Patent Application
20230149208
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.
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.
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'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.
The present invention is described by way of example with reference to accompanying drawings, wherein:
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
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.
Further,
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.
