Patent Publication Number: US-2023149208-A1

Title: Non-invasive contraceptive device

Description:
FIELD OF THE INVENTION 
     The present invention relates to the field of contraceptive devices. More particularly, the invention relates to a female contraceptive device that is implanted via a non-invasive occlusion of both fallopian tubes. 
     BACKGROUND 
     Female contraception and/or sterilization may be affected by transcervically in introducing an object bilaterally into fallopian tubes to inhibit conception. Devices, systems, and methods for such a contraceptive approach have been described in various patents and patent applications. For example, U.S. Pat. Nos. 6,526,979 6,634,361 describe devices that are transcervically inserted via an ostium of a fallopian tube and mechanically anchored within the fallopian tube. One example of such a device is known as “Essure” from Conceptus, Inc. of Mountain View, Calif. 
     Tissue in-growth tends to provide a long-term contraception and/or permanent sterilization. Tissue in-growth is not immediate, and, as in the case of Essure noted above, physicians typically advised patients to wait to have unprotected intercourse for about three months after insertion of the device for long-term contraception/sterilization based upon tissue in-growth to become effective. 
     Prior art occlusion devices have several problems associated with their use. For example, some of the problems with their use include tear or hole (i.e*., “perforation”) of the uterus and/or the fallopian tube (s). Other problems include the implanted device may move unexpectantly to the abdominal or pelvic cavity causing damage to the fallopian tube and such lack of closure of the tube (due to an incomplete or disrupted tissue in-growth process) may cause unintended pregnancy and infection. 
     Accordingly it would be desirable to provide an occlusion device that assists in preventing perforations of the uterus and fallopian tubes or from falling back into the uterine cavity. 
     It would also be desirable to provide an occlusion device to prevent unintended pregnancy. 
     It would be further desirable to provide an occlusion device that resists movement of the occlusion device into the abdominal or pelvic cavity. 
     It would be still further desirable to provide an occlusion device that resists post-operative infections. 
     It would be yet still further desirable to provide an occlusion device that has deployable securing means to secure the occlusion device to the wall of the fallopian tube. 
     Accordingly, it is an object of the present invention to provide an occlusion device that assists in preventing perforations of the uterus and fallopian tubes. 
     It is another object of the present invention is to provide an occlusion device to prevent unintended pregnancy. 
     It is a further object of the present invention to provide an occlusion device that resists movement into the abdominal or pelvic cavity. 
     It is still a further object of the present invention to provide an occlusion device that resists post-operative infection. 
     SUMMARY OF THE INVENTION 
     Various embodiments of the present invention are disclosed below, and the following summary provides a brief description of only some of these embodiments. 
     In an embodiment, the present invention relates to a device for occluding a tubular body lumen that may include a device having a proximal end (meaning front/top) and a distal end (meaning back/bottom). The occlusion device may include a means for anchoring the occlusion device to the wall of a fallopian tube prior to tissue in-growth. The occlusion device may have fixed anchor points or deployable anchor points. The occlusion device may be constructed partially or fully from a radio-opaque substance to determine its proper location within the fallopian tube, so that is viewable on an x-ray or other diagnostic equipment. The occlusion device may have two or more spikes, bumps, grooves, protrusions on the surface of the occlusion device to secure the device to the wall of a fallopian tube prior to tissue in-growth and assist with the removal of an insertion rod by using the anchoring means to provide resistance against the force being applied to remove the insertion rod. Furthermore, the porous surface is to improve and enhance the process of tissue in-growth into the occlusion device&#39;s outer wall. The distal end or back/bottom of the occlusion device includes a connection means for connecting to the insertion rod. The connection means may include one or more or the following structures, for example, a groove, a suction dimple, a twist lock/unlock, or any other suitable connection means that allows the occlusion device to be temporarily secured to the insertion rod. Other aspects or the present invention may further include the outer construction of the occlusion device being constructed from a rigid or semirigid material. Further, other aspects of the present invention may include a smooth, a porous, and a combination smooth and porous outer surface to promote tissue in-growth. 
