Device For And Method Of Temporary Sterilizing A Female

Abstract

A female is temporarily sterilized by blocking the entrance to the uterus at the oviduct exit by means of a plug comprising (a) a blocking plate, which blocks the uterus entrance, (b) a plug positioning plate, which is passed through the wall of the uterus and (C) a stem which joins the blocking and positioning plates. For emplacing the plug, the shaft which carries the plug to its blocking position has a cutting blade at its forward end which cuts an opening through the wall of the uterus through which the positioning plate of the plug is then passed. The plug is then ejected from the support rod, which is thereafter withdrawn. Dye may be pumped into the uterus to facilitate observation of the process.

Description

This invention relates to temporary sterilization of females, and more particularly to a device and method of emplacement thereof for blocking the entrance into the uterus from an oviduct.

Conventionally, mechanical contraceptive devices for temporarily sterilizing a female may consist of intra-uterine contraceptive devices, which are located within, but are not secured against falling out of, the uterus. Hence, temporary sterilization might be lost without the female being aware of it. In addition, such devices damage the walls of the uterus and interfere with the menstrual cycle. Furthermore, intra-uterine devices do not block the oviducts and their contraceptive action is not known yet.

Alternatively, temporary sterilization is accomplished by occluding the oviducts. But, such occlusion may cause the walls of the oviducts to adhere to each other, thereby permanently blocking them.

It is desirable therefore, to provide a mechanical means for temporarily sterilizing a female, which means will not accidentally fall out or shift or cause damage to the uterus or permanent sterilization.

The device of the invention comprises a plug. The plug includes a blocking plate located within the uterus near its entrance and of a size to block both the entrance of ova into the uterus from the oviduct and the exit of sperm from the uterus into the oviduct. The plug also includes a positioning plate, which is passed through an opening that has been cut in the wall of the uterus, and seats upon the exterior wall of the uterus. A thin, stretchable and resilient stem passes through the aforementioned opening in the wall of the uterus and joins the blocking and positioning plates. The two plates are drawn toward each other, which locks them in position. The stem causes the plates to be oriented to each other such that the blocking plate is held over the entrance to the uterus. To accomplish this, the stem meets both of the plates at an oblique angle. The stem permits the two plates to maintain their proper positions no matter how thick the wall of the uterus may be.

One benefit provided by the present invention is that the plug used for blocking the entrance to the uterus does not contact the part of the wall of the uterus which is shed during menstruation. The adverse influence on the body of the female, that frequently occurs with intra-uterine contraceptive devices which contact the parts of the uterine wall that are shed, is avoided.

The plug has a removal means secured to it for permitting removal of the plug when temporary sterilization is no longer desired. The removal means may include a suture which hangs freely within the uterus, where it is available for being grasped and pulled. Pulling draws the positioning plate of the plug through the opening in the wall of the uterus and causes the entire plug to shift into the uterus, from which it can be readily removed.

An insertion device is provided for emplacing the plug. The insertion device includes a shaft which is passed through the vagina and the cervix and into the uterus. At the forward end of the shaft is positioned a means for causing an opening in the wall of the uterus, e.g., a cutting blade. Immediately behind the uterine wall opening means is located a means for carrying the plug into the uterus and for positioning it. The carrying means also carries the positioning plate of the plug through the opening in the wall of the uterus.

On the shaft, behind the position at which the plug positioning plate is supported is a projecting stopper device to prevent overtravel of the cutting blade through the uterine wall.

In alternate embodiment, the insertion device is curved gradually near its forward end, so that the device can be oriented during its insertion to the natural curvature of the vagina and uterus. After the cutting blade has entered the uterus, the shaft is rotated to orient it so that the blade faces toward the side of the uterus through which an opening is to be made, thus facilitating cutting an opening near the oviduct outlet.

An ejection means, associated with the insertion device shaft, is operated to release the plug from the carrying means on the shaft after the plug has been positioned. Then the shaft with its attachments is removed. The plug is now in position.

A hollow transport tube is passed through the vagina and the cervix into the uterus. The shaft, attachments and plug are passed through this tube, which protects the body and directs the shaft.

It is usually necessary for the doctor emplacing the plug to observe the emplacement procedure. Accordingly, means is provided for pumping an observable dye into the uterus. The dye could be one that is opaque to X-rays, so that the entire emplacement procedure may be observed by fluoroscopy. The dye is carried through a conduit that runs along the hollow transport tube.

After emplacement has been completed and it is felt that the plug is in its proper position, observable dye is again pumped into the uterus to make certain that the oviduct and the uterus have been sealed off, thereby ensuring temporary sterilization.

