US20070062542A1 - Contraceptive transcervical fallopian tube occlusion devices and methods - Google Patents

Abstract

The invention provides intrafallopian devices and non-surgical methods for their placement to prevent conception. The efficacy of the device is enhanced by forming the structure at least in part from copper or a copper alloy. The device is anchored within the fallopian tube by a lumen-traversing region of the resilient structure which has a helical outer surface, together with a portion of the resilient structure which is biased to form a bent secondary shape, the secondary shape having a larger cross-section than the fallopian tube. The resilient structure is restrained in a straight configuration and transcervically inserted within the fallopian tube, where it is released. Optionally, permanent sterilization is effected by passing a current through the resilient structure to the tubal walls.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 10/600,298 filed on Jun. 20, 2003, which is a continuation of U.S. patent application Ser. No. 09/592,123 filed on Jun. 12,2000, which is a continuation of U.S. patent application Ser. No. 09/324,078 filed on Jun. 1, 1999, which is a continuation-in-part of International Application No. PCT/US98/20031, filed Sep. 23, 1998, which is a continuation-in-part of U.S. patent application Ser. No. 09/093,835, filed Jun. 8, 1998, which claims the benefit of priority from U.S. Provisional Application No. 60/059,861, filed Sep. 24, 1997, and is also a continuation-in-part of U.S. patent application Ser. No. 08/475,252 filed Jun. 7, 1995, and a continuation-in-part of U.S. patent application Ser. No. 08/474,779 filed Jun. 7, 1995, now U.S. Pat. No. 6,176,240, the full disclosures of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates generally to contraception, and more particularly to intrafallopian contraceptive devices and nonsurgical methods for their delivery.
• Worldwide demand exists for safe, effective methods of both contraception and permanent sterilization. Although a variety of contraception and sterilization methods are available, all of the existing methods have limitations and disadvantages. Thus, the need for additional safe, low cost, reliable methods of contraception and permanent sterilization, both in developed and less developed countries, is widely recognized.
• Many presently available contraception methods require significant user involvement, and user non-compliance results in quite high rates of failure. While the theoretical effectiveness of existing contraceptives, including barrier methods and hormonal therapies, is well established, overcoming user noncompliance to improve overall efficacy has proven difficult.
• One form of contraception which is less susceptible to user noncompliance is the intrauterine device (IUD). IUDs have been found to have higher rates of reliability, and are effective for a longer period of time, than most other commercially available contraceptives. Unfortunately, IUDs are also associated with serious infectious complications. For this reason, the use of IUDs within the United States has decreased dramatically. Additionally, IUDs are subject to unplanned expulsion, and must be removed due to excessive pain or bleeding in a percentage of cases, further reducing the acceptance of the IUD as a contraceptive method. Interestingly, the efficacy of copper IUDs appears to be higher than that of non-metallic IUDs. The reason for this has not been fully explained.
• Commercially available options for permanent sterilization include fallopian tube ligation and vasectomy. These methods are surgical, are difficult to reverse, and are not available to many people in the world. It is common knowledge that fertilization occurs in the fallopian tubes where the sperm and ovum meet. Tubal ligation avoids this by complete occlusion of the fallopian tubes.
• It has previously been proposed to reversibly occlude the fallopian tubes, for example, by in vitro formation of an elastomeric plug, or otherwise anchoring a device on either side of the narrowest region of fallopian tube, called the “isthmus.” Such fallopian tube occlusion methods appear promising; however, an unacceptably high percentage of the non-surgical devices proposed to date have become dislodged during previous studies. Even where non-surgical intrafallopian devices have remained in place, they have been found to be only moderately effective at preventing conception.
• For these reasons, it would be desirable to provide effective, reliable intrafallopian devices for contraception and sterilization. It would be particularly desirable to provide highly effective intrafallopian devices which did not require surgery for placement. It would be especially desirable if such devices and methods allowed easy placement of the device, but were less susceptible to being dislodged than previously proposed non-surgical intrafallopian devices.
• 2. Description of the Related Art
• The experimental use of a stainless steel intrafallopian device is described in Transcatheter Tubal Sterilization in Rabbits, Penny L. Ross,RT 29 “Investigative Radiology”, pp. 570-573 (1994). The experimental use of an electrolytically pure copper wire as a surgical contraceptive intrafallopian device in rats was described in “Antifertility Effect of an Intrafallopian Tubal Copper Device”, D. N. Gupta, 14 Indian Journal of Experimental Biology, pp.316-319 (May 1976).
• U.K. Patent Application Pub. No. 2,211,095 describes a uterine screw plug for blocking the fallopian tube. European Patent Application Pub. No. 0,010,812 describes a device for placement in the oviducts having enlargements at either end for anchoring the device. The same device appears to be described in Netherlands Patent No. 7,810,696.
• The use of tubal occlusion devices is described in “Hysteroscopic Oviduct Blocking With Formed-in-Place Silicone Rubber Plugs”, Robert A. Erb, Ph.D., et al., The Journal of Reproductive Medicine, pp. 65-68 (August 1979). A formed-in-place elastomeric tubal occlusion device is described in U.S. Pat. No. 3,805,767, issued to Erb. U.S. Pat. No. 5,065,751, issued to Wolf, describes a method and apparatus for reversibly occluding a biological tube. U.S. Pat. No. 4,612,924, issued to Cimber, describes an intrauterine contraceptive device which seals the mouths of the fallopian tubes.
• German Patent No. 28 03 685, issued to Brundin, describes a device for plugging a body duct with a device which swells when in contact with a body fluid.
• Alternative contraceptive devices are disclosed in co-pending U.S. patent application No. 08/474,779, the full disclosure of which is herein incorporated by reference.
SUMMARY OF THE INVENTION
• The present invention provides intrafallopian devices and methods for their placement to prevent conception. The intrafallopian devices of the present invention are transcervically delivered and mechanically anchored within the fallopian tube to provide long term contraception, or alternatively permanent sterilization, without the need for surgical procedures or the risks of increased bleeding, pain, and infection associated with intrauterine devices (IUDs).
• The intrafallopian devices of the present invention will often comprise a structure having a lumen-traversing region with a helical outer surface. The helical surface is mechanically anchored by a resilient portion of the structure which is biased to form an enlarged secondary shape, preferably forming distal and proximal anchoring loops. The anchoring loops help prevent the helical outer surface from rotating out of position, and also directly deter axial motion within the fallopian tube. In alternative embodiments, anchoring may be provided by a straight coil which is resiliently deflected by the axial curvature of the tortuous fallopian tube, and a radially expandable braid, malecott, or some other tubular structure may help affix the device within the fallopian tube.
• The use of copper in the intrafallopian device of the present invention improves its efficacy as a contraceptive method. Devices formed from plastically deformable materials, however, are less readily restrained in the fallopian tube. Apparently, the large variation in the actual shape and dimensions of fallopian tubes does not provide reliable anchoring for a pre-formed deformable intrafallopian device. The intrafallopian device of the present invention therefore often comprises a resilient structure, usually a metallic coil, which includes a copper alloy or plating, ideally comprising an alloy including at least 75% copper. The coil material typically includes beryllium, zinc, stainless steel, platinum, a shape memory alloy, such as Nitinol®, or the like. Preferably, the coil is composed of an alloy of beryllium and copper.
• Although the present device will generally result in occlusion, it need not completely occlude the fallopian tube to prevent the meeting of the sperm and ovum. Instead, in some embodiments, the presence of the copper on the resilient structure is sufficient to provide effective contraception. Hence, contraception can be provided by disrupting the normal architecture and/or function of the fallopian tube, despite the presence of an open lumen. This concept is referred to herein as “functional occlusion”. As used herein, functional occlusion means that the device, when implanted in the fallopian tube, disrupts the normal architecture and/or functioning of the fallopian tube so as to inhibit fertilization and/or conception.
