Deployment actuation system for intrafallopian contraception

The The present invention relates generally to medical devices and systems. In a particular embodiment, the invention provides temporary or permanent intrauterale contraceptive devices and -Verabreichungssysteme.

Although the theoretical level of effectiveness of current non-surgical contraceptive techniques including Barrier methods and hormonal therapies is well founded, the actual Effectiveness of the most conventional methods disappointing. One reason for this disappointing Results is that many of the currently available methods of contraception without surgery of a high involvement of users individual depends. An infringement leads generally to high failure rates, with the overcoming the infringement of the users individual to the overall effectiveness improve, has proven to be quite difficult.

A Form of Langzeitkontrazeption that of an infringement Users individual less susceptible is the intrauterine device is (intrautine device, IUD). It was found that IUDs higher reliability rates exhibit and for a longer Period than most contraceptives commercially available effective are. Unfortunately, IUDs are also associated with serious infectious complications. For this reason, the use of IUDs in the United States declined sharply. In addition, IUDs are an unplanned expulsion and subjected to due to excessive pain or bleeding in a large Percentage of cases removed, thus further the acceptance of the IUD as a method of contraception reduced.

in the available commercial options permanent sterilization include ligation and vasectomy the oviduct. These methods are surgical and for many People not available in the world. It is common knowledge that fertilization in the oviducts occurs when sperm and egg come together.

A Tubal ligation avoids this by surgical and complete occlusion the fallopian tubes.

at work performed in connection with the present invention earlier been proposed, an elastic coil transcervical in a introduce fallopian tubes, order to this way of conceiving to prevent. WO-A-99/15116, transferred to the assignee, describes devices in transcervical introduced a tubal ostium be and mechanically anchored in the fallopian tube. The devices described can a network ingrown tissue promote a long-term contraception and / or effecting permanent sterilization without surgery requiring, and should result in increased blood flow, greater pain and an infection associated with intrauterine devices avoid.

Although the recently Time proposed intrauteralen contraceptive devices a substantial progress in this area represent, would further Improvements desirable. General should not improved surgical devices, Systems and procedures are in place to prevent pregnancy. It would be beneficial if these improved techniques, the ease, speed, and the reliability, with which these contraceptive devices could be used or developed, would increase. It would be further benefit if these improved access and deployment techniques could be safely and effectively used without several assistants and if they do not require expensive medical equipment so they are implemented by medical personnel in a clinic could. Some or all of these advantages are described by the below Device materializes.

The Invention is set out in Claim first

The present invention generally provides improved medical Devices and systems. The techniques of the present invention are particularly useful for the Increase the ease, speed and reliability, with the contraceptive devices in an ostium of a transcervical oviduct can be used. The invention provides intrauterale contraceptive systems with a Handle, which is capable of medical personnel with a Hand handled and operated to become. Generally contains the handle at least one actuating element, that with the same hand used to grip the handle is, can be handled. In many embodiments, a physician or a medical assistant the contraceptive device by Handling of the handle moving into an ostium of a fallopian tube forward, wrapping deduct from the contraceptive device, the contraceptive device from a training with small profile to training with great stretch profile and / or the expanded contraceptive device from dissolve the remaining components of the contraceptive system, and all this idealennreise with one hand. Advantageously, this leaves free to grab the other hand to a hysteroscope and handle, what the doctor or medical assistant orienting the system in the direction of Tubenostiums and effecting its Entfal<?page 3?>tion under optical observation and checking the unfolding enables instead of two on coordinating the efforts of various Persons to reach the target site and the contraceptive device to employ, to leave. The Deployment may alternatively under different manner the imaging including Ultrasound and fluoroscopy, or possibly even with tactile guide be steered. Also a mechanical coupling of the various elongated Deployment components to a common proximal housing a Uncertainty as to which Component is to be moved and which in a fixed position is to be maintained to avoid. Consequently, the invention facilitates the use or deployment intrauteraler contraceptive devices before a broad medical background.

In a first embodiment the invention provides with a contraceptive delivery system a contraceptive device that small of a training with Profile to training large profile is expandable. The contraceptive device in the small configuration is in a usable ostium of a fallopian tube. A first elongate body has a proximal end and a distal end, with a receptacle adjacent to the distal End is located. The recording takes contraceptive device solvable on. At the proximal end of the first elongate body is a proximal handle arranged. The handle has a size and shape for gripping are suitable with a single hand. On the handle is at least an actuator appropriate. The actuator may by hand, while it grips the handle, are moved to the contraceptive device to the training with great stretch profile and the contraceptive device within the ostium to fix the oviduct.

The Contraceptive delivery system further comprises an enclosure with a lumen which receives the recording slidably, so that movement of the at least one actuator wrapping withdrawing proximally from the contraceptive device. This arrangement allows the Physician or the medical assistant maintaining the position the contraceptive device by the handle with the same Hand, the effort to move the actuating element is used, which maintains in a fixed position. This can free the other hand to to guide the hysteroscope, the often is used to direct the deployment procedure optically.

The System includes frequently means for the not after stripping the sheath expansion covered contraceptive device. The expansion means is often coupled to the contraceptive device, and, by the actuating element actuated will. Separating at least a portion of the Ausdehn- and Umhüllungsabziehmechanismus can help to avoid that resulting from elastic stretch staff on the envelope act that hinder the movement of the envelope and make it difficult could, the contraceptive device while to position its development closely. Although various expansion devices may be provided (Such as inflatable balloons and fluid lumens for plastically deforming a stent-like Structure or the like), the preferred expansion means a second elongate Body, the relative to the first elongate body moved to cause the expansion of the contraceptive device after wrapping has been subtracted. In the exemplary embodiment the first hold and the second elongate body a resilient outer helical coil the contraceptive device back, by maintaining a torque until the at least one actuator the second elongate body emotional.

In some embodiments moving a first movement of a dual-function actuator relative to the handle, the sheath relative to the first elongate Body, without the second elongate body relative to the first elongate body to move. A second movement of the dual-function actuator after the first movement moves the second elongate body relative to the first elongated Body. Optionally, a latch, the movement of the second elongate body relative to the first elongate body solvable reside. As the first elongate body the Contraceptive device frequently releasably holding, may this apparatus during the hold at least a portion of the deployment procedure at the destination. Of the first elongate body may be connected to the contraceptive device in a screw- and by the contraceptive device by turning the handle or a decoupling actuator be decoupled.

It should also a contraceptive delivery system is disclosed that a contraceptive device includes that small of a training profile to training great is expandable profile. The contraceptive device in the small training is insertable into an ostium of a fallopian tube. A first elongate body has a proximal end and a distal end. Recording is fitting disposed at the distal end of the first elongate body. recording takes the contraceptive device to releasably. A serving has a lumen at least a portion of the contraceptive device slidably receives. A second<?page 4?>elongated body extending proximally from the contraceptive device to a proximal end. At the proximal end of the first elongate body, a handle is arranged. The handle has at least one actuating element, wherein a first movement of the at least one control element, the sheath proximally subtracting from the contraceptive device. A second movement of the least an actuating element moves the second elongate body relative to the first elongate Body, around the contraceptive device to the large profile education extend.

It should also a medical device is disclosed that an elongated Füh cing structure includes having a proximal end and a distal end. The management structure is laterally flexible and increases toward the distal end of elasticity, so that the management structure suitable for distal tracking a body lumen. In near the proximal end of the guide structure secured a proximal handle. The handle has a Slot, the management structure, the near the distal end side receives. A locking device can the management structure hold back in the slot, to facilitate the insertion the distal portion into a lumen to facilitate.

On Operationsvertahren involves inserting a transcervical Contraceptive device in an ostium of a fallopian tube by a medical assistant with one hand grasping a handle and the hand moves. The handle is through an elongate body coupled to the contraceptive device. Introduced contraceptive device is extended by an actuator on the handle, while the hand gripping the handle is moved. The expanded contraceptive device is of the elongate body solved so that the contraceptive device prevents conception.

in the Generally handles the doctor or medical assistant with the other hand, a hysteroscope to the contraceptive device, while he using the hysteroscope, an image of the ostium sees toward to orient the ostium. This allows the doctor or medical Assistant simultaneous handling of these two components of the contraceptive delivery system, which is a comprehensive coordination Needless between two people.

SUMMARY THE DRAWING

<figref idrefs="S40">1</figref> shows the uterine and tubal anatomy for the deployment of the contraceptive devices of the present invention.