Accordingly, it is the primary object of the present invention to provide temporary sterilization of a female.

It is another object of the present invention to provide a means for temporary sterilization of a female without the possibility that the sterilization will terminate without the knowledge of the female.

It is a further object of the present invention to provide a means for blocking the passage of sperm into the oviduct and for blocking the passage of ova into the uterus.

It is another object of the present invention to provide a means for emplacing a means for providing temporary sterilization.

It is yet another object of the present invention to provide a method for temporarily sterilizing a female.

These and other objects of the present invention will become apparent from the following description of the accompanying drawings, in which:

FIG. 1 is a perspective view of a blocking means of the invention;

FIG. 2 is a cross-sectional view of a device for inserting the blocking means of FIG. 1;

FIG. 3 is a fragmentary elevational view of the forward section of the means of FIG. 2 in the direction of and between arrows 3 of FIG. 2;

FIG. 4 is a fragmentary elevational view of an alternate form of the means shown in FIG. 3;

FIG. 5 is a cross-sectional view of the means of FIG. 2 along the line and in the direction of arrows 5 of FIG. 2;

FIGS. 6-9 illustrate a sequence of events in the blocking means emplacement procedure.

Turning to the drawings, and in particular to FIG. 6, the present invention is directed to a means for blocking the narrowed entrance 10 into the uterus 12 from the oviduct or Fallopian Tube 14 for preventing ova from traveling from the ovary through the oviduct into the uterus and for preventing sperm within the uterus from traveling into the oviduct. The invention is also directed to a device for and a method of emplacing this means. The blocking means of the invention is readily positioned within the uterus, rather than in the outlet intramural part 14 of the oviduct, because the outlet of the oviduct, includes a narrow, tortuous pathway which is difficult to locate and block.

Turning to FIG. 1, blocking means 20 of the invention comprises a plug which includes a blocking plate 22 and a positioning plate 24.

Blocking plate 22 is slightly domed but substantially flat and is shaped and of a size so that it blocks the entrance to the uterus when plug 20 has been positioned. The blocking plate need be on the order of about 1 1/2 cm. in diameter in order to effectively block the entrance to the uterus when properly positioned.

Positioning plate 24 is relatively thick in its height dimension so that it may be occluded and squeezed flat by the carrying means of the insertion device for the plug, as described below. Plate 24 is relatively long and narrow as shown in FIG. 3. The length is sufficient so that when the positioning plate has been passed through the wall of the uterus, it will be blocked from returning through the opening in the wall. The positioning plate is narrow so that it can be inserted in to be carried by the narrow carrying means and to permit the carrying means to orient plug 20 properly for insertion at an orientation which causes blocking plate 22 to block the entrance t the uterus.

Plates 22, 24 are joined by narrow stem 26. The stem is comprised of a resilient material which can be readily stretched. The thickness of uterus walls varies, and it is intended that stem 26 may stretch to more than twice its unstretched length to compensate for the variations. The resilient stem draws the positioning and blocking plates 24, 22 toward each other, thereby holding them in position. The stem must not exert a pressure so great as to damage the uterine wall. The resilience of the stem also permits the positioning plate to be popped through the opening in the uterus wall when the plug is removed, as described below.

When plug 20 is positioned within uterus 12, as shown in FIG. 9, blocking plate 22 is canted obliquely with respect to the positioning plate 24, at an angle of about 45.degree. so that the blocking plate will completely close off entrance 10 to the uterus. The is necessitated by the curvature of the uterine wall. To provide the necessary canting as shown in FIG. 1, substantially straight stem 26 meets each of positioning and blocking plates 24, 22 at an oblique angle.

Since plug 20 stays within the body of the female, it is comprised of an inert material. Stretchable stem 26 of the plug is preferably comprised of a filled rubber material, based upon trifluoropropylmethylsiloxane units, a proprietary product marketed under the trademark "SILASTIC" by Dow-Corning Company, U.S.A. For simplicity of manufacture and for permitting occlusion of positioning plate 24, as described below, the entire plug may be formed as a unit and of the same material.

Plug 20 has a removal means, suture 32, secured to it, which hangs free in uterus 12. The suture may be secured at the end of the plug or, as shown in FIG. 2, may pass entirely through the plug for better securement thereto. When it is desired to remove plug 20, suture 32 is grasped and plug 20 is pulled until positioning plate 24 is popped through the opening in the uterus wall and the entire plug is within the uterus, from which it may be readily removed.