• Conveniently, the present invention further comprises non-surgical placement of such intrafallopian devices by transcervical introduction. The resilient structure is restrainable in a straight configuration, e.g., by use of a corewire, greatly facilitating and reducing the risks of introduction. Thus, the cost and dangers associated with existing surgical contraceptive and sterilization procedures are avoided. The resilient structure will often comprise a coil. In some embodiments, an element is disposed along the coil, and is adapted to incite a tissue reaction in the tubal tissues which inhibits conception. A distal anchor of the coil may be inserted into the ampulla, distal of the isthmus, while a proximal anchor is located in the ostium. These anchors prevent rotation of the device, and also help avoid axial movement. Alternatively, at least one of the anchors may be positioned anywhere past the ostium and within the fallopian tube, while the other extends into the uterus, depending on their length and configuration. Preferably, at least some anchoring is provided along the intramural to isthmic region of the fallopian tube. In some embodiments, electrosurgical attachment of an intraluminal device to a surrounding lumenal wall may provide effective anchoring even without loops and other anchoring structures. Electrical current may also be used to decouple the intrafallopian device from the delivery system, typically by electrolytically dissolving a solder bond. Current may also actuate an anchor, such as by releasing a resilient radially expandable tubular structure within the fallopian tube.
• The present invention also provides improved contraceptive devices which incite a tissue reaction within the fallopian tube to prevent conception. This group of intrafallopian devices will often make use of a highly flexible coil structure to avoid damaging or penetrating through the delicate tubal tissues. The desired tissue reaction may be the result of the material of intrafallopian device, or may be incited by a coating, a surface treatment, a mechanical interaction between the device and the surrounding tubal wall, or the like. The tissue will often help impede conception by occluding the fallopian tube, by interrupting the transport mechanisms of the tubal tissues, and/or by restraining the intrafallopian tubal device within the tube. Specific tissue reactions which may provide these intended results include tissue ingrowth into the contraceptive device and/or the tubal lumen, scar tissue formation, sclerosing of the tubal tissues, and the like.
• In one aspect, the invention provides a tissue reaction contraceptive device for use in a fallopian tube. The contraceptive device comprises a coil having a proximal end and a distal end and defining an axis therebetween. The coil is axially flexible and has a cross-section suitable for insertion into the fallopian tube. An element disposed along the coil is adapted to incite a tissue reaction in the tubal tissues adjacent the coil so as to inhibit conception.
• In some embodiments, the element may promote ingrowth of the tubal tissues into the contraceptive device. For example, the element may include a braided or woven polyester, a micro-porous material or surface treatment, or the like. Alternatively, a sharp edged helical ribbon or other mechanical interaction element may incite the formation of scar tissue, or a surface coating of the coil may sclerose the tubal tissues, exciting formation of tough fibrous connective tissues which interfere with conceptive transport. In many embodiments, the presence of the contraceptive device in combination with the tissue reaction can provide effective contraception without having to rely on total occlusion of the fallopian tube.
• In another aspect, the present invention provides a tissue ingrowth contraceptive device for use in a fallopian tube. The contraceptive device comprises a tubular retention structure having a proximal end, a distal end and an axis therebetween. The retention structure is axially flexible, and is insertable within the fallopian tube. A material which can incite ingrowth of the tubal tissue is attached to, and exposed radially from, the retention structure.
• In the exemplary embodiment, the retention structure comprises a helical coil in which the ingrowth material is disposed. Such helical coils may optionally be radially expansible within the fallopian tube, thereby allowing the device to accommodate a wide variety of tubal physiologies. The ingrowth material may be in the form of braided or woven fibers of polyester, P.T.F.E., or the like.
• In another aspect, the present invention provides a tissue ingrowth contraceptive device for use in a fallopian tube. The contraceptive device comprises a resilient elongate body having a proximal end and a distal end and defining an axis therebetween. A retention structure is disposed along the resilient body. The retention structure is adapted to restrain the resilient body within the fallopian tube. A bond affixes the retention structure to the resilient body. At least one of the resilient body, the retention structure, and the bond comprises a micro-porous material which promotes tissue ingrowth therein.
• In another aspect, the present invention provides a contraceptive method comprising transcervically inserting a contraceptive device within a fallopian tube. The device is inserting by resiliently deflecting a distal body of the contraceptive device against a tubal wall, so that the distal body guides the contraceptive device axially along the fallopian tube. A tissue reaction is incited with an element of the contraceptive device in the tubal tissues. This tissue reaction affixes the contraceptive device within the fallopian tube.
• The present invention also provides improved contraceptive devices, systems, and methods adapted for use in the widely varying geometry of the fallopian tube. In recognition of the wide variations in tubal physiology, the contraceptive structures of the present invention are radially expandable within the fallopian tube to engage the tubal wall. Surprisingly, the contraceptive devices of the present invention will often make use of tubular structures such as resilient helical coils. Such tubular devices will often effect contraception by disrupting the architecture and/or transport mechanisms of the tubal tissues, rather than relying entirely on total blockage of the tube. The passages through the tubular contraceptive devices of the present invention may optionally be occluded by promoting tissue ingrowth within the device, for example, by including woven or braided polyester fibers within a helical coil. Regardless, such tubular retention structures are capable of radially expanding against tubal walls throughout a wide range of tubal sizes to safely anchor the contraceptive device, without having to resort to protruding barbs or the like.
• In one aspect, the present invention provides a contraceptive device for use in fallopian tube having a tubal wall. The contraceptive device comprises a tubular retention structure having a proximal end, a distal end, and an axis therebetween. The retention structure is radially expandable in situ from a narrow configuration (in which the retention structure has a first diameter which is suitable for axial insertion into the fallopian tube) so as to define a second, enlarged diameter. The expanded retention structure is adapted to engage the surrounding tubal wall and retain the contraceptive device within the fallopian tube.
• In another aspect, the present invention provides a contraceptive device for use in a fallopian tube having a tubal wall. The contraceptive device comprises a conception inhibiting body which defines an axis. A helical coil is disposed about the body. A portion of the helical coil is movable relative to the body so that the helical coil can expand resiliently throughout a range of tubal cross-sectional sizes. Hence, the coil can radially engage the surrounding tubal wall and safely affix the contraceptive device within the fallopian tube.
• The present invention also provides intrafallopian contraceptive devices having elongate coils which are substantially straight. Surprisingly, when such straight coils are positioned axially within the tortuous fallopian tubes, the bends imposed on the coil by the fallopian tube can result in resilient anchoring of the coil. Such straight coils are also highly advantageous when advancing the contraceptive device into (and within) the fallopian tube. Straight resilient coils can act as an integral guidewire during transcervical deployment of the device within the fallopian tube, thereby avoiding the delay associated with the sequential use of guidewires, tubal axis catheters, and the like.
• The present invention provides an intrafallopian contraceptive device for use in a fallopian tube. The contraceptive device comprises an elongate coil having a proximal end, a distal end, and an axis therebetween. The axis is substantially straight when the coil is at rest, and the coil is axially resilient to facilitate insertion of the body axially into the tube. The device is adapted to be retained within the fallopian tube so as to inhibit conception.
• In another aspect, the present invention provides an intrafallopian contraceptive device for use in a fallopian tube. The tube has a tubal wall with a tubal cross-section and an axial curvature. The contraceptive device comprises an elongate body having a proximal end and a distal end and defining an axis therebetween. The body has a cross-section suitable for axial insertion within the tubal cross-section. At least a portion of the body is straighter than the axial curvature of the fallopian tube. The body is sufficiently flexible to deflect against the tubal wall without injuring the tubal wall. The body is also sufficiently resilient to impose an anchoring force against the tubal wall when the straight portion flexes along the axial curvature of the fallopian tube.