     Still further aspects of the present invention may include an occlusion device that has antimicrobial properties coated on or impregnated with, such as, for example, silver nanoparticles to prevent post-operative infection. 
     Yet still further, the present invention may include the proximal and distal ends of the occlusion device having a circular shape, an oval shape, a half oval shape, a cylindrical shape, a cone shape, a cylinder with a rounded top (i.e., bullet shape), a sphere shape or any other shape that would provide obstruction of the fallopian tube and allow for tissue in-growth, which would cause semi-permanent or permanent sterilization. Additionally, the distal end of the occlusion device may include a means of inserting the occlusion device into the fallopian tube and deploying deployable anchors. 
     It is therefore an object of the present invention to provide a female contraception/serialization device that minimizes infection. 
     It is a further object of the present invention to provide a female contraception serialization device that promotes in-growth of tissue around the occlusion device such that upon implanting the device, the occlusion device begins working immediately due to the device being secured via a tight fit within the fallopian tube by a securing means, which may be a plurality of spikes, bumps, grooves, protrusions on the surface of the occlusion device. Also, the size of the occlusion device is a means to create a tight fit placement of the occlusion device within the tubular wall of the fallopian tube. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention is described by way of example with reference to accompanying drawings, wherein: 
         FIG.  1    is a schematic view illustrating the uterine and tubal anatomy for deployment of the contraceptive device into the intra-mural portion of the fallopian tube. 
         FIG.  2   a - 2   d    illustrate different views of one example of an occlusion device in accordance with embodiments of the present invention. 
         FIG.  3 A- 3 E  are illustrative examples of deployable and adjustable anchoring system and different shapes of the occlusion device according to embodiments of the present invention. 
         FIG.  4 A  is an illustrative example of an insertion means according to an embodiment of the present invention. 
         FIG.  4 B  is a cross sectional view of a tip of an insertion means showing how and where the insertion rod connects to the occlusion device and other aspects of the present invention. 
         FIG.  5    is an illustrative example of an hysteroscope that may be used with embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention discloses a contraceptive device and insertion means that provides substantially immediate and permanent sterilization. 
     More particularly, the present invention may include an embodiment of an occlusion device having a proximal and a distal end. The occlusion device may include an anchoring means ( 215 ,  216 ,  217 ) shown in FIG. 2  for securing the occlusion device to the wall of a fallopian tube prior to tissue in-growth. For example, the anchoring means for securing the occlusion device may include two or more fixed spikes, bumps, grooves, protrusions on the surface of the occlusion device and/or may include a deployable anchoring system  300  shown in  FIG.  3    that may be used to secure the occlusion device to the fallopian tube wall. 
       FIG.  2    shows illustrative examples of different views contemplated for occlusion device  210  and different non-deployable anchoring means  215 ,  216 ,  217  for securing occlusion device  210  to the fallopian tube wall.  FIGS.  2 A and  2 B  show a longitudinal view and a longitudinal cross-sectional view of occlusion device  210  as a bullet shape with two or more non-deployable anchoring means  215 ,  216 ,  217  on the surface of the occlusion device.  FIG.  2 C  shows a top view with non-deployable anchoring means  215 ,  216 ,  217 .  FIG.  2 D  shows a bottom view of occlusion device  210  with connection means  235 . In  FIGS.  2 B and  2 D  also shows one embodiment of a connection means  235  where insertion rod  410  may be connected to the occlusion device (shown in  FIG.  4 B ) As set forth above, connection means may include a groove, a suction dimple, a twist lock/unlock, or any other suitable connection means that allows the occlusion device to be temporarily secured to insertion rod  410 . 