Turning to FIGS. 2 and 3, an insertion device 40 for inserting plug 20 in the uterus includes a tubular cannula 42, which has a narrowed forward section 43 that is supported at the forward end 43a of the main body of cannula 42. Forward section 43 is cut out at a slant 44 at its forward end and terminates in a cutting blade 45 for cutting through the wall of the uterus. The cutting blade is defined by the sharpened edge of the forward end of the cannula section 43. The cutting blade may be rounded, as illustrated, or formed into a sharpened point.

Rearward of cutting blade 45 is located a carrying means 46 for carrying positioning plate 24 of plug 20. Means 46 includes the base panel 48, which is defined by one wall of cannula forward section 43. Above and in opposed relationship to base panel 48 are supported two holding panels 50, 52, which are formed by cutting out of the walls around cannula forward section 43. Panels 50, 52 wrap around the hollow 62 of the cannula forward section 43. Because base panel 48 and holding panels 50, 52 are all part of the walls defining the forward section 43 of the cannula, the carrying means 46 of the cannula is rigid.

Respective facing edges 54, 56 of holding panels 50, 52 gradually taper toward each other and form a narrowed notch 58 which is rearward of edges 54, 56. Stem 26 of plug 20 can pass through notch 58.

For positioning plug 20 in carrying means 46, positioning plate 24 is slid and becomes trapped beneath holding panels 50, 52 and is then moved rearward, with the stem 26 moving through notch 58. The height of positioning plate 24 is such that it is occluded by holding panels 50, 52 against base panel 48 and is thereby securely gripped as insertion device 40 emplaces plug 20.

Rearward of carrying means 46 is located a means for preventing cutting blade 45 from moving too far through the opening that has been formed in the uterine wall, thereby precluding damage to the abdomen. This prevention means comprises an outwardly projecting collar 59 or similar stopper device located about 1 1/2 inches back from the tip of blade 45. Collar 59 must project far enough to block movement of knife 45 but not so far as to inhibit movement of shaft 42 through tube 72, as described below.

An alternate form of cannula is shown in FIG. 4. The features in FIG. 4 that correspond to those in FIGS. 2 and 3 are correspondingly numbered with prime (') numbers. Both forward section 43' of the alternate form of cannula and the forward segment 61 of shaft 42' are gradually curved so that the cutting blade 45' is oblique with respect to the main portion of shaft 42'. The curvature conforms to the gradual forward facing curvature of the passage through the vagina, cervix and uterus to facilitate the passage of the insertion device when that device is so oriented that the curvature of the insertion device conforms to that of the body. Both the forward section 43' and portion 61 of cannula 42' are formed of resilient material to enable them to flex to pass through below described tube 72, but are sufficiently rigid to support blade 45' and plug 20 as they are operated into position. Forward section 43' is capped by a cutting blade 45' made of metal. After cannula 42' is passed into the uterus, it is rotated so that cutting blade 45' is able to make its cut off to the side of and near the entrance into the uterus from the oviduct. The orientation of the cutting blade also permits the angle of the cut through the wall of the uterus to facilitate proper positioning of a plug 20.

Returning to FIG. 2, cannula 42 is hollow, and within hollow opening 62 is positioned rigid ejection rod 64 for plug 20. Rod 64 is of a width so as to engage and be guided by the narrowed interior walls 66 of cannula forward section 43. Rod 64 is normally retracted away from plug 20. Once positioning plate 24 has been passed through the wall of the uterus and been properly located, operator 68 of ejection rod 64 is depressed, the ejection rod moves forward into the cannula, and its forward end 69 pushes positioning plate 24 of plug 20 out from beneath hold down panels 50, 52, thereby releasing plug 20 from the cannula. The cannula may thereafter be removed without removing the plug.

An outer transport tube 72 is provided having a widened hollow opening 74 therethrough, which is wide enough so that cannula 42, or 42' and plug 20 may freely pass. Forward end 73 of tube 72 is passed through the vagina and cervix 75 and into the uterus. Tube 72 serves as a sheath over cutting blade 45 during most of the travel of the cutting blade into the body of the female, thereby preventing unnecessary damage.

On the alternate embodiment of FIG. 4, the forward portion of tube 72 is also gradually curved to conform to the curvature of the cannula passing therethrough. Tube 72 can be oriented to cooperate with the curvature of the passage into the uterus to ease its insertion. Thereafter, it can be reoriented, like the cannula within it, so that the blade 45' will be facing in the desired direction and an opening can be made where described in the uterine wall.

Along the exterior of tube 72 is a dye carrying conduit 76. Transport tube 72 and conduit 76 may be jointly formed during a single extrusion operation, as suggested in the structure of FIG. 5. Conduit 76 receives and passes along an observable dye which is transmitted through the conduit into the uterus. A conventional pump means 78 pumps dye through conduit 76, into the uterus and into the oviducts to permit observation of the entire emplacement procedure. The dye is preferably of a type that is opaque to X-rays, whereby conventional fluoroscopy apparatus 80 may be used to observe the entire procedure.

