MECHANICAL TUBAL OCCLUSION CONTRACEPTIVE DEVICE

A tubal occlusion contraceptive device/appliance (100/200) and methods of implant and removal. The device (100) includes a plurality of barbs (124) with some preferentially resisting movement in a first axial direction and others preferentially resisting movement in a second opposite axial direction. The device (100) is implanted in a Fallopian Tube (FT) through a sheath. The appliance (200) includes an oversized cap (220) to prevent continued insertion of appliance (200) into a Fallopian Tube (FT), and a plurality of barbs (240) to facilitate a first axial direction slide fit insertion of the appliance (200) into a Fallopian Tube (FT) while preferentially resisting axial movement in a second opposite axial direction out from the Fallopian Tube (FT) once inserted. The barbs (240) can be replaced with screw threads (250).

BACKGROUND

The ability to use minimally invasive techniques to permanently occlude fallopian tubes has been unsuccessful for a variety of reasons, the most important being that simple plugs and fallopian tubular occluders have not been designed to primarily occlude the fallopian tube. They have been designed for ease of deployment and for hysteroscopic delivery that can be performed in office based practices. This leads to suboptimal results.

Accordingly, a need exists for a highly effective yet minimally invasive mechanical tubal occlusion contraceptive device.

SUMMARY OF THE INVENTION

A first aspect of the invention is a mechanical contraceptive device/appliance.

A first embodiment of the first aspect of the invention is a mechanical tubal occlusion contraceptive device that includes an axially elongated scar-inducing occlusion element and a pair of axially elongated anchors. The occlusion element has first and second axial end portions terminating at first and second axial ends, respectively. The pair of anchors include a leading anchor and a trailing anchor. The leading anchor is secured to and extends in a first axial direction from the first axial end portion of the occlusion element while the trailing anchor is secured to and extends in a second axial direction opposite the first axial direction from the second axial end of the occlusion element. The leading anchor includes a plurality of radially extending barbs operable for resisting axial movement of the leading anchor relative to a fallopian tube into which the mechanical tubal occlusion contraceptive device has been implanted. The trailing anchor includes a plurality of radially extending barbs operable for resisting axial movement of the trailing anchor relative to a fallopian tube into which the mechanical tubal occlusion contraceptive device has been implanted, and a head proximate a free axial end of the trailing anchor, configured and arranged for releasable engagement by a pusher delivery catheter for delivery of the mechanical tubal occlusion contraceptive device into a fallopian tube.

A second embodiment of the first aspect of the invention is a mechanical tubal occlusion contraceptive device that includes an axially elongated shaft, a head and a plurality of barbs. The shaft has a proximal axial end spaced in a first axial direction from a distal tip, and defines a second axial direction opposite the first axial direction. The head projects in the first axial direction from the proximal end of the shaft, and is configured and arranged for releasable engagement by a pusher delivery catheter for delivery of the mechanical tubal occlusion contraceptive device into a fallopian tube. The plurality of barbs extend radially from the shaft intermediate the head and the distal tip of the shaft, and collectively resist axial movement of the mechanical tubal occlusion contraceptive device in both the first and second axial directions relative to a fallopian tube into which the mechanical tubal occlusion contraceptive device has been implanted.

A third embodiment of the first aspect of the invention is a tubal occlusion contraceptive appliance that includes an axially elongated shaft, a cap and a plurality of barbs. The shaft has a proximal axial end spaced in a first axial direction from a distal axial end, and defines a second axial direction opposite the first axial direction. A guideway extends through the shaft proximate the distal axial end of the shaft for accommodating passage of a guidewire for guiding insertion of the appliance into a fallopian tube. The cap is positioned proximate the proximal axial end of the shaft, and is sized, configured and arranged to inhibit axial travel of the cap into a fallopian tube. The barbs extend radially from the shaft intermediate the distal axial end of the shaft and the cap, and are configured and arranged to facilitate slide fit insertion of the shaft into a fallopian tube in the second axial direction while preferentially resisting axial movement of the shaft in the first axial direction out from the fallopian tube once inserted.

A fourth embodiment of the first aspect of the invention is a tubal occlusion contraceptive appliance that includes an axially elongated shaft, a cap, a pair of axially extending guideways, and a plurality of barbs. The shaft has a proximal axial end spaced in a first axial direction from a distal tip, and defines a second axial direction opposite the first axial direction. The cap is positioned proximate the proximal end of the shaft, and is sized, configured and arranged to inhibit axial travel of the cap into a fallopian tube. The pair of guideways includes a proximal guideway and a distal guideway, both operable for accommodating passage of a guidewire for guiding insertion of the appliance into a fallopian tube. The proximal guideway extends through the cap in radially spaced relationship from the shaft. The distal guideway extends through the shaft proximate the distal tip of the shaft. The barbs extend radially from the shaft intermediate the distal axial end of the shaft and the cap, and are configured and arranged to facilitate slide fit insertion of the shaft into a fallopian tube in the second axial direction while preferentially resisting axial movement of the shaft in the first axial direction out from the fallopian tube once inserted.

A fifth embodiment of the first aspect of the invention is a tubal occlusion contraceptive appliance that includes an axially elongated shaft, a cap, a pair of axially extending guideways, and screw threads. The shaft has a proximal axial end spaced in a first axial direction from a distal tip, and defines a second axial direction opposite the first axial direction. The cap is positioned proximate the proximal end of the shaft, and is sized, configured and arranged to inhibit axial travel of the cap into a fallopian tube. The pair of guideways includes a proximal guideway and a distal guideway, both operable for accommodating passage of a guidewire for guiding insertion of the appliance into a fallopian tube. The proximal guideway extends through the cap in radially spaced relationship from the shaft. The distal guideway extends through the shaft proximate the distal tip of the shaft. The screw threads extend radially around the shaft intermediate the distal tip of the shaft and the cap, and are configured and arranged to (i) facilitate slide fit insertion of the shaft into a fallopian tube in the second axial direction with or without rotation of the appliance in a first direction while preferentially resisting sliding axial movement of the shaft in the first axial direction out from the fallopian tube once inserted, and (ii) effect withdrawal of the tubal occlusion contraceptive appliance from the fallopian tube upon rotation of the appliance in a second direction opposite the first direction.

A sixth embodiment of the first aspect of the invention is a tubal occlusion contraceptive appliance that includes an axially elongated shaft, a cap, a pair of axially extending guideways, and screw threads. The shaft has a proximal axial end spaced in a first axial direction from a distal tip, and defines a second axial direction opposite the first axial direction. The cap is positioned proximate the proximal end of the shaft, and is sized, configured and arranged to inhibit axial travel of the cap into a fallopian tube. The pair of guideways includes a proximal guideway and a distal guideway, both operable for accommodating passage of a guidewire for guiding insertion of the appliance into a fallopian tube. The proximal guideway extends through the cap in radially spaced relationship from the shaft. The distal guideway extends through the shaft proximate the distal tip of the shaft. The screw threads extend radially around the shaft intermediate the distal tip of the shaft and the cap for effecting axial insertion of the tubal occlusion contraceptive appliance into a fallopian tube upon rotation of the appliance in a first direction, and withdrawal of the tubal occlusion contraceptive appliance from the fallopian tube upon rotation of the appliance in a second direction opposite the first direction.