<figref idrefs="S41">1A</figref> shows schematically process steps for an exemplary contraceptive device deployment method.

<figref idrefs="S42">1B</figref> is a partially cutaway side view of a contraceptive system according to the principles of the present invention,

<figref idrefs="S43">2</figref> is a side view of a removable core wire of the contraceptive system of <figref idrefs="S42">1B</figref>,

<figref idrefs="S43">3</figref> is a contraceptive device of the contraceptive system of <figref idrefs="S42">1B</figref>. in which an outer helical coil in an education major Profile is.

<figref idrefs="S43">3A</figref> is an end view of the contraceptive device from <figref idrefs="S43">3</figref>,

<figref idrefs="S44">3B</figref> shows a contraceptive device having a tubular band for smoothly releasing a release pin a release catheter.

<figref idrefs="S43">4</figref> is a lateral cross section of a distal end of a delivery catheter of the contraceptive system of <figref idrefs="S42">1B</figref>,

<figref idrefs="S43">4A</figref> is an axial cross-sectional view of the delivery catheter of <figref idrefs="S43">4</figref>,

<figref idrefs="S45">5</figref> is a side cross-sectional view of an outer sheath of the delivery system from <figref idrefs="S42">1B</figref>,

The <figref idrefs="S44">5A</figref>-<figref idrefs="S44">5F</figref> show wrappings with positioning surfaces for axially positioning the contraceptive device relative the tubal ostium.

<figref idrefs="S45">6</figref> is a partial, cut-away view, the engagement between the the outer helical coil the contraceptive device and the release catheter to the wind-down torque on the outer helical coil maintain.

<figref idrefs="S45">7</figref> is a perspective view of the proximal handle of the contraceptive system of <figref idrefs="S42">1B</figref>,

The <figref idrefs="S46">8A</figref> and <figref idrefs="S46">8B</figref> show a syringe-like Handle for use with the contraceptive system of <figref idrefs="S42">1B</figref>,

The <figref idrefs="S47">9A</figref> and <figref idrefs="S47">9B</figref> show another alternative a pistol grip-like handle for use with the contraceptive system of <figref idrefs="S42">1B</figref>,

<figref idrefs="S48">10</figref> is a perspective view of egg&lt;?page 5?&gt;nes preferred proximal handle of the contraceptive system of <figref idrefs="S42">1B</figref> With a thumbwheel, a latch and a knob for exposing, Stretching and triggering the contraceptive device at the destination.

<figref idrefs="S49">11</figref> is a perspective view of an alternate handle with inline slider for use with the contraceptive system of <figref idrefs="S42">1B</figref>,

The <figref idrefs="S49">11A</figref> to <figref idrefs="S59">11K</figref> show schematically illustrates a method for deploying a contraceptive device using the system from <figref idrefs="S42">1B</figref>,

The <figref idrefs="S60">12A</figref> and <figref idrefs="S60">12B</figref> are lateral and axial end views showing the use of a recess in the handle to facilitate insertion of the guidewire-like distal end of the contraceptive delivery system show in a lumen such as the working lumen of a hysteroscope.

<figref idrefs="S61">13</figref> shows an alternative deployment method using an alternative Imaging system.

The <figref idrefs="S62">14A</figref> and <figref idrefs="S63">14B</figref> show a deployment system having a sleeve disposed around the outer sheath , and the use of the sleeve for preventing inadvertent movement of the contraceptive device when pulling the sheath.

<figref idrefs="S64">15</figref> shows schematically shows a side view of alternative distal components for a Contraceptive system.

<figref idrefs="S64">16</figref> shows an alternative coupling structure at a proximal end of an outer helical coil, the alternative to the contraceptive Sys tem of <figref idrefs="S48">10</figref> is used.

<figref idrefs="S64">17</figref> shows schematically illustrates a contraceptive system having a separate positioning catheter, slidably over the envelope is arranged, wherein the positioning catheter having a positioning surface, that supports the axial positioning of the contraceptive device.

<figref idrefs="S65">18</figref> shows a method for using the positioning surface of a wrapping or positioning catheter to assist in axially positioning the contraceptive device.

<figref idrefs="S65">19</figref> shows schematically shows a side view of a contraceptive system, the Axial coupling of the positioning catheter to the contraceptive device shows.

<figref idrefs="S66">20</figref> shows schematically illustrates a lateral cross section of an alternative outer sheath of the Contraceptive system of <figref idrefs="S42">1B</figref>,

<figref idrefs="S66">21</figref> shows schematically an alternative proximal handle of the contraceptive system.

DESCRIPTION THE SPECIFIC EMBODIMENTS

The present invention provides a contraceptive device, a Contraceptive system and a contraceptive methods that typically pregnancy prevention, is used for long-term contraception and often a permanent birth or Sterilization effect. By introducing at least a portion these contraceptive devices into an ostium of a fallopian tube can the risk of unplanned expulsion, of lower abdominal pain and infectious Complications are significantly reduced. Although the present Invention in a group of contraceptive techniques generally be referred to as tubal occlusion procedures included can, the invention need not be advanced fully into the fallopian tube and in some embodiments, the tubal lumen not fully block to effectively disrupt fertilization. As described in co -pending WO-A-99/15116, assigned to the assignee, contraception may optionally by completely close of the tubal lumen, and / or by hinlängliches interrupting the fertilization process without complete closure be effected. In some embodiments, allows the inclusion of bioactive material such as copper to increase level of effectiveness of the devices.

If a structure of the uterus into the tubal ostium (and optionally beyond), in the transition uterotubal and / or the fallopian tube is advanced, it is said here, that a structure "in a tubal ostium "is introduced.

As in <figref idrefs="S40">1</figref> shown, access to uterus U will generally achieved through the cervix C. From within the uterus are the U Fallopian tubes F on Tubal ostia O accessible.

The Fallopian tubes F generally include three segments between the ostium O and the fimbria FIM. Beginning in the area of ​​the uterus is the U intramural segment INT of fallopian tubes F by the muscular uterine tissue surround. On uterotubal transition UJT starting the fallopian tubes F extend along an isthmic Segment ISC, and then along an ampullary segment AMP on Uterine tissue beyond. Into the peritoneal cavity

&lt;?page 6?&gt;

in the Generally, the ideal position for a intrauteralen contraceptive devices of the present invention spanning the intramural INT to isthmic ISC portion of the fallopian tube. When a radially expandable at intrauteralen contraceptive device Attachment mechanism such as an outer coil is included, it can expandable or anchored structure preferably the transition uterotubal UJT span. It should be noted that the junction UTJ uterotubare as a plane in which the fallopian tubes with the peritoneal cavity coincides, can be defined. It should also be noted that the not necessarily Isthmian narrowest portion of the fallopian tube in the Segment ISC must be arranged, particularly once the contraceptive Intrafallopian device (often a radially expandable anchoring structure includes) therein is deployed. Indeed has the work shown in connection with the present invention, that really narrowest portion of the tube at or near the transition uterotubal may be UTJ.

In <figref idrefs="S41">1A</figref> is an overview of an exemplary method <figref>2</figref> for deploying and using the Contraceptive devices of the present invention, which for the understanding selecting used in those devices structures helpful is. Of course have to Not every unfolding all steps are performed. Still wearing Meeting of the exemplary deployment method <figref>2</figref> to the understanding described below in structures.

A Identification of the anatomy and the destination, <b>3</b>, Allows the Operator to set the preferred placement of the contraceptive device in the ostium and also determining whether specific issues for a particular device placement procedure given are. The anatomy and target location identification can means various conventional Visualization types including Hysteroscopy, sonography (ultrasound), fluoroscopy, and the like be facilitated. Hence, an exemplary contraceptive device using more than one type of image forming on the be adapted to administration.

The exemplary contraceptive device may be located at preferably customize a wide variety of anatomies. Two factors contribute the importance of this variability in: First, a large observed deviation between tubal anatomies of different patients will. Second, it can be quite difficult, the specific Tubal anatomy of a particular patient to determine and identify. As a result, the preferred contraceptive device may safeguards Unite that a sufficiently accurate placement (with a tolerance opposite to a normal error of the operator) and the deviation the length Allow and the diameter of the various segments of the fallopian tube.