• In another aspect, the present invention provides a contraceptive device for use in a fallopian tube having an axis. The contraceptive device comprises a structure having a proximal end, a distal end, and an axis therebetween. The structure is adapted to provide effective tubal occlusion when disposed substantially coaxially within the fallopian tube. An elongate member is affixed to the occlusion structure. The member extends distally of the occlusion structure and is sufficiently flexible and axially resilient to help guide distal advancement of the occlusion structure within the fallopian tube.
• In a contraceptive method provided by the present invention, an elongate resilient body is transcervically inserted into an axially curving fallopian tube so that the fallopian tube imposes an axial bend on the body. The bent body imposes an anchoring force which helps anchor the bent body within the fallopian tube. The body is anchored within the fallopian tube so that the affixed resilient body inhibits conception.
• In another aspect, the present invention provides a contraceptive method comprising transcervically inserting an intrafallopian contraceptive device along the fallopian tube by guiding the contraceptive device with a distal guidewire-like structure of the contraceptive device. The device, including at least a portion of the guidewire-like structure, is retained within the fallopian tube so that the device inhibits conception.
• In another aspect, the present invention provides a contraceptive kit. The kit comprises an intrafallopian contraceptive device and instructions for its use. The instructions describe and/or set forth the method steps of transcervically introducing the contraceptive device into a fallopian tube and affixing the contraceptive device within the tube. Optionally, a variety of delivery structures may also be provided in the kit, including guidewires, corewires, delivery catheters, and the like.
• In yet another aspect, the invention provides an intrafallopian contraceptive system comprising an elongate delivery body having a proximal end and a distal end. A first energy conduit extends therebetween, and an intrafallopian structure near the distal end has a first cross-section. An energy source is coupled to the structure by the first conduit. Energy from the energy source reconfigures the structure to a second cross-section to restrain the structure within a fallopian tube and inhibit conception.
• In a final aspect, the invention provides an elongate delivery body having proximal and distal ends with first and second conductors extending therebetween. An intrafallopian contraceptive structure is near the distal end of the delivery body. An electrical power supply can be coupled to the structure by the first and second conductors. This advantageous bipolar arrangement can, for example, allow actuation of a shape-memory alloy structure by transmitting current through at least a portion of the structure from a hand-held battery.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a first embodiment of a contraceptive intrafallopian device according to the present invention.
• FIG. 2 illustrates a primary coil used in the contraceptive intrafallopian device ofFIG. 1.
• FIG. 3 illustrates a secondary coil which has been imposed on a primary coil as used in the contraceptive intrafallopian device ofFIG. 1.
• FIG. 4 illustrates a corewire for use with the contraceptive intrafallopian device ofFIG. 1.
• FIG. 5 is a cross-sectional view of a contraceptive delivery system having the contraceptive intrafallopian device ofFIG. 1.
• FIG. 6 illustrates an alternative embodiment of the present contraceptive intrafallopian device.
• FIG. 7 illustrates a primary coil used in the contraceptive intrafallopian device ofFIG. 6.
• FIG. 8 schematically illustrates a contraceptive delivery system including the contraceptive intrafallopian device ofFIG. 6.
• FIGS. 9 and 10 illustrates a method of delivery of a contraceptive intrafallopian device according to the present invention.
• FIGS.11A-D illustrate intrafallopian contraceptive devices having straight primary coils, together with associated delivery devices and systems.
• FIGS.12A-E illustrate a variety of intrafallopian contraceptive devices which are adapted to promote a tissue reaction that enhances the contraceptive efficacy of the device.
• FIG. 13 illustrates a method for introducing a dense braid of fiber material into a helical coil of a contraceptive device.
• FIGS. 14-14E illustrate helical coils which adapt to varying tubal sizes to enhance retention of the contraceptive device within the fallopian tube.
• FIG. 15A-D illustrate cross-sectional views through the fallopian tube before, during, and after delivery of a contraceptive device having a radially expandable helical coil, and also illustrates the enhanced efficacy provided by tissue reactions such as tissue ingrowth into and around the helical coil.
• FIG. 15E illustrates the self-guiding capabilities of a contraceptive device having a straight primary coil.
• FIG. 16 illustrates a contraceptive delivery system having a detachable distal corewire.
• FIG. 17 schematically illustrates a kit including a contraceptive delivery system and instructions for its use.
• FIGS.18A-C schematically illustrate alternative tubular radially expandable retention structures which can mechanically anchor a contraceptive device in the fallopian tube.
• FIGS. 19A and B illustrate an intrafallopian contraceptive system in which a hand-held battery electrically actuates the retention structure by transmitting a current which heats a shape-memory alloy of the retention structure.
• FIGS. 20A and B illustrate an intrafallopian contraceptive device and method for its use to support a coil comprising copper within the utero-tubal junction.
• FIGS.21A-C illustrate alternative structures comprising copper and methods for their use to inhibit conception, according to the principles of the present invention.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
• The present invention encompasses a contraceptive intrafallopian device which can alternatively be used as both a permanent and a reversible means of contraception. The present contraceptive methods and devices minimize the danger of non-use which has limited the efficacy of prior art contraceptive techniques. Moreover, the location of the present devices within the fallopian tubes provides a reduced risk of the infectious complications, increased bleeding, and pelvic pain associated with intrauterine devices (IUDs). The location and the novel shape of the present intrafallopian device provides significant advantages over IUDs, which have been found to be susceptible to unplanned expulsion and removal due to excessive pain and bleeding. The present invention takes advantage of the increase in effectiveness associated with copper IUDs, providing a resilient structure including copper which may be transcervically positioned without the need for surgery.
• Although the present contraceptive method is included within a group of contraceptive techniques generally referred to as fallopian tube occlusion methods, the present invention does not necessarily rely solely on blocking the fallopian tube to prevent fertilization. Instead, contraception is apparently provided by disrupting of ovum transport, the process of fertilization, and/or cleavage of the ovum. While the effect that copper has on these processes is not fully understood, it does appear that copper intrafallopian devices offer potentially significant increases in effectiveness over intrafallopian devices formed of other materials. Contraception may alternatively be provided or enhanced by a spermicidal agent attached to the device. Optionally, the present invention further encompasses devices which promote the growth of tissue within the tube to induce tubal occlusion, further inhibiting conception. In some embodiments, polyester fibers such as Dacron®, Rayon®, or the like, are bonded to the surface of the coil using a polymeric adhesive. The polyester fibers promote increased tissue growth around the coil, thus further reducing the possibility of expulsion of the device from the fallopian tube.
• Conveniently, the present resilient structures are adapted to be releasably affixed over a corewire, the corewire restraining the resilient structure in a straight configuration. As the resilient structure has an outer diameter when in the straight configuration which is less than the inner diameter of the fallopian tube, the catheter containing the present intrafallopian device is easily transcervically introduced.
• The present invention may be anchored within the isthmus of the fallopian tube, overcoming the unintended expulsion of the device and the resulting failure of the contraceptive method. Such intrafallopian device expulsion has been the single greatest factor limiting the efficacy of easily positioned intrafallopian contraceptive techniques. The present intrafallopian devices are generally elongate resilient structures pre-formed into secondary shapes. These secondary shapes will preferably form anchors proximally and distally of the narrowest portion of the fallopian tube, called the isthmus. The secondary shape preferably has a larger outer diameter than the inner diameter of the isthmus. Anchoring may also be possible with a structure spanning other portions of the tubal lumen, often between the ostial opening and the isthmus.