A second aspect of the invention is a method of implanting the mechanical contraceptive devices/appliances in accordance with the first aspect of the invention.

A first embodiment of the second aspect of the invention includes the steps of (i) transvaginal introduction of a sheath having a lumen into a fallopian tube with an introduction end of the sheath exterior the vagina and a delivery end of the sheath within the fallopian tube, (ii) axially pushing the mechanical tubal occlusion contraceptive device in accordance with the first embodiment of the first aspect of the invention along the lumen of the sheath with a delivery device from the introduction end to proximate the delivery end of the sheath, and (iii) withdrawing the delivery device and the sheath while leaving the mechanical tubal occlusion contraceptive device within the fallopian tube.

A second embodiment of the second aspect of the invention includes the steps of (i) transvaginal introduction of a sheath having a lumen into a fallopian tube with an introduction end of the sheath exterior the vagina and a delivery end of the sheath within the fallopian tube, (ii) axially pushing the mechanical tubal occlusion contraceptive device in accordance with the second embodiment of the first aspect of the invention along the lumen of the sheath with a delivery device from the introduction end to proximate the delivery end of the sheath, and (iii) withdrawing the delivery device and the sheath while leaving the mechanical tubal occlusion contraceptive device within the fallopian tube.

A third embodiment of the second aspect of the invention includes the steps of (i) transvaginal introduction of a guidewire into a fallopian tube with a first end of the guidewire exterior the vagina and a second end of the guidewire within the fallopian tube, (ii) sliding the first end of the guidewire through the guideway in a tubal occlusion contraceptive appliance in accordance with the third embodiment of the first aspect of the invention, (iii) axially pushing the tubal occlusion contraceptive appliance along the guidewire towards the second end of the guidewire with a delivery device until the shaft is positioned within the fallopian tube and the cap is seated over the opening from the uterus to the fallopian tube, and (iv) withdrawing the delivery device and the guidewire while leaving the tubal occlusion contraceptive appliance extending into the fallopian tube.

A fourth embodiment of the second aspect of the invention includes the steps of (i) transvaginal introduction of a guidewire into a fallopian tube with a first end of the guidewire exterior the vagina and a second end of the guidewire within the fallopian tube, (ii) serially sliding the first end of the guidewire through the distal guideway and then through the proximal guideway in a tubal occlusion contraceptive appliance in accordance with the fourth embodiment of the first aspect of the invention, (iii) axially pushing the tubal occlusion contraceptive appliance along the guidewire towards the second end of the guidewire with a delivery device until the shaft is positioned within the fallopian tube and the cap is seated over the opening from the uterus into the fallopian tube, and (iv) withdrawing the delivery device and the guidewire while leaving the tubal occlusion contraceptive appliance extending into the fallopian tube.

A fifth embodiment of the second aspect of the invention includes the steps of (i) transvaginal introduction of a guidewire into a fallopian tube with a first end of the guidewire exterior the vagina and a second end of the guidewire within the fallopian tube, (ii) serially sliding the first end of the guidewire through the distal guideway and then through the proximal guideway in a tubal occlusion contraceptive appliance in accordance with the fifth embodiment of the first aspect of the invention, (iii) axially pushing the tubal occlusion contraceptive appliance along the guidewire towards the second end of the guidewire with a delivery device until the shaft is positioned within the fallopian tube and the cap is seated over the opening from the uterus into the fallopian tube, and (iv) withdrawing the delivery device and the guidewire while leaving the tubal occlusion contraceptive appliance extending into the fallopian tube.

A sixth embodiment of the second aspect of the invention includes the steps of (i) transvaginal introduction of a guidewire into a fallopian tube with a first end of the guidewire exterior the vagina and a second end of the guidewire within the fallopian tube, (ii) serially sliding the first end of the guidewire through the distal guideway and then through the proximal guideway in a tubal occlusion contraceptive appliance in accordance with the sixth embodiment of the first aspect of the invention, (iii) axially pushing the tubal occlusion contraceptive appliance along the guidewire towards the second end of the guidewire with a delivery device until the screw threads on the shaft contact the fallopian tube, (iv) rotating the tubal occlusion contraceptive appliance in the first direction until the cap is seated over the opening from the uterus into the fallopian tube, and (v) withdrawing the delivery device and the guidewire while leaving the tubal occlusion contraceptive appliance extending into the fallopian tube.

A third aspect of the invention is a method of removing an implanted tubal occlusion contraceptive appliance.

A first embodiment of the third aspect of the invention includes the steps of (i) gripping the cap of a previously implanted tubal occlusion contraceptive appliance according to the fifth embodiment of the first aspect of the invention with a forceps, (ii) rotating the cap with the forceps about the axial axis of the implanted tubal occlusion contraceptive appliance whereby the screw threads on the implanted tubal occlusion contraceptive appliance effect axial travel of the implanted tubal occlusion contraceptive appliance completely out from the fallopian tube to create a withdrawn appliance, and then (iii) removing the withdrawn appliance completely from the body. Alternately the delivery cable is rotated clockwise and the appliance is torqued out because of the reverse threads. This is possible before the delivery cable is rotated counter clockwise to release it.

A second embodiment of the third aspect of the invention includes the steps of (i) gripping the cap of a previously implanted tubal occlusion contraceptive appliance according to the sixth embodiment of the first aspect of the invention with a forceps, (ii) rotating the cap with the forceps about the axial axis of the implanted tubal occlusion contraceptive appliance whereby the screw threads on the implanted tubal occlusion contraceptive appliance effect axial travel of the implanted tubal occlusion contraceptive appliance completely out from the fallopian tube to create a withdrawn appliance, and then (iii) removing the withdrawn appliance completely from the body. Alternately the delivery cable is rotated clockwise and the appliance is torqued out because of the reverse threads. This is possible before the delivery cable is rotated counter clockwise to release it.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Nomenclature