The exemplary deployment method <figref>2</figref> in <figref idrefs="S41">1A</figref> includes also the positioning of the device at the target location, <figref>4</figref>, In turn can be applied to a wide variety of techniques to a doctor or medical assistant when positioning the device to assist in the correct location, visualization techniques, providing high contrast Markers (such as radiopaque markers, echogenic Markings, or the like), providing tactile Specifying the placement location by including physical stops or "buffers" (obtaining the so could be, that they in such a tactile way with reference tissue engaged reach that a signal sent to the medical staff is), and the like. The device positioning can be substantially simplified by using a suitable device and / or Deployment system design having the proper flexibility, navigation characteristics, Friction reduction surfaces, provided small delivery profile, coatings and the like becomes. Again compensates for the device positioning,<figref>4</figref>. preferably anatomical deviations, a fault of the operator and difficulties in visualization so as to support a contribute accurate placement.

In the exemplary deployment method <figref>2</figref> the device in the step of by the reference numeral <figref>5</figref> is specified, deployed at the destination and / or extended. Optionally, the fixture and / or deployment system visualization and / or confirmation of Device expansion while the expansion takes place, allow.

in the Generally, the contraceptive device in step <figref>6</figref> at the Destination detached from its deployment system. Again, it is helpful for a Visualization and / or confirmation the detachment to ensure that visually, via Ultrasound, fluoroscopy can be performed or the like. Of course, a wide variety of detachment mechanisms be used to decouple the device from the deployment system.

In the exemplary method, it should be possible, the position of Device to confirm the destination, <figref>7</figref>, confirmation can in turn by visualizing at least a portion of the device after detachment, frequently using the same type of visualization such as during Placement, be made. In addition to optical visualization techniques can &lt;?page 7?&gt;this by including radiopaque markers for the fluoroscopic placement confirmation, sonographic markers for the ultrasound placement confirmation, or like happened. Optionally, along the contraceptive device<figref>2</figref> for example be provided specific marker locations to the specific specify locations of proximal and / or distal ends of the device.

The exemplary methods <figref>2</figref> further comprising a step <figref>9</figref> for the anchorage and stability of the Device at the destination. Aspects of this step include providing with visualization of the device in order to monitor their stability. Anchoring of the device at the target location, the anchoring on short-term basis (such as by using an extended helical Coil, the deviations of the tubal lumen compensates and this can customize an extended stent-like structure, an extended Braid or the like) and the long-term anchoring (as it by including a fiber network or -gitters, the tissue reaction, such as stimulating ingrowth, which fibrous tissue are created, securing the device in place in the Fallopian tube, causes can be) include. Similar preferably both short and long term stability prepared by generally to a device with the proper resiliency and shape, to a physiological movement without shifting up, adjust, is designed. The device is preferably in the wear profile balanced to lifetime of the patient for a sufficient anchor to ensure, without causing pain or stability due losing by erosion.

Of the last step in the exemplary method <figref>2</figref> from <figref idrefs="S41">1A</figref> stated is, is the effectiveness. This can by integrating a lumen / space filling design, who modifies the function and architecture of the fallopian tubes that conception prevented will be realized. This may include the use of polyester fibers lock in, to the desired stimulate tissue reaction.

in the generally, the devices of the present invention be such that by the presence of polyester fibers or the like, is triggered reaction tissue response in the fallopian tube. Ideally, Re this action as purely local, benign tissue reaction are classified. This reaction results in Incorporation of the contraceptive device into the tubal lumen tissues, so that the device firmly embedded in the surrounding tissue structure is. This reaction may be typically carried out by proliferation characterized by smooth muscle cells and associated fibrosis be. also shows the tubal lumen generally a lack of normal tubal architecture, the principle for a conception necessary is. The tubal lumen may also clogged, closed and / or by the presence of the device and an associated fibrosis sufficiently be closed to conception to prevent. The reaction is a benign reaction, wherein no change the anatomy or structure of the outer tubal wall seems to be that about over 5 to 10 mm radially from the outer coil outside the apparatus goes. Similar is a normal tubal architecture often about 5 mm axially beyond the device (typically distal of the device, because the device often extends into the uterus) visibility, and a very local Reaction indicates.

As in <figref idrefs="S42">1B</figref> is shown, an exemplary contraceptive system <figref>10</figref> in the Generally, a contraceptive device <figref>12</figref>, An enclosure <figref>14</figref>. the Kontraz surrounds eptiv device partially, a delivery catheter<figref>16</figref> and a core shaft <figref>18</figref>, The contraceptive device<figref>12</figref> has generally includes a proximal portion <figref>20</figref> in the vicinity of a proximal end <figref>22</figref> (Which are arranged in the Umhül-lung) and a distal portion <figref>24</figref> in the vicinity of a distal end <figref>26</figref> (the beyond the distal end of the sheath <figref>14</figref> exposed are). The distal portion<figref>24</figref> is used, while the system <figref>10</figref> is moved into the tubal ostium forward, generally as a distal guidewire. The proximal portion <figref>20</figref> comprises a radially expandable Structure which can be extended, after the envelope <figref>14</figref> withdrawn is to the contraceptive device in the deployed position to fix.

The wrapping <figref>14</figref> is a generally tubular structure, the distal ends <figref>28</figref> and extending proximally a proximal handle <figref>30</figref> extends. The enclosure<figref>14</figref> has in general a length in the range of about 25 to 50 cm, and typically has an outer diameter in the range from about 0.5 mm to about 1.5 mm (0.020 to about 0.060 Inches), the exemplary sheath has a length of about 39.5 cm and an outer diameter has from about 1 mm (0.04 inches). The inner diameter of the sheath<figref>14</figref> can in the range of about 0.5 mm (0.02 inch) to 1.25 mm (0.05 inches), the exemplary envelope has an inner diameter of about 0.8 mm (0.03 inches).

Of the delivery catheter <figref>16</figref> generally comprises a tube having a distal end <figref>34</figref>That with the contraceptive device <figref>12</figref> releasably Is engaged, and a proximal end, the actuating element via a <figref>33</figref> With a housing <figref>30</figref> coupled.

In the exemplary embodiment, around&lt;?page 8?&gt;summarizes the core shaft <figref>18</figref> an elastic, tapered structure, extending from within the distal portion <figref>24</figref> the contraceptive device proximal to the handle <figref>30</figref> extends. The core shaft<figref>18</figref> is proximal of the distal end <figref>28</figref> the envelope <figref>14</figref> With the contraceptive device <figref>12</figref> in Threaded engagement. In the exemplary embodiment, the transmitted core shaft<figref>18</figref> and the delivery catheter <figref>16</figref> a down spiraling torque on an expandable structure of the contraceptive device to the expandable structure in the small profile configuration to maintain. Therefore allows releasing the core shaft <figref>18</figref> relative to the release catheter <figref>16</figref> on Activating the expandable structure independent of the movement of the surrounding Wrapping.

Of the handle <figref>30</figref> has a housing <figref>31</figref> having a size and a Form suitable for grasping by a single hand are suitable. A thumb wheel actuator<figref>33</figref> met two Operating functions: First, a rotation of the thumbwheel relative to the housing attracts <figref>31</figref> the wrapping <figref>14</figref> proximally by engagement between the pinion <figref>35</figref> (The thumbwheel on is attached) and the rack <figref>37</figref> (The sheath at the <figref>14</figref> secured is). While initial of this Movement of the release catheter <figref>16</figref> through the latch <figref>39</figref> relative to the housing <figref>31</figref> retained. Once the proximal end of the rack <figref>37</figref> with a cooperating, on the delivery catheter <figref>16</figref> paved area engaged passes, the latch <figref>39</figref> be operated to allow the delivery catheter <figref>16</figref> relative moved to the housing, and the thumbwheel <figref>33</figref> again in the direction shown is rotated. may in some embodiments a feather <figref>51</figref> prior to actuation of latch <figref>39</figref> by a rotation of the thumb wheel are pressed together, so that an actuation of the Latch can slide so the delivery catheter that extend from the contraceptive device <figref>12</figref> solves. In this embodiment is a proximal end of the core shaft <figref>18</figref> secured to the housing, so that the core shaft is rotated by rotating the entire housing becomes.

The Components of the housing <figref>31</figref> and the actuators <figref>33</figref>. <figref>39</figref> consist generally made of polymers, metals or the like. The actuating mechanism contain can cast and / or machined parts and permanently to the pouch <figref>14</figref>. release catheter <figref>16</figref>, The core shaft <figref>18</figref> and like be fixed, while the remaining components of the delivery system <figref>10</figref> disposed of , once the contraceptive device <figref>12</figref> unfolded has been. Alternatively would it if desired possible, sterilizable, reusable and / or responsive delivery system components to accomplish.