• The present device is generally readily removed by snaring the resilient structure near the proximal end and pulling proximally on the resilient structure, thereby straightening the resilient structure and allowing it to be withdrawn without injuring the fallopian tube. Alternatively, an electrical current is applied to the device after it is positioned within the fallopian tube, providing permanent sterilization. Electrical current might also effect detachment of the device from the delivery system using a system similar to that described in U.S. Pat. No. 5,624,449, the full disclosure of which is incorporated herein by reference. In situ actuation of an anchor might be effected by releasing a resilient structure to expand in situ with a similar mechanism, or by a current induced phase change of a shape memory alloy (for example, causing a straight Nitinol® ribbon to curl within the fallopian tube with a current).
• Referring now toFIG. 1, a first embodiment of the present contraceptiveintrafallopian device10 is formed from a resilientprimary coil12.Primary coil12 has aproximal end14 and adistal end16, the latter having anatraumatic endcap18.Primary coil12 further includes three portions: aproximal anchor portion20, adistal anchor portion22, and a lumen-traversingregion24. Proximal anddistal anchors20,22 are biased to form anchoringloops26, as described hereinbelow.
• Lumen-traversingregion24 comprises a substantially straight portion ofprimary coil12. Aribbon28 is wound over the outer surface ofprimary coil12 to provide a helical shape.Ribbon28 includes sharpouter edges29, which firmly anchor lumen-traversingregion24 in the fallopian tube wall when torque is applied tointrafallopian device10. The ribbon is preferably formed of a high strength biocompatible metal, ideally being stainless steel. The ribbon is attached toprimary coil12 at a proximal joint30 and a distal joint32, which may be formed of solder, heat-shrink tubing, or the like.
• Referring now toFIG. 2,primary coil12 is most easily formed in a straight configuration as a cylindrical coil or spring, preferably having an outer diameter in the range from 0.005 inch to 0.05 inch, and having a length in the range from 20 mm to 150 mm. Ideally,primary coil12 has an outer diameter in the range from 0.01 inch to 0.05 inch and a length in the range from 30 mm to 125 mm.
• Preferably,primary coil12 is formed from a beryllium copper alloy wire. Beryllium copper provides the resilience necessary to avoid expulsion of the device, and also provides the increased effectiveness of a copper contraceptive intrafallopian device. Such a beryllium copper wire will typically have a diameter from 0.002 inch to 0.01 inch. To provide the increased efficacy of a copper intrafallopian device,primary coil12 preferably comprises an alloy including 75% copper. Alternatively,primary coil12 is formed from a resilient metal, such as stainless steel, platinum, a shape memory alloy, or the like. If such materials are used,primary coil12 is preferably plated with copper or a copper alloy or otherwise has copper attached.
• Primary coil12 includes a body winding42 and a thread winding44. Body winding42 is formed with the minimum possible pitch to increase the stiffness ofprimary coil12. Thread winding44 will typically comprise from 0.1 cm to 2.0 cm adjacent toproximal end14, and will have a pitch roughly twice that of body winding42.
• Referring now toFIG. 3, the proximal and distal anchors are formed by imposing a bent secondary shape on selected portions ofprimary coil12. The secondary shape preferably comprisesloops26 formed by bendingprimary coil12, and heat treating the primary coil while it is bent. A wide variety of secondary shapes may be used, including sinusoidal curves, alternating loops, or loops separated by straight sections so as to form a “flower coil,” as more fully described in co-pending U.S. patent application Ser. No. 08/474,779, the full disclosure of which is herein incorporated by reference. In most cases, the bent secondary shape will have anouter cross-section46 which is larger than the fallopian tube to provide effective anchoring.
• Referring now toFIG. 4, acorewire50 for use with intrafallopian device10 (FIG. 1) comprises aresilient wire52 which tapers towards adistal end54.Wire52 is sufficiently stiff to restrainintrafallopian device10 in a straight configuration, typically comprising stainless steel, platinum, or the like. A short section of coil forms corewirethreads56 attached atthreadjoint58.Threads56 match the windings and pitch of threadwindings44 ofprimary coil12.
• Referring now toFIG. 5, an intrafallopiancontraceptive system60 comprisescorewire50 inserted within alumen62 throughintrafallopian device10.Intrafallopian device10 is releasably attached by engagingthread windings44 withthreads56. Thus,intrafallopian device10 is disengaged by torquing a proximal end ofcorewire50 onceintrafallopian device10 is in position.
• Referring now toFIG. 6, an alternative embodiment of the present intrafallopian device is again formed from a resilientprimary coil112 having aproximal end114 and adistal end116. The former includes a friction fitting115.Primary coil112 again includes three portions: aproximal anchor portion120, adistal anchor portion122, and a lumen-traversingregion124. Proximal anddistal anchors120,122 are here biased to form opposed anchoringloops26, thereby increasing the relaxed overall cross-section of the proximal and distal anchors. Aribbon128 is wound over the outer surface ofprimary coil112 to provide a helical shape, as described above.
• Referring now toFIG. 7,primary coil112 comprises a uniform body winding142. The secondary shape is imposed on
• the straight cylindrical coil asopposed loops126, or alternatively as multiple loops of a flower coil.
• Referring now toFIG. 8, an intrafallopian contraceptive system using alternativeintrafallopian device100 includes acorewire152 which tapers towards a distal end154. Friction fitting115 fittingly engagescorewire152, which restrainsprimary coil112 in a straight configuration. A release catheter164 is slidably disposed overcorewire152 proximally of alternativeintrafallopian device100, allowing the device to be released by withdrawingcorewire152 relative to the release catheter.
• Use of the present contraceptive intrafallopian device will be described with reference toFIGS. 9 and 10. Auterine introducer canula70 is inserted transcervically through auterus72 to the region of anostium74. Alternatively, a hysteroscope may be used in place ofcanula70, or an echogenic and/or radiopaque device might be placed under sonographic or radiopaque guidance.
• Intrafallopiancontraceptive system60 is advanced distally ofintroducer cannula70 and maneuvered through the fallopian tube, preferably untilintrafallopian device10 extends distally of the isthmus. Optionally, intrafallopiancontraceptive system60 is self-guided, withcorewire52 bent neardistal end54 to assist intraluminal maneuvering. Alternatively, a guide wire and catheter are advanced into the fallopian tube first, and the guide wire is replaced with intrafallopiancontraceptive system60. In either case, the intrafallopian device will generally be axially positioned with lumen-traversingregion24 within atarget region84 adjacent to isthmus80. Preferably, at least one loop ofdistal anchor22 is distal oftarget region84, and at least one loop ofproximal anchor20 is proximal oftarget region84 to form the distal and proximal anchor bends.
• Onceintrafallopian device10 is properly positioned, corewire50 is torqued to setribbon28 in the tubal wall. The corewire may then be unthreaded fromintrafallopian device10 by rotating the corewire in the opposite direction, disengagingthreads56 fromthread windings44. The corewire is then free to slide proximally, releasing the primary coil. As the distal end of the primary coil is released, adistal anchor bend90 is formed. Similarly, a proximal loop forms aproximal anchor bend92. The anchor bends help to axially restrain the device within the fallopian tube, and also prevent rotation around the helical shape of lumen-traversingregion24. As seen inFIG. 10, the loops need not assume their relaxed form to provide effective distal or proximal anchors.
• The present invention further encompasses permanent sterilization by passing a current through the corewire to the intrafallopian device prior to withdrawing the corewire. Fallopian tube tissue in contact with the intrafallopian device is desiccated, and thus attached to the present intrafallopian device. This action also causes permanent tubal damage, leading to the formation of scar tissue which encapsulates the intrafallopian device and causes permanent occlusion of the tubal lumen. Clearly, the corewire/primary coil interface must be conductive to allow the present non-surgical method of permanent sterilization.
• The intrafallopian contraceptive methods and devices of the present invention can provide highly effective contraception even when the contraceptive device does not totally occlude the lumen of the fallopian tube. To minimize distention of the delicate tubal tissue, the present invention will often leave some open lumen within the fallopian tube, at least when initially deployed. In fact, these contraceptive devices will often comprise perforate tubular structures having lumens. Nonetheless, contraception can be provided by disrupting the normal architecture and/or function of the fallopian tube, despite the presence of an open lumen. This concept is referred to herein as “functional occlusion”. As used herein, a device which provides functional occlusion means that the device, when implanted in the fallopian tube, disrupts the normal architecture and/or functioning of the fallopian tube so as to inhibit fertilization and/or conception.