Nomenclature TableREF NO.DESCRIPTION100Mechanical Tubal Occlusion Contraceptive Device110Occlusion Element1101First Axial End Portion of Occlusion Element1102Second Axial End Portion of Occlusion Element1103Central Portion of Occlusion Element110x1First Axial End of Occlusion Element110x2Second Axial End of Occlusion Element120Anchor1201Leading Anchor1202Trailing Anchor120x1Free Axial End of Anchor120x2Secured Axial End of Anchor121Sleeve122Head123Shaft123x1Proximal Axial End of Shaft123x2Distal Axial Tip of Shaft124Barb1241Barb Preferentially Resisting Movement in theFirst Axial Direction1242Barb Preferentially Resisting Movement in theSecond Axial Direction126Crimp127Radial Visual Inspection Hole Through Sleeve128Axial Orifice in Head129Radial Hole Through Head200Tubal Occlusion Contraceptive Appliance210Shaft210x1Proximal First Axial End of Shaft210x2Distal Second Axial End of Shaft (Distal Tip of Shaft)210sSide of Shaft218Distal Guideway Through Shaft220Cap221Knurled Circumferential Surface227Internally Threaded Axial Orifice in Cap228Proximal Guideway Through Cap229Radial Hole Through Cap240Barb250Screw Threads251Screw Thread SegmentxAxial Directionx1First Axial Directionx2Second Axial DirectionrRadial DirectionPdCPusher Delivery CatheterPdCx1Distal Tip of Pusher Delivery CatheterPdCx2Proximal End of Pusher Delivery CatheterHHub of Pusher Delivery CatheterFTFallopian TubeGGuidewireGdCGuidewire Delivery CatheterSVascular SheathTTether

First Embodiment

Device

Referring toFIGS.1and2, a first embodiment of a mechanical tubal occlusion contraceptive device100includes an axially x elongated scar-inducing occlusion element110and a pair of axially elongated anchors120.

Polyester fabric and fibers have a long history dating back to the 1950s for its use in permanent implants for instance in surgical repair of cardiac septal defects and are biocompatible. They are also known to produce significant scar formation and do not biodegrade and hence provide permanent repair.

A thick polyester cord110positioned within the fallopian tubes FT for a few weeks would lead to scar formation and permanent occlusion of the fallopian tubes FT. However, due to the contractility of the fallopian tubes FT a simple cord110is likely to be expelled into the uterus or abdominal cavity.

The cord110is secured in place in the fallopian tubes FT by an anchor120at each axial end110x1and110x2. After placement of the mechanical tubal occlusion contraceptive device100into a fallopian tube FT the mechanical tubal occlusion contraceptive device100will remain fixed in place and lead to scar formation in a matter of weeks leading to complete occlusion of the fallopian tubes FT. The anchors120can be CNC micro machined from biocompatible metallic alloys. In the preferred embodiment the anchors120are machined from 316 L stainless steel alloy that has been used in human implants for decades in orthopedic screws, plates etc. and is biocompatible, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). The anchors120could potentially be manufactured from biocompatible polymers that biodegrade over time, for instance PLLA or PGA, whereby the anchors120biodegrade and no metallic components remain in the body once the cord110leads to scar formation and occlusion of the fallopian tubes FT.

The occlusion element110is conveniently divided into first and second axial end portions1101and1102and a central portion1103therebetween. The first and second axial end portions1101and1102terminate at first and second axial ends110x1and110x2, respectively. A preferred occlusion element110is a multifilament woven polyester cord around 1 mm in diameter and 30 to 50 mm in length.

The pair of anchors120include a leading anchor1201and a trailing anchor1202. The leading anchor1201is secured to and extends in a first axial direction x1from the first axial end portion1101of the occlusion element110while the trailing anchor1202is secured to and extends in a second axial direction x2opposite the first axial direction x1from the second axial end110x2of the occlusion element110.

Both leading and trailing anchors1201and1202each preferably include an axially x extending hollow tube or sleeve121configured and arranged to encase the respective first and second axial end portions1101and1102of the occlusion element110, thereby enabling a robust attachment of the leading and trailing anchors1201and1202to their respective first and second axial ends110x1and110x2of the occlusion element110such as by mechanical crimping of the sleeves121onto the occlusion element110. A visual inspection hole127about 1 mm in diameter can be provided through the sleeve121at the lower end of the sleeve121for confirming complete insertion of the occlusion element110into the sleeve121. The central portion1103of the occlusion element110remains exposed.

The trailing anchor1202further includes and a head122proximate a free axial end120x1of the trailing anchor1202, configured and arranged for releasable engagement by a pusher delivery catheter PdC for delivery of the mechanical tubal occlusion contraceptive device100into a fallopian tube FT.

The head122can include an approximately 1 mm diameter radial r through hole129configured and arranged to accommodate passage of a releasable tether T (e.g., a thin nitinol wire) extending from the distal tip PdCx1of a pusher delivery catheter PdC for securing the tip PdCx1of the catheter PdC to the head122.

The mechanical tubal occlusion contraceptive device100preferably has an axial length of about 4 to 7 cm and a cross-sectional area of about 1 to 3 mm2, with a 2 to 5 cm long exposed central portion1103. The anchors120are each preferably about 11 mm long and 1.5 mm in diameter.

The leading anchor1201includes a plurality of radially r extending barbs124extending from a shaft123operable for resisting axial x movement of the leading anchor1201relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted. Similarly, the trailing anchor1202includes a plurality of radially extending barbs124extending from a shaft123operable for resisting axial x movement of the trailing anchor1202relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted. The barbs124can be axially x spaced, radially r projecting, conical discs.

Preferably, at least one of the barbs124on each of the leading and trailing anchors1201and1202preferentially resists axial x movement of the mechanical tubal occlusion contraceptive device100in the first axial direction x1relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted (i.e., barbs1241depicted inFIGS.3and4), and at least one of the barbs124on each of the leading and trailing anchors1201and1202preferentially resists axial x movement of the mechanical tubal occlusion contraceptive device100in the second axial direction x2relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted (i.e., barbs1242depicted inFIGS.3and4).

As depicted inFIGS.3and4, the anchors120can each include four sharp retention disks or barbs124, so configured that two have the conical segments oriented towards one axial end120x1of the anchor120and two have the conical segments oriented towards the other axial end120x2of the anchor120. Such orientation of the anchors120ensure that once the mechanical tubal occlusion contraceptive device100is placed in a fallopian tube FT elastic recoil of the fallopian tube FT around the anchor120will lock the anchor120in place. If all the retention disks or barbs124are oriented in the same direction, it is easy to pass it into the fallopian tube FT in one direction, but cannot be pulled out. However, having two each oriented as inFIGS.3and4locks the anchor120in place. It cannot be moved in either axial direction x1or x2.

The barbs124on the leading anchor1201preferably project radially r from a shaft123which projects in the first axial direction x1from the sleeve121of the leading anchor1201, and the barbs124on the trailing anchor1202preferably project radially r from a shaft123which projects in the second axial direction x2from the sleeve121of the trailing anchor1202to the head122.

The leading and trailing anchors1201and1202can conveniently be mirror images of one another.