       FIG.  3    shows illustrative examples of different shapes contemplated for an occlusion device.  FIG.  3    also shows illustrative examples of a deployable anchoring means  300  in a deployed position. Occlusion device  210  may include two or more deployable anchor means  300 . Deployable anchor means  300  may have smooth or jagged edges and/or may include any other subtable type of surface to promote tissue in-growth to secure the occlusion device to the fallopian tube wall.  FIG.  3 A  shows an occlusion device with anchor means  300 , which may be deployed from the surface or from within the body of the occlusion device by rotating insertion rod  410  using any suitable means for rotating the rod. For example, insertion rod  410  may be connected to a knob, a handle, a button/trigger, or any other device that when rotated or actuated causes the occlusion device to deploy the anchoring means. Anchor means  300  may be deployed in predetermined distances with each rotation of the rotation means (shown in  FIG.  4 B ) (e.g., one micron per revolution or half a micron per revolution, etc.) allowing for a custom fit of the occlusion device. These custom fit deployable anchors are designed to prevent rupturing of the fallopian tube wall by allowing the anchoring means to deploy in miniscule increments to prevent movement and provide enough resistance to remove insertion rod  410 . 
     All of the various occlusion device embodiments may be coated, impregnated, or made from an antimicrobial substance such as, for example, silver, tungsten carbide and copper nanoparticles. These antimicrobial substances may work alone or in combination with each other to prevent or reduce the possibilty of infection. One skilled in the art will appreciate that other antimicrobial substances may be used to prevent or impede infections and such use is explicitly contemplated herein. 
     Occlusion device  210  may be constructed partially or fully from a radiopaque substance (not shown). A radio radiopaque substance blocks radiation rather than allow it to pass through. In other words, the occlusion device would show up on an x-ray film in order to determine the desired position of an occlusion device  210  within the fallopian tube. 
     Other aspects of the present invention may further include the outer shell of the occlusion device being constructed from a rigid material, such as, for example, metal or semirigid material such as, for example, high density polyethylene (not shown). One skilled in the art will appreciate that other substances may be used and are specifically contemplated herein. Still other features and aspects of the present invention may further include smooth, a porous, and a combination smooth and porous outer surface. 
       FIG.  4 A  shows an illustrative example of an insertion means  400  with handle  410 , delivery Catheter  405 , protective membrane  420 , introducer  415 , and teeth-like structures  425  at the very end of delivery catheter  405 , which may be needed for a secure and firm placement of the insertion catheter  405  against the uterine wall and encircling an ostium immediately prior to the deployment of an occlusion device  210  into a fallopian tube. Additionally these teeth-like structures  425  may be in a shape/form of spikes, needles and other types of protrusions.  FIG.  4 B  is showing a cross-sectional view of a tip of delivery catheter  405  with membrane  420 , insertion rod  410 , occlusion device  210 , and teeth-like structures  425 . Insertion rod  410  may be used to insert occlusion device  210  into a fallopian tube. Membrane  420  may be a one-way penetrable membrane that keeps occlusion device  210  in place while passing through a working/operative channel of the hysteroscope. For example, in operation, catheter  405  may be used to house occlusion device  210 . Membrane  420  in conjunction with insertion rod  410  holds occlusion device  210  in place prior to its insertion into a fallopian tube. Once at the desired location at the ostium, a force is applied to insertion rod  410 , which advances occlusion device  210  forward and pushes through membrane  420  and into a fallopian tube. 
     Further,  FIG.  4 A  shown an illustrative embodiment of a delivery catheter  405 , which may be a flexible catheter. Further,  FIG.  4 A  shows introducer  415 , which may start at the base of delivery catheter  405  and advance along catheter  405  and continues to advance until it covers and protects a tip of the delivery catheter with a preloaded occlusion device. Once a scope has been placed within the female introducer  215  with the distal portion of the catheter is passed through the working/operating channel of a scope  500  (shown in  FIG.  5   ) into the uterine cavity. 
       FIG.  5    shows a prior art hysteroscope with its entry point  510  into the working/operating channel that may be used in connection with the present invention to assist in inserting of occlusion device  210  by providing a safe pathway via operating channel from the outside of the female&#39;s body into the uterine cavity. 
     The foregoing description with attached drawings is only illustrative of possible embodiments of the described devices and should only be construed as such. Other persons of ordinary skill in the art will realize that many other specific embodiments are possible that fall within the scope and spirit of the present idea. The scope of the invention is indicated by the following claims rather than by the foregoing description. Any and all modifications which come within the meaning and range of equivalency of the following claims are to be considered within their scope.