In the exemplary embodiment, , the housing <figref>31</figref> a total length in the range of about 5 to about 20 cm (2 to 8 inches), and ideally a length of about 19 cm (7.5 inches). The exemplary embodiment the rack <figref>37</figref> has a length of about 5.5 cm and a Total travel distance of about 4.0 cm. The delivery catheter<figref>16</figref> has a stroke of about 1 cm, wherein movement of the release catheter relative to the core shaft <figref>18</figref> prior to actuation of latch <figref>39</figref> is locked. The unscrewing of the core shaft<figref>18</figref> from the device <figref>12</figref> typically by <figref>10</figref> revolutions or less finished, which he ideally one with about quarter turn or two turns of the handle (or a other rotational mechanism) is unscrewed.

Although the exemplary device <figref>12</figref> of a radially expandable helical coil makes use, to retaining the structure during to support tissue ingrowth, for example, could alternative mechanical Anchorages such as resilient coils biased to that they form loops, loops, or other secondary forms with enlarged cross sections, slotted pipes, Malecot structures, radially expandable braids, stent similar devices and the like to be attached to the device. The mechanical structures may elastic, plastically deformable, or the like, where appropriate Structures, for example, in PCT publication no. WO-A-99/15116 described in more detail are.

It could another device restraint techniques including thermal and chemical techniques, techniques and the like applied adhesive will. These techniques can be used to prevent expulsion by the friction is increased between the device and the surrounding tissue, by a limited tissue damage brought , in order to promote the formation of scar tissue, and / or by the ingrowth is sponsored by tissue into the device. Thermal techniques For example, the transfer electrical energy or laser energy along the contraceptive system <figref>10</figref> include. The heat resistance of Contraceptive device <figref>10</figref> could be obtained by with conductors running along the enclosure <figref>14</figref> and the release catheter <figref>16</figref> extend, an electric potential is applied to the device, along one on the core wire <figref>18</figref> attached optical fiber Laser energy is applied or the like. About a large return electrode patch could by energizing the core wire <figref>18</figref> with radio frequency energy a monopolar tissue desiccation sought or it could be a Adhesive and / or mordant (such as Cya&lt;?page 9?&gt;nacrylat or silver nitrate) over any the lumen of the delivery system via a specially assigned Lumen or a specially assigned structure or the like can be introduced. Biodegradable plugs and the like could also incwuded be, the structure held optional copper or other bioactive contain agents that contribute to preventing conception, could.

The Tissue reaction to the retained contraceptive device <figref>12</figref> can contribute to the long-term contraception and / or sterilization cause. To the tissue reaction contraceptive to promote, contains the device <figref>12</figref> frequently Tissue reaction material, the material often comprising fibers. The fibers can of a polyester such as Dacron^®-Polyester, Silk, nylon or the like. The fibers can The form of a knitted fabric, a braid, a felt or the like comprise own or on the device body mounted scaffolding.

The Components of the contraceptive system <figref>10</figref> by referring on the <figref idrefs="S43">2</figref> to <figref idrefs="S45">5</figref>, in which these components are shown separately, understandable. In order to<figref idrefs="S43">2</figref> to begin is the core shaft <figref>18</figref> proximally from the distal end <figref>40</figref> conical made so that its diameter gradually increases to a greater support for the distal portion <figref>24</figref>, The proximal portion <figref>20</figref> and the Catheter structures proximal of contraceptive device <figref>12</figref> to cause. This greater support (and the associated increase in column strength) enhances the pushability of the contraceptive system while access to the target deployment site. A thread<figref>42</figref> accepts a coil of the contraceptive device in threaded engagement and is formed so generally that they have a coil with individual Turns on a collar <figref>44</figref> at a central core wire fasten. On the Bund<figref>44</figref> in addition, a tube <figref>43</figref> be fixed, the joining and / or jumping of the cooperating threads prevented, and the tube idealennreise stainless steel, platinum, or the like. In the exemplary device, the core shaft <figref>18</figref> out a metallic structure high strength.

The exemplary contraceptive device <figref>12</figref> is in <figref idrefs="S43">3</figref> shown in more detail. The contraceptive device <figref>12</figref> comprises a primary coil <figref>50</figref>. viewed distal of a ball point <figref>52</figref> to the proximal thread <figref>54</figref> extends and expedient by separating the proximal Turns of the primary coil may be formed. The expandable structure, here in the form of a helical outer coil <figref>56</figref>, has a proximal Endbiegung, affixing a <figref>58</figref> for lowering winches forms, and a distal end, the coils on the Bund <figref>60</figref> at the coil <figref>50</figref> is attached. Between the inner and the outer coil extend a fiber <figref>62</figref>, Which are also in the primary coil <figref>50</figref> arranged is to tissue ingrowth throughout the cross-section the contraceptive device <figref>12</figref> to promote. The arrangement of the coil attachment<figref>58</figref> and the position of the fiber <figref>62</figref> are in the axial view of <figref idrefs="S43">3A</figref> to recognize. By of a contraceptive device having a distal portion <figref>24</figref>. of the guidewire can serve, use is made, no open lumen need by the center of the contraceptive device (for example, for a separate guidewire) be provided and several Access / deployment steps (for example, with a guidewire Access to win the final destination, a catheter over the guidewire to move forward, the guidewire extract from the positioned catheter and then the contraceptive device forward to move) are avoided. Although the exemplary system Thread used to the core wire (or other deployment shaft) to be coupled to the contraceptive device, could be a variety of alternative releasable Compounds including cooperating Longitudinal wedge / slot connectors or like.

In the exemplary embodiment, the coil <figref>50</figref> from a high strength, elastic material formed, which ideally of a stainless steel wire having a diameter of about 0.125 mm (0.005 inches) which is wound around a Coil having an outer diameter of about 0.6 mm to form (0.022 inches). The ball tip<figref>52</figref> has preferably a cross section which is larger than the cross section of Kitchen sink <figref>50</figref> , said ball tip generally a Diameter in the range of about 0.5 mm (0.020 inch) to about 1.25 mm (0.050 inches) has and the exemplary ball tip having a diameter comprising of 0.7 mm (0.027 inches).

The helical Kitchen sink <figref>56</figref> consists of a highly elastic, high-strength Metal, which is biased to extend from the in <figref idrefs="S40">1</figref> shown Small profile configuration to the in <figref idrefs="S43">3</figref> shown education major extending profile when it is released at the target site. In the exemplary embodiment, is the outer coil <figref>56</figref> out a ribbon of a superelastic shape memory alloy and has a thickness of about 0.025 mm (0.001 inch) and a width of about 0.4 mm (0.015 inches), wherein the tape is biased to a helical coil with an outer diameter from about 2 mm to form (0.080 inches) and a length of about 3.5 cm, if it is not otherwise retained becomes. The outer coil<figref>56</figref> is preferably by a collar <figref>60</figref> of solder at the primary coil <figref>50</figref> attached. The Bund <figref>60</figref> is preferably by a distance in the range of about 0.3 cm to about 1.0 cm of the ball tip <figref>52</figref> ge&lt;?page 10?&gt;separates. Advantageously, the collar <figref>60</figref> on the distal end <figref>28</figref> the envelope <figref>14</figref> aligned be to help ensure that prior to deployment atraumatic Increase in diameter between distal portion <figref>24</figref> of the Contraceptive device <figref>12</figref> and the sheathed proximal portion <figref>20</figref> necessary becomes.

The fiber <figref>62</figref> may consist of a polyester or the like. The fiber may correspond loosely woven or tangled assembled filaments, wherein at least one end of the fibers at the primary coil <figref>50</figref> or the outer coil <figref>56</figref> secured can be.

in the carries general the expandable structure at least help, the contraceptive device <figref>12</figref> at to keep in place until sufficient tissue ingrowth occurs and the contraceptive device is kept permanently. Therefore pulling the expandable structure frequently Benefit from an outer surface with a relatively high friction. Such outer surface may make it difficult, to push the contraceptive device into position if the device without wrapping <figref>14</figref> moved forward becomes.