The first embodiment of the mechanical tubal occlusion contraceptive device100is capable of being deployed under radiographic control. The mechanical tubal occlusion contraceptive device100is a larger device passed through standard vascular sheaths S, rather than through the relatively small channels of a hysteroscope (not shown). For this reason the mechanical tubal occlusion contraceptive device100does not have to expand after delivery. Radial expansion of existing contraceptive occlusion devices post deployment leads to stretching of the fallopian tubes FT and has been the primary reason for pain and cramping in patients. Using angiographic catheters and interventional radiologic (IR) techniques permit superior results.

Assembly

The first and second axial end portions1101and1102of the occlusion element110are each inserted into the sleeve121of a respective leading and trailing anchor1201and1202until the occlusion element110is visible in the inspection hole127. The sleeve121of each anchor1201and1202is then crimped126with a mechanical crimper onto the occlusion element110. This robustly secures an anchor120to each end of the occlusion element110to form the mechanical tubal occlusion contraceptive device100.

The mechanical tubal occlusion contraceptive device100is assembled in a clean room, packaged and sterilized.

Summary Implant Technique

Referring toFIGS.6and7, a guidewire G is transvaginally introduced via guidewire delivery catheter GdC into a fallopian tube FT and the guidewire delivery catheter GdC withdrawn.

Referring toFIGS.8and9, a conical tipped vascular introducer sheath S is introduced into the fallopian tube FT over the guidewire G and both the distal tip and the guidewire G withdrawn.

Referring toFIG.10, the trailing anchor1202is connected to a pusher delivery catheter PdC (e.g., 40 cm custom pusher delivery catheter). A tether T, such as a 110 cm long 0.005 inch diameter Nitinol wire, is passed through the radial hole129in the head122on the trailing anchor1202until both ends of the tether T come together. The ends of the tether T are then passed through the lumen of the pusher delivery catheter PdC from the tip of the catheter PdCx1until they exit the hub H of the catheter PdC at the other end of the catheter PdCx2. Both ends of the tether T are pulled taut such that the trailing anchor1202is held snuggly against the tip of the catheter PdCx1. The ends of the tether T are wrapped around the hub H and a threaded screw cap (not shown) is firmly screwed onto the hub H to lock the ends of the tether T into place.

Referring toFIGS.11-13, the assembled mechanical tubal occlusion contraceptive device100, tethered to the pusher delivery catheter PdC, is axially x pushed through the lumen of the introducer sheath S by the pusher delivery catheter PdC until the entire assembled mechanical tubal occlusion contraceptive device100is positioned within the fallopian tube FT. The ends of the tether T wrapped around the hub H are then detached from one another and one end of the tether T pulled until the other end of the tether T is pulled through the radial hole129in the head122on the trailing anchor1202. The pusher delivery catheter PdC and the introducer sheath S are then withdrawn, leaving the mechanical tubal occlusion contraceptive device100within the fallopian tube FT.

Referring toFIG.14, the process is repeated for the other fallopian tube FT.

Referring toFIG.15, scar tissue will form around the implanted mechanical tubal occlusion contraceptive devices100, resulting in a permanent occlusion of both fallopian tubes FT.

Second Embodiment

Device

Referring toFIGS.16-21, a second embodiment of a mechanical tubal occlusion contraceptive device100includes an axially elongated shaft123, a head122and a plurality of barbs124.

The shaft123has a proximal axial end123x1spaced in a first axial direction x1from a distal tip123x2, and defines a second axial direction x2opposite the first axial direction x1.

The head122projects in the first axial direction x1from the proximal axial end123x1of the shaft123, and is configured and arranged for releasable engagement by a pusher delivery catheter PdC for delivery of the mechanical tubal occlusion contraceptive device100into a fallopian tube FT.

The plurality of barbs124extend radially r from the shaft123intermediate the head122and the distal tip123x2of the shaft123, and collectively resist axial x movement of the mechanical tubal occlusion contraceptive device100in both the first and second axial directions x1and x2relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted. The barbs124can be axially x spaced, radially r projecting, conical discs.

Preferably, at least one of the barbs124on each of the leading and trailing anchors1201and1202preferentially resists axial x movement of the mechanical tubal occlusion contraceptive device100in the first axial direction x1relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted, and at least one of the barbs124on each of the leading and trailing anchors1201and1202preferentially resists axial x movement of the mechanical tubal occlusion contraceptive device100in the second axial direction x2relative to a fallopian tube FT into which the mechanical tubal occlusion contraceptive device100has been implanted.

As depicted inFIGS.16-19, the second embodiment of a mechanical tubal occlusion contraceptive device100can include 11 or 12 sharp retention disks or barbs124, so configured that half have the conical segments oriented towards one axial end123x1of the shaft123and the other half have the conical segments oriented towards the other axial end123x2of the shaft123. Such orientation of the barbs124ensure that once the mechanical tubal occlusion contraceptive device100is placed in a fallopian tube FT elastic recoil of the fallopian tube FT around the mechanical tubal occlusion contraceptive device100will lock the mechanical tubal occlusion contraceptive device100in place, as it cannot be moved in either axial direction x1or x2.

The entire second embodiment of the mechanical tubal occlusion contraceptive device100can be CNC micro machined from biocompatible metallic alloys. In the preferred embodiment the mechanical tubal occlusion contraceptive device100is machined from 316 L stainless steel alloy that has been used in human implants for decades in orthopedic screws, plates etc. and is biocompatible, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). Alternatively, the second embodiment of the mechanical tubal occlusion contraceptive device100can be manufactured by injection molding a biocompatible polymer such as PET (Polyethylene Terephthalate). PET will promote scarring and make the mechanical tubal occlusion contraceptive device100a permanent implant. The polymer may have substances added to make it radiopaque as is commonly employed, including the addition of Tantalum powder, or may have Platinum marker bands incorporated.

The head122can include an approximately 1 mm diameter radial r through hole129configured and arranged to accommodate passage of a releasable tether T (e.g., a thin nitinol wire) extending from the distal tip PdCx1of a pusher delivery catheter PdC for securing the tip PdCx1of the catheter PdC to the head122.

The second embodiment of the mechanical tubal occlusion contraceptive device100preferably has an axial length of about 1 to 4 cm and a radial cross-sectional area of about 0.8 to 7 mm2.

The second embodiment of the mechanical tubal occlusion contraceptive device100is capable of being deployed under radiographic control. The mechanical tubal occlusion contraceptive device100is a larger device passed through standard vascular sheaths S, rather than through the relatively small channels of a hysteroscope (not shown). For this reason the mechanical tubal occlusion contraceptive device100does not have to expand after delivery. Radial expansion of existing contraceptive occlusion devices post deployment leads to stretching of the fallopian tubes FT and has been the primary reason for pain and cramping in patients. Using angiographic catheters and interventional radiologic (IR) techniques permit superior results.