• The size of an occlusive device required to provide functional occlusion may depend on the material of the device, the position the device is to be deployed within the fallopian tube, the interaction between the device and the surrounding tubal wall, and the like. For example, intrafallopian contraceptive structures which include fibers of polyester may incite ingrowth of the tubal tissues into the device. As a result of this tissue/device interaction, a relatively small device which promotes ingrowth may be capable of providing effective occlusion. In fact, such a device may be capable of providing total occlusion by inciting sufficient ingrowth so that the hyperplastic tubal walls, in combination with the device, block all passage through the tubal lumen. Hence, relatively small, easily inserted structures may effectively inhibit conception without the danger of distending the tubal wall.
• One easily inserted intrafallopian contraceptive structure which may be capable of providing effective tubal occlusion is illustrated inFIG. 11A. A straightcontraceptive device200 includes a straightprimary coil202 around which is disposed a secondaryhelical coil204 as described above.Secondary coil204 is affixed toprimary coil202 at a pair ofbonds206. As illustrated above inFIG. 6, the secondary helical coil may have an inner surface which is larger than the outer surface ofprimary coil202, which may facilitate embedding the corners of the secondary coil in the surrounding tubular wall. However, unlike the intrafallopian devices described hereinabove,straight device200 remains substantially straight between aproximal end208 and adistal end210 when the primary coil is at rest.
• Primary coil202 will typically be formed from wire having a diameter of between about 0.002 and 0.009 inches, by winding the wire to form a coil having a diameter between about 0.010 and 0.040 inches.Primary coil202 will often have a length of between 2.9 and 3.5 cm. The ribbon used to form secondaryhelical coil204 will generally have a width between about 0.005 and 0.020 inches, and a thickness of between about 0.0005 and 0.005 inches.
• In the exemplary embodiment,straight device200 includes aprimary coil202 having a total length of between about 3.0 and 3.35 cm. The exemplaryprimary coil202 is wound from platinum wire, the platinum wire having a thickness of 0.005 inches, which is wound to provide a primary coil having an outer diameter of about 0.018 inches and a length of about 3.0 cm.Secondary coil204 is formed from a platinum ribbon having a width of 0.012 inches and a thickness of 0.002 inches.Bonds206 comprise gold solder andsecondary coil204 has a length of about 0.5 to 1.0 cm and an outer diameter of between about 0.035 to 0.040 inches when affixed to theprimary coil202. Solder is also used to form an atraumatic tip atdistal end210.
• Referring now toFIGS. 11B and 11C, a self-guidingcontraceptive delivery system212 includes straightcontraceptive device200 and aflexible tip corewire214. As described above,threads216 onflexible tip corewire214 mate with theproximal end208 of straightcontraceptive device200, the threads ideally comprising a stainless steel coil having approximately the same dimensions asprimary coil202 and affixed to the corewire with yet anothergold solderjoint206.
• Advantageously,distal end218 ofcorewire214 need not have sufficient stiffness and strength to restrain a coil biased to form a bent secondary shape. As a result, the thickness ofcorewire214 may be optimized to enhance the trackability and pushability of self-guidedcontraceptive system212, thereby enhancing the ability of the contraceptive system to act as its own guidewire.
• Delivery of the contraceptive device is facilitated by using a corewire having a relatively long, stiff proximal section and a relatively short, flexible section, the flexible section typically being tapered as illustrated. The thickness and material properties of these sections are selected to provide enough column strength to allowcorewire214 to advancestraight device200 within the fallopian tube, but enough flexibility at the distal end of the delivery system fordistal end210 to navigate the tortuous fallopian tube. A relatively thick proximal section also improves the torque transmission capabilities of the wire, particularly for torquing and embedding the outer coil against the tubal wall.
• Proximal section220 ofcorewire214 will preferably be flexible enough for delivery through a flexible catheter and/or through the working channel of an endoscope. The corewire will generally comprise a material which resists kinking and resiliently returns to its original shape, ideally comprising a shape memory alloy such as Nitinol® or a treated stainless steel. Such resilience may be tailored to enhance the ability of the delivery system to access the tubal ostium and advance the contraceptive device into the fallopian tube. In some embodiments, corewire214 will be capable of transmitting heat, electrical current, and/or some other energy which induces scarring, electrocautery, or the like, so as to attach the contraceptive device within the fallopian tube. Alternatively, the transmitted energy may decouple the device from the corewire, for example, by melting a coupler.
• In a particularly advantageous aspect,threads216 ofdelivery system200 may be adapted to enhance visualization of the detachment process. For example, a first portion of thethreads222 may be a first color (such as green) while a second portion of thethreads224 may be a second color which contrasts sharply with the first color (such as red). As they are near the proximal end of the device,threads216 will often be more visible than the remainder of the contraceptive device. The threads may even protrude through the tubal os into the uterus for viewing through the hysteroscope. By visually monitoring highly contrasting colors of the thread portions through the hysteroscope, the attending physician will be provided with direct feedback on the decoupling process. The thread portions may be colored by coating, anodizing, oxidation, polishing, the use of differing materials, or the like. A stripe or other mark may also be provided on the delivery wire to help monitor rotation. Alternative embodiments may use threads having high contrast under imaging.
• Still further capabilities may be incorporated into the delivery system. For example, a “smart” delivery device may be able to sense its position within the fallopian tube magnetically, electrically, optically, ultrasonically, or the like. Similarly, the deployed device may incorporate structures which allow the physician to remotely verify the position and presence of the device without having to access the fallopian tube (e.g., using a magnetic sensor, impedance, and/or radio activity).
• In the exemplary embodiment, corewire214 comprises a shape memory alloy such as Nitinol®.Proximal portion220 ofcorewire214 has a thickness of between about 0.018 and 0.040 inches, ideally being about 0.035 cm, and the corewire tapers over a length of about 5.0 cm to a minimum thickness of between about 0.002 and 0.008 inches, typically about 0.003 inches atdistal end218.
• One method for attachingpolyester fibers226 to straightcontraceptive device200 is illustrated inFIG. 11D. As described above, such polyester fibers promote tissue ingrowth, which can help affix the device within the fallopian tube. Additionally, such tissue ingrowth may also help to further occlude the lumen of the fallopian tube.Fibers226 are shown tied in loops around the secondary coil, ideally using between about 5 and 7 loops and fiber.
• A wide variety of alternative mechanisms may be employed to incite a tissue reaction which enhances the functional occlusion of the intrafallopian contraceptive device. For example, materials such as collagen, hydroxyapatite, solid or fibrous PTFE, or the like may be used. Biodegradable coatings may cause tissue ingrowth or scarring, and then degrade to leave a fully or partially occluded lumen. In some embodiments, the engagement betweenouter coil204 and the tubal wall injures the epithelial tissues, and the healing process results in the formation of scar tissues which interfere with the functioning of the fallopian tube.
• A variety of alternative ingrowth promoting intrafallopian contraceptive devices are illustrated in FIGS.12A-E. Generally, each of these devices includes some element which promotes ingrowth of tubal tissues therein. A poroussecondary coil230 may be formed of a porous metal, ideally comprising a micro-porous shape memory alloy such as Nitinol®. In some embodiments,ingrowth bonds232 may be formed of, or coated with, a material such as bioglass, ceramics, or the like so as to promote tissue ingrowth, so that the entire device may promote ingrowth. Surface treatments may also encourage ingrowth. For example, blasting a surface with small particulates can create a somewhat divoted and porous texture. Such porous textures at the surface, with micron-sized pores, may produce the desired tissue reaction. Alternative embodiments may include an open cell ingrowth promoting structure, such as the open cell foams used to attach some breast implants.
• In some embodiments,discrete bodies234 may be formed as rings or annular beads using any of the above listed tissue ingrowth materials, coatings, or treatments. Wound, wrapped, or braidedfiber material236 may also be disposed between the primary and secondary coils, the fiber material typically comprising a polyester such as Dacron®, Vicril®, or the like. Dense fiber materials within the device may enhance the reaction and/or ingrowth of the surrounding tubal tissues, and also decreases the amount of open space within the device, thereby minimizing any prosthetic lumen.Fiber material236 may also be in the form of a thick felt, or may simply be spun with several layers of windings.