The Work in conjunction with the present invention has shown in that elastic, expandable structures which have a strength sufficient to the contraceptive device reliable in to keep the ostium of the fallopian tube, strong frictional forces on a surrounding envelope exercise can. These frictional forces can the exact feed the contraceptive device substantially complicate. Therefore, the outer coil <figref>56</figref> preferably in a small profile configuration within the enclosure <figref>14</figref> kept, by between the core wire <figref>18</figref> and the delivery catheter <figref>16</figref> on is applied down spiraling torque. The core wire, the wind-down torque on cooperating thread <figref>42</figref>. <figref>54</figref> on the outer coil <figref>16</figref> transfer, wherein the direction of the wind-down angular momentum oriented is that it prevents the thread from disengaging. In other words, the Rotation of the core wire <figref>18</figref> relative to the contraceptive device <figref>12</figref> in a direction which is down opposite to the winding torque, is used to the core wire <figref>18</figref> of the contraceptive device <figref>12</figref> to to solve.

In <figref idrefs="S44">3B</figref> is a slight change in Attachment shown for lowering winches. An alternative contraceptive device<figref>12a</figref> includes a small tube or a tape <figref>59</figref>That in a proximal portion of the outer coil <figref>56</figref> small diameter soldered is. The ribbon<figref>59</figref> a relatively large joint face with the coil <figref>56</figref> have to facilitate bonding. bears Use of the Bands helps to prevent stress concentrations, and also provides a smooth inner lumen lock connecting the release catheter can. The ribbon<figref>59</figref> may be made of stainless steel or platinum and ideally has an inner diameter of about 0.6 mm (0.023 Inches) and an outside diameter with a thickness of the surrounding outer coil and the Confederation of solder of about 0.8 mm (0.030 inches). A similar band<figref>59 '</figref> can in the thread <figref>54</figref> the coil <figref>50</figref> be arranged to a radiopaque to establish mark and prevent a thread jump. The tape <figref>59 '</figref> can in the structure of the tape <figref>59</figref> same, but in the Length shorter. It Still other alternative attachment mechanisms possible. For example can at the proximal end of the outer coil <figref>56</figref> a Mass or a button from a simple ball of solder, a coil material, a loop or the like be. This mass may in the slot of the delivery catheter slidably receivable be.

The distal structure of release catheter <figref>16</figref> is in the <figref idrefs="S43">4</figref> and <figref idrefs="S43">4A</figref> shown. The wind-down torque is created by the interaction between the loop <figref>58</figref> and the pin <figref>66</figref> at the distal end <figref>34</figref> of release catheter <figref>16</figref> sharable between the outer coil <figref>56</figref> and the delivery catheter <figref>16</figref> transfer. The delivery catheter<figref>16</figref> includes in general a tubular body <figref>68</figref>. which is formed of rigid polymers such as polyimide. The pencil<figref>66</figref> is in a lumen of the tubular body <figref>68</figref> arranged and in this by a helical support coil <figref>70</figref> and one adhesive <figref>72</figref> supported. Interestingly, the dimensions of the tubular body by proximally by release catheter <figref>16</figref> transmitted controlled wind-down torque.

The Structure of the envelope <figref>14</figref> is in <figref idrefs="S45">5</figref> closer shown. The distal end<figref>28</figref> (please refer <figref idrefs="S44">5A</figref>) of the wrapping <figref>14</figref> is preferably rounded, which is ideally the coils Bund <figref>60</figref> of the Contraceptive device <figref>12</figref> cooperates that friction is avoided and the distal navigation of delivery system <figref>16</figref> by the transition uterotubal is facilitated in the oviduct. The rounded distal end<figref>29</figref> can optionally both along the inner diameter and the outer diameter the envelope <figref>14</figref> rounded his or primary along the outer diameter be rounded so that it extends distally tapered inwardly.

The wrapping <figref>14</figref> has preferably a multilayer structure, wherein the layers (beginning on the outside) a hydrophilic coating <figref>76</figref>To reduce friction during the to reduce tracking and navigation, includes. Sol&lt;?page 11?&gt;che hydrophilic coatings become quite slippery when exposed to fluid are. Among the hydrophilic coating<figref>76</figref> is located along the proximal portion of the sheath <figref>14</figref> a structural layer of a polymer <figref>78</figref> such as Tecoflex^TM. wherein within a polyimide layer of the polymer layer <figref>78</figref> on Splicing weave <figref>80</figref> of a metal, ideally of stainless steel, is arranged. Along a more distal portion of the sheath<figref>14</figref> is within the Polymedschicht <figref>78</figref> from Tecoflex^TM or like is arranged a metal mesh, said polyimide layer is absent, to effect a greater elasticity in this manner. The inner lumen of the sheath <figref>14</figref> is by a low friction polymer coating <figref>84</figref> defined, wherein the low-friction polymer ideally from a PTFE such as Teflon^® consists. exemplary servings <figref>14</figref> are available from various suppliers in the trade. Suitable structures are described in published PCT patent application WO-A-98/57589 described in more detail.

As in the <figref idrefs="S44">5A</figref> shown to F schematically, include alternative servings <figref>14A</figref>. B and C buffer <figref>57</figref>. <figref>57 '</figref> or. <figref>57 ''</figref>, The buffer <figref>57</figref> has an outer surface of radially the outer surface of underlying wrapping extends. Although the buffer<figref>57</figref> optional tactile indication, that the envelope <figref>14A</figref> distally beyond the Target deployment position moved out, can provide, does not have to be prevented that the sheath is moved forward, so that the Buffer can penetrate into the tubal ostium. The buffer<figref>57</figref> can also provide a visible marker that that such a pushing of the sheath, the buffer over the ostium moved out, is staying. Optionally, the buffer <figref>57</figref> of a colored adhesive or a clear adhesive with a arranged underneath colored Material band made.

alternative buffer <figref>57 '</figref> and <figref>57 ''</figref> can from polymer or metal structures, ideally from a polyethylene or a super-elastic shape memory alloy, consist. These radially expandable buffer structures for feed through a working lumen of a hysteroscope are compressed and then expanded in order by engaging the uterine tissue in the vicinity of the Tubenostiums forward movement of wrapping to prevent.

In <figref idrefs="S45">6</figref> is the sliding engagement between the pin <figref>66</figref> the release catheter <figref>16</figref> and the loop <figref>58</figref> the outer coil <figref>56</figref> more clear shown. <figref idrefs="S45">6</figref> also shows how the wind-down Torque through the core shaft <figref>18</figref> and the delivery catheter <figref>16</figref> on the outer coil is applied, keeping the outer coil in a small profile configuration within the enclosure <figref>14</figref> can support, what a simple pull of the envelope allowed. The wind-down Torque can by sliding the release catheter so that the pin <figref>66</figref> out of the loop <figref>58</figref> slides, are released. Optional can be first admitted that the release catheter to rotate relative to the core shaft to the engagement forces between the loop <figref>58</figref> and the pin <figref>66</figref> to shrink.

As in <figref idrefs="S45">7</figref> As shown, the thumbwheel are <figref>33</figref> and the latch <figref>39</figref> for actuation by the surgeon, the nurse or other medical personnel with the thumb, during the handle <figref>39</figref> gripped with the remaining fingers of the hand is suitably arranged. this makes possible the medical staff run multiple deployment steps with a single hand. In general, the movement of the entire housing <figref>31</figref> used around the contraceptive device <figref>12</figref> distally into the tubal ostium advance and the contraceptive delivery system in the transition uterotubare and navigate the oviduct. Once the contraceptive device is positioned, pulls the thumbwheel <figref>33</figref> wrapping <figref>14</figref> from the contraceptive device, while the housing <figref>31</figref> furthermore the proximal ends of the release catheter <figref>16</figref> and core shaft <figref>18</figref> rotationally and axially coupled, whereby the maintaining wind-down torque on the contraceptive device is to keep them in their small profile.

As soon as exposing the proximal portion of the contraceptive device is, the latch <figref>39</figref> be depressed and the thumbwheel <figref>33</figref> again proximally rotated to the pen <figref>66</figref> the release catheter <figref>16</figref> of the down winding outer coil To solve the contraceptive device, and thereby the contraceptive device radially expand. Advantageously, it is possible, the contraceptive device before expansion proximally into the sheath <figref>14</figref> withdraw and / or reposition slightly in the tubal ostium if welcome this is.

As soon as the contraceptive device both exposed and expands is, the handle is <figref>30</figref> turned as shown to the core shaft <figref>18</figref> by unscrewing of the contraceptive device <figref>12</figref> to to solve. Therefore allows the handle <figref>30</figref> medical personnel positioning the contraceptive device, expose the contraceptive device, pressing the contraceptive device, to attach to the surrounding tissue, and the uncoupling of the contraceptive device from the remaining Components of the delivery system with a single hand.