Summary Implant Technique

As with the first embodiment, the second embodiment of the mechanical tubal occlusion contraceptive device100is implanted by connecting a pusher delivery catheter PdC (e.g., 40 cm custom pusher delivery catheter) to the head122at one of the axial ends123x1or123x2of the shaft123. A tether T, such as a 110 cm long 0.005 inch diameter Nitinol wire, is passed through the radial hole129in the head122until both ends of the tether T come together. The ends of the tether T are then passed through the lumen of the pusher delivery catheter PdC from the tip of the catheter PdCx1until they exit the hub H of the catheter PdC at the other end of the catheter PdCx2. Both ends of the tether T are pulled taut such that the head122is held snuggly against the tip of the catheter PdCx1. The ends of the tether T are wrapped around the hub H and a threaded screw cap (not shown) is firmly screwed onto the hub H to lock the ends of the tether T into place.

The tubal occlusion contraceptive appliance200is used to occlude the cornual region of the uterine cavity and the proximal fallopian tube FT.

First Embodiment

Product

Referring toFIGS.23and24, a first embodiment of a tubal occlusion contraceptive appliance200includes an axially elongated shaft210, a cap220, a plurality of barbs240and a guideway.

The shaft210has a proximal axial end210x1spaced in a first axial direction x1from a distal tip210x2, and defines a second axial direction x2opposite the first axial direction x1.

The shaft210preferably has an axial length of about 1 to 4 cm and a radial cross-sectional area of about 0.8 to 7 mm2.

The cap220projects in the first axial direction x1from the proximal axial end210x1of the shaft210, and is sized, configured and arranged to inhibit axial x travel of the cap220into a fallopian tube FT. The cap220should have a radial r diameter greater than the radial r diameter of the shaft210and a radial r diameter greater than the radial r diameter of each barb240.

The plurality of barbs240extend radially r from the shaft210intermediate the cap220and the distal tip210x2of the shaft210, and are configured and arranged to facilitate slide fit insertion of the shaft210into a fallopian tube FT in the second axial direction x2while preferentially resisting axial x movement of the shaft210in the first axial direction x1out from the fallopian tube FT once inserted. The barbs240can be axially x spaced, radially r projecting, conical discs.

The guideway is a distal guideway218that extends through the shaft210proximate the distal tip210x2of the shaft210for accommodating passage of a guidewire G for guiding insertion of the contraceptive appliance200into a fallopian tube FT.

The distal guideway218preferably angles inward in the second axial direction x2from a side210sof the shaft210to the distal tip210x2of the shaft210.

The entire first embodiment of the tubal occlusion contraceptive appliance200can be CNC micro machined from biocompatible metallic alloys. In the preferred embodiment the contraceptive appliance200is machined from 316 L stainless steel alloy that has been used in human implants for decades in orthopedic screws, plates etc. and is biocompatible, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). Alternatively, the first embodiment of the tubal occlusion contraceptive appliance200can be manufactured by injection molding a biocompatible polymer such as PET (Polyethylene Terephthalate). PET will promote scarring and make the contraceptive appliance200a permanent implant. The polymer may have substances added to make it radiopaque as is commonly employed, including the addition of Tantalum powder, or may have Platinum marker bands incorporated.

The cap220can include an approximately 1 mm diameter radial r through hole229configured and arranged to accommodate passage of a releasable tether T (e.g., a thin nitinol wire) extending from the distal tip PdCx1of a pusher delivery catheter PdC for securing the tip PdCx1of the catheter PdC to the cap220.

Summary Implant Technique

Referring toFIG.25, a guidewire G is transvaginally introduced via a guidewire delivery catheter GdC into a fallopian tube FT and the guidewire delivery catheter GdC withdrawn.

The cap220is connected to a pusher delivery catheter PdC (e.g., 40 cm custom pusher delivery catheter). A tether T, such as a 110 cm long 0.005 inch diameter Nitinol wire, is passed through the radial hole229in the cap220until both ends of the tether T come together. The ends of the tether T are then passed through the lumen of the pusher delivery catheter PdC from the tip of the catheter PdCx1until they exit the hub H of the catheter PdC at the other end of the catheter PdCx2. Both ends of the tether T are pulled taut such that the trailing anchor1202is held snuggly against the tip of the catheter PdCx1. The ends of the tether T are wrapped around the hub H and a threaded screw cap (not shown) is firmly screwed onto the hub H to lock the ends of the tether T into place.

Referring toFIG.26, the free end of the guidewire G is fed through the distal guideway218in the shaft210and the tethered tubal occlusion contraceptive appliance200pushed along the guidewire G by the pusher delivery catheter PdC until the shaft210is positioned within the fallopian tube FT and the cap220is seated against the opening from the fallopian tube FT to the uterus. The ends of the tether T wrapped around the hub H are then detached from one another and one end of the tether T pulled until the other end of the tether T is pulled through the radial hole229in the cap220. The pusher delivery catheter PdC and the guidewire G are then withdrawn, leaving the shaft210of the tubal occlusion contraceptive appliance200within the fallopian tube FT.

Referring toFIG.27, the process is repeated for the other fallopian tube FT.

Second Embodiment

Product

Referring toFIGS.28-31, a second embodiment of a tubal occlusion contraceptive appliance200includes an axially elongated shaft210, a cap220, a plurality of barbs240and a dual passage guideway.

The shaft210has a proximal axial end210x1spaced in a first axial direction x1from a distal tip210x2, and defines a second axial direction x2opposite the first axial direction x1.

The shaft210preferably has an axial length of about 1 to 4 cm and a radial cross-sectional area of about 0.8 to 7 mm2.

The cap220projects in the first axial direction x1from the proximal axial end210x1of the shaft210, and is sized, configured and arranged to inhibit axial x travel of the cap220into a fallopian tube FT. The cap220should have a radial r diameter greater than the radial r diameter of the shaft210and a radial r diameter greater than the radial r diameter of each barb240.

The plurality of barbs240extend radially r from the shaft210intermediate the cap220and the distal tip210x2of the shaft210, and are configured and arranged to facilitate slide fit insertion of the shaft210into a fallopian tube FT in the second axial direction x2while preferentially resisting axial x movement of the shaft210in the first axial direction x1out from the fallopian tube FT once inserted. The barbs240can be axially x spaced, radially r projecting, conical discs.

The dual passage guideway includes an axially x extending proximal guideway228through the cap220and an axially x extending distal guideway218that extends through the shaft210proximate the distal tip210x2of the shaft210. Both are configured and arranged to accommodate passage of a guidewire G for guiding insertion of the contraceptive appliance200into a fallopian tube FT.

The proximal guideway228is preferably in radially r spaced relationship from the shaft210, while the distal guideway218preferably angles inward in the second axial direction x2from a side210sof the shaft210to the distal tip210x2of the shaft210.