• Still farther alternative ingrowth promoting elements are possible, such astubular fabric238 of felt, braided or woven material, or the like.Tubular fabric238 provides an open conduit at the proximal end of the device to avoid impeding with the removal of the corewire, and the outer diameter of the tubular fabric will preferably be less than the outer diameter of the secondary coil. In some embodiments, simply providing aninternal fabric240 in the form of a textile mesh or felt inside the primary coil may be sufficient to incite ingrowth of the tubal tissues into the coil, affixing the coil in place and providing functional occlusion of the fallopian tube.
• Referring now toFIG. 13, a particularly advantageous method for producing a contraceptive device having adense fiber braid250 is illustrated.Dense fiber braid250 is initially formed by wrapping several layers of fiber around a mandrel. After about fifteen layers of fiber have been wrapped over the mandrel, the wound fiber is slid off the mandrel, and the windings are processed to form the braid. The braid is affixed tocontraceptive device200 adjacent one of the bonds, and the fiber braid is then wound between the windings ofsecondary coil204. As a result, at least a portion offiber tube250 is disposed in the annular space between the primary coil andsecondary coil204. Often times, some portion of the fiber will also extend radially beyondsecondary coil204, as illustrated.
• The use ofdense fiber braid250 provides a much greater amount of fiber and a more radially compact, easily deployable assembly than a structure which includes loops tied radially around the secondary coil. Such densely packed fiber thereby makes use of an otherwise open space, and the enhanced amount of fiber should provoke a more robust tissue reaction. Specifically,dense fiber braid250 will have a smaller pore size, which is generally advantageous for tissue ingrowth. This combination of an enhanced tissue reaction, with a less axially open design, would appear to provide significant advantages for functional occlusion of the fallopian tube.
• A still further alternative intrafallopiancontraceptive device200′ is illustrated inFIG. 14.Alternative device200′ includes several of the same primary structures described hereinabove regarding straightcontraceptive device200, but makes use of afiber tube252 to provide the advantages of high fiber density and a small radial package. In this embodiment, the fiber is again wrapped around a mandrel several times (ideally about 15 times) and then removed as a fiber tube.Tube252 is slid off the mandrel and onto the primary coil. The tube may be positioned before or aftersecondary coil204 is attached atbond206, and will generally occupy the annular space between the primary and secondary coils. The ends oftube252 can be tied to keep the tube in position during delivery.
• Alternativecontraceptive device200′ also differs from the previous structures in thatsecondary coil204 has afree end254 which is not affixed toprimary coil202. Asfree end254 can move relative toprimary coil200,secondary coil204 can expand radially well beyondbond206, and can also be radially compressed to provide a very small outer diameter during delivery of the device. Hence, the diameter ofsecondary coil204 inalternative device200′ provides a highly radially variable tubular structure which can easily adapt to a wide variety of tubal lumen cross-sectional sizes to retain the contraceptive device within the fallopian tube.
• A highly radially expandable tubular retention structure has several significant advantages. First, the structure can be inserted in a narrow profile configuration and radially expanded within the fallopian tube to provide a secure anchor with minimal danger of protruding through the delicate tubal wall. Additionally, the stiffness of the helical secondary coil can be tailored to provide the appropriate engagement force and/or damage to the wall tissue so as to provoke the desired tissue reaction, whether it be scar tissue formation, ingrowth, or the like. Torquing of a free ended helical coil may also be used to adjust the outer diameter during delivery.
• The enhanced variability in outer diameter provided by anouter coil204 having afree end254 can be understood with reference to FIGS.14A-C. Generally,outer coil204 will here have an outer diameter of over about 0.080 mm in its relaxed state, the outer diameter of the secondary coil preferably being biased to form a helix with an outer diameter of about 1.0 mm when at rest, and will ideally be compressible to an outer diameter of 0.1 mm for insertion.Outer coil204 ofalternative device200′ may be easily radially compressed by drawingfree end254 proximally away frombond206, by wrapping the free end aroundprimary coil202, or by some combination of both.
• As illustrated inFIGS. 14B and C, the device may be restrained in a small diameter configuration by adelivery catheter256, byarticulatable jaws258, or the like. Regardless,secondary coil204 will generally be restrained until the device is positioned within the fallopian tube, and will then be released in situ by axially withdrawingcatheter256, articulatingjaws258, or the like. Still further alternative in situ release mechanisms are possible, such as dissolving or dissipating a crystal or electrolytic coating which radially restrains the secondary coil, a phase change in a shape memory alloy, or the like, as described above. It should be noted that the free ended secondary coil is illustrated in FIGS.14A-C without the optional dense fiber tube ofFIG. 14A for clarity. Nonetheless, the enhanced radial variability provided by a free ended helical coil (or by other perforate tubular structures) may be either used alone or combined with other tissue reaction structures described hereinabove to provide functional occlusion and contraception.
• Alternative helical retention structures are illustrated inFIGS. 14D and 14E. A taperedcoil203 may be advanced distally, either axially or by rotationally threading the device, to embed the structure into a tapering portion of the tubal wall. The device can accommodate a variety of tubal sizes, as it need only be advanced until proper engagement has been achieved. Variable stiffness along the outer coil may be provided by a coil formed with a taperingribbon207, or the like.
• Alternative structures for releasably restrainingsecondary coil204 are illustrated in FIGS.14F-H. In the embodiments ofFIGS. 14F and G, corewire152 is rotationally coupled toprimary coil202, and hence to the distal portion ofsecondary coil204 by bond206 (seeFIG. 14C). Atab259 is affixed to a proximal end ofsecondary coil204, the tab preferably protruding radially inwardly from the coil, the tab ideally comprising a small diameter annulus or collar having an axis parallel to the secondary coil axis.Tab259 is releasably received by akeyhole slot257 indelivery catheter256. The tab is axially restrained in the slot when the tab engages one side of the slot, but is free to slide axially from the slot when rotationally disengaged or pressed against the other side.
• Prior to delivery,secondary coil204 is restrained in a small diameter configuration by engagement betweentab259 andslot257.Secondary coil204 is tightly wound down, so that the secondary coil biases the tab toward the restrained position. The proximal portions of the corewire and delivery catheter can be rotationally affixed to each other (ideally by a Tohey-Borst valve) to restrain the device in the small configuration. This may also prevent distal movement of the contraceptive device from the catheter and corewire.
• Once the device is positioned, allowing the proximal portions of the corewire and catheter to rotate relative to each other (by releasing the Tohey-Borst valve or the like), and/or actively rotating one of these structures, can unwind the secondary coil and allowtab259 to slide axially free of the catheter. Optionally, as shown inFIG. 14G, analternative keyhole slot263 having an angled or radiused proximal surface may be used to urgetab259 toward arelease portion261 of the slot by pushing the surface distally against the tab.
• Still further release mechanisms are possible, including the system illustrated inFIG. 14H. A proximally inwardly tapering body or brake265 is affixed toprimary coil202, and is fittingly received by a tapering receptacle at the distal end ofdelivery catheter267 when a proximal portion ofsecondary coil204 is disposed therebetween.Secondary coil204 may optionally be held in its wound-down configuration at the proximal end of the delivery system by a Tohey-Borst valve, and can be released to unwind by moving the catheter proximally relative to corewire152 (and henceprimary coil202 and body265), and/or by releasing the Tohey-Borst valve.
• The use of a tubular, radially expandable intrafallopian device, and also the significance of tissue reaction in providing functional occlusion, can be further understood with reference to FIGS.15A-D. A lumen L of a fallopian tube F is largely a potential space, much like a deflated balloon. Tubal wall W can expand around structures which are inserted into lumen L, such as aroundcatheter256 which radially restrains a free endedsecondary coil204. Hence, the size of the irregular lumenal cross-section may be measured by the diameter of a device it can accommodate.