To prevent dye that is pumped into the uterus from undesirably exiting through hollow 74 between the cannula 42 and outer tube 72, a collar or washer 82 encircles the inner cannula and moves along with it as it passes through the outer tube. The dimensions of the washer are such as to effectively plug the opening between the cannula and the tube, while permitting cannula 42 to shift.

Using the apparatus just described, temporary sterilization of a female is accomplished in the following way. Positioning plate 24 of plug 20 is moved into plug carrying means 46.

Transport tube 72 is positioned. Cannula 42' is passed, cutting blade 45' first, through transport tube 72 and into the uterus as shown in FIG. 6. Observable dye is then pumped through dye carrying conduit 76 into the uterus to facilitate observation of the further procedures. Cannula 42' and transport tube 72 are rotated so that blade 45' faces toward the side (left in FIG. 6) of the uterus where plug 20 is to be positioned. Redirecting of cutting blade 45' also reorients plug 20 so that when plug positioning plate 24 has been passed through the wall of the uterus, the plug will be oriented so that its blocking plate 22 will block entrance 10 to uterus 12.

Turning to Fig. 7, cannula 42' is now moved further through the uterus until blade 45' contacts and then cuts an opening 84 through the upper wall of the uterus and into the abdominal cavity. Cannula 42' is moved further into the uterus until carrying means 46' for positioning plate 24 has passed at least part way through the opening that has been cut in the wall of the uterus. The cannula may be rotated or otherwise manipulated to ensure that blocking plate 22 is properly oriented to block entrance 10 to the uterus. During the operations upon positioning plate 24, stem 26 of plug 20 will elongate.

Now, ejection rod 64' is operated (FIG. 8) to push positioning plate 24 out from carrying means 46' so that plate 24 is above the wall of the uterus. During this entire procedure, the blocking plate remains within the uterus and is not moved through opening 84 in the wall of the uterus.

Cannula 42' is partially withdrawn through transport tube 72 (see FIG. 9), but is not fully withdrawn so that the flow blocking ability of washer 82 still can be realized. Additional dye is pumped into the uterus and its course is observed to ensure that none leaks past the blocking plate 22 of plug 20. If none leaks past, then the female has been temporarily sterilized. If any leaks past, plug 20 will have to be further manipulated until blocking plate 22 is in position to prevent any dye from passing by it.

Cannula 42' is then removed through transport tube 72, and the transport tube is thereafter removed.

When it is eventually decided to terminate the temporary sterilization, suture 32 is grasped and pulled to draw plug 20 completely into uterus 12. Then the entire plug is withdrawn from the uterus.

There has just been described a novel means for and method of temporarily sterilizing a female. Although this invention has been described with respect to the embodiments of the apparatus and method of the invention, it should be understood that many variations and modifications will now be obvious to those skilled in the art, and it is preferred, therefore, that the scope of the invention not be limited by the specific disclosure herein, but only by the appended claims.

Claims

I claim:

1. Means for blocking the entrance into the uterus from an oviduct, comprising a plug comprising,

a blocking plate of a size and shape to be positioned within the uterus near the inlet thereof from the oviduct and being of a size to block exit material from the oviduct into the uterus, and vice versa; said blocking plate being of sufficiently rigid material to maintain its position and perform its blocking function;

a positioning plate of a size and shape for being positioned outside the uterus within the abdominal cavity for holding said blocking plate in position;

a narrowed connecting stem joining said blocking and said positioning plates for enabling said positioning plate to position said blocking plate; said stem and positioning plate being adapted to be inserted from within the uterus through an artificial opening in the wall of the uterus adjacent the inlet from the oviduct, and being of dimensions such that they can pass through said opening in the wall of the uterus while said blocking plate would not as readily pass therethrough.

2. The means of claim 1 for blocking the entrance into the uterus, wherein said stem is comprised of a resilient and stretchable material, whereby when said blocking means has been positioned, said blocking plate is drawn into blocking position and said positioning plate is drawn against the exterior of the uterus.

3. The means of claim 2 for blocking the entrance into the uterus, wherein said blocking and said positioning plates are oblique to each other to facilitate the proper positioning of said blocking plate and said stem holds said plates at the oblique orientation.

4. The means of claim 2 for blocking the entrance into the uterus, further comprising a removal means secured to said plug and extensible into the uterus for being grasped and operated upon to draw said plug entirely into the uterus.

