborted and was re-attempted after 6 weeks, after the perforation had healed. Both fallopian tubes were successfully embolized during the second attempt and are listed as technically successful. All animals experiencing perforation were treated with antibiotics andAttorney docket # 206030-0287-00WO recovered uneventfully. There were no unexpected deaths among the animals or evidence of illness or abnormal behavior of concern to the veterinarian during the study.

[0049] Follow-up salpingography: Endpoint salpingography was performed at 31.1 days. 13 / 17 embolized tubes were found to be occluded on salpingography (76%): 7 / 9 tubes embolized with NBCA / lipiodol only (78%), and 6 / 8 tubes embolized with NBCA / lipiodol and a coil (75%) (p=0.45).

[0050] Gross pathologic evaluation: Following euthanasia, the peritoneum was inspected for evidence of adhesions or embolic agent outside the fallopian tubes. Six embolized fallopian tubes had glue adjacent to the fallopian tube or in the adjacent paracolic gutter or peritoneum. No dense adhesions were noted by the veterinarian performing necropsy; one rabbit had evidence of soft adhesions, which were easily disrupted with a blunt instrument.

[0051] Histopathologic evaluation: Histopathological analysis of the selected sections of the embolized tubes confirmed either direct or indirect evidence of tubal occlusion in 14 of 17 tubes (82%). This included 9 / 9 of the glue embolized fallopian tubes (100%) and 5 / 8 of the glue and coil embolized fallopian tubes (63%). Indirect evidence of tubal occlusion included epithelial changes involving the circumference of the tube lumen. The absence of glue at these locations was likely related to exposure to processing chemicals for paraffin embedding. Mild or early fibrosis was observed in 11 / 17 of tubes (65%) — 6 in the glue arm (67%) and 5 in the glue + coil arm (63%). The remaining tubes showed no fibrosis. The mean fibrosis score was 0.94 ± 0.80 — 1.0 ± 0.82 for glue embolization and 0.88 ± 0.78 for glue / coil embolization. All fallopian tubes but 1 demonstrated no or mild inflammation. The mean inflammation score was 0.62 ± 0.56. All fallopian tubes had at least some areas of normal epithelium proximal to the occlusion, with 2 / 17 fallopian tubes (12%) showing some areas of hyperplasia of the proximal fallopian tube epithelium. 10 / 17 fallopian tubes (59%) had some normal epithelium distal to the occlusion. 8 / 17 (47%) showed hyperplasia of the distal epithelium; one tube had mild smooth muscle hypertrophy at this location. Histopathological findings for each fallopian tube are presented in A & Table IB, with representative findings shown in FIGs. 4A-4C. Small fragments of glue outside the fallopian tubes were found to be surrounded by macrophages. Data on angiographicAtorney docket # 206030-0287-00WQ and histological occlusion, as well as grading of fibrosis and inflammation, is summarized in FIGs. 5A-5B and Table 2.

[0052] FIGs. 4A-4C are a series of images depicting examples of histopathologic findings at the level of tubal embolization. FIG. 4A is an image depicting a section from a central portion of the right fallopian tube of rabbit 5 at the level of embolization, which has been fixed in formalin and stained with hematoxylin and eosin. The lumen is distended due to complete occlusion by NBCA (black arrow) and lined by variably attenuated epithelium. The adjacent epithelium and submucosa contain mild inflammation, with scattered individual inflammatory cells, and mild fibrosis. FIG. 4B and FIG. 4C are images showing a section at the level of the embolized portion of the right fallopian tube from rabbit 8 demonstrating a lumen completely occluded by NBCA, with admixed sloughed cells, and protein debris (black arrow). The surrounding epithelium displays small areas of regeneration, and the subjacent, mildly inflamed tissue contains scattered foreign body granulomas (white arrow), and areas of plump fibroblasts with admixed small caliber congested vessels (curved black arrow), indicative of granulation tissue.

[0053] FIGs. 5A-5B are graphs summarizing the findings of salpingography and histopathologic analysis in the disclosed example. FIG. 5 A shows the 1 -month post-embolization for fallopian tubes embolized with NBCA / lipiodol only. FIG. 5B shows the 1-month post-embolization for fallopian tubes embolized with NBCA / lipiodol + coil.