• Work in connection with the present invention has found that fallopian tubes can vary significantly in inner lumen cross-sectional sizes. The maximum diameter of a device which a fallopian tube can accommodate at its smallest point can range anywhere from 0.2 to 1.5 mm. For devices having a fixed cross-section, relatively large diameters will make the device more difficult to deliver. However, if the device is made too small, it can be more easily ejected from the fallopian tube. While fixed cross-sectional devices may still be effective (for example, by providing a range of different device sizes), the use of a radially expandable tubular structure such as free endedhelical coil204 allows the device to compensate for the substantially anatomical differences between users.
• As generally described above,catheter256 may optionally be positioned by first accessing the fallopian tube with a guidewire, and then advancing the catheter over the positioned guidewire. Alternatively, the catheter and contraceptive device may be advanced distally using the distal end of the primary coil as a guidewire. Regardless, once the contraceptive device is positioned at the desired axial location (generally from adjacent the isthmus to the intraluminal region, but optionally anywhere from the cornual area to adjacent the distal fimbria),catheter256 is withdrawn proximally while restraining the contraceptive device axially with the proximal end ofcorewire214. Ascatheter256 is withdrawn,secondary coil204 expands radially and engages the surrounding tubal wall W, as illustrated inFIG. 15C.Secondary coil204 may optionally be torqued against the surrounding tubal wall from the proximal end ofcorewire214, after which the corewire is unthreaded from the contraceptive device and removed.
• Although the tissues of the tubal wall protrude between the windings ofsecondary coil204, a significant portion of lumen L remains open. Nonetheless, functional occlusion is provided so long as the deployed device adequately interferes with fertilization so as to inhibit conception. Functional occlusion may be enhanced by the formation of scar tissues and the growth of tissues from the tubal wall so as to occlude lumen L (ideally both inside and outside of the tubular retention structure), as illustrated inFIG. 15D. Such scar tissue formation will also aid in anchoring the device.
• As can be understood with reference toFIG. 15D andFIG. 16, open areas within the contraceptive device along the axis of fallopian tube F can present some risk of providing a passageway for fertilization. To avoid providing a prosthetic lumen defined by the inner surface ofprimary coil202 aftercorewire214 is removed, adetachable delivery wire260 is formed in two pieces.Distal delivery wire264 is coupled toproximal delivery wire262 by a threadedfastener266.Fastener266 provides column strength to the detachable delivery wire. This allows the distal portion of the delivery wire to remain within the primary coil when the contraceptive device is detached. Clearly, a wide variety of coupling mechanisms might be used. Advantageously, a threaded coupler allows the device to be torqued in one direction and detached by rotating theproximal delivery wire262 in the other direction, generally as described above.
• The use of primary coil202 (in combination with corewire214) as a guidewire can be understood with reference toFIG. 15E. The good proximal column strength of the corewire and the distally increasing flexibility of the combined corewire and primary coil at the distal end of the delivery device greatly facilitates axially advancing the device within fallopian tube F. The ability of thecorewire214 to transmit torque can also help advance the delivery system distally, as well as allowing the user to embedsecondary coil204 into the surrounding tubal wall. As can also be understood with reference toFIG. 15E, the use of a straight primary coil in a portion of the fallopian tube having significant axial curvature results in resilient engagement of the coil against the tubal wall, and can thereby provide anchoring similar to that described above for pre-bent coils in straight lumens.
• Referring now toFIG. 17, akit300 includes contraceptive system212 (in which straightcontraceptive device200 is mounted on corewire214) within asterile package302. Also included inkit300 areinstructions304, the sterile package and instructions being disposed inpackaging306. The instructions may set forth any of the method steps for using a contraceptive system as described hereinabove.Delivery system212 may be protected by aprotective sheath308, and other system components described hereinabove may also be included. Also visible inFIG. 17 is the proximal torquable handle310 of the delivery system.
• Instructions304 will often comprise printed material, and may be found in whole or in-part onpackaging306 orsterile packaging302. Alternatively,instructions304 may be in the form of a recording disk or other computer readable data, a video tape, a sound recording, or the-like.
• Alternative radially expandable retention structures are illustrated inFIGS. 18A through C. A slottedtube retention structure320 can shorten and expand within the fallopian tube. In general, such expansion may be the result of external forces (such as actuation of a two part delivery system322), or the retention structure may self-expand when released in situ. Forcibly expanded retention structures may have a latching mechanism which prevents collapse when the device is detached from the delivery system in the fallopian tube, and such detachment may be effected by any of the mechanisms described hereinabove.
• Still further alternative retention structures may be used in place of helicalsecondary coil204 and slottedtube320. For example, aMalecott retention structure324 or a braidedfilament retention structure326 might be expanded to engage a surrounding tubal wall. In some cases, tubal anchoring may be enhanced by including two or more retention structures, or by providing small barbs which extend axially and/or radially from the expanded retention structure to prevent axial migration. Preferably, such barbs would be too short to perforate through the tubal wall. A wide variety of alternative radially expansible structures which might be adapted for use as a retaining structure in the present intrafallopian contraceptive device are described with reference to vascular stents.
• An intrafallopian device having a retaining structure comprising a shape memory alloy is illustrated inFIGS. 19A and B. In general, the system applies energy to the contraceptive device so that the device expands from a low profile (for delivery) to a deployed profile so as to hold the device in place. The device may be heated by transmitting current along two electrically isolated conductors toprimary coil202.Corewire152 here has an insulatinglayer271 and is coupled to a first portion of the coil, while aconductor269 indelivery catheter256 is coupled to another portion of the coil. The resistance of the coil to a small current is sufficient to heat and reconfigure the retaining structure. Electrical energy from a common 9-volt hand-held battery within energy source will be sufficient to reconfiguresecondary coil204, which will generally remain in the deployed configuration at body temperature. Alternative energizing systems may use heated saline or the like.
• As described above, copper may enhance the efficacy of an intrafallopiancontraceptive device400. A1 illustrated inFIGS. 20A and B, a copper body (for example, in the form of copper coil402) may extend proximally into and/or through the utero-tubal junction from the fallopian tube. As can be seen inFIGS. 21A and C, the copper may alternatively be in the form ofcopper beads404, which may be used to form bonds, ingrowth structures, or the like. The copper may be in the form of aplating406 over acore material408 for use in the primary coil, secondary coil, or the like.
• The release rate of copper is often closely related to the surface area of copper on the device. A total copper surface area over 100 mm2, and most often in a range from about 300 mm2 to about 400 mm2 will be preferred to provide contraception.
• The total volume of copper will affect the duration of the enhanced efficacy the copper provides. To provide lifelong contraception, we should provide sufficient copper for about 25 years (based on the fertility life of a woman). For an exposed copper surface area of 400 mm2, average copper release rates may be about 25 micrograms per day, based on intrauterine device studies. To allow our intrafallopian contraceptive devices to release copper at this rate for 25 years, we will preferably include at least 0.23 grams or 25.6 mm3 of total copper. To provide a reasonable safety factor, a 25-year device may include at least about 0.34 grams or 38.4 mm2 of copper volume. These quantities may be provided by each device, or by two devices (in the left and right fallopian tubes) in combination. Similar calculations may be performed for 5-year devices (using the same exposed area and at least ⅕ of the above volume), or to adjust for differing release/areal efficacy resulting from the copper structures being carried in different regions of the fallopian tubes.
• In conclusion, the present invention provides a contraceptive intrafallopian device which may be positioned without surgery. While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. For example, a wide variety of secondary shapes, including open loops, continuous bends, sinusoidal curves, or the like, may be imposed on the primary coil. Additionally, aspects of these intrafallopian contraceptive devices which are described separately may often be combined (for example, a self-guiding device may also promote ingrowth to affix the device in the fallopian tube). Therefore, the above description should not be taken as limiting the scope of the invention, which is defined instead solely by the appended claims.