The entire first embodiment of the tubal occlusion contraceptive appliance200can be CNC micro machined from biocompatible metallic alloys. In the preferred embodiment the contraceptive appliance200is machined from 316 L stainless steel alloy that has been used in human implants for decades in orthopedic screws, plates etc. and is biocompatible, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). Alternatively, the first embodiment of the tubal occlusion contraceptive appliance200can be manufactured by injection molding a biocompatible polymer such as PET (Polyethylene Terephthalate). PET will promote scarring and make the contraceptive appliance200a permanent implant. The polymer may have substances added to make it radiopaque as is commonly employed, including the addition of Tantalum powder, or may have Platinum marker bands incorporated.

The cap220can include an internally threaded axial orifice227open opposite the shaft210for threadable engagement with the threaded distal tip PdCx1of a pusher delivery catheter PdC for securing the tip PdCx1of the catheter PdC to the cap220.

Summary Implant Technique

A guidewire G is transvaginally introduced via a guidewire delivery catheter GdC into a fallopian tube FT and the guidewire delivery catheter GdC withdrawn.

The cap220is threadably attached to a pusher delivery catheter PdC (e.g., 40 cm custom pusher delivery catheter).

The free end of the guidewire G is fed through the distal guideway218in the shaft210and then through the proximal guideway228in the cap220. The attached tubal occlusion contraceptive appliance200is pushed along the guidewire G by the pusher delivery catheter PdC until the shaft210is positioned within the fallopian tube FT and the cap220is seated against the opening from the fallopian tube FT to the uterus. The pusher delivery catheter PdC is rotated about its axial axis to threadably disengage from tubal occlusion contraceptive appliance200, and the disengaged pusher delivery catheter PdC and the guidewire G withdrawn, leaving the shaft210of the tubal occlusion contraceptive appliance200within the fallopian tube FT.

The process is repeated for the other fallopian tube FT.

Third Embodiment

Product

Referring toFIG.32, a third embodiment of a tubal occlusion contraceptive appliance200includes an axially elongated shaft210, a cap220, a plurality of screw thread segment251and a dual passage guideway.

The shaft210has a proximal axial end210x1spaced in a first axial direction xi from a distal tip210x2, and defines a second axial direction x2opposite the first axial direction x1.

The shaft210preferably has an axial length of about 1 to 4 cm and a radial cross-sectional area of about 0.8 to 7 mm2.

The cap220projects in the first axial direction x1from the proximal axial end210x1of the shaft210, and is sized, configured and arranged to inhibit axial x travel of the cap220into a fallopian tube FT. The cap220should have a radial r diameter greater than the radial r diameter of the shaft210and a radial r diameter greater than the radial r diameter of each screw thread segment251.

The plurality of screw thread segment251extend radially r from the shaft210intermediate the cap220and the distal tip210x2of the shaft210, and are configured and arranged to (i) facilitate slide fit insertion of the shaft210into a fallopian tube FT in the second axial direction x2with or without rotation of the contraceptive appliance200in a first direction while preferentially resisting sliding axial x movement of the shaft210in the first axial direction x1out from the fallopian tube FT once inserted, and (ii) effect withdrawal of the tubal occlusion contraceptive appliance200from the fallopian tube FT upon rotation of the contraceptive appliance200in a second direction opposite the first direction. The plurality of screw thread segments251are discrete, axially spaced, screw threads, each having a limited number of turns, preferably between about 1 to 2 turns.

The dual passage guideway includes an axially x extending proximal guideway228through the cap220and an axially x extending distal guideway218that extends through the shaft210proximate the distal tip210x2of the shaft210. Both are configured and arranged to accommodate passage of a guidewire G for guiding insertion of the contraceptive appliance200into a fallopian tube FT.

The proximal guideway228is preferably in radially r spaced relationship from the shaft210, while the distal guideway218preferably angles inward in the second axial direction x2from a side210sof the shaft210to the distal tip210x2of the shaft210.

The entire first embodiment of the tubal occlusion contraceptive appliance200can be CNC micro machined from biocompatible metallic alloys. In the preferred embodiment the contraceptive appliance200is machined from 316 L stainless steel alloy that has been used in human implants for decades in orthopedic screws, plates etc. and is biocompatible, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). Alternatively, the first embodiment of the tubal occlusion contraceptive appliance200can be manufactured by injection molding a biocompatible polymer such as PET (Polyethylene Terephthalate). PET will promote scarring and make the contraceptive appliance200a permanent implant. The polymer may have substances added to make it radiopaque as is commonly employed, including the addition of Tantalum powder, or may have Platinum marker bands incorporated.

The cap220can include an internally threaded axial orifice227open opposite the shaft210for threadable engagement with the threaded distal tip PdCx1of a pusher delivery catheter PdC for securing the tip PdCx1of the catheter PdC to the cap220.

An exterior circumferential surface221of the cap220is preferably knurled to facilitate gripping and rotation of the cap220with a forceps (not shown) to effect withdrawal of the tubal occlusion contraceptive appliance200from a fallopian tube FT after insertion.

Summary Implant Technique

A guidewire G is transvaginally introduced via a guidewire delivery catheter GdC into a fallopian tube FT and the guidewire delivery catheter GdC withdrawn.

Referring toFIG.33, the cap220is threadably attached to a pusher delivery catheter PdC (e.g.,40cm custom pusher delivery catheter).

The free end of the guidewire G is fed through the distal guideway218in the shaft210and then through the proximal guideway228in the cap220. The attached tubal occlusion contraceptive appliance200is pushed along the guidewire G by the pusher delivery catheter PdC, with or without insertional rotation of the contraceptive appliance200about its axial x axis, until the shaft210is positioned within the fallopian tube FT and the cap220is seated against the opening from the fallopian tube FT to the uterus. The pusher delivery catheter PdC is rotated about its axial x axis to threadably disengage from tubal occlusion contraceptive appliance200, and the disengaged pusher delivery catheter PdC and the guidewire G withdrawn, leaving the shaft210of the tubal occlusion contraceptive appliance200within the fallopian tube FT. If desired, at any time prior to disengagement of the pusher delivery catheter PdC from the tubal occlusion contraceptive appliance200, the pusher delivery catheter PdC can be rotated about its axial x axis in the threadable engagement direction to effect rotation of the entire tubal occlusion contraceptive appliance200in a direction that effects threaded withdrawal of the tubal occlusion contraceptive appliance200out from the fallopian tube FT.

The process is repeated for the other fallopian tube FT.

Fourth Embodiment

Product

Referring toFIGS.34-38, a fourth embodiment of a tubal occlusion contraceptive appliance200includes an axially elongated shaft210, a cap220, screw threads250and a dual passage guideway.

The shaft210has a proximal axial end210x1spaced in a first axial direction xi from a distal tip210x2, and defines a second axial direction x2opposite the first axial direction x1.

The shaft210preferably has an axial length of about 1 to 4 cm and a radial cross-sectional area of about 0.8 to 7 mm2.