As by reference to the <figref idrefs="S46">8A</figref> to <figref idrefs="S49">11</figref> course, is could along with the contraceptive delivery system of <figref idrefs="S42">1B</figref>&lt;?page 12?&gt;a used wide variety of alternative one-handed release handles will. As in the<figref idrefs="S46">8A</figref> and B is shown, used a handle <figref>30a</figref> For axial motion "T" an axial pulling motion syringe type to the envelope <figref>30</figref> With the fingers of one hand in the direction of the bale of the hand (which is generally is held in a fixed position) to withdraw. This causes a axial movement of the shroud <figref>14</figref>. in order to pull it off of the contraceptive device, followed by an axial movement of the release catheter <figref>16</figref>, around to allow the expansion of the contraceptive device. Optional can at the proximal end of the core shaft <figref>18</figref> a button <figref>41</figref> secured be such that the rotation of the knob <figref>41</figref> the core wire redeemed by unscrewing of the expanded contraceptive device. Of the button <figref>41</figref> can a releasable Include latch coupling the knob to the housing, to prevent rotation of the core shaft and the wind-down Torque to be maintained until a release is desired. Advantageously allows the handle <figref>30a</figref> for axial Movement several hand sizes and various hand positions, and has a shape which doctors is familiar.

The <figref idrefs="S47">9A</figref> and B show a still another pistol grip handle <figref>30b</figref> to the performing a handed Deployment of the contraceptive device. In this embodiment, moving a shutter actuator <figref>43</figref> the wrapping <figref>14</figref> and the delivery catheter <figref>16</figref> a Wulstkette <figref>45</figref> and a Wulstketten-driven wheel and -Zahnradanordnung. After pressing the trigger actuator <figref>43</figref>. For example, with the index finger of the hand, a locking button (Not shown) is depressed be and the button <figref>41</figref> rotated with the thumb of the hand are to the contraceptive device from core shaft <figref>18</figref> to decouple.

In <figref idrefs="S48">10</figref> includes a preferred one-handed release handle <figref>30c</figref> a thumbwheel <figref>33</figref>. which in turn, when it is rotated relative to the surrounding housing will initially a movement of the shroud <figref>14</figref> relative to the core shaft <figref>18</figref> effected as described in more detail below becomes. Once the contraceptive device has been covered, Allowed depressing security lock <figref>39</figref> a further rotation of the Thumbwheel, the release catheter <figref>16</figref> in relation to the core shaft to move and the expansion of the contraceptive device enable. These movements of thumb wheel <figref>33</figref> can be readily carried out, while housing the preferred handle <figref>30c</figref> held in a fixed location is avoided and thus a movement of the contraceptive device becomes. Once the deployment, the contraceptive device at the target site has exposed and expanded, the button can <figref>41</figref> in turn are rotated while holding the remaining handle at a fixed location. Of the internal mechanism which causes these movements is in the <figref idrefs="S52">11D</figref>. <figref idrefs="S53">11E</figref>. <figref idrefs="S54">11F</figref> and <figref idrefs="S56">11H</figref> shown.

It can further alternative one-handed release handles, including a Handle with inline slider <figref>30d</figref> scheduled be, the thumb slide a <figref>47</figref> for sequential movement of the sheath <figref>14</figref> having and then the catheter <figref>16</figref> relative to the core shaft <figref>18</figref> frees as in <figref idrefs="S48">10</figref> is shown. A button<figref>41</figref> can relatively rotated to the housing be, by a latch <figref>39</figref> is depressed, or it may be the entire housing be rotated, as has been described above, the threaded engagement to solve.

On exemplary method for use of contraceptive system <figref>10</figref> becomes by reference to the <figref idrefs="S49">11A</figref> to <figref idrefs="S59">11K</figref> understandable. default way handles a medical assistant the contraceptive delivery system <figref>10</figref> With one hand H1 while he like with the other hand an imaging and / or access device about a Fluoroskopiekatheter, an ultrasound catheter or a hysteroscope S leads. this makes possible the medical assistant, the orientation of distal advancement the contraceptive system and its movement and deployment under Consideration of the procedure by the Skop S (here through the eye E indicated) personally to control. Although the Skop S here as a simple optical device is shown, by the system and method of the present Invention of course a variety of Skopstrukturen including rigid optical scopes, Scopes with a coherent Glass fiber bundles, Microscopes, the charge-coupled devices (CCDs) for displaying a Image of the procedure on a monitor and the like are included. Exemplary Hysteroscopes for use with the present invention are from Richard Wolf of Chicago, Illinois, under the model name 5 MM OVAL SCOPE commercially available.

As now in <figref idrefs="S50">11B</figref> is shown, the system is, generally under optical steering, transcervical through the Uterus U introduced. Using hysteroscope S the physician directs the distal end the system toward ostium O of fallopian tube F. Uterus U can by means of the scope and / or a separate irrigation or purged gas injection be softened and / or. Once ostium O localized and Skop S is oriented toward the ostium out, the system will <figref>10</figref> distally advanced through the working lumen of the scope into the ostium wherein the distal portion <figref>24</figref> of the contraceptive device as a guidewire is used, while the remaining contraceptive device through the enclosure <figref>14</figref> covered remains.

&lt;?page 13?&gt;

The outer hydrophilic Coating the envelope <figref>14</figref> minimized friction during the forward movement the system <figref>10</figref>, Wherein the enclosure the system further comprises structural column strength gives. The distal ball tip of distal section <figref>24</figref> supports tracking and navigation through the fallopian tube F, while the primary coil structure side bends to the winding turns, often in find oviduct to follow. In the exemplary embodiment extends the core wire <figref>18</figref> in the distal portion <figref>24</figref>. to the column strength of the distal portion beyond sheath <figref>14</figref> to strengthen, However, it does not extend to the ball tip. Therefore takes the stiffness of the distal portion <figref>24</figref> proximal to, what ability of the distal portion to follow the lumen further increases.

In the exemplary embodiment, contains wrapping <figref>14</figref> a visible mark <figref>98</figref>That of the Skop the hysteroscope S can be seen. The mark<figref>98</figref> is preferably partly in the ostium O and partially positioned in the uterus U, thereby indicates that the contraceptive device <figref>12</figref> in the target position is located, since, during the forward movement and positioning an opening the envelope, of the core shaft and the contraceptive device releasably locked together are (as during the forward movement and the positioning of the envelope, the core shaft and the contraceptive on-device releasably together are locked). As has been described above, the marker may<figref>98</figref> a Buffer, a structure which extends radially from the sheath to to provide a tactile positioning indication will include.

A Preferred positioning of contraceptive device <figref>12</figref> is in <figref idrefs="S51">11C</figref> shown. Preferably, the device extends<figref>12</figref> by the uterotubal transition UJT, with the device ideally both proximal also extends distally from the uterotubal transition. The intramural Section INT (see <figref idrefs="S40">1</figref>), Typically has a length in The range of about 1 to 2 cm, with the outer coil <figref>56</figref> preferably by a distance in the range of about 0.2 to 1.2 cm above the ostium O also extends into the uterus U. The outer coil<figref>56</figref> extends distally from the intramural section INT and / or the transition uterotubal UJT preferably by a distance of at least about 0.6 cm. Since the uterotubare transition UJT near is from muscle tissues, which often of higher Strength than the delicate tubal tissues of the more distal portions the fallopian tube F, the narrowest portion of the fallopian tube (particularly after the deployment of the device <figref>12</figref>) Frequently near the junction uterotubal detected. The extending the expandable structure both distally and and proximally of this narrowing can an anchor against a create proximal and distal movement of the device, thereby a movement of the contraceptive device <figref>12</figref> from the target position is avoided, while tissue ingrowth takes place Advantageously, a Positioning accuracy in the range of about 1 cm by limiting marks <figref>98</figref> created by up to 1 cm in length. This gives a sufficient positional tolerance in favor of a ease of use, which is helped reliable and well anchored unfolding needs.