[0054] Table 2. Summary of the Results of Fallopian Tube Embolization Procedures by Salpingography and HistopathologyAtorney docket # 206030-0287-00WQ

[0055] This pilot study found that the fallopian tube embolization procedure was technically successful in the majority of the tubes. The technical failures were secondary to perforation of the small, tortuous uterine horns or distal vagina by the catheter prior to salpingography, resulting in inability to access or embolize one of the fallopian tubes. The rabbits experiencing perforation were given antibiotics and recovered uneventfully. Imaging and histopathologic evaluation of tubal occlusion at 1 month indicates that the embolization procedures were largely effective. The majority of the embolized tubes were found to be occluded on salpingography at 1 month in each of the NBCA / lipiodol and NBCA / lipiodol and coil arms. An even greater percentage of fallopian tubes were observed to be directly or indirectly occluded on histopathology, including all of the tubes embolized with NBCA / lipiodol only. Inflammation was minimal with only 1 fallopian tube having inflammation graded as moderate. The majority of fallopian tubes had some degree of fibrosis, with only 1 fallopian tube noted to have mild distal smooth muscle hypertrophy.

[0056] While the majority of fallopian tubes were noted to be occluded on follow-up salpingography at approximately 1 month post-embolization, 4 were noted to be patent, with spillage of contrast into the peritoneum. One of the patent fallopian tubes, embolized with NBCA / lipiodol only, was mostly likely related to a small perforation of the fallopian tube itself by the microwire immediately prior to embolization, which was seen on fluoroscopy. For the other patent fallopian tube embolized with NBCA / lipiodol only, the tube was extremely tortuous, and the microcatheter was unable to be advanced further than 1 cm into the tube. These were considered technical successes because glue was noted within the distal aspects of the fallopian tubes and the tubes were noted to be occluded on immediate post-embolization salpingography. The above factors may have contributed to the patency of these tubes on endpoint salpingography. It is possible that the presence of the microcoil itself could have contributed to endpoint tubal patency in two rabbits embolized with NBCA / lipiodol and a microcoil; the coil may have actually served to hold the fallopian tube open, rather than serve as a backstop or scaffold for the NBCA / ethiodized mixture as hypothesized. In addition, only 63% of fallopian tubes embolized with NBCA / lipiodol and a microcoil demonstrated histopathologic evidence of tubal occlusion, compared to 100% of fallopian tubes embolized with NBCA / lipiodol only. However, this pilot study is not adequately powered to compare the two embolization techniques. The degree of inflammation observed on histopathology was mild and in line withAttorney docket # 206030-0287-00WO that observed in other studies and may decrease over time after the immediate post-procedural period. There were few hyperplastic changes distal to the occlusion in this short-term study. Fibrosis of the fallopian tubes is a desirable outcome, essentially leading to permanent occlusion by scar tissue. Early or mild fibrosis was observed in 65% of fallopian tubes at approximately 1 month post-embolization. Ongoing fibrosis over time could contribute to potentially permanent occlusion and sterilization. This phenomenon was observed in two separate clinical trials using Essure where fallopian tubes that were initially patent on salpingography at 3 months were occluded by 7 months. Though small amounts of glue were seen outside the fallopian tubes in 6 rabbits, no dense adhesions were noted, and the glue deposits were surrounded by macrophages as part of an expected foreign body response. This could possibly be avoided in the future with additional technical refinement but appeared to have no adverse effects.

[0057] Advances in catheter technology, specifically the development of microcatheters, has led to the investigation of innovative transcervical, transcatheter methods of tubal occlusion. The mechanism of intra-luminal tubal sterilization involves damaging of the tubal epithelium and connective tissue, followed by proliferation of scar tissue that effectively and durably blocks the tubes. Transcatheter occlusion methods include chemical, thermal, and mechanical. Berkey et al. investigated methyl cyanoacrylate as a sclerosing agent administered through a microcatheter. Despite success in preventing pregnancy, there was development of fallopian tube cysts and inflammation on histopathologic analysis. There are also safety concerns surrounding the use of methyl cyanoacrylate. Transcatheter radiofrequency electrocoagulation has been described but advancing a metallic wire into the tortuous fallopian tube proved difficult. Mechanical methods studied include the Essure device, coil embolization (which had a high failure rate), and liquid embolic agents. The Essure device is an implant containing a nickel-titanium alloy outer coil wrapped in a layer of fibers that induce tubal fibrosis. Although envisioned for deployment under fluoroscopic observation, it was approved for placement using hysteroscopy as well. Because of thousands of reports of complications, some of which may have been related to inappropriate placement under hysteroscopy rather than fluoroscopy, as originally intended, the device is no longer sold in the United States. A rabbit study by Abdala et al. demonstrated that ethylene vinyl alcohol copolymer administered through a microcatheter resulted in 100% sterilization, no or mild inflammation, and moderate to marked fibrosis and tubal occlusion. However, this substance is expensive and time-consuming to prepare. There was also expulsion of the plug intoAtorney docket # 206030-0287-00WQ the uterine horn when only a small amount was administered into the fallopian tube, and in the instance of a very small fallopian tube which could not be traversed with the microcatheter by more than 1 cm. It otherwise remained in place within the tube in the short-term, similar to what we observed in this study. Rivoire, et al. investigated the use of various surgical adhesives injected under hysteroscopic administration into the rabbit fallopian tube ostium in 2008. They found that injection of 0.25 mL of NBCA into the ostium resulted in 100% tubal occlusion and prevention of pregnancy. However, the muscular myosalpinx distal to the glue plug became hypertrophied, perhaps related to increased peristalsis in the distal fallopian tube. For this study, we theorized that embolizing a long segment of the fallopian tube would prevent hypertrophy of tube components distal to the embolic. This did appear to be the case, with only 1 fallopian tube demonstrating mild hypertrophy of the smooth muscle layer distal to the embolic. Inflammation was graded as absent or mild in the majority of the animals in the Rivoire study. The glue remained in place for 6 months, without dislodgment or absorption. A subsequent study by the same authors in a sheep model found that hysteroscopic administration of NBCA into the fallopian tube ostium prevented pregnancy and were occluded by burst pressure testing in sheep for 90 days, though this study did not evaluate architectural changes of the fallopian tube. Thus, NBCA has previously been identified as a potentially effective agent for tubal embolization with minimal associated inflammation. The findings of minimal or no inflammation in the study by Rivoire et al. are similar to what we observed in this study. Investigations of NBCA applied hysteroscopically into the orifice of the fallopian tube in rabbit and sheep models did not attempt to canalize the fallopian tube with a microcatheter and apply the adhesive to a long segment of the tube. Injection of NBCA into the orifice of the fallopian tubes under hysteroscopy does not allow for intra-procedural confirmation of placement, including verification that the embolic remained in the tube, and does not offer the immediate ability to verify that the fallopian tube is occluded, an advantage of fluoroscopic guidance.