5. In combination, the means of claim 1 for blocking the entrance into the uterus, and an insertion device for inserting and positioning said plug;

said insertion device comprising,

carrying means for carrying said plug into position; and

uterus wall opening means for forming an opening in the wall of the uterus through which opening said positioning plate and said stem may be passed to position the blocking means.

6. The combination of claim 5, further comprising ejection means carried by said insertion device and adapted to be operable to release said plug from said carrying means after said carrying means has carried said plug into position in the uterus.

7. The combination of claim 6, wherein said carrying means includes support panels which engage and hold said positioning plate so that said carrying means may carry said positioning plate through the wall of the uterus to position said plug;

said ejection means comprising a rod adapted to be operated into engagement with said positioning plate to eject same from said carrying means.

8. The combination of claim 5, wherein said carrying means includes support panels which engage and hold said positioning plate so that said carrying means may carry said positioning plate through the wall of the uterus to position said plug.

9. The combination of claim 8, wherein said uterus wall opening means comprises a cutting blade;

a cannula comprising a support shaft which carries said carrying means and positions and supports said blade forward of said carrying means;

whereby as said cannula is moved through the uterus, said blade cuts the wall of the uterus and passes through same, with said carrying means carrying said positioning plate through the opening in the wall of the uterus which has been formed by said blade.

10. The combination of claim 9, wherein said support shaft is gradually curved in the vicinity of said blade to conform to the curvature of the passage into the body.

11. The combination of claim 9, wherein said stem of said plug is shaped to cause said blocking and said positioning plates to be oblique to each other to facilitate the proper positioning and blocking functions of said blocking plate when said stem passes through the wall of the uterus;

said cutting blade being arranged at an angle oblique to said support shaft therefor, so as to permit said cannula to pass straight into the uterus while also permitting said blade to cut the uterus off to the side and to be oriented to make the opening in the wall of the uterus at a desired angle to facilitate the proper positioning of said plug.

12. The combination of claim 9, further comprising ejection means supported on said shaft and movable therealong so as to be operable into engagement to release said positioning plate from said carrying means after said carrying means has carried said positioning plate into position.

13. The combination of claim 12, wherein said support panels comprise two holding panels supported on said shaft, which panels gradually taper toward each other away from said cutting blade; said holding panels being supported above a base panel which is also supported on said shaft, whereby said positioning plate can be trapped in the space between said two holding panels and in the space between said base panel and said two holding panels.

14. The combination of claim 13, wherein said shaft is hollow and said ejection means comprises a rod within the hollow in said shaft; said rod being movable through said hollow of said shaft to contact said positioning plate and push same forward and away from said support panels of said carrying means.

15. In combination, the combination of claim 12 and a hollow transport tube having an outlet, which is positioned in the uterus, having an inlet, and having an opening therethrough through which said cutting blade, said carrying means and said support shaft are passed into the uterus;

dye carrying means being connected to travel with said transport tube and directed so as to dispense dye into the uterus to permit observation of the operations being performed in the uterus.

16. The combination of claim 15, wherein said transport tube is gradually curved in the vicinity of its outlet to conform to the curvature of the passage into the body.

17. The combination of claim 15, wherein said dye transporting means comprises a conduit running along said transport tube with an exit near said outlet from said tube.

18. The combination of claim 15, wherein a fluid flow obstructing washer encircles said shaft and engages the interior of said transport tube to prevent exit of dye from the uterus through the space between said shaft and said tube.

19. A method for temporarily sterilizing a female, comprising the steps of:

positioning a blocking plate across the entrance into the uterus from the oviduct; and

securing the blocking plate in position by forming an opening through the wall of the uterus, passing a positioning plate, which is connected to the blocking plate, through the opening in the wall of the uterus and positioning the positioning plate outside the wall of the uterus.

20. The method for temporarily sterilizing of claim 19, wherein the opening is formed by cutting the wall of the uterus.

21. The method for temporarily sterilizing of claim 20, comprising the additional steps of pumping a detectable dye into the uterus before the wall of the uterus is cut so as to permit observation of the cutting of the wall of the uterus and the blocking of the entrance to the uterus; and

pumping a detectable dye into the uterus after the entrance to the uterus has been blocked to permit observation to assure that the entrance has been properly blocked.

22. The method for temporarily sterilizing of claim 21; including the steps of pumping a radiopaque dye into the uterus and observing the uterus by fluoroscopy.

23. The method for temporarily sterilizing of claim 20 including the step of mounting the positioning plate on a carrying means located on a shaft and then passing the shaft through the wall of the uterus to carry the positioning plate through the wall; and ejecting the positioning plate from the carrying means to position it outside the wall of the uterus.