As in the <figref idrefs="S51">11C</figref>. <figref idrefs="S52">11D</figref> and <figref idrefs="S42">1B</figref> shown is the positioned contraceptive device is <figref>12</figref> deployed by first the envelope <figref>14</figref> from the expandable structure is peeled off. When using the embodiment from <figref idrefs="S48">10</figref> is the thumbwheel <figref>33</figref> with the thumb TH proximal rotated to the sheath <figref>14</figref> proximally deduct from the contraceptive device. The handle<figref>30</figref> becomes, while the thumb wheel is rotated, in a fixed position, that the core shaft <figref>18</figref> the contraceptive device <figref>12</figref> at the holds destination in the tubal ostium. Once the rack <figref>37</figref> with the respective proximal Structure of the release catheter <figref>16</figref> comes into engagement, a further movement of the shroud <figref>14</figref> and the thumbwheel <figref>33</figref> prevented until the latch <figref>39</figref> is depressed, such as with respect to <figref idrefs="S50">11B</figref> understandable becomes. At this time, the device<figref>12</figref> at the destination been positioned and the envelope <figref>14</figref> proximally been drawn off, which allows the the proximal portion of the contraceptive device by the Skop consider to the initial to check positioning.

In the <figref idrefs="S54">11F</figref>. <figref idrefs="S55">11G</figref> and <figref idrefs="S56">11H</figref> the latch <figref>39</figref> depressed, that the proximal structure of the release catheter <figref>16</figref> by the rack <figref>37</figref> can be moved axially. after the latch <figref>39</figref> is depressed, the thumb wheel can <figref>33</figref> again be rotated to both the envelope <figref>14</figref> as well as release catheter <figref>16</figref> proximally with respect to the core shaft <figref>18</figref> to pull.

As in <figref idrefs="S56">11H</figref> can be seen with reference to <figref idrefs="S45">6</figref> above has been described, it decouples the outer coil of the contraceptive device rotationally of the delivery catheter <figref>16</figref> thus allowing the expansion the release catheter.

Although of the <figref idrefs="S54">11F</figref> and <figref idrefs="S55">11G</figref> shown Thumbwheel and safety locking mechanism double action is preferred, a variety of alternative cover / expansion mechanisms be used. For example, as in<figref idrefs="S42">1B</figref> continue is shown, prevents &lt;?page 14?&gt;a feather <figref>51</figref> the rotation of the thumbwheel <figref>33</figref>. until the latch <figref>39</figref> is depressed. Optionally, the feather <figref>51</figref> enough save energy to release catheter <figref>16</figref> relative to the core shaft <figref>18</figref> moving, when the latch <figref>39</figref> is actuated, or spring <figref>51</figref> may be completely absent, so that the latch <figref>39</figref> allows that the thumb wheel to expand the expansible structure by both wrapping <figref>14</figref> as and the delivery catheter <figref>16</figref> relative to the core shaft <figref>18</figref> emotional.

As soon as the core shaft <figref>14</figref> subtracted from the expandable structure has been and the delivery catheter <figref>16</figref> from the exposed expandable structure that expands and the contraceptive device secured in place, solved is, the handle can <figref>30</figref> be rotated to the Contraceptive device <figref>12</figref> from the remaining components the delivery system <figref>10</figref> to solve. As in the<figref idrefs="S54">11F</figref> and <figref idrefs="S55">11G</figref> continue is shown, allows a proximal sliding proximal structure <figref>16a</figref>, the at the proximal end of the catheter release <figref>16</figref> secured is that a proximal structure <figref>18a</figref> of the core shaft <figref>18</figref> rotates. More wedges are on the proximal structure of the release catheter axially over cooperating splines on the proximal structure of the core shaft moved out. The proximal structure<figref>18a</figref> of the core shaft is rotationally with the knob <figref>41</figref> coupled, so that the cooperating Wedges before the stroke of the release catheter upon deployment a Rotation of the knob to prevent, but then while turning the knob Allow to the decoupling of the core shaft <figref>18</figref> of the Contraceptive device easier.

As in the <figref idrefs="S57">11I</figref>. <figref idrefs="S58">11J</figref> and <figref idrefs="S59">11K</figref> is shown, the operator rotates once the proximal structures of the release catheter and core shaft <figref>16a</figref> and <figref>18a</figref> themselves have shifted so that the knob <figref>41</figref> may be rotated, the button by means of his thumb TH and / or the fingers of the hand, which the release handle <figref>30C</figref> holds. As described above is, the direction of rotation of the core shaft for disengagement in Generally to those who smashed through the wind-down torque is opposite, so that the wind-down torque to is, maintain threaded engagement. Once the core shaft<figref>18</figref> from the contraceptive device <figref>12</figref> is unscrewed, can the handle <figref>30</figref>, Wrapping <figref>14</figref>. the delivery catheter <figref>16</figref> and the core shaft <figref>18</figref> proximally retracted into and / or through the Skop S will. The Skop S can remain in the uterus U and another delivery system to develop a contraceptive device in the ostium of the opposed introduced into the oviduct Skop will. After deployment of both contraceptive devices in the two fallopian tubes and after use of the scope for visual check whether both Unfoldings were successful, the Skop is transcervical pulled out of the uterus, as shown in <figref idrefs="S59">11K</figref> shown is.

In the <figref idrefs="S60">12A</figref> and B contains a slotted handle <figref>30d</figref> preferably a slot <figref>100</figref>, The side wrapping <figref>14</figref> receives, when the distal portion of the delivery system <figref>10</figref> as is bent shown. As in the view along the distal axis of Administration system, which in <figref idrefs="S60">12B</figref> shown is, is best seen, takes the slot <figref>100</figref> the wrapping <figref>14</figref> in nearby the distal end of the delivery system in fit. From the housing extending detents <figref>102</figref> in the slot <figref>100</figref> and keep the envelope <figref>14</figref> answer the resilient straightening forces from the sheath of release catheter <figref>16</figref> and by the core shaft <figref>18</figref> in the slot <figref>100</figref>,

The elongated Components of the delivery system <figref>10</figref>Extending distally from the handle <figref>30d</figref> the distal end of the distal portion <figref>24</figref> extend, form an elongate management structure with a lateral elasticity, the distal increases toward the distal end. By releasably securing this leading yourself Structure in the slot <figref>100</figref> can the management structure by means of handle <figref>30d</figref> in a simple manner in a working lumen W introduced a hysteroscope S will. This eliminates a long, elastic, guidewire similar Structure cantilevered over itself a big Distance away from the handle extends, or avoids, that specific weight of the handle this, while the delivery system in the vicinity of the distal end of the sheath <figref>14</figref> moved is to the distal portion <figref>24</figref> in the working lumen introduce, uncontrollable tilts downwards. Such a structure has a wide variety of applications for guidewires and guidewire-like structures having proximal Handles to facilitate the introduction of their distal ends in lumens of vascular access catheters, Introduction Cases, monorail catheter lumens and the same.

As in <figref idrefs="S61">13</figref> As shown, a variety of alternative might Deconvolution methods are applied to the contraceptive system <figref>10</figref> to unfold. For example, the deployment using a simple Zervikalkatheters <figref>102</figref> sonography, fluoroscopically, under magnetic resonance generation and possibly even steered only by tactile information. In the in <figref idrefs="S61">13</figref> alternative method shown, a balloon <figref>104</figref> of Zervikalkatheters <figref>102</figref> about an inflation <figref>106</figref> inflated. This allows the uterus U by introducing a Aufblähmediums by through the working lumen of Zervikalkatheters <figref>102</figref> introduced uterine catheter <figref>108</figref> be bloated. Preferably are the anatomy and Zielortiden&lt;?page 15?&gt;fication, the device positioning, deployment, detachment and the position confirmation (as in the process <figref>2</figref> regarding <figref idrefs="S41">1A</figref> outlined has been) under the leadership an ultrasound and / or fluoroscopic imaging performed. relevant Uterine catheter manipulation structures and procedures are described in US Patent Nos. 5,346,498 and 5,389,100 described.

As has been described above, keeping the delivery systems of the present invention, the contraceptive device frequently in a fixed position, while covered it, extended and / or released. For example, the outer envelope <figref>14</figref> so is moved such that the proximal portion of the contraceptive device is exposed, the friction between the outer sheath and the surrounding hysteroscope (Or other introducing structure, the surrounding tissue or the like) inadvertent movement cause the contraceptive device. To such an unintentional to avoid movement, an outer sleeve may be slidably around the outer envelope <figref>14</figref> arranged be. manages the sleeve a sliding interface between the sheath and surrounding structures. By axially coupling the sleeve the core shaft <figref>18</figref> the friction between the sleeve and surrounding structures movement of the contraceptive device prevent.