Claims (35)

1. A contraceptive device, comprising a tubular body in a first radially restrained configuration having a first outer diameter, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger outer diameter than the first configuration to engage a wall of said lumen, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.

2. The contraceptive device ofclaim 1 wherein the tubular body is formed of a helical wire.

3. The contraceptive device ofclaim 1 wherein the tubular body is formed of a helical coil.

4. The contraceptive device ofclaim 1 wherein the tubular body has an open proximal end and an open distal end.

5. The contraceptive device ofclaim 1 wherein the tubular body is enlarged at least partially by self-enlarging.

6. The contraceptive device ofclaim 1 wherein the tubular body is formed at least in part of a nickel-titanium alloy.

7. The contraceptive device ofclaim 1 wherein the tubular body in the second configuration is restrained by the patient's reproductive lumen, whereby the tubular body substantially conforms to inner transverse dimensions of the patient's reproductive lumen at an expansion site therein.

8. The contraceptive device ofclaim 1 wherein the tubular body is configured at least in part to retain the second configuration for sufficient time for tissue to grow into and around at least a portion of the tubular body.

9. The contraceptive device ofclaim 1 wherein the tubular body is configured to be restrained by the patient's reproductive lumen in the second configuration and thereby substantially conform to the inner transverse dimensions of the patient's reproductive lumen and to at least in part retain substantially the second configuration for sufficient time for tissue to grow into and around at least a portion of the tubular body.

10. The contraceptive device ofclaim 1 wherein the enlarging of the tubular body to the second configuration secures at least a portion of the tubular body at an expansion site within the patient's reproductive lumen.

11. The contraceptive device ofclaim 1 wherein at least part of the tubular body is configured to be retained in the second configuration.

12. The contraceptive device ofclaim 1 wherein tissue growth facilitates substantial occlusion of the patient's reproductive lumen.

13. The contraceptive device ofclaim 1 wherein the member at least partially within the tubular body promotes tissue growth and is substantially formed of copper.

14. The contraceptive device ofclaim 1 wherein contraception is aided by a contraceptive agent.

15. The contraceptive device ofclaim 14 wherein the contraceptive agent is copper.

16. A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body in a first radially restrained configuration having a first outer diameter, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger outer diameter than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body from the first radially restrained configuration having the first outer diameter to the second configuration having the second, larger outer diameter which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.

17. The method ofclaim 16 wherein the step of inserting at least a portion of the contraceptive device within the patient's reproductive lumen further comprises using a catheter to introduce at least the portion of the contraceptive device into the patient's reproductive lumen.

18. The method ofclaim 16 wherein the tubular body is formed of a helical wire.

19. The method ofclaim 16 wherein the tubular body is formed of a helical coil.

20. The method ofclaim 16 wherein the tubular body has an open proximal end and an open distal end.

21. The method ofclaim 16 wherein the tubular body is enlarged at least partially by self-enlarging.

22. The method ofclaim 16 wherein the tubular body is formed at least in part of a nickel-titanium alloy.

23. The method ofclaim 16 wherein the tubular body is configured at least in part to retain the second configuration for sufficient time for tissue to grow into and around at least a portion of the tubular body.

24. The method ofclaim 16 wherein the enlarging of the tubular body to the second configuration secures at least a portion of the tubular body at an expansion site within the patient's reproductive lumen.

25. The method ofclaim 16 wherein at least part of the tubular body is configured to be retained in the second configuration.

26. The method ofclaim 16 wherein tissue growth facilitates substantial occlusion of the patient's reproductive lumen.

27. The method ofclaim 16 wherein the member at least partially within the tubular body promotes tissue growth and is substantially formed of copper.

28. The method ofclaim 16 wherein contraception is aided by a contraceptive agent.

29. The method ofclaim 28 wherein the contraceptive agent is copper.

30. A contraceptive device, comprising a tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from a first configuration to a second configuration having larger transverse dimensions than the first configuration to engage a wall of said lumen, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.

31. A contraceptive device, comprising a tubular body in a first radially restrained configuration having a first cross-section, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger cross-section than the first configuration to engage a wall of said lumen, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.

32. A contraceptive device, comprising a tubular body in a first radially restrained configuration having a longitudinal axis, said tubular body at least in part configured to enlarge in a direction transverse to the longitudinal axis within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having larger transverse dimensions than the first configuration, which has an open framework in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient's reproductive system lumen, which has at least one open end and which has a member at least partially within an interior portion thereof configured for tissue growth.

33. A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from a first configuration to a second configuration having larger transverse dimensions than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body from the first configuration to the second configuration having larger transverse dimensions than the first configuration which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.

34. A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body in a first radially restrained configuration having a first cross-section, said tubular body at least in part configured to enlarge within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having a second, larger cross-section than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body from the first radially restrained configuration having the first cross-section to the second configuration having the second, larger cross-section which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.

35. A method of human contraception comprising: a) providing a contraceptive device comprising a tubular body in a first radially restrained configuration having a longitudinal axis, said tubular body at least in part configured to enlarge in a direction transverse to the longitudinal axis within a lumen of a patient's reproductive system from said first radially restrained configuration to a second configuration having larger transverse dimensions than the first configuration to facilitate securing a least a portion of the enlarged tubular body to a wall portion defining at least in part the patient's reproductive lumen, which has at least one open end and which has an open framework in the enlarged configuration facilitating ingrowth of tissue cells and which has a member which is configured for tissue growth disposed at least partially within the tubular body; b) inserting within the lumen of a patient's reproductive system at least a portion of the contraceptive device including at least part of the tubular body; and c) within a region of the patient's reproductive lumen, enlarging at least a portion of the tubular body in a direction transverse to the longitudinal axis from the first radially restrained configuration to a second configuration having larger transverse dimensions than the first configuration which is restrained by the patient's reproductive lumen and thereby substantially conforms to inner transverse dimensions of the patient's reproductive lumen in the region where the tubular body is enlarged and which facilitates tissue growth that at least in part surrounds the enlarged tubular body within the patient's reproductive lumen to substantially occlude the patient's reproductive lumen.

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