The cap220projects in the first axial direction x1from the proximal axial end210x1of the shaft210, and is sized, configured and arranged to inhibit axial x travel of the cap220into a fallopian tube FT. The cap220should have a radial r diameter greater than the radial r diameter of the shaft210and a radial r diameter greater than the radial r diameter of each screw thread segment251.

The screw threads250extend radially r around the shaft210for effecting axial x insertion of the tubal occlusion contraceptive appliance200into a fallopian tube FT upon rotation of the contraceptive appliance200about its axial x axis in a first rotational direction, and withdrawal of the tubal occlusion contraceptive appliance200from the fallopian tube FT upon rotation of the contraceptive appliance200about its axial x axis in a second rotational direction opposite the first direction. The screw threads250include several turns.

The dual passage guideway includes an axially x extending proximal guideway228through the cap220and an axially x extending distal guideway218that extends through the shaft210proximate the distal tip210x2of the shaft210. Both are configured and arranged to accommodate passage of a guidewire G for guiding insertion of the contraceptive appliance200into a fallopian tube FT.

The proximal guideway228is preferably in radially r spaced relationship from the shaft210, while the distal guideway218preferably angles inward in the second axial direction x2from a side210sof the shaft210to the distal tip210x2of the shaft210.

The central axis of the proximal guideway228and distal guideway218preferably extend along a common line.

The entire first embodiment of the tubal occlusion contraceptive appliance200can be CNC micro machined from biocompatible metallic alloys. In the preferred embodiment the contraceptive appliance200is machined from 316 L stainless steel alloy that has been used in human implants for decades in orthopedic screws, plates etc. and is biocompatible, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). Alternatively, the first embodiment of the tubal occlusion contraceptive appliance200can be manufactured by injection molding a biocompatible polymer such as PET (Polyethylene Terephthalate). PET will promote scarring and make the contraceptive appliance200a permanent implant. The polymer may have substances added to make it radiopaque as is commonly employed, including the addition of Tantalum powder, or may have Platinum marker bands incorporated.

The cap220can include an internally threaded axial orifice227open opposite the shaft210for threadable engagement with the threaded distal tip PdCx1of a pusher delivery catheter PdC for securing the tip PdCx1of the catheter PdC to the cap220.

An exterior circumferential surface221of the cap220is preferably knurled to facilitate gripping and rotation of the cap220with a forceps (not shown) to effect withdrawal of the tubal occlusion contraceptive appliance200from a fallopian tube FT after insertion.

Summary Implant Technique

A guidewire G is transvaginally introduced via a guidewire delivery catheter GdC into a fallopian tube FT and the guidewire delivery catheter GdC withdrawn.

The cap220is threadably attached to a pusher delivery catheter PdC (e.g., 40 cm custom pusher delivery catheter).

The free end of the guidewire G is fed through the distal guideway218in the shaft210and then through the proximal guideway228in the cap220. The attached tubal occlusion contraceptive appliance200is pushed along the guidewire G by the pusher delivery catheter PdC until the screw threads250engage the sidewalls of the fallopian tube FT. Thereafter, the pusher delivery catheter PdC is rotated so as to effect insertional rotation of the contraceptive appliance200about its axial x axis. The contraceptive appliance200is rotated until the shaft210is positioned within the fallopian tube FT and the cap220is seated against the opening from the fallopian tube FT to the uterus. The pusher delivery catheter PdC is rotated about its axial x axis to threadably disengage from tubal occlusion contraceptive appliance200, and the disengaged pusher delivery catheter PdC and the guidewire G withdrawn, leaving the shaft210of the tubal occlusion contraceptive appliance200within the fallopian tube FT. If desired, at any time prior to disengagement of the pusher delivery catheter PdC from the tubal occlusion contraceptive appliance200, the pusher delivery catheter PdC can be rotated about its axial x axis in the threadable engagement direction to effect rotation of the entire tubal occlusion contraceptive appliance200in a direction that effects threaded withdrawal of the tubal occlusion contraceptive appliance200out from the fallopian tube FT.

The process is repeated for the other fallopian tube FT.

An implanted tubal occlusion contraceptive appliance200can be removed after implant by gripping the knurled circumferential surface221of the cap220with a forceps, rotating the cap220with the forceps about the axial x axis of the implanted tubal occlusion contraceptive appliance200whereby the screw threads250or screw thread segments251on the implanted tubal occlusion contraceptive appliance200effect axial x travel of the implanted tubal occlusion contraceptive appliance200completely out from the fallopian tube FT, and then removing the tubal occlusion contraceptive appliance200completely from the body.

In its preferred embodiment, the tubal occlusion contraceptive appliance200is about 19 mm in length with a main shaft210about 1.25 mm in diameter. There are 4 retention disks 240 that are 2 mm in diameter each, located at the mid region of the shaft210. The cap220is about 3.5 mm in diameter. There is a 1 mm hole229machined radially r across the cap220, to permit it to be attached to the tether T of a delivery system such as a pusher delivery catheter PdC. At the distal tip210x2of the shaft210there is a machined angled distal guideway218, that permits a 0.018″ guidewire G to be passed through it. The retention disks240are all oriented with their conical faces towards the distal tip210x2of the shaft210. This permits the tubal occlusion contraceptive appliance200to be passed in the second axial direction x2in a fallopian tube FT, and then due to the elasticity of the fallopian tube FT and the orientation of the retention disks240is locked in place and will not pull out of the fallopian tube FT. The oversize nature of the cap220, prevents the tubal occlusion contraceptive appliance200from migrating into the fallopian tube FT.

Deployment Protocol

The procedure can be performed in a radiology suite that permits deployment under state of the art fluoroscopy and cine-radiography. The patient should be screened with a blood test to rule out early pregnancy. A long term subcutaneous hormonal implant would preferably have been implanted in the weeks prior to the procedure or the patient will be on birth control pills to prevent a pregnancy in the first 3 months after the implant (till such time a repeat hysterosalpingography (HSG) confirms bilateral tubal occlusion). The patient should be provided with materials explaining the risks and benefits of the procedure and an informed consent obtained.

The procedure can be performed by a physician team consisting of an Interventional radiologist and a gynecologist.

The patient will be prepped and draped for the procedure. An IV access should be obtained and normal saline infused at a slow rate to ensure access. The patient should be sedated with 50 microgram bolus of Fentanyl and 0.5 mg Atropine injected to prevent bradycardia and a vasovagal reaction. The vagina and cervix should be cleansed with povidone-iodine using soaked sterile sponges on a long ring forceps. 1 to 2 ml of lidocaine should be intracervically injected, noting the presence of a wheal on the cervix, usually at the 6 and 12 o'clock positions where the tenaculum will be placed. A four quadrant cervical block can be undertaken by injecting 20 cc of 1% lidocaine without epinephrine at 4 spots around the cervix at 2, 4, 8 and 10 o'clock positions. The cervix can be held with a tenaculum, and a 6 French hystero-salpingography (HSG) catheter passed through the Os of the cervix into the uterine cavity. The balloon inflated, traction on the catheter maintained, and a standard HSG performed with a few ml of radiographic contrast injected into the uterine cavity till the fallopian tubes are also filled. The radiographs can be reviewed to confirm that both tubes are patent.