In the <figref idrefs="S62">14A</figref> and <figref idrefs="S63">14B</figref> is a sleeve <figref>112</figref> slidably at least a proximal portion of the sheath <figref>14</figref> arranged. The sleeve <figref>112</figref> becomes by axially connecting the proximal end of the sleeve with the housing <figref>110</figref> of handle <figref>30c '</figref> axial with respect to the core shaft <figref>18</figref> retained, optionally a rotatable connector <figref>114</figref> is used (relative to the sleeve to the housing to rotate). The sleeve <figref>112</figref> has frequently a distal end disposed proximally of the contraceptive device is.

As in <figref idrefs="S63">14B</figref> It can be seen penetrating the sleeve <figref>112</figref> frequently in a sealing structure Introduction such as a nipple value V of hysteroscope S before. The sleeve<figref>112</figref> can They also at least through the bend where a working lumen WL of the hysteroscope adjoins the main shaft of the scope, extend. The sleeve<figref>112</figref> permits despite the frictional engagement between the sleeve and the nipple value V and between the sleeve and the working lumen WL of an independent movement of the envelope <figref>14</figref>, The rotatable connector <figref>114</figref> allows free rotation of the handle <figref>30c '</figref> (and of the core shaft <figref>18</figref>) while the detachment of the core shaft from the contraceptive device.

In the <figref idrefs="S64">15</figref> and <figref idrefs="S64">16</figref> includes an alternative contraceptive system <figref>150</figref> a contraceptive device <figref>152</figref> With many of the components described above, but includes an alternate connector <figref>154</figref> for the descent winds of the outer coil, the at a proximal end of the outer coil <figref>56</figref> arranged is. An alternative delivery catheter<figref>158</figref> with a corresponding connector <figref>160</figref> for engagement with the connector <figref>154</figref> of the Contraceptive device <figref>152</figref> in turn allows, as described above has been, the releasable maintaining a down spiraling Torque. In this embodiment, has the Down Wind connector <figref>160</figref> the release catheter <figref>158</figref> an opening, which a protrusion <figref>162</figref> receives, extending radially from a tubular band the connector <figref>154</figref> extends. These alternative connector and other alternative Screw <figref>170</figref>. <figref>172</figref> for one releasable Engagement between the primary coil and the core wire are in a patent application entitled "Insertion / Deployment Catheter System for Intrafallopian Contraception ", which is filed concurrently herewith, described. provide one or more of these connector structures under at least one conventional Type of medical imaging, preferably a high-contrast Image. Such labels can the positioning of the contraceptive device <figref>150</figref> and or the review of the separation the corresponding connectors (particularly when each of the to the engaged connector of a connector pair a high image contrast provides) support.

As in the <figref idrefs="S64">17</figref> and <figref idrefs="S65">18</figref> shown is, can be connected to the enclosure <figref>14</figref> optional a positioning surface <figref>57</figref> secured be that, as has been described above, the axial positioning the contraceptive device <figref>152</figref> in the intramural portion INT supported. The engagement between the radially protruding positioning surface <figref>57</figref> and the uterine tissue surrounding ostium O facilitates initial axial positioning by the axial coupling of sheath <figref>14</figref> With the contraceptive device is utilized. However, the envelope is<figref>14</figref> during the development often early retracted proximally into the Skop S, which is why it often desirable is, at least to maintain the axial position of the contraceptive device as long as, until the proximal coil <figref>56</figref> begins to expand radially.

As in <figref idrefs="S64">17</figref> is shown schematically, by fixing the axial positioning surface <figref>57</figref> (the optional one of the alternative positioning surface configurations described below or again may include other alternative structures) on the distal end of a separate positioning catheter <figref>184</figref>. slidably over the envelope <figref>14</figref> arranged is that caused by the positioning surface positioning during and / or after retraction the envelope <figref>14</figref> maintain will.

&lt;?page 16?&gt;

As in the <figref idrefs="S64">17</figref> and <figref idrefs="S65">19</figref> shown is, a proximal portion <figref>186</figref> the positioning catheter <figref>184</figref> axial having a distal portion of the handle <figref>30</figref> coupled be. This arrangement is quite easy to prepare and couples the contraceptive device <figref>152</figref> via the handle <figref>30</figref> effective with the positioning surface <figref>57</figref>, Alternatively, the positioning catheter <figref>184</figref> axially the release catheter within the envelope <figref>14</figref> or with one of the other axially elongate delivery system components, extending distally from the handle, may be coupled.

It should be noted that when the positioning surface <figref>57</figref> distally from the proximal end of the outer coil <figref>56</figref> extends, the proximal portion of the outer coil may be partially extends into the positioning catheter, especially, when the positioning catheter axially on the handle <figref>30</figref> secured and the handle is <figref>30</figref> axially attached to the core wire is. The axial coupling of the positioning catheter to the release catheter (Rather than to the core wire), at least a partial withdrawal of the positioning catheter prior to expansion of the outer coil allow. In some embodiments, can a distal portion of positioning catheter <figref>184</figref>, the positioning surface <figref>57</figref> and or a proximal portion of outer coil <figref>56</figref> so be adapted to the proximal retraction of the positioning catheter, after the outer coil has expanded, lightening, such as by limiting the diameter a proximal portion of the outer coil, Providing a low-friction surface along an inner lumen of the release catheter and / or along the outer surface of the the proximal portion of the outer coil or similar. Fortunately wears a relatively high friction outer surface of the distal portion having the outer coil <figref>56</figref> in the Ostium of the fallopian tube helping to an axial movement of the contraceptive device, after the envelope <figref>14</figref> withdrawn proximally is to be prevented.

As in <figref idrefs="S66">20</figref> is shown, in the system of <figref idrefs="S42">1B</figref> instead an outer envelope <figref>14</figref> a alternative outer sheath <figref>214</figref> be used. The enclosure <figref>214</figref> has a proximal portion <figref>216</figref> with a relatively stiff, thicker-walled tubular structure such as a Pebax^®-Polymerröhre with an outer diameter of about 1.6 mm (0.062 '') and an inner diameter of about 1 mm (0.042 ''). A distal portion the envelope <figref>14</figref> includes an inner tube <figref>218</figref> out a low-friction polymer and an outer tube <figref>220</figref> from a Polymer (such as Carbo Than^TM<figref>73A</figref>) with at least one reel <figref>222</figref> between. The inner tube <figref>218</figref> can of a PTFE (such as a Teflon^®- Material) with a Inner diameter of about 0.9 mm (0.034 '') and a wall thickness of about 0.025 mm (0.001 ''), wherein the outer diameter etched , and a length consist of about 5.0 cm, and preferably two counter wound reels <figref>222</figref> from a super-elastic alloy or a shape memory alloy such as nickel titanium (optionally with chromium) of about 0.2mm (0.007 '') by about 0.25 mm (0.010 '') with a pitch of about 0.4 mm (0.015 '') and a length of are about 4.0 cm available. The inner tube<figref>218</figref> could alternatively resisting in ETFE, gamma PTFE, FEP, or the like made while the reel <figref>222</figref> stainless steel or other materials medical grade may exist. The inner diameter of the distal portion can about 0.9 mm (0.034 ''), respectively, wherein the distal outer diameter the envelope <figref>214</figref> about 1 mm (0.041 '') is. A intermediate outer tube <figref>224</figref> can of a polyurethane with a hardness of about <figref>55</figref> consist. The length the outer tube <figref>220</figref> can about are 1.0 cm, the length the intermediate tube <figref>224</figref> about 5 mm and the length the proximal portion <figref>216</figref> about 40 cm.

In <figref idrefs="S66">21</figref> contains a further Another alternative proximal handle <figref>230</figref> many of above Axialbewegungskomponenten the handle <figref>30c</figref>, Instead of a rotatable knob <figref>41</figref> provide, the detachment of Kontrazeptiv- device of the core wire <figref>18</figref> the delivery system by rotation of the handle <figref>230</figref> carried around the axis of the core wire. There are other options, including the detachment of a distal Portion of the core wire from the proximal portion, in such a way that the distal portion after deployment in the contraceptive device remains possible.

Although the exemplary embodiment of the present invention, for better understanding and by way of examples in Individual has been discussed, are skilled in the art a variety of adaptations, changes and modifications apparently. Therefore, the scope is the present Invention limited only by the independent claims.