[0058] In summary, this study demonstrated the technical feasibility of fallopian tube embolization with NBCA administered via a microcatheter in a rabbit model, which resulted in successful occlusion of the majority of fallopian tubes at 1 -month post-procedure, with minimal inflammatory changes. These results warrant further investigation of this procedure, specifically the rates of tubal occlusion, histopathologic changes, and efficacy in prevention of pregnancy in the long-term.Atorney docket # 206030-0287-00WQ

[0059] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

Atorney docket # 206030-0287-00WQCLAIMSWhat is claimed is:

1. A tubal sterilization system, comprising: a catheter having a first lumen and a second lumen; a footplate or plug deployable from the first lumen; and an adhesive deployable from the second lumen.

2. The system of claim 1, wherein the footplate or plug is bioabsorbable.

3. The system of claim 1, wherein the footplate or plug is cone-shaped.

4. The system of claim 3, wherein the cone-shaped footplate or plug is oriented with the base of the cone facing in a distal direction.

5. The system of claim 1, wherein the footplate or plug is expandable.

6. The system of claim 1, wherein the footplate or plug is deployable with retention suture for traction.

7. The system of claim 1, wherein the adhesive comprises one or more embolizing agents.

8. The system of claim 1, wherein the adhesive comprises H-butyl-cyanoacrylate.

9. The system of claim 1, wherein the adhesive comprises / z-butyl-cyanoacrylate + lipiodol.

10. The system of claim 1, wherein the catheter ranges between 1-5 French in size.

11. The system of claim 1, further comprising a sheath enclosing at least a portion of the catheter, wherein the catheter may extend out of and retract into the sheath.Atorney docket # 206030-0287-00WQ12. The system of claim 1, wherein the catheter is soft and hydrophilic.

13. A method of tubal sterilization, comprising the steps of: positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a fallopian tube of a subject; deploying a footplate or plug from the first lumen of the catheter to a long segment of the fallopian tube; and deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug.

14. The method of claim 13, wherein the step of deploying a footplate or plug comprises moving the footplate or plug proximally into the long segment of the fallopian tube.

15. The method of claim 14, wherein the footplate or plug is moved proximally by retracting the catheter into a sheath.

16. The method of claim 13, wherein the footplate or plug is expandable and cone-shaped, and oriented with the base of the cone facing in a distal direction.

17. The method of claim 13, wherein the step of deploying a footplate or plug comprises providing traction to the footplate or plug with retention suture.

18. The method of claim 13, wherein the method is image-guided.

19. The method of claim 13, wherein the method is trans-cervical.

20. A method of sterilization, comprising the steps of positioning a distal end of a catheter having a first lumen and a second lumen near the distal end of a vas deferens of a subject; deploying a footplate or plug from the first lumen of the catheter to a long segment of the vas deferens; andAtorney docket # 206030-0287-00WO deploying an adhesive from the second lumen of the catheter, such that the adhesive remains proximal to the footplate or plug.

Images