The HSG catheter can then be removed.

Exemplary Deployment Protocol

Referring toFIGS.6-9,11and13-15, a 6 Fr. Short JR 4 (Judkins Right Coronary 4) guidewire delivery catheter GdC is passed into the uterus. Under fluoroscopy control and using the HSG image as a road map, the right fallopian tube FT is cannulated. One ml or two of non-ionic radiographic contrast is injected to selectively visualize the fallopian tube FT. An 80 cm soft tip, 0.018″ guidewire G is passed into the fallopian tube FT and the guidewire G advanced until it exits the fimbriated end of the fallopian tube FT. The guidewire delivery catheter GdC is withdrawn under fluoroscopic guidance, leaving the guidewire G in place.

A custom 35 cm, 5 Fr flexible introducer sheath S with dilator is passed over the guidewire G until the tip of the sheath S is at least 6 to 7 cms beyond the ostium of the fallopian tube FT. Once confirmed, the dilator and guidewire G are withdrawn, leaving the sheath S in place. The side arm is aspirated and the sheath S gently flushed with sterile normal saline.

The mechanical tubal occlusion contraceptive device100with its pusher delivery catheter PdC is removed from its sterile packaging. The hemostatic valve is disconnected from the 5 Fr. sheath S. The tip of the mechanical tubal occlusion contraceptive device100is placed into the sheath S and gently advanced until the pusher delivery catheter PdC enters the 5 Fr. sheath S. The pusher delivery catheter PdC is advanced into the sheath S under fluoroscopy. The rigid portions of the mechanical tubal occlusion contraceptive device100, is easily visible under fluoroscopy as they are made from 316 L SS, or from solid rods of polymers such as PEEK (Polyether Ether Ketone). The pusher delivery catheter PdC is advanced until the leading anchor1201reaches the tip of the sheath S.

Visually confirm that the entire mechanical tubal occlusion contraceptive device100is beyond the ostium of the fallopian tube FT and junction with the uterine cavity. The mechanical tubal occlusion contraceptive device100is, at this point, ready for deployment. Holding the pusher delivery catheter PdC firmly with one hand, the sheath S is slowly backed out with the other hand until the tip of the sheath S comes just proximal to the trailing anchor1202. It is desirable at this time to watch carefully for 1 to 2 minutes for the fallopian tube FT tone to return and for it to clamp down around the mechanical tubal occlusion contraceptive device100. Gentle traction backwards over 1 to 2 mm will confirm this. This then is the stage to release the mechanical tubal occlusion contraceptive device100. The screw cap over the hub H of the pusher delivery catheter PdC is unscrewed and placed to a side. The double 0.005″ Nitinol wire tether T is unwound from the hub H and the two are separated. Holding one wire firmly the other is gently pulled back till the first end goes into the lumen. The wire is continued to be gently pulled out. At all times the pusher delivery catheter PdC is held firmly with one hand and the hand should rest on the procedure table so that there is no traction on the pusher delivery catheter PdC. Once the Nitinol wire is completely removed, the mechanical tubal occlusion contraceptive device100is released.

The 5 Fr. custom introducer sheath S and the pusher delivery catheter PdC are removed. This completes deployment for one fallopian tube FT.

The same procedure is repeated for the other fallopian tube FT. The 6 Fr. JR 4 guidewire delivery catheter GdC is passed into the uterus and the other fallopian tube FT is cannulated. The other fallopian tube FT is wired G. The 5 Fr. introducer sheath S is passed into the other fallopian tube FT. The dilator and guidewire G are removed. A second mechanical tubal occlusion contraceptive device100is passed into the introducer sheath S and deployed in similar fashion.

After the second mechanical tubal occlusion contraceptive device100is deployed, no HSG should be performed because of concerns that the high pressure injection of contrast may dislodge or push the mechanical tubal occlusion contraceptive device100outwards in the fallopian tube FT.

The patient should be observed for a couple of hours and a plain Xray of the pelvis performed to document the position of the mechanical tubal occlusion contraceptive device100.

The patient can then be discharged home, after being advised not to have any sexual activity for 4 weeks and protected sex after that for a total of 12 weeks.

Any symptoms should be recorded on a form that is provided and can also be entered electronically.

She should return in 3 months for a repeat HSG to confirm complete occlusion of both fallopian tube FT, due to dense scar formation. If both fallopian tubes FT are completely occluded, she can discontinue birth control pills and have unprotected sex. She should have follow-up checks for one year for symptoms or any pregnancy.

Patients should also be followed-up long term for 3 years for symptoms and any occurrence of pregnancies.

Referring toFIGS.25-27, after the baseline HSG is performed, the cervical OS can be dilated with serial dilators to about 5 mm. A 6 Fr JR 4 type guidewire delivery catheter GdC can be used to cannulate the right fallopian tube FT. A 0.018″ 80 cm guidewire G can be used to wire a first fallopian tube FT. The guidewire delivery catheter GdC is then exchanged out, leaving the guidewire G in place. A tubal occlusion contraceptive appliance200is loaded onto the guidewire G through the guideway(s)218and/or228in the contraceptive appliance200. This allows the contraceptive appliance200to be advanced over the guidewire G in a mono rail fashion. The guidewire G is held firmly. The pusher delivery catheter PdC is advanced, with intermittent use of the fluoroscopy as desired. When the distal tip210x2of the contraceptive appliance200reaches the ostium of the fallopian tube FT, the freeze frame (road map) from the HSG should be reviewed. Using this as a guide the pusher delivery catheter PdC can be firmly advanced until the contraceptive appliance200advances into the fallopian tube FT and forward progress beyond the cornu is halted by the cap220of the contraceptive appliance200. The contraceptive appliance200should be allowed to rest for a couple of minutes. Mild traction, will ensure that the contraceptive appliance200is locked in place. The guidewire G is then gently pulled out, while firmly holding the pusher delivery catheter PdC. Once the guidewire G is removed, the contraceptive appliance200can be deployed by firmly holding the pusher delivery catheter PdC in place while an assistant unscrews the lure lock screw cap over the hub H and unwinds the Nitinol tether T. The two ends of the tether T are separated, one of the wires is pulled until the entire wire comes out, and the pusher delivery catheter PdC is removed from the uterus.

The same procedure is repeated for the other fallopian tube FT. The JR4 guidewire delivery catheter GdC is re-introduced and the other fallopian tube FT is cannulated. It is then wired and the above steps are repeated in the other fallopian tube FT.

A final plain cine run will document the position of the two contraceptive appliance200. The post procedure care is similar to that set forth previously.